healthy4u

ONC and "Health IT Patient Safety Action & Surveillance Plan": When Sociologists Uphold the Hippocratic Oath While Physicians Pay Respect to the Lords of Kobol, We Are in a Dark Place, Ethically

[Note: this essay contains many hyperlinks. They can be right-clicked and opened in a separate tab or window.] I've been meaning to write more on the just-before-Christmas, Friday afternoon, minimal-visibility release of the ONC report I'd written about in my Dec. 23, 2012 post "<a href="http://hcrenewal.blogspot.com/2012/12/oncs-christmas-confessional-on-health.html" target="_blank">ONC's Christmas Confessional on Health IT Safety: HIT Patient Safety Action & Surveillance Plan for Public Comment</a>."   (The ONC report itself is available <a href="http://www.healthit.gov/sites/default/files/safetyplanhhspubliccomment.pdf" target="_blank">at this link</a> in PDF.) The Boston Globe and Globe staff writer Chelsea Conaboy, however, have beaten me to the punch in the Jan. 3, 2013 article "Federal government releases patient safety plan for electronic health records", link below. ('<a href="http://en.wikipedia.org/wiki/Lords_of_Kobol" target="_blank">Lords of Kobol</a>', of course, is a pun.  They were fictional gods in a sci-fi series from the 1970's and a remake a few years ago, but in my circles the term is used satirically and derisively to reflect people expressing inappropriate overconfidence in - and perhaps worship of - computers.   <a href="http://en.wikipedia.org/wiki/COBOL" target="_blank">Cobol</a>, the COmmon Business-Oriented Language, is one of the oldest programming languages and was the major programming language of the merchant computing sector, including business, finance, and administrative systems for companies and governments.) First, I do want to reiterate what I'd mentioned in my earlier post:  the new ONC report is a sign of progress, in terms of a government body explicitly recognizing the social responsibilities incurred by conducting the mass human subjects experiment of national health IT.  However, I also wrote: <blockquote class="tr_bq">... [The ONC report] is still a bit weak in acknowledging the likely magnitude of under-reporting of medical errors, including HIT-related, in the available data, and the issue of risk vs. 'confirmed body counts' as I wrote at my recent post "<a href="http://hcrenewal.blogspot.com/2012/12/a-very-signifcant-additonal-observation.html" target="_blank">A Significant Additional Observation on the PA Patient Safety Authority Report -- Risk</a>". </blockquote> The Globe quoted a number of people involved the health IT debate, and I am now commenting on their Jan. 3 article: <blockquote class="tr_bq"><a href="http://www.boston.com/whitecoatnotes/2013/01/03/federal-government-releases-patient-safety-plan-for-electronic-health-records/KBqYjU4Gsup8vnx6ppgfOP/story.html?comments=all#readerComm" target="_blank">Federal government releases patient safety plan for electronic health records</a> Boston Globe</blockquote><blockquote>01/03/2013 11:16 AM    By Chelsea Conaboy, Globe Staff The federal office in charge of a massive rollout of electronic health records has issued a plan aimed at making those systems safer by encouraging providers to report problems to patient safety organizations. Though some in the field say it doesn’t go far enough, others said the plan is an important step for an office whose primary role has been cheerleader for a technology that has the potential to dramatically improve health care in the United States but that may come with significant risks.</blockquote> A major issue at the heart of the controversy is the fact that, admittedly, nobody knows the magnitude of the risks - in large part due to systematic impediments to knowing.  This has been admitted by organizations including the Joint Commission (<a href="http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html" target="_blank">link</a>), U.S. FDA (<a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">link</a>; albeit in an "internal memo" never intended for public view, and discovered only through the hard work of Center for Public Integrity investigative reporter Fred Schulte when he was at the Huffington Post Investigative Fund), Institute of Medicine of the U.S. National Academies (<a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">link</a>, quoted at midsection of post), and others.  I have made the claim that when you don't know the level of harm of an intervention in healthcare, and there are risk management-relevant case reports of dangers, you don't go gung-ho and start a national-scale implementation with penalties for non-adopters, and then decide to study safety, quality, usability etc.  You determine safety first in more controllable and constrained environments.  Anything else is, as I wrote, putting the cart before the horse (<a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html" target="_blank">link</a>). <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/AVvXsEh7nInx820f0ENnQAtyZPnEg9adrMvhxLkh-27yVmfwbjwdrm-ybDsdcNvioqVXyXGr_jquEVlg5-HtZ-d5lkfacpkRkVIgVfJbGXHB6iEAHGFAMDFmOy8xsmqHRl_de_qjAh1p2VB0fpoC/s1600/horse-cart.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="131" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh7nInx820f0ENnQAtyZPnEg9adrMvhxLkh-27yVmfwbjwdrm-ybDsdcNvioqVXyXGr_jquEVlg5-HtZ-d5lkfacpkRkVIgVfJbGXHB6iEAHGFAMDFmOy8xsmqHRl_de_qjAh1p2VB0fpoC/s200/horse-cart.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Things are a bit out of order here.</td></tr></tbody></table> You also certainly don't dismiss risk management-relevant case reports from credible observers as "anecdotal", the common refrain of hyperenthusiasts and (incompetent) scientists who conflate scientific research with risk management - as a researcher from Down Under eloquently observed in the Aug. 2011 guest post "<a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html" target="_blank">From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things</a>."  Back to the Globe: <blockquote class="tr_bq"> A year ago, the Institute of Medicine issued a report urging the federal government to do more to ensure the safety of electronic health records. It highlighted instances in which the systems were linked to patient injury, deaths, or other unsafe conditions. The report suggested creating an independent body to investigate problems with electronic records and to recommend fixes, similar to how the National Transportation Safety Board investigates aviation accidents. Instead, the Office of the National Coordinator for Health Information Technology delegated various monitoring and data collection duties to existing federal offices, including the Agency for Healthcare Research and Quality [AHRQ].</blockquote> The problem is that <a href="http://www.ahrq.gov/" target="_blank">AHRQ</a> is a research agency (as its name suggests), has no regulatory authority nor any experience in regulation, and most clinicians have never heard of it.  In effect, this ONC recommendation is lacking teeth, even compared to the relatively milquetoast recommendations of IOM itself (as I wrote about in a Nov. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">IOM Report - 'Health IT and Patient Safety: Building Safer Systems for Better Care' - Nix the FDA; Create a New Toothless Agency</a>"). <blockquote class="tr_bq">The [ONC] office has asked patient safety organizations, which work with doctors and hospitals to monitor and analyze medical errors, to add health IT to their agendas. Data from the organizations would be aggregated by the agency, but reporting by doctors and hospitals is completely voluntary.  [A prime example of what I term an extraordinary regulatory accommodation afforded the health IT industry - ed.] </blockquote> Now we're into septic shock blood pressure-level weakness. Here is PA Patient Safety Authority Board Member Cliff Rieders, Esq. on mandatory, let alone voluntary reporting. From “Hospitals Are Not Reporting Errors as Required by Law", Philadelphia Inquirer, pg. 4, <a href="http://articles.philly.com/2008-09-12/news/24991423_1_report-medical-mistakes-new-jersey-hospital-association-medication-safety" rel="nofollow" target="_blank">http://articles.philly.com/2008-09-12/news/24991423_1_report-medical-mistakes-new-jersey-hospital-association-medication-safety:</a>    <blockquote class="tr_bq">... Hospitals don’t report serious events if patients have been warned of the possibility of them in consent forms, said Clifford Rieders, a trial lawyer and member of the Patient Safety Authority’s board. He said he thought one reason many hospitals don’t want to report serious events is that the law also requires that patients be informed in writing within a week of such problems. So, if a hospital doesn’t report a problem, it doesn’t have to send the patient that letter. [Thus reducing risk of litigation, and, incidentally, potentially infringing on patients' rights to legal recourse - ed.] Rieders says the agency has allowed hospitals to determine for themselves what constitutes a serious event and the agency has failed to come up with a solid definition in six years. Fixing this “is not a priority,” he added.</blockquote> To expect hospitals to voluntarily report even a relevant fraction of mistakes and near-misses out of pure altruism, or permit their clinicians to do so, with the inherent risks to organizational interests such reporting entails, is risible. The near-lack of reporting by most health IT sellers and hospitals in the already-existing FDA Manufacturer and User Facility Device Experience (MAUDE) database is substantial confirmation of that; the fraction of reports in MAUDE, however, are hair-raising.  See my Jan. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html" target="_blank">MAUDE and HIT Risks: What in God's Name is Going on Here</a>?" for more on that issue. Here's an example of what happens to 'whistleblowers', even those responsible for system development and safety: "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=lawsuit" target="_blank">A Lawsuit Over Healthcare IT Whistleblowing and Wrongful Discharge</a>." ONC's recommendations thus in my opinion reflect bureaucratic window dressing, designed to create progress - but progress that can probably be measured in microns. <blockquote class="tr_bq">“There was no evidence that a mandatory program was necessary,” Jodi Daniel, the [ONC] office’s director of policy and planning, said in an interview.</blockquote> Really?  See the aforementioned Philadelphia Inquirer article “Hospitals Are Not Reporting Errors as Required by Law", as well as numerous articles on pharma and medical device industry reporting deficits such as starting at page 5 in my paper "A Medical Informatics Grand Challenge: the EMR and Post-Marketing Drug Surveillance" <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Silverstein_Drug_Surveillance.pdf" target="_blank">at this link</a> in PDF. There is no evidence mandatory reporting is necessary ... to someone who's either naïve, incompetent - or persuaded, e.g. with money, to not find evidence or rationale. <blockquote class="tr_bq"> The [ONC] office has been under pressure to roll out the electronic health records systems quickly while protecting patient data and making sure that the systems don’t cause problems in medical care, said Dr. John Halamka, chief information officer at Beth Israel Deaconess Medical Center. </blockquote> Under pressure by the health IT lobby, perhaps; but nobody else that I can think of. <blockquote class="tr_bq">“It’s this challenging chicken-and-egg problem,” he said. </blockquote> No, actually, it isn't.  Patient safety must come first. This becomes clear when one considers the late 5th century BC ethical principle <a href="http://en.wikipedia.org/wiki/Primum_non_nocere" target="_blank">Primum non nocere</a> ("first, do no harm" or "abstain from doing harm") versus the late 20th and early 21st century IT-hyperenthusiast credo I've expressed as "<a href="http://hcrenewal.blogspot.com/2011/10/cybernetik-uber-alles-computers-have.html" target="_blank">Cybernetik Über Alles</a>"  ("Computers above all"). Under CÜA, the computer has more rights than the patients, and the IT industry receives extraordinary regulatory accommodation to sloppy practices that no other healthcare or mission-critical non-healthcare sector enjoys. I sent Dr. Halamka a set of arguments such as I make here, and a picture of a health IT 'chicken', my deceased mother in her death robes. I received back a "thank you for the views" message - but no condolences.  (It occurs that I have rarely if ever received condolences from any senior HIT-hyperenthusiast Medical Informatics academic or government official to whom I've mentioned my mother.  Not to play amateur psychologist, but I believe it reflects the level of disdain or even hatred felt by these people towards health IT iconoclasts/patient's rights advocates.) <blockquote class="tr_bq">The plan, which is subject to public comment through Feb. 4, “is a reasonable start,” in part because it puts more pressure on hospitals and doctors to monitor safety, Halamka said. </blockquote> As I expressed to Dr. Halamka, we are in agreement on that point. <blockquote class="tr_bq"> The government would have risked stifling innovation in the industry if it had opted instead to require the kinds of tests and review by the Food and Drug Administration that new medical devices and drugs must go through, he said.</blockquote> To that, I mention here (as I did in my email to him) my response to this industry meme, as I had expressed it at Q&A after my August 2012 <a href="http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html" target="_blank">keynote address to the Health Informatics Society of Australia</a>: <blockquote class="tr_bq">... I had a question from the audience [after my talk], from fellow blogger <a href="http://thehealthcareblog.com/blog/category/matthew-holt/" target="_blank">Matthew Holt of the Health Care Blog</a>.  (I've had some online debate with him before, such as in the comment thread at my April 2012 post <a href="http://hcrenewal.blogspot.com/2012/04/allscripts-shares-plunge-on-weak.html" target="_blank">here</a>.) Matthew asked me a somewhat hostile question (perhaps in retaliation for the thrashing he received at the end of my May 2009 post on the WaPo's HIT Lobby article <a href="http://hcrenewal.blogspot.com/2009/05/machinery-behind-healthcare-reform-how.html" target="_blank">here</a>), that I was well prepared for, expecting a question along these lines from the seller community, actually.  The question was preceded by a bit of a soliloquy of the "You're trying to stop innovation through regulation" type, with a tad of Merck/VIOXX ad hominem thrown in (I ran Merck Research Labs' Biomedical libraries and IT group in 2000-2003). His question was along the lines of - you were at Merck; VIOXX was bad; health IT allowed discovery of the VIOXX problem by Kaiser several years before anyone else; you're trying to halt IT innovation via demanding regulation of the technology thus harming such capabilities and other innovations. The audience was visibly unsettled.  Someone even hollered out their disapproval of the question. My response was along the lines that: <ul><li>VIOXX was certainly not Merck at its best, but regulation didn't stop Merck from "revolutionizing" asthma and osteoporosis via Singulair and Fosamax;</li><li>That I'm certainly not against innovation; I'm highly pro-innovation;</li><li>That our definitions of "innovation" in medicine might differ, in that innovation without adherence to medical ethics is not really innovation.  It is exploitation.</li></ul></blockquote> I stand by that assessment. More from the Globe article: <blockquote class="tr_bq">There is little good research into how the systems improve health care and there are big obstacles to fixing even the known problems, said Ross Koppel, a professor of sociology at the University of Pennsylvania who studies hospital culture and medication errors. Some developers require providers to sign nondisclosure agreements before using their systems, and the safety plan does not prohibit such gag clauses.  [Note: I wrote on this issue <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda" target="_blank">here</a>, and in a published July 2009 JAMA letter to the editor "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" <a href="http://jama.jamanetwork.com/article.aspx?articleid=184302" target="_blank">here</a> - ed.]  While the plan addresses reporting of known problems, Koppel said it will not help researchers and developers understand problems that go unnoticed but that may be causing real patient harm.  “We only know the tip of the iceberg” about how electronic health records affect patient care, said Koppel, who was an official reviewer for the Institute of Medicine report. </blockquote>As per the title of this blog post, we are in a dark place, ethically, when a PhD sociologist who's never taken the Oath of Hippocrates (to my knowledge) appears to express more concern for patient safety and patient's rights than a Harvard physician-informatics Key Opinion Leader such as Dr. Halamka. <blockquote class="tr_bq">Koppel said the mantra of the Office of the National Coordinator has been that more health IT leads to better health care. “It probably is better than paper,” he said, “but it could be so much better than it is.”</blockquote> I agree, but with caveats.  I opine that bad health IT is likely worse for patients than a good, well-staffed paper based system.  For instance, the former can cause systematic dangers that even a bad paper system cannot, such as tens of thousands of prescription errors (see my Nov, 2011 post "<a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html" target="_blank">Lifespan Rhode Island: Yet another health IT 'glitch' affecting thousands - that, of course, caused no patient harm that they know of - yet</a>") or mass privacy breaches (see the current 30 or so posts on that issue at this blog query link: <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy" target="_blank">http://hcrenewal.blogspot.com/search/label/medical record privacy</a>). On good health IT and bad health IT from my teaching site "Contemporary Issues in Medical Informatics: Good Health IT, Bad Health IT, and Common Examples of Healthcare IT Difficulties" at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/</a>: <blockquote class="tr_bq"> Good Health IT ("GHIT") is IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealthinformation secure, protects patient privacy and facilitates better practice of medicine and better outcomes.  Bad Health IT ("BHIT") is IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.  </blockquote> The Boston Globe article concludes: <blockquote class="tr_bq">Ashish Jha, associate professor of health policy at Harvard School of Public Health and a member of the panel that drafted the Institute of Medicine report, said he wants doctors to be able to report problems -- errors in medication lists, for example -- in real-time so they can be found and fixed quickly. The safety plan does not require systems to have that capability, but Daniel said her office could soon add such a requirement for products that receive federal certification. The bigger problem is that health care as a whole needs a better way of tracking patient safety, Jha said. Monitoring issues caused by electronic health records “should be a part of it, and then we can actually know if this is a small, medium or large contributor to patient safety issues,” he said. “But we don’t know that.”</blockquote> I agree with Dr. Jha, but the IT sellers and healthcare organizations will (legitimately) claim that adding real-time error reporting/forwarding to their products will be extremely resource-intensive. I have an alternate approach that will require little effort on the part of the sellers and user organizations. <ul><li>Post a message at the sign-in screen of all health IT along the lines that "This technology is experimental, adopted willingly by [organization] although not rigorously vetted for safety, reliability, usability, nor fitness for purpose, and thus you use it at your own risk.  If problems occur, report them to the following" ...</li></ul> "The following" could include a list of alternatives such as I wrote in my Aug. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/08/clinicians-how-to-document-ehr-screens.html" target="_blank">Clinicians: How to Document the EHR Screens You Encounter That Cause Concern</a>." <div class="date-posts"><div class="post-outer"><div class="post hentry" itemprop="blogPost" itemscope="itemscope" itemtype="http://schema.org/BlogPosting"><a href="http://www.blogger.com/blogger.g?blogID=9551150" name="613349029890366576"></a> <div class="post-body entry-content" id="post-body-613349029890366576" itemprop="description articleBody"><blockquote class="tr_bq">... When a physician or other clinician observes health IT problems, defects, malfunctions, <a href="http://www.tinyurl.com/hostileuserexper">mission hostility</a> (e.g., poor user interfaces), significant downtimes, lost data, erroneous data, misidentified data, and so forth ... and most certainly, patient 'close calls' or actual injuries ... they should (anonymously if necessary if in a hostile management setting): <ul><li>Inform their facility's senior management, if deemed safe and not likely to result in retaliation such as being slandered as a "<a href="http://www.jpands.org/vol9no3/huntoon.pdf">disruptive physician</a>" and/or or being subjected to sham peer review (<a href="http://www.aapsonline.org/index.php/article/sham_peer_review_resources_physicians/">link</a>).</li></ul><ul><li>Inform their personal and organizational insurance carriers, in writing. Insurance carriers do not enjoy paying out for preventable IT-related medical mistakes. They have begun to become aware of HIT risks. See, for example, the essay on Norcal Mutual Insurance Company's newsletter on HIT risks<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=norcal"> at this link</a>. (Note - many medical malpractice insurance policies can be interpreted as requiring this reporting, observed occasional guest blogger <a href="http://hcrenewal.blogspot.com/search/label/Dr.%20Scott%20Monteith">Dr. Scott Monteith</a> in a comment to me about this post.)</li></ul><ul><li>Inform the Joint Commission (or similar national accreditor of hospital safety if not in the U.S.) via their complaint site at <a href="http://www.jointcommission.org/report_a_complaint.aspx">http://www.jointcommission.org/report_a_complaint.aspx</a> . Also consider writing the JC senior officers (<a href="http://www.jointcommission.org/about_us/joint_commission_officers.aspx">link to officer's list</a>), whose awareness of HIT issues I can personally attest to via our correspondences.</li></ul><ul><li>Inform the FDA (or similar healthcare regulator if not in the U.S.) via the FDA Medwatch Form 3500 reporting site at <a href="https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm">https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm</a>. An example of such an adverse event report I filed myself (when the involved hospital refused) is <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1729552">at this link</a> in the FDA MAUDE (Manufacturer and User Facility Device Experience) database.</li></ul><ul><li>Inform the State Medical Society and local Medical Society of your locale.</li></ul><ul><li>Inform the appropriate Board of Health for your locale.</li></ul><ul><li>If applicable (and it often is), inform the Medicare Quality Improvement Organization (QIO) of your state or region. Example: in Pennsylvania, the QIO is "<a href="http://www.qipa.org/Home.aspx">Quality Insights of PA</a>."</li></ul><ul><li>Inform a personal attorney.</li></ul><ul><li>Inform local, state and national representatives such as congressional representatives. Sen. Grassley of Iowa is aware of these issues, for example.</li></ul> </blockquote></div><div class="post-body entry-content" id="post-body-613349029890366576" itemprop="description articleBody">See the actual post for an idea about clinicians seeking indemnification when forced by healthcare organizations to use bad health IT.  I can attest to actually seeing HIT policies that call for "human resources actions" if clinicians refuse to use HIT, or cannot learn to use it at a sufficient pace. (Left out of this reiteration is the demonstration on photographing problematic EHR screens.  See the post for the details - it is easy to do, even with a commodity cellphone.) HHS should be promoting laws on protection from retaliation upon clinicians reporting problems in good faith. Thus, physicians, nurses and other clinicians can create needed health IT transparency and help our society discover the true level of risks of bad health IT.  They simply need the right information on what to do and where to report, bypassing the ONC office and, in the spirit of medicine, taking such matters into their own hands in the interests of patient care and medical ethics. I also made recommendations to the Pennsylvania Patient Safety Authority on how known taxonomies of health IT-related medical error can be used, and need to be used, to promote error reporting in common formats.  Slides from my presentation to the Authority entitled "Asking the Right Questions:  Using Known HIT Safety Issues to Improve Risk Reporting and Analysis", given in July 2012 at their invitation, are at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/PA_patient_safety_Jul2012.ppt" rel="nofollow" target="_blank">http://www.ischool.drexel.edu/faculty/ssilverstein/PA_patient_safety_Jul2012.ppt</a> Finally, another sign of progress:  unlike the HITECH Act, this new ONC plan is open to public comment. -- SS Addendum Jan. 8., 2012: Dr. Halamka has put more details regarding his views in his blog.  The entry is entitled "Electronic Health Record Safety" at this link:  <a href="http://geekdoctor.blogspot.com/2013/01/electronic-health-record-safety.html">http://geekdoctor.blogspot.com/2013/01/electronic-health-record-safety.html .</a> He writes: <blockquote class="tr_bq">... Some have questioned the wisdom of moving forward with EHRs before we are confident that they are 100% safe and secure.   [That, of course, is not my argument - nothing is ever 100% safe and secure.  However, we don't yet know just how safe and secure - or unsafe and insecure - HIT is.  That is the issue I am concerned about - ed.] I believe we need to continue our current implementation efforts. I realize it is a controversial statement for me to make, but let me use an analogy. When cars were first invented, seat belts, air bags, and anti-lock brakes did not exist.    Manufacturers tried to create very functional cars, learned from experience how to make them better, then innovated to create new safety technologies. many of which are now required by regulation. Writing regulation to require seat belts depended on experience with early cars. My grandmother was killed by a medication error caused by lack of an EHR.  My mother was incapacitated by medication issues resulting from lack of health information exchange between professionals and hospitals.   My wife experienced disconnected cancer care because of the lack of incentives to share information.     Meaningful Use Stage 2 requires the functionality in EHRs which could have prevented all three events.</blockquote> I express my condolences on those events. I disagree, however, with continuing national implementation efforts at the current rate, with penalties for non-adopters.  I opine from the perspective of believing health IT has not reached a stage where it is ready for national rollout and remains experimental, its magnitude of harms admittedly unknown and information flows systematically impaired.  I recommend and prefer great caution under those circumstances, and remediation of those circumstances before full-bore national implementation. I will leave it to the reader ponder the two views. -- SS</div></div></div></div>

ONC and "Health IT Patient Safety Action & Surveillance Plan": When Sociologists Uphold the Hippocratic Oath While Physicians Pay Respect to the Lords of Kobol, We Are in a Dark Place, Ethically

[Note: this essay contains many hyperlinks. They can be right-clicked and opened in a separate tab or window.] I've been meaning to wr...

Đọc thêm »

BLOGSCAN - When Private Equity Owns Hospitals

On his Not Running a Hospital blog, Paul Levy <a href="http://www.runningahospital.blogspot.co.il/2013/01/beyond-guns-and-gurneys.html">discussed</a> reasons for concern when private equity firms purchase and operate hospitals.  He used the example of<a href="http://hcrenewal.blogspot.com/search/label/Steward%20Health%20Care"> Steward Health Care,</a> now a for-profit hospital system (which also employs physicians to provide direct patient care), which in turn is owned by <a href="http://hcrenewal.blogspot.com/search/label/Cerberus">Cerberus Capital Management</a>.   The issue is pertinent due to recent discussion in the media about Cerberus' newly stated intention to sell the large firearms and ammunition business it assembled, Freedom Group.  This intention was only stated after the tragic multiple murders of children and teachers by gunfire from a weapon manufactured by Freedom Group at a Connecticut elementary school.  We have previously posted about questions raised when private equity buys hospitals and employs physicians, specifically about <a href="http://hcrenewal.blogspot.com/search/label/Cerberus">Cerberus</a> and <a href="http://hcrenewal.blogspot.com/search/label/Steward%20Health%20Care">Steward Health Care</a>, and have questioned whether a private equity group is a suitable owner and operator of hospitals and physicians' practices when said private equity group also owns a large firearms and ammunition business, and, for that matter, a military contracting company which has been accused or providing "mercenaries" (look <a href="http://hcrenewal.blogspot.com/2012/08/private-equity-obfuscatory-advertising.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/05/continuing-parade-of-legal-settlements.html">here</a>).

BLOGSCAN - When Private Equity Owns Hospitals

On his Not Running a Hospital blog, Paul Levy discussed reasons for concern when private equity firms purchase and operate hospitals. He u...

Đọc thêm »

Oh, the Prices we Pay ... for Questionable Drug Marketing to Enrich Corporate Insiders - the Case of Questcor's H P Acthar Revisited

In 2007, we first <a href="http://hcrenewal.blogspot.com/2007/10/once-again-oh-prices-we-pay-acthar-for.html">discussed</a> the case of the amazing pricing of H P Acthar, a very old drug of questionable usefulness, as an example of the irrationality of health care prices in the US, and of the failure of the organizations that ought to resist outrageous pricing in our mixed, pseudo-market based health care system to do so.  A recent New York Times <a href="http://www.nytimes.com/2012/12/30/business/questcor-finds-profit-for-acthar-drug-at-28000-a-vial.html">article</a> has updated this case. Background As we wrote in 2007, ACTH (adrenocorticotrophic hormone) is a naturally occurring hormone that stimulates the activity of the adrenal gland, which produces cortisol and other glucocorticoid and mineralocorticoid hormones.   ACTH produced from pigs' adrenals was first marketed as a biologic agent in the 1940s.  It was used for some conditions that appear to benefit from the effects of increasing cortisol production induced by ACTH. It has been traditionally used to treat infantile spasms, a rare but distressing condition, and exacerbations of multiple sclerosis (MS).  However, since the drug was introduced so long ago, it was never subject to rigorous controlled trials to assess its efficacy and adverse effects for these indications.  Furthermore, since the 1940s, synthetic glucocorticoid hormones have become widely available as generic drugs.  Yet these slightly newer drugs have never been rigorously compared to ACTH for infantile spasms or MS.  The most recent review (edited in 2009) by the Cochrane Collaboration found that steroids and ACTH have some evidence in their favor for the treatment of acute MS, but found no evidence showing that ACTH was superior.  [Filippini G, Brusaferri F, Sibley WA, Citterio A, Ciucci G, Midgard R, Candelise L. Corticosteroids or ACTH for acute exacerbations in multiple sclerosis. Cochrane Database of Systematic Reviews 2000, Issue 4. Art. No.: CD001331. DOI: 10.1002/14651858.CD001331].  Also, the most recent review (edited in 2009) of treatment of infantile spasms concluded, "it is not clear which treatment [including ACTH] is optimal." [Hancock ED, Osborne JP, Edwards SW. Treatment of infantile spasms.  Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No. : CD001770. DOI: 10.1002/14541858.CD001700.pub2.] The Pricing of H P Acthar Possibly because some physicians thought ACTH might be useful for some patients with two conditions, infantile spasms and acute exacerbations of MS, ACTH has remained on the market.  It was manufactured by a single company, Aventis, (now part of Sanofi-Aventis), the successor to Rhone-Poulenc-Rorer.  In 2001, Aventis sold the rights to manufacture ACTH, with the trade name H P Acthar, to a new, small biotechnology company, Questcor.  In 2007, Questcor raised the price of ACTH from $1650 per vial to more $23,000 per vial.  That got <a href="http://www.philly.com/philly/business/20071002_Drugs_price_up_more_than__21_000.html">the attention</a> of the Philadelphia Inquirer, on whose article we based <a href="http://hcrenewal.blogspot.com/2007/10/once-again-oh-prices-we-pay-acthar-for.html">our commentary.</a> We used the price increase as an example of how pricing in health care has become untethered from any sort of clinical reality, and wondered why insurance companies and the US government seemed willing to pay this outrageous price for an old drug with little evidence from clinical research to support its use.  But the issue then seemed, like many others we have discussed , to become anechoic, until the very end of 2012. Now the  <a href="http://www.nytimes.com/2012/12/30/business/questcor-finds-profit-for-acthar-drug-at-28000-a-vial.html">New York Times story</a> has provided an example of how health care corporations can do very well without doing anyone, except corporate insiders, much good.  It included instances of many of the kinds of ethically questionable practices we have discussed over the years on<a href="http://hcrenewal.blogspot.com/"> Health Care Renewal</a>. Deceptive Marketing Per the NY Times, <blockquote class="tr_bq">Questcor did almost no research or development to bring Acthar to market, merely buying the rights to the drug from its previous owner for $100,000 in 2001. And while the manufacturing of Acthar is complex, it accounts for only about 1 cent of every dollar that Questcor charges for the drug. <div itemprop="articleBody">Moreover, the tiny 'orphan' market soon became much bigger. Before long, Questcor began marketing the drug fo multiple sclerosis, nephrotic syndrome and rheumatologic conditions, even though there is little evidence that Acthar is more effective for those other conditions than alternatives that are far cheaper. And the company did so without being required to prove that the drug actually works. That is because Acthar was approved for use in 1952, before the Food and Drug Administration required clinical trials to show a drug is effective for a particular disease. Acthar is essentially grandfathered in. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Today, only about 10 percent of the drug’s sales are for infantile spasms. The new uses, Mr. Bailey has told analysts, represent multibillion-dollar opportunities for Acthar and Questcor, its sole maker. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">The results have been beyond even the company’s wildest dreams. Sales of Acthar, which accounts for essentially all of Questcor’s sales, totaled nearly $350 million in the first nine months this year, up 145 percent from the period a year earlier. In the same period, Questcor’s earnings per share nearly tripled, to $2.12. In the five years after the big Acthar price increase in August 2007, Questcor shares rose from around 60 cents to about $50, in one of the best performances of any stock in any industry. </div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">So Questcor leadership was clever enough to use loopholes in the law to promote ACTH for particular kinds of patients without any good evidence that it did those patients any good.  Furthermore, Questcor used several questionable tactics  </div>in this promotion. <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">Manipulated Research</a> Apparently Questcor leaders decided they needed some sort of minimal research results to promote their products, so as the Times reported, <blockquote class="tr_bq"><div itemprop="articleBody">Because Acthar was approved for these conditions decades ago, Questcor has not had to do large clinical trials to show that the drug works. It has paid for some small studies, mainly by individual doctors, who then publish a paper that the sales force can present to doctors. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">The study that justified calling on rheumatologists involved five patients with rare conditions, all of them treated by a single doctor. All the patients had much improvement on Acthar after failing to benefit from more standard therapies, the doctor, Todd Levine, said in a Questcor conference call. </div></blockquote> Too call the research Questcor sponsored minimalist would be too polite.  A case series of five patients, lacking any control group proves almost nothing.  It proves less when the research is done in an unblinded  fashion by a single doctor who presumably was invested in the outcome being favorable for his sponsor's product.  (I suppose some might quibble with calling this research manipulated, but I contend but doing such crude research when it would be possible to do something much more credible amounts to manipulation.) <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">Suppression of Research</a> Moreover, it seems that even such rudimentary studies sometimes failed to produce the wanted results.  In these cases, the Times reported that Questcor simply suppressed them. <blockquote class="tr_bq"><div itemprop="articleBody">Still, it appears that at least a couple of small studies that may have raised questions about the drug have been suspended. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">'From my standpoint it just didn’t work,' said Dr. Sungchun Lee, a Phoenix nephrologist who stopped a small study testing Acthar as a treatment for nephrotic syndrome. 'I think they were O.K. with me stopping because we weren’t getting the results,' he said. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Another study that was terminated sought to determine whether multiple sclerosis patients who did not have a good response to steroids should be treated with either another round of steroids or with Acthar. The study was halted midway through 'to analyze data,' according to the summary of the trial on the federal clinical trial database. </div></blockquote><div itemprop="articleBody"></div><div itemprop="articleBody"> <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">Use of Paid Key Opinion Leaders</a> Despite the lack of good clinical evidence in support ACTH, there are some physicians who defend its use.  One example in the Times article was a physician who is paid by Questcor <blockquote class="tr_bq"><div itemprop="articleBody">But some doctors say Acthar can be effective in cases that are not well treated by steroids. They say that there is emerging evidence that Acthar does more than just stimulate the body to produce its own steroids. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">'It really looks like the ACTH does bring something different to the table that standard steroids don’t,' said Dr Ben W Thrower, director of the multiple sclerosis institute at the Shepherd Center, a hospital in Atlanta. Dr. Thrower, who is a paid speaker for Questcor, said his institute had tried Acthar for about 60 of its 3,000 patients, ones who did not respond to steroid treatment. Acthar made the symptoms subside in about half of them. </div></blockquote></div><div itemprop="articleBody">Where to begin?  Just because ACTH is different does not mean it is better.  Since MS is a disease whose symptoms wax and wane, patients who fail standard treatment may get better on their own, and without a control group, it is impossible to say whether the ACTH given to such patients was the reason they got better.  </div><div itemprop="articleBody">Creation of <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">Institutional Conflicts of Interest</a> for Disease Specific Foundations Questcor's ACTH also has support from a disease specific foundation, but one that Questcor has also supported financially. <blockquote class="tr_bq"><div itemprop="articleBody">Dr Lawrence Brown, a neurologist at the Children's Hospital of Philadelphia, and the president of the Child Neurology Foundation<a href="http://www.childneurologyfoundation.org/" title="The foundation’s Web site.">,</a> says of Questcor: 'They have gone out of their way to help every kid who needs the medicine to get it quickly and efficiently.'</div><div itemprop="articleBody"> </div><div itemprop="articleBody">This year, the foundation awarded its first corporate citizenship award to Questcor. Dr. Brown says Questcor’s donations — the amount has not been disclosed — to the foundation didn’t influence the award. </div></blockquote></div><div itemprop="articleBody"></div><div itemprop="articleBody"> Who could be so naive to think that giving an organization funding might influence its actions?  After all, human response to financial incentives is the basis for most current economic thinking. Insiders Get Rich Admittedly, these questionable tactics did lead to an increase in "shareholder value,"  As the <a href="http://files.shareholder.com/downloads/ABEA-2S424C/2250593841x0xS1193125-12-143634/891288/filing.pdf">company's proxy statement </a>boasted in 2011, <blockquote class="tr_bq">While we generated strong financial returns in 2011, we are most proud of our patient focus and investments in Questcor which we believe will generate sustainable value to our shareholders, employees, patients and all of the communities that we serve. We believe that our patient focus and commitment to generating sustainable value to all of our constituencies results in strong value creation for our shareholders.</blockquote> However, as of today, Qustcor's share price has dropped to $26.74 from a peak of 53.42 in June, 2012, with most of the drop in December, 2012, around the time the Times article came out, <a href="https://www.google.com/finance?hl=en&gl=us&q=questcor&um=1&ie=UTF-8&sa=N&tab=ne">according to Google Finance</a>.  So whether share holder value will turn out to have increased in the long run is not clear.  Meanwhile, some Questcor employees did very well.  The largess started with some drug representatives, <blockquote class="tr_bq">Questcor sales representatives who are lucky enough or skillful enough to have a big prescriber in their territory can reap bonuses of $50,000 a quarter, according to former employees of the company. </blockquote></div><div itemprop="articleBody"> More highly placed corporate insiders did even better. <blockquote class="tr_bq">Executives are paid well, too. In 2009, Mr. Bailey, [the CEO]  hired his daughter Kirsten Fereday as director of business analytics and evaluation, a job that paid $275,000 in cash and stock last year. </blockquote>  Left out of the Times article, somewhat surprisingly, was what the top executives make.  Information from up to 2011 is publicly available, however, in proxy fillings. In the company's <a href="http://files.shareholder.com/downloads/ABEA-2S424C/2250593841x0xS1193125-12-143634/891288/filing.pdf">2012 proxy statement</a>, we find the following figures for total compensation: Don M Bailey, President and CEO - $4,546,230, up 192% of his compensation in $1,554,503 in 2009 Michael H Mulroy, Senior Vice President, Chief Financial Officer and General Counsel -  $1,749,891 (his first year) Stephen L Cartt, Chief Operating Officer -  $2,298,308, up 168% from $855,460 in 2009 David J Medeiros, Executive Vice President and Chief Technical Officer - $1,232,556, up 78% from $692,188 in 2009 David Young Pharm D, Chief Scientific Officer - $1,948,804 up 182% from $1,066,159 in 2009 In addition, by 2011, Mr Bailey, the CEO, had acquired 1.92% of the company's total stock, 3,834,910 shares, today worth $102,545,490. </div><div itemprop="articleBody"> Finally, per the Times, <blockquote class="tr_bq">one group of shareholders has done pretty well for itself. Over the last two years, as the company’s share price mainly soared, Questcor insiders have sold more than $100 million of stock. </blockquote> Summary  So, in summary, a small biotechnology company drastically increased the price of its only product, a drug which has never been subject to modern clinical trials, and whose efficacy has never been proven.  Its marketing tactics have included manipulation and suppression of research, and payments to physicians and non-profit organizations.  Although its most breathtaking price increases were made in 2007, they attracted little public attention until five years later.   Meanwhile, corporate insiders, from drug representatives to top executives and their relatives, have done very well for themselves. In the US, there a lot of people who advocate free market based health care for its efficiency and innovation.  For example, see "<a href="http://www.cato.org/sites/cato.org/files/pubs/pdf/pa650.pdf">Yes, Mr President, a Free Market Can Fix Health Care,</a>" published by the Cato Institute, in which its Director of Health Policy Studies proclaimed, "The great advantage of a free market is that innovation and more prudent decisionmaking means that fewer patients will fall through the cracks," and then "a free market can and would control costs, expand choice, improve health care quality, and make health coverage more secure." [italics added for emphasis] Unfortunately, the case of Questcor's ACTH makes it seem that in the current US system, which is supposedly more market based than systems in many other countries, the efficiency and innovation is characteristic of the marketing of corporate health care, not of the health care itself.  Here is a stellar example of how clever, and not always very scrupulous marketing can be used to sell a very old drug with little demonstrated clinical value for a stratospheric price, enriching corporate insiders, perhaps enriching stockholders (although, not so much lately, and we will see how they do in 2013), at the expense of the public who pays taxes and insurance premium.  This case suggests a need for more attention to market failures and less insistence on market fundamentalism.  Of course, it also suggests the continuing need for health care professionals, policy makers, patients and the public to be extremely skeptical about heavily promoted commercial health products.</div><div itemprop="articleBody"> </div>

Oh, the Prices we Pay ... for Questionable Drug Marketing to Enrich Corporate Insiders - the Case of Questcor's H P Acthar Revisited

In 2007, we first discussed the case of the amazing pricing of H P Acthar, a very old drug of questionable usefulness, as an example of the...

Đọc thêm »

Question for the New Year: Why is There Next to No Reaction to the Gilded Age of Health Care?

For the New Year, it is time to ponder- why is there still no organized outrage over the ongoing <a href="http://hcrenewal.blogspot.com/search/label/ill-informed%20management">incompetent</a>, <a href="http://hcrenewal.blogspot.com/search/label/mission-hostile%20management">uncaring</a>, <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">self-interested</a>, <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicted</a>, and often outright <a href="http://hcrenewal.blogspot.com/search/label/crime">corrupt</a> leadership of health care organizations we have documented incessantly on Health Care Renewal? For example, just a few days ago, we <a href="http://hcrenewal.blogspot.com/2012/12/tis-season-for-legal-settlements.html">documented</a> a series of cases in which large US and multinational health care organizations settled cases alleging they deceptively marketed drugs so as to exaggerate their benefits and conceal their harms, bribed doctors and officials  outside of the US, gave kickbacks to US doctors, defrauded the US government, and monopolized markets for drugs, yet few leaders, and no top leaders of the companies involved suffered any negative consequences for authorizing, directing, or implementing these activities.  We have discussed many previous <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> involving similar bad behavior and similar impunity by the leaders of the organizations involved.   Again and again we have discussed how large organizations, often but not always drug, biotechnology and device companies, have manipulated the scientific literature (e.g., see examples of <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation of clinical research</a>, <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of clinical research,</a> and specific practices such as <a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing">ghost-writing</a> of apparently scholarly articles to benefit vested interests.)   We have discussed <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">overblown compensation</a> that made top managers and other organizational insiders rich without any rationale other than their ability to take such money off the top.  Yet in the US, despite ever rising costs presumably provoked by such leadership, without corresponding improvements in quality or access, there is still no organized movement for change. The problems in US health care, however, seem to parallel problems in the larger society, and the world at large.  We have discussed parallels with bad leadership of <a href="http://hcrenewal.blogspot.com/search/label/finance">financial firms</a>, including the firms that drove us into the global financial collapse/ great recession, and to continuing income stagnation, recession, austerity, and decreasing opportunity for the poor and middle class around the world. Yet parallel questions are just beginning to be asked about larger related political economic problems.  Recently, historian Brad DeLong attempted to address the question, "why next to no reaction to the second gilded age?"  (See <a href="http://delong.typepad.com/sdj/2012/12/brad-delong-why-next-to-no-political-reaction-to-the-second-gilded-age.html">this</a>.).  Unfortunately, while he could demonstrate two powerful political movements that opposed the first Gilded Age, he was completely at a loss to explain why there has been no similar organized outrage about the second Gilded Age in which we exist today.  Despite incompetent, uncaring, self-interested, conflicted, and often outright corrupt leadership of many large corporations, non-profit organizations, and government agencies only a few voices, often bloggers like us, have objected. Economist Mark Thoma then took up the question, but the best he could do was suggest that outrage has been moderated because of the existing, if frayed, social safety net, and because many people nonetheless saw the last two decades as a time of increasing economic opportunity. (See <a href="http://economistsview.typepad.com/economistsview/2012/12/why-next-to-no-political-reaction-to-the-second-gilded-age.html">this</a>. )   He did not address how this view may have been wrong, since the last two decades were a time of obviously worsening income inequality. Yves Smith of Naked Capitalism finally offered some insight (see <a href="http://www.nakedcapitalism.com/2012/12/links-123012.html">this</a>) by noting the importance of "propaganda," corresponding, I think, to the widespread deceptive <a href="http://hcrenewal.blogspot.com/search/label/marketing">marketing</a> and <a href="http://hcrenewal.blogspot.com/search/label/public%20relations">public relations</a>, and the use of covertly paid <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">key opinion leaders </a>to further both that we frequently discuss.  Finally she suggested that people feel powerless because they see themselves as "atomized individuals," even though they many are currently being treated as interchangeable parts by the leaders of large organizations who can control the actions of large number of employees to further their self-interest. There must be more reasons.  There ought to at least be some organized discussion of these reasons.  After that there needs to be some organized action to promote real reform.  I conclude the often miserable 2012 with a plea for those who are interested and concerned to come together to create real solutions. ADDENDUM (1 January, 2013) - see <a href="http://theeconomismscam.blogspot.com/2012/12/why-no-outrage-more-on-how-economism.html">comments</a> by Dr Howard Brody on the Economism Scam blog.

Question for the New Year: Why is There Next to No Reaction to the Gilded Age of Health Care?

For the New Year, it is time to ponder- why is there still no organized outrage over the ongoing incompetent , uncaring , self-interested ,...

Đọc thêm »

'Tis the Season for Legal Settlements: GlaxoSmithKline, Eli Lilly, Orthofix, Sanofi all Settle

Reports of legal settlements by big health care organizations tend to dribble out towards the end of the year, maybe in a rush to finalize the year's accounting, maybe because the news will not register as well at times when people are distracted by holidays.  Here is a round-up in alphabetical order of some recent settlements of interest made by drug and device companies. GlaxoSmithKline Earlier this year GSK made the largest settlement, in monetary terms, ever by a pharmaceutical company (see <a href="http://hcrenewal.blogspot.com/2012/07/giant-gsk-settlement-provides-reminder.html">this post</a>).  At the end of the year it made two more.  Neither got much media attention.  The first was related to the earlier $3 billion settlement.  As <a href="http://lebanon-express.com/news/glaxosmithkline-pays-to-settle-avandia-lawsuit/article_59b5a4fe-3426-11e2-ae3b-001a4bcf887a.html">reported</a> by the [Great] Lebanon [Oregon] Express: <blockquote class="tr_bq">Oregon Attorney General Ellen Rosenblum announced in a press release that pharmaceutical giant GlaxoSmithKline has agreed to pay $90 million to Oregon and 37 other states to settle claims that it unlawfully promoted its diabetes drug, Avandia. As the co-leader of the lawsuit, Oregon will receive $3.9 million of the settlement, according to the release. The 38 attorneys general claimed in lawsuits filed Nov. 15 that GlaxoSmithKline misrepresented the cardiovascular risks posed by Avandia. A negotiated consent judgment was filed shortly thereafter.  Avandia was a blockbuster drug for GlaxoSmithKline. First approved by the Food and Drug Administration in 1999, annual sales peaked at more than $2.5 billion in 2006.</blockquote> Furthermore, <blockquote class="tr_bq"> Oregon and the 37 other states claim GlaxoSmithKline made safety claims about Avandia not supported by the scientific evidence. The states allege the company failed to disclose negative information about Avendia’s cardiovascular health effects.</blockquote> In addition to the monetary settlement, the agreement included all sorts of pledges by GSK: <blockquote class="tr_bq">As part of the consent judgment between the parties, GlaxoSmithKline agreed to reform how it markets and promotes diabetes drugs. It agreed to several conditions:  • To refrain from making false, misleading, or deceptive claims about any diabetes drug; • To refrain from making comparative safety claims not supported by substantial evidence or substantial clinical experience; • To refrain from presenting favorable information previously thought of as valid but rendered invalid by contrary and more credible recent information; •   To refrain from misusing statistics or otherwise misrepresenting the nature, applicability, or significance of clinical trials. The Consent Judgment also has the following terms that are effective for at least eight years: • GlaxoSmithKline must post summaries of all company sponsored observational studies or meta-analyses conducted by the company that are designed to inform the effective, safe, and/or appropriate use of its diabetes drugs; • The company post summaries of company-sponsored clinical trials of diabetes products within eight months of the primary completion date; • GlaxoSmithKline must register and post all company-sponsored clinical trials as required by federal law.</blockquote> Even more under the radar was a second, unrelated settlement, only briefly chronicled by Reuters (here <a href="http://www.chicagotribune.com/business/sns-rt-us-glaxosmithkline-settlementbre8bi14f-20121219,0,2970904.story">via</a> the Chicago Tribune): <blockquote class="tr_bq"> British drugmaker GlaxoSmithKline Plc has reached a $150 million preliminary settlement with U.S. drug wholesalers who claimed the company improperly delayed entry to the market of generic alternatives to its nasal spray Flonase, according to court documents. The settlement was reached with, among others, AmerisourceBergen Corp, Cardinal Health Inc, and McKesson Corp, who maintained that Glaxo had abused the citizen's petition process to maintain a market monopoly and overcharge for the spray by restricting access to less expensive generic versions.</blockquote> Note that while the first settlement was clearly about misleading, deceptive marketing of a relatively dangerous drug as safe, a practice that likely lead to suffering and death of some patients, the second settlement which involved an unfair business practice that likely increased the cost of care to some patients, and decreased the profits of some competitors, lead to a monetarily larger settlement. Again, these latter two settlements seem to just ice the cake of the $3 billion settlement earlier this year.  Eli Lilly Eli Lilly pleaded guilty to a misdemeanor charges and settled allegations about questionable marketing practices for its anti-psychotic drug Zyprexa for over $1 billion in 2009 (see post <a href="http://hcrenewal.blogspot.com/2009/01/what-me-worry-lilly-fined-over-zyprexa.html">here</a>).  The settlement provided some instructive information about how big pharmaceutical companies employ ghost writing to sell product (see <a href="http://hcrenewal.blogspot.com/2009/06/handbook-for-ghost-writing.html">this post</a>).  Now at the end of 2012, Eli Lilly has settled charges that it bribed government officials in countries outside of the US.  The most colorful version of this story <a href="http://online.wsj.com/article/SB10001424127887324461604578191550218188808.html">appeared</a> in the Wall Street Journal.  In summary, <blockquote class="tr_bq"> Eli Lilly & Co. agreed to pay $29.4 million in a settlement of U.S. government allegations that the drug maker's units made improper payments to foreign government officials to win business. Indianapolis-based Lilly didn't admit or deny the allegations, but agreed to have an outside consultant review the company's internal controls and its measures to comply with the U.S. Foreign Corrupt Practices Act, or FCPA. </blockquote> The colorful details were: <blockquote class="tr_bq">The SEC said in a civil complaint filed in U.S. District Court for the District of Columbia that employees of Lilly's China unit falsified expense reports to provide spa treatments, jewelry and other gifts and cash payments to government-employed doctors between 2006 and 2009. The SEC also alleged: Lilly hired a drug distributor in 2007 that paid bribes to health officials in a Brazilian state to facilitate about $1.2 million in sales of a Lilly drug to the state; Lilly's Polish unit paid $39,000 between 2000 and 2003 to a charitable foundation run by the head of a regional government health authority and dedicated to restoring a castle in Chudow, Poland; and that its Russian unit paid millions of dollars between 1994 and 2005 to offshore entities that the SEC said 'appear to have been used to funnel money to government officials' to obtain business for the Lilly unit. The SEC said Lilly didn't curtail the activities of its Russian unit for several years, even after an internal Lilly review raised questions about its use of these offshore arrangements. </blockquote> As in the previous set of settlements, no individual was charged or had to pay any penalty for authorizing, directing, or implementing any unethical actions.  Note that the alleged bribery went on in multiple different countries, suggesting a systemic problem with the operations of the company.  Note also that the allegations involved bribing doctors as well as bureaucrats. Orthofix We <a href="http://hcrenewal.blogspot.com/2012/11/phony-consulting-and-royalty-agreements.html">discussed</a> three settlements made by medical device company Orthofix only a month ago.  These involved various vivid details including bribes to physicians disguised as consulting and royalty agreements, bribes of foreign government officials disguised as chocolate, and a device sales representative turned stripper.  As best as I can tell, Orthofix just made yet another settlement, maybe not quite so picaresque.  As<a href="http://www.bloomberg.com/news/2012-12-15/orthofix-medicare-probe-settlement-accepted-by-u-s-judge-1-.html"> per Bloomberg</a>, <blockquote class="tr_bq">Orthofix International NV won court approval of a settlement of federal regulators’ claims that the maker of bone-repair products defrauded Medicare through a kickback scheme involving doctors, prosecutors said. U.S. District Judge William G. Young in Boston<a href="http://topics.bloomberg.com/boston/"></a> yesterday accepted an Orthofix unit’s offer to plead guilty to a felony count of obstructing an audit and pay a $7.6 million criminal fine....</blockquote> This settlement like some of the previous ones involved allegations of payments to doctors to induce them to use Orthofix devices. <blockquote class="tr_bq">As part of the agreement, Orthofix also will pay $32.3 million plus interest to resolve civil claims first raised in a whistle-blower’s lawsuit that the company defrauded the federal Medicare program through payments to doctors who used its bone-growth stimulators....</blockquote> This series of cases is unusual because they resulted in a guilty plea to a felony (but by a subsidiary of the company, not the company itself), and in guilty pleas by some company employees (but not apparently any penalties to top management). <blockquote class="tr_bq">Five Orthofix employees have pleaded guilty in connection with the probe, the U.S. Justice Department<a href="http://topics.bloomberg.com/justice-department/"></a> said. Thomas Guerrieri<a href="http://www.justice.gov/usao/ma/news/2012/April/GuerrieriThomasPleaPR.html" rel="external" title="Open Web Site"></a>, a company vice president, pleaded guilty to violating the federal anti-kickback statute by setting up fake consulting agreements for doctors who used the company’s products. </blockquote> Sanofi French multinational pharmaceutical corporation Sanofi-Aventis settled charges of overcharging the US Medicaid system in 2009 for over $90 million  (see post<a href="http://hcrenewal.blogspot.com/2009/05/sanofi-aventis-settles.html"> here</a>),  and of overcharging the US Medicare system in 2007 for over $190 million (see post <a href="http://hcrenewal.blogspot.com/2007/09/190-million-settlement-for-sanofi.html">here</a>).  Now it just settled charges that it gave kickbacks to doctors to induce them to prescribe its product.  <a href="http://www.bloomberg.com/news/2012-12-19/sanofi-to-pay-109-million-to-settle-false-claims-case.html">Per Bloomberg</a>, <blockquote class="tr_bq"> Sanofi,  France’s biggest drugmaker, reached a settlement to pay $109 million over allegations that its U.S. units gave doctors free doses of a medicine to win their business and subvert Medicare’s drug reimbursement system. </blockquote><blockquote class="tr_bq">Sanofi sales representatives entered into 'illegal sampling arrangements' with physicians, giving them the arthritis drug Hyalgan as kickbacks and 'promising to provide negotiated' amounts of the medication to lower its effective price in violation of the False Claims Act, the U.S. Justice Department said yesterday in a statement. 'Kickback schemes subvert the health-care marketplace and undermine the integrity of public health-care programs,” Stuart Delery,  who heads the department’s civil division, said in the statement. 'We will continue to hold accountable those who we allege are providing illegal incentives to influence the decision-making of health-care providers in federal health-care programs.'</blockquote> Again, no individual suffered any negative consequences for authorizing, directing or implementing the bad behavior in this case. Summary So here we go again, four more settlements by large, rich, well known pharmaceutical and device companies.  Most of the companies involved now have a history of recent settlements for a variety of ethical misadventures.  Most of the new settlements involved allegations of deceiving and bribing physicians. As we have noted endlessly before, <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> like this are useful to provide documentation of how unethical the practices, particularly marketing practices of large health care organizations have become.  However, the increasing number of repeat settlers suggest that the settlements are not deterring bad behavior.  Since the fines involved are usually small compared to the revenues that can be generated by deceptive and unethical marketing of expensive drugs, and the fines are paid out of company coffers, and are thus spread out in their impact over employees and stockholders alike, they usually have no more impact than a lash with a wet noodle, maybe at best a slap on the wrist.  Since the people involved in authorizing, directing and implementing the bad behavior can likely greatly improve their "numbers" and hence generate big salaries and bonuses, but face a minimal risk of any individual negative consequences, they are likely to continue unethical practices. Given that so many of these cases involve deception and/or bribery of health care professionals, I still hope that some will get upset at the effect on their professional values to take action. Meanwhile, I repeat until blue in the face....   we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

'Tis the Season for Legal Settlements: GlaxoSmithKline, Eli Lilly, Orthofix, Sanofi all Settle

Reports of legal settlements by big health care organizations tend to dribble out towards the end of the year, maybe in a rush to finalize t...

Đọc thêm »

Denying the Inconvenient Truth About Study 329

On 1BoringOldMan, Mickey, the semi-anonymous retired psychiatrist blogger, has updated the saga of <a href="http://hcrenewal.blogspot.com/search/label/Study%20329">Study 329</a>.  The manipulation of Study 329 was a central part of the US government's case against GlaxoSmithKline that was recently settled for $3 billion and resulted in three guilty pleas by the company (look <a href="http://hcrenewal.blogspot.com/2012/07/giant-gsk-settlement-provides-reminder.html">here</a> and <a href="http://hcrenewal.blogspot.com/2012/09/twilight-of-anechoic-effect-new-england.html">here</a>.) Mickey's previous voluminous series of posts on this subject are listed <a href="http://hcrenewal.blogspot.com/2012/08/continuing-dissection-of-infamous-study.html">here</a>.  He and others, most notably Dr Jon Jureidini, have attempted to get the journal that published the now widely ridiculed Study 329 retracted.  His three recent posts on the subject are: <a href="http://1boringoldman.com/index.php/2012/12/23/the-lesson-of-study-329-an-unfinished-symphony/" rel="bookmark">the lesson of Study 329: an unfinished symphony…</a>  <a href="http://1boringoldman.com/index.php/2012/12/21/hide-and-go-seek/" rel="bookmark">hide-and-go-seek… </a>  <a href="http://1boringoldman.com/index.php/2012/12/21/a-response-2/" rel="bookmark">a response… </a>  In the most recent of these, he argued, <blockquote class="tr_bq">In this particular case, there are no facts in question. It was a negative trial, declared negative by the people who did it. The paper was ghost-written and reviewed by the sponsor before any of the twenty two authors ever saw a manuscript. The science was jury-rigged to imply a positive outcome where none was supported using well-documented sleight of hand. None of that is speculative. And the article has been a centerpiece for court settlements worth billions of dollars.</blockquote> Yet, the  Journal of the American Academy of Child and Adolescent Psychiatry refused to retract the article. Mickey's opinion in the second of the posts listed above, <blockquote class="tr_bq">One can only conclude that they found this article to be an inconvenient truth, and that Dr. Andres Martin and his colleagues in the American Academy of Child and Adolescent Psychiatry believe that acknowledging that truth would do more harm than good [or maybe even found a way not to see the truth at all, though it's hard to imagine how]. Sooner or later, this whole tawdry saga is going to find its way out of the blogs and courtrooms and into the full light of day. And the question that’s going to be asked is why didn’t Medicine itself deal with the problem? Why didn’t the Journal itself retract the misinformation once they knew about it? Why didn’t the industry sponsor itself call for the retraction as part of their settlement with the DOJ? What possible reasonable reason could there be for leaving a paper that is a lie in their journal without even an expression of concern, much less a retraction? And there aren’t going to be any believable answers.</blockquote> Mickey concluded the most recent post, <blockquote class="tr_bq">The loser in this story is the American Academy of Child and Adolescent Psychiatry, and ultimately psychiatry itself…</blockquote> The longer inconvenient truths are ignored or suppressed, the more inconvenient, and hazardous they will ultimately become.  ADDENDUM (26 December, 2012) - One more post on 1BoringOldMan: <a href="http://1boringoldman.com/index.php/2012/12/26/telling-the-truth-as-a-liability/" rel="bookmark">telling the truth as a liability… </a> Its conclusion <blockquote class="tr_bq">By any criteria, the conclusion to the 2001 Keller et al article is wrong ["Paroxetine is generally well tolerated and effective for major depression in adolescents"]. That’s not the reason that some of us have been so persistent in pushing for retraction. The reason is that it was wrong at the time the article was published, and they knew it was wrong, but published it anyway. We want to make a statement about the integrity of the scientific literature. </blockquote>

Denying the Inconvenient Truth About Study 329

On 1BoringOldMan, Mickey, the semi-anonymous retired psychiatrist blogger, has updated the saga of Study 329 . The manipulation of Study 32...

Đọc thêm »

ONC's Christmas Confessional on Health IT Safety: "HIT Patient Safety Action & Surveillance Plan for Public Comment"

This time of year is certainly appropriate for a confessional on the health IT industry and <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">hyperenthusiasts</a>' sins. In the first report I've seen that seems genuinely imbued with a  basic level of recognition of social responsibility incurred by conducting the grand human subjects experiment known as national health IT, ONC has issued a Dec. 21, 2012 report "Health Information Technology Patient Safety Action & Surveillance Plan for Public Comment." It is available <a href="http://www.healthit.gov/sites/default/files/safetyplanhhspubliccomment.pdf" target="_blank">at this link</a> in PDF. Statements are made that have appeared repeatedly since 2004 at this blog, and my health IT difficulties site that went online years before this blog (1998 to be exact); it is possible through my early writing and that of like-minded colleagues that we were the origin of most of these memes.  We wrote them with the result of bringing much scorn upon ourselves. After all, "how could health IT possibly not be a panacea?" was the "you are an apostate" attitude I certainly experienced (e.g., as in my Sept. 2012 post "<a href="http://hcrenewal.blogspot.com/2010/09/dangers-of-critical-thinking-in.html" target="_blank">The Dangers of Critical Thinking in A Politicized, Irrational Culture</a>"). Observations echoed in the new ONC report: <ul><li>"Just as health IT can create new opportunities to improve patient care and safety, it can also create new potentials for harm."</li><li>Health IT will only fulfill its enormous potential to improve patient safety if the risks associated with its use are identified, if there is a coordinated effort to mitigate those risks, and if it is used to make care safer.</li><li>Because health IT is so tightly integrated into care delivery today, it is difficult to interpret this initial research [such as the PA Patient Safety Authority study  - ed.], which would seem to suggest that health IT is a modest cause of medical errors. However, it is difficult to say whether a medical error is health IT-related. [Not emphasized, as I wrote <a href="http://hcrenewal.blogspot.com/2012/12/a-very-signifcant-additonal-observation.html" target="_blank">here</a>, is the issue of risk when, say, <a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html" target="_blank">tens of </a><a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html" target="_blank">thousands of prescriptions are erroneous</a> due to one software bug, a feat impossible with paper - ed.]</li><li>The proper steps to improve the safety of health IT can only be taken if there is better information regarding health IT’s risks, harms, and impact on patient safety.</li></ul> Suggested steps to be taken include: <ul><li>Make it easier for clinicians to report patient safety events and risks using EHR technology.</li><li>Engage health IT developers to embrace their shared responsibility for patient safety and promote reporting of patient safety events and risks. [I am frankly amazed to see this admission.  In the past, that sector excused itself entirely on the basis of the "learned intermediary" doctrine and "hold harmless" clauses; where the clinician is an all-knowing Deity between computer and patient.  I've been writing for years, however, that the computer is now the intermediary between clinician and patient since all care 'transactions' have to traverse what is now an enterprise clinical resource and clinician control system - ed.]</li><li>Provide support to Patient Safety Organizations (PSOs) to identify, aggregate, and analyze health IT safety event and hazard reports.</li><li>Incorporate health IT safety in post-market surveillance of certified EHR technology</li><li>Align CMS health and safety standards with the safety of health IT, and train surveyors.</li><li>Collect data on health IT safety events through the Quality & Safety Review System (QSRS).</li><li>Monitor health IT adverse event reports to the Manufacturer and User Facility Device Experience (MAUDE) database. [I've been promoting the use of MAUDE for just that purpose, and much more regarding documenting and reporting on mission-hostile health IT; see <a href="http://hcrenewal.blogspot.com/2012/08/clinicians-how-to-document-ehr-screens.html" target="_blank">this </a><a href="http://hcrenewal.blogspot.com/2012/08/clinicians-how-to-document-ehr-screens.html" target="_blank">post </a>- ed.]</li></ul> These steps are to be taken in order to "Inspire Confidence and Trust in Health IT and Health Information Exchange." The title of my keynote address to the Health Informatics Society of Australia this summer was, in fact, "<a href="http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html" target="_blank">Critical Thinking on Building Trusted, Transformative Medical Information:  Improving Health IT as the First Step</a>". My thoughts on this report: <ul><li>It is at least two decades overdue.</li><li>It was produced largely if not solely due to the pressure of the "HIT apostates", finally overcoming industry memes and control of information flows through great perseverance.</li><li>It is indeed a confessional of the sins committed by the health IT industry over those decades.  Creating, implementing and maintaining mission critical software in a safety-cognizant way is not, and was not, a mystery.  It's been done in numerous industries for decades.</li><li>It is still a bit weak in acknowledging the likely magnitude of under-reporting of medical errors, including HIT-related, in the available data, and the issue of risk vs. 'confirmed body counts' as I wrote at my recent post "<a href="http://hcrenewal.blogspot.com/2012/12/a-very-signifcant-additonal-observation.html" target="_blank">A Significant Additional Observation on the PA Patient Safety Authority Report -- Risk</a>". </li><li>It is unfortunate that this report did not come from the informatics academic community in the United States, i.e., the <a href="http://www.amia.org/" target="_blank">American Medical Informatics Association (AMIA)</a>.  AMIA's academics have done well in advancing the theoretical aspects of the technologies, and how to create "good health IT" and not "bad health IT."  However, they have largely abrogated their social responsibilities and obligations, including but not limited to those of physicians, in ensuring the theories were followed in practice by an industry all too eager to ignore academic research (which, in order to follow, utilizes money and resources and reduces margins).</li></ul>(On the latter point, just last week did the American College of Medical Informatics [ACMI] refuse to permit me to be a speaker at their early 2013 annual retreat despite support from some of its members.) And this: <ul><li>If the industry and the academics had been doing their job responsibly, I might be spending this Christmas and New Years's holiday with my mother, rather than visiting her in the cemetery. </li></ul> All that said, the report is welcome. Finally, it is hoped - and expected - that public comments will indeed be "public", and that any irregularities in such comments (such as appeared in the public comments period for MU2 due to industry ghostwriting as in my Aug. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/08/health-it-vendor-epic-uses-clients-as.html" target="_blank">Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?</a>" and Sept. 2012 post "<a href="http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html" target="_blank">Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?</a>") will be reported and acted upon in an aggressive manner. And finally, from the Healthcare Renewal blog, Merry Christmas. -- SS

ONC's Christmas Confessional on Health IT Safety: "HIT Patient Safety Action & Surveillance Plan for Public Comment"

This time of year is certainly appropriate for a confessional on the health IT industry and hyperenthusiasts ' sins. In the first report...

Đọc thêm »