How an interview for Kaiser Health News rekindled memories of health IT dysfunction in the 90's that persist in the 10's

I was interviewed in my home yesterday by Jay Hancock, Senior Correspondent, <a href="http://www.kaiserhealthnews.org/About.aspx" target="_blank">Kaiser Health News</a> about my background, how I got to the current point in my Healthcare Informatics career, my opinions on the state of health IT in 2012, and related matters<span style="color: windowtext;"> for a possible article</span>:<br /><br /><blockquote class="tr_bq">Kaiser Health News (KHN) is a nonprofit news organization committed to in-depth coverage of health care policy and politics. KHN’s mission is to provide high-quality coverage of health policy issues and developments at the federal and state levels. In addition, KHN covers trends in the delivery of health care and in the marketplace.<br /><br />KHN is an editorially-independent program of the <a href="http://www.kff.org/" shape="rect" target="_blank">Kaiser Family Foundation</a>, a non-profit private operating foundation, based in Menlo Park, Calif., dedicated to producing and communicating the best possible analysis and information on health issues. </blockquote><br />Mr. Hancock has quoted me regarding health IT in the past in his current role and when he was a reporter for the Baltimore Sun, for instance in the April 2012 article "<a href="http://www.washingtonpost.com/health-insurance-companies-push-to-diversify-raises-concerns/2012/04/27/gIQAWoSkoT_story.html" target="_blank">Health insurers’ push to diversify raises ethical concerns</a>" that appeared in the Washington Post as well, and the Nov. 2011 article "<a href="http://weblogs.baltimoresun.com/business/hancock/blog/2011/11/advice_to_hospitals_be_careful.html" target="_blank">Advice to hospitals: Be careful what you bill for</a>" in the Baltimore Sun.<br /><br />Mr. Hancock wanted to get an understanding of me, the person.  In doing so, I dug out some of my past technology "toys" to show him at the onset of the interview.  <b>Ironically, doing so reminded me of some irritating occurrences in the past that both inform present views, and served as early experiences in why health IT suffers the problems it does.</b><br /><br />I will illustrate by showing some of the devices I presented to Mr. Hancock in order for him to better know my interests/knowledge of technology, and then presenting the unpleasant recollections that doing so brought on.<br /><br />Bear with me for a few moments (and pictures). <br /><br />I showed Mr. Hancock devices I'd built and/or used in teaching such as (click to enlarge):<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhNI2bBd1cOfE5MXq_R7FhoDuqo7tsA0MIEZM-DFZRq2L_RF0nbjYKfMTqCbBLXMf05XS_DIX3LXnmrJC14UHPKHVGxIqkzRF_p0dJtjzyaXY4Ku6kswyTxr4uM62C-SoiTDDjY3RX_XHqE/s1600/monitor.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="184" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhNI2bBd1cOfE5MXq_R7FhoDuqo7tsA0MIEZM-DFZRq2L_RF0nbjYKfMTqCbBLXMf05XS_DIX3LXnmrJC14UHPKHVGxIqkzRF_p0dJtjzyaXY4Ku6kswyTxr4uM62C-SoiTDDjY3RX_XHqE/s1600/monitor.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><i style="mso-bidi-font-style: normal;">An infrared-sensing heart monitor I built in 1980 during a clerkship in biomedical engineering, Boston University Hospital, 1980</i></td></tr></tbody></table><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjLRMslJ-L6uo5Up8v3f8gW6Tpn1DsKPohhPgjvkTPgXFzTIiBvxK4QWY04-9OZAPrwntaxdyaXc3FpVl_eBpxroWG5Pbjs1u0pi9D_3uU0e6N2bsn44mmgGA3GlflHNkoBoRJWSjK3E_ET/s1600/monitor_inside.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="264" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjLRMslJ-L6uo5Up8v3f8gW6Tpn1DsKPohhPgjvkTPgXFzTIiBvxK4QWY04-9OZAPrwntaxdyaXc3FpVl_eBpxroWG5Pbjs1u0pi9D_3uU0e6N2bsn44mmgGA3GlflHNkoBoRJWSjK3E_ET/s1600/monitor_inside.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span class="GramE"><i style="mso-bidi-font-style: normal;"><span style="color: windowtext;">Inside the heart monitor.</span></i></span><i style="mso-bidi-font-style: normal;"><span style="color: windowtext;"><span style="mso-spacerun: yes;">  </span>I etched and drilled the printed circuit boards myself.</span></i></td><td class="tr-caption" style="text-align: center;"></td><td class="tr-caption" style="text-align: center;"></td></tr></tbody></table><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjfaQ4LIqHZqETVHyBYLKV7nBObQVnYUWtTMyFPyCPsLa0TFUf7OPEyf3-MsobysGudPtzn-AikRxWl0IQF8mB_TPCoCWMEmHpu_WNA-6MKmEy2HZhMrPq1Ws_5mAQkjl5Vhi5uM9RwHF3N/s1600/pbox.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="264" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjfaQ4LIqHZqETVHyBYLKV7nBObQVnYUWtTMyFPyCPsLa0TFUf7OPEyf3-MsobysGudPtzn-AikRxWl0IQF8mB_TPCoCWMEmHpu_WNA-6MKmEy2HZhMrPq1Ws_5mAQkjl5Vhi5uM9RwHF3N/s320/pbox.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">A 3-transistor breadboard shortwave radio I built as a kid.</td></tr></tbody></table><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhRBkW3a2lwQrI8Z1iqGOfk9HVmZYLs3atqSj2DqdhEAzgtbr11HcMJQ0UkAQuradR-gr4UeEQk1GcJDAnwyAxgC9PbIwQknRZtk7mnjajZDhoS7AnABcvRkc-EzIfRrIeVxrv0ereDyMJx/s1600/hw101.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="201" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhRBkW3a2lwQrI8Z1iqGOfk9HVmZYLs3atqSj2DqdhEAzgtbr11HcMJQ0UkAQuradR-gr4UeEQk1GcJDAnwyAxgC9PbIwQknRZtk7mnjajZDhoS7AnABcvRkc-EzIfRrIeVxrv0ereDyMJx/s1600/hw101.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><i>A somewhat more sophisticated radio kit.  My <span class="SpellE">Heathkit</span> HW-101 ham radio transceiver, built myself over several months when I was a medical trainee.  Also built its matching power supply box, not shown.</i></td></tr></tbody></table><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEioHh-zMYfMv-DtCyWAxE4DsLkBTmP_l0mLMs4LSgcj90n_y6IplsjDBkyE5fFqKU7VaFeMbqzJf9r1R_TLMwZoUbeDVh-5PogmI3F1rJugTWpJcDwqRi_bzsz37ZnkqPL4sp6xJSA9sjxc/s1600/hw101_inside.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="275" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEioHh-zMYfMv-DtCyWAxE4DsLkBTmP_l0mLMs4LSgcj90n_y6IplsjDBkyE5fFqKU7VaFeMbqzJf9r1R_TLMwZoUbeDVh-5PogmI3F1rJugTWpJcDwqRi_bzsz37ZnkqPL4sp6xJSA9sjxc/s1600/hw101_inside.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><i style="mso-bidi-font-style: normal;">HW-101 innards, top view.  Not exactly a simple device.</i></td></tr></tbody></table><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjMqX4MYZmY9Ir7PY_5ldAliBxLTsZaW_yERtsdfCgBKjFsTz04ptod_hZCir8n3L_GUh8EohaUfULwL7KGBc-PHpXtCFqlmDQHDvHnupKdFuvctFnTx0_2Ue6kktj9iodAFpu42cdWhvpY/s1600/hw101_under.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="243" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjMqX4MYZmY9Ir7PY_5ldAliBxLTsZaW_yERtsdfCgBKjFsTz04ptod_hZCir8n3L_GUh8EohaUfULwL7KGBc-PHpXtCFqlmDQHDvHnupKdFuvctFnTx0_2Ue6kktj9iodAFpu42cdWhvpY/s1600/hw101_under.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><i style="mso-bidi-font-style: normal;">HW-101 underside of chassis.<span style="mso-spacerun: yes;">  </span>Each and every one of those solder connections was done by me.  In bulding it, I learned how each circuit worked (and had to debug it when, on initial powerup, smoke rose due to a defective ceramic capacitor and two bad tubes, one of which glowed a delightful cherry-red.)</i></td></tr></tbody></table><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhxcE0GYwocATWczjbtZGBlKniF-7aPALWsis0MBi5u__4pa_VHxmCing_cd6seWbzIamDdbGL2CiAb957sOGYa2nPSKlt1COjY6apzsvGBinI_W8_jq3deMH0X-mlX_LisIeDZlwzOMtBm/s1600/h8.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="194" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhxcE0GYwocATWczjbtZGBlKniF-7aPALWsis0MBi5u__4pa_VHxmCing_cd6seWbzIamDdbGL2CiAb957sOGYa2nPSKlt1COjY6apzsvGBinI_W8_jq3deMH0X-mlX_LisIeDZlwzOMtBm/s1600/h8.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><i style="mso-bidi-font-style: normal;"><span style="color: windowtext;">My <span class="SpellE">Heathkit</span> H8 computer, introduced 1977. <span style="mso-spacerun: yes;"> </span><span class="GramE">Intel 8080 processor.</span> <span class="GramE">One of the first personal computers.</span><span style="mso-spacerun: yes;">  </span>In true minicomputer style, the 8080 general registers, accumulator/flags register, program counter, stack pointer, and memory addresses were directly accessible via the front panel pushbuttons and the split-octal display.</span></i></td></tr></tbody></table><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjHGHE5EygfpJBKVtX14fYUUJfIBoAfLSl2qS0MnTelvSda98KbpWW7dgdhroNFhb12xExI1UQssJ9La2gOfpse1R4TrbQSAPkOCfLdcmzZdrMkQgnbzLH5xn0v7R0O1F3ZUqFeDd_KR7yN/s1600/h8_inside.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="251" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjHGHE5EygfpJBKVtX14fYUUJfIBoAfLSl2qS0MnTelvSda98KbpWW7dgdhroNFhb12xExI1UQssJ9La2gOfpse1R4TrbQSAPkOCfLdcmzZdrMkQgnbzLH5xn0v7R0O1F3ZUqFeDd_KR7yN/s1600/h8_inside.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span class="GramE"><i style="mso-bidi-font-style: normal;"><span style="color: windowtext;">Inside the H8.</span></i></span><i style="mso-bidi-font-style: normal;"><span style="color: windowtext;"><span style="mso-spacerun: yes;">  </span>I used this to teach computer and CPU architecture to Medical <span class="GramE">Informatics <span style="mso-spacerun: yes;"> </span>postdoctoral</span> fellows at Yale School of Medicine.<span style="mso-spacerun: yes;">  </span>I did not, and do not believe healthcare IT leaders should be mere “appliance operators.”<span style="mso-spacerun: yes;"> </span></span></i></td></tr></tbody></table><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiaQg4SB7pJYQ5Qdi4e4ld8PE41FFf2XnL-l8kA0woZYT5-WCgiS7yayoTWkekfcNI91YlDZDecsp2FTk6sWrQ030m7RDX8CVoNVLS9EOgHCgZO0X3Z6eEOXpm4t93HVe7HUstW4GhetGce/s1600/vtos.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="249" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiaQg4SB7pJYQ5Qdi4e4ld8PE41FFf2XnL-l8kA0woZYT5-WCgiS7yayoTWkekfcNI91YlDZDecsp2FTk6sWrQ030m7RDX8CVoNVLS9EOgHCgZO0X3Z6eEOXpm4t93HVe7HUstW4GhetGce/s1600/vtos.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><i style="mso-bidi-font-style: normal;"><span style="color: windowtext;">My TRS-80 Model I running VTOS 4.0, a pre-IBM PC precursor to LDOS 5 and TRSDOS 6.<span style="mso-spacerun: yes;">  </span>All were far superior to MS-DOS of any flavor in my opinion.</span></i></td></tr></tbody></table><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhm2GpffAVXmQfo1n78BVq860ijo7GEmRcNpAb9ZX4p80_nuN3399P32r8UOg40-BBBGcwLMZbLsVb79GUGLdApiKm1vSN_zkt8rWuzBN0L7xjmJhLK2hYSnqmsbKu3gbCQL-PI96d60zY1/s1600/trs80_fix.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="244" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhm2GpffAVXmQfo1n78BVq860ijo7GEmRcNpAb9ZX4p80_nuN3399P32r8UOg40-BBBGcwLMZbLsVb79GUGLdApiKm1vSN_zkt8rWuzBN0L7xjmJhLK2hYSnqmsbKu3gbCQL-PI96d60zY1/s1600/trs80_fix.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span class="GramE"><i style="mso-bidi-font-style: normal;"><span style="color: windowtext;">TRS-80 Model I about to undergo repair by me.</span></i></span></td></tr></tbody></table><br />As I mentioned before the pictures, unpacking from their storage boxes and showing this personal technology brought out numerous formative memories, and not always good ones, from my CMIO (Chief Medical Informatics Officer) days.<br /><br /><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;">Seeing all this, it may be easier to imagine why, as a CMIO in the mid 1990's I was offended when patronized by hospital IT personnel about how an information system <span style="mso-spacerun: yes;"> </span>in an invasive cardiology <span class="SpellE">cath</span>lab, a critical care area, could not be moved from unstable Windows 3.1 to Windows NT to prevent frequent crashes and data loss because “Windows NT needed RAID disk arrays” and other<span class="SpellE"><span style="color: windowtext;"> </span>B.S</span>., and also by similar personnel patronizing me on my serious concerns about ICU patients put at risk of infection by improper hardware for a biohazard-prone environment.<span style="mso-spacerun: yes;">  </span>(See <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story</a> and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU</a>.)</span></span><br /><br /><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;">I was further reminded a<span style="color: windowtext;">bout how I was </span>alarmed by the selfsame hospital IT "experts", lac<span style="color: windowtext;">ki</span>ng healthcar<span style="color: windowtext;">e and medical informatics knowledge and experience,</span> simply ignoring my cou<span style="color: windowtext;">nsel, as if medicine was a harmless parlor game to <span style="color: windowtext;">be <span style="color: windowtext;">played</span></span></span>, winner take all.  And likewise regar<span style="color: windowtext;">din<span style="color: windowtext;">g hospital seni<span style="color: windowtext;">or management who's hired me in the first p<span style="color: windowtext;">lace - at least one of whom expressed to me more conce<span style="color: windowtext;">rn for the career advancement of the IT staff than for patient safety.</span></span></span></span></span></span></span><br /><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;"><br /></span></span><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;">The latter ICU incident, in fact, directly led to my starting to write about health IT issues on the Web in 1998.  Sadly, my colleagues, as well as former students and mentees, tell me little has changed.</span></span><br /><br /><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;">That type of territorial, political behavior might perhaps be more appropriate (or at least hardly harmful) in a nail salon or pizza parlor, but not in an ICU or cardiac cath lab.</span></span><br /><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;"><br /></span></span><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;">Yet today's health IT domain is rife with leadership by health IT amateurs</span></span><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;"><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;">**</span></span> [see note below] who patronize, bully and play nasty politics with healthcare informatics-educated clinicians and specialists, and accuse clinicians of being "Luddites" for resist<span style="color: windowtext;">ing <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" target="_blank">bad health IT</a> pushed on them <span style="color: windowtext;">by hyperenthusia<span style="color: windowtext;">sts (<a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">Ddulites</a>) who ignore the downsides</span></span>. </span> </span></span><br /><br /><blockquote class="tr_bq"><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;"><span style="font-size: x-small;"><b><span style="color: black; font-family: Arial;">Good Health IT</span></b><span style="color: black; font-family: Arial;"> ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps <span class="SpellE">eHealth</span>information secure, protects patient privacy and facilitates better practice of medicine and better outcomes.  <br /><br /><b>Bad Health IT</b> ("BHIT") is defined as 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 <span class="SpellE">hypervigilance</span> (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.   </span></span></span></span></blockquote><br /><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;">What is lost in these dysfunctional dynamics is that the true "customer" who suffers is the patient.<span style="color: windowtext;">  Patients </span>come to the hospital sick and with expectations that the personnel there will put the patients' interests first.  If they are injured or leave in a pine box, they care little about who<span style="color: windowtext;">se political empires were threatened<span style="color: windowtext;"> by internecine and/or industry battles over IT.</span></span></span></span><br /><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;"><br /></span></span><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;">Mr. Hancock's Kaiser Health News profile of me, if published, should prove interesting.   It will probably mention my own relative's injury and death related to health IT, and may cite the Complaint itself, a public document.  </span></span><br /><br /><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;">I will link to it when it if an<span style="color: windowtext;">d when it </span>appears. </span></span><br /><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;"><br /></span></span><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;">-- SS</span></span><br /><br /><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;">** </span></span><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;"><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;">(<span style="color: windowtext;">Amateur, </span>used in the same sense that I am a <a href="http://www.arrl.org/" target="_blank">radio amateur</a> licensed by the government <span style="color: windowtext;">after a series of written exams, </span>but not a professional te<span style="color: windowtext;">lecommunications engineer, </span>knowing I would not want to, nor should be allowed to, lead a mission critical telecommunications project.)</span></span></span></span><br /><br /><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;"><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;">----------------------- </span></span></span></span><br /><br /><b><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;"><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;">Feb. 18, 2013 <span style="color: windowtext;">Addendum:</span></span></span></span></span></b><br /><br /><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;"><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;"><span style="color: windowtext;">The art<span style="color: windowtext;">icle was published as <a href="http://hcrenewal.blogspot.com/2013/02/kaiser-health-newsphiladelphia-inquirer.html" target="_blank">here</a>.</span></span></span></span></span></span><br /><br /><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;"><span style="mso-bidi-font-style: normal;"><span style="color: windowtext;"><span style="color: windowtext;"><span style="color: windowtext;">-- SS </span> </span> </span></span></span></span>

How an interview for Kaiser Health News rekindled memories of health IT dysfunction in the 90's that persist in the 10's

I was interviewed in my home yesterday by Jay Hancock, Senior Correspondent, Kaiser Health News about my background, how I got to the curre...

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The Parts of Professionalism We Are Not Supposed to Discuss

A recent article in a a relatively obscure medical ethics journal dared to approach some important aspects of medical ethics that medical ethicists fear to discuss, but did not address the reasons for this fear or what to do about it. (Glenn JE. The eroding principle of justice in teaching medical ethics.  HEC Forum 2012; 24: 293-305.  Link <a href="http://link.springer.com/article/10.1007%2Fs10730-012-9199-4">here</a>.)<br /><br /><b>The Basic Ethics Case - A Prescription for the Patient's Spouse? </b><br /><br />Glenn began with a case typically discussed in medical school ethics courses: <br /><br /><blockquote class="tr_bq">a scenario where a standardized patient asks the student at the end of the examination if his prescription can be written in his spouse’s name as the spouse has health insurance which includes prescription drug coverage while the patient does not.</blockquote><br />This <br /><br /><blockquote class="tr_bq">poses the question as to whether it is ethical for physicians to deceive third party payers to secure coverage for their patients.</blockquote><br /><b>The Politically Correct Way to Teach the Case </b><br /><br />Glenn stated that there is a politically correct way for faculty to teach this case:<br /><br /><blockquote class="tr_bq"> Though we are never expressly instructed to tow [sic] a party line,<i> there is a 'correct' answer to this ethical quandary as far as the institution we work for is concerned</i>. Students who express a willingness to practice deception of third party payers for the good of their patients are to be commended for having their heart in the right place. However, we discuss many reasons why this action would not be a good solution to the problem. One of the issues is that to do so would be committing fraud.</blockquote><br />Now, of course, writing a prescription for a patient who does not actually need the drug in question, understanding that the patient will give the drug to someone else who does not have insurance coverage to pay for it, is dishonest.  However, the larger point that Glenn made is that it is not politically correct to allow discussion about why the patient made such a request in the first place, and that this ought to be troubling.<br /><br />Note that Glenn did not explain how he inferred what the "correct" answer was, nor its actual source within the institution.<br /><br /><blockquote class="tr_bq">Over the first few years of having this conversation with young medical students, I have always come away feeling empty and flat. Framed as a session on the ethics of 'truth telling,' the conversation and the readings we provide to prepare for it works to <i>obfuscate the much larger ethical issue</i> impossible to tackle in an hour’s time. In essence, 'truth telling' is only a secondary ethical issue at play. <i>The more important ethical issue is a question of social justice: what commitment do doctors have to poor patients and making sure that they get the health care services that they need?</i></blockquote><br /><b>Social Justice as Part of Professionalism, and its Avoidance</b> <br /><br />The article by Glenn then emphasized that some of the original conceptions of physicians' professionalism included social justice.  A definition promulgated by Herbert Swick in 2000 expressly included these relevant competencies.  Physicians ought to:<br />-  subordinate their own interests to the interests of others<br />-  respond to social needs and work toward the benefit of the communities in which they live and serve<br />-  adhere to the core humanistic values of honesty and integrity, compassion, altruism, empathy, respect for others, and trustworthiness.<br /><br /><br />Glenn noted that these three competencies, however, have been turned into a more narrow imperative, that<br /><br /><blockquote class="tr_bq">doctors should treat patients with an equally high quality irrespective of their race, ethnicity, gender, religion or cultural background according to what is best for them. In most codes of professionalism, however, class is <span class="EmphasisTypeItalic">not</span> expressly implicated.</blockquote><br />Note that Glenn did not question why the issues of race, ethnicity, gender, religion, or cultural background became important in this context.  He did further question why the issue of class did not.  While<br /><br /><blockquote class="tr_bq"> The professionalism code adopted by the American Board of Internal Medicine in 1999 was bolder and specifically states that doctors <span class="EmphasisTypeItalic">are</span> to advocate for 'the best possible care [for their patients] regardless of the ability to pay'</blockquote><br />Glenn asked<br /><br /><blockquote class="tr_bq"> But where in the medical school curriculum <i>do we teach medical students to be strong patient advocates and take on third party payers and hospital administrators?</i> We now discuss the importance of prescribing generic drugs and we warn against the influence of big pharma, but when do we teach students to rebel against the high cost of medical education that drives students toward boutique medicine and fields of specialty care that offer the most money and most comfortable lifestyles?</blockquote><br />Furthermore, he noted,<br /><br /><blockquote class="tr_bq"> When it comes to justice in medical ethics instruction,<i> the parameters of the discussion are usually constricted to focus on the conservation of health care resources and rationing care rather than providing more care to more patients.</i></blockquote><br />So, now seemingly getting to the key question,<br /><br /><blockquote class="tr_bq">We have created an entire system where all the middlemen that stand between a patient and her health care are expecting to get rich. No oath or professionalism curriculum is structured to teach medical students how to ethically and morally navigate through that. How did the terms of the debate get so co-opted by the health care economists?</blockquote><br /><b>The Key Question also Avoided </b><br /><br />However, after this build up, Glenn then had trouble grappling with that question.  He noted that the prices of various parts of US health care are rarely questioned, and wrote about some of the particular issues in pricing new technologies, including the costs of development of new drugs, the tax treatment of drug development, and whether the licenses drug companies obtain from universities to develop drugs are fairly priced.  He also touched on the rising cost of medical school tuition and students' consequent assumption of large levels of debt.  This was interesting, and provided some useful references, but never really directly addressed the key questions above: why was the discussion framed in terms only of current health economics, and more importantly,  why did he and other ethicists feel they could not openly discuss any larger issues?<br /><br />Only at the very end of the article did this appear<br /><br /><blockquote class="tr_bq">the structure of our current medical system has created a<i> network of health care providers, researchers, purveyors and administrators who have strong financial incentives to work against the best interests of patients.</i> This situation makes it difficult to talk with students about the ethical principle of justice in any meaningful way that is not hypocritical, leaving it seldom emphasized relative to the other three core principles of medical ethics.</blockquote><br />Glenn did not further explain these "financial incentives," detail further who had them, explain how they "work against the best interests of patients," and most importantly, explain how these incentives make "it difficult to talk with students about the ethical principal of justice in any meaningful way that is not hypocritical."  He concluded only<br /><br /><blockquote class="tr_bq"> How can we cultivate within our students an understanding of the threats to medical professionalism <i>posed by the conflicts of interest inherent in the various financial and organizational arrangements in the practice of medicine?</i>  We start by not shying away from the conversation.</blockquote><br /><b>Summary</b><br /><br />So Professor Glenn argued that social justice has been considered part of health care ethics, and that ethicists should teach about it by questioning the current economic arrangements within the health care system.  He then suggested that ethicists have been somehow pressured not do raise such questions, and that this pressure has something to do with <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">perverse incentives</a> and <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> prevalent within health care.  However, he never actually addressed who pressured the ethicists, how the pressure was applied, and how that pressure was related to conflicts of interest.<br /><br />Thus, it seems that authors in scholarly health care journals may now hint that there are certain things one must not discuss, that are taboo to discuss in health care, but cannot actually say what exactly is taboo, and why it became that way.  Thus, the article by Glenn seems related to what we sometimes coyly call the "<a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>,"  that the issues we discuss on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> often do not seem to be considered topics of polite conversation.  But in a strange recursive way, the article never could quite manage to discuss what it is it said others cannot discuss, which in a way just further validates the importance of the anechoic effect.<br /><br />The Glenn article is reminiscent of another article we <a href="http://hcrenewal.blogspot.com/2012/01/elephants-we-can-notice-but-cannot-name.html">posted</a> about.  That article, by Souba and colleagues,  found that there are many "elephants," that is,  unmentionable subjects, in academic medicine,  However, that article also never clearly defined what these unmentionable subjects actually are, other than subjects that displease those in power.  Thus this too reinforced just how taboo these topics are.  Even those willing to admit that taboo topics exist are still unable to name them.<br /><br />At least the Glenn article did suggest, however vaguely, a relationship between conflicts of interest and the anechoic effect.  We have documented that <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">individual </a>and<a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest"> institutional</a> conflicts of interest are rampant in health care, including, and probably particularly academic medicine.  For example, pharmaceutical companies (and also all sorts of other health care corporations) may pay medical school faculty members and administrators (as consultants, <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">"key opinion leaders,"</a> speakers, advisers, even board members).  The leaders of academic medicine seem particularly prone to such conflicts. For example, a majority of US medical school department chairs have significant financial relationships with health care corporations (see post <a href="http://hcrenewal.blogspot.com/2007/10/medical-school-leaders-conflicts-of.html">here</a>).  We have shown how top medical school leaders may simultaneously serve on the boards of directors of health care corporations (see post <a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html">here</a>). Such health care corporations may now also support various aspects of medical academia (through research grants, "unrestricted" and other educational grants, other gifts to hospitals and universities, etc).  Financial conflicts of interest may help to directly enrich many faculty and academic leaders, and indirectly enrich them by enriching their organizations. People who are personally profiting from relationships with health care corporations are unlikely to question such relationships.  The leaders of organizations which depend on funding from such corporations are unlikely to question whether conflicts of interest might lead to corruption.  People whose colleagues, friends, family members, or supervisors are personally benefiting from conflicts of interest may hesitate to challenge such relationships.   Since these relationships permeate the economics of health care, is it any wonder that the entire topic has become taboo?   <br /><br />So the first step in challenging this taboo is to acknowledge it exists, and to not "shy away" from discussing it, as Glenn suggested.  People are beginning to acknowledge there is an elephant in the room.  Now we have to describe the elephant, discuss the elephant, and eventually figure out how to get the elephant out of the room.      <br /><br />Hat tip - to the <a href="http://blog.abimfoundation.org/recommended-reading-november-3-9/">Medical Professionalism Blog</a>.

The Parts of Professionalism We Are Not Supposed to Discuss

A recent article in a a relatively obscure medical ethics journal dared to approach some important aspects of medical ethics that medical et...

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The Life of a Clicker, and Putting the "A" back in "SOAP"

A brief post.<br /><br />I found these two recent links worthy of perusal:<br /><br /><a href="http://livewellthy.org/2012/11/14/the-life-of-a-clicker.aspx" target="_blank">The Life of a Clicker</a> - by a Family Physician - describes how EHRs have turned physicians into "clickers", at their own expense, and double-binds them - damned if they do, damned if they don't.<br /><br /><a href="http://173.254.12.148/?p=1881#comment-222141" target="_blank">Electronic notes as "yard sales"</a> - one has to wade through a huge pile of garbage to find a single useful item A comment to a post on Bob Wachter's blog.<br /><br />Indeed. <br /><br />-- SS

The Life of a Clicker, and Putting the "A" back in "SOAP"

A brief post. I found these two recent links worthy of perusal: The Life of a Clicker - by a Family Physician - describes how EHRs have tur...

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Corporate Medicine Marches On - Putting Revenue Ahead of Patients

The ongoing transformation of physicians from independent professionals to corporate employees has attracted considerable recent media attention.<br /><br /><b>The Ranks of Corporate Physicians Grow</b><br /><br />Several articles noted examples of the rush to corporate medicine.  In early November, Anna Wilde Matthews<a href="http://online.wsj.com/article/SB10001424052970203347104578100774135846646.html"> wrote</a> in the Wall Street Journal about the push by for-profit health insurer/ managed care organization/ hospital chain Humana to hire more physicians to provide direct patient care.  <br /><br /><blockquote class="tr_bq">The insurer said Monday it is spending around $500 million in cash—or $850 million including debt—to acquire Metropolitan Health Networks Inc, a Boca Raton, Fla., company that operates health-care-provider networks serving people on Medicare, Medicaid and other plans. </blockquote><br />Also,<br /><br /><br /><blockquote class="tr_bq">Humana also said its Concentra unit had acquired 55 primary-care practices in 2012.<br />Between direct employment, owning stakes in practices, or close contracting that also involves providing services to the doctors, Humana said it had close ties with around 2,300 physicians, and it planned to add 300 to 400 next year.</blockquote>An <a href="http://www.bloomberg.com/news/2012-11-19/hospital-medicare-cash-lures-doctors-as-costs-increase.html">article</a> in Bloomberg in mid-November noted how several large for-profit hospital chains were seeking to hire physicians to provide direct patient care. <br /><br /><blockquote class="tr_bq">This year, HCA increased the number of doctors it employs through acquisitions and direct hiring by about 150 to 200 for a total of 3,200, said Samuel Hazen, president of operations for HCA, on a conference call Nov. 1 with analysts. The Nashville, Tennessee-based company plans to continue expanding the number of doctors it employs, though at a slower pace than over the past several years, he said.<br /><br />Tenet spokesman Rick Black said acquiring physician practices is part of the company’s effort to 'ensure our hospitals provide the medical services needed by the communities they serve, and to foster the development of ongoing clinical initiatives that improve the quality of care that is delivered to patients and control costs.' He declined to comment on how many physicians Dallas-based Tenet has added through acquisitions. </blockquote><br />Focusing on cardiology, the article highlighted a larger trend,<br /><br /><blockquote class="tr_bq">In Wisconsin, the <i>number of heart doctors in private practice has declined to 11 percent from 62 percent of cardiologists in 2007</i>, according to the American College of Cardiology, whose main offices are in Washington.  <i>The trend is similar nationwide</i>. The number of heart doctors working for U.S. hospitals has more than tripled, while the number in private practice has fallen 23 percent over five years, the ACC said. </blockquote><br />An <a href="http://www.ama-assn.org/amednews/2012/11/19/bil21119.htm">article</a> in the American Medical News provided the big picture,<br /><br /><blockquote class="tr_bq"><i>Only 36% of practicing physicians will hold a practice ownership stake by the end of the 2013, down from 57% in 2000</i>, according to Accenture’s analysis of data from the American Medical Association and MGMA-ACMPE.</blockquote><br />These and several other articles began to describe the adverse effects of having physicians employed by corporations to take care of patients.   <br /><br /><b>Excess Costs</b><br /><br />The Bloomberg article noted that the rush to employ physicians is<br /><br /><blockquote class="tr_bq">creating a new dynamic that threatens to raise the price of health care, even as the federal government and states strain to keep a lid on costs.<br /><br />Under Medicare’s tangled payment system,<i> hospitals get higher reimbursements than individual doctors</i> for cardiology treatment, as they do for other specialty services, in some cases as much as three times more. At the same time, the <i>added bargaining power gained by controlling more of the heart care in a geographic market has given large hospital systems added leverage in negotiating reimbursements from insurers</i>, such as UnitedHealth Group Inc and WellPoint Inc.<br /><br />'Clearly, in the short run, it raises costs,' said Paul Ginsburg, president of the Center for Studying Health System Change, a Washington-based nonprofit research group. 'We have a case where a physician becomes employed by a hospital and now a payer, like Medicare, has to start paying more.' </blockquote><br />Specifically,<br /><br /><blockquote class="tr_bq">Medicare, the U.S. government’s health program for the elderly and disabled, pays a hospital $400 for an echocardiogram, $180 for a cardiac stress test and more than $25 for an electrocardiogram, according to data from the American College of Cardiology. At a private physicians office, Medicare pays $150 for an echocardiogram, about $60 for a cardiac stress test and $10 for an electrocardiogram.</blockquote><br /><b>Doctors Pressured to Put Revenue Ahead of Patients' Welfare</b><br /><br />A far more serious concern is that physicians who are now reporting to corporate executives will be pushed to actions that increase corporate revenue even if they put patients at risk.  The Bloomberg article noted,<br /><br /><blockquote class="tr_bq">While they may gain more stable incomes, <i>doctors often have less freedom over how they care for their patients</i> under strict hospital protocols. Some doctors are also <i>under pressure to see more patients each day</i> when they are employed by a hospital, ... </blockquote><br />Two major examples of investigative journalism provided concrete examples of employed physicians enticed with incentives for making decisions that put revenue ahead of patients' interests, or threatened for doing the opposite.  An <a href="http://www.nytimes.com/2012/12/01/business/a-hospital-war-reflects-a-tightening-bind-for-doctors-nationwide.html">article</a> in the New York Times provided these examples<br /><br /><u>Bonuses for Early, Possibly Premature Discharge</u><br /><br /><blockquote class="tr_bq">One Florida primary care physician said he could <i>earn a $5,000 bonus for keeping patients in the hospital for less than three days</i>, according to a lawsuit he filed this year. Hospitals, which are typically reimbursed a fixed amount of money for treating a specific illness, can make more money if patients stay for shorter periods of time. </blockquote><br /><br /><u>Bonuses for Ordering Possibly Unnecessary Tests</u><br /><br /><blockquote class="tr_bq">Last month, the Justice Department reached a $9.3 million settlement with Freeman Health System, a hospital group in Joplin, Mo., which was <i>rewarding doctors it employed partly based on how many tests they ordered. </i></blockquote><br /><u>Pressure to Refer Patients Only to Other Physicians Employed by the Same Corporation</u><br />  <br /><blockquote class="tr_bq"><div itemprop="articleBody">Other physicians say they are <i>pushed to ignore what is best for patients by referring them to doctors working for the same hospital</i>. Dr. Victoria Rentel, a family practice doctor near Columbus, Ohio, recalled feeling pressured when she was employed by a local hospital to send her patients to doctors there for tests and procedures.</div><div itemprop="articleBody"><br /></div>'I routinely got reports about the money I kept in the system,' Dr. Rentel said, detailing how much revenue she was generating for the hospital through in-house referrals. </blockquote><br />Also,<br /><br /><blockquote class="tr_bq">In Boise, doctors are <i>pressured to refer only within their own system</i>, according to St. Alphonsus in its complaint. It reported a 90 percent drop in admissions to its hospitals by physicians employed by St. Luke’s. </blockquote><u><br /></u><u>Incentives for Possibly Unnecessary Admissions</u><br /><br />The Times article provided evidence that physicians were pressured to admit patients regardless of need,<br /><br /><blockquote class="tr_bq">Health Management Associates, a for-profit hospital chain; EmCare, a Dallas-based emergency room staffing company for hospitals; and other hospitals have disclosed that they are the subjects of federal investigations. Regulators are looking into <i>whether the hospitals improperly pressured physicians to admit patients.</i><br />  <br /><div itemprop="articleBody">According to two emergency room doctors who worked at Carlisle Regional Medical Center in Pennsylvania, the message could not have been clearer: <i> more patients needed to be admitted. </i></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">The doctors were employed by EmCare, whose parent company was later acquired by the private equity firm Clayton, Dubilier & Rice in 2011 as part of a $3.2 billion deal. EmCare, in turn, was under contract to provide emergency room doctors for the hospital, which is owned by Health Management Associates. In interviews, <i>doctors said that hospital administrators created targets for how many patients they should admit.</i> More admissions translated into more dollars for the hospital. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Dr. Jean-Paul Romes, one of the physicians, recalled getting phone calls in the middle of the night questioning why he had not admitted an older patient whose hospitalization he could easily have justified. 'The pressure to admit was so high,' he said. Dr. Romes left the hospital last year. </div></blockquote><br /><br /><u>How Incentives for Unnecessary Admissions are Disguised</u><br /><br />A major<a href="http://www.cbsnews.com/8301-18560_162-57556670/hospitals-the-cost-of-admission/"> report</a> on the famous muck-raking CBS television program 60 Minutes provided more detail about how Health Management Associates prettied up apparent demands to increase hospital admissions, no matter what.  The reporting was based on interviews with "more than 100 current and former employees," and featured an on air discussion with three former HMA physicians and one former HMA administrator, a video clip of a deposition by a former HMA executive vice president, and an interview with a former director of compliance with HMA.<br /><br />All asserted that HMA pressured physicians to increase admissions to an arbitrary proportion of emergency department patients, at times between 16 ad 20 percent.   Several alleged that physicians who failed to meet that "benchmark" were threatened with termination of their jobs.  For example,<br /><br /><blockquote class="tr_bq">[Dr] Cliff Cloonan: My department chief said, <i>we will admit 20 percent of our patients or somebody's going to get fired.</i></blockquote><br />A former executive vice president of HMA contended that the admission quotas came from the very top of corporate leadership.<br /><br /><blockquote class="tr_bq">In August, a former executive vice president of the hospital chain - John Vollmer - testified under oath in a deposition, that HMA's aggressive admission policies came directly from the top: CEO Gary Newsome. <br /><br /><i>[John Vollmer: Mr. Newsome's thought was that an average of 16 percent was accomplishable at all hospitals or more and we should seek to do that and make that happen.]</i><br /><br />Vollmer, who was also fired by HMA, became angry when the company lawyers challenged him.<br /><br /><i>[John Vollmer: I did my duty by informing HMA that what they are doing is wrong. You can't require them all to have 16 percent admission rates and beat up doctors and administrators and all these folks over it when you are doing it to increase your revenue for the facility.</i><br /><i> </i><i>HMA attorney: I'm going to move to strike what you just said.]</i></blockquote><br />By using such a benchmark, the hospital executives seemed to be trying to maintain "plausible deniability" that they meddled in individual treatment decisions.  No one accused executives of directing the admission of a specific patient.  However, there seems to have been no way for a doctor to achieve the "benchmark" without unnecessary admissions. <br /><br /><br /><blockquote class="tr_bq">[CBS Correspondent] Steve Kroft: They're saying, 'You will admit these people whether they're sick or not, whether they need to be hospitalized?'<br />[Dr] Scott Rankin: Correct--<br />[Dr] Cliff Cloonan: They never phrase it that way. <i>They did say admit 20 percent. The reality of that is that there's only one way that that can happen. And that is if it is arbitrary. That is, if you do admit patients that don't need to be admitted.</i></blockquote><br />Furthermore, the hospital corporation seemed to disguise the admission imperative as part of quality assurance.  This supposed quality assurance was administered through commercial health care information technology, "corporate wide computer software called Pro-MED which was installed in every emergency room. HMA says it was designed and approved by medical experts to improve the quality of patient care."  However,<br /><br /><blockquote class="tr_bq">The computer program also generated printed reports like this one evaluating each doctor's performance and productivity. On this document the doctors who hit corporate admissions goals received praise from company managers. Those who didn't knew it.<br /><br />[Dr] Cliff Cloonan:<i> The primary purpose of the scorecard was to track how you were doing in terms of revenue generation based on number of tests ordered and number of patients admitted to the hospital.</i><br />[Dr] Scott Rankin: It has nothing to do with patient safety and patient care. It has everything to do with generating revenues. <br /><br />They say that <i>when a doctor decided send to an emergency room patient home, the computer would often intervene</i>, prompting the doctor to reconsider. <br /><br />[Dr] Jeff Hamby: The minute I hit 'Home', it says, 'Qual Check.' And then it comes up with a warning, 'This patient meets criteria for admission. Do you want to override?' <br />[CBS Correspondent] Steve Kroft: What was the reaction from the administrators if you overrode the computer?<br /><br />[Dr] Jeff Hamby: It was like being called to the principal's office. </blockquote><br /><b>Summary</b><br /><br />Recent articles in the media have shown that physicians are increasingly practicing medicine as corporate employees (look <a href="http://hcrenewal.blogspot.com/search/label/corporate%20physician">here</a>).  It is not clear how physicians in this situation can make sure they are always putting the interests of their individual patients ahead of other interests, including their corporate leaders' interests in increasing revenue and enriching themselves.  The most recent media reports discussed above add to the evidence that corporate physicians are constantly pressured to put short-term revenue generation ahead of patient welfare, and that they may specifically be pushed to admit patients unnecessarily, order unneeded laboratory tests, and discharge patients prematurely to satisfy corporate dictates.  One new wrinkle in this latest set of reports is how corporate executives may try to pretty up what they are doing by cloaking their actions within the quality assurance rubric, thus corrupting another important and well-intentioned component of health care.<br /><br />The American Medical Association once declared "<i><b>the practice of medicine should not be commercialized, nor treated as a commodity in trade." </b></i>(Look <a href="http://hcrenewal.blogspot.com/2009/06/why-did-us-physicians-give-up-their.html">here</a>)  Despite such historic but now seemingly forgotten exhortations, and a complete lack of evidence of any benefits of the corporate practice of medicine to patients' or the public's health that might outweigh its obvious risks, the new movement to make every doctor a corporate employee marches on. <br /><br />A false hope of some resistance to it was just raised by that same American Medical Association in its new "<a href="http://www.ama-assn.org/resources/doc/hod/ama-principles-for-physician-employment.pdf">AMA Principles for Physician Employment</a>," but this only provided the ambiguous advice,<br /><br /><blockquote class="tr_bq">A physician’s paramount responsibility is to his or her patients. Additionally, given that an employed physician occupies a position of significant trust, he or she owes a duty of loyalty to his or her employer. This divided loyalty can create conflicts of interest, such as financial incentives to over- or under-treat patients, which employed physicians should strive to recognize and address.</blockquote><br />How physicians could strive to recognize and address the inherent strong conflict of interest remains a mystery. <br /><br />Worse, while the principles recognized that physicians may be asked to sign "agreements or understandings (explicit or implicit) restricting, discouraging, or encouraging particular treatment or referral options," but rather than condemning such restraints on physicians' autonomy to give patients the best possible care, the principles only suggested that they "are disclosed to patients."<br /><br />Furthermore, while the AMA response has been weak-kneed at best, I am not aware of any stronger responses from any other professional societies, or from state licensing boards, physician accrediting organizations, or any other organizations that are supposed to be concerned about patient's and the public's health, or about physicians' professionalism.<br /><br />As I have said before, we need to challenge the notion that direct health care should ever be provided, or that medicine ought to be practiced by for-profit corporations. I submit that we will not be able to have good quality, accessible health care at an affordable price until we restore physicians as independent, ethical health care professionals, and until we restore small, independent, community responsible, non-profit hospitals as the locus for inpatient care. <br /><br />

Corporate Medicine Marches On - Putting Revenue Ahead of Patients

The ongoing transformation of physicians from independent professionals to corporate employees has attracted considerable recent media atten...

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"The Scent ... of a Casino" - Clinical Research Results as Fodder for Insider Trading

<i>"The scent and smoke and sweat of a casino are nauseating at three in the morning. Then the soul-erosion produced by high gambling - a compost of greed and fear and nervous tension - becomes unbearable and the senses awake and revolt from it."</i> - Ian Fleming.  Casino Royale.  1953<br /><br />A major theme of this blog has been threats to the integrity of clinical research.  When I started out as a young naive academician in medicine, I viewed clinical research through the lens of <a href="http://hcrenewal.blogspot.com/search/label/evidence-based%20medicine">evidence-based medicine</a>, as primarily a means to develop better evidence to aid in the care of patients, and secondarily a way to advance science and public health.  Yet in the past 20 to 30 years, clinical research has become commercialized.  Now most randomized controlled clinical trials are done to support the licensing of drugs and devices for particular indications.  Furthermore, clinical research has become de facto a primary avenue of marketing of drugs and devices.  So we have discussed endlessly how clinical research has been <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulated</a> by those with vested interests in selling drugs and devices, and may be <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed</a> when even such manipulation fails to produce results desired by commercial sponsors.<br /><br />If that was not bad enough - and it is - now there is evidence that clinical research has become the roulette wheel in an investment casino.  This is the lesson provided by new US government charges that giant hedge fund SAC Capital used insider knowledge to trade drug company stocks.<br /><br /><br />Let me try to provide a narrative of the key elements of the case.<br /><br /><b>The Key Players</b> <br /><br /><i>Matthew Martoma</i> was a " former student at Harvard Law School, ... [who] co-wrote papers on medical ethics before seeking a business degree at Stanford University and joining a little-known Boston hedge fund."  Then, "in 2006, at age 32, Martoma made it to <i>SAC Capital Advisors</i> LP and gained the attention of the firm’s billionaire owner <i>Steven A. Cohen</i>."(1)<br /><br /><i>Dr Sidney Gilman</i> is<br /><br /><blockquote class="tr_bq">an 80-year-old neurologist with expertise in neurodegenerative disorders, including Alzheimer’s disease. According to his <a href="http://www.med.umich.edu/neurology/faculty/gilman_research_bio.htm">biography</a> on the University of Michigan website, Gilman first served on the faculty at Harvard and Columbia and then had a long and distinguished career at the University of Michigan, where he was the chair of the department of neurology for many years. He is a member of the Institute of Medicine of the National Academy of Sciences and a past president of the American Neurological Association. In other words, he’s a bigshot.<br /><br />Gilman moonlighted as a consultant, working for an expert networking firm, where he provided advice to the financial industry (and which eventually led to the insider trading case), and for Elan Pharmaceuticals. In addition to his consulting for Elan, he also served as the <i>chair of the Safety Monitoring Committee for a phase II clinical trial of a highly promising (at the time) Alzheimer’s drug, bapineuzumab, under development by Elan and Wyeth</i>.(2)</blockquote><br />The owner of SAC Capital, a hedge fund worth $14 billion, is <i>Steven A Cohen</i>, "a prodigious art collector, an investor in the New York Mets, a supporter of Mitt Romney’s presidential campaign."  His "career ... has reached mythic status on Wall Street. Over the last 20 years, Mr. Cohen has amassed a multibillion-dollar fortune by posting returns averaging 30 percent a year. SAC has grown into a firm with about 1,000 employees around the world."(3)<br /><br /><b>The Maneuver</b><br /><br /><br />Per the NY Times(4),  <br /><br /><blockquote class="tr_bq">The doctor met Martoma as a consultant for an expert- networking firm based in Manhattan and had sessions with Martoma from mid-2006 to July 2008, according to the government. <br /><br />Gilman worked for Gerson Lehrman Group’s Scientific Advisory Board starting in 2002,...  </blockquote><br />Also according to the NY Times(5)<br />  <br /><blockquote class="tr_bq"><i>Dr. Gilman’s consulting work for Mr. Martoma earned him about $108,000</i>, according to court filings. Based in part on <i>Dr. Gilman’s leaks about positive developments related to the clinical trials of a new Alzheimer’s drug, SAC accumulated a roughly $700 million position in the stocks of Wyeth and Elan,</i> according to the government.<br /><br />The S.E.C. said that <i>the fund’s owner, Mr. Cohen, took a large position in Wyeth and Elan in his personal portfolio based on Mr. Martoma’s recommendation</i>. Mr. Cohen maintained his holdings even though there was significant internal debate about the wisdom of such a large position in the drug makers, the government said.</blockquote>Furthermore, per Larry Husten writing in Cardiobrief(2),<br /><br /><blockquote class="tr_bq"> While serving on the Safety Monitoring Committee of the trial, from the summer of 2006 through mid-July 2008, <i>Gilman had access to the safety (but not the efficacy) data from the trial. Throughout this period he leaked the positive safety information to his contact at SAC</i> (the enormous hedge fund), which then began to accumulate a large position in both Elan and Wyeth.</blockquote><br /><br />So, allegedly based on information from Dr Gilman, the high-ranking academic physician doubling as a data monitoring committee chair for a drug trial, paid for these services by Elan, SAC Capital and Mr Cohen made a large investment in Elan and Wyeth, the companies sponsoring the trial.<br /><br />But then, again per Husten(2),<br /><br /><blockquote class="tr_bq"> Later in June, Elan chose Gilman to present the full trial data at ICAD. Gilman did not become privy to this data until the middle of July when Elan gave him the full results of the trial. <i>The results, in sharp contrast to the earlier view in the press release, were decidedly negative, </i>offering little hope that the drug would be considered effective. Gilman apparently understood this, because <i>he immediately gave the results to the hedge fund, which then rapidly and dramatically reversed its long position on Wyeth and Elan.</i></blockquote><br />Specifically, per the New York Times(5), after<br /><br /><blockquote class="tr_bq"><i>Dr. Gilman told Mr. Martoma that patients were experiencing serious side effects</i>, prosecutors say. Afterward, <i>Mr. Martoma e-mailed Mr. Cohen</i>, telling him 'it’s important' that they speak. They spoke on the phone for nearly 20 minutes, the government says, and <i>Mr. Martoma told his boss that he was no longer 'comfortable' with the investments.</i><br /><br />The following day, SAC reversed course. <i>Mr. Cohen’s head trader sold the firm’s entire inventory of roughly 10.5 million shares of Elan and about seven million shares of Wyeth</i>, the government said. Once it had dumped the shares, <i>SAC built a short position in the two stocks, betting their value would drop.</i><br /><br />According to the S.E.C., the trader, Mr. Cohen and Mr. Martoma <i>kept the sales confidential.</i> The trade, wrote the head trader in an e-mail to Mr. Cohen, 'was executed quietly and efficiently over a four-day period through algos and darkpools' — referring to trades using algorithms and to trading platforms that do not have the same reporting requirements as the stock exchanges — 'and booked into two firm accounts that have very limited viewing access.'<br /><br />After the companies announced the results of the trials, Elan’s stock fell about 42 percent and Wyeth’s about 12 percent.<br /><br /><i>The trading allowed SAC to avoid about $194 million in losses and earn about $83 million in profits </i>on Elan and Wyeth, according to prosecutors.<br /><br />At the end of 2008, <i>Mr. Martoma received a bonus of about $9.3 million</i>, the S.E.C. said. </blockquote><br />So, having bet heavily on Elan and Wyeth based on Dr Gilman's initial information that the trial was showing positive results, SAC Capital and Mr Cohen then bet heavily against these companies based on Dr Gilman's new information that the trial would end up not showing such results.  Because they had this information allegedly before it was made public, these bets yielded huge profits.  Mr Martoma, the conduit between SAC Capital and allegedly Mr Cohen, made millions.  Dr Gilman made over a hundred thousand. <br /><br /><b>The Charges</b><br /><br />Per Bloomberg(4),<br /><br /><blockquote class="tr_bq">Martoma, 38, was accused by prosecutors in Manhattan federal court with <i>playing a lead role in what they called the most lucrative insider-trading scheme in history,</i> given the $276 million profit he allegedly helped the hedge fund achieve.</blockquote>The government started off taking a tough approach, per the NY Times(5),<br /><br /><blockquote class="tr_bq"><i>FBI agents arrested Mr. Martoma</i>, 38, early Tuesday morning at his home in Boca Raton, Fla. He was released on bail after making an appearance in Federal District Court in West Palm Beach. Mr. Martoma, who has been unemployed since leaving SAC in 2010, is expected to appear in federal court in Manhattan on Monday and enter a plea.</blockquote><br /> In addition, Dr Gilman, per Bloomberg(1), "has <i>entered into a non- prosecution agreement </i>with prosecutors in which he agreed to testify before a federal grand jury and to <i>forfeit $186,761, money which he was paid by Elan for his consulting work."</i><br /><br />Mr Cohen has not been charged.  However, according to John Cassidy writing in the New Yorker(6),<br /><br /><blockquote class="tr_bq">the complaints do <i>assert that Cohen, identified as 'Portfolio Manager A,' personally authorized many of Martoma's trades, and pocketed the bulk of the profits they generated</i>.  In a statement accompanying the indictment [US Attorney Preet] Bharara was careful to state that S.AC., and by extension Cohen, <i>reaped enormous rewards from the criminal wrongdoing,</i> even though they weren't being charged.</blockquote><div style="background-color: white; border: medium none; color: black; left: -1001px; overflow: hidden; position: absolute; text-align: left; text-decoration: none; top: -1000px;">the complaints do assert that Cohen, identified as “Portfolio Manager A,” personally authorized many of Martoma’s trades, and pocketed the bulk of the profits they generated. In a statement accompanying the indictment, Bharara was careful to state that S.A.C., and by extension Cohen, reaped enormous rewards from the criminal wrongdoing, even though they weren’t being charged. <br /><br />Read more: <a href="http://www.newyorker.com/online/blogs/johncassidy/2012/11/sharks-circle-around-hedge-fund-big.html#ixzz2DdLAchwv" style="color: #003399;">http://www.newyorker.com/online/blogs/johncassidy/2012/11/sharks-circle-around-hedge-fund-big.html#ixzz2DdLAchwv</a></div><div style="background-color: white; border: medium none; color: black; left: -1001px; overflow: hidden; position: absolute; text-align: left; text-decoration: none; top: -1000px;"><br /><br />Read more: <a href="http://www.newyorker.com/online/blogs/johncassidy/2012/11/sharks-circle-around-hedge-fund-big.html#ixzz2DdKdZcAY" style="color: #003399;">http://www.newyorker.com/online/blogs/johncassidy/2012/11/sharks-circle-around-hedge-fund-big.html#ixzz2DdKdZcAY</a></div>In addition, there is now some likelihood that there will be legal actions against SAC Capital.  The company has reportedly received a "Wells notice" that the SEC is considering pursuing such action.  In addition, according to the New York Times(7), "an additional action against SAC, or even Mr. Cohen, could involve accusations of fraud based on the so-called control-person liability theory, meaning that it was in 'control' of Mr. Martoma when he engaged in insider trading."<br /><div style="background-color: white; border: medium none; color: black; left: -1001px; overflow: hidden; position: absolute; text-align: left; text-decoration: none; top: -1000px;">the complaints do assert that Cohen, identified as “Portfolio Manager A,” personally authorized many of Martoma’s trades, and pocketed the bulk of the profits they generated. In a statement accompanying the indictment, Bharara was careful to state that S.A.C., and by extension Cohen, reaped enormous rewards from the criminal wrongdoing, even though they weren’t being charged.<br /><br />Read more: <a href="http://www.newyorker.com/online/blogs/johncassidy/2012/11/sharks-circle-around-hedge-fund-big.html#ixzz2DdKdZcAY" style="color: #003399;">http://www.newyorker.com/online/blogs/johncassidy/2012/11/sharks-circle-around-hedge-fund-big.html#ixzz2DdKdZcAY</a></div><br /><br /><b>Summary</b><br /><br />At one point, I would have simply regarded the trial of bapineuzumab as a clinical scientific experiment meant to determine if a promising new therapy would work for the important clinical problem of Alzheimer's disease, and incidentally as means to learn more about the biology of that disease.  More recently, I would have regarded the trial as primarily a means for Elan and Wyeth to persuade the US Food and Drug Administration to approve this drug as a treatment for this disease, and then if so, a means for these companies to market it.  I would have been skeptical about the value of the clinical evidence supplied by the trial to support use of this drug, but would not have dismissed this evidence out of hand.<br /><br />Now it appears that a major role of this trial was to be a roulette wheel in a Wall Street casino.  Big bettors on this wheel included people who may have had advance knowledge about the slot in which the ball would land.<br /><br />Ideally, clinical research ought to be done by people who have no particular interest in the results turning out one way or the other.  Obviously, clinical investigators as humans may have opinions about how studies might turn out.  However, they should not be in positions to gain or lose money according to the results, or to be intimidated by those with interests in having the studies obtain particular results. Our current system in which many clinical studies are funded by organizations with interests in how the results turn out has lead to numerous cases of <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> of study results, and sometimes <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression</a> of studies whose results could not be manipulated successfully in the desired direction.  Such threats to study integrity make it difficult to make the best clinical decisions for individual patients, distort health policy, and break the trust of patients who volunteered to participate in the studies.<br /><br />Now it appears that short-term stock trading that bets on the results of clinical research, sometimes informed by insider information about these results, could be another powerful external influence on clinical research that could additionally threaten its integrity.  Furthermore, as we speculated seven years ago (see <a href="http://hcrenewal.blogspot.com/2005/09/wall-street-and-clinical-trials.html">this post </a>and links backward), fear of insider trading may be making clinical research more opaque, and this opacity may allow even more control of research by sponsors (companies funding it) rather than investigators.<br /><br />We have previously suggested that real consideration ought to be given to taking clinical research out of the hands of organizations, particularly health care corporations, that have vested interests in the direction of the results.  Knowledge that clinical research is increasingly becoming a casino for stock traders and hedge funds, and that research results are becoming the stuff of insider trading should further prompt this consideration.  <br /><br /><br /><span style="font-size: x-small;"><b>References</b></span><br /><span style="font-size: x-small;">1.  Burton K, Kishan S, Van Voris B. Cohen's 'Elan Guy' Martoma dropped ethics for hedge fund.  Bloomberg, Nov 23, 2012.  Link <a href="http://www.businessweek.com/news/2012-11-23/cohen-s-elan-guy-martoma-dropped-ethics-for-hedge-fund">here</a>.   </span><br /><span style="font-size: x-small;">2.  Husten L. The doctor and the center of the insider trading scandal.  Cardiobrief, Nov 27, 2012.  Link <a href="http://cardiobrief.org/2012/11/27/the-doctor-at-the-center-of-the-insider-trading-scandal/">here</a>.</span><br /><span style="font-size: x-small;">3.  Lattman P. S.E.C. weighs suit against SAC Capital.  New York Times, Nov 28, 2012.  Link <a href="http://dealbook.nytimes.com/2012/11/28/securities-and-exchange-commission-weighs-suing-sac-capital/">here</a>. </span><br /><span style="font-size: x-small;">4.  Van Voris B, Hurtado P. Insider crackdown uses SAC manager in health-care pivot.  Bloomberg, Nov 21, 2012.  Link <a href="http://www.bloomberg.com/news/2012-11-21/insider-crackdown-uses-sac-manager-in-healthcare-pivot.html">here</a>. </span><br /><span style="font-size: x-small;">5.  Lattman P. Insider inquiry inching closer to a billionaire.  New York Times, Nov 20, 2012.  Link <a href="http://dealbook.nytimes.com/2012/11/20/federal-prosecutors-charge-former-sac-capital-trader/">here</a>.</span><br /><span style="font-size: x-small;">6.  Cassidy J. It's time for Obama to bite the hedge-fund sharks.  New Yorker, Nov 21, 2012.  Link <a href="http://www.newyorker.com/online/blogs/johncassidy/2012/11/sharks-circle-around-hedge-fund-big.html">here</a>.</span><br /><span style="font-size: x-small;">7.  Lattman P. S.E.C. weighs suit against SAC Capital.  New York Times, Nov 28, 2012.  Link <a href="http://dealbook.nytimes.com/2012/11/28/securities-and-exchange-commission-weighs-suing-sac-capital/">here</a>.  </span>

"The Scent ... of a Casino" - Clinical Research Results as Fodder for Insider Trading

"The scent and smoke and sweat of a casino are nauseating at three in the morning. Then the soul-erosion produced by high gambling - a ...

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Cybernetik Über Alles Again: HHS and Sebelius - Hospitals And Their Computers Have More Rights Than Patients

A Nov. 29, 2012 New York Times article by Reed Abelson entitled "<a href="http://www.nytimes.com/2012/11/29/business/medicare-is-faulted-in-electronic-medical-records-conversion.html" target="_blank">Medicare Is Faulted on Shift to Electronic Records</a>" observes that:<br /><br /><blockquote class="tr_bq">The conversion to electronic medical records — a critical piece of the Obama administration’s plan for health care reform — is “vulnerable” to fraud and abuse because of the failure of Medicare officials to develop appropriate safeguards, according to a sharply critical report to be issued Thursday by federal investigators <i><b><span style="color: red;">[the report from HHS OIG is </span><a href="https://oig.hhs.gov/oei/reports/oei-05-11-00250.pdf" target="_blank">here</a> <span style="color: #cc0000;">- ed.]</span></b></i> ... Medicare, which is charged with managing the incentive program that encourages the adoption of electronic records, has failed to put in place adequate safeguards to ensure that information being provided by hospitals and doctors about their electronic records systems is accurate. To qualify for the incentive payments, doctors and hospitals must demonstrate that the systems lead to better patient care, <b>meeting a so-called meaningful use standard</b> by, for example, checking for harmful drug interactions. <span style="color: red;"><i><b>[I note that meeting EHR "meaningful use" standards does not necessarily signify better care; the "standards" are experimental - ed.]</b></i></span></blockquote><br />Hospitals and doctors are lying about their EHR efforts, in order to gain incentive payments, it seems.<br /><br />In an article "<a href="http://www.publicintegrity.org/2012/11/29/11865/medicare-paid-36-billion-electronic-health-records-didnt-verify-quality-goals-were" target="_blank">IG says program is 'vulnerable' to abuse, better oversight needed</a>", Fred Schulte at the Center for Public Integrity notes:<br /><br /><blockquote class="tr_bq">... the Centers for Medicare and Medicaid Services has since paid out more than<b> $3.6 billion</b> to medical professionals who made the switch without verifying they are meeting the required quality goals, according to a new federal <a href="https://oig.hhs.gov/oei/reports/oei-05-11-00250.pdf">audit</a> to be released today </blockquote><br />Observes the CEO of the American Health Information Management Association:<br /><blockquote class="tr_bq"><br />“We’ve gone from the horse and buggy to the Model T, and we don’t know the rules of the road. Now we’ve had a big car pileup,” said Lynne Thomas Gordon, the chief executive of the American Health Information Management Association, a trade group in Chicago.  </blockquote><br />More Horse and Buggy than Model T.  At least the Model T was reasonably dependable.  <br /><br />Also mentioned is this:<br /><br /><blockquote class="tr_bq"><div itemprop="articleBody">House Republicans echoed these concerns in early October <a href="http://waysandmeans.house.gov/uploadedfiles/hhs_ehr_mu2_final.pdf" title="The letter to Ms. Sebelius.">in a letter</a> to Kathleen Sebelius, secretary of health and human services. Citing the Times article, they called for suspending the incentive program until concerns about standardization had been resolved. “The top House policy makers on health care are concerned that H.H.S. is squandering taxpayer dollars by asking little of providers in return for incentive payments,” said a statement issued at the same time by the Republicans, who are likely to seize on the latest inspector general report as further evidence of lax oversight. Republicans have said they will continue to monitor the program.</div><div itemprop="articleBody"><br /></div>In her letter in response, which has not been made public, Ms. Sebelius dismissed the idea of suspending the incentive program, arguing that it “<b>would be profoundly unfair to the hospitals and eligible professionals that have invested billions of dollars and devoted countless hours of work to purchase and install systems and educate staff</b>.”</blockquote><br /><br />I was taught "first, do no harm."  Fairness <i>to patients injured and killed</i> by this technology in its present "Horse and Buggy" state (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" target="_blank">buggy</a> being a particularly apropos term) seems not a matter of particularly high concern to HHS.   A suspension of incentives would slow the adoption rate down, necessary in order to "get the bugs" out of the technology before mass deployment and develop safety, validation and surveillance standards (currently non-existent), as I wrote in my Oct. 24, 2012 "<a href="http://hcrenewal.blogspot.com/2012/10/letter-to-us-senators-and.html" target="_blank">Letter To U.S. Senators and Representatives Who've Sought HHS Input On EHR Problems</a>."<br /><br />This is despite the fact that FDA, IOM and others have indicated the level of harm is <b>not known</b>, due to systematic impediments to diffusion of that knowledge (see IOM statements in the midsection of my post on health information technology hyper-enthusiasm <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">at this link</a>, and an internal FDA memo on HIT safety <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">at this link</a>).  <br /><br />HHS seems to care not about health and human services, or at best to be severely misguided.  "<a href="http://hcrenewal.blogspot.com/2011/10/cybernetik-uber-alles-computers-have.html" target="_blank">Cybernetik Über Alles</a>" seems their current credo.<br /><br />-- SS

Cybernetik Über Alles Again: HHS and Sebelius - Hospitals And Their Computers Have More Rights Than Patients

A Nov. 29, 2012 New York Times article by Reed Abelson entitled " Medicare Is Faulted on Shift to Electronic Records " observes th...

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What If the Institute of Medicine Wrote a Report and Nobody Followed it? - the Case of the Standards for Developing Trustworthy Guidelines

<br />For over 20 years, clinical practice guidelines (CPGs) have been touted to improve health care quality and control costs.  Enormous numbers of guidelines have been developed, but with seemingly little impact on health outcomes.  While some of those leading health care organizations have predictably blamed individual practitioners for obstinately ignoring or challenging guidelines, there is increasing evidence that maybe the guidelines themselves are part of the problem.<br /><br /> <b>An Example of a Guideline that Apparently was Not Trusted</b><br /><br />One example Dr Wally Smith and I have taught in our recurring mini-course on why physicians fail to follow guidelines (and otherwise appear not to practice in accord with others' wishes) is that of the guidelines on management of depression in primary care.  Most existing guidelines urge physicians to screen patients for (presumably mild-to-moderate) depression and treat them aggressively, with emphasis on the use of the newer anti-depressants.  These guidelines, in turn, were based on numerous published randomized clinical trials that showed that these drugs were safe and efficacious.  Yet multiple studies showed that physicians failed to follow these guidelines, and various attempts to improve their adherence did little.  So for years the assumption was that physicians at best experienced practical and system barriers to follow these guidelines, and at worst were ill-informed or irrational.  <br /><br /><br />However, information that came out gradually during the early part of the 21st century suggested that perhaps the problem was within the guidelines, not the health care professionals.  First, documents produced during New York Attorney General Eliot Spitzer's lawsuit against GlaxoSmithKline about the marketing of one of these drugs (Paxil, paroxetine) suggested that the company had suppressed clinical trial data that reflected poorly on the drug (See Kondro W.  Drug company experts advised staff to withold data about SSRI use in children.  Can Med Assoc J 2004; 170: 783.  Link <a href="http://www.cmaj.ca/content/170/5/783.full">here</a>.)    These suspicions were later fleshed out  by consideration of documents further disclosed in litigation (e.g., see <a href="http://hcrenewal.blogspot.com/2012/08/continuing-dissection-of-infamous-study.html">this post</a> and its links).  Then several studies, most particularly that by Erick Turner and colleagues, showed that numerous trials of new anti-depressants had been suppressed, that is, never published (Turner et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008; 358:252-260.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMsa065779">here</a>).  When the results of these trials were added to those that were published, the efficacy of anti-depressants was no longer so clear.  So maybe the guidelines that physicians did not follow were not trustworthy, and should not have been followed in the first place.<br /><br /><b>Would IOM Standards to Improve Guideline Trustworthiness Help?</b><br /><br />So in 2011, the prestigious Institute of Medicine released a report on the development of  better standards to produce more trustworthy guidelines (Clinical Practice Guidelines We Can Trust.  Link <a href="http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust.aspx">here</a>.)  We posted about that report <a href="http://hcrenewal.blogspot.com/2011/03/institute-of-medicines-release-reports.html">here</a>, but noted that it was receiving little other attention, an example of the anechoic effect.  <br /><br />A few weeks ago, an article appeared documenting a study meant to assess the the trustworthiness of clinical practice guidelines published soon after the IOM report.  Its title telegraphs the results. ( Kung J, Miller RR, Mackowiak PA. Failure of clinical practice guidelines to meet Institute of Medicine standards: two more decades of little, if any progress.  Arch Intern Med 2012.  Link <a href="http://archinte.jamanetwork.com/article.aspx?articleid=1384245">here</a>.)<br /><br /><b>Methods and Results</b><br /><br />The investigators selected a random sample of 114 individual guidelines available during June, 2011 stratified by 26 clinical topics. The versions of the guidelines used were those archived in the National Guideline Clearinghouse (NGC) maintained by the Agency for Healthcare Research and Quality (AHRQ).<br /><br /><br />The goal of the study was to "examine adherence to the IOM standards" by guidelines published after the standards were published.  Actually, the study only assessed adherence to 18 of the 25 standards espoused by the IOM (because the remaining seven were "too vague and subjective to be analyzed.")<br /><br />Furthermore, the criteria used to determine if a specific guideline met each of the three items above were rather lax:<br /><br /><br /><blockquote class="tr_bq">In evaluating each guideline summary, care was taken to be as liberal as possible in considering that a standard was met when the individual guideline summary provided any information pertaining to that particular standard.</blockquote><br />Nevertheless, using these lax standards to only evaluate adherence to 18/25 guidelines, the authors found that "the overall median number of IOM standards satisfied (out of 18) was 8 (44.4%) ....  Fewer than half of the guidelines surveyed met more than 50% of the IOM standards."<br /><br />An examination of the details of the study's methods reveals things are even worse than that.<br /><br /><b>Analyzing the Study's Methods to Find that Things Are Worse Than They Seem</b><br /><br />Review of the study's methods show that they provided a very optimistic view of adherence to the IOM standards.  As noted above, the study did not look for adherence to all of the IOM standards.  Moreover, those they did consider were simplified and made less rigorous.  For example, Standard 2 from the IOM on management of conflict of interest (COI) was:<br /><br /><blockquote class="tr_bq">  STANDARD 2<br />Management of conflict of interest (COI) <br /><br />2.1 <br />Prior to selection of the Guideline Development Group (GDG), individuals being considered for membership should declare all interests and activities potentially resulting in COI with development group activity, by written disclosure to those convening the GDG.<br />- Disclosure should reflect all current and planned commercial (including services from which a clinician derives a substantial proportion of income), non-commercial, intellectual, institutional, and patient/public activities pertinent to the potential scope of the CPG.<br /><br />2.2 <br />Disclosure of COIs within GDG<br />- All COI of each GDG member should be reported and discussed by the prospective development group prior to the onset of their work.<br />- Each panel member should explain how their • COI could influence the CPG development process or specific recommendations.<br /><br />2.3 <br />Divestment<br />- Members of the GDG should divest themselves of financial investments they or their family members have in, and not participate in marketing activities or advisory boards of, entities whose interests could be affected by CPG recommendations. <br /><br />2.4 <br />Exclusions<br />- Whenever possible GDG members should not have COI.<br />- In some circumstances, a GDG may not be able to perform its work without members who have COIs, such as relevant clinical specialists who receive a substantial portion of their incomes from services pertinent to the CPG.<br />- Members with COIs should represent not more than a minority of the GDG.<br />- The chair or co-chairs should not be a person(s) with COI.<br />- Funders should have no role in CPG development.</blockquote><br />However, the study boiled all this down to three items:<br />-  COIs stated<br />-  Chair has COI<br />-  Co-chairperson has COI<br /><br />Thus the study did not address standards requiring full and complete disclosure (not just some disclosure) of all COIs; consideration of how the COIs might influence the particular guideline; divestment of specific types of conflicts of interest, that is, financial investments, and cessation of participation in marketing activities or advisor boards; minimization of conflicts of all members of the committee; and barring of participation of funders in guideline development.<br /><br />Even so, the guidelines assessed did a very poor job upholding even these few liberalized standards regarding conflicts of interest.  Of the guidelines assessed, less than half, 46.8% provided ANY disclosure of conflicts of interest.  Those written by sub-specialty societies were particularly opaque in this regard.  Less than one-third, 29.3%, provided any disclosure.  Thus the majority of guidelines assessed were not at all transparent about conflicts of interest affecting the guideline development process. <br /><br />Furthermore, of the 46.8% of all the guidelines which made any disclosures of conflicts of interest, 71.4% admitted their chair people HAD a conflict of interest.  Thus, only (0.468 * [1 - .714]) = 13.3% provided assurance that they fulfilled the single requirement (from standard 2.4 above) that the chair person did not have a COI.  For the guidelines written by sub-specialty societies, by a similar calculation, only 12.2% provided an assurance that the chair had no COI.  (The proportions providing assurance that the co-chair people had no COI were even lower.)  Thus the vast majority of guidelines did not clearly follow two straight-forward standards for minimizing the effects of conflict of interest, that the guideline committee chair and co-chair should not have any relevant conflicts.  <br /><br />Given the miserable results concerning even minimal adherence to some of the IOM report's conflict of interest standards, it is likely that almost no published guidelines from 2011 came close to fulfilling the full set of IOM standards.  Despite the best efforts of the IOM, it appears that guideline developers have not progressed at all towards providing trustworthy guidelines.  <br /><br /><b>Summary</b><br /><br />An <a href="http://archinte.jamanetwork.com/article.aspx?articleid=1384244">editorial</a> (Shaneyfelt T. In guidelines we cannot trust.  Arch Intern Med 2012) accompanying the article by Kung and colleagues summarized its results thus:<br /><br /><blockquote class="tr_bq">The same problems that have plagued guideline development continue to plague guideline development; namely, their variable and opaque development methods, their often conflicted and limited panel composition, and their lack of significant external review by stakeholders throughout the development process.   As a result,<i> the trustworthiness of guidelines is limited.</i></blockquote><br />While guidelines may have seemed to be a promising method to improve health care in the early 1990s, they have failed to live up to that promise.  Shaneyfelt was not optimistic they would improve in the future:<br /><br /><blockquote class="tr_bq">I am not optimistic that much will improve.  No one seems interested in curtailing the out-of-control guideline industry.</blockquote><br />On the other hand, in my humble opinion, it is not that on one is interested in better guidelines.  It would clearly be in the best interests of patients and the public, and of health care professionals who care about the quality of their practice and the outcomes of their patients to curtail that industry.  The issue is why patients', the public's, and professional's interests were ignored.<br /><br />Neither Shaneyfelt nor Kung et al discussed why there has been so little attention to patients' and the public's health, and to health care professionalism in all this.  For a quick answer, we do not have to look far on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>.  <br /><br /><br />In fact, the IOM report on guideline development from 2011 was a serious challenge to the powers that be in health care.  In particular, it challenged the cozy relationships that had grown up among the organizations that undertook guideline development and the health care professionals on guideline panels on one hand and organizations that stand to gain were specific guidelines to favor their products, services, and agendas on the other.  The standards mandated transparency and honesty about conflicts of interest affecting guideline committees and the organizations which assembled them, and if upheld would have greatly reduced these relationships.<br /><br />Now it turns out that the guideline standards have been honored mainly in the breach.  Of course, these standards, while increasing trustworthiness, would have cost a lot of medical societies considerable commercial funding, and would have cost a lot of health care professionals on guideline panels considerable personal wealth.  These standards would probably also have cost a lot of companies whose products and services were addressed by guidelines to lose revenue.  So it is not surprising that the IOM standards were ignored.  Their implementation would have cost too many people who are financially benefiting from the status quo too much money.  And these people, that is, leaders of professional societies dependent on commercial outside funding, health care professionals and academic used to financial support from commercial interests, and health care corporations are good at making sure their interests are not ignored, even if their interests conflict with those of patients, the public, and well-intentioned health care professionals.   <br /><br />So, the flouting of the well reasoned IOM guideline standards adds one more reason for patients and the general public to distrust modern health care and all those who "deliver" it, even to distrust well-intentioned health care professionals who have not been able to distinguish themselves from their colleagues who are too happy to help commercial interests while taking commercial money.  If health care professionals want to regain the public's trust, they could do worse than publicly declaring their intention to show that their practice in the future will be guided by trustworthy guidelines based on clinical research evidence and knowledge of biomedical science, drawn up by health care professionals independent of commercial interests.

What If the Institute of Medicine Wrote a Report and Nobody Followed it? - the Case of the Standards for Developing Trustworthy Guidelines

For over 20 years, clinical practice guidelines (CPGs) have been touted to improve health care quality and control costs.  Enormous numbers ...

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