healthy4u

EHR Story for Mother's Day 2014: Even The Formerly Simple Act Of Giving IV Fluids in ICU's Can Kill Babies. But's Let's Be Objective and Happy!

<div style="text-align: center;">[Note to the humorless:  this post is satirical and sardonic to make a very serious point about the perversity of downplaying/ignoring health IT risks, issues too often ignored by those who know better.  If you don't like satire, don't read it.] </div> I've been critiqued for posting in too gloomy a manner for some's taste, even those who like me are in the Medical Informatics field.  For example, in the Feb. 2013 Kaiser Health News article "Health Technology’s ‘Essential Critic’ Warns Of Medical Mistakes" at <a href="http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx">http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx</a>: <blockquote class="tr_bq">... Many say he comes on too strong. Even admirers cringed when he began blogging about the 2011 death of his mother, which he blames in a lawsuit on a computer error that allegedly caused Abington Memorial Hospital to overlook a key medication. (Both he and the hospital said they couldn’t comment on a pending suit.) Personalizing his campaign, some thought, made him seem less objective.</blockquote> Of course, if a close relative of these unnamed "many" were killed by, say, a drunk driver (something this unobjective group of mothers takes seriously:  <a href="http://www.madd.org/">http://www.madd.org/</a>), or if their child were abducted and decapitated (<a href="http://en.wikipedia.org/wiki/Murder_of_Adam_Walsh">http://en.wikipedia.org/wiki/Murder_of_Adam_Walsh</a>), or if something like this event (<a href="https://www.youtube.com/watch?v=55XJivhjB4U">https://www.youtube.com/watch?v=55XJivhjB4U</a>) happened, their response would surely be "oh well, stuff happens, let's all be 'objective', not 'personalize' things, not advocate with our personal stories, and above all, be happy!    <div class="separator" style="clear: both; text-align: center;"> <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgz2Sc_Ep0eHVvzgNTK2PPqnYAKho1OUX3pg4Y8MMphHPtZ3nKt71CbjXSeq3PvKwzIPeU6vw8CW5WskPOtYVfQe2bYtIbV9DW-T1KShF-n_EMiMdFwTzT_HR-m58p4oHUhj1JuMVtKbhpg/s1600/smiley.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgz2Sc_Ep0eHVvzgNTK2PPqnYAKho1OUX3pg4Y8MMphHPtZ3nKt71CbjXSeq3PvKwzIPeU6vw8CW5WskPOtYVfQe2bYtIbV9DW-T1KShF-n_EMiMdFwTzT_HR-m58p4oHUhj1JuMVtKbhpg/s1600/smiley.jpg" /></a></div> I really do admire the unnamed "many" for their ability to detach, so am presenting the following story of "anecdotal" patient harm to a child in a pediatric ICU in the spirit of happiness, joy, and Mother's Day love! <div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj1nVbtntosQYTim-y3sdm6vTMvInD2jgP1ZlsrcxGevCVfigNMgPvzd8HUqh4qznVDYUP4YCPDpMpgcXg4RaT3XCIO4RjdDTdAPL_aExrCYK3A5ePMQZwv8cEk2lGgbZspCOR74YLbtkRd/s1600/vintage_housewife_cook.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj1nVbtntosQYTim-y3sdm6vTMvInD2jgP1ZlsrcxGevCVfigNMgPvzd8HUqh4qznVDYUP4YCPDpMpgcXg4RaT3XCIO4RjdDTdAPL_aExrCYK3A5ePMQZwv8cEk2lGgbZspCOR74YLbtkRd/s1600/vintage_housewife_cook.jpg" width="175" /></a></div><div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiBVdvcXC2vRHlGd1UhzTgr2F7Ut7bWo3S_ppYkE1Ji-F5AMjm1uHvJx2apITS82nBcYMZDHEVDUwW7IUVMpLLc22Y-7Q318dPGia2NwyjsGojNmzNO4Hpsovvd2f9c42UgYEeaEuEq755A/s1600/smiley1.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"> </a></div> Here's the event we should all be happy about, reported via FDA - I note the FDA's said these devices are not "sufficiently risky" to warrant a high level of their attention even though they secretly admitted in an internal memo that there's no way to really know te true level of risk and harm (<a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>), so clearly they're all a really jolly bunch: <blockquote class="tr_bq"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?id=117690">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?id=117690</a> FDA MedSun report Type of device: medical device data system Device brand name: PowerChart Device manufacturer's name: Cerner Corporation Date of this report: (mm/dd/yyyy) 03/04/2014 Describe the event or problem:     Medication Error. This event was related to Health Information Technology. Specifically, the manner in which the system processed an order for free water replacement. Order was intended to be 20ml/hr for 6 hours for a total of 120ml. It was a 1000 ml bag so first they put 20ml/hr which would have defaulted the infuse over time to 50 hrs. They tried to change the infuse over to 6 hours which then changes the ml/hr rate to 167 ml/hr. They did not notice this had changed. </blockquote> Well, that's WONDERFUL!!  :-)  that the computer recalculates the flow rate for them when they change the infusion time, by paternalistically assuming that's what they wanted to do - change the RATE of infusion - when what they actually did is manually change the TIME (duration) of infusion.  How LOVELY of some programmer to have given them this FANTASTIC convenience!! <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/AVvXsEi8yEnZHeor2UZZlhUf4qKrE_4fxFfxrQna0eHhEQagUgU-_a9j1wpRZEfLCAMhkhyphenhyphenOsXIplxq3wLZU4cE3m0rrvjUniE-RugNfZbwUtYsoZXALSsI9k4Grh7jfb78Uc0hHnW_Eh6NGrjDg/s1600/behappy.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi8yEnZHeor2UZZlhUf4qKrE_4fxFfxrQna0eHhEQagUgU-_a9j1wpRZEfLCAMhkhyphenhyphenOsXIplxq3wLZU4cE3m0rrvjUniE-RugNfZbwUtYsoZXALSsI9k4Grh7jfb78Uc0hHnW_Eh6NGrjDg/s1600/behappy.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Aren't computers wonderful!!!</td></tr></tbody></table> Even the following should not be cause for ardent technophiles to wipe the smile from their downside-ignoring faces!! <blockquote class="tr_bq">... They did not realize that they needed to go into details tab to show the time frame so the patient got 167ml/hr instead of 20ml/hr for 6 hours. </blockquote> How obvious!!!  Every doctor, nurse, medical student and janitor knows from time immemorial knows you have to go into the detail tab to show the time frame!  (Smile) <blockquote class="tr_bq">... Order was verified by pharmacy and administered at that rate via peripheral IV. After approximately 1L of fluid had infused, patient showed seizure activity.  PICU (pediatric ICU) team called to bedside. Treatment provided for seizures and critical sodium and potassium. </blockquote> Awww ...  some seizures and critical sodium and potassium levels in the PICU.  Awww.....too bad!!!  We should be happy anyway!  For if this child died...the sacrifice would have been WORTH IT for the betterment of electronic medical records worldwide, and the parents no doubt would be flattered and joyous about their contribution to computing science.  After all, how better to figure out how to make this technology work?? After all, it takes a few broken eggs to make an omelette, and a few bumps in the road (like grave mounds) should be of little concern. Because, remember ... w.e. c.a.r.e! <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/AVvXsEiyOy_d372Rp11w3A5pCQBf6qnkp-yS-f-doYNL_pYtAkTMY8Rzj24CbQOHIUMcYdrEvM8d38R1Y1DKCwpakFqeoc3ZHv67S5PpRuDwz-sq_fpE3DstFh_OLkzQGej3MaZbuWAuHH8BQPTe/s1600/words+that+work.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiyOy_d372Rp11w3A5pCQBf6qnkp-yS-f-doYNL_pYtAkTMY8Rzj24CbQOHIUMcYdrEvM8d38R1Y1DKCwpakFqeoc3ZHv67S5PpRuDwz-sq_fpE3DstFh_OLkzQGej3MaZbuWAuHH8BQPTe/s1600/words+that+work.jpg" width="155" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">i c.a.r.e!!!!  As at U. Arizona Healthcare System, let's only use Happy Words with our patients about these systems! (click to enlarge, see <a href="http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html">http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html</a> )</td></tr></tbody></table> Further, we should use only Words That Work to describe the wonders of these systems in their current state!!! <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/AVvXsEjgAtZ_SQ0RVtQt8McdXxf2OEPLie5Sk706vuqci5i-jIWHJpJS0iZa7s09yVFO41Bbwq4GvWWpzRRMw9AxeldgzFHxb18eCHSaTtZn73KyFqrypUR2XyQHFf_UhSsRPXw0U5t4WQSm3fFv/s1600/flowers.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjgAtZ_SQ0RVtQt8McdXxf2OEPLie5Sk706vuqci5i-jIWHJpJS0iZa7s09yVFO41Bbwq4GvWWpzRRMw9AxeldgzFHxb18eCHSaTtZn73KyFqrypUR2XyQHFf_UhSsRPXw0U5t4WQSm3fFv/s1600/flowers.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Some flowers from Cerner CEO Patterson to momma to make up for her little baby having seizures and critically deranged potassium and sodium levels from those big, bad doctors' EHR mistake!</td></tr></tbody></table> <blockquote class="tr_bq">... The Cerner powerchart software system has functionality for continuous medications/fluid ordering that does not prevent "user error." </blockquote> Ut oh ... Looks like I'm going to have to be a sourpuss for just a moment and re-introduce the nasty, ill-tempered, non-objective idea of what the dastardly National Institute of Technology and Standards (NIST) calls "use error" (as opposed to "user error", A.K.A. "Blame the User",  <a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html">http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html</a>): <blockquote class="tr_bq">... The EUP (EHR usability protocol) emphasis should be on ensuring that necessary and sufficient usability validation and remediation has been conducted so that use error [3] is minimized. [3] “Use error” is a term used very specifically to refer to user interface designs that will engender users to make errors of commission or omission. It is true that users do make errors, but many errors are due not to user error per se but due to designs that are flawed, e.g., poorly written messaging [or lack of messaging, e.g., no warnings of potentially dangerous actions - ed.], misuse of color-coding conventions [see below], omission of information, etc. </blockquote> Awwwwww....aren't I just mean and non-objective? <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/AVvXsEh8h7Y65reXdJO632szxyY2e3UhlY3P8xr5VhF4vPIz_8cTZXCU_8L4DKIks0v0LLVJwWrKKd9BzQKa7OJpJv5NXGJkqpvjMd7xKU1mjfEaUD6F7MkhesXaq0Gw_4wHcv1DTduyxsr3atPO/s1600/frown.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="165" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh8h7Y65reXdJO632szxyY2e3UhlY3P8xr5VhF4vPIz_8cTZXCU_8L4DKIks0v0LLVJwWrKKd9BzQKa7OJpJv5NXGJkqpvjMd7xKU1mjfEaUD6F7MkhesXaq0Gw_4wHcv1DTduyxsr3atPO/s1600/frown.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"> </td></tr></tbody></table> That mean doctor Silverstein's just not happy and objective!!  Bad, bad, bad man! <blockquote class="tr_bq">... When the provider orders the fluid, example is D5W, the screen opens to a "continuous details" ordering window. Within the screen, the ordering provider is presented with a preselected bag volume and type of fluid with a brownish background. They have the ability to modify bag volume but it was made this color to discourage that change by Cerner. </blockquote> Golly gee!  There's something to be happy about once again!  Brown, the universally-understood color, in any language, means "Warning, do not change this value, it could kill someone!!!" See how GOOD this technology really is!!!  Why use alerts and confirmation dialogs when a mere COLOR like brown suffices!! <blockquote class="tr_bq"> ... The rate and "infuse over" fields are a yellow color to show that they need to be completed. The intent [of the programmer, clearly an expert in human-computer interaction and communication by color and smoke signals - ed.] is for an ongoing continuous fluid and not to limit the time. </blockquote> Golly Gee Times Two!  Yellow, the absolutely universal color for "Warning, you need to complete this to prevent killing someone!"   <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/AVvXsEiB07i36jmKHcewYx3Gz9u_Dn1b_sU77r5meRSlFySibvF182tqSVyjtTqOuue6t6pDz1RWP6W580szZKrms1eEmRSb_RIpzZGgVfKNduKoAx7uHGW2dKivEC1nq0UCSXHoKm4H1Q_gHPfw/s1600/yellow-light.jpeg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="133" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiB07i36jmKHcewYx3Gz9u_Dn1b_sU77r5meRSlFySibvF182tqSVyjtTqOuue6t6pDz1RWP6W580szZKrms1eEmRSb_RIpzZGgVfKNduKoAx7uHGW2dKivEC1nq0UCSXHoKm4H1Q_gHPfw/s1600/yellow-light.jpeg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Yellow!  Don't you just think every time you see this color that "warning, you need to complete data entry to avoid killing someone?  Who needs WORDS?</td></tr></tbody></table> It's all so CLEAR!!!! <blockquote class="tr_bq">... Providers can misinterpret this field to mean the length of time they want the order to infuse over, when the system intent for that field is to be the system-calculated length of time until the next bag supply will need to be sent to maintain the continuous infusion.  </blockquote> See how simple!!!!   Isn't it OBVIOUS!!!! <blockquote class="tr_bq"> The completed fields turn white. Cerner does not have an intermittent fluid administration order [who the hell needs that, says Cerner and the hospital executives who bought this package for the PICU!! Never a need for that in ICU's!! - ed] so providers are expected to go to a second tab, the "details" tab, where they have the options for identifying the duration of the infusion in terms of # doses or time. If the provider does not have awareness of this intent and modifies the "infuse over" field from the "continuous details" tab, they may inadvertently order a higher rate than intended.</blockquote> Ha ha!  Those silly doctors can't even figure out a simple thing like that!!  What stooges they are!! <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/AVvXsEhT3rcoW8Gw85QLLLUqEtmVvyIqCGPmTDBoLqWmwLa5zC0a-4ORhr7iLkFrSZBeA02TCfVLzn5pqH7WxtywG0kyZt54ExddyyuDE_UjALynE545TJIgb5SaosZIC6vFUiC9jt6yhyphenhyphenPpqf5i/s1600/three-stooges.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="156" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhT3rcoW8Gw85QLLLUqEtmVvyIqCGPmTDBoLqWmwLa5zC0a-4ORhr7iLkFrSZBeA02TCfVLzn5pqH7WxtywG0kyZt54ExddyyuDE_UjALynE545TJIgb5SaosZIC6vFUiC9jt6yhyphenhyphenPpqf5i/s1600/three-stooges.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">NYUK NYUK NYUK ... Hey Moe!!  Those silly doctors and nurses cannot understand the simple fact that Cerner does not have an intermittent fluid administration order so providers are expected to go to a second tab, the "details" tab, where they have the options for identifying the duration of the infusion in terms of # doses or time. If the provider does not have awareness of this intent and modifies the "infuse over" field from the "continuous details" tab, they may inadvertently order a higher rate than intended.  </td></tr></tbody></table> See how much FUN health IT problems can be?  After all, in this ANECDOTAL case, all that happened was: <blockquote class="tr_bq">The device(s) may have caused or contributed to: Potential for patient harm, Serious Injury </blockquote> But nobody died of this particular problem (that we know of), so this technology is SAFE!!!! <div class="separator" style="clear: both; text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgNHrlprFiMwMg8w-uhH23RA1KLiJ7O5qDqdj547Mc40zYY4nDhmNEqZ_d5163YRafaQ34simadB6lLrldXAktiWpOZNGbn2kctTetmpIBNH6FhjjBEO7ZIqwQm9Lgo68p7sjlS1Z5FofgT/s1600/Happy-Mothers-Day.png" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="268" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgNHrlprFiMwMg8w-uhH23RA1KLiJ7O5qDqdj547Mc40zYY4nDhmNEqZ_d5163YRafaQ34simadB6lLrldXAktiWpOZNGbn2kctTetmpIBNH6FhjjBEO7ZIqwQm9Lgo68p7sjlS1Z5FofgT/s1600/Happy-Mothers-Day.png" width="320" /></a></div> Happy mother's day!!! -------------------- Additional not-so-funny thought:  depending on brown, yellow etc. instead of clear, written alerts/warnings, plus the fact that the system likely "knew" the weight of the child and should have alerted that the infusion of a liter was a very dangerous thing, reflect Bad Health IT on its face: <blockquote class="tr_bq">Bad Health IT ("BHIT") is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.   </blockquote> Had I been a pre-marketing tester of this system working for FDA, those fluid-ordering characteristics would have been changed before the system would have been released to market. Oh, wait ... there is no premarketing testing process for health IT, and FDA, via advice from the FDASIA committees as in the linked FDA-related post above, writes that none is really needed. And who wants to damage TRUE INNOVATIONS like this - turning something that takes 5 seconds for a clinician to write, "D5W, 20 ml/hr x 6 hrs" (meaning dextrose 5% in water, 20 milliliters per hour for 6 hours) into a cryptic and muddled exercise with tabs, colors and numerous caveats - via regulation? -- SS

EHR Story for Mother's Day 2014: Even The Formerly Simple Act Of Giving IV Fluids in ICU's Can Kill Babies. But's Let's Be Objective and Happy!

[Note to the humorless: this post is satirical and sardonic to make a very serious point about the perversity of downplaying/ignoring heal...

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Some Authoritative Skepticism about the "Triumph" of Sovaldi to Add to Outrage about "Blood Money"

Three weeks ago we posted about the continuing controversy over the stratospheric price of the new antiviral drug for hepatitis C (HCV), sofosbuvir (Sovaldi, by Gilead).  While the amazing $1000 per pill price got deserved attention, at that time no one but your humble blogger seemed to be <a href="http://hcrenewal.blogspot.com/2014/04/knee-deep-in-hoopla-triumph-of-medical.html">publicly skeptical </a>about published assertions that the drug was some sort of modern miracle, and a triumph of medical science.  At that time, we noted that there is no "strong clear evidence that this drug is extremely effective and remarkably safe, i.e., that the drug is a 'triumph' that will cure nearly everyone without risk or harm to them, and therefore warrants a princely price." Since then, two other skeptical opinions have become public. The German Institute for Quality and Efficiency in Health Care (IQWiG) Early Benefit Assessment The German agency performed this assessment based on a dossier submitted by the drug manufacturer (presumably Gilead).  The assessment found some reason to think the drug beneficial, but that the evidence was sparse, left many questions unanswered, and was inadequate to assess the drug for some important patient populations.  At this point, only a <a href="https://www.iqwig.de/en/press/press_releases/press_releases/sofosbuvir_indication_of_added_benefit_for_specific_patients.6099.html">summary</a> is available in English.  It includes links to further information in German. The overall assessment was, <blockquote class="tr_bq">The dossier submitted by the drug manufacturer provides indications of added benefit for non-pretreated patients infected with the virus of genotype 2. However, the extent cannot be quantified. There were no suitable data in the dossier for patients who are infected with other virus types (genotype 1 and 3 to 6) or who are coinfected with HIV.</blockquote>Limited Generalizability Particular problems with data about genotypes other than 2 were: <blockquote class="tr_bq">The manufacturer presented no adequate analyses for infection with type 1 and type 3 to 6 viruses and for <acronym title="human immunodeficiency virus">HIV</acronym> coinfection. It analysed results from studies in which the respective comparator therapy was tested in at least one study arm and compared these in a 'historical' comparison. It included both randomized controlled trials (<acronym title="randomized controlled trial ">RCTs</acronym>) and one-arm studies on the sofosbuvir side, but only <acronym title="randomized controlled trial ">RCTs</acronym> on the comparator side. It justified this by claiming that it wanted to reduce the number of hits of its literature search. However, the database for the comparison was different because of this and the comparison itself was therefore unsuitable. A first literature search by <acronym title="Institute for Quality and Efficiency in Health Care">IQWiG</acronym> showed that a number of studies were not considered in the dossier.</blockquote>Thus the assessment concluded that the drug company dossier included at best irrelevant data that it tried to pass off  as important, and inexplicably left out other data that might have been relevant. Problem with Random Allocation The German assessment focused on the single randomized controlled trial which compared sofosbuvir and ribavirin to peg-interferon and ribavirin whose results were published in the New England Journal and discussed in our previous posts (<a href="http://hcrenewal.blogspot.com/2014/04/knee-deep-in-hoopla-triumph-of-medical.html">here</a> and <a href="http://hcrenewal.blogspot.com/2014/03/too-good-to-be-true-sovaldi-kerfuffle.html">here</a>).   However, the German assessment analyzed what was submitted in the company's dossier about this trial, rather than the published results in the NEJM.  It found problems in addition to those we found, starting with problems with the randomization, <blockquote class="tr_bq">Overall, <abbr title="Institute for Quality and Efficiency in Health Care">IQWiG</abbr> assessed the risk of bias of the FISSION study as high. The main reason was that the manufacturer only included those participants in the analysis who had received at least one dose of the medication they were randomized to. However, particularly in the control arm, where not the new drug, but conventional drugs were administered, some patients refused to have their planned treatment. This is a general problem of open-label studies, where it is known who receives which treatment. This poses the risk that patients discontinue the study prematurely depending on which treatment they were randomized to. This compromises the aim of randomization: the comparability of the treatment groups.  This is exactly what happened in the FISSION study, which may lead to (highly) biased results.</blockquote> Thus, the assessment concluded that the study had a major problem with randomized allocation.  This should be added to the other problems we found: unblinded ascertainment of adverse effects potentially leading to bias, apparently deliberate obfuscation of adverse effects, especially deaths occurring during the trial, and lack of long term followup.  This suggests that the study was manipulated to increase the likelihood of favorable results Failure to Consider Important Outcomes The German assessment also concluded that the trial provided no information about mortality or quality of life benefits, <blockquote class="tr_bq"> As no deaths occurred in the FISSION study in the therapeutic indication genotype 2, there could be no differences between the treatment groups, and therefore no proof of added benefit, in the outcome 'mortality'. This also applies to health-related quality of life, but in this case because the dossier contained no evaluable data for this outcome.</blockquote> Note, however, that this suggests that the data submitted in the dossier was different than that reported in the New England Journal of Medicine.  We <a href="http://hcrenewal.blogspot.com/2014/04/knee-deep-in-hoopla-triumph-of-medical.html">noted</a> that in the supplemental data from the trial available on the web appeared data on mortality.  However, it showed higher (albeit still very minimal) mortality in the sofosbuvir group than in the peg-interferon group. The fact that the dossier submitted in Germany omitted all mortality results should be added to the fact that the NEJM report buried the mortality data in the on-line supplement, increasing the likelihood that the dissemination of this part of the results was manipulated to forestall the questions that it ought to provoke. The German assessment further noted that the dossier included no good data about possible harms or adverse effects of the new drug, <blockquote class="tr_bq">The data on side effects contained in the dossier could only be assessed to a limited extent. The manufacturer presented these data on the basis of the proportions of patients with at least one event. However, this type of analysis is only suitable to a limited extent because the observation period of the patients was different in the two study arms.</blockquote> Note that is suggests another type of study manipulation, unequal assessment of harms in the study arms perhaps meant to minimize the apparent harms of the new drug.   Furthermore, again the data in the dossier appeared discrepant from that in the NEJM article (which we discussed <a href="http://hcrenewal.blogspot.com/2014/04/knee-deep-in-hoopla-triumph-of-medical.html">here</a>), <blockquote class="tr_bq"> Severe adverse events only occurred once in each of the two study arms. A statistically significant difference in the outcome 'treatment discontinuation due to adverse events' in favour of sofosbuvir was not robust in the sensitivity analyses performed by <abbr title="Institute for Quality and Efficiency in Health Care">IQWiG</abbr>. With regard to side effects, <abbr title="Institute for Quality and Efficiency in Health Care">IQWiG</abbr> therefore considers the added benefit as not proven.</blockquote> The severe adverse event rates reported in the New England Journal article were higher, and the reason for this discrepancy is unclear.   A Non-Quantifiable Benefit? So ultimately only a qualitative assessment of the drug's benefits for genotype 2 patients was possible, <blockquote class="tr_bq"> For treatment-naive patients with genotype 2 chronic hepatitis C, an overall positive effect of sofosbuvir in comparison with the appropriate comparator therapy remains with regard to serious secondary diseases. The extent of this added benefit – which was determined with the surrogate '<acronym title="Sustained virological response">SVR</acronym>' – is non-quantifiable, however, because it is unclear how often the development of liver cancer can in fact be prevented. </blockquote> Note that mention of the IQWiG assessment has been made so far in only one major US media outlet, <a href="http://www.bloomberg.com/news/2014-05-02/gilead-s-sovaldi-has-unclear-cancer-benefit-german-agency-says.html">Bloomberg</a>.    The Institute for Clinical and Economic Review Evidence Report This report just appeared online in JAMA Internal Medicine [Ollendorf DA, Tice JA et al.  The comparative clinical effectiveness and value of simeprevir and sofosbuvir in chronic hepatitis C viral infection.  JAMA Inte Med 2014.  Link <a href="http://archinte.jamanetwork.com/article.aspx?articleid=1867174">here</a>.]  The review found again that there were major limitations in the available data, and so much of it was based on a network meta-analysis and simulation studies, <blockquote class="tr_bq">The review was limited to patients with genotype 1, 2, and 3 infections, which account for most HCV cases in the United States. At the time of the review, no head-to-head trials of the direct-acting antiviral drugs had been performed, and most of the data on sofosbuvir came from uncontrolled studies We therefore used network meta-analytic techniques to perform indirect comparisons of sustained virologic response outcomes across treatment options<a class="reflink" href="http://archinte.jamanetwork.com.revproxy.brown.edu/article.aspx?articleid=1867174#iep140001r6" id="archinte.jamanetwork.com.revproxy.brown.edu/article.aspx?articleid=1867174#iep140001r6-scm6MainContent_ucArticleContent_rptSections_lblSection_6"></a> and used these results as the input to a simulation model that compared the estimated clinical and economic outcomes of treatment after 1 and 20 years.</blockquote> It is very hard for me to independently evaluate the credibility of these indirect methods of analysis of what amounts to sketchy data.  However, I should note that Ollendorf et al did not some other specific problems with the available data on sofosbuvir: <blockquote class="tr_bq">Yet at the time of this review there were several reasons for caution. First, the evidence base on the comparative clinical effectiveness of these 2 new drugs remained thin in most areas and notably incomplete in others. For example, in some subgroups, such as patients who have failed earlier treatments, there were little or no data available. There were no long-term data demonstrating the durability of short-term sustained virologic response rates for either drug; nor had either drug been compared head-to-head in a randomized clinical trial with each other or with a first-generation direct-acting antiviral drug. Finally, the evidence necessary for sofosbuvir to gain marketing approval through the FDA’s breakthrough designation was particularly sparse and did not include requirements for controlled trials.</blockquote> Furthermore, it suggested reduced enthusiasm for treatment since most patients with hepatitis C will not develop severe complications, limiting the potential benefits of treatment, <blockquote class="tr_bq"> HCV is an indolent infection, and most adults with this infection will never develop negative health effects during their lifetime. Many people with HCV infection have no evident liver dysfunction. For such patients, the decision about whether and when to initiate treatment should involve careful consideration of the balance of risks and benefits and shared decision-making with experienced clinicians.</blockquote> Note that at least to date, I have seen no discussion of the Ollendorf report in the media. Pricing Unrelated to Production or Research and Development Costs Meanwhile, there has been continued outrage in the media over the pricing of this probably not so miraculous drug.  Some has focused on the likelihood that most of the price represents pure profit, excess marketing (and perhaps huge payments to corporate insiders), rather than production or research and development costs.  For example, Bernard Munos <a href="http://www.forbes.com/sites/bernardmunos/2014/04/16/has-healthcare-embraced-a-hit-and-run-strategy/">wrote</a> in Forbes <blockquote class="tr_bq">To compound the outrage, there is hardly a relationship between drug prices and their actual costs, which makes many patients feel as if they were held to ransom. Gilead, to its credit, has negotiated a deal that makes Sovaldi available to Egyptian patients at a <a href="http://www.fiercepharma.com/story/express-scripts-adds-fuel-fire-fight-over-gilead-sciences-sovaldi/2014-04-09">99% discount</a>, but it may have also bolstered suspicions of profiteering.</blockquote> Similarly, Julian Urrutia <a href="http://blogs.law.harvard.edu/billofhealth/2014/04/13/you-cant-put-a-price-tag-on-sovalid-unless-its-over-84k/">wrote</a> in the Bill of Health blog from the Harvard Law School Petrie-Flom Center, <blockquote class="tr_bq">Gilead is working to offer lower prices in dozens of developing countries (of the 150 million patients with HCV, only about 1% are in the USA). <div style="text-align: justify;">To me, this implies one of two things. Either Gilead will be selling the drug in developing countries at a price that allows it to make normal profits (in which case Gilead is capturing enormous rents in the USA market from $84K price tag), or whoever pays for the treatment of patients with HCV in developed countries will be subsidizing the treatment of patients in the developing world.</div></blockquote><div style="text-align: justify;"> </div><div style="text-align: justify;"></div> The Editor of Modern Healthcare, Merrill Goozner <a href="http://www.modernhealthcare.com/article/20140503/MAGAZINE/305039983">wrote</a>, an analysis of how Gilead's immense revenue was built on US government funded research, and academics who could privatize the research they did with such funding on university time, <blockquote class="tr_bq"> The National Institutes of Health invested heavily in university-based scientists to understand the genetic weak points of hepatitis C, just as it did for HIV. It gave grants to build virology labs, come up with potential drugs and conduct clinical trials. One of those scientists was Raymond Schinazi, director of the Laboratory of Biochemical Pharmacology at the Emory School of Medicine in Atlanta. During the past 20 years, Schinazi's laboratory received at least $7.7 million from the National Institute of Allergy and Infectious Diseases. He wasn't alone. Some, like Kevin Raney, chair of the biochemistry and molecular biology department at the University of Arkansas for Medical Sciences, even developed drugs on their government grants, although his never made it into clinical trials. Schinazi, a serial entrepreneur, took a different path. In the late 1990s, he formed the pharmaceutical company Pharmasset, to develop an antiviral drug invented at Emory. The company also worked on cures for HIV and hepatitis B. The original drug candidate went nowhere, he told me in a telephone interview. But chemists working inside Pharmasset—at the time of its sale to Gilead in 2011 it had only 82 employees—developed several novel therapeutics for the diseases, including one that eventually became Sovaldi. Securities and Exchange Commission filings for Pharmasset during its years as a stand-alone research and development company revealed it spent under $7 million on R&D in 2003. In its early years, it received $1 million in government grants. Its total losses through 2011 came to $314.8 million. It was also investigating drugs for HIV and hepatitis B throughout that period. The company hit the jackpot with hepatitis C and Sovaldi though, which led Gilead, whose initial success came from HIV drugs, to pay $11 billion for the company. Schinazi, who had retained a sizable stake in the firm after cutting his ties in 2006, walked away with over $400 million, according to a published report. Gilead spent tens of millions of dollars to complete Sovaldi's clinical trials. Yet last August, the NIAID issued a news release touting its role in running one of those trials when positive results were reported in JAMA. The government, it turns out, had kept its hand in the development of Sovaldi.</blockquote> So it appears that the pricing of Sovaldi has almost nothing to do with production or research and development costs.  Much of the initial research needed to develop Sovaldi was underwritten by the government.  Gilead paid royally for the results of the research, but most of the money went to investors and executives, including the former academic who did some early development work on government money and became tremendously rich from Gilead's largesse. Growing Outrage over Extortionate Behavior Some has focused on how the price represents unethical, if not extortionate behavior by corporate executives.  For example, Munos also wrote, <blockquote class="tr_bq">What has changed is perhaps the fact that the industry no longer realizes – or accepts – that it has a covenant with society. This is no ordinary business as it can only operate by the will of the people. Drug makers get intellectual property rights, which are essentially a license to print money, but in exchange society expects affordable innovation. For most of the past century, that bargain has worked remarkably well. But, if drug companies fail to live up to it, society can also revisit its part, and scale back patent rights, or deny reimbursement. And this is happening in a rapidly-growing list of countries – not just India and China, but Germany, the UK, France, Canada, and soon… coming to a drugstore near you. The legendary leaders who built the pharmaceutical industry as one of the most respected understood that bargain. One remembers George <a class="exit_trigger_set" href="http://www.forbes.com/companies/merck/">Merck's</a> <a href="http://books.google.com/books?id=A99WFv8v8bkC&pg=PA93&lpg=PA93&dq=%22george+merck%22+%22Medicine+is+for+the+people.+It+is+not+for+the+profits%22&source=bl&ots=_ziwZk3lLM&sig=KhWStbwfjWoBFpjB5sH7Ha8A1Zw&hl=en&sa=X&ei=FLZLU86SL4bhyQG4nIGwBQ&ved=0CE0Q6AEwBA#v=onepage">admonition</a> ('Medicine is for the people. It is not for the profits'), Jonas Salk’s quaint <a href="https://en.wikipedia.org/wiki/Jonas_Salk">remark</a> about the polio vaccine patent, Robert Wood Johnson’s <a href="http://www.jnj.com/about-jnj/jnj-credo/">Credo</a>, and Roy Vagelos’ more recent <a href="http://knowledge.wharton.upenn.edu/article/roy-vagelos-talks-about-leadership-and-the-need-for-new-drug-pricing-policies/">warning</a> about the industry’s ill-conceived pricing policies.  They understood that self-policy is always better than regulation, and such moderation served them well. But their successors’ failure to uphold their advice has led to an onslaught of regulations and policy changes that threatens to permanently remake the industry.</blockquote> Elisabeth Rosenthal <a href="http://www.nytimes.com/2014/04/27/sunday-review/it-will-save-lives-but-whats-the-cost.html">wrote</a> in the NY Times, quoting Steve Francesco, a pharmaceutical consultant, <blockquote class="tr_bq">'To understand drug pricing you have to shed your sense of value as a consumer and as a noble human being,' Mr. Francesco said. 'You have to put on the lens of the health care industry, where what you’re doing is looking for opportunities to maximize return.'</blockquote> Also in Forbes, Dr Robert Pearl <a href="http://www.forbes.com/sites/robertpearl/2014/04/24/americas-broken-health-care-system-the-role-of-drug-device-manufacturers/">wrote</a> this about Sovaldi pricing, <blockquote class="tr_bq"> But at $1000 a pill, its pricing is exorbitant, monopolistic, and disrespectful to the purchasers and patients who will bear the brunt of the massive cost.</blockquote> Dr Frank Huyler <a href="http://www.nydailynews.com/opinion/life-worth-article-1.1761457">wrote</a> in the New York Daily News about blood money, <blockquote class="tr_bq">This sort of blood money is nothing new. But it is among the worst of recent examples; yet another evil act, yet another predation on mostly poor, mostly desperate people, who inevitably will ask taxpayers to save them.</blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Summary</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">It is even bloodier money if the assumption that the drug is a "well-tolerated and effective cure," which  Dr Huyler held, proves not to be true.  It is clear that most of the money that Gilead is now scooping up in the US is not to pay retrospectively for research and development or drug production. Instead, it seems likely to be supporting marketing, public relations, some investors' profits, and huge executive compensation.  When the public realizes that the money may not be buying miracles, the outrage should increase.  </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">The Sovaldi case is a signal example of how our health care system is awash in marketing hype and public relations buzz that has swamped rational skeptical thinking about logic and evidence.  That marketing and PR is ever enriching managers while it will send the rest of us, health care professionals included, to the poor house.  And all the money we spend will not buy us the promised miracles and triumphs.  </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">True health care reform would revisit the pact society once made with drug, biotechnology and device companies meant to promote reasonably priced innovation, but now promoting oligarchy; support transparency and honesty in clinical research; and challenge how health care managers can make millions or billions from unproven, and sometimes worthless or dangerous products. </div>

Some Authoritative Skepticism about the "Triumph" of Sovaldi to Add to Outrage about "Blood Money"

Three weeks ago we posted about the continuing controversy over the stratospheric price of the new antiviral drug for hepatitis C (HCV), sof...

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Abort, Retry, Fail? - Lancet Avoided Much Recent Unpleasantness in Reporting on New Gates Foundation CEO (Including Her Defense of $55,000 a Year for Bevacizumab)

The April 26, 2014 issue of the prestigious journal Lancet used two full pages and two separate articles by the same author to discuss the ascension of the Gates Foundation new CEO, Dr Susan Desmond-Hellmann.(1-2) Two Somewhat Redundant Lancet Articles Dr Desmond-Hellmann trained as an oncologist, spent time working on AIDS and Kaposi's Sarcoma in Uganda, but then spent much of her career as a pharmaceutical/ biotechnology executive, as described in the first article,(1) <blockquote class="tr_bq">After returning from Uganda, Desmond-Hellmann joined the nascent Taxol development programme at Bristol-Myers Squibb, before being poached by Arthur Levinson, the then Head of Research and Development at Genentech. Levinson was convinced Genentech had a strong pipeline of anticancer therapies, and brought Desmond-Hellmann on board to help guide them through to approval. The pipeline went stratospheric, and took Desmond-Hellmann with it. By 2009 she had been promoted to President of Product Development, having overseen the introduction of two of the first gene-targeted therapies for cancer, bevacizumab and trastuzumab.</blockquote> After Genentech was bought out by Roche, Dr Desmond-Hellmann became Chancellor of the University of California, San Francisco, <blockquote class="tr_bq">Over the next 5 years, Desmond-Hellmann instituted wide-ranging reforms at UCSF, including aggressively cutting administrative waste and putting a greater emphasis on partnerships with the biotech and pharmaceutical sectors, coming in for some criticism in the process. 'Some of the press suggested one of Sue's goals was to take UCSF out of the public system', says [current UCSF interim Chancellor Sam] Hawgood. 'Nothing could be further form the truth. She was very proud of the public mission of UCSF, and had no intent to alter that.' Mindful of how damaging perceived conflicts of interest could have been to her credibility during her time at UCSF, Desmond-Hellmann says she 'specifically avoided being on pharma and biotech boards'.</blockquote> The article suggested we should expect nothing but great things from Dr Desmond-Hellmann at the Gates Foundation, <blockquote class="tr_bq">it is Desmond-Hellmann's ability to forge partnerships and her wide network of contacts, rather than her knack for cutting administrative overheads, that will have seemed most attractive to the Gates Foundation as it looks to speed up the process of translating research into results.</blockquote> The second article used remarkably similar wording(2), e.g., regarding her career in the pharmaceutical business, <blockquote class="tr_bq">Soon after joining the Taxol team, Desmond-Hellmann was leading it; the kind of progress that was bound to catch the eye of Genentech's then Head of Research and Development Arthur Levinson. What happened next is part of pharmaceutical folklore, as Desmond-Hellmann helped to mastermind one of the most profitable drug-development pipelines in history, including the approval of two of the first targeted cancer therapies, for Genentech.</blockquote> Also, regarding her career at UCSF,(2) <blockquote class="tr_bq"> Desmond-Hellmann from embarking on a programme of structural reforms to cut administrative inefficiency and forge closer links with private industry, something that still stirs up controversy. 'There definitely were concerns, and there remain concerns in academia, about conflicts of interest, privatisation. I think what helped most was that I was clear in my actions that I did and do value that UCSF is a public institution, and I think my actions spoke and speak for themselves', she says. But Desmond-Hellmann is robust in her defence of the importance of public—private partnerships for driving innovations that ultimately benefit society.</blockquote> Finally, regarding expectations for her performance in the future, <blockquote class="tr_bq">'There are a lot of people who are looking to the foundation, and in the world of philanthropy there's a lot of visibility to the Bill & Melinda Gates Foundation, so I certainly feel accountable and responsible for doing a good job.' But, she asserts, 'I'm up for it'. With a track record that ranges from clinical research, global health, and the sharp end of commercial drug development, she seems to be made for it.</blockquote> So Lancet, a very well known journal which normally is very parsimonious about its use of the printed page, used two full pages for two very similar articles about the new Gates Foundation CEO.  Both articles made the same points, -  Dr Desmond-Hellmann had a brilliant career in the pharmaceutical/ biotechnology business, and was responsible for the development of several important cancer drugs -  Dr Desmond-Hellmann made major reforms at UCSF, including pushing for some sort of privatization, and for public-private partnerships, while dismissing concerns about any resulting conflicts of interest  -  Dr Desmond-Hellmann is likely to be very successful as Gates Foundation CEO. What the Articles Did Not Say When Dr Desmond-Hellmann's appointment as Chancellor of UCSF was announced in 2009, I <a href="http://hcrenewal.blogspot.com/2009/05/bio-tech-u.html">suggested</a> that she was a very unusual choice because of aspects of her track record in the pharmaceutical/ biotechnology business.  Yet the Lancet's two articles on her prospects as new Gates Foundation CEO ignored these considerations, and ignored or downplayed aspects of her track record as UCSF Chancellor.  In particular, Defending $55,000/ Year Bevacizumab As I noted in 2009, Dr Desmond-Hellmann's defense as a Genentech executive of the sky high prices the company was charging for its new drugs was well documented in an article in the Journal of the National Cancer Institute)(3) <blockquote class="tr_bq">And cancer biologics, though among the most costly drugs, are still only a tiny fraction of total GDP, said Genentech's Susan Desmond-Hellmann, president for product development, at AACR. Hellmann and others argue that with these drugs’ potential to alleviate the huge societal burden of cancer, biologics are worth the cost. The industry has responded to concerns about costs by putting more resources into patient assistance programs. When Genentech received U.S. Food and Drug Administration approval for bevacizumab in lung cancer last October, it also announced a cap on expenditures for the drug for patients with family incomes less than $100,000 a year. In 2005, the median household income was $46,326. Originally announced as $55,000, the cap actually doesn't kick in until after a patient has received 10,000 mg. At the wholesale acquisition cost, 10,000 mg is about $55,000, said Genentech spokesperson Edward Lang. What the companies have not done so far is reduce prices. The reason, industry representatives say, is the need to recoup massive research and development costs, including high manufacturing costs for biologics. These costs have long kept biotech companies from making much of a profit overall, Hellmann said. She noted that profit levels of publicly held biotech firms have 'hovered close to zero' throughout the life of the industry.</blockquote> Whatever the company's nominal profit levels, its executives, including Dr Desmond-Hellmann, have made extremely good money.   According to <a href="http://www.sec.gov/Archives/edgar/data/318771/000095013408004633/0000950134-08-004633-index.htm">Genentech's 2008 proxy statement</a>, (the last available, since the company has been bought out by Roche), Dr Desmond-Hellmann's total compensation was $8,361,348 in 2007 and $7,820,142 in 2006. In 2007, her total compensation was equal to 0.3% of the firm's total net income. Of course, since 2007, and especially since 2009, the problem of hugely expensive pharmaceuticals as a driver of health care costs, especially in the US, has become all too apparent.  The Lancet articles were completely silent about this aspect of Dr Desmond-Hellmann's track record, and what implications it might have for her new role of a foundation that spends $3 billion a year, mainly ostensibly to improve the health of poor people. Since she began as Chancellor of UCSF in 2009, other aspects of Dr Desmond-Hellmann's track record came to light that might have a bearing on how she will conduct herself as Gates Foundation CEO.  Investments in Tobacco Stocks As I <a href="http://hcrenewal.blogspot.com/2010/06/smoke-detector-medical-center-leader.html">posted</a> in 2010, then NY Times reporter Duff Wilson discovered that Dr Desmond-Hellmann and her husband (also a physician), had stock holdings in Altria, the parent company of tobacco company Phillip Morris USA, worth between $100,000 and $1,000,000.  When this made public, they abruptly sold the stock.  The head of the UCSF tobacco control center then said,  “I do find that kind of shocking, but at least she got rid of it,...” The goals of tobacco companies seem completely antithetical to those of a medical school, especially one with a tobacco control center, and incidentally seem antithetical to those of the Gates Foundation, which has a <a href="http://www.gatesfoundation.org/What-We-Do/Global-Policy/Tobacco-Control">tobacco control initiative</a>, with a stated goal: <blockquote class="tr_bq">to reduce tobacco-related death and disease in developing countries by preventing the initiation of new smokers, decreasing overall tobacco use, and reducing exposure to secondhand smoke. </blockquote> The Lancet articles were silent on this issue.   Questions Whether Industry Partnerships Threaten the University Mission In 2011, I <a href="http://hcrenewal.blogspot.com/2011/10/logical-fallacies-to-support-putting.html">posted</a> about Dr Desmond-Hellmann's vigorous push to create public-private partnerships, which seemed meant to turn UCSF into a de facto drug company research and development contract shop.  At the time, I noted that many of her arguments seemed to be based on logical fallacies, and that she never provided any good evidence for her claims of marvelous new "innovations" that would result from such supposed partnerships.  The Lancet articles did not mention any substantive concerns about this issue. Dismissing Concerns about Conflicts of Interest In 2012, I <a href="http://hcrenewal.blogspot.com/2012/02/logical-fallacies-in-defense-of.html">posted</a> about how Dr Desmond-Hellmann also dismissed concerns that public-private partnerships could lead to damaging conflicts of interest, again employing several logical fallacies.  In particular, she implied that medical academics should no longer just do research to advance knowledge, but had become responsible for getting their "discoveries to society," and therefore would have to "start a company or work with a company to commercialize a product."  She did not seem to acknowledge the possibility that academics could make discoveries, but perhaps other people would be better at turning these discoveries into useful products.  The Lancet articles were silent on these issues. Minimizing Concerns about Conflicts of Interest due to Membership on the Board of Corporations with Health Care Agendas As noted above, Dr Desmond-Hellmann stated that she demonstrated her sensitivity to the issue of conflicts of interest affecting academic health care by avoiding membership on boards of directors of "pharma or biotech" companies.  These, of course are not the only sorts of for-profit corporations who have health care agendas.  This statement appears to have been carefully worded to avoid dealing with Dr Desmond-Hellmann's membership since 2010 on the board of directors of Procter & Gamble (see the company's <a href="http://www.pginvestor.com/file.aspx?IID=4004124&FID=19227491&O=3&OSID=9">2013 proxy statement</a>.)   While Procter & Gamble is no longer a major pharmaceutical company, it has a <a href="http://www.pg.com/en_US/brands/global_health_grooming/index.shtml">Global Health and Grooming unit</a>, whose products include over the counter pharmaceuticals (e.g., Pepto-Bismal, Metamucil, Prilosec OTC).  Also, while Procter & Gamble does not make it very obvious, it has also owned MDVIP, a company that employs physicians to provide concierge medical services, since 2010, although as Cincinnati.com just <a href="http://www.cincinnati.com/story/money/business/2014/05/02/pg-sells-concierge-medicine-unit/8622903/">reported</a>, it will soon sell this unit to private equity.   So while perhaps Dr Desmond-Hellmann could claim that while she was UCSF Chancellor she was not on the board of directors of any pure pharmaceutical or biotechnology company, she was certainly on the board of a major international company that sells pharmaceuticals and other health care related products, and employs physicians to provide direct patient care.  (Presumably, she will be staying on the P&G board while she is Gates Foundation CEO.)  The Lancet did not mention this issue.  Privatizing UCSF Also, the Lancet articles seemed to contradict other reports that Dr Desmond-Hellmann made a serious attempt to privatize at least some aspects of UCSF, but that this effort failed. (Note that quote by Dr Hawgood from the first article above.)     However, in 2012, I posted about a prevalent conspiracy theory that University of California managers were trying to take the university private.  However, it seemed to be more of a theory, because at least one news report included statements that Dr Desmond-Hellmann wanted to take UCSF out of the state university system.  This week, an <a href="http://www.bizjournals.com/sanfrancisco/blog/2014/04/university-of-california-uc-ucsf-janet-napolitano.html">article</a> in the San Francisco Business Times suggested that this was a serious plan, in that Dr Desmond-Hellmann <blockquote class="tr_bq">ran into opposition when she  <a href="http://pubads.g.doubleclick.net/pagead/adview?ai=B46LUcTVlU4KNFIrUkwT0tYG4DYnY2pwFAAAAEAEgADgAWJmX6YiuAWDJvriM1KSoEIIBF2NhLXB1Yi05NzM2MDkyNjA0Njc3NTE2sgETd3d3LmJpempvdXJuYWxzLmNvbboBCWdmcF9pbWFnZcgBCdoBa2h0dHA6Ly93d3cuYml6am91cm5hbHMuY29tL3NhbmZyYW5jaXNjby9ibG9nLzIwMTQvMDQvdW5pdmVyc2l0eS1vZi1jYWxpZm9ybmlhLXVjLXVjc2YtamFuZXQtbmFwb2xpdGFuby5odG1smALohAHAAgLgAgDqAiI0NjM1L2J6ai5zYW5mcmFuY2lzY28vYXJ0aWNsZV9wYWdl-AL00R6QA-ADmAPgA6gDAeAEAZIFCwgHEAEYByDp888YoAYg&sigh=t4VXjjLVbHw&adurl=http://pagead2.googlesyndication.com/pagead/imgad?id=CICAgKCNn-yIxgEQARgBMggPKtH7CIiUnA%26t%3D10%26cT%3Dhttp%253A//bizjournals.com%26l%3Dhttp%253A//www.bizjournals.com/sanfrancisco/blog/2012/01/susan-desmond-hellmann-ucsf-uc.html">proposed in early 2012 that some of UCSF's functions be separated from the rest of the UC system</a>. The autonomy coming from the separation, Desmond-Hellmann argued at the time, would have meant that the sole graduate-level-only campus in the 10-campus UC system would no longer subsidize UC undergrad programs. It also would have translated into UCSF having more control over the money it generates from its medical center and other operations.</blockquote> However, the same article noted that the current University of California President, <blockquote class="tr_bq">dismissed as 'loose talk' a more than two-year-old plan for UCSF to weaken its ties to the larger UC system. 'UCSF is firmly part of the system and will remain so,...' </blockquote>The current president seemed to thus acknowledge that this plan existed, however "loose" it may have been.  Clearly, the Lancet articles suggested rather that Dr Desmond-Hellmann did not have any privatization plans, whatever the criticisms people could have made of them.   Summary We have often discussed the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, how it seems taboo to discuss certain unpleasant facts and issues relevant to the health care system, especially those that might lead to questions about the abilities of the current leadership of large health care organizations.  This taboo seems to particularly affect public discourse within the health care system, such as is found in medical and other scholarly health care journals. The Lancet is one of the largest circulation and most prestigious medical journals.  The Gates Foundation is one of the biggest foundations working in the health care sphere.  In their <a href="http://www.gatesfoundation.org/Who-We-Are/General-Information/Letter-from-Bill-and-Melinda-Gates">latest letter</a>, Bill and Melinda Gates stated, <blockquote class="tr_bq">Our foundation is teaming up with partners around the world to take on some tough challenges: extreme poverty and poor health in developing countries, and the failures of America’s education system.</blockquote> Yet when the Lancet devoted two full pages to often repetitive discussion of the new leader of the Gates Foundation, it avoided discussion of several issues that might have lead to questions about whether her future leadership would really be about challenging "poor health in developing countries," rather than promoting the interests of large pharmaceutical/ biotechnology and other health care related companies, as she had apparently tried to do before.  That such an important medical journal would publish such incomplete health news reporting suggests the operation of the anechoic effect. I hope the questions that ought to be raised about Dr Desmond-Hellmann's priorities as CEO of the Gates Foundation will eventually be put to rest.  It would be more reassuring, however, if they could be confronted directly rather than obfuscated.  As long as big health care journals remain so deferential to big health care leaders, concerns we have raised before about whether health care is now primarily lead by a small in-group of executives and managers who may put private interests ahead of entrusted responsibilities remain acute. As we have said many, many times, true health care reform would ensure that leaders of big health care organizations really put patients' and the public's health ahead of private interests.  References 1.  Holmes D. New CEO takes the reins at the Gates Foundation.  Lancet 2014; 383: 1440.  Link <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2960702-9/fulltext">here</a>. 2.  Holmes D. Susan Desmond-Hellmann taking charge at the Gates Foundation.  Lancet 2014; 383: 1455.  Link<a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2960706-6/fulltext"> here</a>. 3.  McNeil C. Sticker shock sharpens focus on biologics.  J Nat Cancer Instit 2007; 99: 910-914.  Link <a href="http://jnci.oxfordjournals.org/content/99/12/910.extract">here</a>. ADDENDUM - Material about MDVIP as subsidiary of Procter & Gamble added 5 May, 2014 PM.

Abort, Retry, Fail? - Lancet Avoided Much Recent Unpleasantness in Reporting on New Gates Foundation CEO (Including Her Defense of $55,000 a Year for Bevacizumab)

The April 26, 2014 issue of the prestigious journal Lancet used two full pages and two separate articles by the same author to discuss the a...

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The Pervasiveness of Health Care Corruption as Shown by Another Roundup of Legal Settlements

Legal settlements are one way to document unethical and even corrupt behavior by large health care organizations, even if they may not deter bad behavior in the future.  It is time for another roundup of settlements by large pharmaceutical and device companies, presented in alphabetical order Abbott Laboratories This one goes back to late December, 2013.  As <a href="http://www.chattanoogan.com/2013/12/27/266328/Abbott-Laboratories-To-Pay-5.475.aspx">described</a> in the Chattanoogan (from Tennessee): <blockquote class="tr_bq">Abbott Laboratories, a global healthcare company, has agreed to pay $5.475 million to settle alleged violations of the False Claims Act, and other federal laws and regulations in connection with the operation of its medical device business which manufactures, markets and supplies carotid, biliary, and peripheral vascular products.</blockquote> The US Justice Department accused Abbott of kickbacks to physicians, <blockquote class="tr_bq"> As alleged in the settlement agreement, between 2005 and 2010, through its employees and a third party continuing medical education providers, Abbott offered physicians paid teaching and training assignments, consulting arrangements, speaking engagements, and/or sponsorship grants for physician conferences, for the purpose of inducing physicians to arrange for or recommend that the hospitals with which they were affiliated purchase or order Abbott’s carotid, biliary and peripheral vascular products.</blockquote> Note in particular that the kickbacks were disguised as payments for consulting or speaking.  As is usual in such cases, no individual seems to have paid any penalty or been subject to any punishment.  Because this was a legal settlement, the company did not admit wrongdoing. Abbott's previous issues are discussed <a href="http://hcrenewal.blogspot.com/search/label/Abbott">here</a>, including a <a href="http://hcrenewal.blogspot.com/2012/05/abbott-pleads-guilty-settles-for-16.html">$1.6 billion settlement in 2012</a>.  Baxter International This was <a href="http://www.modernhealthcare.com/article/20140421/INFO/304219992">reported</a> in April, 2014 by Modern Healthcare, <blockquote class="tr_bq"> Baxter International agreed to pay $64 million to settle a class-action lawsuit that alleged the Deerfield, Ill.-based company and some of its competitors colluded to raise prices of plasma-based therapies.</blockquote> Unlike the other cases above and below, this seemed to be a purely financial misadventure, although one that clearly increased health care costs, <blockquote class="tr_bq">Hospitals and drug distributors, saying they bought the plasma products at inflated prices, sued in 2009 Baxter; Victoria, Australia-based CSL; and the Plasma Protein Therapeutics Association, an Annapolis, Md.-based trade group.</blockquote> Once more, the company admitted no wrongdoing, and no individuals seemed to be subject to any negative consequences.   Baxter International's previous misadventures are <a href="http://hcrenewal.blogspot.com/search/label/Baxter">here</a>, including the <a href="http://hcrenewal.blogspot.com/2011/08/jama-article-begs-key-questions-about.html">striking case</a> of its marketing of contaminated and sometimes deadly heparin made from Chinese pigs.  Endo Health Solutions This one is from February, 2014, as<a href="http://www.bloomberg.com/news/2014-02-21/endo-to-pay-193-million-in-lidoderm-marketing-probe.html"> reported</a> by Bloomberg <blockquote class="tr_bq">Endo Health Solutions entered a deferred-prosecution agreement and will pay $193 million to settle whistle-blower claims that it marketed the shingles drug Lidoderm for unapproved purposes, the U.S. said. Endo will pay $20.8 million in forfeitures and $171.9 million in civil false claims settlements with the states and the U.S. government, the Justice Department said today in a statement. </blockquote> This one was all about marketing for uses not approved by the US Food an Drug Administration, <blockquote class="tr_bq">Between 2002 and 2006, Endo sales managers instructed some representatives on how to expand 'sales conversations' with doctors beyond the treatment of shingles-related pain, the U.S. said. Under the deferred-prosecution agreement, Endo admitted that it intended Lidoderm to be used for uses not approved by the U.S. Food and Drug Administration, the Justice Department said. </blockquote> Note that this case involves false claims, that is, fraud, because it is illegal to bill government programs for unapproved uses. Again, no individual suffered any consequences, and the company offered the usual kind of statement that admitted neither responsibility nor guilt, <blockquote class="tr_bq">'We are pleased to resolve this matter and are confident that we have robust programs in place to assist us in satisfying our legal and regulatory agreements,' Endo Chief Executive Officer Rajiv De Silva said in a statement.  </blockquote> One wonders, as usual, why a company would pay so much merely to avoid the legal expenses of a trial, unless of course the lawyers suspected the trail would not go well? Hospira This one was about hiding quality problems due to cost-cutting from investors, as<a href="http://www.reuters.com/article/2014/03/27/hospira-lawsuit-idUSL1N0MO2BS20140327"> reported</a> by Reuters in March, 2014.   <blockquote class="tr_bq">Hospira Inc has agreed to pay $60 million to resolve a class action lawsuit accusing the drug maker of misleading investors about quality control problems that undermined an initiative to improve the company's margins and operations.</blockquote> The details included, <blockquote class="tr_bq">As Hospira was promising to address issues raised by the U.S. Food and Drug Administration following inspections, the plaintiffs said the company was 'making the problems worse by gutting quality control efforts through cost cutting aimed at boosting short-term profitability.' The lawsuit said those cost-cutting moves stemmed from a March 2009 initiative called 'Project Fuel' intended to increase shareholder value by eliminating underperforming and duplicative units and reducing its global workforce. Plaintiffs contended the cuts in the budget and workforce hurt Hospira's quality control efforts, particularly at Rocky Mount, the company's largest facility. An FDA inspection in January 2010 of the Rocky Mount facility found a number of problems with the company's quality control and drug validation processes, the lawsuit said, and the agency issued a warning letter that April.</blockquote> Note that this involved quality control problems presumably in drug or device production, possibly leading to safety risks for patients.  Yet it was investors who brought the lawsuit. Note also that this seemed to be a clear case in which cost-cutting measures meant to improve short-term corporate revenue lead to problems that could have caused such risks.   One interesting feature of this case was that company executives were named as defendant (presumably again because it was investors, not patients or law-enforcement officials who initiated the suit.) <blockquote class="tr_bq">The lawsuit ... also named executives including Chief Executive Officer Michael Ball as defendants,...</blockquote> I cannot find any information about whether these executives were personally liable for any payments, however.    Pfizer This is yet another settlement involving the marketing of Neurontin, as <a href="http://www.bloomberg.com/news/2014-04-22/pfizer-agrees-to-pay-190-million-to-settle-neurontin-case-1-.html">reported</a> by Bloomberg in April, 2014, <blockquote class="tr_bq">Pfizer Inc the world’s biggest drugmaker, agreed to pay $190 million to end a lawsuit claiming it violated federal antitrust laws by delaying generic versions of its Neurontin epilepsy drug.  </blockquote><blockquote>Pfizer agreed to settle the class-action litigation pending in federal court in Newark, New Jersey, according to a filing today. U.S. District Judge Faith Hochberg must approve the accord, which would cover purchasers of Neurontin from December 2002 to August 2008. </blockquote> Note that this settlement, like many others, is of matter from a long time ago.  When it comes to bad behavior by big health care corporations, any form of justice is not swift. Note also that this is only the latest chapter in the long saga of Neurontin, for whose mis-marketing Pfizer has already shelled out a lot of money (see<a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html"> this post</a> to start, and <a href="http://hcrenewal.blogspot.com/search/label/Neurontin">here</a> for the collection).  Pfizer has an amazing record of bad behavior on view <a href="http://hcrenewal.blogspot.com/search/label/Pfizer">here</a>.  In fact, it has had a conviction as a Racketeering Influenced Corrupt Organization (RICO) on the basis of its previous marketing of Neurontin (look <a href="http://hcrenewal.blogspot.com/2013/12/blogscan-us-supreme-court-turns-down.html">here</a>). This particular bad behavior involved included, <blockquote class="tr_bq"> improperly listing certain patents with the U.S. Food and Drug Administration, engaging in illegal promotion and sales of Neurontin for unapproved uses, filing and maintaining sham litigations with respect to certain patents, and making misrepresentations to the patent courts,</blockquote> Note that while much of this was legalistic, illegal marketing was in there too. Once more, I found nothing about any negative consequences for individuals who authorized, directed, or implemented questionable actions. Summary So it is all drearily familiar.  Big health care organizations seem to repeatedly engage in deceptive marketing, providing kickbacks to health professionals, fraudulent billing, anti-competitive practices, etc, etc.  These practices increase health care costs, and may risk patients' health and safety.  Many of these practices are corrupt, at least according to the Transparency International definition of corruption, "abuse of entrusted power for private gain."  Drug and device companies, for example, are entrusted to provide safe and effective products.  Deceptive marketing, kickbacks to health professionals to encourage overuse, and cutting quality control to cut costs all seem to be examples of abuse of this entrusted power.  The private gain obviously goes to any managers and executives who score bigger bonuses due to the increases in revenue that result.  Yet there are very few examples of any individuals who gained ever being subject to any negative consequences.  Given that lack, and the lack of any requirement for corporate leaders to admit responsibility, much less guilt, is it any surprise that these practices go on and on.  The failure of current limp legal efforts against such corruption is evident by how many corporations have become ethical repeat offenders.   (Note that in fact, as noted above, one of the pharmaceutical companies above actually was convicted of being a RICO, racketeering influenced corrupt organization, yet that conviction seemed to have no real negative consequences for the organization or any of the people involved.) As I have said again and again, pervasive bad behavior by large health care organizations has got to be a major cause of our ongoing health care dysfunction. So, to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable. As long as they are not, expect the bad behavior to continue.

The Pervasiveness of Health Care Corruption as Shown by Another Roundup of Legal Settlements

Legal settlements are one way to document unethical and even corrupt behavior by large health care organizations, even if they may not deter...

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From a physician and former USAF air traffic controller/pilot on the state of healthcare IT

From a colleague, a physician and blogger and fellow AMIA member with an eclectic background, on the state of healthcare information technology.  Reposted with his permission. Emphases in bold are mine: <div id="divRpF835024" style="direction: ltr;"></div><blockquote class="tr_bq">To restate the old joke, the nice things about medical informatics standards, are their are so many of them too chose from… don’t think we necessarily need to invest even more time and energy on ever more sophisticated data models or ever more exhaustive standards (which are then largely ignored).  <div> </div><div>The fact of the matter is that the EMR remains in the United States a tool for maximization of reimbursement and as such is not a  technological destination but rather a technological dead end. The driver for proliferation of this ‘dead end’ is the government being willing to fund its expansion with their fervent hope that it will be their magic bullet for finding the cheats and cheaters of Medicare. </div><div> </div><div>When I was in the USAF, I was trained to be a software and systems engineer at their great expense and at my great pleasure. Additionally, I was for several years prior to my medical school career a USAF Air Traffic Controller and so I was intimately familiar with perhaps the most perfect of all known systems engineering efforts the Worldwide Air Traffic Control System, and most remarkably (from the wellsprings of my fading memories) I have 50 hours of stick time in the F-16. </div><div> </div><div>The flying environment of the F-16 which is ‘eyes outside the cockpit’ was made possible by advanced human engineering efforts that resulted in Heads Up Displays of both intense rational and aesthetic beauty that made the machine a joy to fly. </div><div> </div><div>Fast forward 20 years and what am I given as a clinician to work with…. to keep my head out of the cockpit…… spreadsheets…… designed by engineers who like spreadsheets and think in spread sheets…..  and who don’t even take the 30 minutes it takes to articulate the logic of presentation of clinical data, i.e., present the serum salts together with the BUN/Creatinine, present the RDW with the RBC indices and the hematocrit and hemoglobin … present the last 3 d’s worth of data together aggregated by type rather than alphabetized and homogenized and distributed in clinically illogical boxes. </div><div> </div><div>The F-16 was designed by engineers, but pilots oversaw its development and the display of its information systems were always the results of intense end user interaction with the design teams. This type of intense physician interaction and veto power of poor information design efforts does not exist in [the health IT] industry. Their goal is feature proliferation and uniqueness (not commonality) of function as a market differentiation tool and to avoid suits for ‘look and feel’ viz a viz the Apple vs Microsoft suits of the 80’s. </div><div> </div><div>The reality is the train has left, those of us addicted to patient care watch in dismayed horror as our productivity plunges and we struggle to restructure not our workflows but our clinical thought processes to badly designed, logically flawed, and obscenely overpriced documentation tools that distract the expert clinician from a high quality clinical encounter. </div><div> </div><div>Quite honestly gentleman and gentlewomen of the jury, I don’t give a ‘rats a**’ about superior documentation, I am obsessed with superior outcomes, and as somebody who actually has to work with this junk, it all sucks………. and will continue to suck until such time as real world clinicians have veto power over the efforts of systems design teams with respect to their information design efforts…. What information design efforts?  My point precisely……. </div><div> </div><div>As always Acerbically Yours, </div><div> </div><div> </div><div>frnk m (Frank Meissner)</div><div> </div><div>“I am not a pessimist, I am an optimist who has not arrived’ </div><div>                                                                      Mark Twain</div></blockquote> My reply back was: <blockquote class="tr_bq">Frank, on a related note, I was at a fleamarket yesterday looking for radio & electronics stuff (my hobby) and came across a man selling copies of "Aviation Week" from 1960.  He had the entire year's set. I looked through them and was STUNNED. The engineering prowess described in not just the articles but in the advertisements as well - bearings, servos, instrumentation, etc. for aircraft and spacecraft was stunning.  There was even an ad for a desktop computer, a Packard Bell PB-250 with "microsecond add time, 350 transistors and 46 (or so) instructions" for a mere $30,000. What you are describing - and what I have been trying to describe for over a decade and a half - is an intellectually impoverished industry that ignores our specialty [Medical Informatics] and good engineering practices in general. That AMIA has made itself appear comfortable with that status quo has been a disappointment to say the least.  What you just wrote should have come from the leadership, and years ago, not from the grass roots. If physicians could refuse use of clinical IT without sanction, I believe in 2014 that most would walk away. The fact that this technology is now forced on clinicians is not what the pioneers in informatics intended, I am confident; our medical leadership, furthermore, should be ashamed of this set of affairs. As a former medical manager for the Southeastern PA Transportation Authority, even bus drivers and porters in public transit had more rights to determine what equipment they would or would not use in their work, and its configuration, than physicians have in theirs.</blockquote> -- SS

From a physician and former USAF air traffic controller/pilot on the state of healthcare IT

From a colleague, a physician and blogger and fellow AMIA member with an eclectic background, on the state of healthcare information technol...

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In ECRI Institute's new 2014 "Top 10 Patient Safety Concerns for Healthcare Organizations", Healthcare IT is #1. (FDA: E-cigarettes are REALLY dangerous.)

The ECRI Institute in Pennsylvania (<a href="https://www.ecri.org/About/Pages/default.aspx">https://www.ecri.org/About/Pages/default.aspx</a>) has had health IT as among the "Top Ten Healthcare Technology Risks" for several years running.  Search this blog on "ECRI" for mention of those reports. Just off the press, though, is ECRI's "Top Ten patient safety concerns for 2014".  The PDF report is available at <a href="https://www.ecri.org/EmailResources/PSRQ/Top10/Top10PSRQ.pdf">https://www.ecri.org/EmailResources/PSRQ/Top10/Top10PSRQ.pdf</a>. Health IT is number one, perhaps as a result of the ECRI Deep Dive study of Health IT risk with its hair-raising numbers of 171 "IT incidents", 8 resultant injuries, and 3 possible deaths in 36 hospitals in just 9 weeks (<a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>). From the new report: CONCERN #1: Data integrity failures with health information technology systems <div>At page 7:</div><div> <div style="font-family: serif; margin-left: 40px;">With the federal government offering financial incentives for hospitals and physician practices to adopt EHR systems, use of these systems more than tripled from 2009 through 2012. “Health IT systems are very complex,” says James P. Keller, M.S., vice president, technology evaluation and safety, ECRI Institute. “They are managing a lot of information, and it’s easy to get something wrong” if the systems are not designed and implemented well. While appropriately designed and implemented systems can provide complete, current, and accurate patient care information so that the clinician can make appropriate treatment decisions, the presence of incorrect data can lead to incorrect treatment, potentially leading to patient harm.</div> <div style="font-family: serif; margin-left: 40px;">For example, the integrity of data in health IT systems can be compromised from any of the following: data entry errors, missing data or delayed data delivery, inappropriate use of default values, copying and pasting older information into a new report, use of both paper and electronic systems for patient care, and patient/data association errors (i.e., patient data from a medical device is mistakenly associated with another patient’s record). Key steps in safeguarding the integrity of electronic patient data include the following:</div><div dir="ltr" style="font-family: serif; font-size: 16.6667px;"> <div style="font-family: serif; margin-left: 40px;"> </div><div style="font-family: serif; margin-left: 40px;">x  Assessing the clinical workflow to understand how the data is, or will be, used by frontline staff  x  Testing the system and the associated interfaces, preferably in a simulated setting, to verify that the system is functioning as intended x  Providing sufficient user training and support x  Establishing a mechanism for users to report problems as they are discovered </div></div></div>In the Bizarro world in which we find ourselves in 2014, however: <ul><li>FDA has decided that healthcare information technology systems "for health information and data management" (I quote) are of "sufficiently low risk", even if they "meet the statutory requirements as medical devices" and thus fall under the Food, Drug & Cosmetic Act, to not require FDA oversight, and even though FDA admits they really do not and cannot know the true level of risks (<a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>).  </li></ul>(Got that?) While: <ul><li>Regulation of E-cigarettes is a National Priority of the Highest Importance due to Their Possible Deadly Dangers (<a href="http://hcrenewal.blogspot.com/2014/04/hypocrisy-at-fda-lets-regulate.html">http://hcrenewal.blogspot.com/2014/04/hypocrisy-at-fda-lets-regulate.html</a>).</li></ul>The E-cigarette focus is For The Children, no doubt. <ul><li>Except for children such as these, one might conclude:  <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html</a>.</li></ul> <ul> </ul> <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/AVvXsEh0BV8P-O5io5HPCOYJHdjddYwVGrOt4Fj_vfeeLDGHu1cvrn3-1iryc-KRA_e-toY6ak2nFKFtijMIOvXB0W2PE8xMQe8IX6Pbbs42QmR4cTSR9swsk-IG3i371ljixE3-GSUn7QbQXzqZ/s1600/bizzaroworld.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="200" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh0BV8P-O5io5HPCOYJHdjddYwVGrOt4Fj_vfeeLDGHu1cvrn3-1iryc-KRA_e-toY6ak2nFKFtijMIOvXB0W2PE8xMQe8IX6Pbbs42QmR4cTSR9swsk-IG3i371ljixE3-GSUn7QbQXzqZ/s1600/bizzaroworld.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Bizarro World (<a href="http://en.wikipedia.org/wiki/Bizarro_World">http://en.wikipedia.org/wiki/Bizarro_World</a>).</td></tr></tbody></table> Note that ECRI Concerns #2 and #3 also may involve electronic medical records systems. CONCERN #2: Poor Care Coordination with Patient’s Next Level of Care (page 8): <blockquote>... Electronic health records (EHRs) can facilitate communication about a patient’s care among providers, but organizations must establish procedures that address accessing, reviewing, and acting on the findings in those records. For example, what happens if a provider who is viewing a patient’s record discovers that results of tests ordered by another provider have not been acted upon? EHRs could become a barrier “if physicians are second-guessing one another,” says Possanza. Organizations might find it helpful to develop a policy specifying procedures for a provider who finds an abnormal laboratory or pathology result with no indication that the abnormal result was acted upon.</blockquote><ul></ul> CONCERN #3: Test Results Reporting Errors (page 10): <blockquote class="tr_bq">... Callahan observes that breakdowns in test results reporting, particularly in physician practices, typically have one of three causes or a combination of them: (1) technology limitations, such as an inadequate interface between an EHR system and a laboratory system that provides the results electronically; (2) provider-to-provider communication gaps, such as those that occur when no backup plan is in place to designate a provider to review test results for another provider who is unavailable or on vacation; and (3) staffing and training failures, such as requiring a staff member to periodically check an EHR system for test results but not informing the person of what to expect in terms of the volume of test results typically reported to the practice. As more healthcare organizations adopt EHR systems, Callahan warns against being lulled into thinking the systems are a panacea and can prevent test reporting failures. “It’s another tool,” she says. “It won’t improve test results reporting if it’s not used correctly.”</blockquote> I was involved as consultant in a related scenario, in a case that settled out of court, where an ordered lab test was never performed (probably due to an EHR-lab interface failure!) and automatically "expired" in the EHR after a year.  However, no subsequent provider acted upon the expired order, with disastrous results. -- SS

In ECRI Institute's new 2014 "Top 10 Patient Safety Concerns for Healthcare Organizations", Healthcare IT is #1. (FDA: E-cigarettes are REALLY dangerous.)

The ECRI Institute in Pennsylvania ( https://www.ecri.org/About/Pages/default.aspx ) has had health IT as among the "Top Ten Healthcare...

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Followup to "CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives"

At my April 16, 2014 post "CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives" (<a href="http://hcrenewal.blogspot.com/2014/04/cms-does-not-have-any-information-that.html">http://hcrenewal.blogspot.com/2014/04/cms-does-not-have-any-information-that.html</a>) I noted that the American Association of Physicians and Surgeons (AAPS) had received a reply from CMS to a FOIA request that: <blockquote class="tr_bq">"We [CMS] do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives." </blockquote> Put another way, the country is embarking on a $1 trillion healthcare experiment, and blindly. I mentioned I'd post the letter when received from AAPS.  That just occurred. The letter is below (click to enlarge): <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/AVvXsEhXyGzY3biU0IcibR_jpNBb18X__sIeFWVd7E3T1MoAa300RBg2N_3-t_UMmx2bhlwk3KnobEgycCWCVmwWTy13uQVLGi3VBPFpgdzCHBu_0Qq5-fDamfZIWx-WeLaeYztcEayTGeCU7JIC/s1600/CMS_Letter.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhXyGzY3biU0IcibR_jpNBb18X__sIeFWVd7E3T1MoAa300RBg2N_3-t_UMmx2bhlwk3KnobEgycCWCVmwWTy13uQVLGi3VBPFpgdzCHBu_0Qq5-fDamfZIWx-WeLaeYztcEayTGeCU7JIC/s1600/CMS_Letter.jpg" width="308" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But let's spend hundreds of billions of dollars anyway.]  Click to enlarge. </td></tr></tbody></table> I've added it as an addendum to the original post, but thought it worthwhile to call out the letter in a post of its own to those who might not revisit the original. An additional thought: While CMS may "not have any information that supports or refutes claims that a broader adoption of EHRs can save lives", they do have (or should have made it their business to have) information that EHRs cause harm and take lives (e.g., via FDA at <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a> , ECRI at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a> and others). -- SS

Followup to "CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives"

At my April 16, 2014 post " CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save ...

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