Too Good to be True - Sovaldi Kerfuffle Focuses on Price, While Ignoring Limits of Evidence about Effectiveness and Safety

There seems to be rising skepticism about the prices we pay for the latest drugs, devices, and health care programs, especially in the US.  However, our faith in the near miraculous properties of the newest technology appears to go on unabated.  Skepticism, driven by the rigorous thinking that ought to be engendered by the dutiful application of the principles of <a href="http://hcrenewal.blogspot.com/search/label/evidence-based%20medicine">evidence-based medicine</a>, is rarely in evidence. <br /><br />The latest example is of how concern about the sky high price of one new medication seems to have eclipsed any skepticism about how much good that medicine may do for patients.<br /><br /><b>The Sovaldi Pricing Kefuffle</b><br /><br />Starting in early March, 2014, a media discussion began about the extremely high price set for a new drug for the treatment of hepatitis C.  As first<a href="http://www.washingtonpost.com/national/health-science/costly-hepatitis-drug-sovaldi-rattles-industry/2014/03/01/86cab0b4-a091-11e3-9ba6-800d1192d08b_story.html"> reported</a> by the Washington Post,<br /><br /><blockquote class="tr_bq">When the Food and Drug Administration approved a medication called Sovaldi [sofosbuvir, Gilead] in December,<i> it was hailed as a breakthrough in the fight against hepatitis C</i>, a blood-borne disease that affects 3.2 million Americans and <i>kills more people in the U.S. annually than AIDS</i>.<br /><br />Then California-based Gilead Sciences, the manufacturer, announced the price:<i> <b>$84,000</b> for a 12-week course</i>, more than what many cancer treatments cost in a year. </blockquote><br />The coverage focused on whether the price could possible be justified, while it generally conceding that the drug was a huge advance that was genuinely valuable. For example, the Post article noted, <br /><br /><blockquote class="tr_bq">The drug has also prompted a new round of hand-wringing over a larger issue: the escalating cost of specialty drugs, which are designed to treat chronic illnesses such as rheumatoid arthritis and multiple sclerosis and sometimes require special handling.<br /><br />While these <i>therapies are delivering body blows to some of the world’s most pernicious diseases</i>, they also are<i> testing the limits of what society is willing to pay for sought-after treatments or cures. </i></blockquote><br />The articles justified the drug's value with several assertions: <br /><br /><u>Sofosbuvir cures nearly everyone of hepatitis C</u><br /><br />For example, the Post article stated, <br /><br /><blockquote class="tr_bq">Sovaldi promises to cure nearly all sufferers... </blockquote><br />Similarly, a report by the authoritative <a href="http://www.kaiserhealthnews.org/stories/2014/march/03/insurers-debate-who-should-get-costly-hepatitis-c-drug.aspx">Kaiser Health News</a> stated that the drug has,<br /><br /><blockquote class="tr_bq">a success rate of better than 90 percent.</blockquote><br />A Bloomberg<a href="http://www.bloomberg.com/news/2014-03-03/gilead-ceo-becomes-billionaire-on-84-000-hepatitis-drug.html"> article</a> quoted Dr Leonard Berkowitz, chief of infectious disease as Brooklyn Hospital Center as saying the drug is<br /><br /><blockquote class="tr_bq">producing 'spectacular improvements' in cure rates....</blockquote><br />Going even farther, a Denver Post <a href="http://www.denverpost.com/news/ci_25275400/hepatitis-c-breakthrough-drug-sovaldi-promises-high-cure">article</a> quoted Dr Greg Everson, a hepatologist at the University of Colorado,<br /><br /><blockquote class="tr_bq">The word is cure.  To me, the cure of hep C is one of the most significant medical developments of the last 50 years.</blockquote><br /><u>Sofosbuvir is extremely safe and has few side effects </u><br /><br />For example, the Post article stated Sovaldi is <br /><br /><blockquote class="tr_bq">a once-daily pill that has far fewer side effects [than other treatments] </blockquote><br />The Bloomberg article again quoted Dr Berkowitz as saying the drug has<br /><br /><blockquote class="tr_bq">minimal toxicity</blockquote><br />The Denver Post quoted Dr Everson,<br /><br /><blockquote class="tr_bq">the side effects are almost nonexistent - mild headache and fatigue.</blockquote><br /><u>Without treatment, hepatitis C leads to very bad outcomes </u><br /><br />For example, the Post article stated, <br /><br /><blockquote class="tr_bq">The disease can go undetected for years and can eventually lead to cancer or cirrhosis of the liver. </blockquote><br />Kaiser Health News added,<br /><br /><blockquote class="tr_bq">If left untreated, hepatitis C can cause liver damage over the course of decades. </blockquote><br />An<a href="http://articles.latimes.com/2014/mar/09/business/la-fi-hepatitis-c-drug-costs-20140310"> article</a> in the Los Angeles Times noted,<br /><br /><blockquote class="tr_bq">Left unchecked, some hepatitis C infections result in liver damage, liver cancer or death.</blockquote><br />The Denver Post again quoted Dr Everson,<br /><br /><blockquote class="tr_bq">It's a devastating disease. [Also,] It can smolder for years without symptoms, then it destroys the liver - cirrhosis, cancer.</blockquote><br /><u>Sofosbuvir prevents nearly all these bad outcomes.</u><br /><br />This was more implied by the media than directly stated, although the Los Angeles Times did quote an executive vice president of Gilead, the manufacturer of Sovaldi,<br /><br /><blockquote class="tr_bq">Sovaldi ... results in very high cure rates that can avoid future costs related to disease progression or treatment failure....</blockquote><br />Only the New York Times provided just a hint of skunk odor at the garden party.  Its later <a href="http://www.nytimes.com/2014/03/22/business/lawmakers-attack-cost-of-new-hepatitis-drug.html">article</a> on some US congress members' attempt to investigate the pricing of Sovaldi contributed,<br /><br />But most people with hepatitis C never experience serious liver problems.  So many people would be fine without treatment.<br /><br />That little bit of odor notwithstanding, one could ask what is not to like about this drug.  But the coverage really focused on how many people felt the cost was still just too high.  Unstated, but again implied was the notion that these complaints were just sour grapes.  How could anyone begrudge a mere $84,000 for a safe, extremely effective curative drug that would prevent severe morbidity and premature death, yet cause almost no significant side effects?<br /><br />The problem is that the evidence that actually supports the "value proposition" for Sovaldi is actually not clear at all.  The bigger problem is that so far, discussion of this evidence in the media seems to be absent.<br /><br /><b>The Evidence about Treatment of Hepatitis C</b><br /><br />Let us consider the assertions above, and what evidence there may be to support them,  in slightly different order.<br /><br /><u>Without treatment, hepatitis C leads to very bad outcomes</u><br /><br />The earliest research on hepatitis C focused on patients who already had severe complications of the disease.  Thus, as Seeff et al wrote in 2000(1),<br /><br /><blockquote class="tr_bq">retrospective studies of person who have chronic, clinically obvious HCV infection may overemphasize more serious outcomes because they risk omitting persons with subclinical infection as well as those in whom infection spontaneously resolves.</blockquote><br />Yet popular conceptions of hepatitis C, especially those reflected by the current Sovaldi pricing kerfuffle, seem to reflect only the experience of the most unfortunate hepatitis C patients.  In contrast, studies that have followed cohorts of patients who have evidence of early hepatitis C infection show very different results.<br /><br />In 1999, Kenny-Walsh and colleagues reported a cohort of 390 women who had tested positive for hepatitis C after receiving infected immune globulin.(2)  They were able to follow them for 17 years.  In that time period, 43% of the women had no or minimal inflammation of the liver; 49% had no evidence of liver fibrosis; and only 2% had developed fibrosis.<br /><br />In 2000, Seeff and colleagues reported 45 years of follow up of young military men who were found to have evidence of hepatitis C infection from analysis of long stored frozen serum.  Only one (less than 3%) of their admittedly small cohort of 34 positive men had been found to have any sort of liver problem in that time period.(1)<br /><br />In 2001, Seeff and colleagues reported 20-year follow up of several cohorts including 222 patients who developed hepatitis characterized by abnormal liver enzymes after blood transfusion and for whom retrospective tests on stored blood revealed hepatitis C at that time.(3)  The total mortality over 20 years of the hepatitis C patients was not greater than a group of control patients who had been transfused but did not develop clinical hepatitis.  51% of the hepatitis C infected patients had no evidence of chronic hepatitis.  23% had no evidence of continuing hepatitis C infection. <br /><br />These admittedly old studies show that a significant minority of patients with hepatitis C infection spontaneously resolve their infections, and that a majority of patients have no evidence of significant liver disease over decades of observation.  Cirrhosis is actually a relatively rare outcome of hepatitis C infection, and there is no clear evidence that hepatitis C infection increases total mortality.<br /><br />Of course, once a patient with hepatitis C has been unfortunate enough to develop clear liver disease, that patient's prognosis is not so good. <br /><br />Thus, there is <i>no</i> clear evidence that the majority of patients with hepatitis C infection could benefit from anti-viral treatment given prior to development of any significant complications of the infection, because the majority of such patients may never develop any adverse effects of the infection.  Thus it is not at all obvious that any current hepatitis C treatment could be widely life-saving.<br /><br /><u>Treatment Prevents Nearly All Bad Outcomes</u><br /><br />There have been no long-term randomized controlled trials of any anti-viral treatment for hepatitis C that evaluated clinical outcomes like cirrhosis, liver failure, liver cancer, need for transplantation or death.  All trials of all agents have been relatively short term, and focused on reduction or elimination of detectable virus from the blood as an outcome.  As detailed in the latest evidence report from the US Preventive Services Task Force,(4) there have been observational studies that compared patients who were treated and had sustained virological responses (elimination of detectable virus from the blood) and those who did not in terms of long-term outcomes.  Such observational studies are liable, however, to confounding.  Patients who are willing to take treatment, fully comply with treatment, and respond better to therapy may be systematically different from those who refuse treatment, do not adhere to treatment, or whose treatment is not initially successful.  Most of these studies were considered to be of poor methodological quality, although the best, still only considered of fair quality, did show an association between virological responses and clinical outcomes.  There have been no studies of the comparative effectiveness of different anti-viral treatments.<br /><br />Thus, the evidence that anti-viral treatment for hepatitis C prevents any bad clinical outcomes, like cirrhosis, liver failure, liver cancer, or premature death is unclear. <br /><br />Now to consider the best evidence available about sofosbuvir.<br /><br /><u>Sofosbuvir cures nearly everyone of hepatitis C</u><br /><br />So far, the best study reported about sofosbuvir seems to be one in the New England Journal of Medicine in 2013.(5)  This report included an open-label (not blinded) controlled trial called FISSION of sofosbuvir plus ribivirin versus peginterferon alfa-21 plus ribivirin.  Its primary outcome measure was viral response 12 weeks after therapy (which lasted 12 weeks in the first group, 24 in the second).  The proportion of patients with responses 12 weeks after therapy were 67% in both groups.  Patients who received sofosbivir had lower rates of the common, uncomfortable complications attributed to interferon therapy than those who received peginterferon (e.g., fatigue, 36% versus 55%; nausea, 18% versus 29%).  However, while small, the proportion of patients with serious adverse events, not further defined in the article, were higher in the sofosbivir group, 3% versus 1%. <br /><br />Note that the above report also included what was euphemistically called a "single-group, open-label study."  This seems to be a fancy name for what is usually called a case series, that is, a series of patients given a particular treatment, without a control group.  The consensus in the evidence-based medicine community has long been that barring miraculous results, case series are nearly useless as evidence about treatments, primarily because it is not possible to separate the effects of the patient selection process from the treatment on the apparent outcomes.  Why this case series was included in the report is a secret known only to New England Journal editors. <br /><br />So setting aside that distraction, it is not obvious that sofosbivir increases even short-term virological response (at 12 weeks after treatment) compared to the best previously available treatment.  There is no evidence that sofosbivir can cure nearly everyone.  (Much of the enthusiasm seems to come from blood tests on treatment, disregarding the results shortly after treatment.)  These are not "spectacular" results."<br /><br /><u>Sofosbuvir is extremely safe and has few side effects</u><br /><br />From the above trial results, it is not obvious that the drug is extremely safe.  In fact, there is a suggestion that it may lead to an increase in serious adverse effects.<br /><br />While the drug does seem to produce fewer bothersome adverse effects, even the rates of these symptoms in those treated are not negligible.<br /><br /><b>Summary</b><br /><br />While there is concern about the gargantuan price asked for Sovaldi, the new treatment for hepatitis C, there seems to be little skepticism about the near miraculous claims made for the value of the new drug.  In fact, it almost appears that the debate about the price is reinforcing current dogma which promises nearly universal cures without major risks.  Yet the evidence is that many, perhaps most patients with hepatitis C will not benefit from treatment, and that the new drug is not much more, or any more likely to cure patients than older drugs.  Meanwhile, the evidence that the new drug is safer and causes fewer adverse effects is weak at best.<br /><br />The US health care system, and to some extent the health care systems in most developed countries are experiencing ever higher prices.  Much of these prices' effects seem to drive up remuneration of health care executives and managers, but whether they buy better care or outcomes for most people is not so clear.  The ever rising prices seem to be buoyed by endless enthusiasm for new tests, treatments, programs, and unbridled faith in the benefits of all new technology.  It is not clear how much of that is due to evidence, how much is based on ideology and unquestioning faith in technological progress, and how much is driven by marketing and public relations, which not always may be entirely honest and free from deception.<br /><br />Evidence-based medicine rigorously applied suggests that individual health care and health policy decisions should be driven by the best available evidence, mostly from clinical research, about the benefits and harms of tests, treatments, programs, and so on, in the context of what outcomes matter to patients.  The skepticism EBM should engender lead to health care that is more about patients and their outcomes, and less about ideology, hype, and hucksterism. <br /><br /><b>References</b><br />1.  Seeff LB, Miller RN, Rabkin CS et al.  45-year follow-up of hepatitis C virus infection in healthy young adults.  Ann Intern Med 2000; 132: 105-111.  Link <a href="http://annals.org/article.aspx?articleid=713226">here</a>.<br />2.  Kenny-Walsh E, for the Irish Hepatology Research Group.  Clinical outcomes after hepatitis C infection from contaminated anti-D immune globulin.  N Engl J Med 1999; 340: 1228- 1233.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJM199904223401602">here</a>.<br />3. Seeff LB, Hollilnger B, Alter HJ et al.  Long-term mortality and morbidity of transfusion- associated non-A, non-B, and type C hepatitis: a National Heart Lung and Blood Institute Collaborative Study.  Hepatology 2001; 33: 455-463.  Link <a href="http://www.ncbi.nlm.nih.gov/pubmed/11172349">here</a>.<br />4. Chou R, Hartung D, Rahman B et al.  Comparative effectiveness of antiviral treatment for hepatitis C virus infection in adults: a systematic review.  Ann Intern Med 2013; 158: 114.-123.  Link <a href="http://annals.org/article.aspx?articleid=1402433">here</a>.<br />5.  Lawitz E, Mangia A, Wyles D et al.  Sofosbuvir for previously untreated chronic hepatitis C infection.  N Engl J Med 2013; 368: 1878-1887.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1214853">here</a>.<br /><br />

Too Good to be True - Sovaldi Kerfuffle Focuses on Price, While Ignoring Limits of Evidence about Effectiveness and Safety

There seems to be rising skepticism about the prices we pay for the latest drugs, devices, and health care programs, especially in the US.  ...

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Senate Majority Leader Harry Reid on Bad Health IT: "People Aren’t Educated on How to Use the Internet"

The ultimate "blame the user" excuse for bad health IT comes from, of all places, Senate Majority Leader Harry Reid:<br /><br /><blockquote class="tr_bq"><b>Washington Free Beacon </b><br /><a href="http://freebeacon.com/issues/harry-reid-people-arent-educated-on-how-to-use-the-internet/">http://freebeacon.com/issues/harry-reid-people-arent-educated-on-how-to-use-the-internet/</a><br /><time class="entry-date" datetime="2014-03-26T13:16:44+00:00" pubdate="">March 26, 2014 1:16 pm</time><br /><br />Senate Majority Leader Harry Reid (D., Nev.) said the fault of struggling to sign up on the Obamacare exchanges <b>didn’t lie with the faulty website,</b> but <b>with the people who weren’t “educated on how to use the Internet.”</b><br /><br />Explaining the reasoning behind the latest Obamacare delay, Reid said too many people <b>just didn’t know to use their computer properly </b>and needed more time. Apparently, it had nothing to do with the well-documented <a href="http://youtu.be/AAtgsizDWV0">failings of the website</a> that have embarrassed the White House for months. <span style="color: red;"><i><b> [Really?  What an amazing theory about IT difficulties - ed.]</b></i></span><br /><br />“We have hundreds of thousands of people who tried to sign up who didn’t get through,” he said. “There are some people who are not like my grandchildren who can handle everything so easily on the Internet, and these people need a little extra time. It’s not — the example they gave us is a 63-year-old woman came into the store and said, ‘<b>I almost got it. Every time I just about got there, it would cut me off.’ </b> </blockquote><br />Obviously due to user error, not due to poor health IT. <br /><br /><blockquote class="tr_bq">We have a lot of people just like this through no fault of the Internet, <b>but because people are not educated on how to use the Internet.”</b></blockquote><br />It's not the software designer's or website's fault, it's the fault of Americans, most of whom are dummies and who should know how to get around bad health IT's flaws.  <br /><br />Wow. <br /><br />That's why physicians complain about health IT too, no doubt.  They're dummies. <br /><br />Maybe Mr. Reed should speak with the inventor of the Internet, former Veep Al Gore, about that.  Mr. Gore can perhaps write a better <b>"Internet Instruction Manual for Dummies."</b><br /><br />(I'll bet most of the dummies who "do not know how to use the Internet" have no problems using Amazon.com or eBay.)<br /><br />-- SS

Senate Majority Leader Harry Reid on Bad Health IT: "People Aren’t Educated on How to Use the Internet"

The ultimate "blame the user" excuse for bad health IT comes from, of all places, Senate Majority Leader Harry Reid: Washington Fr...

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James Fallows - The Atlantic - "The Use and Misuse of Information Technology in Health Care"

<a class="author-name" href="http://www.theatlantic.com/james-fallows/">James Fallows</a>, a national correspondent for The Atlantic, wrote <b>"The Use and Misuse of Information Technology in Health Care: Several Doctors Reply"</b> at <a href="http://www.theatlantic.com/health/archive/2014/03/the-use-and-misuse-of-information-technology-in-health-care-several-doctors-reply/284601/">http://www.theatlantic.com/health/archive/2014/03/the-use-and-misuse-of-information-technology-in-health-care-several-doctors-reply/284601/</a><br /><br />It includes several physician responses to an interview with health IT hyper-enthusiast David Blumenthal, former ONC director, at <a href="http://www.theatlantic.com/magazine/archive/2014/04/the-paper-cure/358639/">http://www.theatlantic.com/magazine/archive/2014/04/the-paper-cure/358639/</a>.<br /><br />It would be a poor use of your time for me to add commentary.  Simply read the pieces at the links above.<br /><br />The doctors' responses piece speaks for itself.<br /><br />(Actually. I will add commentary:  the sum total of all my posts on health IT here at HC Renewal blog dating to 2004, and all my writing at my site at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases">http://cci.drexel.edu/faculty/ssilverstein/cases</a>/ dating to 1998.) <br /><br />-- SS<br /><br />

James Fallows - The Atlantic - "The Use and Misuse of Information Technology in Health Care"

James Fallows , a national correspondent for The Atlantic, wrote "The Use and Misuse of Information Technology in Health Care: Several ...

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This EHR "glitch" killed three-year-old Samuel Starr - but patient safety was not compromised

Actually, safety was compromised. <br /><br />I have written repeatedly that the term "glitch", an often-seen euphemism (usually accompanied with the phrase <b>"but patient care/patient safety was not compromised"</b>), is really a term for life-threatening health IT bugs and malfunctions.  See query link <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a> for examples of health IT "glitches" (retrieves multiple posts).<br /><br /><br /><div class="separator" style="clear: both; text-align: center;"><a href="http://4.bp.blogspot.com/-eqIOgVf-gaA/UzITSBug5fI/AAAAAAAAB5o/L7CpteY2-XI/s1600/Main-Samuel-Starr-3204412.jpg" imageanchor="1" style="margin-left: 1em; margin-right: 1em;"><img border="0" height="200" src="http://4.bp.blogspot.com/-eqIOgVf-gaA/UzITSBug5fI/AAAAAAAAB5o/L7CpteY2-XI/s1600/Main-Samuel-Starr-3204412.jpg" width="150" /></a></div><br /><br />Here's a "glitch" that tragically killed this boy: <br /><br /><blockquote class="tr_bq"><b>Three-year-old boy dies after new NHS computer system delays heart treatment</b><br /><br />Mar 05, 2014<br />By James Tute<br /><br /><a href="http://www.mirror.co.uk/news/uk-news/samuel-starr-death-nhs-computer-3209365">http://www.mirror.co.uk/news/uk-news/samuel-starr-death-nhs-computer-3209365 </a><br /><br />Coroner Maria Voisin rules that new booking system meant he did not receive life-saving treatment<br /><br />A three-year-old boy died in his parents' arms <b>after a new NHS computer system failed to schedule him for a vital heart scan</b>, a coroner has ruled.<br /><br />Samuel Starr was born with a congenital cardiac defect and needed surgery not long after he was born in 2010.<br /><br />Although he made a good recovery doctors said he would need regular tests to check on his progress.<br /><br />But he did not have a scan until 20 months after his first major operation <b>because of a delay following the introduction of a new computer system</b>, Cerner Millennium.<br /><br />When he finally had the appointment doctors found Samuel needed open heart surgery. During the procedure, Samuel had a stroke.<br /><br />A month later, after further complications, he died in the arms of his devastated parents, Catherine Holley and Paul Starr, at Bristol Royal Hospital for Children.</blockquote><br />There are some in my field who would (and have) called incidents like this "anecdotes" or "bumps in the road."<br /><br />Yet, as I've recently posted, an internationally-renowned healthcare safety tester, ECRI Institute (<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 the medical malpractice insurer of the Harvard medical community, CRICO (<a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html">http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html</a>), have confirmed cases like this are no mere anecdotes.  I estimate from their numbers, and from cases known to me personally and from descriptions of others, that on the order of ten thousand (that's likely low) patients annually are being injured and/or die as a result of bad health IT in the U.S. alone.  Lack of transparency about such incidents impairs knowing the true numbers.<br /><br /><blockquote class="tr_bq">Ms Holley wept as she told the hearing of the moment she kissed her son goodbye, saying: "He was a kind and gentle boy with a great understanding of the world.<br /><br />"As we read Samuel his favourite stories, he died in our arms."<br /><br />Avon Coroner Maria Voisin, recording a narrative conclusion, <b>ruled the booking system meant Samuel was not seen and did not receive treatment.</b></blockquote><br />This case somewhat reminds me of the case of a newborn whose x-ray test was done, but never looked at due to a bug in the software that scheduled films to be read, see <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>, case #2<br /><br /><blockquote class="tr_bq">Concluding a three-day inquest at Flax Bourton Coroner's Court in North Somerset, Ms Voisin said: "Samuel Starr was born with a complex cardiac disease. "He required surgery and regular check-ups at outpatients to manage his conditions.  "Due to the failure of the hospital outpatients booking system there was a five month delay in Samuel being seen and receiving treatment. "Samuel's heart was disadvantaged and he died following urgent surgery."</blockquote><br />Just a "glitch."<br /><br /><blockquote class="tr_bq">Doctors diagnosed that Samuel had a restricted pulmonary artery - causing blood to easily flow away from his heart to his lungs - during a 20-week scan in pregnancy ... On March 3, 2010, Samuel underwent open heart surgery at Bristol Royal Hospital for Children. He was discharged six days later and referred to the Paediatric Cardiac Clinic at the Royal United Hospital (RUH) in Bath for check-ups.<br /><br />In October 2010, Samuel had his first check-up, in which an echocardiogram, also known as an "echo", was carried out. Ms Holley said she was told the procedure would be next carried out early in the new year.<br /><br />But it did not happen until April 2011 and an echo was not performed.  Paediatric cardiologist Dr Andrew Tometzki told the inquest he did not "deem it necessary" on that day to carry out the echo scan. Dr Tometzki then ordered a further review - where an echo scan would be carried out - in nine months' time.<br /><br /><b>Samuel's parents did not receive information about the check-up and raised their concerns with community children's nurse Clare Mees.</b><br /><br />Ms Mees, who works for Sirona Lifetime Services, <b>said she would chase up the matter</b> with Dr Tometzki's secretary.<br /><br />Medical secretary Annabelle Attridge insisted she had taken details and forwarded them on to a dedicated appointments team.<br /><br /><b>However, the inquest heard <span style="color: red;">"glitch problems"</span> with a new booking system meant the appointment was not logged.  <span style="color: red;"></span></b></blockquote><br />Apparently not due to human fault: <br /><br /><blockquote class="tr_bq">Paediatric clinic co-ordinator Donna McMahon said while Samuel's medical records had been created on the new Millennium computer programme, <b>no appointments had been transferred across.</b></blockquote><br />Just a "glitch."  Just a "bump in the road."<br /><br /><blockquote class="tr_bq">Ms McMahon said she was first aware of the appointment delay when she received an email from nurse Ms Mees in May 2012.<br /><br />Samuel did not have the vital check-up until June 21.<br /><br />Coroner Ms Voisin added: "This overall failure led to a five month delay in Samuel being seen by his cardiologist.<br /><br />"This meant Samuel had not been seen for five months and had not had an echo for 20 months."<br /><br />His parents were horrified when Dr Tometzki informed them Samuel required heart surgery that spring.</blockquote><br />Just a "glitch."  Just a "bump in the road."<br /><br /><blockquote class="tr_bq">... "Just hours before his operation Samuel was dancing around the ward and telling the nurses all about Spiderman - we had to remind him to quieten down," Ms Holley said.<br /><br />Samuel's chest was closed on August 8. As he was brought out of sedation on August 9, he suffered a stroke and cardiac arrests.<br /><br />"It is clear that if the surgery had been performed earlier, the procedure would have been the same," Ms Voisin said.<br /><br /><b>But she said expert evidence found that as time went on "the more complicated the surgery is, as the more disadvantaged the heart is and the more difficult it is to get over the operation".</b></blockquote><br />Delays in care of fragile patients - in this case a young child, but in many other cases, ED and ICU patients of all ages - is very unwise.<br /><br /><blockquote class="tr_bq">Samuel's condition continued to deteriorate and on September 6 his parents were recommended for treatment to be withdrawn after he had a second cardiac arrest.<br /><br />The coroner said she would not write a report making recommendations to the hospital, as changes had already been implemented.</blockquote><br />Likely, workarounds to bad health IT, inviting future catastrophe.<br /><br />In my view, many cases such as this never make headlines, as the findings ignore the role of the IT and blame people, cases are settled with gag clauses, patients (who survive) or family are never told of the role of the IT, or lawsuits prove too expensive or too unpleasant to pursue.<br /><br />But patient safety is never compromised by "glitches", and regulation will just stifle innovation.<br /><br />My condolences to the parents.  I've suffered a death in my own family as a result of health IT, and I'm a specialist in the field.  Laypeople have no chance. <br /><br />One should pray the next child affected in this way is not one's own.<br /><br />-- SS<br /><br /><b>Mar. 25, 2014 addendum:  </b><br /><br />Also see these related posts, the first mentioning <b>"teething problems"</b>, another euphemism for potentially-deadly EHR malfunctions:<br /><br /><blockquote class="tr_bq"><b>Cerner's Blitzkrieg on London: Where's the RAF?</b><br /><b> </b><a href="http://hcrenewal.blogspot.com/2010/08/cerners-blitzkrieg-on-london-wheres-raf.html">http://hcrenewal.blogspot.com/2010/08/cerners-blitzkrieg-on-london-wheres-raf.html</a><b> </b><br /><br /><b>North Bristol Hits Appointment Problems: Another "Our Lousy IT Systems Screwed Up, But Patient Safety Was Never Compromised" Story</b><br /><a href="http://hcrenewal.blogspot.com/2012/01/another-our-crappy-computers-screwed-up.html">http://hcrenewal.blogspot.com/2012/01/another-our-crappy-computers-screwed-up.html</a></blockquote><br />-- SS

This EHR "glitch" killed three-year-old Samuel Starr - but patient safety was not compromised

Actually, safety was compromised. I have written repeatedly that the term "glitch", an often-seen euphemism (usually accompanied w...

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Turnabout is Fair Play - Why University of Illinois Students, Faculty and Alumni Should Question the Dean of Medicine about Novartis' Ethical Misadventures

Since 2006, we have posted repeatedly about  what was then a new species of severe conflicts of interest.  This occurred when leaders of academic medical institutions or other health care non-profit organizations or non-governmental organizations (NGOs) also serve as members of <a href="http://hcrenewal.blogspot.com/search/label/boards%20of%20directors">boards of directors</a> of for-profit corporations  whose products and actions have major effects on health care.<br /><br />Most recently, we <a href="http://hcrenewal.blogspot.com/2014/03/american-board-of-internal-medicine.html">discussed </a>the cases of the current CEO of the National Quality Forum and past CEO of the American Board of Internal Medicine who was found to be on the board of for-profit hospital group purchasing organization Premier Inc, and had been on the board of its privately held but for-profit predecessors.  We also <a href="http://hcrenewal.blogspot.com/2014/02/incoming-president-of-iom-outed-as.html">discussed</a> the case of the incoming president of the US Institute of Medicine and former Chancellor of Health Affairs at Duke University who was on the boards of Alnylam Pharmaceuticals, Medtronic and Pepsico.<br /><br />We also recently <a href="http://hcrenewal.blogspot.com/2014/03/better-late-than-never-jama-article.html">posted</a> about the first time these sorts of severe conflicts of interest issue have been addressed in a large circulation medical journal.  A commentary in JAMA called for many such conflicts to be banned.<br /><br />The JAMA article, and much of the discussion surrounding the NQF and IOM cases focused on how loyalties to outside for-profit corporations could affect leaders of academic and other non-profit organizations.  However, we also noted (e.g., <a href="http://hcrenewal.blogspot.com/2014/02/the-carefusion-dr-denham-nqf-leapfrog.html">here</a> and <a href="http://hcrenewal.blogspot.com/2014/02/incoming-president-of-iom-outed-as.html">here</a>) how company directors should be accountable for the actions of their companies, even if they also happen to also be academic or non-profit leaders. <br /><br />Thus, academic and non-profit leaders may find themselves in the awkward position of being held accountable for unethical or even illegal actions of the companies on whose boards they sit.  Such corporate actions may contradict the mission of the institutions whose leadership is their primary job, and whose mission they are supposed to uphold.  <br /><br />While we were writing about these somewhat convoluted, but very important issues, a fellow blogger discovered yet another academic leader serving on the board of a health care corporation, while simultaneously the media reported multiple examples of that corporation's ethical misadventures on his watch.  Those who care about that academic institution ought to question whether a leader accountable for such misadventures is fit to continue to lead.  Yet so far, no one has publicly juxtaposed this leaders' responsibilities to his institution's mission and how the corporation over which he is supposed to exercise stewardship has been taking actions that contradict that mission<br /><br /><b>The Dean of the College of Medicine at the University of Illinois Is a Director of Novartis</b><br /><br />Paul Levy, blogging on Not Running a Hospital, <a href="http://runningahospital.blogspot.com/2014/01/time-to-fire-somebody.html">noted </a>a print advertisement for the Intuitive Surgical daVinci robot.  The advertisement implied endorsements by academic surgeons at the University of Illinois.  Levy suggested that surgical faculty acting as salespeople for a device company appeared to violate the university code of conduct.  This <a href="http://runningahospital.blogspot.com/2014/01/where-is-ui-board-of-trustees.html">concern was heightened</a> by the status of several of the surgeons in the advertisement as clinical and academic leaders.     <br /><br />Mr Levy then <a href="http://runningahospital.blogspot.com/2014/01/how-fish-rots.html">discovered</a> that the Dr Dimitri Azar, Dean of the University of Illinois College of Medicine, to whom these surgeon report, was on the board of Novartis, the multinational pharmaceutical and device company.  Dr Azar's position is easily verified by consulting the <a href="http://www.novartis.com/about-novartis/people/board-directors.shtml">Novartis web-site</a>.  Mr Levy further discussed the case <a href="http://runningahospital.blogspot.com/2014/02/how-much-should-dean-be-paid-who-should.html">here</a> and <a href="http://runningahospital.blogspot.com/2014/02/all-in-days-work-700000-450000.html">here</a>.  Then he  <a href="http://runningahospital.blogspot.com/2014/03/a-matter-of-public-trust.html">reviewed</a>  the extensive dealings between the University of Illinois and Novartis and its subsidiaries, raising suspicion that the Dean's known involvement with the company may have lead to its favorable treatment by the university.<br /><br />But wait, there is another major dimension to this problem.  <br /><br /><b>Novartis' Recent Ethical Misadventures</b><br /><br />Novartis, over which Dr Azar is supposed to be exerting stewardship, has made a series of ethical missteps according to recent media reports.  I will summarize them in chronological order according to the date of media publication.<br /><br /><u>Novartis, Roche Fined for Anti-Competitive and Deceptive Practices in Italy to Encourage Sales of Lucentis</u><br /><br />According to a March 5, 2014 <a href="http://www.nytimes.com/2014/03/06/business/international/italy-fines-novartis-and-roche-in-collusion-case.html">article</a> in the New York Times, Novartis was fined for anti-competitive and deceptive practices,  <br /><br /><blockquote class="tr_bq">Italian antitrust authorities said on Wednesday that they had fined two Swiss pharmaceutical companies, Novartis and Roche Holdings, a total of $250 million for <i>colluding to keep doctors from prescribing a relatively inexpensive eye treatment in favor of a more expensive drug.</i><br /><br /><div class="story-body-text story-content" data-para-count="436" data-total-count="723" itemprop="articleBody">The authorities said the two companies had sought to steer doctors away from Avastin, an anticancer drug developed by Genentech that has been used for years as an off-label treatment for common eye problems. Instead, they said, the companies had tried to 'channel demand toward the much more expensive drug Lucentis, through an artificial distinction between the two products,' essentially by <i>overstating the dangers of Avastin use.</i></div><div class="story-body-text story-content" data-para-count="235" data-total-count="958" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="235" data-total-count="958" itemprop="articleBody">It is not the first time such substitution efforts have brought an unwanted spotlight: Genentech got into trouble in the United States in 2010, when it was found to be offering doctors <a href="http://www.nytimes.com/2010/11/04/business/04eye.html?pagewanted=all" title="Previous coverage of the rebates.">secret rebates</a> to prescribe Lucentis over Avastin.</div><br />Novartis, which holds the rights to market the two drugs outside the United States, has been <i>fined 92 million euros by the Italian regulators. </i>And Roche, which acquired Genentech in 2009, was fined 90.5 million euros, for a total of about $250 million in the Italian case. </blockquote><br />Given that many drug companies have been cited for marketing their products for unapproved, or off-label uses, it is ironic that in this case, Novartis managers said they were shocked, shocked by the ruling because it could encourage off-label use:<br /><br /><blockquote class="tr_bq"> Novartis said in a statement that the Italian decision 'openly encourages and promotes the widespread unlicensed intravitreal use of Avastin contrary to the requirements of European and Italian regulatory law,' and 'undermines the European regulatory framework designed to protect patient safety.'</blockquote><br />The NY Times also reported that one method the two companies were alleged to use to encourage Lucentis rather than Avastin use was to launder their message through patient advocacy groups,<br /><br /><br /><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="230" data-total-count="4756" itemprop="articleBody">The Italian authorities discovered numerous messages between Roche and Novartis in which the two companies discussed what kinds of communications would be needed to induce doctors and hospitals to adopt the more expensive product.</div><div class="story-body-text story-content" data-para-count="230" data-total-count="4756" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="313" data-total-count="5069" itemprop="articleBody">According to one such message from early 2013, cited in documents in the case released Wednesday, growing cost pressure in Italy and France to use Avastin had 'reinforced the political dimension of the debate,' and 'further reinforcement of the Lucentis value proposition to all stakeholders is critical.'</div><div class="story-body-text story-content" data-para-count="239" data-total-count="5308" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="239" data-total-count="5308" itemprop="articleBody">Another message called for the companies to '<i>work with diabetes patient groups to increase voiced concerns about safety risks of unlicensed therapies' — a reference to Avastin</i> — for an eye condition known as diabetic macular edema.</div></blockquote><div class="story-body-text story-content" data-para-count="239" data-total-count="5308" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="239" data-total-count="5308" itemprop="articleBody"><u>Novartis Paid Doctors to Act as Marketers for Starlix and Other Drug</u></div><div class="story-body-text story-content" data-para-count="239" data-total-count="5308" itemprop="articleBody"><br /></div>After the New York state attorney general filed suit against Novartis, a March 15, 2014 Newsday <a href="http://www.newsday.com/news/health/novartis-gave-doctors-thousands-to-prescribe-pills-feds-allege-1.7404245">article</a> included interviews with physicians that suggested how the company turned them into disguised marketers:<br /><br /><blockquote class="tr_bq">Dr. Howard Brand says he had <i>one goal</i> when he gave a speech at a Miami hotel in the early 2000s -- <i>to tout the diabetes pill Starlix for the pharmaceutical company Novartis. </i><br /><br />The giant Swiss drugmaker, which reported $57.9 billion in global sales in 2013, paid the Stony Brook endocrinologist $1,500 for his talk at a doctors' meeting, Brand said in an interview. Novartis also paid for Brand's airfare and his weekend hotel stay, he said.<br /><br />'<i>It was self-serving</i>, but I also thought it was a benefit to patients,' said Brand,...</blockquote><br />Furthermore,<br /><br /><blockquote class="tr_bq"> Brand, the Miami speaker, said in an interview that investigators had not approached him about the payments he accepted.<br /><br />He said Novartis paid him a total of $10,000 to $12,000 for speeches, mostly at restaurant dinners it sponsored. The payments, which Brand said he received before 2010, are not reflected on the Novartis website.<br />'<br />Even [with] the notion that <i>we were paid solicitors</i>, I think people really paid attention,' he said. 'Of course, a lot of doctors just enjoyed going to dinner.'<br /><br />Brand said he accepted more than $60,000 in speaker's fees from drugmakers, including Novartis, in one two-year period. </blockquote><br /><br />Another physician allowed that Novartis furnished the material for his "educational" talks,<br /><br /><blockquote class="tr_bq">Dr. Howard Hertz, a Babylon internist, confirmed that he had received $4,000 from Novartis in 2010 and 2011 for talking about its hypertension drugs to colleagues. Hertz said he <i>dealt with a Novartis sales rep who brought information about the company's pills to his office. 'He would educate me about the product, give me slides to study,</i>' he said.<br /><br />Hertz said the <i>slides were on CDs and made him an expert</i> on Novartis drugs such as Diovan, a blood pressure pill, Lotrel and Valturna. He said he spoke mostly about Diovan and Lotrel.<br /><br />'We had dinners whereby I would speak about the products and speak to the colleagues,' Hertz said. 'I became somewhat of an expert in these products.'</blockquote><br />Note that Dr Hertz's expertise seemed to come exclusively from information provided by a company salesperson, making it obvious that he was not hired for his prior expertise as a physician.<br /><br />The prosecutors allege that Novartis' payments of some $65 million amounted to illegal kickbacks.  This is only an allegation.  However, it seems obvious that Novartis paid physicians to act as salespeople.  Newsday asked bioethicist Arthur Caplan about these actions,<br /><br /><blockquote class="tr_bq">'To even hear about it just takes my breath away,' Caplan said. 'It sounds like <i>egregious, inexcusable violations of agreed upon legal and ethical standards </i>. . . with an inexcusably complicit group of physicians,' Caplan said.</blockquote><br /><u>Japanese Hospital Investigation Alleged Novartis Manipulated Research</u><br /><br />A March 17, 2014 <a href="http://www.fiercepharma.com/story/tokyo-hospital-exec-says-novartis-employees-deeply-involved-leukemia-drug-t/2014-03-17">article</a> in FiercePharma stated that Japanese investigators found that Novartis had manipulated clinical research to make its results appear more favorable to the company's products,<br /><br /><blockquote class="tr_bq">Novartis employees were more involved in a Japanese drug study than previously suspected, a Tokyo hospital official said. In an investigative report released last week, the University of Tokyo Hospital said doctors not only let Novartis  employees collect patient data from various trial sites but also allowed the Swiss drugmaker into its records on all 255 trial participants, Japanese media reports.<br /><br />Plus, at least one Novartis employee was involved in planning the trial, designed to compare side effects of multiple leukemia treatments, the hospital found, according to Japan's <i>Mainichi</i> news. Those treatments included Tasigna<a href="http://www.fiercepharma.com/tags/tasigna"></a>, the company's follow-up to the hugely successful Gleevec (imatinib).<br /><br />In fact, according to<i> NHK World</i>, hospital director Takashi Kadowaki said Friday that Novartis employees were 'virtually managing the study.' </blockquote><br /><a href="http://mainichi.jp/english/english/newsselect/news/20140315p2a00m0na006000c.html">According to Mainichi</a>, this sort of clinical research manipulation is taken very seriously in Japan,<br /><br /><blockquote class="tr_bq"> Senior Ministry of Health, Labor and Welfare officials called the case <i>a serious situation and said the researchers involved showed a lack of ethics. </i>They called for a detailed investigative report from the hospital and are <i>considering punitive measures</i>. The ministry will consider a new law to prevent <i>corruption in clinical tests </i>in the wake of a scandal involving the clinical trial of antihypertensive drug Valsartan.</blockquote><br />It is obvious this story is not from the US, because the drug company has already apologized,<br /><br /><blockquote class="tr_bq"> A representative for Novartis Pharma's PR division said, '<i>We want to apologize to patients and doctors</i>. We must refrain from comment on the investigation, which is being handled outside our company.'</blockquote><br /><u>Indian Regulator Cancels Import License Alleging Fraud by Novartis to Market Veterinary Drug</u><br /><br />A March 18, 2014 <a href="http://www.business-standard.com/article/companies/novartis-might-face-legal-action-penalty-for-faking-documents-114031800760_1.html">article</a> in the New Delhi Business Standard told how Indian regulators accused Novartis of fraud, opening with,<br /><br /><blockquote class="tr_bq">Swiss drug maker Novaris is likely to face legal action for allegedly <i>faking documents to seek registration of its veterinary product Tiamulin Hydrogen Fumarate (80 per cent granules) in India</i>. The drug regulator, Drugs Controller General of India (DCGI)), has <i>already cancelled the company’s import licences as well as existing registration certificate for the product.</i></blockquote><br /><b>Summary</b><br /><br />So in just the last few weeks, evidence appeared that Novartis engaged in collusive anti-competitive and deceptive practices marketing drugs in Italy, paid physicians to act as marketers in the US, manipulated drug studies in Japan, and lost an import license in India due to alleged fraud.  By the way, in 2013, Novartis was fined for anti-competitive practices in its marketing of Fentanyl by the European Commission (look <a href="http://hcrenewal.blogspot.com/2013/12/the-camels-aching-back-johnson-and.html">here</a>), and in 2011 its Sandoz subsidiary settled allegations of misreporting prices in the US for $150 million (look <a href="http://hcrenewal.blogspot.com/2011/12/legal-settlements-have-become-so-common.html">here</a>)   Other Novartis misadventures from 2010 and earlier appear <a href="http://hcrenewal.blogspot.com/search/label/Novartis">here</a>.  So Novartis has quite an impressive, if not infamous record of ethical failures.<br /><br />While he is Dean of medicine at the University of Illinois, Dr Dimitri Azar is also a director of Novartis, and hence has a fiduciary duty for the company's stewarship.  While questioning Dr Azar's role in the participation of his faculty in advertising for Intuitive Surgical, perhaps those who care about the reputation of the University of Illinois and its ability to fulfill its mission ought to ask how the poor ethical track record of the company Dr Azar is supposed to be overseeing reflects on his ability to defend the mission of the university and the medical school.<br /><br />While parties that enable or enter into arrangements that create conflicts of interest in health care may be thinking mainly of the advantages that they may accrue, many of these arrangements create accountability and obligations, even if they are honored mainly in the breach.  If leaders of academic medicine and health care non-profit organizations insist on becoming directors, and hence stewards of for-profit health care corporations, they ought to be held accountable for the actions of these corporations, and how these actions reflect on their primary obligations to the academic and non-profit organizations they have also pledged to serve.<br /><br />True health care reform would make health care leaders accountable for putting patients' and the public's health ahead of their own self-interest. <br /><br />

Turnabout is Fair Play - Why University of Illinois Students, Faculty and Alumni Should Question the Dean of Medicine about Novartis' Ethical Misadventures

Since 2006, we have posted repeatedly about  what was then a new species of severe conflicts of interest.  This occurred when leaders of aca...

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EHR recall: Use of this affected product may cause serious adverse health consequences, including death

Here is another example of a grossly defective health IT product, this from last year but only posted by FDA publicly on 3/14/2014 at <a href="http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm389356.htm">http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm389356.htm</a><a href="http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm389328.htm" target="_blank"></a>:<i> </i><br /><br /><i>"There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case. <b>Use of this affected product may cause serious adverse health consequences, including death."</b></i><b></b><br /><br />One wonders why problems like this are found in the field when real patients are involved, not in the testing lab...could it have to do with lack of regulatory oversight?<br /><br />Other examples of recalled bad health IT that I know of, including FDA-initiated recalls, are here:  <a href="http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2012/07/health-it-fda-recall-<wbr></wbr>philips-xcelera.html</a>, <a href="http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2011/12/fda-recalls-health-it-<wbr></wbr>software-because.html</a> , <a href="http://hcrenewal.blogspot.com/2013/08/a-good-way-to-cynernetically-harm-or.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2013/08/a-good-way-to-<wbr></wbr>cynernetically-harm-or.html</a>. <br /><br />Also note the FDA advisory:  <b>Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to <a href="https://www.accessdata.fda.gov/scripts/medwatch/" target="_blank">MedWatch: The FDA Safety Information and Adverse Event Reporting Program</a> either online, by regular mail or by FAX:</b><br /><div><br /><blockquote class="tr_bq"><a href="http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm389328.htm" target="_blank">http://www.fda.gov/<wbr></wbr>MedicalDevices/Safety/<wbr></wbr>ListofRecalls/ucm389328.htm</a><b> </b><br /><br /><b>McKesson Technologies, McKesson Anesthesia Care – Patient Case Data May Not Match Patient Data</b><br /><br /><b>Recall Class:</b> Class I<b> </b><br /><br /><b>Date Recall Initiated</b>: March 15, 2013<b> </b><br /><br /><b>Product:</b> McKesson Anesthesia Care<b> </b><br /><br /><b>Use:</b> The device is a computer-based system which collects, processes, and records data both through manual entry and from monitors which are attached to patients, such as in an operating room environment. The system provides clinical decision support by communicating potential adverse drug event alerts proactively during the pre-anesthesia evaluation and at the point-of-care. The system is generally indicated in the anesthetizing environment when the anesthesia provider decides to perform a patient assessment, to generate a paper and/or electronic record of the administration of anesthesia to a patient, and to document care.<b> </b><br /><br /><b>Recalling Firm:<br /></b>McKesson Technologies, Inc.<br />5995 Windward Parkway<br />Alpharetta, Georgia 30005<b> </b><br /><br /><b>Reason for Recall:</b> There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case. Use of this affected product may cause serious adverse health consequences, including death<b>.</b><br /><br /><b>Public Contact:</b> Customers with questions may contact McKesson Customer Support at <a href="tel:1-800-442-6767" target="_blank" value="+18004426767">1-800-442-6767</a> (option 3). For questions regarding this recall, call <a href="tel:404-338-3556" target="_blank" value="+14043383556">404-338-3556</a>.<b> </b><br /><br /><b>FDA District:</b> Atlanta District Office<b> </b><br /><br /><b>FDA Comments:<br /></b>On March 15, 2013, the firm initiated a Clinical Alert which was distributed to potentially affected customers. Phone calls were placed to each customer, followed up by an email. The firm provided their customers with written copies of the communication and Clinical Alert; and obtained acknowledgement that they read and understood the issue and preventive action to take.<br /><br />Customers with questions were instructed to contact McKesson Customer Support at <a href="tel:1-800-442-6767" target="_blank" value="+18004426767">1-800-442-6767</a> (option 3). For questions regarding this recall, call <a href="tel:404-338-3556" target="_blank" value="+14043383556">404-338-3556</a>.<br /><br />Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.<b> </b><br /><br /><b>Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to <a href="https://www.accessdata.fda.gov/scripts/medwatch/" target="_blank">MedWatch: The FDA Safety Information and Adverse Event Reporting Program</a> either online, by regular mail or by FAX.</b></blockquote><br />I encourage clinicians to take advantage of MedWatch with regard to bad health IT, anonymously if necessary to avoid internal repercussions or retaliation from executives who've spent hundreds of millions of dollars on the IT, and whose bonuses and promotions might be tied into its "success."<br /><br />-- SS</div>

EHR recall: Use of this affected product may cause serious adverse health consequences, including death

Here is another example of a grossly defective health IT product, this from last year but only posted by FDA publicly on 3/14/2014 at http:/...

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Better Late than Never - JAMA Article Advocates Banning Academic Medical Leaders from Serving on Many Health Care Corporate Boards

Will wonders never cease? Eight years after we started posting about this issue, it has made it into a large circulation medical journal, albeit not completely<br /><br /><b>A JAMA Commentary Decries Leaders of Academic Medical Centers Serving on Boards of Organizations with Conflicting Priorities </b><br /><br />A recent JAMA commentary(1) noted the importance of conflicts of interest affecting top leaders of academic medicine, <br /><br /><blockquote class="tr_bq">Conflict of interest is particularly relevant for those in the upper echelons of academic health system leadership—presidents, vice presidents, provosts, deans, chief executive officers, and the senior administrators who report to them. </blockquote><br />(The article oddly omitted discussing conflicts of interest affecting the boards of trustees of such institutions, who are charged with their stewardship.)<br /><br />Anyway, the authors' rationale was that, <br /><br /><blockquote class="tr_bq">Unlike most faculty and staff, senior institutional officials are involved in financial and business decisions, including purchasing, resource allocation, and development of corporate partnerships, and have fiduciary responsibility to the entire institution. In addition, it is critical that the public, students, employees, and faculty maintain confidence in the integrity of institutional leaders. Leaders have a responsibility to set an example for others in their institution, especially for those training to be health care professionals.<br /><br />Independence and integrity of judgment are core precepts of professionalism. Every employee, faculty member, and student in an academic health system should feel confident that their leaders are making decisions based on the best interests of the institution and not driven by biases secondary to financial connections to outside corporate entities. </blockquote><br />So, <br /><br /><blockquote class="tr_bq">Having a fiduciary responsibility to 2 separate entities is at best a very difficult situation. Will the leader direct business inappropriately to the outside company on whose board he or she sits? Will the leader inappropriately use information about the institution he or she leads to influence decisions by the outside corporation? It is difficult to separate these types of activities and decisions. In addition, there are administrative costs associated with the management of this level of conflict, and such relationships might have a 'chilling effect' on other companies that could do business with the academic health system. Beyond service on fiduciary boards, undertaking any paid role (consulting, participation on advisory boards, etc) with an outside entity with interests that overlap those of the leader’s institution raises the same issues. </blockquote><br />The authors stressed that the most intense conflicts are generated by service on the boards of directors of "organizations with interests that overlap those of the academic health system."  Presumably they would have included among such organizations health care corporations that sell goods or services that might be used within academic medical centers, and/or be the subject of teaching or research by faculty at these centers, although the article did not make that explicit.<br /><br />The authors suggested such conflicts are not infrequent, noting a survey by Campbell et al of department chairs in academic medical institutions that showed a majority had some sort of relationships with industry, although they did not specify what these relationships were.  In fact, the Campbell article did report that 11% of department chairs admitted to being on the board of directors of companies that had activities that related to the chairs' academic or administrative responsibilities.(2) <br /><br />Finally, the authors called for banning most such conflicts<br /><br /><blockquote class="tr_bq"><span class="Paragraph 0" id="scm6MainContent_ucArticleContent_rptSections_lblSection_5">the fiduciary responsibilities of presidents, provosts, vice presidents, deans, chief executive officers, and those who report to them should <b><i>preclude a paid relationship with an outside entity in related and relevant areas,... </i></b></span> </blockquote><br />Note however that they did offer some loopholes.<br /><br /><blockquote class="tr_bq"><span class="Paragraph 0" id="scm6MainContent_ucArticleContent_rptSections_lblSection_5">unless a case can be made that there is a compelling institutional interest in the leader’s service in such a role, or if the role with the outside organization is outside the scope of the leader’s role at the academic health system.</span></blockquote><br />Despite the omissions and loopholes, this is a very significant article.  It is the first challenge to such severe conflicts of interest affecting academic medicine to appear as an article in a major medical journal, at least to my knowledge.  <br /><br /><b>You Heard It Here First</b><br /><br />However, on Health Care Renewal we have been attempting to challenge such conflicts for at least eight years. In 2006 we first <a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html">discussed</a> a newly discovered species of conflict of interest in health care, in which leaders of medical or health care organizations were simultaneously serving on boards of directors of health care corporations.<br /><br />We posited these conflicts would be particularly important because being on the board of directors entails not just a financial incentive.  It ostensibly requires board members to "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. <a href="http://www.amazon.com/Corporate-Governance-Robert-G-Monks/dp/1405116986"><i>Corporate Governance</i></a>, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]  Of course, after the global financial collapse of 2008 made us sadder and a little wiser, we realized that many board members actually seem to have unyielding loyalty to their cronies among top management.  However, in any case, the stated or actual interests of a member of the board of a health care corporation, like a pharmaceutical company or medical device company, could be very different and at odds with the mission of an academic medical institution or a non-profit ostensibly dedicated to improving health care quality.<br /><br /><b>Vivid Cases Would Strengthen the Argument</b><br /><br />It is odd that the JAMA article included very little evidence about the occurrence of such conflicts of interest.  It really is not hard to find.  Since 2006, we have discussed numerous cases of such conflicts of interest.<br /><br />The case that first attracted <a href="http://hcrenewal.blogspot.com/2006/01/california-nightmares-more-troubles-at.html">our attention</a> was that of Marye Anne Fox, the then Chancellor of the University of California - San Diego, a major campus of the state university that includes a medical school.  January, 2006 media reports noted that Chancellor Fox was simultaneously servingon 10 corporate boards, including those of two health care corporations, Boston Scientific, a medical device company, and Pharmaceutical Product Development Inc (PPDI), a for-profit contract research organization.  At the time, I wrote,<br /><br /><blockquote class="tr_bq">having ultimate leadership responsibilities for a medical school and medical center, while also having ultimate fiduciary responsibilities for the management of a medical device company and a contract medical research company amounts to the biggest conflicts of interest I have ever seen.   </blockquote><br />Nonetheless, beyond local media, the case got little attention at the time.  What attention it did get focused on the magnitude of Chancellor Fox's commitments to outside organizations, not the conflicts they apparently caused (look <a href="http://hcrenewal.blogspot.com/2006/02/academic-medical-leaders-as-corporate.html">here</a>).  Chancellor Fox apparently retired from the PPDI board in 2008 (look <a href="http://www.grace.com/about/leadership/BoardOfDirectors.aspx">here</a>) but did not retire from the Boston Scientific Board until 2011 (look <a href="http://www.massdevice.com/news/boston-scientific-co-founder-john-abele-leave-board">here</a>).  <br /><br />Since then, we found many more striking cases.<br />-  A month later, there was the <a href="http://hcrenewal.blogspot.com/2006/02/tale-of-three-ironies-university-of.html">case</a> of the president of the University of Miami, a board member of for-profit health insurance company UnitedHealth, whose lowest paid employees were on strike to protest their lack of health insurance, among other issues.<br />-  It turned out the UnitedHealth board in particular seemed to be a refuge for multiple academic leaders, at least one of whom seemed partly responsible for allowing the then UnitedHealth CEO to collect many backdated stock options (look <a href="http://hcrenewal.blogspot.com/2006/08/more-entangled-web-unitedhealth-case.html">here</a>)..<br />-  Then there was the 2008 case of the conflict of interest involving an anti-health company.  After Virginia Commonwealth University was criticized for taking money from giant tobacco company Philip Morris for medical research, it turned out that the then president of the university, Eugene Trani, was on the board of another tobacco company, Universal Corp (see post <a href="http://hcrenewal.blogspot.com/2008/05/worse-variant-of-new-species-of.html">here</a>).<br />-  Then, in 2009, some attributed the problems at George Washington University's medical school that caused it to be put on probation to the conflict of interest of its provost and vice president for health affairs, John F Williams, who also sat on the board of Universal Health Services, which owned the university hospital (look <a href="http://hcrenewal.blogspot.com/2009/02/conflicts-of-interest-and-george.html">here</a>).<br /> We posted about a number of other colorful cases since then (look <a href="http://hcrenewal.blogspot.com/search/label/boards%20of%20directors">here</a>)<br /><br /><br />Although this evidence is admittedly case based and therefore anecdotal, it could be used to highlight the importance of the problem and develop support for its solution. <br /><br /><b>A Welcome Addition to Previous Recommendations about Countering Conflicts of Interest</b><br /><br />For whatever reason, this issue somehow seemed to escape the attention of many of those who have written about conflicts of interest in health care.  Even those who advocated taking a harder line on conflicts of interest have generally avoided this issue.<br /><br />Brennan et al made recommendations about reducing conflicts of interest in 2006, but focused on students and faculty, not top leaders and executives (see post <a href="http://hcrenewal.blogspot.com/2006/02/academic-medical-leaders-as-corporate.html">here</a>).(3)  The 2009 <a href="http://www.iom.edu/Activities/Workforce/ConflictOfInterest.aspx">Institute of Medicine report</a> set relatively tough standards for managing conflicts of interest affecting clinical research and teaching, which unfortunately since have largely been ignored.  It did call for senior institutional officials to disclose their conflicts of interest, and for institutional boards of trustees to form conflicts of interest committees that would exclude conflicted individuals, but otherwise did not address conflicts of interest affecting academic leaders or institutional trustees.  The 2013 <a href="http://www.pewhealth.org/reports-analysis/reports/conflicts-of-interest-policies-for-academic-medical-centers-85899514090">Pew Charitable Trusts Conflicts-of-Interest Policies for Academic Medical Centers </a>suggested restrictions on conflicts affecting faculty, trainees, and students, but again did not mention senior institutional leaders or boards of trustees.<br /><br /><b>Conclusion </b><br /><br />So it is very nice to see that the issue of what we once called a new species of conflict of interest finally has made the big time.  Whether it now gets any traction remains to be seen.  Unfortunately, since conflicts of interest can be so profitable for the directly affected parties, I fully expect they will continue to oppose any restrictions.  The money they have made will likely be used to deploy marketing and public relations personnel and legal counsel to counter any attempts to try to make this aspect of health care more honest.<br /><br />As we have said again and again, the web of conflicts of interest that is pervasive in medicine and health care is now threatening to strangle medicine and health care.  For patients and the public to trust health care professionals and health care organizations, they need to know that these individuals and organizations are putting patients' and the public's health ahead of private gain. Health care professionals who care for patients, those who teach about medicine and health care, clinical researchers, and those who make medical and health care policy should do so free from conflicts of interest that might inhibit their abilities to put patients and the public's health first.  <br /><br /><br /><b>References</b><br /><br />1. Pisano ED, Golden RN,Schweitzer L. Conflict of interest policies for academic health system leaders who work with outside corporations.  JAMA 2014<span id="scm6MainContent_lblClientName">;311(11):1111-1112. doi:10.1001/jama.2014.788</span>  Link <a href="https://jama.jamanetwork.com/article.aspx?articleid=1841978">here</a>.<br /><br />2.  Campbell EG, Weissman JS, Ehringhaus S et al.  Institutional academic-industry relationships.  JAMA <span id="scm6MainContent_lblClientName">2007;298(15):1779-1786. doi:10.1001/jama.298.15.1779.  Link <a href="http://jama.jamanetwork.com/article.aspx?articleid=209192">here</a>.</span><br /><span id="scm6MainContent_lblClientName"></span><span id="scm6MainContent_lblClientName">3,  Brennan TA, Rothman DJ, Blank L et al.  Health industry practices that create conflicts of interest.  a policy proposal for academic medical centers.  JAMA  </span><span id="scm6MainContent_lblClientName">2006;295(4):429-433. doi:10.1001/jama.295.4.429  Link <a href="http://jama.jamanetwork.com/article.aspx?articleid=202261">here</a>.</span>

Better Late than Never - JAMA Article Advocates Banning Academic Medical Leaders from Serving on Many Health Care Corporate Boards

Will wonders never cease? Eight years after we started posting about this issue, it has made it into a large circulation medical journal, al...

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Forbes contributor Nicole Fisher, claimed proponent of healthcare human rights, writes long article on EHRs that neglects to mention patient harm

The field of health IT lives a charmed life.<br /><br />Even self-stated human rights advocates in healthcare won't seem to broach the topic of <b>EHR-related harms</b> and<b> lack of informed consent processes</b> regarding their use in a patient's care, even when authors openly state their concerns for patient and human rights.<br /><br />This is despite known harms at potentially alarming levels as indicated by organizations including the IOM, FDA, ECRI Institute, AHRQ, Harvard Med Mal insurer CRICO, The Joint Commission, NHS in the UK, and others.<br /><br />Forbes contributor Nicole Fisher (<a href="http://www.forbes.com/sites/nicolefisher/">http://www.forbes.com/sites/nicolefisher/</a>) published an article in Forbes dated 3/18/2014 and entitled <b>"Electronic Health Records - Expensive, Disruptive And Here To Stay</b>" (<a href="http://www.forbes.com/sites/nicolefisher/2014/03/18/electronic-health-records-expensive-disruptive-and-here-to-stay/">http://www.forbes.com/sites/nicolefisher/2014/03/18/electronic-health-records-expensive-disruptive-and-here-to-stay/</a>).<br /><br />You can read the article at the above link.  It focuses on physician distraction and dissatisfaction, poor usability and usefulness, expense, and related issues.  Of course, quotes from HHS figure prominently.<br /><br />Nowhere, however, is mention of EHR-related harms to patients, such as reported by the aforementioned organizations mentioned - as in this very small sample list of posts, which contain links to source:<br /><br /><blockquote class="tr_bq"><b>Patient Safety & Quality Healthcare: "CRICO Malpractice Claims Analysis Confirms Risks in EHRs"</b><br /><a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html">hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html</a><br /><br /><b>Peering Underneath the Iceberg's Water Level: ECRI "Deep Dive" Study of Health IT "Events"</b><br /><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><br /><br /><b>Internal FDA memorandum on HIT risks</b><br /><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><br /><br /><b>IOM Report - "Health IT and Patient Safety: Building Safer Systems for Better Care"</b><br /><a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html</a><br /><br /><b>EHRs and Deadly glitches</b><br /><a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a> (multiple posts)<br /><br /><b>Not to forget issues of breach of privacy:</b>  <br /><a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy</a> (multiple posts)</blockquote><br />Nor are mentioned the issues of the experimental, unregulated nature of this technology, and the lack of any informed consent process regarding patient's rights to decide whether or not to have these systems used in their care.<br /><br />The only mention of "<b>unintended consequences</b>" links to "<a href="http://www.emrandhipaa.com/guest/2014/03/11/unintended-icd-10-consequences-inadequate-clinical-documentation-can-negatively-impact-physician-profiles-icd-10-tuesdays/">Unintended ICD-10 Consequences: Inadequate Clinical Documentation Can Negatively Impact Physician Profiles</a>." <br /><br />This is in my view disappointing, and seems to be yet another extraordinary healthcare IT industry accommodation, remarkable for an author with the following bio (emphases mine):<br /><br /><blockquote class="tr_bq"><a href="http://www.forbes.com/sites/nicolefisher/">http://www.forbes.com/sites/nicolefisher/</a><br /><br />Nicole Fisher is the Founder and Principal at HHR Strategies, <b>a health care and human rights focused advising firm.</b> Additionally, she is a Senior Policy Advisor and health policy expert on health economic analyses mainly focusing on Medicare, Medicaid and health reform, <b>specifically as they impact women and children</b>. Nicole runs a Health Innovation and Policy page at Forbes.com highlighting and advising companies, ideas and people that are changing the health care landscape. She is also currently pursuing her PhD at the University of North Carolina in the Health Policy and Management Department. Her writing has appeared in other publications such as Health Affairs, Wall Street Journal, Washington Post, Centers for Medicare & Medicaid Services Journal, Wright on Health, The Health Care Blog and Health Services Research. Before pursuing her PhD in health policy, Nicole earned her Master’s degree in Public Policy from the University of Chicago and her undergraduate degree from the University of Missouri. Her health care and policy work at those institutions <b>had an emphasis on underserved populations, women's and children’s issues</b>. She presides on several Boards for domestic and international health organizations and <b>frequently speaks on health reform and human rights.</b></blockquote><br />One might conclude the computer has more rights than the patient and the clinician via this Forbes piece.<br /><br />Finally, although I am a domain specialist (<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>), I am getting rather tired of having to point out the obvious to major media outlets and writers, in essence doing their homework for them.  I'm sure other bloggers feel the same way.  <br /><br />The title of the Forbes piece should have been "<b>Electronic Health Records - Expensive, Disruptive, Deadly."</b><br /><br />To the author of the Forbes piece and other HIT writers, here is the face (and gravestone) of someone injured by this "disruptive" technology.  <b> </b><a href="http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html">http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html</a><br /><b><br /></b>A few babies too:  <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><b></b><br /><b><br /></b>A family man:  <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html">http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html</a><br /><br />I know of others from my legal work supporting the EHR-related injured and deceased that I cannot mention.  And I am but one person.<br /><br />If health IT were causing rapes** and child abuse, rather then merely causing mundane severe injuries and equally mundane deaths, would the media would pay more attention? <br /><br />-- SS<br /><br />** I sadly note that EHR's without proper security measures in force actually did enable rape-like behavior in 2011, as at <b>"EHR as Molestation Candidate Selector: What was this Resident looking for in the EHR before 'examining' female patients?"</b> at <a href="http://hcrenewal.blogspot.com/2011/02/what-was-this-medical-resident-looking.html">http://hcrenewal.blogspot.com/2011/02/what-was-this-medical-resident-looking.html</a>.<br /><br />

Forbes contributor Nicole Fisher, claimed proponent of healthcare human rights, writes long article on EHRs that neglects to mention patient harm

The field of health IT lives a charmed life. Even self-stated human rights advocates in healthcare won't seem to broach the topic of EHR...

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CA Supreme Court upholds "whistleblower" protection for Modesto physician - and on replacing the abuser-favoring connotations of "whistleblower" with "Corporate Integrity Advocate"

"Whistleblower" is a term commonly used to refer to insiders in an organization who do not "go along to get along" or look the other way with regard to corruption and malfeasance.<br /><br />The connotation, of course, is that these individuals are "snitches" and "non-team players", in other words, the "bad guys."  They are then punished for their good deeds.<br /><br />(More on the term "whistleblower" below.)<br /><br />Here's one "whistleblower" who punished back:<br /><br /><blockquote class="tr_bq"><b>California Supreme Court upholds whistleblower protection for Modesto physician</b><br /><br />By Ken Carlson<br />February 20, 2014 <br /><a href="http://www.modbee.com/2014/02/20/3201156/california-supreme-court-upholds.html">http://www.modbee.com/2014/02/20/3201156/california-supreme-court-upholds.html</a><br /><br />The California Supreme Court ruled Thursday that a Modesto physician who challenged the termination of his hospital privileges has whistleblower protections.<br /><br />Dr. Mark Fahlen, a kidney specialist, filed a March 2011 whistleblower lawsuit in Stanislaus County Superior Court after Sacramento-based Sutter Health <b>canceled his privileges to care for patients at Memorial Medical Center.</b><br /><br />Fahlen’s lawsuit claims that Sutter Central Valley Hospitals and Steve Mitchell, then the chief operating officer of Memorial, persuaded the Sutter Gould medical group to fire him and terminated his hospital privileges <b>because of his complaints about insubordination and substandard care by hospital nurses.</b></blockquote><br />At least they didn't threaten to plaster his complaints to his forehead as occurred in Ohio (<a href="http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html">http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html</a>).<br /><br /><blockquote class="tr_bq">His attorney said the court decision guarantees that physicians have the same protections as hospital employees if they report problems that threaten to harm patients.</blockquote><br />That "<b>guarantees protections</b>" and "<b>report problems that threaten to harm patients</b>" have to appear in the same sentence at all is symptomatic of the most severe form of patient-be-damned dysfunction in this industry. <br /><br /><blockquote class="tr_bq">It’s “the biggest victory for patient rights since California’s health care whistleblower law was adopted in 1999,” said attorney Stephen Schear of Oakland. “In a hospital environment dominated by corporate giants too often more focused on protecting their marketing and brand name than patient health, <b>today’s ruling will finally unshackle doctors from fear of retribution so they can protect patients.”</b></blockquote><br />Ditto my prior comment.<br /><br /><blockquote class="tr_bq">In a case closely watched by the hospital industry, the American Medical Association supported Fahlen with a “friend of the court” brief. <b>The California Hospital Association and groups such as Kaiser Foundation Hospitals, Scripps Health and Dignity Health filed briefs on behalf of the defendants.</b></blockquote><br />That is rather indicative of the mindsets of those who filed briefs on behalf of the defendants.<br /><br /><blockquote class="tr_bq">... After he was given staff privileges at Memorial in 2004, Fahlen complained to administrators that nurses refused or failed to follow his patient care instructions. According to facts in the case, Fahlen had six clashes with nurses about patient care from August 2007 to April 2008. He told supervisors and administrators that nurses were insubordinate and that their care was substandard.<br /><br />One complaint was regarding <b>a nurse’s refusal to transfer a patient to intensive care, delaying for five hours the appropriate level of care for the patient,</b> the doctor said.</blockquote><br />What if the patient had died, I ask?<br /><br /><blockquote class="tr_bq">Mitchell, the chief operating officer, <b>blamed Fahlen for his conflicts with nursing staff</b> and contacted Sutter Gould’s medical director about Fahlen’s conduct. Sutter Gould cut ties with Fahlen in May 2008, causing his malpractice insurance to be canceled. Fahlen decided to start his own practice and arranged a meeting with Mitchell to talk about his hospital privileges.<br /><br />Mitchell wrote in an email to Memorial’s chief executive officer that <b>Fahlen “does not get it,” </b>meaning that he was going to lose his privileges. The CEO replied that it “looks like we need to have the medical staff take some action on his MedQuals!!! (or medical qualifications). Soon!”<br /><br />According to the lawsuit, Mitchell told Fahlen at the meeting t<b>hat he should resign and leave town, or the hospital would report him to the Medical Board of California</b>. Fahlen charged that a subsequent in-house investigation, and an executive committee decision not to renew his privileges, occurred in retaliation for his complaints about patient care.</blockquote><br />In other words, the doctor was a "disruptive physician" - a bad schoolboy who needed to be spanked - which was, of course, more important to the executives than maimed or dead patients.<br /><br /><blockquote class="tr_bq">Fahlen asked for a hearing, resulting in an October 2009 to May 2010 review by a six-physician committee at Memorial. The panel concluded that the evidence did not show he was incompetent or that his behavior had endangered patients. [But] <b>Memorial’s board of trustees overruled the panel in early 2011.  <span style="color: red;"><i>[It's not hard to imagine that few if any on that board were themselves medical professionals - ed.]</i></span></b></blockquote><br />It's more likely in my view that this physician was ultra-competent.<br /><blockquote class="tr_bq"><br />Sutter attorneys argued that the doctor first needed to exhaust other legal remedies before bringing the whistleblower lawsuit. <b>The Supreme Court dismissed a previous expectation that doctors exhaust other remedies before filing suit with claims of retaliation. </b>Such conditions would “<b>seriously undermine the Legislature’s purpose to afford a whistleblower on a hospital medical staff the right to sue</b>,” the Supreme Court’s opinion said.</blockquote><br />Next, a typical circular argument:<br /><blockquote class="tr_bq"><br />Attorney Lowell Brown, who handles physician disciplinary cases for hospitals, said Thursday’s ruling will “change the rules of the game,” though additional court decisions will be needed to clarify issues. He predicted doctors will be reluctant to serve on hospital panels that review the competency or behavior of physicians.<br /><br />“The doctor can claim the action is being taken because he or she is whistleblowing,” Brown said. “<b>No one ever produces evidence that a sham peer review has taken place. </b>What we will see is sham whistleblower complaints about peer reviews.”</blockquote><br />Since <b>sham peer review</b> (see more at <a href="http://hcrenewal.blogspot.com/2009/10/sham-peer-review-could-this-bad-faith.html">http://hcrenewal.blogspot.com/2009/10/sham-peer-review-could-this-bad-faith.html</a>) is done secretly and behind closed doors, with protections, it's pretty hard to produce "evidence" of the type required in court.<br /><br /><blockquote class="tr_bq">... Fahlen said the ruling means that “<b>doctors no longer have to choose between speaking out for their patients or continuing with their careers</b>.”</blockquote><br />Again, this is an absolutely perverse choice foisted upon clinicians by corporatized, financialized medicine and its leadership.<br /><br />------------ <br /><br />More on the term "whistleblower" itself.<br /><br />My attitude about that term is clear - the people who use it are attempting an ad hominem attack in one word.  It is a bad term, with bad connotations, and does not actually describe what the individual is attempting to accomplish.<br /><br />AHIMA's  Kim Baldwin Stried-Reich has a similar view, and a suggestion for replacement of that term with a more descriptive and non-abusable term:<br /><br /><blockquote class="tr_bq"><b>"Changing Perception of ‘Whistleblowers’"</b></blockquote><blockquote>From  <a href="http://journal.ahima.org/2014/03/01/hipaa-whistleblower-protections-promote-information-governance/">http://journal.ahima.org/2014/03/01/hipaa-whistleblower-protections-promote-information-governance/</a><br /><br />... According to <b>Kim Baldwin Stried-Reich</b>, the former Speaker of the AHIMA House of Delegates, the new amendment to the HITECH-HIPAA Omnibus rule demonstrates both the increasing importance and value HIM professionals have today in ensuring both integrity and compliance with rules, regulations, and laws governing access and disclosure of health information within their organizations. Baldwin Stried-Reich is a privacy and compliance officer with the Lake County Physicians Association, in Waukegan, IL.<br /><br />She notes that while the new provision provides specific protections against disclosures reported to an oversight agency by whistleblowers and workforce members who are victims of a crime, <b>she’s not so sure this new rule will encourage individuals, such as HIM professionals to speak-up and speak-out when or if they see evidence of systematic and ongoing non-compliance with federal mandates.</b><br /><br />One reason for this is the widespread use of the word “whistleblower,”<b> which often carries negative connotations. </b>She prefers the term <b>“corporate integrity advocate.”</b></blockquote><br /><b>"Corporate Integrity Advocate"</b> clearly and unequivocally describes what the individuals - including those who write for blogs such as this one - are trying to accomplish.<br /><br />It is also a term that is rather hard for malfeasance-doers to use as ad hominem..<br /><br /><blockquote class="tr_bq">“Perhaps if Health and Human Services had utilized another term, such as ‘corporate integrity advocate’ more individuals would understand what the intent of this new law is and that it is meant as <b>an avenue individuals can choose to pursue if their professional integrity and ethics are not in alignment with the corporation’s</b> any longer,” Baldwin Stried-Reich says.</blockquote><br /><br />"Not in alignment with the <i>lack</i> of the corporation's integrity and ethics" is a more direct, and likely more accurate, way to put it.<br /><br /><blockquote class="tr_bq">A relevant example of this is evident in the settlement that Shasta Regional Medical Center (SRMC) entered into with the Department of Health and Human Services (HHS) following an investigation concerning the breach of PHI after senior-level executives intentionally disclosed protected information to the media on at least three separate occasions.<br /><br />The Shasta case demonstrates how and why corporate integrity advocates or whistleblowers are needed to facilitate change within their organizations when it is warranted, Baldwin Stried-Reich explains.</blockquote><br />That example is but the tip of the iceberg.  There are many posts on this blog alone dealing with the issues of <s><span style="mso-bidi-font-weight: bold;">whistleblowers</span></s><span style="mso-bidi-font-weight: bold;"> Corporate Integrity Advocates</span> (see the query link <a href="http://hcrenewal.blogspot.com/search/label/whistle-blowers">http://hcrenewal.blogspot.com/search/label/whistle-blowers</a>).<!--[if gte mso 9]><xml> <w:WordDocument> <w:View>Normal</w:View> <w:Zoom>0</w:Zoom> <w:PunctuationKerning/> <w:ValidateAgainstSchemas/> <w:SaveIfXMLInvalid>false</w:SaveIfXMLInvalid> <w:IgnoreMixedContent>false</w:IgnoreMixedContent> <w:AlwaysShowPlaceholderText>false</w:AlwaysShowPlaceholderText> <w:Compatibility> <w:BreakWrappedTables/> <w:SnapToGridInCell/> <w:WrapTextWithPunct/> <w:UseAsianBreakRules/> <w:DontGrowAutofit/> </w:Compatibility> <w:BrowserLevel>MicrosoftInternetExplorer4</w:BrowserLevel> </w:WordDocument></xml><![endif]--><br /><br />The term "whistleblower" needs to be retired ASAP.<br /><br />-- SS

CA Supreme Court upholds "whistleblower" protection for Modesto physician - and on replacing the abuser-favoring connotations of "whistleblower" with "Corporate Integrity Advocate"

"Whistleblower" is a term commonly used to refer to insiders in an organization who do not "go along to get along" or lo...

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Medical Malpractice Insurer CRICO Challenges "EMR Complacency" - Or Do They?

In my Feb. 28, 2014 post "<b>Malpractice Claims Analysis Confirms Risks in EHRs</b>" (<a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html">http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html</a>) I pointed out that the annual medical malpractice claims related to health IT received by the insurer for the Harvard medical community, one of the world's best users of health IT, might represent a significant percentage of the annual med mal claims in the state of Massachusetts.  Many involved serious injury.<br /><br />I also pointed out that the claims themselves represent only a small fraction of total incidents of med mal-related harms (including due to IT), due to the economic realities of med malpractice litigation.<br /><br />In the press release reproduced below, CRICO writes of poor integration and "design deficiencies" - <b>bad health IT</b> - and that "there has been <b>no apparent leader in this field</b> making a concerted effort to design the next generation of EMRs <b>with the physician in mind</b>", and that they hear "<b>significant frustration from physicians related to their experience with EMRs."  </b><br /><br />However, CRICO does not write of the reasons<b> why</b> these issues are as prevalent as they are.<br /><br />Their claim appears to be, in essence, that these problems will be solved through dialog and "conversation" - in other words, appeals to corporate altruism.<br /><br />Why this industry receives special accommodation even from those who have to pay for their mistakes is beyond me: <br /><br /><blockquote class="tr_bq"><b><span style="font-size: small;"><span style="font-family: inherit;">CRICO Challenges EMR Complacency</span></span></b><span style="font-size: small;"><span style="font-family: inherit;"> </span></span><br /><span style="font-size: small;"><span style="font-family: inherit;"><a href="http://www.rmf.harvard.edu/EMR">http://www.rmf.harvard.edu/EMR</a></span></span><span style="font-size: small;"><span style="font-family: inherit;"> </span></span><br /><b><span style="font-size: small;"><span style="font-family: inherit;">February 6, 2013</span></span></b><br /><br />In a recently released video, CRICO offers a vision of how EMRs of the future might improve health care safety for both patient and physician.<b> </b><br /><br /><b>Press Release:  Cambridge, MA —</b> CRICO, the patient safety and medical professional liability company serving the Harvard medical community, has produced a video that puts forth a future vision of how Electronic Medical Records (EMRs) might be embedded into the physician workflow in a manner that would improve health care delivery. CRICO has based the dramatization on real malpractice cases. Through combined analysis of how harm can come to patients from flawed encounters with providers, and conversations with medical and technological visionaries across the country, the video integrates various scenarios into an idealized patient/physician encounter.<b> </b><br /><br /><b>Hearing significant frustration from physicians related to their experience with EMRs</b>, CRICO was inspired to envision a way in which they might be better integrated into  the clinical workflow. This would allow the EMR to offer some relief to physicians and nurses who face seemingly insurmountable challenges of time and data management.<br /><br />Luke Sato, MD, chief medical officer and senior vice president for CRICO said, “The impetus behind this video was to facilitate a dialogue among health care professionals—physicians, IT, hospital administrators—about why we aren’t making better progress in the development of EMRs.  Through analysis of medical malpractice claims, we have line of sight to <b>design deficiencies in the EMR that contribute to claims.</b> The best technological design is one that is integrated seamlessly into one’s workflow. The current EMR is passive—the physician has to actively look for data instead of the technology anticipating what the physician needs to act on.”<br /><br />Opinions within the health care industry are diverse about EMRs but <b>there has been no apparent leader in this field making a concerted effort to design the next generation of EMRs with the physician in mind.</b> In addition to a need for standards across systems, <b>the manual data entry of today’s EMRs adds to the burden of already time-pressed physicians.</b><br /><br />The film was created as a collaborative effort between CRICO’s Luke Sato, MD and David Ting, MD, associate medical director for information systems at Massachusetts General Physicians Organization, who acted as an expert resource for script development and video production. Ting said, “<b>The actual purpose of the video is to ask whether we might intelligently prioritize today’s choices to move our institutions toward improved patient care and improve provider and practice work-life experience.”</b><br /><br />While most of the technology that is used in this dramatization is available today, other elements are further out. CRICO’s future vision, as depicted in the video, is meant as a launching pad <b>to begin the conversation </b>about how new technologies can provide a way to enable EMRs to enhance, streamline, and make safer the patient-physician encounter.<br /><br />Dr. Ting has encouraged his colleagues at MGH to view the video and share their feedback. The physician reaction has elicited a variety of reactions and diverse feedback ranging from “cool, efficient, saves time, and improves outcomes” to “I don’t want voices interfering with my patient interactions.”  The video is available for viewing on the CRICO website, <a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=boV17iId5ky3j-AH7i-8UbFkSFsPF9EI1dNj1bsYgpqo6Y-wxui_17h2gLlU68Tga7gAZSNP4So.&URL=https%3a%2f%2fwww.rmf.harvard.edu%2fEMR" target="_blank">www.rmf.harvard.edu/EMR</a>.<b> </b><br /><br /><b>ABOUT CRICO</b><br /><br />For more than 30 years, CRICO has been the patient safety and medical professional liability company owned by and serving the Harvard medical community.<br /><br />CRICO is an internationally renowned leader in evidence-based risk management, proudly serving more than 12,000 physicians (including residents and fellows), 22 hospitals, and nearly 209 other health care organizations.</blockquote><br />They see the problems but do not engage the human reasons for the problems, including generic leadership, conflicts of interest, incompetence, territoriality, profit motive, and the other ills that we write of till our faces turn blue at Healthcare Renewal.<br /><br />In other words, their "challenge to EHR complacency" is about as powerful as our challenges have been to Vladimir Putin regarding Crimea and Ukraine. <br /><br />Perhaps when the payouts become even more severe, insurers will think it a good idea to stop 'making nice' with an intrusive and unregulated industry that has invaded clinical affairs <i>like a bull in a china shop.</i><br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="http://2.bp.blogspot.com/-rsEkyy_MIU8/UynJFh0rjaI/AAAAAAAAB5U/38E2LXzy0kI/s1600/bull.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="243" src="http://2.bp.blogspot.com/-rsEkyy_MIU8/UynJFh0rjaI/AAAAAAAAB5U/38E2LXzy0kI/s1600/bull.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Can we please, pretty please dialog for a bit about your breaking the dishes?</td></tr></tbody></table><br />-- SS

Medical Malpractice Insurer CRICO Challenges "EMR Complacency" - Or Do They?

In my Feb. 28, 2014 post " Malpractice Claims Analysis Confirms Risks in EHRs " ( http://hcrenewal.blogspot.com/2014/02/patient-sa...

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Clinical Trial Prestidigitation - Making Old Data Look Worse So New Data Looks Better

Prestidigitation, also known as <a href="http://en.wikipedia.org/wiki/Sleight_of_hand">sleight of hand</a> or legerdemain, is a form of stage magic which uses dextrous manipulation and misdirection to distract the viewer from seeing it. <br /><br />The example, <a href="http://www.bloomberg.com/news/2014-02-25/boehringer-kept-pradaxa-analysis-from-fda-records-show.html">reported</a> by Bloomberg on 26 February, 2014, is discussed late because the nature of the trick meant it took me a while before I understood how it was done.<br /><br /><b>Background</b><br /><br />Pradaxa, a new anticoagulant, was approved by the US Food and Drug Administration (FDA) in 2010 for use by patients with atrial fibrillation to prevent strokes.  We <a href="http://hcrenewal.blogspot.com/2014/02/cant-this-be-avoided-how-corporate.html">discussed</a> previously the release of documents during litigation that showed how marketers from its manufacturer, Boehringer - Ingelheim, attempted to manipulate the results of a clinical study of the drug.  The study results initially seemed to suggest that blood tests should be used to monitor therapy with it.  However, that would have contradicted a key marketing message, that Pradaxa was more convenient than warfarin because it did not require blood tests for monitoring.<br /><br />Litigation by patients alleging that Boehringer-Ingelheim concealed the severity of the bleeding risks caused by the drug<br />continues.  The Bloomberg <a href="http://www.bloomberg.com/news/2014-02-25/boehringer-kept-pradaxa-analysis-from-fda-records-show.html">report</a> dealt with how the company responded to requests by the FDA for data about these risks.   <br />  <br /><b>The Question from the FDA</b><br /><br />As per Bloomberg,<br /><br /><blockquote class="tr_bq">In the Pradaxa case, the regulators asked Boehringer to compare fatal bleeding reports received by the FDA against the number of patients using the drug in order to establish a death rate. The request was made to allow the FDA to 'evaluate the need for modifications to the Pradaxa label or future study,' according to a letter made public as part of the court files.<br /><br /> The company reported back that 6.1 of every 10,000 patients who used the drug after approval developed fatal bleeding, the court documents showed. The regulators also asked Boehringer to reanalyze results from an earlier study used to gain approval to see how that rate compared. </blockquote><br />So, in other words, the FDA wanted to assess the rate of bleeding reflected by reports received after the drug had gone on the market (that is, the FDA was evaluating data from post-marketing surveillance.)  To do so, it wanted to calculate the proportion of patients who took the drug who developed fatal bleeding.  Then it wanted to compare this rate to the rate of fatal bleeding found in the previous controlled trials of the drug done by the manufacturer to secure drug approval.  Note that these trials are also considered the major source of clinical research evidence about the benefits and harms of the drug.<br /><br />The major source of clinical evidence about Pradaxa (dabigatran) was the RE-LY trial (Randomized Evaluation of Long-Term Anticoagulation Therapy), sponsored by Boehringer-Ingelheim, published in the New England Journal of Medicine [Connolly SJ, Ezekowitz MD, Yusuf S et al.  Dabigatran versus warfarin in patients with atrial fibrillation.  N Engl J Med  <span class="citation">2009; 361:1139-1151.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa0905561">here</a>.]   The trial reported that the rates of life-threatening bleeding were 1.8% per year for warfarin, 1.45% for high dose dabigatran, and the rates of major bleeding of 3.36% versus 2.21%.  However, the trial report did not include rates of fatal bleeding per se, nor the rates of patients with major bleeding who then died.   </span><br /><br /><b>Presto Chango</b><br /><br />According to Bloomberg, here is how Boehringer-Ingelheim responded to the question from the FDA about the rate of fatal bleeding.<br /><br /><blockquote class="tr_bq"><i>That effort produced two separate analyses</i> by the company, according to the unsealed court documents. One, looking only at <i>people whose primary cause of death was bleeding, found 5.8 of 10,000 patients died per year</i>. The other, which included anyone who <i>had a major bleeding event and died for any reason, found a rate of 19.5 fatal events per 10,000 patients per year,</i> the documents show.<br /><br /> The report sent to the FDA, though, <i>contained only the analysis indicating the death rate from the earlier research was much higher than the numbers seen after approval,</i> according to the court filings. Potentially, such a finding <i>could head off any after-market action by the FDA because the data showed the drug was safer after it was approved and widely used.   </i></blockquote><br />So, to recapitulate, Boehringer-Ingelheim used results from the RE-LY trial to persuade the FDA that its new drug was safe and effective.  However, the company did not include, at least in the results reported publicly, any measure of fatal bleeding in patients given the drug.  It now appears that the rate of major bleeding in patients who subsequently died was high, perhaps high enough to have raised questions about the safety of the drug prior to approval, had it been revealed.<br /><br />However, after the drug had been approved, when the question was about rates of severe bleeding after the drug had been marketed, the company furnished an analysis of data from the clinical trial that now showed a very high bleeding rate. That was the major misdirection, the sleight of hand.. It would make the rate of fatal bleeding in the post-marketing surveillance data appear low.  <br /><br />But apparently this data also kept the eyes of the FDA focused on the question of bleeding in the post-marketing period.  Did no one in the FDA notice that while this high rate of bad bleeding in the trial made the post-marketing surveillance look good, it also raised questions about whether the drug should have been thought to have been safe enough to be approved in the first place?   <br /><br /><br />By the way, Bloomberg also reported that Boehringer-Ingelheim performed a trick for European regulators,  <br /><br /><blockquote class="tr_bq"><i>Selective disclosure of Pradaxa information may have camouflaged a serious safety signal</i>, according to an assessment report from <a href="http://www.ema.europa.eu/ema/" rel="external" title="Open Web Site">European Medicines Agency’</a>s Committee for Medicinal Products for Human Use in August 2012. That agency is the European Union’s drug regulator.<br /><br />Boehringer also didn’t give the EMA the figures showing that real-world bleeding rates were higher when the committee conducted a similar review and published a report in August 2012. The panel’s analysis, which concurred with Boehringer’s, concluded that Pradaxa’s bleeding risks among the general population were 'substantially less' than the rates seen in the study the drugmaker used as the basis for approval. It didn’t have the analysis showing the risk was higher using a different approach, according to the unsealed files. <br /> <br />'If the reporting rate in the post-marketing phase had been higher than in' Boehringer’s study, 'there would clearly have been a safety concern,' agency officials wrote. </blockquote><br /><b>Summary</b><br /><br />We have discussed a variety of ways that companies that sell health care goods (like drugs or devices) and services may <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulate clinical research</a> to make their products look better than they may actually be.  It appears that these companies may hire very clever people who are very knowledgeable about the design of clinical research to game the system to aid marketing, but meanwhile obfuscate the clinical research data that clinicians and patients rely on to make clinical decisions in the best interests of patients, and that policy makers rely on to make decisions in the best interests of the public.  So far, the hands of the corporate marketers seem to be quicker than the eyes of the clinicians, patients, and policy makers. <br /><br />I wonder, though, how those very clever people sleep well at night knowing that their talents for legerdemain are being used to increase revenues and make corporate insiders rich, at the expense of patients, and of patients' health? <br /><br />As I have said before, and most recently in the context of <a href="http://hcrenewal.blogspot.com/2014/02/cant-this-be-avoided-how-corporate.html">discussing</a> the previous example of manipulation of clinical research to support Pradaxa marketing,  I strongly advocate that those who author authoritative systematic reviews, meta-analyses, and clinical practice guidelines base their work on extremely rigorous, skeptical reviews that assume the likelihood that all commercially sponsored published clinical research has been manipulated (and that research that even post manipulation could not be twisted to support marketing many have been <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed</a>)  Reviews, meta-analyses, and guidelines that were not so based on extremely critical review should also be viewed with a jaundiced eye.  <br /><br />Perhaps it is possible to devise legal and regulatory methods to at least make such manipulation more transparent.  Maybe this case, however, should again suggest that clinical research, that is, research on human beings, should be completely separated from those with vested interests in selling products or services which could be better hyped were the research turn out in their favor. <br /><br />Hat tip to <a href="http://1boringoldman.com/index.php/2014/02/26/foot-in-mouth-disease/">1BoringOldMan</a>.

Clinical Trial Prestidigitation - Making Old Data Look Worse So New Data Looks Better

Prestidigitation, also known as sleight of hand or legerdemain, is a form of stage magic which uses dextrous manipulation and misdirection ...

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