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A comment posted to the website "Doctors Helping Doctors Transform Healthcare", Peter Basch, William Bria et al.

A new website has appeared that purports to be: <blockquote>A collaborative effort led primarily by doctors for doctors to provide a "trusted resource" for physicians as they work to transform health care - initially through the use of health IT.</blockquote> The site is entitled "Doctors Helping Doctors Transform Health Care" and is at <a href="http://doctorshelpingdoctorstransformhealthcare.org/">this link</a>. (I note that when one encounters such platitudinous and potentially highly ideological titles, one should ask "transform how, and into what, exactly?" I presume "transform" means, in part, to reduce risk and improve safety and outcomes - while protecting patient and physician rights.) The site has a significant number of people on their advisory board (<a href="http://doctorshelpingdoctorstransformhealthcare.org/leadership/">link</a>), but no information on compensation. I note there are industry people involved, representing a potential conflict of interest. According to one of the principals, <a href="http://doctorshelpingdoctorstransformhealthcare.org/author/pbasch/">Peter Basch, MD</a>, Medical Director, Ambulatory EHR and Health Information Technology Policy, MedStar Health, Washington, DC, <a href="http://doctorshelpingdoctorstransformhealthcare.org/2011/why-doctors-helping-doctors/">on funding:</a> <blockquote>A Few Words About Our Supporters It takes resources to create and maintain this site, to make the work of Doctors Helping Doctors possible. We have solicited unrestricted contributions from individuals and organizations who believe in our mission and are able to support its work. In particular, we wish to thank Patrick Soon-Shiong of the Chan Soon-Shiong Family Foundation, John Glaser of Siemens Health Services; and Andy Slavitt of Optum’s Institute for Sustainable Health.</blockquote> To my knowledge, I've never met Dr. Basch, but at meetings I have met one of the other principals of the new website, <a href="http://doctorshelpingdoctorstransformhealthcare.org/author/wbria/">William Bria, III, MD</a>, Chief Medical Information Officer, Shriners Hospitals for Children; President and Co-Founder, Association of Medical Directors of Information Systems (AMDIS), St. Petersburg, FL. Dr. Basch's writing has appeared at Healthcare Renewal before, such as at the Jan. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/01/throwing-national-research-council.html">Throwing The National Research Council Report On Health IT Under The Bus, Part 1: MedStar Health</a>." In the new site, Dr. Basch states that: <blockquote>As early adopters, EHR implementers, and practicing physicians, we have seen the “bad and the ugly” as well as the promise of health IT. We understand how health IT can and should be used to make care better, safer, and more value-laden. As such, we believe that unnecessarily harsh criticism of Meaningful Use—which we have heard from some quarters—and uncritical cheerleading—which we have also heard—are equally unhelpful. We see physician “extremism” essentially marginalizing what is needed now more than ever—a clear and constructive physician voice, articulating not for compliance with Meaningful Use, but rather leveraging the opportunity that Meaningful Use presents, and consistently inserting the highest ideals that led us all to choose a career in medicine.</blockquote> While on the surface this is not an unreasonable position, I fear the word "extremism" is used as a metaphor for those who express genuinely critical appraisals of the state of health IT as it now exists, on issues regarding safety, efficacy, usability, need for regulation, vendor, buyer and user liability, and other "unpleasant" topics. I do note precious little on the site about educating physicians on the considerable downsides of health IT as it currently exists, nor on the scientific literature expressing doubts about its safety, efficacy, usability, ROI and other issues (such as <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">here</a>). There is, it would seem obvious, no ethical excuse for introducing medical devices and other technology of unknown benefit and of unknown risk magnitude (as recently reported by the IOM, see <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">this post</a>), that is <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">unregulated</a>, into life-critical domains such as medicine without explicit acknowledgement of experimentation. Human subjects experimentation requires, of course, explicit informed consent under the <a href="http://grants.nih.gov/grants/policy/hs/ethical_guidelines.htm">many guidelines</a> formulated as a result of past systemic abuses. Also, users need to be fully aware of the risks. Such informed consent cannot be accomplished, and awareness attained by physicians regarding the dangers of use of health IT in its present form, through simple "best practices" protagonism. For instance, health IT can be inherently defective and/or <a href="http://www.tinyurl.com/hostileuserexper">mission hostile</a> (worse, the industry is unregulated), and can injure or kill. Several illustrative examples just off the top of my head are at: <ul><li>"<a href="http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html">FDA Recalls Draeger Health IT Device Because This Product May Cause Serious Adverse Health Consequences, Including Death</a>";</li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">Lifespan (Rhode Island): Yet another health IT 'glitch' affecting thousands</a>";</li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2010/07/maude-database-patient-outcome-death.html">FDA MAUDE Database: Patient Outcome - Death</a>" and "<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">FDA Manufacturer and User Facility Device Experience (MAUDE) database - case reports of EHR defects</a>";</li></ul><ul><li>"<a href="http://hcrenewal.blogspot.com/2010/12/ecri-healthcare-it-in-top-ten-health.html">ECRI: Healthcare IT In Top Ten Health Technology Threats to Patient Safety</a>";</li></ul><ul><li>"<a href="http://iig.umit.at/efmi/badinformatics.htm">Bad Health Informatics Can Kill</a>" [European Federation for Medical Informatics]; </li></ul><ul><li> "<a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">A Study of an Enterprise Health information System</a>" [Australia - severe deficiencies in software engineering noted in major U.S. vendor ED EHR system that cause user confusion as well as data corruption/loss];</li></ul><ul><li>"<a href="http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009/0160182009specification.pdf">Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software</a>" [ISO/UK NHS - with an accounting of EHR-related medical errors in Annex A]; </li></ul><ul><li> and a personal account "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=diary">A Diary of EHR-Initiated Tragedy</a>."</li></ul> Not even including privacy and confidentiality issues (see <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">this query link</a> on those issues), should physicians, nurses, patients and other stakeholders not be explicitly educated on the issues of risk, that can be greatly replicated/amplified across hundreds or thousands of patients by EHRs as opposed to paper, and on actual injuries and deaths that have occured? If not, why not? Are not these issues and the issue of the <a href="http://hcrenewal.blogspot.com/2010/08/health-it-via-observation-and-research.html">lack of a culture of safety in the health IT field</a> at least as important, if not more important for clinicians, patients, healthcare executives and other stakeholders to be strongly aware of than "best practices" and "meaningful use?" (I note that the "negative reports are mere anecdotes" argument commonly used by health IT pundits only shows, as in the Aug. 2011 essay by a senior clinician in Australia "<a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things</a>", that those making that argument need to attend revision courses in research methodology and risk management.) In consideration of the "Doctors Helping Doctors" site's seemingly uncritical pro-HIT advocacy, I have posted the following note at the end of Dr. Basch's introductory essay. The comment appears <a href="http://doctorshelpingdoctorstransformhealthcare.org/2011/why-doctors-helping-doctors/#comment-20">at this link</a> and is awaiting moderation. The comment's remaining online would be a sign that the site is not another attempt to "<a href="http://hcrenewal.blogspot.com/2011/03/how-lousy-health-it-gets-pushed-on.html">control the channel</a>", and is truly serious about being "trusted." It would be a sign of a site truly concerned with "physicians helping physicians transform health care" while not sacrificing patients as unconsenting test subjects of unregulated, experimental <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">software-based medical devices</a> in the process. <cite class="fn"><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" rel="external nofollow" class="url"></a></cite><blockquote><cite class="fn"><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" rel="external nofollow" class="url">S Silverstein MD</a></cite> says: <div class="comment-meta commentmetadata"> <a href="http://doctorshelpingdoctorstransformhealthcare.org/2011/why-doctors-helping-doctors/#comment-20">December 17, 2011 at 10:29 pm</a> </div> Doctors, One way to help doctors transform healthcare would be to educate them on the downsides of information technology in healthcare, how to avoid them, and the conflicting literature on benefits (e.g., as at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglis">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist</a>). I do not see such information here yet. I do expect some such information will follow. Sincerely, Scot Silverstein --------------------------------------------------- Scot M. Silverstein, MD Consultant/Independent Expert Witness in Healthcare Informatics (May 2010-present) Adjunct faculty in Healthcare Informatics and IT (Sept. 2007-present) Assistant Professor of Healthcare Informatics and IT, and Director, Institute for Healthcare Informatics (2005-7) Drexel University College of Information Science and Technology 3141 Chestnut St., Philadelphia, PA 19104-2875 Email: sms88 AT drexel DOT e-d-u Bio: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm">http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm</a> Common Examples of Healthcare IT Difficulties: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/ </a> Note: I am cross-posting this comment on Healthcare Renewal blog under the title "A comment posted to the website 'Doctors Helping Doctors Transform Healthcare, Peter Basch, William Bria et al.'"</blockquote> It is my hope the comment stays, and receives a reasoned reply. -- SS Dec. 23, 2011 addendum: My comment appears to have disappeared. I leave it to the reader to determine what that means about the site "Doctors Helping Doctors Transform Healthcare." -- SS

A comment posted to the website "Doctors Helping Doctors Transform Healthcare", Peter Basch, William Bria et al.

A new website has appeared that purports to be: A collaborative effort led primarily by doctors for doctors to provide a "trusted resou...

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Medtronic Settles, Yet Again

And the march of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> continues... Circling around the block and coming in front of the viewing stand again is device manufacturer Medtronic.  The Latest Medtronic Settlement As Bloomberg <a href="http://www.bloomberg.com/news/2011-12-13/medtronic-to-pay-23-5-million-to-settle-allegations-of-doctor-kickbacks.html">reported</a>: <blockquote>Medtronic (MDT) Inc., the world’s biggest maker of heart rhythm devices, agreed to pay $23.5 million to settle claims it paid kickbacks to doctors who implanted its pacemakers and defibrillators in patients, the U.S. Justice Department said in a statement. Medtronic agreed yesterday to settle two lawsuits filed in federal courts in California and Minnesota accusing the company of violating the federal False Claims Act by paying physicians $1,000 to $2,000 for each patient who was implanted with one of the company’s devices, according to the Justice Department. 'Patients who rely on their health-care providers to implant vital medical devices expect that those decisions will be made with the patients’ best interests in mind,' Tony West, assistant attorney general for the Justice Department’s Civil Division, said in an e-mailed statement. 'Kickbacks, like those alleged here, distort sound medical judgments with financial incentives paid for by the taxpayers.' </blockquote> As usual, Medtronic did not admit doing anything wrong: <blockquote>Medtronic said in an e-mailed statement that it makes no admissions that the studies were 'improper or unlawful.' The company also said it established a reserve for the anticipated payment in the fourth quarter of fiscal year 2011. 'We are happy that the investigation is behind us, so we can continue designing and executing clinical trials that generate evidence to improve patient care, outcomes and cost effectiveness,' Marshall Stanton, vice president of clinical research and reimbursement for the cardiac and vascular group....</blockquote>Previous Legal Settlements by Medtronic Note that this is not the first time Medtronic has been accused of paying doctors (kickbacks, this time, which seem to be the ethical equivalent of bribes) to use its products. The Bloomberg report also noted: <blockquote>In 2006, Medtronic agreed to pay $40 million to settle allegations that its Sofamor Danek unit violated state laws and the False Claims Act by paying sham consulting fees and providing lavish trips to doctors who used its products from 1998 to 2003. </blockquote>Perusing the <a href="http://hcrenewal.blogspot.com/search/label/Medtronic">Medtronic file on Health Care Renewal</a> also showed that Medtronic has had to settle other lawsuits alleging misconduct: - In 2008, Medtronic subsidiary Kyphon settled a suit for $75 million and signed a corporate integrity agreement for allegations that it defrauded Medicare through a scheme that lead to excessive hospitalization for patients who received the company's spine surgery device (link <a href="http://hcrenewal.blogspot.com/2008/05/corporate-integrity-agreement-for.html">here</a>) - In 2010, Medtronic settled multiple civil lawsuits for $268 million for allegations that it marketed an implantable cardiac defibrillator with faulty leads whose failures lead to 13 deaths (link <a href="http://hcrenewal.blogspot.com/2010/10/last-weeks-scandals.html">here</a>) Cases of Apparent Conflicts of Interest Generated by Medtronics' Payments In fact, paging through the <a href="http://hcrenewal.blogspot.com/search/label/Medtronic">Medtronic file on Health Care Renewal</a>, we also found these cases of apparent conflicts of interest that Medtronic caused by making payments to or otherwise creating financial relationships with: - FDA advisory board members (2007 link <a href="http://hcrenewal.blogspot.com/2007/07/blogscan-more-conflicted-members-on-fda.html">here</a>), - health care professionals who appeared on public television programs about heart disease and treatments of it (2007 link <a href="http://hcrenewal.blogspot.com/2007/10/funding-of-mysterious-human-heart-and.html">here</a>), - members of a non-profit organization which was supposed to guide the FDA regarding drug development  (2007 link <a href="http://hcrenewal.blogspot.com/2007/11/questions-about-board-of-new-reagan.html">here</a>), - prominent academic orthopedic surgeons who were in positions to influence other physicians' choices of orthopedic devices (2008 link <a href="http://hcrenewal.blogspot.com/2008/09/more-lucrative-payments-to-orthopedic.html">here</a> and 2009 links <a href="http://hcrenewal.blogspot.com/2009/01/on-wisconsins-talking-heads.html">here</a>, <a href="http://hcrenewal.blogspot.com/2009/07/polly-want-million-plus.html">here</a> and <a href="http://hcrenewal.blogspot.com/2009/12/20-million-dollar-journal-editor.html">here</a>), - a military surgeon who wrote questionable articles about the supposed virtues of a Medtronic bone growth product (2009 link <a href="http://hcrenewal.blogspot.com/2009/05/breach-of-trust.html">here</a>), - a top leader of US Veterans Affairs Department who objected to the appointment of an industry critic as US Surgeon General (2010 link <a href="http://hcrenewal.blogspot.com/2010/10/toxic-and-dangerous-watchdog-vs.html">here</a>), - spine surgeons apparently who could promote Medtronics' spine surgery products in (2010 link <a href="http://hcrenewal.blogspot.com/2010/12/blogscan-medtronics-multi-million.html">here</a>) and who did not disclose all such payments when writing ostensibly scholarly articles on the subject (2010 link <a href="http://hcrenewal.blogspot.com/2010/12/spine-surgeons-reticent-about.html">here</a>) So prior to the current settlement for "alleged" kickbacks, Medtronic had a long history of allegations that it had financial relationships with physicians who were in a position to promote the use of its products or its policy interests. Why the Bad Behavior Continues The latest settlement by Medtronic illustrates why the anemic approach by US government agencies to health care corporate misbehavior does not deter bad behavior. - The punishment was a fine not large enough to have any effect on the finances of the corporation.. Such a relatively small financial penalty might just be seen as a cost of doing business by company executives.  (See <a href="http://brodyhooked.blogspot.com/2011/12/here-we-go-again-with-form.html">these comments</a> on the current case by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.) -  The punishment was not a result of any specific bad behavior.  In this case, like many others, the corporation did not have to admit to anything.  This leads to the paradox of a punishment meted out for apparently nothing other than "alleged" actions, making it appear that the actual punishment was just a payment by the company to allow it to continue the sorts of actions that were alleged with impunity.  (Such punishments without clear crimes happen all the time in cases affecting the finance sector.  See a federal judge's condemnation of this practice <a href="http://hcrenewal.blogspot.com/2011/11/will-citigroup-ruling-challenge-health.html">here</a>.)  -  The punishment seems unrelated to the corporation's historic behavior.  In this case, there was no reference to the company's previous settlements, or the other allegations of questionable payments to physicians and health care decision makers in other circumstances listed above.  (Keep in mind that <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> strives to present interesting cases, but does not have the resources to report on every single case of bad behavior by health care organizations.  Hence the list above of apparent bad behavior may not be complete.) -  The punishment applied to the corporation as a whole, and hence may disadvantage many people, stockholders and corporate employees in particular, who had nothing to do with the alleged bad behavior.  On the other hand, those who authorized, directed, or implemented the bad behavior were not subject to any negative consequences.  So why on earth would corporate leaders cease bad behavior which could increase revenues short-term and hence increase their compensation (e.g., in 2011, the Medtronic CEO received $9,624,709 according to the <a href="https://www.proxydocs.com/0/000/427/737/proxy_statement.pdf">2011 proxy statement</a>), when the likelihood of any negative consequences for them appears to be near zero?  This would be bad enough if the bad behavior only causes financial disadvantage for stockholders or corporate employees. However, the bad behavior in question seems to repeatedly involve paying physicians and other health care decision makers in ways likely to influence their decisions in favor of Medtronics' products and corporate well-being.  Making decisions this way, however, is unlikely to be good for patients' and the public's health, as it is likely to lead to excess use of expensive tests and treatments that may have adverse effects, sometimes severe.  Thus patients may suffer unnecessary morbidity and mortality, and the public at large may pay far too much for medical care. So will we see in our lifetimes honest, tough policing of health care corporate behavior?  Will the punishments start to fit the crime, and will they be significant enough to deter future misbehavior?  Why do we continue to accept government actions that seem more solicitous of the executives of big corporations than the public for whose benefit government is supposed to be run?  Where is the outrage?    So, once more, with feeling.... in my humble opinion, until the people responsible for the bad behavior experience negative consequences from that behavior, they will continue to perform, direct, and condone bad behavior. We will not achieve real health care reform in the US until we effectively deter unethical, self-serving behavior by leaders of health care organizations. ADDENDUM (15 December, 2011) - <a href="http://gooznews.com/?p=3437">On the GoozNews blog</a>, Merrill Goozner called Medtronic's actions "a crime against science."

Medtronic Settles, Yet Again

And the march of legal settlements continues... Circling around the block and coming in front of the viewing stand again is device manufact...

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FDA Recalls Draeger Health IT Device Because "This Product May Cause Serious Adverse Health Consequences, Including Death"

More health IT madness, in the form of an actual FDA recall: <a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=6d6383ecf8a447d49bdd4de3b034a759&URL=http%3a%2f%2fwww.fda.gov%2fMedicalDevices%2fSafety%2fRecallsCorrectionsRemovals%2fListofRecalls%2fucm282461.htm"></a> <blockquote><a href="http://www.fda.gov/MedicalDevices/Safety/ucm282461.htm" target="_blank">FDA Recall notice</a> Draeger Medical Inc., Infinity Acute Care System Monitoring Solution (M540) Recall Class: Class I [the most serious type of recall, see below - ed.] Date Recall Initiated: October 18, 2011 Product: Infinity Acute Care System Monitoring Solution (M540), Catalog number MS25510 All serial numbers are affected by this recall. This product was manufactured from March 1, 2011 through September 30, 2011 and distributed only to the Rush University Medical Center (Chicago, Illinois) from July 1, 2011 through September 30, 2011. Use: This product is a networked solution system used to monitor a patient’s vital signs and therapy, control alarms, review Web-based diagnostic images, and access patient records. The number of monitored vital signs can be increased or decreased based on the patient’s needs. Recalling Firm: Draeger Medical, Inc. 3135 Quarry Rd., Telford, Pennsylvania 18969-1042 Manufacturer: Draeger Medical GmbH, Moislinger Allee 53-55_23558, Lubeck, Germany Reason for Recall: The weight-based drug dosage calculation may indicate incorrect recommended values, including a drug dosage up to ten times the indicated dosage. Additionally, there may be a 5-10 second delay between the electrocardiogram and blood pressure curves (waveforms) at the Infinity Central Station. This product may cause serious adverse health consequences, including death. Public Contact: Draeger Medical, Inc. 3135 Quarry Road Telford, Pennsylvania 18969-1042_215-660-2349 FDA District: Philadelphia FDA Comments: On October 17, 2011, the company sent the Rush University Medical Center a letter stating that users should enter the patient’s weight by way of the admin/demographics screen to ensure the drug dosage is calculated as intended. Additionally, the company’s letter states that users should follow the instructions for Use of the Infinity Acute Care System Monitoring Solution. The Instructions for Use includes, "For primary monitoring and diagnosis of bedside patients, use the bedside monitor. Use the Infinity Central Station only for remote assessment of a patient's status." [That is, clinicians should work around the device's defects, which would seem to hold the computer's rights over the patients' rights -- rather than taking the device out of service immediately and having the vendor fix it - ed.] Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.</blockquote> I find a software company advising clinicians to make sure to "work around" blatant IT defects in "acute care environments" the height of arrogance and contempt for patient safety. Yes, acute care environments are not unpredictable, chaotic environments often moving a mile a minute. They are precisely the environment where everyone can sit around on their butts and leisurely hold, over pizzas and cokes, a committee meeting where each and every move can be discussed, just like in a software development shop ... I also find the statement that this medical device was "distributed only to the Rush University Medical Center" remarkable. If true, it raises a number of issues that make me very uncomfortable: <ul><li>How did the company's letter to Rush make its way to FDA? Whistle blower?</li></ul><ul><li>What testing was done by the manufacturer of this medical device before release to a live-patient environment?</li></ul><ul><li>Who approved this software "going live?" What due diligence was performed?</li></ul><ul><li>Was this a software beta test of experimental software on live subjects?</li></ul><ul><li>Did Rush University Medical Center have some sort of quid pro quo (e.g., financial arrangement) with the software company?</li></ul><ul><li>Did Rush seek IRB approval of this device?</li></ul><ul><li>Were patients presented with an informed consent process regarding its use in their care?</li></ul><ul><li>Were any patients actually injured or did any die as a result of this software?</li></ul> The answers to these questions need to be sought by FDA. -- SS

FDA Recalls Draeger Health IT Device Because "This Product May Cause Serious Adverse Health Consequences, Including Death"

More health IT madness, in the form of an actual FDA recall: FDA Recall notice Draeger Medical Inc., Infinity Acute Care System Monitoring S...

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The EHR Mission Hostile User Experience, Part 10: Cerner Powerchart - via FDA's MAUDE Database

<center style="font-weight: bold;">"You should not have to work around something that is not in the way" - SS</center> Some time ago, I'd written an eight part (later expanded to nine part) series on health IT mission hostile user interfaces and experiences. (Note: Part 1 of this series is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-idiots-part-1.html">here</a>, part 2 is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and.html">here</a>, part 3 is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and_24.html">here</a>, part 4 is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and_26.html">here</a>, part 5 is <a href="http://hcrenewal.blogspot.com/2009/02/are-health-it-designers-testers-and_27.html">here</a>, part 6 is <a href="http://hcrenewal.blogspot.com/2009/02/it-makes-healthcare-easier-is-this.html">here</a>, part 7 is <a href="http://hcrenewal.blogspot.com/2009/03/information-technology-makes-healthcare.html">here</a>, and part 8 is <a href="http://hcrenewal.blogspot.com/2009/03/malpractices-of-multitudes-mission.html">here</a>. 2011 addendums: a post that can be considered part 9 is <a href="http://hcrenewal.blogspot.com/2011/04/special-k-red-berries-mission-hostile.html">here</a>, part 10 is <a href="http://hcrenewal.blogspot.com/2011/12/ehr-mission-hostile-user-experience.html">here</a>.) Here is an addendum, part 10, from the FDA <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm" style="font-family: arial;">Maude</a> (Manufacturer and User Facility Device Experience) Database. I do not know who wrote it or where it was from. It was received by FDA as indicated on 3 April 2011: <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2045867" style="font-family: arial;"></a> <blockquote style="font-family: arial;">FDA MAUDE REPORT <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2045867">CERNER POWERCHART </a> Event Type Other Event Description I am writing to report a problem in the design of the cerner powerchart computer provider order entry (cpoe) product. As i will describe below, these design flaws are largely responsible for approximately 100 medication errors per day in our 240 bed hosp. The (b)(6) hosp in (b)(6) is a 240 bed teaching hosp. We are owned by the (b)(6). We have to be one of the only hospitals in the country to fully implement cpoe with two entirely different electronic medical records (emr). In 2007, we completed a comprehensive cpoe implementation using idx 3. 1 (which was later purchased by general electric). Our self-reported medication error rate was <2 error reports per day. In (b)(6) of 2010, we transitioned our emr to cerner millennium - powerchart (b)(4). This implementation was done as a first step to converge onto a single electronic medical record across the (b)(6) enterprise. Despite extensive nursing informatics support (approx. 7000 hrs per month for the first six months after implementation), our error rate went from approx. 176 medication errors per day one month after implementation to approx. 100 medication errors per day currently. It has been stable at this level for at least the past 3 months. Many of these errors involve high risk medications (e. G. Heparin, morphine). In order to understand the etiology of the errors, i need to explain how cerner processes cpoe orders. With cerner, orders are grouped into plans ("powerplans"). These plans can include sub-plans ("phases") and sub-sub-plans ("sub phases"). A typical orders display screen appears as follows: (b)(4). Under the plans is an order tab which displays other orders. This design allows two distinct sources of error. First, there is no consistent way to view orders for medications. A medication order can display either in a plan, sub-plan, or under the orders tab. In order to find a given medication, cerner mandates that you click through each and every plan. This facilitates duplication of both medication and non-medication orders (there is a medication checker which is so poorly designed and does little to aid the pharmacists in detecting duplicate medications). Second and more dangerous, high risk intravenous medications can be run either inside or outside of the plan. Cerner programming [i.e., the user interface design -ed.] does not keep high risk medications in a consistent spot. It is very easy to stop monitoring for heparin (which is included in the heparin plan) while continuing the heparin (which is outside the plan) or vice-versa. As you can probably guess, we formed multiple interdisciplinary teams to address these deficiencies. [Workarounds - ed.] I was the lead physician on the orders team. Although we were unable to reduce the error rate, it is not close to an acceptable level. Again, i believe this is because of the design of the cerner product which is why i chose to bring this to your attention. With issues this complex, i am a firm believer that "seeing is believing. " if desired, i would be happy to arrange a web conference to demonstrate my concerns. Brand Name CERNER POWERCHART COMPUTER Type of Device NONE Manufacturer (Section F) CERNER Manufacturer (Section D) CERNER Device Event Key 2081342 MDR Report Key 2045867 Event Key 1942844 Report NumberMW5020161 Device Sequence Number 1 Product Code LNX Report Source Voluntary Reporter Occupation Other Type of Report Initial 1 Device Was Involved in the Event 1 Patient Was Involved in the Event Date FDA Received 04/03/2011 Is This An Adverse Event Report? No Is This A Product Problem Report? No Device Operator Service Personnel Was The Report Sent To Manufacturer? No Is the Device an Implant? No Is this an Explanted Device? Page Last Updated: 11/30/2011 </blockquote>I will let the FDA report speak for itself, with only one question: When will the designers, developers, purchasers and implementers of medical devices like this start to be held criminally liable for patient injuries that occur from the risk these devices pose to patient safety? <blockquote style="font-family: arial;"> <a href="http://www.thefreedictionary.com/criminal+negligence">criminal negligence</a> - (law) recklessly acting without reasonable caution and putting another person at risk of injury or death (or failing to do something with the same consequences)</blockquote> It's not as if the issues related to good user interface design are a mystery, nor have those issues been a mystery for at least a few decades. An EHR design as described, if accurate, while perhaps "nifty" in some way from the computer-techie perspective, would require significant recklessness to design and to actually implement in a life-critical setting. Those who try to point out these issues internally are sometimes subject to retaliation (for not being a "team player", of course, which in today's parlance means someone who is silent, or silenced, or a co-conspirator regarding managerial mediocrity, malfeasance, or madness). An example is <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=lawsuit">here</a>. We at Healthcare Renewal simply refuse membership on that team. (Did I mention this deterministic miracle-making technology is slated via the HITECH Act for rollout in the U.S., unless the medical professional or organization is willing to accept progressive cuts to their Medicare reimbursement?) -- SS

The EHR Mission Hostile User Experience, Part 10: Cerner Powerchart - via FDA's MAUDE Database

"You should not have to work around something that is not in the way" - SS Some time ago, I'd written an eight part (later exp...

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"It's All Been Done Before," If We Only Could Remember What it Was - the AHERF Example

A big Wall Street Journal <a href="http://online.wsj.com/article/SB10001424052970204319004577084553869990554.html">article</a> by Anna Wilde Mathews featured the latest wave of mergers affecting large health care organizations. Large, Vertically Integrated Health Care Systems (Redux) <blockquote>Call it the united state of health care. Amid enormous pressure to cut costs, improve care and prepare for changes tied to the federal health-care overhaul, major players in the industry are staking out new ground, often blurring the lines between businesses that have traditionally been separate. Hospitals are bulking up into huge systems, merging with one another and building extensive new doctor work forces. They are exploring insurance-like setups, including direct approaches to employers that cut out the health-plan middleman. On the other side, insurers are buying health-care providers, or seeking to work with them on new cooperative deals and payment models that share the risks of health coverage. And employers are starting to take a far more active role in their workers' care.</blockquote> This ongoing consolidation is being discussed as inevitable. <blockquote>'We're seeing a marketplace reacting to an economic imperative,' says Michael O. Leavitt, a former U.S. Secretary of Health and Human Services who is now chairman of a health-information company. 'The new delivery models are far more integrated.'</blockquote> The ongoing consolidation is also being proclaimed as leading to a brave new world of health care. For example, <blockquote>Jim Taylor, the chief executive of the University of Louisville Hospital, says his institution's future depends on an ambitious statewide merger with two other hospital systems. Now, he has to persuade others that he's right.</blockquote> These mergers often are meant to lead to the creation of large, vertically integrated health systems which may include hospitals, physicians and other health professionals (sometimes as hired help), and an insurance function. It's All Been Done Before "Large, vertically-integrated health care systems," of course, were all the rage in the 1990s.  In fact, the WSJ also published a companion article by Anna Wilde Mathews that suggested "it has all been done before," it did not necessarily work then, and therefore, it may not work now. One example used in the <a href="http://online.wsj.com/article/SB10001424052970204319004577086330087780146.html">latter article </a>: <blockquote>Perhaps the most dramatic flameout was the Allegheny Health, Education, and Research Foundation. Starting in the mid-1980s, it was built from a Pittsburgh hospital into a statewide system through hospital and doctor-practice acquisitions. In 1998, AHERF, as it was called, became the U.S.'s largest health-care nonprofit bankruptcy. Its debts became unsustainable after it piled on too many money-losing assets, failed to manage the new primary-care physicians successfully, and lost money on capitated business, according to an account published in Health Affairs in 2000. The hospitals' moves in the 1990s 'did not improve quality, they did not reduce costs. In fact they increased everyone's spending,' partly because some hospitals eventually used their bulked-up leverage to push for higher rates, says Lawton Robert Burns, a Wharton School professor and the AHERF history's lead author. 'Nobody's showed me we're going to do it a whole lot better this time....To expect that with one piece of legislation, everyone's going to sit around the campfire and sing kumbaya, forget about it.'</blockquote> However, the Mathews article showed that even people who ought to have been familiar with this case seemed to think that this time things would be different. For example, it included this quote from the CEO of Humana which had problems with the integrated model in the 1990s: <blockquote>'It's not like we don't understand what we are getting back into here,' said Michael B. McCallister, Humana's CEO, at an investor conference. 'But things have changed.'</blockquote> Maybe so, but maybe if the enthusiasts of the resurrected vertically integrated health system model realized how badly things went in the past they would not be so optimistic. A More Complete Version of the AHERF Story In fact, Professor Burns' take on the AHERF bankruptcy above did not seem to reflect all that went on then. A somewhat more pointed summary of that massive failure had appeared in 2008. Then, Moody's Investor Service issued a report on the 10 year anniversary of the fall of the house of AHERF. Per <a href="http://www.post-gazette.com/pg/08204/898514-28.stm">an article again by Steve Twedt in the Pittsburgh Post-Gazette</a>, who also wrote a significant <a href="http://www.post-gazette.com/aherf/">series</a> in the same newspaper summarizing the collapse of AHERF, <blockquote> From the distance of 10 years, the historic bankruptcy of Allegheny General Hospital's then-parent organization still offers valuable lessons for today's health-care industry, says a new report by Moody's Investor Service. 'AHERF left such a stain, such an indelible mark on hospital management teams, they realized that if one of the big systems can fail, no one is immune,' said Lisa Goldstein, leader of the Moody's health-care team that produced the report. On July 21, 1998, Allegheny Health and Education Research Foundation (AHERF) defaulted, resulting in what is still the largest bankruptcy ever among the 560 Moody's-rated not-for-profit health-care entities. At the time, AHERF had $2 billion in revenue and $555 million in outstanding debt, according to the Moody's report. Analyst Lisa Martin, who wrote the report, says industrywide forces converged with 'the organization's own management and governance failures' to cause the foundation's failure. The external forces included Medicare reimbursement cuts -- still an issue a decade later -- and highly competitive markets in both Pittsburgh and Philadelphia. But, she added, 'we believe its ultimate downfall was driven more by decisions of the organization itself -- weak governance, poorly executed strategies, lack of refined leadership, and absence of methodical execution.'</blockquote> Even that version seems too polite. Although the AHERF bankruptcy appears to be the largest failure of a not-for-profit health care corporation in US history, its story has produced remarkably few echoes for doctors, other health care professionals, health care researchers, and health policy makers. I often use the fall of AHERF as major example in talks, at least the few talks I am allowed to give on such unpleasant subjects. Rarely have more than a few people in the audience heard of AHERF prior to my discussion of it. The only scholarly <a href="http://content.healthaffairs.org/cgi/reprint/19/1/7.pdf">article </a>I could locate on the topic that discussed the case in any detail, albeit incompletely since it was written before Abdelhak's guilty plea, was written by Professor Burns, who was quoted above, and colleagues [Burns LR, Cacciamani J, Clement J, Aquino W. The fall of the house of AHERF: the Allegheny bankruptcy. Health Aff (Millwood) 2000; 19: 7-41.] I doubt the case is used for teaching in most medical or public health schools. The lack of discussion of such a significant case is a prime example of the <a href="http://hcrenewal.blogspot.com/2007/08/bling-bling-poltical-correctness-and.html">anechoic effect</a>. Therefore, let me repeat my <a href="http://hcrenewal.blogspot.com/2008/07/10-years-later-eerie-echo-of-fall-of.html">2008 summary</a> of some of important points about AHERF not found above (see also <a href="http://www.acponline.org/chapters/ri/nl-fall04.pdf">this more detailed narrative</a>, starting on page 5): <ul><li>AHERF, one of the largest health care systems of its day, was built by the poster-boy for health care  CEOs at the time, Sherif Abdelhak.</li><li>Abdelhak, who <a href="http://www.post-gazette.com/aherf/part2.asp">started as food services purchasing manager </a>at Allegeheny General Hospital, was repeatedly hailed as a "visionary" (<a href="http://www.acponline.org/journals/news/mar97/phillymc.htm">in the March, 1997, ACP Observer</a>) a "genius," and the like. His plans to create a huge integrated health care system were part of the wave of the future. Abdelhak was even invited to give the prestigious John D Cooper lecture at the annual meeting of the American Association of Medical Colleges (AAMC), which was published in Academic Medicine [Abdelhak SS. How one academic health center is successfully facing the future. Acad Med 1996; 71: 329-336.] He proclaimed then that "we will need to create new forms of organization that are more flexible, more adaptive, and more agile than ever before." And he announced that "my aim as chief executive has been to unleash the creativity and productive potential of every individual and to provide an environment that encourages teamwork" </li><li>While Abdelhak was making these grandiose promises, he paid himself and his associates very well. For example, he received $1.2 million in the mid-1990s, more than three times the average then for a hospital system CEO. He lived in a hospital supplied mansion worth almost $900,000 in 1989. Five of AHERF's top executives were in the top 10 best paid hospital executives in Philadelphia.</li><li>Although Abdelhak talked of teamwork, he warned the combined faculty of the new Allegheny University of the Health Sciences (AUHS): <a href="http://www.post-gazette.com/aherf/part6.asp">"Don’t cross me or you will live to regret it."</a></li><li>As AHERF was hemorrhaging money, Abdelhak continued to pay himself and his cronies lavishly.</li><li>After the AHERF bankruptcy, which was at the time the second largest bankruptcy recorded in the US, Abdelhak was charged with numerous felonies involving receiving charitable assets. In a plea bargain, <a href="http://www.post-gazette.com/localnews/20020830abdelhak0830p4.asp">he pleaded no contest </a>to misusing charitable funds, a misdemeanor, and was sentenced to more than 11 months in county prison.</li></ul>The Moral of the Story The story of AHERF was not merely that of an unlucky bankruptcy. It shows what can go wrong when health care adopts business practices such as jumping on the latest management band-wagons and genuflecting before imperial CEOs. Yet since the fall of AHERF, we are still hearing breathless stories about the latest wonderful plans to save health care (think about, for example, electronic medical records, pay for performance schemes, etc), and the the need to genuflect to brilliant CEOs who may turn out to be not so brilliant (think about, for example, Dr William McGuire, the former CEO of UnitedHealth, and his<a href="http://hcrenewal.blogspot.com/2010/08/despite-scandal-former-unitedhealth-ceo.html"> back-dated stock options</a>). We health care professionals need to stop falling for this hype and spin. Saving health care will take clear thinking and hard work by a lot of people. The "visionaries," if we let them, are likely to depart with a huge cache of money, leaving us and health care worse off. If it is just "not done" to talk about cases such as that of AHERF, and other examples of "recent unpleasantness," how will be learn not to fall for the propaganda? Of course, it is those who benefit from the propaganda who do not want us catching on to their game. If physicians, health professionals, health care researchers, and health policy makers do not learn the lessons of the fall of AHERF, they will be doomed to see its repetitions. With apologies to the Bare Naked Ladies - do not forget <a href="http://www.youtube.com/watch?v=Zs3xXlXSOKk">"it's all been done (before)"</a> <iframe allowfullscreen="" frameborder="0" height="315" src="http://www.youtube.com/embed/BlEW-QoJqTE" width="420"></iframe> (only live version I could find, actual song starts at about 3:00)

"It's All Been Done Before," If We Only Could Remember What it Was - the AHERF Example

A big Wall Street Journal article by Anna Wilde Mathews featured the latest wave of mergers affecting large health care organizations. Larg...

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The Center for Medicare and Medicaid Services' Quiet Coziness with Wall Street

An <a href="http://www.pogo.org/pogo-files/alerts/government-corruption/wall-street-in-washington-gc-ii-20111208.html">article</a> from the Project on Government Oversight (POGO) reveals a new aspect of the growing coziness between the US government and big corporations with obvious relevance to health care. CMS' Coziness with Leaders of the "Capital Markets" Here is the introduction and the example most relevant to health care: <blockquote>Nearly a dozen senior staff at the Centers for Medicare and Medicaid Services (CMS), the giant agency that administers hundreds of billions in federal health care dollars, had been called to a meeting. After a discussion with five Wall Street professionals that lasted nearly two hours, one senior CMS analyst filed an ethics complaint that later went to the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS). His beef: that a handful of deep-pocketed investors had won a private hearing to probe whether the agency would allow Medicare reimbursement for specific medical devices manufactured by companies in which they already held a stake or might put new money. The market for one device, already approved for Medicare, was rapidly heading toward $1 billion annually; the agency’s impending decision to reimburse competing devices could have major market impact, a shift potentially worth hundreds of millions of dollars. 'This meeting forced agency staff to redirect their attention toward a select group from Wall Street, when neither competing investors nor patient-oriented stakeholders were present,' the whistleblower told the Project On Government Oversight (POGO). 'They got to probe us for hours in private about what we planned to do and how we approached procedures for reimbursing medical devices, the mechanics and psychology of CMS decision-making, in general and with respect to these specific devices.' The meeting was set up by a former CMS employee working for the Marwood Group, an asset manager that counsels big health-care industry investors, the whistleblower says. The firm’s president is Edward 'Ted' Kennedy Jr., son of the late Massachusetts senator and a major supporter of President Obama’s health care reforms, and includes Kennedy cousins Robert F. Kennedy, Jr. and Stephen E. Smith, Jr., as senior advisors. The firm’s website highlights its staff recruitment among Congressional aides, the Executive Office of the President and CMS. One CMS veteran who joined Marwood after the 2009 meeting with Wall Streeters is Barry Straub, the agency's former Chief Medical Officer, who is also an expert on Medicare reimbursement, the website says. A company spokesman had no comment. A supervisor at CMS’s Coverage Advisory Group, which decides which services the agency will pay for, also helped organize the session with investors. The whistleblower says he was told by a supervisor that such get-togethers are 'a routine practice at CMS.' At the time, in 2009, CMS’s top administrator had an aide with the title, 'capital markets advisor,' tasked with tracking investment community activity in Washington and elsewhere. At the investor meeting, Wall Streeters asked a range of questions 'about confidential CMS information.' The whistle blower says he does not believe they received illegal disclosures, though they peppered CMS analysts with queries about the agency’s decision-making process and other sensitive matters which, if answered, could have violated the law or related regulations that bar the sharing of internal deliberations and decisions. The whistleblower first filed his complaint in April 2009. He was terminated in 2011 for being disloyal to the agency mission after he made a series of internal protests, including the objection to what he calls a pattern and practice of unfettered access to CMS staff by Wall Street investors. He says he is currently fighting his dismissal through all available legal and administrative channels. </blockquote>Implications and Summary As the POGO article put it, <blockquote>CMS does have a set of 'Open Door' policies and affords a variety of avenues for public access. The disclosure of payments to physicians and teaching hospitals by pharmaceutical companies and other interests are required under President Obama’s health reform. In practice, however, the public, not to mention competing investors and stakeholders, rarely get the kind of information and insight available in meetings like the whistleblower described.</blockquote> In general, <blockquote>A balance is necessary between the danger of too much insider access, and imposing excessive limitations. Indeed, the biggest problem with special access for Wall Street insiders is not just that they seem to get meetings and acquire information that may be privileged and non-public, but that others, including other investors, do not get a crack at the same material.</blockquote>The activities above have all the usual elements of excess corporate - government coziness.  These include enhanced access for corporate leaders beyond what any ordinary members of the public might achieve; the <a href="http://hcrenewal.blogspot.com/search/label/revolving%20doors">revolving door</a> between government service and corporate leadership; the participation of well-connected inside the beltway types, etc, etc.  It also includes the apparent formalization of representation of corporate interests, e.g., the "Capital Markets Advisor," with no parallel formalization of the public's or patients' interests.  Even more worrisome is that an effort to make this all less <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a> resulted in alleged intimidation of a <a href="http://hcrenewal.blogspot.com/search/label/whistle-blowers">whistle-blower</a>. So, let's see, CMS, the Center for Medicare and Medicaid Services, the US Department of Health and Human Services (DHHS) branch which controls the Medicare and Medicaid programs, the government run single-payer programs for the elderly, the disabled, and the poor, does not seem to be able to afford to figure out in-house how to pay physicians for specific services.  Instead, it has effectively farmed out this task to a private committee, the American Medical Association's <a href="http://hcrenewal.blogspot.com/search/label/RUC">RBRVS Update Committee (RUC</a>).  As we have <a href="http://hcrenewal.blogspot.com/search/label/RUC">discussed many times</a>, this obscure and secretive committee likely had a major role in structuring the financial incentives that favor procedures and disfavor primary care. leading to excess costs, declining access, and degrading quality.  However, CMS can afford to have a "Capital Markets Adviser" and to use up staff time briefing wealthy investors and hedge fund types.  What is wrong with this picture? In my humble opinion, government health care agencies ought to put the public's and patient's health first. They should not give special consideration to the rich, the powerful, the well-connected, whom some now call the one percent. Yet in the US we seem to have an increasingly <a href="http://hcrenewal.blogspot.com/search/label/corporatism">corporatist</a> state in which government and the plutocrats work together for their mutual interests, regulatory capture writ large. We need to restore government, and our health care agencies to being of the people, by the people, and for the people.  Obviously, true health care reform would start with the government and its officials putting patients' and the public's health first, way ahead of the financial comfort of corporate leaders.

The Center for Medicare and Medicaid Services' Quiet Coziness with Wall Street

An article from the Project on Government Oversight (POGO) reveals a new aspect of the growing coziness between the US government and big c...

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A Logical Fallacy Affecting Selection of Panelists on an FDA Advisory Committee

An old argument used to defend against criticisms of conflicts of interest was just employed in a disturbing context.  Expert Removed from FDA Advisory Committee for Having an Opinion As first reported <a href="http://www.pharmalot.com/2011/12/fda-pulls-wolfe-off-panel-over-intellectual-conflict">on the PharmaLot blog</a>, and later <a href="http://www.nj.com/business/index.ssf/2011/12/fda_disqualifies_public_citize.html">by the Newark Star-Ledger</a>, a panelist was just disqualified from voting on a US Food and Drug Administration (FDA) panel for having previously expressed an opinion about the safety of the drug up for re-evaluation.  Per the Star-Ledger, <blockquote>Federal drug regulators have notified Sidney Wolfe, one of the nation's leading advocates for drug safety, that he would not be permitted to join a committee of experts asked to review new dangers associated with a group of birth control pills, including Bayer Healthcare's top-selling Yaz. The Food and Drug Administration scheduled a meeting Thursday of two advisory committees — one on drug safety and risk management and the other on reproductive health drugs — after new information emerged on the safety of oral contraceptives containing the synthetic hormone </blockquote> Why Was Dr Wolf removed from the committee? <blockquote>The agency recently learned that Public Citizen, a non-profit consumer advocacy organization, had placed one of the contraceptives, Bayer’s Yasmine — a predecessor to Yaz — on its list of 'Do Not Use Pills' in 2002. 'He did not volunteer this information,' said agency spokeswoman Erica Jefferson. 'It was brought to our attention.' The FDA offered Wolfe two options: He could present information to the advisory committee like other members of the public or he could sit on the committee, participate in the discussion but refrain from voting.</blockquote> Logical Fallacy: False Dilemma We frequently post about <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> affecting health care decision-makers.  It is now clear (e.g., look <a href="http://hcrenewal.blogspot.com/2007/10/medical-school-leaders-conflicts-of.html">here</a>) that leading health care academics often have significant financial relationships with drug and device companies and other health care corporations which could potentially influence their clinical research, clinical teaching, health policy recommendations, or direct patient care.  These relationships are frequently defended, often with <a href="http://hcrenewal.blogspot.com/search/label/logical%20fallacies">logical fallacies</a> used by those who themselves have conflicts.  One common argument is based on the assertion that conflicts of interest are ubiquitous and everyone is conflicted.  Therefore, if one were to ban people with conflicts from responsible positions, there would be no one left to fill these positions, so such a ban would be untenable.  This seems to be an example of the <a href="http://www.nizkor.org/features/fallacies/false-dilemma.html">false dilemma</a>.  It is often employed by people who themselves have conflicts of interest. One way to make it appear that everyone has conflicts of interest is to broaden the concept of conflicts of interest to "intellectual conflicts of interest."  Doing this facilitates the assertion that everyone who has an opinion on a subject has a conflict of interest, so this argument implies that all sentient beings have important conflicts.  This argument would make equivalent a doctor who would not use a particular drug because his or her reading of the clinical research literature about this drug suggests its benefits do not outweigh its harms, and a doctor who advocates using the drug, and is paid $100,000 a year by the marketing division of the company that makes this drug as a marketing consultant.  The decision to prevent Dr Wolfe from voting on this committee seems to be based on this logical fallacy. As Dr Wolfe said, <blockquote>In his statement, Wolfe said if intellectual conflict of interest means being informed and subsequently having opinions on a drug, then 'many more members of advisory committees would have to be excluded.' 'For members of a scientific and technical advisory committee, possessing information and expert views on matters within the purview of the committee is not a conflict of interest,' Wolfe wrote. 'To the contrary, qualified experts are likely to have developed views on a variety of subjects based on their professional experience.'</blockquote> As Larry Husten wrote <a href="http://cardiobrief.org/2011/12/08/oops-she-did-it-again-fda-disinvites-another-advisor">on the CardioBrief blog</a>, <blockquote>do we really want to choose advisory committee panelists who have never expressed opinions about the topics they are reviewing? Are we reaching the point where potential FDA panelists will be required, like Supreme Court nominees, to have avoided any discussion of all important issues at every point in the past?</blockquote> Thus they point out the absurdity of banning people with "intellectual conflicts of interests," that is, with relevant opinions, as if they had real conflicts of interest. (But wait for someone to argue that if Wolfe were allowed to serve, it would be unfair to ban anyone with financial conflicts of interest from serving.) What is most distressing about this case is that the sort of fallacious arguments usually employed by the conflicted to defend conflicts of interest are now being employed by leaders of government agencies, who are supposed to not have their own conflicts, and to serve the people, and in this case, to be dedicated to improving the health and safety of the population and of individual patients. Every fallacious argument made in support of financial conflicts of interest affecting health care decision makers suggests we need to do more to combat such conflicts.  At an absolute minimum, all such conflicts should be fully disclosed in detail in any context in which they possibly could influence medical research, medical education, clinical care, or health policy.  Furthermore, we need to work towards ending as many such conflicts as possible.  A good starting point would be the recommendations made by the Institute of Medicine committee reports on <a href="http://iom.edu/Activities/Workforce/ConflictOfInterest.aspx">conflicts of interest</a>, and <a href="http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust.aspx">clinical practice guidelines</a>. See also comments by Merrill Goozner <a href="http://gooznews.com/?p=3421">on the GoozNews blog</a>. ADDENDUM (9 December, 2011) - In response to comments below, see two posts by Dr Howard Brody in the Hooked: Ethics, Medicine, and Pharma blog on the problems with the concept of "intellectual conflict of interest" - <a href="http://brodyhooked.blogspot.com/2007/12/intellectual-bias-latest-salvo-from.html">here</a> and <a href="http://brodyhooked.blogspot.com/2008/03/more-on-intellectual-conflict-of.html">here</a>. ADDENDUM (9 December, 2011) -  See further discussion by posted by Dr Brody today <a href="http://brodyhooked.blogspot.com/2011/12/intellectual-conflict-of-interest-rides.html">here</a>.

A Logical Fallacy Affecting Selection of Panelists on an FDA Advisory Committee

An old argument used to defend against criticisms of conflicts of interest was just employed in a disturbing context. Expert Removed from F...

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