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EHR importance vastly oversold? Community health center battles for electronic patients' records - but patient care goes on anyway

There are two lessons from the Milwaukee Journal Sentinel story below. 1) Beware outsourcing the ownership of your hospital or clinic's medical records. 2) The value of EHRs has been massively and repeatedly exaggerated.  Milwaukee Health Services have been operating without access to electronic patient charts for almost a month, yet there are no reports of massive casualties.  There are numerous reports on this blog of EHR system downtimes lasting weeks, loss and sabotage of electronic records, and other mishaps, yet patient care is claimed to have not been compromised.  Perhaps those who make such claims need to be taken at face value. It follows that expenditures of hundreds of billions of dollars for EHR systems is simply unnecessary and the technology's importance vastly oversold. Excerpts are below; read the full story at the hyperlink. -- SS <blockquote class="tr_bq"><a href="http://www.jsonline.com/business/community-health-center-battles-for-patients-records-b9957634z1-216291331.html">Community health center battles for patients' records</a></blockquote><blockquote class="tr_bq">By Guy Boulton of the Journal Sentinel July 20, 2013 Doctors at Milwaukee Health Services have not had access to the medical records of 40,000 patients since June 30, when an Atlanta company cut off the community health center's access to its electronic medical records after their contract ended. Milwaukee Health Services sued Business Computer Applications Inc., the Atlanta company, last week in federal court and is seeking a court order to restore access to patients' medical records. The records include patients' medications, problem lists, allergies, immunization records, treatment plans and other clinical information. The doctors and other health care providers at the community health center can get key information, such as medication lists and lab results, from pharmacies and other sources, said Tito Izard, a physician and chief executive of Milwaukee Health Services. But access to patients' medical records is "obviously important," Izard said. Milwaukee Health Services sought a court order last week to require Business Computer Applications, known as BCA, to restore access to the medical records, contending that the safety of patients was at serious risk. The court denied the request for a temporary restraining order. ... Milwaukee Health Services, which provides care to about 30,000 people a year and has medical records for about 40,000 people, entered into a five-year agreement with BCA on July 1, 2008. The community health center contends that BCA's system was not fully functional after paying the company $3.1 million over the past five years. "There was a never-ending request for more money to fix the system," Izard said. ... In its complaint, Milwaukee Health Services alleges BCA violated the Wisconsin law that requires health care records to be released upon the request of a health care provider in the care of patients. The community health center plans to seek a court order in the next several weeks that requires BCA to provide access to the medical records of its patients.</blockquote> More here:  <a href="http://www.courthousenews.com/2013/07/17/59431.htm">http://www.courthousenews.com/2013/07/17/59431.htm</a>.  Looks like the patients affected are predominantly poor and/or minorities: <blockquote class="tr_bq">... A computer firm is "jeopardizing the health and safety of about 40,000 people" - many of them uninsured or underinsured - by freezing a hospital out of access to its own medical records because of a billing dispute, the hospital claims in court ...  Milwaukee Health Services Inc. "specializ(es) in the care of underserved populations," the hospital says in its complaint. It says it "serves everyone regardless of income or third party coverage." </blockquote> -- SS

EHR importance vastly oversold? Community health center battles for electronic patients' records - but patient care goes on anyway

There are two lessons from the Milwaukee Journal Sentinel story below. 1) Beware outsourcing the ownership of your hospital or clinic's ...

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Electronic siloing: An unintended consequence of the electronic health record - Cleveland Clinic Journal of Medicine

EHR systems have largely been designed by those of a manufacturing, mercantile, and management computing background, largely due to abdication of responsibility and acquiescence by medical professionals, and political impotence of organized medicine and medical informatics organizations. The results were predictable - a toxic effect on healthcare.  One such toxic effect is an impairment of essential communications between caregiving personnel - exactly the opposite effect the hundreds of billions of dollars spent on today's health IT was intended to improve. <blockquote class="tr_bq">From the Cleveland Clinic Journal of Medicine: <a href="http://www.ccjm.org/content/80/7/406.full">Electronic siloing: An unintended consequence of the electronic health record</a> July 2013</blockquote><blockquote>JAMES K. STOLLER, MD, MS Chair, Education Institute; Staff, Department of Pulmonary, Allergy, and Critical Care Medicine, Cleveland Clinic; Jean Wall Bennett Professor of Medicine, Cleveland Clinic Lerner College of Medicine, Cleveland, OH For all the purported benefits of the electronic health record (EHR), an unintended adverse effect is “electronic siloing.” I define electronic siloing as the isolating effect of the EHR on clinical workflow that drives caregivers to work in silos, ie, alone at their workstations, thereby discouraging spontaneous interaction. To the extent that increasing evidence supports the importance of interaction among clinical colleagues and of teamwork to optimize clinical outcomes, electronic siloing threatens optimal practice and quality.</blockquote> Not only does it "threaten" optimal quality, it causes that quality to deteriorate to the point where a recent volunteer study at 36 hospitals by the renowned ECRI Institute (<a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>) found more than 170 health IT-related mishaps in a mere 9 weeks, 8 of those incidents resulting in patient harm and 3 possibly contributory towards patient death. <blockquote class="tr_bq">... THE EHR BRINGS CHANGES, GOOD AND BAD [the latter especially from bad health IT - ed.] The EHR represents a major change in health care, with reported benefits that include standardized ordering, reduced medical errors, embedded protocols for guideline-based care, data access to analyze clinical practice patterns and outcomes, and enhanced communication among colleagues who are geographically separated (eg, virtual consults). On the basis of these benefits and the federal Medicare and Medicaid financial incentives associated with “meaningful use,” the EHR is being increasingly adopted.</blockquote> The literature supporting those benefits is scarce, of poor quality, and refuted by other literature by credible authors - not the optimal environment to justify spending hundreds of billions of dollars (e.g., see <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html</a>). <blockquote class="tr_bq"> Yet for all these benefits and the promise that technology can enhance interaction among health care providers, unintended risks of the EHR paradoxically threaten optimal clinical care.6Recognized risks include the threat to care should the EHR fail, the time and inefficiency costs of typing and multiple log-ons, and the perpetuation of errors in the medical record caused by the cutting and pasting of clinical notes.</blockquote> To name just a few, all covered on this blog in various posts. <blockquote class="tr_bq"> ... Niazkhani et al noted that computerized ordering can change communication channels and collaboration mechanisms. More specifically, they point out that these systems can “replace interpersonal contacts that may result in fewer opportunities for team-wide negotiations."</blockquote> This is, in fact, obvious to any practicing physician or nurse and requires no academic "proof." <blockquote class="tr_bq"> Similarly, Ash et al cited the unintended consequences of patient care information systems, especially increased overreliance on the system to communicate, which can undermine direct communication between healthcare providers ... Taken together, these observations suggest that the EHR and computerized order entry in particular can disrupt interaction between physicians and other health care providers, such as nurses and pharmacists.</blockquote> Similarly, that this needs to be stated in 2013 is akin to stating that it's a good idea to use sterile technique in surgery. <blockquote class="tr_bq"> ...  the EHR can inadvertently lessen spontaneous interaction between physicians as they care for outpatients. I have proposed the term electronic siloing to reflect the isolating impact of the EHR on clinical workflow that drives caregivers to work alone at their workstations, thereby discouraging spontaneous interaction between colleagues (eg, between primary care physicians and subspecialists, and between subspecialists in different disciplines). Because spontaneous face-to-face encounters and conversations among clinicians can encourage clinical insights that benefit patient care, electronic siloing can undermine optimal care. My thesis here is that the EHR predisposes to electronic siloing and that the solution is to first recognize and then to design care to prevent this effect.</blockquote> The solution is first to force the industry and its pundits to admit the problem is poor design and hyper-enthusiasm that resulted in a premature national program for health IT diffusion, and abandon claims that clinicians are "Luddites" (see "Doctors and EHRs: Reframing the 'Modernists v. Luddites' Canard to The Accurate 'Ardent Technophiles vs. Pragmatists' Reality" at <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html">http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html</a>). <blockquote class="tr_bq">Defenders of the EHR will point out that the EHR does not preclude such face-to-face encounters.</blockquote> "Defenders of the EHR" will frequently default to fictitious and often ad hominem "blame the user" canards, since their scientific rationale for the proliferation of today's very poor systems is very weak. <blockquote class="tr_bq"> While technically this is correct, it is also equally true that such encounters are less likely because they no longer flow naturally from the workflow of writing a note side-by-side with colleagues with the films displayed nearby. Pressured for time, clinicians learn efficiency of motion and are simply less likely to leave their workstations to seek another colleague who, in turn, may be tethered to a workstation and absorbed in keyboarding and monitor-watching. The net effect is that such spontaneous face-to-face encounters are clearly less common in the EHR era.</blockquote> Again, this thinking will be countered by the hyper-enthusiasts by blaming users.  My response is that good health IT never depends on users to compensate for poor design or implementation, and there's nothing else to debate on that point. <blockquote class="tr_bq">... So, given the many clear benefits of the EHR and its current wave of adoption in health care, how can we maximize the benefits of the EHR while minimizing the adverse effects of electronic siloing?</blockquote> Reasonable suggestions follow; see the article at the link above.  The problem is that the reasonable suggestions are being proffered in an unreasonable, industry-dominated environment. The first step is political action and activism by clinicians to take charge of the clinical information technology playing field.  Until and unless that occurs, even thoughtful articles from Cleveland Clinic, Harvard, Yale etc. will simply be shelved. -- SS

Electronic siloing: An unintended consequence of the electronic health record - Cleveland Clinic Journal of Medicine

EHR systems have largely been designed by those of a manufacturing, mercantile, and management computing background, largely due to abdicati...

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Pharmaceutical Industry "'Mobilised' an Army of Patient Groups to Lobby Against" Improving Clinical Research Integrity

I had guessed that this sort of thing was going on all the time, but being kept very well hidden.  Now we have some more evidence. An<a href="http://www.guardian.co.uk/business/2013/jul/21/big-pharma-secret-drugs-trials"> article</a> in yesterdays Guardian showed how the pharmaceutical industry is using pet patient advocacy groups in a public relations campaign to defeat calls for for measures against <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression</a> and <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> of clinical research. In summary, <blockquote class="tr_bq">The pharmaceutical industry has 'mobilised' an army of patient groups to lobby against plans to force companies to publish secret documents on drugs<a href="http://www.guardian.co.uk/science/drugs" title="More from guardian.co.uk on Drugs"></a> trials.</blockquote> More specifically, <blockquote class="tr_bq">The strategy was drawn up by two large trade groups, the <a href="http://hcrenewal.blogspot.com/search/label/PhRMA">Pharmaceutical Research and Manufacturers of America (PhRMA)</a> and the European Federation of Pharmaceutical Industries and Associations (EFPIA), and outlined in a memo to senior industry figures this month, according to an email seen by the Guardian.  The memo, from Richard Bergström, director general of EFPIA, went to directors and legal counsel at <a href="http://hcrenewal.blogspot.com/search/label/Roche">Roche</a>, <a href="http://hcrenewal.blogspot.com/search/label/Merck">Merck</a>, <a href="http://hcrenewal.blogspot.com/search/label/Pfizer">Pfizer</a>, <a href="http://hcrenewal.blogspot.com/search/label/GlaxoSmithKline">GSK</a>, <a href="http://hcrenewal.blogspot.com/search/label/AstraZeneca">AstraZeneca</a>, <a href="http://hcrenewal.blogspot.com/search/label/Eli%20Lilly">Eli Lilly</a>, <a href="http://hcrenewal.blogspot.com/search/label/Novartis">Novartis</a> and many smaller companies. It was leaked by a drugs company employee. The email describes a four-pronged campaign that starts with 'mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data'. Translated, that means patient groups go into bat for the industry by raising fears that if full results from drug trials are published, the information might be misinterpreted and cause a health scare. The lobbying is targeted at Europe where the European Medicines Agency (EMA) wants to publish all of the clinical study reports that companies have filed, and where negotiations around the clinical trials directive could force drug companies to publish all clinical trial results in a public database.</blockquote> The argument for continuing to allow clinical trials to be suppressed was to be, <blockquote class="tr_bq">The patient groups focus on the concern that if companies release all of their clinical trials data, the information might be misconstrued, or intentionally cherry-picked, and spark damaging health scares around certain drugs or vaccines.</blockquote> The Guardian story did not disclose which patient groups were cooperating with this effort. By the way, the other parts of this strategy involved using scientific associations and academics to push the pharmaceutical companies' agenda, <blockquote class="tr_bq"> Two other strands of the campaign include discussions with scientific associations about the risks of data sharing, and work with other businesses that are concerned about the release of trade secrets and confidential data. The final strand calls, in the long term, for a network of academics across Europe that can be called on to correct false interpretations of the data. </blockquote>Several of the large multinational drug companies contacted by the Guardian issued the usual non-denial denials <blockquote class="tr_bq">In response to queries from the Guardian, GSK said: 'This is not something we are doing. One of the reasons we're involved in this is we want more companies to move towards greater transparency. I don't think it's for us to be mobilising patient groups to campaign on a negative level.' A Roche spokesperson said the company consulted patient groups to understand their concerns about clinical trials, but 'to our knowledge Roche has not been involved in any EFPIA's potential activity in mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data'. A Lilly spokesman said: 'Lilly is committed to working with Europe-based patient advocacy organisations for the benefit of patients in a way that is true to the EFPIA code of practice and Lilly's integrity in business policy.'</blockquote> Summary We have long discussed and decried how vested interests, chiefly health care corporations with services and products to sell, have<a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research"> manipulated clinical research</a> to make their wares look better, and <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed research </a>whose results, even if manipulated, could not be made sufficiently favorable. This has resulted in making drugs and devices look more efficacious and/or less hazardous than they really are.  See <a href="http://hcrenewal.blogspot.com/2013/06/a-call-to-restore-integrity-of-clinical.html">this post</a> for our latest discussion, and information on the latest effort to counter suppression and manipulation of clinical research. It is not surprising that pharmaceutical companies do not want to have to publish every clinical trial they sponsor, or expose their manipulations of these trials.  Instead, the Guardian article suggests that companies and their trade associations, including the US based pharmaceutical trade association, and several large US companies, and well as large companies based elsewhere, are using a third-party public relations strategy.  Wendell Potter's muckraking book on the US commercial health care insurance industry, Deadly Spin, revealed how similar strategies were used by US based health insurance companies to defeat the Clinton administration's attempt at health care reform, and other measures targeted to make the US commercial health care insurance system more equitable and ethical  (see post <a href="http://hcrenewal.blogspot.com/2011/02/health-care-corporate-disinformation.html">here</a>).  Third party strategies are fundamentally deceptive.    The current alleged use of the third party strategies by pharmaceutical companies to support ongoing suppression and manipulation of clinical research is more than just deceptive.  It is corrupt. Patient advocacy groups are usually believed to represent patients' interests.  For such groups to support a public relations campaign that could allow ongoing harm of patients (by suppressing and manipulating evidence to prevent it from being used to forestall excess use of ineffective, dangerous drugs) is abuse of their entrusted power.  To do it for money, money used to support these groups, or help underwrite generous compensation for their executives, fits the definition of corruption used by Transparency International - abuse of entrusted power for private gain. Note that the Guardian provided this viewpoint, <blockquote class="tr_bq">Tim Reed, of Health Action International, a group that has previously exposed the pharmaceutical industry's financial links with patient groups, said: 'It's incredibly ironic that this is a transparency initiative and we've now got clear indications that the pharmaceutical industry is ready to use patient organisations to fight their corner. 'It underlines the fact that patient groups who are in the pay of the pharmaceutical industry will go into battle for them. There's a hidden agenda here. The patient groups will say they think it's a great idea to keep clinical trials data secret. Why would they do that? They would do that because they are fronts for the pharmaceutical industry. 'Patient groups get traction because they are assumed to represent the voice of the suffering. But industry uses them to say we're not going to get innovative medicines if the industry is deterred from investing by having to be transparent about their clinical trials,' he added.</blockquote> We have previously noted isolated examples of evidence that particular US based <a href="http://hcrenewal.blogspot.com/search/label/patient%20advocacy%20groups">patient advocacy groups</a> were being supported by commercial firms presumably to aid their marketing.  We have also found examples of conflicts of interest affecting<a href="http://hcrenewal.blogspot.com/search/label/medical%20societies"> medical societies</a>, and <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">many affecting</a> non-profit hospitals and academic medical institutions, and<a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest"> their staff and faculty</a>.  I begin to wonder if most health care non-profit organizations in the US, and now it appears maybe in UK and in Europe, have been paid off to support marketing and/or public relations interests of health care corporations. This latest example suggests that health care worldwide has become deeply corrupt, even more corrupt than <a href="http://hcrenewal.blogspot.com/search/label/Transparency%20International">Transparency International</a>'s <a href="http://www.transparency.org/whatwedo/pub/global_corruption_report_2006_corruption_and_health">Global Report on health care corruption in 2006</a>, or the those responding to Transparency International's <a href="http://hcrenewal.blogspot.com/2013/07/43-believe-that-us-health-care-corrupt.html">global corruption survey in 2013</a>, could envision. I only hope that the pile up of new examples - each seemingly worse than the one before - of health care corruption, will be sufficient to overcome the anechoic effect, and create enough global outrage to give us a chance to clean up our corrupt health care before it destroys our health. ADDENDUM (25 July, 2013) - See also <a href="http://brodyhooked.blogspot.com/2013/07/the-astroturf-speaks-out-more-industry.html">comments</a> by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.  ADDENDUM (29 July, 2013 - See the <a href="http://1boringoldman.com/index.php/2013/07/28/a-closing-argument/">comment</a> on the 1BoringOldMan blog.

Pharmaceutical Industry "'Mobilised' an Army of Patient Groups to Lobby Against" Improving Clinical Research Integrity

I had guessed that this sort of thing was going on all the time, but being kept very well hidden. Now we have some more evidence. An artic...

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Johnson and Johnson Settles Suit Alleging Management Incompetence and Deception, Managers Continue to Prosper

Very quietly, pharmaceutical/ biotechnology/ medical device corporate giant Johnson & Johnson just settled another lawsuit. The most pithy version is <a href="http://www.pharmalive.com/jj-pays-23m-to-settle-class-action-suit-over-otc-troubles">by Ed Silverman on Pharmalot</a>, although <a href="http://www.reuters.com/article/2013/07/18/us-johnson-recall-settlement-idUSBRE96H01S20130718">Reuters</a> and <a href="http://www.bloomberg.com/news/2013-07-17/j-j-agrees-to-pay-22-9-million-to-settle-case-over-drug-recalls.html">Bloomberg</a> published short accounts. The New Settlement Per Mr Silverman, the gist is: <blockquote class="tr_bq">The health care giant agreed to resolve the dispute brought over allegations that J&J management shirked their responsibilities and allowed a chain of events that resulted in congressional probes; lost market share, consumer confidence and revenue, and a consent decree with the FDA. In the lawsuit, a shareholder charged that J&J bungled the integration of the Pfizer consumer health acquisition, placed inexperienced execs in charges of its OTC unit and cut costs so drastically that quality control suffered. The lawsuit, which was brought by Ronald Monk, alleged that the health care giant made misleading statements about its products before disclosing problems with the Fort Washington plant and another in Puerto Rico. He also maintained that J&J withheld material information before its decision three years ago to shut down the Fort Washington plant, where contamination led to the unpublicized recall of defective Motrin tablets in 2009. In agreeing to the settlement, J&J refused to admit any wrongdoing</blockquote> So let me review. The allegations in this case were all about problems with the management of Johnson and Johnson.  They included allegations that management was incompetent and deceptive.  The incompetence was in handling the core functions of the company, assuring that its drug products were pure and unadulterated.  The deception was of patients, the public, and the nominal owners of the company to whom management is supposed to report, and allegedly included an attempt to cover up concerns about the purity of its drug products. The proposed settlement follows the current practice of allowing the defendant not to admit the allegations, leaving their truth unproven.  However, one wonders, given that the allegations are about the core responsibilities of management and were leveled by the company owners, why the management would not defend their honor more forthrightly. The Company's Sorry Legal Record Furthermore, this settlement also follows the current practice of being made without reference to any other seemingly relevant legal proceedings.  In fact, it is just the latest of a long string of settlements and other resolutions of legal actions, including guilty pleas, by Johnson and Johnson management.  As we summarized most recently <a href="http://hcrenewal.blogspot.com/2012/09/how-many-legal-settlements-does-it-take.html">here</a>, these included: - Convictions in two different states in 2010 for misleading marketing of Risperdal - A guilty plea for misbranding Topamax in 2010 - Guilty pleas to bribery in Europe in 2011 by Johnson and Johnson's DePuy subsidiary - A guilty plea for marketing Risperdal for unapproved uses in 2011 (see <a href="http://hcrenewal.blogspot.com/2011/08/why-cultivate-weldons-confidence-ceo.html">this link</a> for all of the above) - A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post <a href="http://hcrenewal.blogspot.com/2011/09/johnson-and-johnson-pleads-guilty.html">here</a>) - In 2012, testimony in a trial of allegations of unethical marketing of the drug Risperdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers. After these revelations, the company abruptly settled the case (see post <a href="http://hcrenewal.blogspot.com/2012/02/texas-tmap-trials-as-illustration-of.html">here</a>). -  Also in 2012,  Johnson & Johnson was fined $1.1 billion by a judge in Arkansas for deceiving patients and physicians again about Risperdal (look <a href="http://hcrenewal.blogspot.com/2012/04/once-more-with-feeling-johnson-and.html">here</a>). -  Also in 2012, Johnson & Johnson announced it would pay $181 million to resolve claims of deceptive advertising again about Risperdal (see this <a href="http://hcrenewal.blogspot.com/2012/09/how-many-legal-settlements-does-it-take.html">post</a>). Even though the record includes a number of settlement in which management did not have to admit guilt, the company has made a surprising number of guilty pleas in just the last few years.  Despite all this evidence of poor, that is incompetent or unethical management, Johnson and Johnson managers have been getting very rich. As we mentioned <a href="http://hcrenewal.blogspot.com/2012/03/despite-recalls-legal-settlements-and.html">here</a>, Mr William Weldon, the outgoing CEO on whose watch most of the misbehavior resulting in the legal actions above occurred, retired with a huge retirement package, after receiving extremely generous compensation prior to that.  The new CEO as of April, 2012,  Mr  Alex Gorsky, per<a href="http://www.investor.jnj.com/common/download/download.cfm?companyid=JNJ&fileid=644762&filekey=44D6D309-4972-4DAE-97C5-60157E6C6CD1&filename=JNJ_2013_Proxy_Statement.PDF"> the company's 2013 proxy statement</a>, already owns more than 190,000 Johnson and Johnson shares,  and received $10,977,109  total compensation in 2012.  Mr Weldon received over $29 million in total compensation just for 2012, the year in which he retired.  Other top executives received from over $3.5 million to over $8 million.  Summary So why do the stockholders, the owners of Johnson and Johnson continue to pay so much to an executive team on whose watch so many bad things have happened?  Why did law enforcement authorities allow the company to continue to plead guilty or settle cases without imposing any negative consequences on these executives?  Maybe only <a href="http://en.wikipedia.org/wiki/The_Shadow">the Shadow</a> knows. Of course, the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">lack of any discussion </a>beyond that on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a>, that puts each new settlement or guilty plea in the context of the ones before, and juxtaposes them to the rewards of given to management, may not help.  As we <a href="http://hcrenewal.blogspot.com/2012/09/how-many-legal-settlements-does-it-take.html">said the last time</a> we addressed the contrast between Johnson and Johnson's sorry legal record and its voluminous payments to executives, we have <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">noted again and again and again</a> that 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.

Johnson and Johnson Settles Suit Alleging Management Incompetence and Deception, Managers Continue to Prosper

Very quietly, pharmaceutical/ biotechnology/ medical device corporate giant Johnson & Johnson just settled another lawsuit. The most pi...

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More than Just a Conflict of Interest? - Should Rutgers University's Own Contract Research Organizations Report to the Board of Covance?

Transparency International's 2013 global survey showed that over 40% of Americans think the country's health care is corrupt (see <a href="http://hcrenewal.blogspot.com/2013/07/43-believe-that-us-health-care-corrupt.html">this post</a>).  <a href="http://www.transparency.org/">Transparency International</a> defines corruption as abuse of entrusted power for private gain.  It is likely that one reason many US citizens feel this way is that they have become aware of the web of conflicts of interest that now permeates health care. The Institute of Medicine <a href="http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx">defined</a> conflicts of interest in medicine as occurring "when an individual or institution has a secondary interest that creates a risk of undue influence on decisions or actions affecting a primary interest."  Since the primary interest of physicians is to provide good care that puts patients' interests first, and the primary interests of academic medicine are to provide education and research of quality and integrity, conflicts of interest affecting physicians or academic medical institutions increase the risk of abuse of the entrusted power defined by these primary interests. The most striking conflicts may occur when one person simultaneously runs two different health care organizations whose missions and interests are at odds.  For example, we have been documenting <a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html">since 2006</a> how some top leaders of academic medicine simultaneously sit on boards of directors of health care corporations.  Thus, <a href="http://hcrenewal.blogspot.com/2011/09/director-of-bristol-myers-squibb-to-run.html">for example</a>, the dean of a prestigious medical school may sit on the board of a large pharmaceutical company.  That person is supposedly responsible both for the honest education of students, including unbiased education about the use of drugs, and for a company whose revenue depends on selling more drugs at higher prices. Rutgers University President, Director of VWR International and Covance Such conflicts attracted little public notice when we first blogged about them, but now occasionally attract more attention.  For example, the NorthJersey.com just <a href="http://www.northjersey.com/news/education/Barchi_draws_pay_from_two_companies_that_do_business_with_Rutgers.html">reported</a> on the conflicts affecting the President of Rutgers University, which includes two medical schools and many other academic health care components, <blockquote class="tr_bq">As he leads the transformation of the state’s flagship university into a medical research hub with national aspirations, Rutgers University President Robert Barchi is also collecting hundreds of thousands of dollars for privately advising two firms that do millions of dollars of business with Rutgers related to scientific research.</blockquote> In particular, <blockquote class="tr_bq">both firms have a business relationship with Rutgers. Those relationships predate Barchi’s appointment. They could expand, however, with Rutgers’ recent merger with most of the University of Medicine and Dentistry of New Jersey. Rutgers has paid VWR International, a publicly traded lab supply company, and its subsidiaries a total of $15 million since 2008, records show. It is on pace to pay the company $2 million this calendar year, even though a contract with the firm expired in 2012. A university spokesman said the deal was extended, but an official who handles public records requests said a copy of the extension was not on file. Covance Inc., a pharmaceutical research firm, has been paid about $100,000 by Rutgers since 2008. It supplies products and services used in biological research. Those two companies paid Barchi a combined $317,000 in fees and stock awards last year to sit on each company’s board, part-time advisory positions he has held more than seven years. Barchi has also accumulated stock in both companies — in the case of Covance, worth the equivalent of $2.5 million as of Friday, according to corporate filings. The annual fees supplement Barchi’s annual pay at Rutgers, which is worth up to $747,000 after bonuses. </blockquote> Dr Barchi argued that since he had disclosed these relationships to the university board of governors, it is all good, <blockquote class="tr_bq">'I disclosed my membership on the board fully during the search process, both on my résumé and in discussions with Rutgers board of governors members,' Barchi wrote in a statement issued in response to questions and an interview request submitted through a spokesman. 'Rutgers University recognizes the value of having its chief executives serve on corporate boards. ... Recognizing the potential for a conflict, however, since becoming president at Rutgers I have not been involved in any decisions at Rutgers involving' the companies. </blockquote> Members of the university governing board did not seem too troubled either. <blockquote class="tr_bq">'It was fully disclosed,' said Gordon MacInnes, a member of the governing board. 'I don’t see any inherent conflict.' </blockquote> However, NorthJersey.com found some people who thought there could be a real issue since the university has direct financial relationships with both companies on whose board Dr Barchi sits. <blockquote class="tr_bq">Cary Nelson, a past president of the American Association of University Professors who has written a dozen books on higher education policy and conflicts of interest, said Barchi’s arrangement 'is not an ambiguous case, unfortunately,' calling it a clear conflict. There’s a danger of impropriety, Nelson said, even if Barchi never actively exerts influence on behalf of the companies he advises. For example, officials who make large buying decisions for the university may choose contracts with the companies to curry favor with the president or because they 'don’t want to make waves,' he said. Nelson is the co-author of an extensive report for the professors’ association due out at the end of this year that will suggest university policies to avoid such problems. 'What we say is that no administrator should serve on a corporate board or have any kind of financial relationship with a company that does business with the university,' he said. 'That’s a fundamental principle that has to be honored.'</blockquote> Public Notice Unlike some cases we have previously discussed (for example, <a href="http://hcrenewal.blogspot.com/2006/01/california-nightmares-more-troubles-at.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/09/director-of-bristol-myers-squibb-to-run.html">here</a>), this one produced an immediate kerfuffle, if not an uproar.  The New York Times reported on it.  Already editorialists (e.g., <a href="http://news.google.com/news/url?sr=1&sa=t&ct2=us%2F0_0_s_7_0_t&usg=AFQjCNHWcgGT8g4KHN66hDJCq4_ZGE-0aQ&did=c47cdb7d453db56d&cid=52778199768898&ei=vpPlUaCzI4jcggfD9wE&rt=STORY&vm=STANDARD&url=http%3A%2F%2Fwww.northjersey.com%2Fnews%2Fopinions%2F215623061_The_Record__Barchi_and_boards.html">here</a>) and a few politicians (look <a href="http://www.nj.com/news/index.ssf/2013/07/rutgers_president_barchi_faces_calls_to_resign_from_paid_posts_on_corporate_boards.html">here</a>) have called for Dr Barchi to step down from his corporate board positions. For example, <a href="http://www.northjersey.com/news/Rutgers_president_Barchis_side_pay_draws_criticism_from_lawmakers_experts.html">per</a> again NorthJersey.com, <blockquote class="tr_bq">'This is a two-way financial arrangement that creates a textbook example of a conflict of interest,' said Senate Majority Leader Loretta Weinberg, a Teaneck Democrat, who called on him to resign from his advisory posts for the companies, VWR International and Covance Inc. 'The president of the university is on the payroll of companies that are paid millions of dollars by the school. Even if Mr. Barchi avoids direct involvement in business decisions between Rutgers and these firms, the appearance of a conflict could undermine his credibility at a key time in the evolution of the university.' </blockquote> Some Additional Perspective Dr Barchi's conflicts of interest have drawn considerable more coverage than similar conflicts of other academic health care leaders whom we have discussed in the past. Unlike these previous cases, they have also provoked upset, if not some outrage. Yet there could be more outrage, because this case is actually worse than it has been so far publicly described. First, the public discussion seems not to have taken into account the nature of Dr Barchi's responsibilities to VWR International and Covance.  He is not on advisory boards to these two companies, as implied by the initial NorthJersey.com report.  He is a member of both these companies' boards of directors. As we <a href="http://hcrenewal.blogspot.com/2008/05/worse-variant-of-new-species-of.html">noted in 2008</a>,  the issue goes beyond just the often generous payments board service entails. The important consideration is that directors of public for-profit corporations have a duty to "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. <a href="http://www.amazon.com/Corporate-Governance-Robert-G-Monks/dp/1405116986">Corporate Governance</a>, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]   (Many people would now argue that many current corporate directors function more like cronies of top management than representatives of the shareholders). But the important message is the boards of directors are responsible for the governance and overall direction of the company.  For example, the 2<a href="http://services.corporate-ir.net/SEC/Document.Service?id=P3VybD1hSFIwY0RvdkwyRndhUzUwWlc1cmQybDZZWEprTG1OdmJTOWtiM2R1Ykc5aFpDNXdhSEEvWVdOMGFXOXVQVkJFUmlacGNHRm5aVDA0T0RFNU16YzVKbk4xWW5OcFpEMDFOdz09JnR5cGU9MiZmbj04ODE5Mzc5LnBkZg==">013 Covance proxy statement </a>includes, "The Board of Directors provides oversight of senior management in its operation of the Company."   The members of the board have a fiduciary duty to align with the companies' interests which goes beyond whatever loyalty their compensation from the company ought to inspire.  Thus, the extreme conflict between, for example, one person's roles as a university president responsible for education, including unbiased education of physicians about drugs,  and a director of a drug company ought to be obvious. Dr Barchi, is not a director of a drug company, but the director of a contract research organization.  The description of Covance in the NorthJersey.com article above was incomplete.  In fact, the Covance web-site describes the company as "one of the world’s largest and most comprehensive drug development services companies."  In particular, Covance functions as a contract research organization (CRO).  Its work includes running clinical research for pharmaceutical and biotechnology companies, including "Early Patient Studies,Clinical Development (Phase II-III)." As university president, Dr Barchi is simultaneously responsible for educating students about clinical research, and for the integrity of clinical research performed within the university.  More acutely, however, he actually is responsible for several contract research organizations that appear to be competing with Covance. As more clinical research has been taken over by CROs, some academic institutions have decided to compete directly with CROs.  In particular, Rutgers University, in particular, seems to have its own CROs.  First, as <a href="http://shrp.rutgers.edu/dept/biopharma/">proclaimed </a>by its Biopharma Educational Initiative, "Rutgers Biomedical and Health Sciences is one of the largest health care research institutions in the US with our own (emerging) contract research organization."  The Rutgers Clinical Research Organization <a href="http://cro.rbhs.rutgers.edu/aboutUs.html">asserts</a> "Rutgers CRO connects industry, patients and academic collaborators with the University's state-wide academic resources."  Meanwhile the Rutgers New Jersey Medical School Institute of Genomic Medicine <a href="http://njms.rutgers.edu/genesweb2/services.cfm">states</a> "the IGM functions as an academic contract research organization (CRO) dedicated to biomarker discovery and the clinical evaluation of biomarkers.". Thus, not only does Dr Barchi's role in the governance of Covance seem to present a conflict with his role in upholding the integrity of research at Rutgers, but it could conceivably be anti-competitive.  While one may question whether university's should directly compete with CROs, as long as they do, it seems they ought not to be run by those responsible for the governance of the CROs with which they are ostensibly competing. Summary As the web of conflicts of interest that entangles health care becomes more visible, the risks of corruption that it generates become more obvious.  I hope as disclosure improves, public outrage about health care corruption will increase.   Ultimately, true health care reform requires more than disclosing conflicts of interest. The IOM  <a href="http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx">report </a> on conflicts of interest suggested full disclosure of all payments that could be considered conflicts of interest, banning clinical research by conflicted individuals, prohibiting academic physicians from giving "drug talks" whose content was provided by industry, and developing methods to fund continuing medical education independent from industry.  This report, and its recommendations have gotten scant attention, maybe because they would threaten a status quo that enriches conflicted health professionals and the companies that create these conflicts.  However, in my humble opinion, implementing all the report's recommendations would only be a beginning down the road of restoring the integrity of clinical care, teaching, and research. Hat tip to Prof Margaret Soltan <a href="http://www.margaretsoltan.com/?p=40518">on the University Diaries blog.</a> See also the <a href="http://loathingbioethics.blogspot.com/2013/07/what-does-rutgers-president-have-in.html">comments </a>by Dr Carl Elliott on the Fear and Loathing in Bioethics blog.   ADDENDUM (24 July, 2013) - see additional comments <a href="http://www.margaretsoltan.com/?p=40606">here</a> and <a href="http://www.margaretsoltan.com/?p=40613">here</a> by Prof Margaret Soltan on the University Diaries blog.

More than Just a Conflict of Interest? - Should Rutgers University's Own Contract Research Organizations Report to the Board of Covance?

Transparency International's 2013 global survey showed that over 40% of Americans think the country's health care is corrupt (see th...

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Kim Kardashian, Meet Electronic Medical Records

In yet another example of breach of medical record privacy (<a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy</a>), Kim Kardashian's privacy on the birth of her daughter, as well as the privacy of more than a dozen other patients, was violated between June 18 and June 24:   <blockquote class="tr_bq"><a href="http://www.reuters.com/article/2013/07/14/entertainment-us-usa-hospital-privacy-idUSBRE96D00520130714">Workers fired in privacy breach at L.A. hospital popular with stars</a> LOS ANGELES | Sat Jul 13, 2013 (Reuters) - Five medical workers have been fired over a patient data breach at Cedars-Sinai Medical Center, the Los Angeles facility said in a statement, while celebrity website TMZ reported on Saturday that the hacking effort targeted reality star Kim Kardashian. Cedars-Sinai, a favorite destination for celebrities seeking medical care, said in the statement it has a "high standard for security" and "in this case that standard was violated."  [How do ordinary hospital workers, medical assistants, and even a volunteer as below violate a "high standard for security", I wonder? - ed.] Kardashian, the star of the reality television show "Keeping Up With the Kardashians," gave birth on June 15 at Cedars-Sinai to daughter North West, whose father is Grammy-winning rap star Kanye West. Cedars-Sinai officials declined to say whose privacy had been breached, but the hospital said it "informed the affected patients" and apologized to them. The breach of 14 patient records occurred between June 18 and June 24, the hospital statement said. TMZ reported that Kardashian checked out of Cedars-Sinai about a week after she gave birth and was contacted by the hospital and told she was one of the patients whose records were accessed. TMZ, which cited unnamed sources, said Kardashian's family suspected a leak of information at Cedars-Sinai after media reports disclosed details Kardashian had not revealed to anyone. Representatives for Kardashian did not return calls or emails seeking comment on Saturday. The Cedars-Sinai statement said four of the workers who inappropriately logged onto the hospital's information system to access patient records were employees of local physicians with staff privileges at the hospital. The other workers were a medical assistant employed by the Cedars-Sinai Medical Care Foundation and a student research assistant who was a volunteer, the hospital said. As a result of the privacy breach, the five medical workers with ties to Cedars-Sinai were fired and the volunteer barred from working there, it said. Cedars-Sinai said that while it had no indication "any criminal acts were committed by the individuals" it was reaching out to law enforcement agencies in "an abundance of caution."</blockquote> It looks like the "high standard for security" needs some work. (A paper chart could have been sequestered, of course, not permitting its access by riff raff, but then there would not be all the tremendous advantages of today's commercial EHRs such as detailed at <a href="http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html">http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html</a>.) -- SS <blockquote class="tr_bq"></blockquote>

Kim Kardashian, Meet Electronic Medical Records

In yet another example of breach of medical record privacy ( http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy ), Kim Ka...

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RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals

Add the following from Sutter East Bay Hospitals to nurses' and physicians' complaints at Marin General Hospital (<a href="http://hcrenewal.blogspot.com/2013/05/marin-general-hospitals-nurses-are.html">http://hcrenewal.blogspot.com/2013/05/marin-general-hospitals-nurses-are.html</a>), Affinity Medical Center (<a href="http://hcrenewal.blogspot.com/2013/06/affinity-rns-call-for-halt-to-flawed.html">http://hcrenewal.blogspot.com/2013/06/affinity-rns-call-for-halt-to-flawed.html</a>), Contra Costa County (<a href="http://hcrenewal.blogspot.com/2012/08/contra-costas-45-million-computer.html">http://hcrenewal.blogspot.com/2012/08/contra-costas-45-million-computer.html</a>), San Francisco Department of Public Health (<a href="http://hcrenewal.blogspot.com/2010/11/avatar-fails-no-not-cameron-movie-but.html">http://hcrenewal.blogspot.com/2010/11/avatar-fails-no-not-cameron-movie-but.html</a>), and others: <blockquote class="tr_bq">For Immediate Release  July 11, 2013 Contact-  Charles Idelson, 510-273-2246 <h2>RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals</h2>Introduction of a new electronic medical records system at Sutter corporation East Bay hospitals has produced multiple problems with safe care delivery that has put patients at risk, charged the California Nurses Association today. Problems with technology are not unique to health care – pilots of the ill fated Asiana airline that tragically crashed at San Francisco International Airport July 6 told federal investigators that an automatic throttle failed to keep the jetliner at the proper speed for landing, the Los Angeles Times reported July 9.  [What is unique to healthcare IT is the complete lack of regulation - ed.] In over 100 reports submitted by RNs at Alta Bates Summit Medical Center facilities in Berkeley and Oakland, nurses cited a variety of serious problems with the new system, known as Epic. The reports are in union forms RNs submit to management documenting assignments they believe to be unsafe. Patient care concerns included computerized delays in timely administration of medications and contact with physicians, ability to properly monitor patients, and other delays in treatment.  Many noted that the excessive amount of time required to interact with the computer system, inputting and accessing data, sharply cuts down on time they can spend with patients with frequent complaints from patients about not seeing their RN.  [Note: patients are not given the opportunity for informed consent about the risks, nor opt-out of EHR use in their care - ed.] "EPIC is a system that is so cumbersome to use for nurses and physicians, that we often feel as though we are caring for a computer, not a patient,” said Thorild Urdal, an RN at Alta Bates Summit’s hospital in Berkeley. “It delays care and treatment, the program is naturally counter-intuitive and it was clearly not designed in concert with nurses and physicians." [Clinicians end up caring for an "iPatient", as others have noted - ed.] "The Epic program developed and implemented by Sutter is neither nurse or patient friendly,” said Alta Bates Summit Oakland RN Mike Hill. “Epic does not enhance my ability to chart instead it takes time away from the bedside and my patients and preventing me from providing the absolute best care that they and I expect from me as a nurse." Sutter CEO Pat Fry last year told the San Francisco Business Times that Sutter will spend $1 billion on Epic, a system that has sparked controversy at several other hospitals, including a Contra Costa facility where several RNs cited serious medical errors in testimony to county supervisors last August. At Alta Bates Summit specific incidents directly related to Epic problems included: • A patient who had to be transferred to the intensive care unit due to delays in care caused by the computer.  [It's happenstance they did not have to be transferred to the morgue - ed.] • A nurse who was not able to obtain needed blood for an emergent medical emergency. • Insulin orders set erroneously by the software. • Missed orders for lab tests for newborn babies and an inability for RNs to spend time teaching new mothers how to properly breast feed babies before patient discharge. • Lab tests not done in a timely manner. • Frequent short staffing caused by time RNs have to spend with the computers. • Orders incorrectly entered by physicians requiring the RNs to track down the physician before tests can be done or medication ordered. • Discrepancies between the Epic computers and the computers that dispense medications causing errors with medication labels and delays in administering medications. • Patient information, including vital signs, missing in the computer software. • An inability to accurately chart specific patient needs or conditions because of pre-determined responses by the computer software. • Multiple problems with RN fatigue because of time required by the computers and an inability to take rest breaks as a result. • Inadequate RN training and orientation. </blockquote>These "incidents" are certainly capable of causing harms or fatalities.  One wonders if hospital executives are providing the usual refrain that these are just "glitches" (<a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>) and that patient care has not been compromised (<a href="http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised">http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised</a>). A bit more background follows: <blockquote class="tr_bq">... Hospitals nationally are spending tens of billions of dollars on technology systems, especially on electronic health records (EHR) programs for which they also receive federal financial incentives. EHR programs are paraded as a panacea for reducing medical errors and cutting costs, but in life the promise is falling short in both areas. A RAND corporation analysis earlier this year said visions of savings and improved efficiency in patient care have had what the New York Times called “mixed results, at best.” The U.S. Food and Drug Administration has acknowledged getting hundreds of reports of problems involving health information technology including numerous patient injuries and deaths. Some examples seen at hospitals across the country: • At Marin General Hospital in Northern California, RNs called on the Marin Healthcare District board to delay implementation of their EHR system. "Orders are being inadvertently passed to the wrong patients. People have gotten meds when they've been allergic to them. This is dangerous," Marin RN Barbara Ryan said in comments reported by the Marin Independent Journal. • In Chicago, the Chicago Tribune in 2011 reported on a patient death at Advocate Lutheran General hospital after an automated machine prepared an intravenous solution containing a massive overdose of sodium chloride — more than 60 times the amount ordered by a physician. • At Affinity Medical Center RNs in Massillon, Oh. RNs in June raised multiple objections to the hurried introduction of an EHR system. Subsequently, they have cited medication errors, delays in care, problems with documentation, computers crashing, and other concerns.</blockquote> I am simply the reporter here. -- SS

RNs Say Sutter’s New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals

Add the following from Sutter East Bay Hospitals to nurses' and physicians' complaints at Marin General Hospital ( http://hcrenewa...

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