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Sickness in the Information Technology Sector: Technical problems, discord plagued Maryland health care site

Eye-opening, ground-level, no-holds-barred accounts of IT mismanagement and mayhem are too rare, considering the stakes in 2013.  The behind-the-scenes crap that goes on needs a great deal of sunlight. Below is such an account of great merit, in the Baltimore Sun. First, I note physicians and nurses are generally able to collaborate to take care of sick patients.  They are natural "team players"; taking care of patients is their professional calling.  I did it all the time in my patient care years, especially in critical care settings, where lack of collaboration with colleagues could lead to dead patients. IT personnel are another species entirely.  It's all about territory, competition, self-promotion, empire-building, drinking from the ever-flowing fountain of money, etc.; process matters more than results; and to hell with the end users, let alone patients. Here is, in macro form, the Fifty Shades of Mass Dysfunction I've often encountered when my professional work intersected with IT personnel, whether in hospitals or industry.  And I was supposed to simply "shut up" about this crap - i.e., go along to get along: <blockquote class="tr_bq">Technical problems, discord plagued Maryland health care site <a href="http://www.baltimoresun.com/health/bs-hs-exchange-woes-20131207,0,6559272.story" target="_blank">http://www.baltimoresun.com/health/bs-hs-exchange-woes-20131207,0,6559272.story</a>  By <a href="http://bio.tribune.com/MeredithCohn" target="_blank">Meredith Cohn</a> and Andrea K. Walker, The Baltimore Sun 10:50 p.m. EST, December 7, 2013 Although state officials have provided the public scant detail about the troubled launch of Maryland's version of <a href="http://www.baltimoresun.com/topic/health/healthcare-laws/affordable-care-act-%28obamacare%29-EVGAP00039.topic" target="_blank" title="Affordable Care Act (Obamacare)">Obamacare</a>, emails and documents show that the project was beset behind the scenes for months by an array of technical issues, warring contractors and other problems. Since Maryland's online health exchange opened Oct. 1 for people to buy insurance under the Affordable Care Act — and immediately crashed — the two main companies in charge of the website have taken their fight to court, a corporate project manager was replaced and a high-powered consulting firm was quietly brought in to restore order. Though state officials initially said the crash of the online exchange was an unexpected and fixable problem, emails and documents obtained by The Baltimore Sun through state open-records laws outline serious issues before and after the launch. The revelations came just days before Rebecca Pearce, the head of the exchange, resigned. State officials announced that move Friday night and pulled Carolyn Quattrocki from the governor's health reform office to serve as an interim replacement</blockquote> I am going to reproduce some paragraphs that show just how chaotic are the processes - in any health IT endeavor, whether they be for the exchanges that are essential to getting insured, or to the hospital IT systems that are essential to getting out of the hospital in something other than a pine box. Emphases mine: <blockquote class="tr_bq">Just two weeks before the launch, Pearce visited the prime contractor's <a href="http://www.baltimoresun.com/topic/us/maryland/anne-arundel-county/linthicum-PLGEO100100602070000.topic" target="_blank" title="Linthicum">Linthicum</a> headquarters and found a room of empty seats. She fired off an email questioning the company's commitment to resolve problems and reminding the contractors of what was at stake: "Tonight, I am begging. I don't know how else to say it: we have got to make this a reality." Despite her proddings, in-fighting between contractor Noridian Healthcare Solutions and a key subcontractor, EngagePoint Inc., disintegrated amid finger-pointing and accusations in court papers. At one point, after Noridian severed contractual ties between the companies but continued to ask for help, EngagePoint CEO Pradeep Goel emailed Noridian officials: "Are you people on <a href="http://www.baltimoresun.com/topic/health/drugs-medicines/cocaine-HEDAR00190.topic" target="_blank" title="Cocaine">crack cocaine</a>?"</blockquote> Contractors, subcontractors, all offering "solutions" in healthcare and all likely to have not a single soul on board with anything beyond a merchant-computing background. And nice, friendly questions amongst the friendly, collaborative finger-pointing and accusations typical of the IT world when mass mayhem occurs. And a begging boss?  How lovely. <blockquote class="tr_bq">... Pearce, who was hired in 2011 at a salary of $175,000, declined to comment on problems surrounding the exchange or her resignation.  [If I were her I would have resigned out of disgust with these idiots.  Oh wait - I did leave IT positions for reasons, in part, like that  - ed.] The emails provided by the state covered the two weeks before and after the website launch. They give only a limited behind-the-scenes view of creating and launching the exchange. Officials withheld an unknown number of emails, saying state law exempts them from disclosure because they involved the decision-making process of high-ranking executive officials. The troubles in Maryland mirror problems faced by other state exchanges, as well as the federal portal providing insurance options to consumers in 36 states.</blockquote>  Emails withheld under claims of legal privilege means we'll never know all the dirt. <blockquote class="tr_bq">... In Maryland, Sharfstein said the complexity was compounded because of an aging state <a href="http://www.baltimoresun.com/topic/health/government-health-care/medicaid-HEPRG00001.topic" target="_blank" title="Medicaid">Medicaid</a> computer system that needed to be integrated into the exchange. Officials also chose to customize existing technology that proved tougher to retrofit than expected, he said. "Unlike buying a book online from <a href="http://www.baltimoresun.com/topic/economy-business-finance/amazon.com-inc.-ORCRP000672.topic" target="_blank" title="Amazon.com Inc.">Amazon</a>, this process is more akin to applying for a passport, buying a home, and receiving an individually calculated tax credit all through a single web portal," O'Malley said Friday night. "We had more user glitches and user problems than we had hoped. "A longer testing period might have allowed us to prioritize and address more of these problems before the launch date. Time and ultimate success will tell whether the decision to purchase off-the-shelf software and employ multiple contractor entities were good or bad decisions."</blockquote> "Hope" is not a proper project management technique of which I am aware, especially in a project of the admitted complexity as this one. "Tougher to retrofit than expected?" Expected by whom?  IT "experts" who believe in unicorns and the tooth fairy?  I point out that in medicine, such mistakes are called "malpractice." A longer testing period might have allowed us to address more problems?  But they went live anyway? <blockquote class="tr_bq">... In early 2012, the state gave a $71 million contract to develop the website to a Noridian-led team that included Curam Software, <a href="http://www.baltimoresun.com/topic/economy-business-finance/ibm-ORCRP008000.topic" target="_blank" title="IBM">IBM</a> and Connecture. To save time in creating the exchange, the Maryland legislature exempted the contract from the normal procurement process, and North Dakota-based Noridian outscored three other bidders. Sharfstein said Noridian will likely remain at work in its Linthicum offices beyond its contract's year-end expiration. The company has already been paid about $57 million but the state contract allows penalties for delays. State officials declined to comment on whether any penalties will be sought. Noridian is ultimately responsible for delivering the system, Sharfstein said. EngagePoint, which is based in Calverton, was not included in the original contract and appeared to have been hired without the exchange's knowledge, officials said. The state first learned of the companies' "deep strains" in the three months before the website launched, according to documents in U.S. District Court in Baltimore. The issues disputed included accounting, project management, intellectual property and payment. Emails offer a glimpse at how their differences affected efforts to build the site and then fix post-launch problems. Pearce repeatedly questioned the contractors' commitment to the project after Gov. Martin O'Malley announced on national TV that Maryland's site would go live on time. On Sept. 22, after Sen. <a href="http://www.baltimoresun.com/topic/politics/government/barbara-a.-mikulski-PEPLT004501.topic" target="_blank" title="Barbara A. Mikulski">Barbara Mikulski</a> echoed the governor in publicly applauding Maryland's readiness, Pearce wrote the contractors: "It's time to get this right. Now. Period." Noridian was also criticizing the subcontractor it hired. On Sept. 25, Noridian's project manager wrote to Goel, complaining that EngagePoint refused to perform critical work: "EngagePoint is responsible for 'designing and implementing [an exchange] system,'" the project manager wrote. The 8 a.m. launch was supposed to allow the estimated 800,000 uninsured Marylanders to sign in and browse 45 plans from six insurers. Officials had warned of "bumps in the road," but the site crashed in minutes. ... "As the executives in charge of this program, I would like to understand from you exactly what is happening with the project and what you are doing to address the issues," she wrote to the contractors at 7:56 a.m. on Oct. 2. By 4:10 p.m., she questioned why 85,000 people had hit the "get started" button, but there fewer than 500 accounts had been created. About a half-hour later, she wrote to the contractors, "Can you please provide an update on what is going on right now? Who is on site? What has anyone learned?" Some of the companies' emails focused on achievements rather than dwelling on worsening problems. Noridian CEO Tom McGraw wrote to state officials on Oct. 4, "We have seen increases in all aspects of the system performance over the last several hours and anticipate that these will start showing in the next report." But four days later McGraw notified state officials that the project manager was being replaced.</blockquote> Conflict, favoritism, fighting, "it's not my job", lies, spin, stonewalling, strife ... chaos. "Efforts to build the site and then fix post-launch problems" is also typical of the IT world.  In health IT, especially clinical IT, those harmed or killed during the "fixing" process are considered a necessary sacrifice, a "bump in the road." <blockquote class="tr_bq">... Paul von Ebers, CEO of Noridian Mutual Insurance Co., Noridian's parent company, wrote on Oct. 10 that the consultants "expressed concern with ongoing coordination issues between the Noridian and EngagePoint teams." He requested a meeting to resolve "working differences" between the companies. This was days before Noridian fired EngagePoint, sparking the angry email exchanges and dueling lawsuits between the companies. Noridian then sought to hire EngagePoint workers; EngagePoint sued and was met with a counter-suit. "We are expected to do piecemeal work for Noridian after contract termination because you just woke up and decided you don't know what you are doing?" Goel wrote Oct. 26. "We are not going to respond to ridiculous emails from Noridian demanding our team members show up for work after being escorted out of the office."</blockquote> That's the path to progress:  firing subcontractors and attempting to steal their employees, and lawsuits and countersuits. I could go on, but read the entire postmortem account (itself rare in large IT projects) at the Baltimore Sun link above. Some of the de-identified cases at my academic site on health IT difficulties reflect this type of discord; some are mine personally such as at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU">http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU</a> , <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story">http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story</a> and <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cultures%20of%20mismanagement%20toxic%20to%20healthcare%20quality">http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cultures%20of%20mismanagement%20toxic%20to%20healthcare%20quality</a>. I was expected to "go along to get along" with this BS, and was deemed "not a team player" when I spoke up for enduser (clinician) and ultimate customer (patient) rights. In summary, the IT world is demonstrably dysfunctional, with the types of conflict as in the Baltimore Sun story more the rule than the exception, especially where healthcare is concerned.  Good, relatively brief resources for better understanding these issues are the following papers: <blockquote class="tr_bq"> Social Informatics.  An introductory essay entitled “Learning from Social Informatics” by R. Kling at the University of Indiana can be found <a href="https://web.archive.org/web/20100310084838/http://rkcsi.indiana.edu/archive/SI/Arts/SI_report_Aug_14.pdf">at this link</a> (PDF).  The book “Understanding And Communicating Social Informatics” by Kling, Rosenbaum & Sawyer, Information Today, 2005 (Amazon.com link <a href="http://www.amazon.com/Understanding-Communicating-Social-Informatics-Communication/dp/1573872288/ref=sr_1_1/102-9749119-8288920?ie=UTF8&s=books&qid=1174318804&sr=8-1">here</a>) was based on this essay. Pessimism, Computer Failure, and Information Systems Development in the Public Sector.  (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand).  Cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT.  <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Goldfinch_pessimism_PAR.pdf">link</a>to pdf <div class="MsoNormal" style="margin-right: 20.4pt;"> </div>“Defensive climate in the computer science classroom” by Barker et al., Univ. of Denver.  Link <a href="http://portal.acm.org/citation.cfm?id=563354&coll=portal&dl=ACM">here</a>(subscription required).  May help explain the control-seeking culture of IT personnel.   As part of an NSF-funded IT workforce grant, the authors conducted ethnographic research to provide deep understanding of the learning environment of computer science classrooms. Categories emerging from data analysis included 1) impersonal environment and guarded behavior; and 2) the creation and maintenance of informal hierarchy resulting in competitive behaviors. These communication patterns lead to a defensive climate, characterized by competitiveness rather cooperation, judgments about others, superiority, and neutrality rather than empathy.</blockquote> If a person thinks this technology will "revolutionize" healthcare anytime soon, considering the "people issues" involved let alone the technical ones, then that person is either hopelessly naïve, or needs a mental health evaluation (colloquially, "needs their head examined"). -- SS

Sickness in the Information Technology Sector: Technical problems, discord plagued Maryland health care site

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09 Dec 2013

But Don't Worry, Your Health Information is Secure: the Enforcers are Themselves Incompetent and Broke

Another in my "But Don't Worry, Your Health Information is Secure" series (see <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy</a>) ... a promise blindly made by the healthcare information technology hyper-enthusiasts. <blockquote class="tr_bq">The Office of the Inspector General for HHS just issued a report finding that the Office of Civil Rights (OCR), which is charged with enforcing the HIPAA/HITECH law, had itself failed to adequately protect the security of the health information it handled. Specifically OIG found that OCR “focused on system operability to the detriment of system and data security.”</blockquote> From “The Office for Civil Rights Did Not Meet All Federal Requirements in Its Oversight and Enforcement of the Health Insurance Portability and Accountability Act Security Rule”, p. ii (Nov. 2013).  <a href="http://oig.hhs.gov/oas/reports/region4/41105025.asp">http://oig.hhs.gov/oas/reports/region4/41105025.asp</a><a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=cnmQxxd1ok6fZ7r1yAFMffFwO7p2yNAIzU9ZEphzhXivZep_Icu-CQf-7PEVpCAa1XTvDnjs5d4.&URL=http%3a%2f%2foig.hhs.gov%2foas%2freports%2fregion4%2f41105025.asp" style="color: purple;" target="_blank"></a> <div class="line">Summary:</div><div class="line"> </div><blockquote class="tr_bq">The Office for Civil Rights (OCR) did not meet certain Federal requirements critical to the oversight and enforcement of the Health Insurance Portability and Accountability Act Security Rule (Security Rule). OCR had not assessed risks, established priorities, or implemented controls for its Federal requirements to provide for periodic audits of covered entities to ensure their compliance with Security Rule requirements. In addition, OCR's Security Rule investigation files did not contain required documentation supporting key decisions made because management had not implemented sufficient controls, including supervisory review and documentation retention, to ensure investigators follow investigation policies and procedures for properly initiating, processing, and closing Security Rule investigations. Further, OCR had not fully complied with Federal cybersecurity requirements for its information systems used to process and store investigation data because it focused on system operability [I presume they mean 'interoperability' - ed.] to the detriment of system and data security. We recommended that OCR (1) assess the risks, establish priorities, and implement controls for its HITECH auditing requirements; (2) provide for periodic audits in accordance with HITECH to ensure Security Rule compliance at covered entities; (3) implement sufficient controls, such as supervisory reviews and documentation retention, to ensure policies and procedures for Security Rule investigations are followed; and (4) implement the National Institute of Standards and Technology Risk Management Framework for systems used to oversee and enforce the Security Rule. In its comments on our draft report, OCR generally concurred with our recommendations and described the actions it has taken to address them. In specific comments on our second recommendation, however, OCR explained that no funds had been appropriated for it to maintain a permanent audit program and that funds used to support audit activities previously conducted were no longer available.</blockquote> The enforcers are themselves negligent, incompetent and broke.  And hospitals are expected to keep electronic protected health information secure? I comment no further.  What more could I possibly write? -- SS Dec. 9, 2013 Addendum: This woman would probably agree that this is a problem <blockquote class="tr_bq">Dec. 9, 2013 <a href="http://www.thestar.com/news/gta/2013/11/28/disabled_woman_denied_entry_to_us_after_agent_cites_supposedly_private_medical_details.html">http://www.thestar.com/news/gta/2013/11/28/disabled_woman_denied_entry_to_us_after_agent_cites_supposedly_private_medical_details.html </a> Disabled woman denied entry to U.S. after agent cites supposedly private medical details A Toronto woman is shocked after she was denied entry into the U.S. because she had been hospitalized for clinical depression. Ellen Richardson went to Pearson airport on Monday full of joy about flying to New York City and from there going on a 10-day Caribbean cruise for which she’d paid about $6,000. But a U.S. Customs and Border Protection agent with the Department of Homeland Security killed that dream when he denied her entry. “I was turned away, I was told, because I had a hospitalization in the summer of 2012 for clinical depression,’’ said Richardson, who is a paraplegic and set up her cruise in collaboration with a March of Dimes group of about 12 others. The Weston woman was told by the U.S. agent she would have to get “medical clearance’’ and be examined by one of only three doctors in Toronto whose assessments are accepted by Homeland Security. She was given their names and told a call to her psychiatrist “would not suffice.’’ At the time, Richardson said, she was so shocked and devastated by what was going on, she wasn’t thinking about how U.S. authorities could access her supposedly private medical information. “I was so aghast. I was saying, ‘I don’t understand this. What is the problem?’ I was so looking forward to getting away . . . I’d even brought a little string of Christmas lights I was going to string up in the cabin. . . . It’s not like I can just book again right away,’’ she said, referring to the time and planning that goes into taking a trip as a disabled person. Richardson said she’d had no discussion whatsoever with the agent at the airport about her medical history or background. </blockquote> Read the whole thing. -- SS

But Don't Worry, Your Health Information is Secure: the Enforcers are Themselves Incompetent and Broke

Another in my "But Don't Worry, Your Health Information is Secure" series (see http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy) ... a promise blindly made by the healthcare infor…

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09 Dec 2013

On Hypervigilance Due to Bad Health IT: "Texting While Doctoring: A Patient Safety Hazard"

An Opinion piece "Texting While Doctoring: A Patient Safety Hazard" appeared in the Annals of Internal Medicine of 3 December 2013, authored by Christine A. Sinsky, MD and John W. Beasley, MD.  Dr. Sinsky is known to me to be what some would call a "heatlhcare IT iconoclast" (more accurately represented by the term "healthcare IT gadfly/realist" IMO). In the piece the authors comment on the distractions caused by the technology, leading to doctors missing important cues in the exam room and to and impaired problem-solving.  This is part of a larger phenomenon that has been called "skill-degrading" or "de-skilling", e.g., see my April 16, 2010 post "Health Information Technology Basics From Calif. Nurses Association and National Nurses Organizing Committee" at <a href="http://hcrenewal.blogspot.com/2010/04/health-information-technology-basics.html">http://hcrenewal.blogspot.com/2010/04/health-information-technology-basics.html</a>).   These effects are likely to be further worsened as more and more clerical tasks such as order entry, the authors point out, get shifted to medical professionals.  To new readers: note that computerized order entry is often a complex and convoluted process; the CPOE systems are most decidedly NOT mere "typewriters for orders."  See, for instance, part 6 of my series on "Mission-hostile health IT" at <a href="http://hcrenewal.blogspot.com/2009/02/it-makes-healthcare-easier-is-this.html">http://hcrenewal.blogspot.com/2009/02/it-makes-healthcare-easier-is-this.html</a>. Most of the Annals article is available as a free preview at <a href="http://annals.org/article.aspx?articleid=1784295">http://annals.org/article.aspx?articleid=1784295</a> as of this writing and is worth reviewing. <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjCxGx3pchjD96z40o0nvd5V3ajmX-dfcQBAPJ3lg1DDvKwmpnSqlwNwHplkPhWZ4m9BCQYD8leE9-tNRfWS_Yy-QB0G5Y4Jp4VYFBEumMmTb3XZmw1lWhMv8yk8L67VrNiGJW0eY_3ukK4/s1600/sinsky1.gif" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjCxGx3pchjD96z40o0nvd5V3ajmX-dfcQBAPJ3lg1DDvKwmpnSqlwNwHplkPhWZ4m9BCQYD8leE9-tNRfWS_Yy-QB0G5Y4Jp4VYFBEumMmTb3XZmw1lWhMv8yk8L67VrNiGJW0eY_3ukK4/s400/sinsky1.gif" width="305" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Article preview, click to enlarge</td></tr></tbody></table> I found one passage in particular striking, though.  In my ongoing discussions with computer scientist/informaticist/polymath Dr. Jon Patrick at U. Sydney (<a href="http://www.healthll.com.au/?page_id=440">http://www.healthll.com.au/?page_id=440</a>) , the issue of hypervigilance necessitated by bad health IT came up, and we arrived at the definition of same seen at my teaching site at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/">http://cci.drexel.edu/faculty/ssilverstein/cases/</a>: <blockquote class="tr_bq">Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.  </blockquote> Note this passage in Dr. Sinsky and Beasley's opinion piece: <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhtHLHXSyRd0Dyolv6mcgLfhmp4J-4oYYVf3u2-ztDbSt0oW2ogHT3vz5rhAcr89y8SNkWv1ZAQB1_WZ5CH4mA7paPhsT8IpQBP_dFwsL5qNya5qnQ8OK6k6Y78jVn0Qsll6PrUa1LgR2o8/s1600/sinsky.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhtHLHXSyRd0Dyolv6mcgLfhmp4J-4oYYVf3u2-ztDbSt0oW2ogHT3vz5rhAcr89y8SNkWv1ZAQB1_WZ5CH4mA7paPhsT8IpQBP_dFwsL5qNya5qnQ8OK6k6Y78jVn0Qsll6PrUa1LgR2o8/s320/sinsky.jpg" width="313" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">"I am always multitasking ... I am entering orders, checking labs, downloading information while I talk to the patient.  It requires chronic hypervigilance, which is exhausting and demands conscious effort to stay in the 'present' with the patient" (Day S., Personal communication.)  Click to enlarge.</td></tr></tbody></table> I don't know if Dr. Day had seen my materials, but I suspect the exhausting hypervigilance is all too common, just not much publicized due to the secretive, closed, retaliatory-towards-whistleblowers nature of the healthcare IT sector. I ask:  is this what we really want, in pursuit of some uncertain cybernetic miracle? I note that the healthcare IT experiment (and the technology is experimental), long usurped from the Medical Informatics pioneers who trained me and put in the hands of commercial interests and those of a mercantile/manufacturing/management computing background, is increasingly a failure. -- SS

On Hypervigilance Due to Bad Health IT: "Texting While Doctoring: A Patient Safety Hazard"

An Opinion piece "Texting While Doctoring: A Patient Safety Hazard" appeared in the Annals of Internal Medicine of 3 December 2013, authored by Christine A. Sinsky, MD and John W. Beasley, MD. Dr. Si…

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08 Dec 2013

How Many Straws? - Johnson and Johnson Settles Again, Again, Again...

It seems like a minor case, but is another straw for the camel. The Latest Settlement <a href="http://www.modernhealthcare.com/article/20131205/NEWS/312059936/two-jj-executives-agree-to-50000-in-fines-over-mislabeled-products">Reported</a> in most detail by Modern Healthcare, <blockquote class="tr_bq">Two executives at a subsidiary of Johnson & Johnson have agreed to pay a total of $50,000 to resolve allegations that they knowingly sold mislabeled products used in the sterilization of gastrointestinal scopes and surgical drills.  The settlement also calls for the J&J subsidiary, Advanced Sterilization Products, to pay $1.25 million to resolve a civil complaint filed by the Food and Drug Administration. ASP President Bernard Zovighian will pay $30,000, while Richard Alberti, quality and compliance vice president, will pay $20,000. None admitted wrongdoing. 'ASP's actions violated the law and put patients at unnecessary risk for infection,' Steve Silberman, director of compliance at the FDA Center for Devices and Radiological Health, said in a statement. Last year, ASP announced two recalls affecting a product called the Cyclesure 24 Biological Indicator, which is used to make sure that medical equipment sterilized using ASP's Sterrad low-temperature cleaning machines is free of bacteria, fungi and viruses. FDA inspectors, according to a civil complaint last July, uncovered evidence that the company sold the Cyclesure 24 tests with 15-month expiration dates even though ASP's internal studies had not established the product's safe shelf life was that long. After the issue was discovered, ASP shortened the shelf life of the Cyclesure indicators to six months. The company also recalled all lots of the products manufactured between February 2008 and December 2011. Dirty endoscopes used during colon cancer screenings, for example, have been implicated in the transmission of hepatitis C and many types of bacteria, according to ASP's own website. </blockquote>Note that this case involves not just legal technicalities, but failures of disclosure that could have put real patients at risk of significant harm. The Context This case comes only one week after we <a href="http://hcrenewal.blogspot.com/2013/11/there-they-go-again-again-johnson-and.html">discussed</a> a huge ($2.5 billion) settlement by Johnson and Johnson of allegations that it withheld data about major safety problems affecting metal-on-metal hip prostheses, and two smaller settlements of allegations that it withheld safety data about the drug Topamax. It is noteworthy that in this much smaller current settlement, two admittedly relatively low-level executives had to pay fines amounting to 4% of what the company had to pay. This is unusual.  Usually corporate executives escape any negative consequences, even in cases involving large amounts of money or possible harm to many patients.  If last week's settlement were to have imposed proportionate fines on executives, those fines would have totaled $100 million The latest settlement does seem to follow the usual pattern: relatively small time individual offenders pay a penalty, while very rich and powerful individual offenders avoid all penalties. (For example, look <a href="http://hcrenewal.blogspot.com/2013/01/the-tragic-case-of-aaron-swartz-unequal.html">here</a> to see how one US prosecutor handled the case of Aaron Swartz versus the cases of misdeeds by big corporations)   <a href="http://hcrenewal.blogspot.com/search/label/impunity">Impunity</a> by rich and powerful leaders of big organizations, and failure to enforce laws broken by such people is a very old story in American history, but that pattern was interrupted briefly after the great depression through the 1970s.  Now impunity for the rich and powerful is back, and maybe that is why 43% of the American population think our health care system is corrupt (look <a href="http://hcrenewal.blogspot.com/2013/07/43-believe-that-us-health-care-corrupt.html">here</a>). Of course, the current settlement involved no admissions of wrongdoing.  Like most <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal actions against big health care organizations</a>, it is thus paradoxical.  Fines are paid, but at least on paper, not because of any wrongdoing.  So what were the penalties for?  Who knows?  But allowing a settlement without an admission of wrongdoing allows the next settlement to be made as if it were dealing with an isolated problem.  As we mentioned in our <a href="http://hcrenewal.blogspot.com/2013/11/there-they-go-again-again-johnson-and.html">last post</a> on Johnson and Johnson, the latest settlement should be added to an increasingly  long list of the company's legal woes, often involving allegations and evidence of other unethical actions, sometimes involving guilty pleas to charges of such actions (see compilation of the record through July, 2013 <a href="http://hcrenewal.blogspot.com/2013/07/johnson-and-johnson-settles-suit.html">here</a>.)  Yet each settlement or action seems to take place in a vacuum, with no attention to what appears to be the company's record of ethical recidivism.  Of course, since nearly every action eschewed admissions of wrongdoing, on paper, there was no legal record of recidivism.  The whole situation is becoming so absurd that Jon Stewart on the Daily Show <a href="http://www.thewrap.com/daily-show-jon-stewart-johnson-grand-theft-auto">parodied</a> the ability of Johnson and Johnson, and other big corporations, to escape any meaningful negative consequences of their actions. <div style="background-color: black; width: 368px;"><div style="padding: 4px;"><iframe frameborder="0" height="293" src="http://media.mtvnservices.com/embed/mgid:cms:video:thedailyshow.com:430976" width="360"></iframe> <div style="background-color: white; font-family: Arial, Helvetica, sans-serif; font-size: 12px; margin-bottom: 0px; margin-top: 4px; padding: 4px; text-align: left;">The Daily Show Get More: <a href="http://www.thedailyshow.com/full-episodes/">Daily Show Full Episodes</a>,<a href="http://www.facebook.com/thedailyshow">The Daily Show on Facebook</a></div></div></div> As quoted on the Wrap <blockquote class="tr_bq">'Holy sh**t. They knowingly bribed doctors to give useless drugs to old people, the disabled and babies,' a stunned Stewart said. 'You’re not even allowed to do that in ‘Grand Theft Auto.''</blockquote> When these issues start becoming subjects of popular parody, maybe I can entertain a tiny hope that something might be done.  Conclusion So I get to say again, again again...  many of largest and once proud health care organizations now have recent records of repeated, egregious ethical lapses. Not only have their leaders have nearly all avoided penalties, but they have become extremely rich while their companies have so misbehaved. These leaders seem to have become like nobility, able to extract money from lesser folk, while remaining entirely unaccountable for bad results of their reigns. We can see from this case that health care organizations' leadership's nobility overlaps with the supposed "royalty" of the leaders of big financial firms, none of whom have gone to jail after the global financial collapse, great recession, and ongoing international financial disaster (look <a href="http://hcrenewal.blogspot.com/2012/08/duchess-of-wellpoint-abdicates-likely.html">here</a>). The current fashion of punishing behavior within health care organization with fines and agreements to behave better in the future appears to be more law enforcement theatre than serious deterrent.  As Massachusetts Governor Deval Patrick exhorted his fellow Democrats, I exhort state, federal (and international, for that  matter) law enforcement to "<a href="http://www.washingtonpost.com/blogs/election-2012/wp/2012/09/04/patrick-it-is-time-for-democrats-to-grow-a-backbone/">grow a backbone</a>" and go after the people who were responsible for and most profited from the ongoing ethical debacle in health care. As we have said before, true health care reform would make leaders of health care organization accountable for their organizations' bad behavior. Roy M. Poses MD on Health Care Renewal

How Many Straws? - Johnson and Johnson Settles Again, Again, Again...

It seems like a minor case, but is another straw for the camel. The Latest Settlement Reported in most detail by Modern Healthcare, Two executives at a subsidiary of Johnson & Johnson have agreed to p…

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06 Dec 2013

EHR Pastel Madness: Cognitive Overload in Critical Care

It's hard to find public postings that show the crazy and dangerous complexity of EHR interfaces, but I found a presentation at <a href="http://www.uiowa.edu/~medtest2/picis/vo_picis.pdf">http://www.uiowa.edu/~medtest2/picis/vo_picis.pdf</a> (PDF slide presentation) that demonstrates ths problem well. These are from a 2006 training presentation on an EHR for Critical Care , where doctors and nurses really don't have the time to wade through complexity like this.    I can honestly and in fact, with great vigor, opine I would not have wanted to use a tool like this when I was working in intensive care units.  And I'm a Medical Informatics specialist x 21 years... EHRs have not changed much; in fact with the higher commodity (cheap) screen resolutions available in 2013 compared to 2006, the problem is worse. Some sample screens: <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgfO5PiBGHM6PxLTm0BkbVqrkXphnnhSJKEMbHJ5bXFDxSzOOsc7nQJgPeaQyB_ZEzV_9tb8I4VMAqYdLN60hctlB3YShdjrEiLakNehhFoxCp8qcHniZhdyg8LPMshtw29EZDXcCmGIG4-/s1600/screen1.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="240" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgfO5PiBGHM6PxLTm0BkbVqrkXphnnhSJKEMbHJ5bXFDxSzOOsc7nQJgPeaQyB_ZEzV_9tb8I4VMAqYdLN60hctlB3YShdjrEiLakNehhFoxCp8qcHniZhdyg8LPMshtw29EZDXcCmGIG4-/s320/screen1.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Click to enlarge</td></tr></tbody></table> <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgm0j77Npta-H0BPqMFVaJyiU_g2TeoPpe9ROw-xBjhDg3y8-XZxpbDn2urD1ZsMNU62slKN5U0ZzCKiG1HCd-XNgc5UJ6GLb_V7gu-H4Lj-2NuCxfP4xI2lm5kYqYPEiEGOfbiwKCVhXZW/s1600/screen2.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="238" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgm0j77Npta-H0BPqMFVaJyiU_g2TeoPpe9ROw-xBjhDg3y8-XZxpbDn2urD1ZsMNU62slKN5U0ZzCKiG1HCd-XNgc5UJ6GLb_V7gu-H4Lj-2NuCxfP4xI2lm5kYqYPEiEGOfbiwKCVhXZW/s320/screen2.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Click to enlarge</td></tr></tbody></table> <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg0B9MFJCQuhlSHk7ziTNTO5L-ybjbN9ZQiMq5N0UduIaL9pIDHYJw62scX0R5xoCZqXKkjqUKYFavHCRqcLhgww1nBYl414GOfqZeGz1yCfd-kfl3XOJxiAfNog-gt5ZMMcvRQwhjSMoX5/s1600/screen3.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="240" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg0B9MFJCQuhlSHk7ziTNTO5L-ybjbN9ZQiMq5N0UduIaL9pIDHYJw62scX0R5xoCZqXKkjqUKYFavHCRqcLhgww1nBYl414GOfqZeGz1yCfd-kfl3XOJxiAfNog-gt5ZMMcvRQwhjSMoX5/s320/screen3.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Click to enlarge</td></tr></tbody></table> <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEixdXLTisQC8eDJSjW2sicQz06WcV2nsSYMA4ecn2_6zDQb5k0q5qD60rEXlxVM1IN-mrUS73TjB1dN1q6BGL1stWms-99PJqTw0pMMauASbx2YEb6D-aho7yWPtuzx97lC-u8TQii0XGTc/s1600/screen4.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="213" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEixdXLTisQC8eDJSjW2sicQz06WcV2nsSYMA4ecn2_6zDQb5k0q5qD60rEXlxVM1IN-mrUS73TjB1dN1q6BGL1stWms-99PJqTw0pMMauASbx2YEb6D-aho7yWPtuzx97lC-u8TQii0XGTc/s320/screen4.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Click to enlarge</td></tr></tbody></table> <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgF0KBIoGM5O3qs9gWxR5sFvdW4ScqaaMSxKT4MhwvC2WV15pBswtWoC4C9dWHLsIq1N8v82loQM_4t6bg4B_dMR47MsYzuOKwS54JwxXCY9SeSLqLjMuZMzGKj_OSatVP2zGLL7aaAY1cW/s1600/screen5.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="198" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgF0KBIoGM5O3qs9gWxR5sFvdW4ScqaaMSxKT4MhwvC2WV15pBswtWoC4C9dWHLsIq1N8v82loQM_4t6bg4B_dMR47MsYzuOKwS54JwxXCY9SeSLqLjMuZMzGKj_OSatVP2zGLL7aaAY1cW/s320/screen5.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Click to enlarge</td></tr></tbody></table> And there's more where these came from at the link above. Insane, in my view, to subject busy, stressed out clinicians to a pastel nightmare like this.  (And that's assuming the application doesn't lose or corrupt data.) This is not to single out this particular seller.  Other EHR sellers' products are similarly visually and operationally complex. But, if you, the reader, like these and think, the more that can be packed in the merrier, bring it on, that's fine with me.  It's your life and limb. Actually, not - because my life and limb are at risk, too. See the entire presentation for more. -- SS

EHR Pastel Madness: Cognitive Overload in Critical Care

It's hard to find public postings that show the crazy and dangerous complexity of EHR interfaces, but I found a presentation at http://www.uiowa.edu/~medtest2/picis/vo_picis.pdf (PDF slide presentatio…

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06 Dec 2013

How Manipulated Clinical Evidence Could Distort Guidelines - the Case of Statins for Primary Prevention

The new American College of Cardiology (ACC)/ American Heart Association (AHA) guidelines on the primary prevention of cardiovascular disease, which we discussed <a href="http://hcrenewal.blogspot.com/2013/11/confused-thinking-about-new-cholesterol.html">here</a>, continue to generate controversy.  Articles in the media and online-first in medical journals underscored some of the issues we discussed before.  Jeanne Lenzer, in a news article in the British Medical Journal, found that the chair of the guideline panel had important past conflicts of interest that were not previously disclosed.(1)  The chair denied their significance (look <a href="http://healthland.time.com/2013/11/22/conflicts-of-interest-cholesterol-panel-head-defends-members-ties-to-industry/">here</a>).   Guideline panel members continued to justify their efforts, but in my humble opinion, raised no new evidence or logic to support it (look <a href="http://www.medscape.com/viewarticle/814711">here</a>  and <a href="http://www.medscape.com/viewarticle/814960">here</a>) Bigger Questions about the Validity of the Clinical Evidence However, several new articles suggested the need for a deeper look at one particular aspect of this case, the validity of the evidence from clinical research about the benefits and harms of statins for primary prevention. JAMA published a summary of the Cochrane review that provided a basis for the guideline developers' confidence in the worth of statin therapy in primary prevention.(2) <blockquote class="tr_bq"> results suggest that the benefits of statin therapy outweigh serious life-threatening hazards.</blockquote> However, almost as an aside, it noted, <blockquote class="tr_bq">Some trials included participants with CVD, but rather than exclude these trials, we included trials that contained 10% or fewer participants with documented CVD.</blockquote> Primary prevention in this case is defined as prevention for patients without existing cardiovascular disease.  There is evidence that statins may well have benefits that outweigh harms when given to patients with known cardiovascular disease, particularly documented coronary artery disease (CAD).  Mixing such patients in any numbers into "primary prevention trials" would likely exaggerate the benefits of statins.  Yet such not quite primary prevention studies were included in a systematic review of primary prevention.  In addition, a commentary by one of the guideline developers defending the group's work also underscored the fact that many of the supposedly primary prevention trials they used as evidence were not pure primary prevention trials.(3) <blockquote class="tr_bq">Notably, the 2013 cholesterol guideline cut points were derived from the placebo rates for myocardial infarction, stroke, and cardiovascular disease death observed in the 3 exclusively primary prevention statin trials, Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS), Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (MEGA) study, and the Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER).[4-6]</blockquote> The wording again suggests that all the other trials used as evidence about primary prevention were NOT "exclusively primary prevention studies," and hence, as I noted above, may have been biased so that they would likely exaggerate the apparent benefits of statins in primary prevention. This suggested to me that the systematic review that provided a basis for the guidelines' aggressive recommendations about statins for primary prevention, and the trials on which it was based needed further skeptical, critical reviews. The Cochrane Review: Was Evidence about Statin Benefits vs Harms Manipulated? We have frequently discussed the <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation of clinical research</a>.  By that we have meant design, implementation, analysis or dissemination of research in ways likely to further vested interests.  In particular, when drug, biotechnology and device companies sponsor and control clinical research on their own products, they may set up the research in ways likely to make their products look better than they actually are.   We looked through the most recent Cochrane review of statins for primary prevention(7) with a skeptical eye out for suggestions that the trials reviewed could have been so manipulated.  We found quite a bit. First, we found that not all trials reported on the "hard" outcomes that one needs to consider when evaluating benefit vs harm of statins in primary prevention. <blockquote class="tr_bq">Data on all-cause mortality were provided in 11 trials.[of 19, and hence missing in 8].</blockquote> And, <blockquote class="tr_bq"> Twelve trials provided data on adverse events.[and hence 7 did not.]</blockquote>  Also, data on specific adverse events was often not reported: myalgia and rhabdomyolysis were reported in only 9/19 trials; new onset diabetes mellitus in only 2/18; hemmorhagic stroke in only 2/19; abnormal liver tests in only 10/19; kidney dysfunction in only 4/19; arthritis in only 2/19, and by implication, cognitive dysfunction in 0/19.     Failure to look for all the possible bad outcomes of treatment could obviously bias the study in the direction of minimizing the harms of the treatment. A substantial number of trials either failed to report on crucial aspects of their methods, or admitted to flaws that could have induced important biases.: 3/19 did not described randomization methods; 4/19 did not use double-blinding; 6/19 did not use intention to treat analysis; 7/19 did not report their drop-out rates. So it is very surprising to me that the authors concluded, <blockquote class="tr_bq">In general there was low risk of bias ... though all trials were either fully or partially funded by pharmaceutical companies.</blockquote>In my humble opinion, the Cochrane review showed many trials that had flaws could have biased their outcomes, and hence the outcomes of the overall review.  Some of the flaws clearly could have lead to biases that would have made statins look more efficacious, or less dangerous than they might actually be.  I do not understand the conclusion that the risk of bias was slow, and the lack of discussion about the direction the bias could have taken.  Review of the "3 Exclusively Primary Prevention Statin Trials" Given the Cochrane review's apparent lack of skepticism about methodologic problems in the industry funded statin prevention trials, I endeavored to take a closer look at the three trials that Dr Robinson held out as the real primary prevention trials.  Instances of manipulation, as we defined it above, for each trial are described below AFCAPS/ TexCAPS(4) Narrow Patient Population - This study excluded many patient for whom the statins were not contraindicated or warned against: uncontrolled hypertension; type 1 or type 2 diabetes mellitus on insulin or with a HgBA1C at least 10%; and body weight more than 50% "desirable limit for height."  (Based on the official contraindications and warnings for commonly used statins, e.g., see contraindications for Lipitor <a href="http://labeling.pfizer.com/ShowLabeling.aspx?id=587">here</a>, active liver disease, pregnancy for likely to become pregnant, nursing mothers, hypersensitivity to the medicine; and warnings: use of cyclosprine or strong CYP3A4 inhibitors, uncontrolled hypothyroidism, renal impairment.)  Thus the results may not generalize to many patients who would otherwise be considered statin candidates.  By excluding such patients, the results may bias the study towards minimizing the probabilities of harms that might occur were statins used on a wide population for primary prevention. Unknown Randomization and Allocation Concealment Procedures - According to the Cochrane Review, the study report did not explain how randomization or allocation concealment were accomplished.   Early Termination/ Multiple Comparisons - The study was terminated early based on an early look at the number of outcome events.  Two such early or interim analyses were planned.  Taking multiple looks at the data over time raises a multiple comparisons problem, and may lead to exaggerating the benefits of the treatment.(8). Furthermore, stopping early decreases the sample size and hence the power to find adverse effects of treatment. Implausible Dropout Rate, Missing Data - According to the Cochrane Review, the study reported no dropouts.  This seems somewhat improbable, suggesting skepticism about the accuracy and completeness of the data collection.  On the other hand, a study chronology suggests that of 6605 patients who started the study, 6540 had data on complete endpoint status, suggesting missing data.  Since dropouts and missing data may be due to different reasons in different arms of the study, they threaten the validity of data about benefits and harms.   Adverse Effects not Reported - The study provided no data about development of diabetes, hemmorhagic stroke, kidney dysfunction, arthritis, or cognitive dysfunction, suggesting incomplete data about harms, and hence bias towards minimizing harms.     MEGA (5) Narrow Patient Population -  [The patient population was not described in the main report, but only in an earlier methods article.](9)  The study excluded patients with congenital or rheumatic heart disease; chronic atrial fibrillation, current diagnosis of malignancy; poorly controlled hypertension or diabetes mellitus; current use of oral or parenteral corticosteroids; and other conditions at the discretion of the physician.  These exclusions seem unrelated to the contraindications or warnings on the stain label.  Again, such a narrow patient population reduces the generalizability of the study results, and may bias the study to minimizing the harms of statins. Only Single Blind - This was an open-label study, so patients and physicians knew who got statins and who got placebo.  Such knowledge could have biased patient management, including how diligently particular diagnoses and outcomes were pursued, and biased data collected from patients or physicians. Adverse Effects Not Reported - The study provided no data about diabetes, hemmorhagic stroke, kidney dysfunction, arthritis, or cognitive dysfunction, again suggesting bias towards minimizing harms.   JUPITER(6) Narrow, Unusual Patient Population - The study was limited to patients without hyperlipidemia but with an increased C-reactive protein.  Thus it is not clear that its results would generalize to a more typically defined primary prevention population.  The study excluded patients receiving post-menopausal hormone-replacement; with diabetes; uncontrolled hyertension; cancer other than non-melanoma skin cancer within 5 years; recent history of drug or alcohol abuse; "another medical condition that might compromise safety or the successful completion of the study;" also patients with "inflammatory conditions such as severe arthritis, lupus, or inflammatory bowel disease...;" and also "patients taking immunosuppressant agents such as cyclosporine, tacrolimus, azathioprine, or long-term oral glucocorticoids."  Again, this narrow patient population would reduce generalizability and bias towards minimizing harms. Early Termination/ Multiple Comparisons - This study was terminated early after an early look at the data.  Allowing for multiple looks at the data may exaggerate efficacy.   Implausible Dropout Rate - According to the Cochrane Review, the study had no dropouts.  This value seems implausible, again suggesting data collection problems.   Adverse Effects Not Reported - The study provided no data about <strike>hemmorhagic stroke</strike>, arthritis, or cognitive dysfunction, again suggesting bias towards minimizing harms.  [Revised December 9, 2013 - see comment below by Marilyn Mann.] Summary Aspects of the continuing controversy over the new ACC/ AHA guidelines for statins in the primary prevention of cardiovascular disease hinted that the clinical trials which provided the evidentiary basis for the guidelines, and for the use of statins in primary prevention in general, was more flawed than is widely appreciated.  The latest Cochrane Collaboration review of this data acknowledged multiple, important flaws affecting most of the studies.  Our more detailed review of the three studies held out as the purest found additional flaws.  Many of these flaws seemed likely to bias the studies towards exaggerating the efficacy and/or minimizing the harms of statins in primary prevention.  Since all these trials were funded, and presumably influenced by pharmaceutical companies that make statins, these flaws seem to be examples of <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation of the clinical evidence</a>.  Rather than being the result of simple mistakes, or inevitable trade-offs, they seem to be study features intended the support the vested interests of the study sponsors. It is not clear why the Cochrane review did not temper its conclusions based on the flaws in the studies, and particularly by the possibility that these flaws represented study manipulation.   The multiple flaws, possibly due to study manipulation, in the clinical evidence about statins in primary prevention suggest that we should be extremely skeptical about whether the benefits of such treatment outweighs its harms, and hence about whether the recommendations in the latest guidelines to give statins to all patients predicted (but perhaps not accurately) to be at even slightly elevated risk are warranted. The flaws in multiple large studies of a very common clinical problem, and their effects on systematic reviews and clinical practice guidelines suggest that suppression and manipulation of research are rife in medicine and health care, presumably fueled by the pervasive web of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interes</a>t that spans health care.  We need extreme skepticism about the integrity of clinical research, especially research sponsored by those whose products and services are being studied, and who thus have vested interests in the research turning out to make their products and services look good.   The good news is that we may not have to look too far to find ways to improve the trustworthiness of guidelines and the soundness of medical decision making.  Implementation of the Institute of Medicine's recommendations on reducing conflicts of interest (look <a href="http://www.iom.edu/Activities/Workforce/ConflictOfInterest.aspx">here</a>), and developing trustworthy guidelines (look <a href="http://www.iom.edu/Activities/Quality/ClinicPracGuide.aspx">here</a>) might lead to the development of sound guidelines in the future.   Furthermore, while endless discoveries of <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulated</a> and <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed research</a> may have lead some <a href="http://hcrenewal.blogspot.com/search/label/evidence-based%20medicine">evidence-based medicine </a>advocates to despair, our latest exercise suggests that the principles of evidence-based medicine, unflinchingly applied, could really do good.  Review of the three statin studies above based on standard principles of critical review readily spotted the multiple signs of manipulation.  The problem with the Cochrane review was not that it missed these signs.  Rather, the reviewers for some reason noted most of them, but then did not react.  If systematic reviews were done with sufficient skepticism about the possibility of manipulation of clinical research, and were willing to call out when the emperor seemed short on fabric, then a lot of mischief could be avoided.   References 1.  Lenzer J. Majority of panelists on controversial new cholesterol guideline have current or recent ties to drug manufacturers.  Brit Med J 2013.  Link<a href="http://www.bmj.com/content/347/bmj.f6989"> here</a>.  2.  Taylor FC, Huffman M, Shah E. Statin therapy for primary prevention of cardiovascular disease.  JAMA 2013.  Link <a href="http://jama.jamanetwork.com/article.aspx?articleid=1785551">here</a>.   3.  Robinson JG.  Accumulating evidence for statins in primary prevention.  JAMA 2013;  Link <a href="http://jama.jamanetwork.com/article.aspx?articleid=1785550">here</a>. 4.    Downs  JR, Clearfield  M, Weis  S,  et al; for the AFCAPS/TexCAPS Research Group.  Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. JAMA. 1998;279(20):1615-1622. Link <a href="http://dx.doi.org./10.1001/jama.279.20.1615">here</a>.  5.  Nakamura  H, Arakawa  K, Itakura  H,  et al; MEGA Study Group.  Primary prevention of cardiovascular disease with pravastatin in Japan (MEGA study): a prospective randomised controlled trial. Lancet. 2006;368(9542):1155-1163. Link <a href="http://dx.doi.org./10.1016/S0140-6736(06)69472-5">here</a>. 6.  Ridker  PM, Danielson  E, Fonseca  FA,  et al; JUPITER Study Group.  Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008;359(21):2195-2207. Link <a href="http://dx.doi.org./10.1056/NEJMoa0807646">here</a>.  7.  Taylor F,  Huffman MD, Macedo AF et al.  Statins for the prevention of cardiovascular disease. Cochrane Library 2013.  Link <a href="http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD004816.pub5/abstract">here</a>. 8. Mueller PS, Montori VM, Bassler D et al.  Ethical issues in stopping randomized trials early because of apparent benefit.  Ann Intern Med 2007; 146: 878-881.  Link <a href="http://annals.org/article.aspx?articleid=735073">here</a>.   9.  Management of Elevated Cholesterol in the Primary Prevention Group of the Adult Japanese (MEGA) Study Group.  Design and baseline characteristics of a study of primary prevention of coronary events with pravastatin among Japanese with mildly elevated cholesterol levels.  Circ J  2004; 68: 860-867.  Link <a href="http://www.ncbi.nlm.nih.gov/pubmed/15329509">here</a>.

How Manipulated Clinical Evidence Could Distort Guidelines - the Case of Statins for Primary Prevention

The new American College of Cardiology (ACC)/ American Heart Association (AHA) guidelines on the primary prevention of cardiovascular disease, which we discussed here, continue to generate controversy…

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03 Dec 2013

There They Go Again, Again... - Johnson and Johnson Loses Two Civil Cases, Makes $2.5 Billion Settlement Based on Claims it Withheld Safety Data on its Products

There has been some talk by US government officials that any day now they will actually get tough on corporate executives whose organizations are involved in multiply unethical actions (perhaps using the legally valid, but massively neglected responsible corporate officer doctrine, look <a href="http://hcrenewal.blogspot.com/2010/06/attempt-to-hold-health-care-leaders.html">here</a>).  However, the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements</a> by such corporations continue without any hints of negative consequences for the people who might have actually been involved in unethical activity.  So, we note another week, another multi-billion dollar settlement and another loss of a civil lawsuit by huge drug, device and biotechnology company <a href="http://hcrenewal.blogspot.com/search/label/Johnson%20and%20Johnson">Johnson and Johnson</a> The Articular Surface Replacement Metal-on-Metal Hip Prosthesis Settlement After various rumors, the report of the settlement appeared in a New York Times <a href="http://www.nytimes.com/2013/11/20/business/johnson-johnson-to-offer-2-5-billion-hip-device-settlement.html">article</a> on November 19, 2013.  The basics were, <blockquote class="tr_bq">Johnson & Johnson and lawyers for patients injured by a flawed hip implant announced a multibillion-dollar deal on Tuesday to settle thousands of lawsuits, but it was not clear whether the deal would satisfy enough claimants. <div itemprop="articleBody">Under the agreement, the medical products giant would pay nearly $2.5 billion in compensation to an estimated 8,000 patients who have been forced to have the all-metal artificial hip removed and replaced with another device. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Separately, the company has agreed to pay all medical costs related to such procedures, expenses that could raise the deal’s cost to Johnson & Johnson to $3 billion, people familiar with the proposal said. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Under the plan, the typical patient payment for pain and suffering caused by the device would be about $250,000 before legal fees. Based on standard agreements, plaintiffs’ lawyers would receive about one-third of the overall payout, or more than $800 million, with those who negotiated the plan emerging as big winners. </div> The proposed settlement, which was submitted on Tuesday to a federal judge in Toledo, Ohio, must receive the support of 94 percent of eligible claimants to go forward.</blockquote> An <a href="http://www.nytimes.com/2013/11/13/business/johnson-and-johnson-said-to-agree-to-4-billion-settlement-over-hip-implants.html">earlier NY Times article </a>on a rumored version of the settlement emphasized that relevant litigation had featured strong allegations that Johnson  and Johnson's DePuy subsidiary hid what it knew about the faults of the device, <blockquote class="tr_bq"><div itemprop="articleBody">The A.S.R. hip was sold by DePuy until mid-2010, when the company recalled it amid sharply rising early failure rates. The device, which had a metal ball and a metal cup, sheds metallic debris as it wears, generating particles that have damaged tissue in some patients or caused crippling injuries. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">DePuy officials have long insisted that they acted appropriately in recalling the device when they did. However, internal company documents disclosed during the trial of a patient lawsuit this year showed that DePuy officials were long aware that the hip had a flawed design and was failing prematurely at a high rate. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Many artificial hips last 15 years or more before they wear out and need to be replaced. But by 2008, data from orthopedic databases outside the United States also showed that the A.S.R. was failing at high rates in patients after just a few years. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Internal DePuy projections estimate that it will fail in 40 percent of those patients in five years, a rate eight times higher than for many other hip devices. </div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">A <a href="http://www.nytimes.com/2013/11/26/business/frustration-from-a-deal-on-flawed-hip-implants.html">later NY Times article</a> about plaintiffs' sometimes negative reactions to the settlement added,</div><div itemprop="articleBody"> </div><blockquote class="tr_bq"><div itemprop="articleBody"> The DePuy Orthopaedics division of Johnson & Johnson estimated in an internal document in 2011 that the device would fail within five years in 40 percent of patients. Traditional artificial hips, which are made of metal and plastic, typically last 15 years or more before replacement. </div><div itemprop="articleBody"> </div></blockquote><div itemprop="articleBody"><blockquote> DePuy officials have insisted that they acted properly in handling the device, including waiting until 2010 to recall it. However, internal company documents show that company officials were warned years before by their own consultants that the device was so problematic they would not use it in their patients. </blockquote> In January, 2013, the NY Times had <a href="http://www.nytimes.com/2013/01/26/business/johnson-johnson-hid-flaw-in-artificial-hip-documents-show.html">reported</a> in more detail about how DePuy executives concealed evidence about safety issues with the hips, <blockquote class="tr_bq">. Johnson and Johnson executives knew years before they recalled a troubled artificial hip in 2010 that it had a critical design flaw, but the company concealed that information from physicians and patients, according to internal documents disclosed on Friday during a trial related to the device’s failure. <div itemprop="articleBody">The company had received complaints from doctors about the device, the Articular Surface Replacement, or A.S.R., even as it started marketing a version of it in the United States in 2005. The A.S.R.’s flaw caused it to shed large quantities of metallic debris after implantation, and the model failed an internal test in 2007 in which engineers compared its performance to that of another of the company’s hip implants, the documents show. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">Still, executives in Johnson & Johnson’s DePuy Orthopaedics unit kept selling the A.S.R. even as it was being abandoned by surgeons who worked as consultants to the company. DePuy executives discussed ways of fixing the defect, the records suggest, but they apparently never did so. </div></blockquote></div><blockquote><div itemprop="articleBody">Plaintiffs’ lawyers introduced the documents on Friday in Los Angeles Superior Court during opening arguments in the first A.S.R.-related lawsuit to go to trial.</div></blockquote><div itemprop="articleBody"></div><div itemprop="articleBody">In particular, </div><div itemprop="articleBody"></div><div itemprop="articleBody"><blockquote class="tr_bq"><div itemprop="articleBody">In 2007, DePuy engineers tested the A.S.R.’s rate of wear to see if it matched the wear rate of another all-metal hip implant made by the company. It did not. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">'The current results for A.S.R. do not meet the set acceptance criteria for this test,' that report stated.</div><div itemprop="articleBody"> </div><div itemprop="articleBody">The same year, company officials began discussing ways to fix the problem, like redesigning the cup to eliminate the groove. But at the same time, it was actively marketing the A.S.R. to surgeons in the United States, who were implanting it into tens of thousands of patients. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">'We will ultimately need a cup redesign, but the short-term action is manage perceptions,' one top DePuy sales official told a colleague in a 2008 e-mail. A DePuy executive, Andrew Ekdahl, who is now the unit’s president, was also told by a company consultant that the A.S.R. was flawed, according to another document. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">In mid-2008, DePuy apparently abandoned the redesign project, an internal document indicates. A company spokeswoman, Mindy Tinsley, declined to comment on the document. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">In the fall of 2009, the Food and Drug Administration rejected DePuy’s application to sell the resurfacing version of the A.S.R. in the United States, saying it was concerned about, among other things, “high concentration of metal ions” in the blood of patients who received it. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">DePuy executives soon started making financial estimates of when the company should stop selling the A.S.R., based on the time it would take to convert surgeons to another company implant, a document shows.</div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">So the evidence introduced in litigation suggested that top DePuy executives knew the design was faulty, but chose to not disclose the evidence of this, and not to withdraw the product, but rather to "manage perceptions."  </div></div><div itemprop="articleBody"> </div><div itemprop="articleBody">As is typical of most settlements made by big health care corporations in the last 10 years, no one at DePuy or its Johnson and Johnson parent who might have authorized, directed, or implemented the continued sales of the device despite warnings that it might be unsafe would have to suffer any negative consequences.  In particular, apparently Mr Ekdahl will not suffer any such consequences (and was not obviously named in the few news reports of the settlement.)   Mr Ekdahl, now Worldwide President, DePuy Synthes Joint Reconstruction, was quoted in the official Johnson and Johnson <a href="http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=808497">news release</a> about the settlement. </div><div itemprop="articleBody"></div><div itemprop="articleBody">The Topamax Verdicts</div><div itemprop="articleBody"> </div><div itemprop="articleBody">This case, which was much smaller in terms of the monetary amounts involved, got much less coverage, but Bloomberg did <a href="http://www.bloomberg.com/news/2013-11-18/j-j-s-janssen-loses-11-million-jury-verdict-over-topamax.html">report</a> on November 18, 2013,</div><div itemprop="articleBody"> </div><blockquote class="tr_bq"><div itemprop="articleBody">Johnson & Johnson's  Janssen Pharmeceuticals unit was ordered by a Philadelphia jury to pay $11 million in a case claiming its anti-seizure drug Topamax caused birth defects, the second such loss in less than a month.</div></blockquote><div itemprop="articleBody"> </div><div itemprop="articleBody">Again, the case involved claims that the company withheld information about the safety of its product,</div><div itemprop="articleBody"> </div><blockquote class="tr_bq">Janssen failed to adequately warn doctors for Haley Powell, a stay-at-home mother, of the risks of Topamax before she gave birth to a son with a cleft lip, jurors in state court in Philadelphia found today. 'Janssen has long known that this drug causes debilitating birth defects and yet intentionally kept this information from physicians and patients,' Shelley Hutson, an attorney for Powell, said after the verdict was read.</blockquote> Furthermore, <blockquote class="tr_bq"> Janssen knew as early as 1997 that animal studies showed an increased risk for birth defects, especially oral clefts, Hutson said during closing arguments on Nov. 15. Hutson accused Janssen of operating in a culture of secrecy and of intentionally concealing safety reports in 2003 and 2005.She rejected arguments by the company that it presented the information on poster boards, in abstracts and at medical conferences. Those actions “do not keep patients safe,” Hutson said. 'As early as 1997 in admission after admission, this company knew and they didn’t tell the doctors,' Hutson said.</blockquote> A <a href="http://www.law360.com/articles/489739">report</a> in Law360 emphasized, <blockquote class="tr_bq"> Plaintiffs in the Pennsylvania suits alleged the company didn't fully, truthfully or accurately disclose Topamax data to the FDA, to them and to their doctors. As a result, Janssen intentionally and fraudulently misled the medical community, the public and herself about the risks to a fetus associated with the use of Topamax during pregnancy, plaintiffs claimed.</blockquote>  Summary There they go again....  So Johnson and Johnson has announced two multi-billion dollar settlements in one month (November, 2013, look <a href="http://hcrenewal.blogspot.com/2013/11/another-and-huge-22-billion-settlement.html">here</a> for the first).  It also announced a smaller settlement involving the marketing of Topamax, which is now in addition to a 2010 guilty plea for misbranding Topamax in 2010 (look <a href="http://hcrenewal.blogspot.com/2013/11/another-and-huge-22-billion-settlement.html">here)</a>.  Note that all the November, 2013 legal actions involved allegations, often backed by seemingly convincing evidence produced in litigation (as noted above), of deceptive, unethical practices.  Both cases above included allegations that the company sold products without fully disclosing those products' harms to patients.  Furthermore, all the month's legal actions are now added to a long list of Johnson and Johnson's legal woes, often involving allegations and evidence of other unethical actions, sometimes involving guilty pleas to charges of such actions (see compilation of the record through July, 2013 <a href="http://hcrenewal.blogspot.com/2013/07/johnson-and-johnson-settles-suit.html">here</a>.)  (By the way, Synthes, which is now another Johnson and Johnson subsidiary, and is not run by the same individual on whose watch the ASR case occurred, has had its own legal and ethical woes, look <a href="http://hcrenewal.blogspot.com/search/label/Synthes">here</a>.)  Yet despite this lengthy and sorry record, no individual manager or executive at Johnson and Johnson, including its many and confusing subsidiaries, seems to have suffered any negative consequences for authorizing, directing, or implementing any unethical activities, whether they risked harming patients, or whether they resulted in a guilty plea by a corporate entity.  Instead, as we have discussed most recently <a href="http://hcrenewal.blogspot.com/2013/11/another-and-huge-22-billion-settlement.html">here</a>, the top executives of the company have grown very rich.  So since the US government seems to continue to recycle its policy of allowing corporate managers and executives impunity regardless of how repetitively harmful their actions might be to patients' and the public's health, I will recycle my comments from earlier in November, 2013,.... The latest settlement in the parade is another marker of the sort of conduct that big health care organizations have exhibited to increase revenue, and to use that revenue as a rationale for making their top insiders very rich.  The particular conduct alleged here could have put patients at risk, partly by deceiving health care professionals.  Yet in their wisdom, top US law enforcement saw fit not to try to hold any individuals accountable for this conduct, and allowed the company to deny any misconduct other than a single misdemeanor by a subsidiary.  This occurred despite the company's history of multiple legal settlements and findings of guilt in various courtrooms. Yet none of these actions has resulted in any negative consequences for any individual within the company.  No one who authorized, directed, or implemented bad behavior will pay any penalty, even were the bad behavior to have lead to significant personal enrichment. As we have said ad infinitum, and <a href="http://hcrenewal.blogspot.com/2012/09/how-many-legal-settlements-does-it-take.html">on the occasion of a previous Johnson and Johnson settlement</a>, many of largest and once proud health care organizations now have recent records of repeated, egregious ethical lapses. Not only have their leaders have nearly all avoided penalties, but they have become extremely rich while their companies have so misbehaved. These leaders seem to have become like nobility, able to extract money from lesser folk, while remaining entirely unaccountable for bad results of their reigns. We can see from this case that health care organizations' leadership's nobility overlaps with the supposed "royalty" of the leaders of big financial firms, none of whom have gone to jail after the global financial collapse, great recession, and ongoing international financial disaster (look <a href="http://hcrenewal.blogspot.com/2012/08/duchess-of-wellpoint-abdicates-likely.html">here</a>). The current fashion of punishing behavior within health care organization with fines and agreements to behave better in the future appears to be more law enforcement theatre than serious deterrent.  As Massachusetts Governor Deval Patrick exhorted his fellow Democrats, I exhort state, federal (and international, for that  matter) law enforcement to "<a href="http://www.washingtonpost.com/blogs/election-2012/wp/2012/09/04/patrick-it-is-time-for-democrats-to-grow-a-backbone/">grow a backbone</a>" and go after the people who were responsible for and most profited from the ongoing ethical debacle in health care. As we have said before, true health care reform would make leaders of health care organization accountable for their organizations' bad behavior. Roy M. Poses MD on Health Care Renewal

There They Go Again, Again... - Johnson and Johnson Loses Two Civil Cases, Makes $2.5 Billion Settlement Based on Claims it Withheld Safety Data on its Products

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29 Nov 2013

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