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Johnson and Johnson Runs Afoul of Foreign Corrupt Practices Act

Johnson and Johnson, the once highly reputed international pharmaceutical and device company, cannot catch a break.  International Bribery Charges As <a href="http://www.bloomberg.com/news/2011-04-08/johnson-johnson-will-pay-70-million-to-resolve-bribery-claims.html">reported </a>by Bloomberg, the latest story is about bribery claims across multiple countries and two continents: <blockquote>Johnson & Johnson (JNJ), the world’s second-biggest seller of medical products, will pay $70 million after admitting that the company bribed doctors in Europe and paid kickbacks in Iraq to win contracts and sell drugs and artificial joints. Subsidiaries of J&J paid bribes to doctors and hospital administrators in Greece, Poland and Romania, the Securities and Exchange Commission and Department of Justice said today in filings at U.S. District Court in Washington. The company also made illegal payments to Iraqi officials to win contracts under the U.N. oil-for-food program, the filings said. J&J, based in New Brunswick, New Jersey, used slush funds, sham contracts and off-shore companies in the Isle of Man to carry out the bribery, the SEC said. Public health system doctors and administrators who ordered J&J products such as surgical implants or prescribed the company’s drugs were rewarded in a variety of ways, including with cash and travel. </blockquote>Simultaneously, in the UK, <blockquote>J&J’s DePuy International Ltd. subsidiary was ordered to pay 4.8 million pounds ($7.9 million) to resolve U.K. claims related to the bribery in Greece, the Serious Fraud Office said in a statement today. </blockquote> <a href="http://online.wsj.com/article/SB10001424052748704415104576250912912672614.html">Per the Wall Street Journal</a>, the company also entered into a deferred prosecution agreement. Admissions of Guilt The company could not deny wrong-doing, as <a href="http://online.wsj.com/article/SB10001424052748704415104576250912912672614.html">reported</a> by the Wall Street Journal: <blockquote>As part of the settlement, J&J acknowledged responsibility for the actions of its units, employees and agents who made 'various improper payments to publicly employed health-care providers in Greece, Poland and Romania in order to induce the purchase of medical devices and pharmaceuticals manufactured by J&J subsidiaries,' according to the Justice Department.</blockquote> Also, <blockquote>J&J also acknowledged that kickbacks were paid on behalf of J&J units to the former government of Iraq under the United Nations Oil-for-Food program in order to secure contracts to provide humanitarian supplies.</blockquote>But No Apology, Nor Acknowledgement of Responsibility The Johnson and Johnson CEO issued the de rigeur non-apology apology: <blockquote>'More than four years ago, we went to the government to report improper payments and have taken full responsibility for these actions,' J&J Chief Executive William C. Weldon said in a press release. 'We are deeply disappointed by the unacceptable conduct that led to these violations.' </blockquote> Notice the clever phrasing that seems to deny that Weldon had any responsibility for these actions, which occurred in the remote past and which were addressed as soon as top management were made aware of them. Management was Aware In fact, however, as <a href="http://www.bnet.com/blog/drug-business/internal-emails-j-j-knew-of-bribery-8220black-hole-8221-for-years/7911">discussed</a> by Jim Edwards on his BNEt blog, it appears that management had been well aware of the bad behavior for a long time: <blockquote>But J&J’s internal emails, plus the U.K. Serious Fraud Office’s records, indicate that J&J management knew as early as 1999 that it was making improper payments to Greek sales agents, and that money was disappearing into what it called a 'black hole' in Europe. Yet J&J later acquired the company that operated that 'black hole' in order to maintain its illegal sales relationships in Greece, according to the SEC’s complaint. And although the SEC praised J&J’s cooperation in its probe, J&J took eight years to initially inform the SEC of its problems.</blockquote> For the gory details, see his blog post. Only the Latest Troubles This latest ethical black eye comes after numerous other troubles for the giant company. As Bloomberg put it: <blockquote>The settlement comes less than a month after J&J’s McNeil Consumer Healthcare unit signed a consent decree giving the Food and Drug Administration more oversight at three plants making children’s Tylenol, Motrin and other over-the-counter drugs recalled in the past year because of faulty ingredients or foul odors caused by chemical contamination of storage pallets. The March 10 agreement left the plants under enhanced scrutiny for five years, and J&J faces fines of as much as $10 million a year if the FDA doesn’t approve of changes at the facilities, the company said in a statement last month. J&J has recalled more than 50 products since the start of 2010, from the consumer medications to failing artificial hips, improperly rinsed contact lenses, insulin cartridges that may leak and cracked syringes loaded with prescription drugs. The company installed a new corporate quality-control director and announced companywide compliance standards in August. In February, J&J reorganized its consumer division and announced the head of its DePuy Orthopaedics unit had resigned. </blockquote> There is actually more. We <a href="http://hcrenewal.blogspot.com/2011/03/jury-finds-johnson-and-johnsons.html">noted</a> last month that Johnson and Johnson's Janssen's subsidiary's Risperdal marketing was found deceptive by a South Carolina jury. In addition,  In 2010, another jury found that the company had committed marketing fraud in its promotion of Risperdal (see post <a href="http://hcrenewal.blogspot.com/2010/10/last-weeks-scandals.html">here</a>), and its Ortho-McNeil-Janssen subsidiary also made a guilty plea to a misdemeanor for and civil settlement of charges of "misbranding" Topamax (see post <a href="http://hcrenewal.blogspot.com/2010/05/sunday-settlement-and-guilty-plea.html">here</a>). No Penalties for Individuals As in many such cases we have <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">discussed </a>before, despite the seriousness of the charges and the corporate, although not individual admissions of responsibility, no individual in the US apparently will suffer any negative consequences for the misbehavior.  (Per the WSJ, one UK executive went to prison for bribery by DePuy in Greece.)  Moreover, rather than suffering, the US company leadership has personally profited.  As we have mentioned more than once, most recently <a href="http://hcrenewal.blogspot.com/2011/03/despite-recalls-legal-settlements.html">here</a>, the increasing numbers of legal and regulatory sanctions and the increasing numbers of product recalls stand in stark contrast to the plutocratic remuneration given to top Johnson and Johnson executives.  CEO Weldon received about $29 million in 2010, while his top five lieutenants each got from over $5 million to just under $9 million.  The company board asserted that Weldon "met expectations," and exerted "strong leadership."  At best, it appears that the clubby and out-of touch governance of health care organizations, generally by fellow members of the CEO's guild, leavened with a few conflicted academic health care leaders, rewards insiders despite, or even because of  failed leadership.   So once more with feeling, ... health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research.  On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior. If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses. Meanwhile, I can only ask Johnson and Johnson executives and board members, have you no shame? ADDENDUM (13 April, 2011) - See also posts <a href="http://gooznews.com/?p=2716">by Merrill Goozner</a> on the GoozNews blog, and <a href="http://www.healthbeatblog.com/2011/04/-bribing-doctors-.html">by Maggie Mahar</a> on the HealthBeat blog.

Johnson and Johnson Runs Afoul of Foreign Corrupt Practices Act

Johnson and Johnson, the once highly reputed international pharmaceutical and device company, cannot catch a break. International Bribery C...

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Toward Meaningful Usability: Five Keys to Creating Physician- Centric CPOE (Wait - The Terms "Safety", "Risk" and "Error" Are Missing)

In a 2011 "White Paper" from a company <a href="http://www.patientkeeper.com/" style="font-family: arial;">PatientKeeper</a> entitled "<a href="http://info.patientkeeper.com/rs/patientkeeper/images/WhitePaper_CPOE_2011.pdf" style="font-family: arial;">Toward Meaningful Usability: Five Keys to Creating Physician-Centric CPOE</a>" (PDF), an organization whose motto is "Enabling Physicians to Focus on Patients ... Not Technology", I again note a common phenomenon. Certain verboten terms are absent. What might those terms be? More on that in a moment... They speak of "the failure of CPOE": <blockquote style="font-family:arial;">The failure of CPOE to date can be attributed to many factors that ultimately lead to a lack of physician adoption. CPOE systems have historically been designed to support the workflow of the departments responsible for fulfilling the orders rather than the physician workflow around entering orders. As a result, entering orders electronically can take significantly longer than written or verbal orders and often requires the physician to change the way they currently practice medicine.</blockquote> That's a problem, considering the following observation (paraphrased from a "why-pharma-fails" post <a href="http://www.eyesopen.com/en/blog/what-is-really-killing-pharma" style="font-family: arial;">at this link</a>): <blockquote>"The machine was made for Clinicians, not Clinicians for the Machine."</blockquote> But still, words are missing from the White Paper. Again, more on that in a moment.<blockquote style="font-family:arial;">... Hospitals often purchase CPOE on the premise that standardization of care through evidence-based order sets is the optimal way to improve patient care delivery and reduce healthcare costs. In fact, most standardized care is not supported by evidence so spending months or even years to achieve order set consensus only serves to delay implementation and use while increasing the overall cost of the order entry system.</blockquote>Well, yes, but where are those missing words?<blockquote style="font-family:arial;">Most CPOE systems expose physicians to all clinical alerts regardless of severity. The preponderance of these alerts disrupts the ordering process, leads to alert fatigue, and results in frustration on the part of the physician. Finally, the number of available workstations, including those on the hospital floors and in patient rooms, is limited, and physicians may have to wait in queue to enter their orders. This may lead to an increase in verbal orders from the physician to the nurse, pharmacist, etc. as well as frustration with a process that requires more physician time than simple pen and paper.</blockquote> There must be a lot of frustrated doctors out there. Still, the shibboleth terms are missing.Cited are the usual KOL's:<blockquote style="font-family:arial;">1 D. W. Bates, J. M. Teich, J. Lee et al., “The Impact of Computerized Physician Order Entry on Medication Error Prevention,” Journal of the American Medical Informatics Association 6 (July/August 1999): 13–21. 2 D. W. Bates and A. A. Gawande, “Improving Safety with Information Technology,” New England Journal of Medicine 348 (June 19, 2003): 2526–34. 3 Jason Hess, KLAS Enterprises (Orem, Utah), “Are We There Yet? Getting to Meaningful CPOE Use”, July 13, 2010</blockquote> Still no mention of the missing critical terms. <blockquote>The next generation of CPOE solutions must ultimately save physicians time, rather than simply being time-neutral. Otherwise, they will suffer the fate of most previous attempts to implement this required functionality – at the cost of improved patient care, better outcomes, and lost ARRA stimulus dollars.</blockquote> In other words, the worst-case scenario is wasted promotional dollars and maintenance of the clinical status quo. Still, key terms are missing. What are those terms? Here they are, the unaccounted-for outcomes of CPOE and its toxicity in its present form: <ul style="font-weight: bold;font-family:arial;"><li>Safety (as in, "reduction of") </li><li>Risk (as in, "of injury, increased") </li><li>Danger (as of, "putting patients in") </li><li>Error (as in, "the outcome of toxic HIT") </li><li>Harm (as in, "injury and death") </li></ul> This was no mere White Paper. A more appropriate term might be a "Snow White" paper: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjiSevn6pb57z1SXyyfyWyiPFVqqkuawTWoi-ugZxPvDk5d_oJIBowDTY3Jw3m6Cn2wJVZ7fxTrwsFsw6mhYMk0rzJetVeM1uk98EFS1ULf2XjY1214rp3Jk-CmpQS0O5TVKsrbTWuyavl5/s1600/snowwhite.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5595065095026637714" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjiSevn6pb57z1SXyyfyWyiPFVqqkuawTWoi-ugZxPvDk5d_oJIBowDTY3Jw3m6Cn2wJVZ7fxTrwsFsw6mhYMk0rzJetVeM1uk98EFS1ULf2XjY1214rp3Jk-CmpQS0O5TVKsrbTWuyavl5/s320/snowwhite.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 110px; height: 153px;" /></a>CPOE, An Enchanted Technology. Find the Prince! </div>Health IT, including dysfunctional and toxic CPOE, causes frustration among doctors. CPOE failure is merely "physician nonacceptance." But the frustration among injured or dead patients and their families seems never to be mentioned or considered in this industry. I pointed out that similar terms were missing from the PCAST (President’s Council of Advisors on Science and Technology) report on health IT at my Feb. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/02/presidents-council-of-advisors-on.html">Brief Comments on the PCAST Report on Health IT</a>." Shhhh! -- SS

Toward Meaningful Usability: Five Keys to Creating Physician- Centric CPOE (Wait - The Terms "Safety", "Risk" and "Error" Are Missing)

In a 2011 "White Paper" from a company PatientKeeper entitled " Toward Meaningful Usability: Five Keys to Creating Physician...

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Security and Privacy Considerations for Health IT Systems

I find the links at this piece from George Mason University, "<a href="http://securehealth.freshdefense.net/">Security and Privacy Considerations for Health IT Systems</a>", and the opinions expressed within it of interest. Emphases and [bracketed comments in red italics] mine: <div id="body"> <div id="hdr"> </div><blockquote><div id="hdr">First posted: 3 March 2010 Last updated: 26 March 2010 </div> <h3>Preface</h3> We seek to understand the nature and distribution of risks to security and privacy inherent in designing and deploying health information technology (HealthIT, eHealth; we use both terms interchangeably). We posit that achieving the appropriate balance of these risks and potential costs (to doctors, patients, hospitals, and the American taxpayer) requires careful, deliberate study to understand the nature of this new problem. [This is not occurring anywhere near the extent it needs to, and the absence of health IT industry regulation in the U.S. does not help; cf. 2009 National Research Council report on health IT summarized <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">here</a> - ed.] Although health care reform in the United States is a highly-charged political issue, this Web page is not meant to be a political document or support a particular political point of view or legislative agenda. Instead, this page supplies a collection of information detailing the pitfalls and challenges involved in deploying a large-scale information infrastructure around the recording, tracking, and maintenance of patient and other medical information. We are interested in the technical security and privacy issues that emerge from what we believe is a fundamentally different data acquisition and storage problem than previous industry efforts at record keeping for other forms of data. [Clinical computing and business computing are indeed different - ed.] Our central hypothesis is that the government and private sector are rushing [you think? - ed.] into the deployment of eHealth technology without careful consideration of the design criteria necessary to ensure accurate and private data collection and without a realistic understanding of the costs of such a large software deployment. We certainly agree that improving the efficiency and efficacy of health care delivery while reducing the cost to the taxpayer and patients is an important and critical activity. Achieving this goal, however, demands a more careful approach than has heretofore been adopted. <h2>Introduction</h2> The application of information technology (especially back-office data storage applications) to various facets of medical care in the U.S.A. and other countries has often promised decreased cost, increased quality of health care, and no risk to privacy, among other benefits. Such belief in the reliability and integrity of information systems is an unwarranted leap of faith on behalf of legislators and the general public. [I have written similar words - ed.] Designing health IT systems for medical environments requires careful, thoughtful analysis. Yet, Health IT (particularly EMR systems) are de facto seen as a solution to the problem of costs, waste, fraud, and needlessly duplicated medical tests. The <a href="http://www.whitehouse.gov/issues/health-care/">White House web site comments</a> on ARRA funding for EMR work: "The Recovery Act also invests $19 billion in computerized medical records that will help to reduce costs and improve quality while ensuring patients’ privacy." The scientific community has largely been silent on this issue, although the political rhetoric can be quite intense. Yet, most every side of the health care debate currently raging in the US accepts without question the benefits of health IT while ignoring the potential pitfalls and downsides of such technology. [Again, this is a common theme here at Healthcare Renewal - ed.] We use the terms "eHealth" and "Health IT" interchangeably. In large part, we consider the application of computer technology in medical devices and procedures (such as remote operating rooms, advances in digital imaging, etc.) as a related but separate area from our criticism of the management of healthcare and patient information. Those systems pose different risks to patients; we comment on them only insofar as their use is driven by analysis of data held in IT systems. <h2>General Resources</h2> <ol><li><a href="http://patientprivacyrights.org/?posts=all">Patient Privacy Rights</a> website (added 26 March 2010, G. Weaver)</li><li>Scot Silverstein's <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/">Healthcare IT Failure and Difficulties Case Examples: Medical Informatics Perspectives on Clinical Information Technology</a> (added 24 March 2010) </li><li> <a href="http://bx.businessweek.com/health-information-technology/reference/">Health Information Technology Reference Guide</a> -BusinessWeek</li><li> The <a href="http://www.privacyrights.org/Medical-Privacy">Privacy Rights Website on Medical Privacy</a> </li><li> <a href="http://openmrs.org/wiki/OpenMRS">OpenMRS</a> an open-source medical records system</li><li> <a href="http://medical.sourceforge.net/">Another MRS</a> </li><li> <a href="http://spectrum.ieee.org/computing/software/learning-from-software-failure">Learning From Software Failures</a> (frontmatter prefacing the IEEE Spectrum analysis of the FBI's Virtual Case File system) [<a href="http://securehealth.freshdefense.net/content/spectrum-learnfrom.pdf">PDF</a><a>]</a></li><a> </a><li><a> </a><a href="http://en.wikipedia.org/wiki/Capability_Maturity_Model">Capability Maturity Model</a> </li><li>A workshop on <a href="http://www.usenix.org/events/healthsec10/cfp/">Health Security and Privacy</a>, sponsored by the USENIX Association </li></ol> <h2>Risks to the Public Trust in Computer Professionals</h2> Hastily undertaking the transformation of the information infrastructure behind health care systems with little forethought or oversight entails the risk of the public rejecting the expertise and credibility of the computing profession. Just because we could do something does not mean that we should. There is an imperative to study the new problems posed by large-scale EMR, particularly one of national scope or connectivity. [One reason is that the risks and benefits are unknown - ed.] No imperative exists, however, to aggressively adopt the current generation of solutions that are little more than back-office data management applications dressed up with new terminology. [This description of health IT and the lack of imperative is excellent. Adopting national HIT prior to reasonable understanding of the possible problems and risks to patients is what I have referred to as "putting the cart before the horse"- ed.] Furthermore, academics and scientific professionals have a conflict of interest in this area. Indeed, academics stand to benefit tremendously from money being spent on this area: schools (<a href="http://hit.gmu.edu/">GMU</a> included) are quick to set up research centers dealing with various aspects of medical IT and eHealth. While there is a need for careful research into the many security, privacy, and functionality aspects of large medical IT systems, academics can be in the uncomfortable position of being funded by government or corporate money and trying to formulate an unbiased opinion as to the quality and efficacy of the state of the art in eHealth systems and practices. [COI in biomedicine is another common topic addressed at HC Renewal - ed.] <ol><li> Dartmouth received $3 million under ARRA for an <a href="http://www.dartmouth.edu/%7Enews/releases/2009/08/05.html">NSF-funded</a> <a href="http://www.ists.dartmouth.edu/projects/tish.html">TISH program</a> </li><li> GMU's internally funded <a href="http://hit.gmu.edu/">Mason Center for Health Information Technology</a> </li><li> <a href="http://cm.bell-labs.com/who/ken/trust.html">Reflections on Trusting Trust</a> (reputation is important in designing infrastructure)</li></ol> <h2>Risks to Good Medicine</h2> Health IT systems are not a panacea. Data models, systems, and user interfaces designed by computer scientists and professional software developers without much substantive input from health care professionals can lead to inefficiency and bad medicine [the common scenario for HIT development today - ed.], and risks loss of life or permanent injury to patients. [I, unfortunately, have family experience in that regard now - ed.] <ol><li> <a href="http://www.syleum.com/2009/03/17/healthcare-data-model/">The Data Model That Nearly Killed me</a> [<a href="http://securehealth.freshdefense.net/content/data-model-killme.pdf">PDF</a>] [An excellent essay by a patient who is also a data modeling expert - ed.] </li><li> <a href="http://www.businessweek.com/magazine/content/09_18/b4129030606214.htm">The Dubious Promise of Digital Medicine</a> [<a href="http://securehealth.freshdefense.net/content/dubious.pdf">PDF</a>] </li><li> Slashdot: <a href="http://science.slashdot.org/article.pl?sid=09/04/28/1229225">Why Digital Medical Records Are No Panacea</a> 28 April 2009 [<a href="http://securehealth.freshdefense.net/panacea.pdf">PDF</a>]</li><li>http://community.livejournal.com/therightfangirl/1142946.html </li></ol> <h2>Data Leakage Models and Data Corruption Issues</h2> One risk of large-scale EMR is a misunderstanding of the data loss dynamics of large public data systems. In addition, large databases tend to have errors: errors that are insidious and easily replicated due to the amount of automation present in such systems. It is an open question whether these errors pose a lesser or greater risk than errors due to bad handwriting on transcribed paper records. [The last point is controversial, but likely accurate - ed.] <ol><li><a href="http://online.wsj.com/article/SB10001424052748703580904575132111888664060.html?mod=WSJ_hpp_sections_opinion">Your Medical Records Aren't Secure</a> [<a href="http://securehealth.freshdefense.net/content/wsj.medrecords.pdf">PDF</a>] (March 23, 2010)</li><li> <a href="http://www.enterprisestorageforum.com/technology/features/article.php/3843151">Why Cloud Storage Use Could Be Limited in Enterprises</a> [<a href="http://securehealth.freshdefense.net/content/cloud.pdf">PDF</a>]</li><li> Dan Geer on <a href="http://www.usenix.org/publications/login/2005-12/openpdfs/geer.pdf">Back-of-the-envelope style estimates</a> [link is to PDF]</li><li> <a href="http://www.wired.com/threatlevel/2009/10/ncic">Woman Loses Job Due to Error in FBI Criminal Database</a> [<a href="http://securehealth.freshdefense.net/content/lost-job-fbi.pdf">PDF</a>]</li><li> <a href="http://www.computerworld.com/s/article/9127066/P2P_networks_rife_with_sensitive_health_care_data_researcher_warns_?taxonomyId=16&intsrc=hm_topic">P2P Networks Rife With Sensitive Health Care Data, Researcher Warns</a></li><li> <a href="http://www.scmagazineus.com/medical-data-leakage-rampant-on-p2p-networks/article/127216/">Medical data leakage rampant on P2P networks</a> [<a href="http://securehealth.freshdefense.net/content/dataleak-p2p.pdf">PDF</a>] </li><li> The previous two links refer to <a href="http://mba.tuck.dartmouth.edu/digital/Research/ResearchProjects/JohnsonHemorrhagesFC09Proceedingd.pdf">this study</a> by <a href="http://mba.tuck.dartmouth.edu/digital/Research/ResearchProjects/ResearchInadvertent.html">researchers from the Tuck School of Business</a> at Dartmouth College</li><li> <a href="http://cacm.acm.org/magazines/2010/3/76292-a-framework-for-health-care-information-assurance-policy-and-compliance/fulltext">A Framework for Health Care Information Assurance Policy and Compliance</a> Communications of the ACM, 1 March 2010 </li></ol> <h2>Assessing the Cost of Large Software Projects and eHealth</h2> Managing the design, construction, and delivery of a large software project is a complicated, fluid process. Government and industry can often fail in expensive and spectacular ways. [Indeed - ed.] Government agencies (particularly state and local government without in-house expertise), may play the role of uninformed client being sold digital snake oil at the expense of the taxpayer. Examples include the FBI's Virtual Case File system, AT&T's wireless database failure, and the Ontario eHealth scandal, among others listed below. <ol><li> <a href="http://www.cnn.com/2005/US/02/03/fbi.computers/">Report: FBI wasted millions on 'Virtual Case File'</a> CNN.com [<a href="http://securehealth.freshdefense.net/content/CNN-FBI-VCF-waste.pdf">PDF</a>] </li><li> <a href="http://www.washingtonpost.com/wp-dyn/content/article/2006/08/17/AR2006081701485.html">The FBI's Upgrade That Wasn't: $170 Million Bought an Unusable Computer System</a> by Dan Eggen and Griff Witte, Washington Post, 18 August 2006 [<a href="http://securehealth.freshdefense.net/content/post-VCF.pdf">PDF</a>]</li><li> <a href="http://spectrum.ieee.org/computing/software/who-killed-the-virtual-case-file">Who Killed the Virtual Case File?</a> IEEE Spectrum [<a href="http://securehealth.freshdefense.net/content/spectrum-VCF.pdf">PDF</a>]</li><li> <a href="http://www.cio.com/article/32228/Project_Management_AT_T_Wireless_Self_Destructs">Project Management: AT&T Wireless Self-Destructs</a> [<a href="http://securehealth.freshdefense.net/content/cio-att.pdf">PDF</a>]</li><li> Slashdot: <a href="http://news.slashdot.org/story/09/12/01/0115246/Harvard-Says-Computers-Dont-Save-Hospitals-Money">Harvard Says Computers Don't Save Hospitals Money</a> [<a href="http://securehealth.freshdefense.net/content/slashdot-harvard.pdf">PDF</a>]</li><li> <a href="http://www.computerworld.com/s/article/print/9141428/Harvard_study_Computers_don_t_save_hospitals_money?taxonomyName=Hardware&taxonomyId=12">Harvard study: Computers don't save hospitals money</a> Computerworld, 30 November 2009 [<a href="http://securehealth.freshdefense.net/content/computerworld-no-save.pdf">PDF</a>]</li><li> The aforementioned <a href="http://www.amjmed.com/webfiles/images/journals/ajm/AJM10662S200.pdf">Harvard Study</a></li><li> <a href="http://www.cbc.ca/canada/toronto/story/2009/10/07/ehealth-auditor.html">EHealth scandal a $1B waste: auditor</a> -CBC News, 7 October 2009 [<a href="http://securehealth.freshdefense.net/content/eHealth-CBC-1B-waste.pdf">PDF</a>]</li><li> <a href="http://www.cbc.ca/canada/story/2009/06/07/ehealth-kramer.html">Head of eHealth Ontario is fired amid contracts scandal, gets big package</a> -CBC News, 7 June 2009 [<a href="http://securehealth.freshdefense.net/content/eHealth-CBC-head-fired.pdf">PDF</a>]</li></ol> <h2>The Role of Health IT in Health Care Public Policy</h2> <ol><li> <a href="http://www.whitehouse.gov/issues/health-care">Health Care: The President's Proposal for Health Reform</a> - whitehouse.gov [<a href="http://securehealth.freshdefense.net/content/whitehouse-health.pdf">PDF</a>]</li><li> <a href="http://money.cnn.com/2009/01/12/technology/stimulus_health_care/">Obama's big idea: Digital health records</a> -CNN.com, 12 January 2009 [<a href="http://securehealth.freshdefense.net/content/CNN-digital-health-records.pdf">PDF</a>]</li><li> <a href="http://www.ihealthbeat.org/perspectives/2009/wheres-the-hit-in-hcr-health-care-reform.aspx">Where's the HIT in HCR (Health Care Reform)?</a> -ihealthbeat, 8 July 2009 [<a href="http://securehealth.freshdefense.net/content/hit.pdf">PDF</a>]</li><li> <a href="http://www.healthleadersmedia.com/content/223238/topic/WS_HLM2_TEC/What-Obama-Means-for-Health-Information-Technology.html">What Obama Means for Health Information Technology</a> -HealthLeadersMedia, 11 November 2008 [<a href="http://securehealth.freshdefense.net/content/healthleaders-obama.pdf">PDF</a>]</li><li> <a href="http://thehill.com/blogs/hillicon-valley/technology/71399-the-healthcare-bills-take-on-technology">The Healthcare Bill's Take on Technology</a> -The Hill, 12 September 2009 [<a href="http://securehealth.freshdefense.net/content/thehill-tech.pdf">PDF</a>]</li></ol></blockquote> </div> I discovered this piece after someone clicked on the contained link to my Drexel University website. I find the thoughts here and the hyperlinks of great interest, forming yet another "primer" on the real world issues affecting health IT adoption. -- SS

Security and Privacy Considerations for Health IT Systems

I find the links at this piece from George Mason University , " Security and Privacy Considerations for Health IT Systems ", and ...

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...THEM OR YOUR LYING EYES?

…THEM OR YOUR LYING EYES? A few days ago I <a href="http://hcrenewal.blogspot.com/2011/04/who-you-gonna-believe.html">discussed</a> stonewalling by the American Psychiatric Association over charges that they were partners in a ghostwritten textbook. The issue resonated with many people, including <a href="http://carlatpsychiatry.blogspot.com/2011/04/like-bad-penny-nemeroffschatzberg.html">Daniel Carlat</a>, <a href="http://1boringoldman.com/index.php/2011/04/05/still-on-the-radar-screen/">John Nardo</a>, <a href="http://pogoblog.typepad.com/pogo/2011/04/ghostwriting-controversy-haunting-the-american-psychiatric-association.html">the POGO blog</a>, <a href="http://alison-bass.blogspot.com/2011/04/tale-of-censorship-and-secrecy-starring.html">Alison Bass</a>, <a href="http://www.pharmalot.com/2011/04/american-psychiatric-association-and-ghostwriting/">Ed Silverman</a>, and others. The APA has not seen its way clear to releasing key documents that might clear up the charges. By stonewalling, the APA just does more damage to its image and credibility. They come across as uninterested in transparency, and they appear to be fighting a rearguard action to defend the indefensible. What kind of key documents could the APA have released? In our <a href="http://pogoblog.typepad.com/pogo/letter-to-apa-20110128.html">letter</a> last January we suggested several, including the contract involving the American Psychiatric Press, the medical communications company (Scientific Therapeutics Information, Inc. or STI), the grant-giving drug company, the professional writers, and the nominal authors of the allegedly ghostwritten book. What might the contract have told us? Well, it probably looks a lot like <a href="http://www.healthyskepticism.org/files/docs/gsk/paroxetine/study329/19980403STIContract.pdf">this contract</a>, which involves the same medical communications company, the same drug company, and one of the same professional writers, Sally Laden. It was developed right around the same time as the textbook was planned, and it is for a ghostwritten journal article promoting the infamous Paxil Study 329. Look carefully at <a href="http://www.healthyskepticism.org/files/docs/gsk/paroxetine/study329/19980403STIContract.pdf">this contract </a>and you will be in no doubt about who did the essential work of writing and framing the article or about whether the corporation had control over the content. Now ask yourselves, if the contract for the textbook doesn’t look like this then why ever would the APA want to suppress it? That behavior just makes people conclude that the contract for the textbook does look like <a href="http://www.healthyskepticism.org/files/docs/gsk/paroxetine/study329/19980403STIContract.pdf">this contract </a>and that the APA knows it has plenty to hide. A first principle of cover-ups and stonewalling is that everyone needs to be on the same page with the cover story. When they are not, the façade collapses and the actors come across like the Three Stooges, all heading for the door at the same time. Today, thanks to the sleuthing of Phyllis Vine at Mental Illness Watch, we saw the stooges exposed in their clumsiness. Phyllis Vine discovered <a href="http://www.miwatch.org/2011/04/apas_ghostwriting_controversy_grows.html">material</a> on the corporate website of STI that has them featuring the textbook in the ‘portfolio’ that aims to attract new business to the company. Juxtapose that with the adjacent claim that STI’s skills are to "develop, write, edit, and submit a high-quality article to your target audience." Now is there any doubt about how this game is played? Now is there any doubt about whether the APA has come clean? Well, if there were any remaining doubt it has been removed by another development: All the materials describing the STI ‘portfolio’ have been removed from the company’s website. Fortunately, Phyllis Vine had captured it <a href="http://www.miwatch.org/2011/04/apas_ghostwriting_controversy_grows.html">here</a>, and so did <a href="http://carlatpsychiatry.blogspot.com/2011/04/new-smoking-gun-in-apa-textbook-fiasco.html">Daniel Carlat </a>through the <a href="http://replay.waybackmachine.org/20081121071704/http:/www.stimedinfo.com/results02_publications.htm">Wayback machine</a>. It was picked up some more by Mickey Nardo <a href="http://1boringoldman.com/index.php/2011/04/11/csi-miwatch/">today</a>. It looks like the APA is going to have more explaining to do. As the old Groucho Marx line goes, Who you gonna believe, them or your lying eyes? Bernard Carroll

...THEM OR YOUR LYING EYES?

…THEM OR YOUR LYING EYES? A few days ago I discussed stonewalling by the American Psychiatric Association over charges that they were partn...

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What's Killing Pharma, With Some Lessons For Hospital IT

<div>An excellent essay on the pathologies killing the pharmaceutical industry is at this link:<a href="http://www.eyesopen.com/en/blog/what-is-really-killing-pharma"> http://www.eyesopen.com/en/blog/what-is-really-killing-pharma</a> . The essay talks about mismanagement, marketing over R&D, management fads, ill-informed managers and many other issues we've discussed in one context or another here at Healthcare Renewal. This paragraph in particular struck my eye for several reasons: <blockquote>... Another good one [reason pharma is dying - ed.]: empowering IT departments to make scientists use the same infrastructure as the guy at the front desk. Rather than see that scientists often have different computing needs than other parts of the business, IT demands obeisance to the corporate norm. In doing so, they hinder the kind of innovation (e.g., Linux, GPU solutions) that used to regularly occur because scientists are quite computer literate, thank you. Instead, IT departments make it impossible for competent people to manage their own resources. They create obstacles instead of removing them. Machine was made for Man, not Man for the Machine.</blockquote> The paragraph struck me because: <ul><li>It fits with my experience and that of my colleagues in other pharmas. See my essay "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=pharma">Sure path to R&D and industrial failure: Conflation of IT with information science in the pharmaceutical industry</a>."</li></ul><ul><li>Replace "scientists" with "doctors" and you have defined a major problem with health IT In the healthcare delivery sector.</li></ul><ul><li>Finally, this bon mot is extremely apropos to both environments: "Machine was made for Man, not Man for the Machine."</li></ul>Sixty years into the "computer revolution", pharma, healthcare, and the IT industry itself have not learned this simple lesson. I have to believe in 2011 this phenomenon is at least in part due to an abundance of powerful computers relative to the supply of humans in these industries with densely-interconnected gray matter. I think the author of the aforementioned piece agrees. He concludes: <blockquote>... The film industry long ago recognized that what is important is talent. No one can predict what will be a blockbuster (drug or movie), but Hollywood has at least recognized that movie-making is a talent-based industry. Perhaps today’s pharma chiefs need to see themselves as latter-day studio heads—I’m sure they’d love that!—and come to the same conclusions. Define the vision, get and keep the right people, stop making it harder for talented people to do their jobs, give them the time and resources to be creative. Then maybe, just maybe, they would start curing pharma.</blockquote> -- SS </div>

What's Killing Pharma, With Some Lessons For Hospital IT

An excellent essay on the pathologies killing the pharmaceutical industry is at this link: http://www.eyesopen.com/en/blog/what-is-really-...

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BLOGSCAN: Circling the Wagons Around the RUC

On the Care and Cost Blog, Brian Klepper <a href="http://careandcost.com/2011/04/08/the-ruc%E2%80%99s-defense/">suggested</a> that the defenders of the <a href="http://hcrenewal.blogspot.com/search/label/RUC">RUC</a> (RBRVS Update Committee) are getting worried.  He showed that a letter signed by medical specialty societies, but not the major societies that represent generalists, deployed logical fallacies in support of the secretive committee dominated by proceduralists that de facto sets payments to physicians by the US Medicare system, and which seems largely responsible for the gulf between payments for procedures and for primary and "cognitive" care.  His summation: <blockquote>The arguments mounted by the AMA and the specialty societies are really nothing more than a vested industry’s efforts to preserve the status quo at all costs. (Think Wall Street’s apologists in this year’s Oscar-winning documentary, <a href="http://www.rottentomatoes.com/m/inside_job_2010/">Inside Job</a>.) But this approach has brought health care and the US economy to the brink of economic catastrophe. Averting disaster will require an approach that dampens or bypasses the voices of the advisors who got us here, and strengthens the voice of primary care, which <a href="http://content.healthaffairs.org/content/29/5.toc">overwhelming data</a> show produce better care at lower costs.</blockquote>

BLOGSCAN: Circling the Wagons Around the RUC

On the Care and Cost Blog, Brian Klepper suggested that the defenders of the RUC (RBRVS Update Committee) are getting worried. He showed ...

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Dr. Silverstein and Dr. Poses in WSJ: "The Literature Is Hardly Pristine"

I have considered Dr. Roy Poses' Dec. 14, 2010 post "<a href="http://hcrenewal.blogspot.com/2010/12/lancet-emphasizes-threats-to-academic.html">The Lancet Emphasizes the Threats to the Academic Medical Mission</a>" (with its hyperlinks to source posts and articles) an excellent summary of many of the pathologies we address at Healthcare Renewal, especially with regard to the academic mission and the disruption of the integrity of the medical literature by commercial interests. His post is consistent with what might be considered our mission statement: <blockquote> Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care. </blockquote> The Wall Street Journal published the following letter to the editor authored by me today in which I cited and summarized Dr. Poses' accounting of the medical literature's ills. Unfortunately, the print version cannot contain the hyperlinks as in the aforementioned source post, but I have included them in the reproduced letter below in [brackets]. They are worth reviewing, along with additional links at the aforementioned source post "<a href="http://hcrenewal.blogspot.com/2010/12/lancet-emphasizes-threats-to-academic.html">The Lancet Emphasizes the Threats to the Academic Medical Mission</a>": <blockquote>April 8, 2011 Wall Street Journal Letters to the Editor <a href="http://online.wsj.com/article/SB10001424052748703712504576245654116005400.html?mod=WSJ_Opinion_MIDDLEThirdBucket#articleTabs_comments">The Literature Is Hardly Pristine</a> I find it unfortunate having to inform reader James Reichmann, (<a class="" href="http://online.wsj.com/article/SB10001424052748704471904576229161711650024.html">Letters, April 1</a>) who prefers his physician to recommend only treatments proven in the "synthesized medical literature," that the very literature on which he wishes his life to depend may be tainted. As Dr. Roy Poses points out on the Healthcare Renewal Blog, numerous factors common in today's culture can and do corrupt the literature. The factors include but are not limited to: rampant commercialization of medicine [<a href="http://hcrenewal.blogspot.com/2007/12/relman-in-jama-on-threats-to-physicians.html" style="font-weight: bold;">here</a>, <a href="http://hcrenewal.blogspot.com/2009/06/why-did-us-physicians-give-up-their.html" style="font-weight: bold;">here</a>, <a href="http://hcrenewal.blogspot.com/2010/12/american-medical-schools-are-only-in-it.html" style="font-weight: bold;">here</a> and <a href="http://hcrenewal.blogspot.com/2007/04/medical-schools-to-faculty-show-me.html" style="font-weight: bold;">here</a>], research universities with lax conflict of interest policies [<a href="http://hcrenewal.blogspot.com/2010/11/who-you-gonna-call-how-should-young.html" style="font-weight: bold;">here</a>], faculty as de facto employees of industry through grants [<a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest" style="font-weight: bold;">here</a>], academics paid to be "key opinion leaders" to stealth-market drugs and devices [<a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders" style="font-weight: bold;">here</a>], control of clinical research given to commercial sponsors [<a href="http://hcrenewal.blogspot.com/2005/05/troubling-study-of-contracts-between.html" style="font-weight: bold;">here</a>], conflicts of interest allowing manipulation and suppression of clinical research [<a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research" style="font-weight: bold;">here</a> and <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research" style="font-weight: bold;">here</a>], academics taking credit for articles written by commercially paid industry "ghost writers," [<a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing" style="font-weight: bold;">here</a> and <a href="http://hcrenewal.blogspot.com/search/label/stealth%20marketing" style="font-weight: bold;">here</a>], whistleblowing discouraged [<a href="http://hcrenewal.blogspot.com/search/label/whistle-blowers" style="font-weight: bold;">here</a> and <a href="http://hcrenewal.blogspot.com/2010/12/american-medical-schools-are-only-in-it.html" style="font-weight: bold;">here</a>], leadership of academic medical centers by business people [<a href="http://hcrenewal.blogspot.com/search/label/ill-informed%20management" style="font-weight: bold;">here</a>] and medical school leaders becoming stewards (as members of boards of directors) of for-profit health-care corporations [<a href="http://hcrenewal.blogspot.com/2010/12/duke-divinity-students-protest-pay-of.html" style="font-weight: bold;">here</a>, <a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html" style="font-weight: bold;">here</a>, <a href="http://hcrenewal.blogspot.com/2010/07/new-york-times-reports-university.html" style="font-weight: bold;">here</a> and <a href="http://hcrenewal.blogspot.com/2010/01/one-small-step-towards-reducing.html" style="font-weight: bold;">here</a>]. As for me, until the medical literature can be freed of these contaminants, I'd rather trust a well-trained personal physician's good judgment in my own medical care. Scot Silverstein, M.D. Drexel University Philadelphia</blockquote> I believe it's also worth reviewing my own views on the subject, that the degree of contamination of medical literature is unknown and may be unrecoverable, due to spread of the contaminant vectors to the "experts" who then propagate the disease. See my Aug. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/08/has-ghostwriting-infected-experts-with.html">Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?</a>" where I raise these questions. At that post I suggest that while the damage might not be easily recoverable, the practices that lead to contaminated literature must be stopped going forward if true evidence-based medicine is ever to be a reality. -- SS 4/12/2011 addendum: Almost predictably, some anonymous person, this time over at the <a href="http://scienceblogs.com/insolence/">Respectful Insolence</a> blog in commenting on a post there that attacks "naturopathic" medicine, proffered strawman arguments about my piece above in <a href="http://scienceblogs.com/insolence/2011/04/fun_with_a_naturopathic_rant_against_skepdoc.php#comment-3621396">comment #26</a>. <blockquote>... So Dr. Silverstein thinks that the defects he cites (many of which have been revealed by and hotly debated within the scientific community) are ample justification for tossing out the entirety of research in favor of the sort of "clinical intuition" that's repeatedly been found false over the years</blockquote> This binary, two-dimensional thinking is quite sad to read, if real. I'll be charitable in saying that the comment does have the "feel" of something contrived, such as received before from <a href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html">corporate sockpuppets</a>. -- SS 4/13 addendum: The proprietor of <a href="http://scienceblogs.com/insolence/">Respectful Insolence</a> assures me that "anonymous" quoted above is not a sockpuppet. My response was basically that before attacking non-anonymous authors by name on the web who in fact (as is clear from my writing here) share similar views on medical quackery, one should contact them first to ensure you truly understand their views. (In my case, my view is that the "well-trained physicians" of good judgment I wrote of consider the literature critically but are not bound to it, in consideration of the unknown level of its commercialization-based contamination and the variability of individual patient situations. They treat the patient, not the guideline.) -- SS<a class="l" href="http://scienceblogs.com/insolence/" style="font-style: italic;"></a>

Dr. Silverstein and Dr. Poses in WSJ: "The Literature Is Hardly Pristine"

I have considered Dr. Roy Poses' Dec. 14, 2010 post " The Lancet Emphasizes the Threats to the Academic Medical Mission " (wit...

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