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The Camel's Aching Back - Johnson and Johnson and Novartis Fined 16 Million Euro for "Anticompetitive" Scheme to Delay Generic Fentanyl

Legal and regulatory actions unfavorable for giant pharmaceutical, biotechnology and device company Johnson and Johnson just keep coming.  We last discussed such a story only two weeks ago <a href="http://hcrenewal.blogspot.com/2013/12/how-many-straws-johnson-and-johnson.html">here</a>.  The Latest Case This latest story got only desultory US coverage from the wire services.  The most complete version is in the European Commission <a href="http://europa.eu/rapid/press-release_IP-13-1233_en.htm">press release</a>.  The basics were: <blockquote class="tr_bq">The European Commission has imposed fines of € 10 798 000 on the US pharmaceutical company Johnson & Johnson (J&J) and € 5 493 000 on Novartis of Switzerland. In July 2005, their respective Dutch subsidiaries concluded an anticompetitive agreement to delay the market entry of a cheaper generic version of the pain-killer fentanyl in the Netherlands, in breach of EU antitrust rules.</blockquote> In more detail, <blockquote class="tr_bq"><div class="A_Standard__35__20_Normal">J&J initially developed Fentanyl and has commercialised it in different formats since the 1960s. In 2005, J&J's protection on the fentanyl depot patch had expired in the Netherlands and Novartis' Dutch subsidiary, Sandoz, was on the verge of launching its generic fentanyl depot patch. It had already produced the necessary packaging material. </div><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">However, in July 2005, instead of actually starting to sell the generic version, Sandoz concluded a so-called 'co-promotion agreement' with Janssen-Cilag, J&J's Dutch subsidiary. The agreement provided strong incentives for Sandoz not to enter the market. Indeed, the agreed monthly payments exceeded the profits that Sandoz expected to obtain from selling its generic product, for as long as there was no generic entry. Consequently, Sandoz did not offer its product on the market. The agreement was stopped in December 2006 when a third party was about to launch a generic fentanyl patch. </div><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">The agreement therefore delayed the entry of a cheaper generic medicine for seventeen months and kept prices for fentanyl in the Netherlands artificially high - to the detriment of patients and taxpayers who finance the Dutch health system.</div></blockquote><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">The obligatory colorful bits,</div><div class="A_Standard__35__20_Normal"> </div><blockquote class="tr_bq"><div class="A_Standard__35__20_Normal"> Why did J&J and Novartis conclude that agreement? According to internal documents Sandoz would abstain from entering the Dutch market in exchange for 'a part of [the] cake'. Instead of competing, Janssen-Cilag and Sandoz agreed on cooperation so as 'not to have a depot generic on the market and in that way to keep the high current price'. Janssen-Cilag did not consider any other existing potential partners for the so-called 'co-promotion agreement' but just focused on its close competitor Sandoz. Sandoz engaged in very limited or no actual co-promotion activities.</div></blockquote><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">So, </div><div class="A_Standard__35__20_Normal"> </div><blockquote class="tr_bq"><div class="A_Standard__35__20_Normal"> The Commission therefore concluded that the object of this agreement was anticompetitive and infringed Article 101 of the Treaty on the functioning of the European Union (TFEU). </div></blockquote><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">Johnson and Johnson's Ever Lengthening Unhappy Legal History There have been so many settlements made by, fines assessed against, and other adverse legal actions affecting Johnson and Johnson in the recent past that we must make a major revision of our summary of such cases (see same appended at the end of this post.)</div><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">Yet despite all these actions, there is no hint that anything will change at the company.  After all, it is extremely profitable, and all the fines, while they individually appear large, are not a big fraction of the money it brings in.  And, as we have noted far too often, not one of these actions actually provides any negative consequences, much less severely punishes anyone at the company who authorized, directed, or implemented the bad behavior.  </div><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">Instead, the leadership of the company continues to make itself very rich. As we wrote <a href="http://hcrenewal.blogspot.com/2013/07/johnson-and-johnson-settles-suit.html">here</a>,  Mr William Weldon, the outgoing CEO on whose watch most of the misbehavior resulting in the legal actions listed in the appendix below 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. One can only imagine how much top executives are making this year.</div><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">So Johnson and Johnson, once admired for proclaiming in its famous <a href="http://www.jnj.com/about-jnj/jnj-credo">credo</a> to "put the needs and well-being of the people we serve first," now seems to put its own hired managers first.  It boggles the mind that despite this amazing record of bad behavior, the executives who presided over it still have jobs, have made no obvious changes in how they manage the company, and in fact continue to get ridiculously rich.  The <a href="http://www.investor.jnj.com/governance/board.cfm">board of directors</a>, which includes the <a href="http://www.investor.jnj.com/governance/biodetail.cfm?bioid=4341">President of the University of Michigan</a>, a <a href="http://www.investor.jnj.com/governance/biodetail.cfm?bioid=4341">Professor and Emeritus Chancellor and Vice President of Health Affairs at Emory</a>, a <a href="http://www.investor.jnj.com/governance/biodetail.cfm?bioid=5191">Professor at MIT</a>, a <a href="http://www.investor.jnj.com/governance/biodetail.cfm?bioid=44646">former FDA Commissioner, and Senior Fellow at the Brookings Institute</a>, and the <a href="http://www.investor.jnj.com/governance/biodetail.cfm?bioid=40456">Vice Chancellor of Health Sciences, Dean of the David Geffen School of Medicine at the University of California, Los Angeles (UCLA); Chief Executive Officer of the UCLA Health System</a>, who seemingly ought to care about the integrity of evidence, protecting patients from harm, and the need for simple honesty, have not obviously done anything about the apparent massive violation of the company credo that has made its managers wealth.   Other than the stockholder lawsuit discussed below, the supposed owners of the company seem to be mute.</div><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">When will the straws break the camel's back?  In the absence of such a fracture, I repeat like an old, broken record... </div><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">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. Again, true health care reform would make leaders of health care organization accountable for their organizations' bad behavior.</div><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">Appendix - Johnson and Johnson Recent Legal Record</div><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal"></div><div class="A_Standard__35__20_Normal">2010 </div><div class="A_Standard__35__20_Normal">- Convictions in two different states in 2010 for misleading marketing of Risperdal - A guilty plea for misbranding Topamax in 2010 2011</div><div class="A_Standard__35__20_Normal">- 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>) 2012 </div><div class="A_Standard__35__20_Normal">- 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>). </div><div class="A_Standard__35__20_Normal">2013 </div><div class="A_Standard__35__20_Normal">-  In 2013, Johnson & Johnson settled case by shareholders alleging that management made misleading statements and withheld material information about manufacturing problems (see this <a href="http://hcrenewal.blogspot.com/2013/07/johnson-and-johnson-settles-suit.html">post</a>)</div><div class="A_Standard__35__20_Normal">-  In 2013, Johnson & Johnson Janssen subsidiary pleaded guilty to a charge of misbranding Risperdal, and settled for a total of $2.2 billion allegations that it promoted the drug for elderly demented patients and adolescents without an indication, and despite evidence of its harms (see this <a href="http://hcrenewal.blogspot.com/2013/11/another-and-huge-22-billion-settlement.html">post</a>).  </div><div class="A_Standard__35__20_Normal">-  In 2013, Johnson & Johnson DePuy subsidiary agreed to settle with multiple plaintiffs for $2.5 billion allegations that it sold defective mental-on-metal artificial hip, and hid evidence of its harms .</div><div class="A_Standard__35__20_Normal">- In 2013, Johnson & Johnsonn Janssen subsidiary was found by two juries to have concealed harms of its drug Topamax (see this <a href="http://hcrenewal.blogspot.com/2013/11/there-they-go-again-again-johnson-and.html">post</a> for this and above case).</div><div class="A_Standard__35__20_Normal">- In 2013, Johnson & Johnson Ethicon subsidiary's Advanced Surgical Products and two of its executives agreed to settle charges by US FDA that is sold mislabeled products used to sterilize equipment such as endoscopes (see this <a href="http://hcrenewal.blogspot.com/2013/12/how-many-straws-johnson-and-johnson.html">post</a>). </div><div class="A_Standard__35__20_Normal">- In 2013, Johnson & Johnson fined by European Commission for anticompetitive practices, that is, collusion with Novartis to delay marketing generic version of Fentanyl (in the current post above).  </div>

The Camel's Aching Back - Johnson and Johnson and Novartis Fined 16 Million Euro for "Anticompetitive" Scheme to Delay Generic Fentanyl

Legal and regulatory actions unfavorable for giant pharmaceutical, biotechnology and device company Johnson and Johnson just keep coming. W...

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A Second Order Cover Up? - Judge Finds Boehringer Ingelheim Allowed Destruction of Records Bearing on Allegations of Cover Up of Drug Adverse Effects

This case generated little coverage, a story in Bloomberg, and a <a href="http://www.pharmalive.com/boehringer-is-fined-nearly-1m-for-disappearing-documents">post</a> on PharmaLot, but perhaps should have received more attention. Background - the Pradaxa Case The background, per Bloomberg, is that <blockquote class="tr_bq">Boehringer [Ingelheim BmbH] is preparing to face the first federal court trial of claims that it hid Pradaxa’s bleeding risks. </blockquote>Pradaxa is dabigatran, a new anti-coagulant drug that can be used without frequent monitoring of blood tests, as is required when using the older drug warfarin.  However, unlike warfarin, the effects of dabigatran cannot be quickly reversed should a patient on the drug start to bleed. The reason for the trial is that <blockquote class="tr_bq">Patients and their families alleged that Boehringer executives knew Pradaxa posed a deadly risk to some consumers when they brought the drug to the U.S. market in October 2010. Unlike older blood thinners, researchers said, Pradaxa has no antidote to reverse its effects, which can lead to so-called bleed-out deaths. Pradaxa has generated more than $1 billion in sales worldwide for Boehringer, the world’s biggest family-owned drugmaker. Researchers have found it more effective at preventing strokes than older competitors, including Bristol-Myers Squibb Co.’s Coumadin. Consumers’ lawyers contend that Boehringer officials marketed the drug as superior to existing blood thinners when they knew its performance was not better than similar medicines. Pradaxa has been linked to more than 500 U.S. deaths over a two-year period, and Boehringer faces claims that it sold the drug knowing the medicine could cause bleed-outs among some patients, according to a federal panel that tracks consolidated cases. </blockquote> The Judge Found that by Letting Documents Vanish, the Company Committed "Egregious Wrongs" The trial has not yet begun, and the allegations by the plaintiffs are unproven.  However, Boehringer Ingelheim already is the subject of a finding by the judge, <blockquote class="tr_bq">Boehringer Ingelheim GmbH  GmbH, the German family-owned drugmaker, withheld or failed to preserve 'countless' files sought by patients suing over the company’s blood thinner Pradaxa and must pay a fine of almost $1 million, a judge ruled.  U.S. District Judge David Herndon in East St. Louis, Illinois, who’s overseeing more than 1,700 consolidated lawsuits over claims that Pradaxa caused excessive and sometimes fatal bleeding, concluded that Boehringer executives acted 'in bad faith' by failing to ensure that documents and files about the drug’s development and marketing were preserved. 'The wrongs here are egregious,' Herndon said in yesterday’s ruling. 'The gross inadequacy' of the company’s efforts to safeguard the documents justified a sanction of more than $931,000 against Boehringer, the judge said. </blockquote> The ruling apparently affirmed allegations made by the plaintiffs' lawyers, <blockquote class="tr_bq">The company can’t produce files of a high-level scientist involved in developing Prada’s or documents by consultants who worked on the marketing plan, patients’ lawyers alleged in court filings. The company also failed to order employees to save phone messages about their work on the medicine, they added. </blockquote> Of course, Boehringer Ingelheim contended otherwise, <blockquote class="tr_bq"> Boehringer said it has made 32 million pages of material about the drug available to the plaintiffs and has been bombarded with 'overly burdensome' document requests by patients’ lawyers, according to court filings. The company also argued that many of the documents sought by the plaintiffs’ attorneys are not relevant to the claims at issue. </blockquote> The judge vigorously disagreed, <blockquote class="tr_bq">In his 51-page ruling, Herndon said he was forced to deal with claims that Boehringer was improperly withholding documents from the inception of the case consolidation in 2012. Pradaxa suits filed in federal court across the country were gathered before Herndon for pretrial information exchanges. Boehringer officials 'made misrepresentations' about their efforts to preserve documents and failed to take obvious steps to preserve files and other records, the judge said. Boehringer executives 'failed to ensure the auto-delete feature of their employee cellphones, company owned and personal, was disengaged for the purpose of preserving text messages,'  Herndon said. This move 'allowed countless records to be destroyed.' </blockquote> Summary We have now discussed numerous examples of what appears to be organized <a href="http://hcrenewal.blogspot.com/search/label/deception">deception</a> by health care organizations about their products or their conduct.  Recent examples included a settlement by Johnson and Johnson of a case alleging its subsidiary had hid evidence about problems with a device for sterilization of endoscopes (look <a href="http://hcrenewal.blogspot.com/2013/12/how-many-straws-johnson-and-johnson.html">here</a>), and just before that a settlement in cases in which the same company was alleged to have hidden evidence about problems with a prosthetic hip device, and the drug Topamax (look <a href="http://hcrenewal.blogspot.com/2013/11/there-they-go-again-again-johnson-and.html">here</a>). The current case is an example of a second order deception, covering up an alleged cover up of a drug's adverse effects.  It appears that a culture of deception has taken hold in many of the world's most important health care organizations.  Deception and dishonesty may be seen as acceptable if it increases revenue, and hence the enrichment of top company insiders.  This seems to be the natural result of the belief that revenue is the only important goal, a product of the <a href="http://hcrenewal.blogspot.com/search/label/financialization">financialization</a> of the world produced by the <a href="http://hcrenewal.blogspot.com/2012/04/health-care-dysfunction-explained-by.html">shareholder value ideology</a> that dominates most Western business schools.  Pope Francis had a <a href="http://world.time.com/2013/11/26/pope-francis-denounces-idolatry-of-money-and-tyranny-of-capitalism/">more incisive description</a> of it, "the idolatry of money." Without vigorous efforts to discover and counteract the countless deceptions that big health care organizations use to make more money and make their executives richer, we will continue to pay ever more for ever poorer results for patients' and the public's health. Roy M. Poses MD for Health Care Renewal

A Second Order Cover Up? - Judge Finds Boehringer Ingelheim Allowed Destruction of Records Bearing on Allegations of Cover Up of Drug Adverse Effects

This case generated little coverage, a story in Bloomberg, and a post on PharmaLot, but perhaps should have received more attention. Backgr...

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Yet Another "Anecdote" - Inpatient Results of Electronic Prescribing "Disappointing"

Many of those in the Medical Informatics community, especially the academics in the upper echelons of the American Medical Informatics Association, are not of a risk recognition / risk management mindset.  Typical of academics, they are often also hostile towards dissent from the party line, as you can read about at my post "The Dangers of Critical Thinking in A Politicized, Irrational Culture" at <a href="http://hcrenewal.blogspot.com/2010/09/dangers-of-critical-thinking-in.html">http://hcrenewal.blogspot.com/2010/09/dangers-of-critical-thinking-in.html</a>. The academics, with a few exceptions, have repeatedly conflated scientific anecdotes of supposed positive results from health IT with risk management-relevant incident reports of bad outcomes and 'near misses', as an Australian colleague wrote about, via me, on August 17, 2011 at "Anecdotes and Medicine, We are Actually Talking About Two Different Things" at <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html</a>). They dismiss the latter incident reports, even when from well-qualified observers, while giving great attention and credence to the former [a few years as a safety manager in a large urban transit authority disabused me of that type of behavior - ed.], when the former conveniently fit their most cherished beliefs about the beneficence and efficacy of today's health IT.  Further, quality or lack thereof of the former type of evidence is often not considered.  See for instance my post of March 9, 2011 "ONC: The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results" at <a href="http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html">http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html</a> for a stunning example of this phenomenon directly from the national leadership of health IT. In my view, this phenomenon has led to a substantial loss of focus on health IT realities needed in order to remediate the industry and realize the true benefits of which the technology is capable. Now there's yet another "anecdote" at Med Page Today.com for the experts to chomp on: <blockquote class="tr_bq"><a href="http://www.medpagetoday.com/MeetingCoverage/ASHP/43400?utm_source=cardio-meetings&utm_medium=email&utm_content=mpt&utm_campaign=DCH">http://www.medpagetoday.com/MeetingCoverage/ASHP/43400?utm_source=cardio-meetings&utm_medium=email&utm_content=mpt&utm_campaign=DCH</a> E-Prescribing: Inpatient Results Disappointing Published: Dec 12, 2013 By Sarah Wickline , Contributing Writer, MedPage Today ORLANDO -- Electronic prescription order entry and medication reconciliation reduced some errors in hospital settings but increased others, and did not meet overall expectations, researchers reported here. After implementation of a computerized prescriber order entry (CPOE) system, one hospital experienced a 29.2% increase in medication dispensation errors (P less than 0.05), Ramadas Balasubramanian, PharmD, PhD, of the Carolinas Medical Center-Pineville in Charlotte, N.C., and colleagues reported at the midyear meeting of the American Society of Health-System Pharmacists.</blockquote> It is likely these are qualified observers who in fact might be expected to be biased towards showing good results of this technology. <blockquote class="tr_bq">In a second study, another hospital experienced a 12% improvement in accuracy (P less than 0.001) after implementation of electronic medication reconciliation charts, according to Jill Covyeou, PharmD, of Ferris State University in Big Rapids, Mich., and colleagues.</blockquote> For the tens of millions of dollars likely spent to achieve a mere 12% improvement, one wonders if a far less expensive investment in experienced human resources might not have accomplished the same results or even far better. <blockquote class="tr_bq">For their study, Balasubramanian and colleagues looked at the impact of CPOE on medication errors in a community hospital setting. At the end of 2011, when the Carolinas Medical Center-Pineville hospital had only 119 beds, officials there implemented the CPOE-CANOPY system. In early 2012, the hospital nearly doubled in capacity to 210 beds and opened the pharmacy to 24-hour operation. The researchers looked at medical errors from October 2008 through October 2012. The categories of medication errors included: drug omission, administration at the wrong time, unauthorized drug, wrong dose, and wrong form of dose. </blockquote> Any of which, of course, can harm or kill, I note. <blockquote class="tr_bq">There was a 57% increase in medication doses from prior to the CPOE system to after implementation, but even after volume adjustments, the number of errors per 1,000 dispensed medications still increased by 29.2% (P less than 0.05).</blockquote> Bad health IT such as CPOE systems designed for (per Joan Ash) "calm and solitary office environments" would be expected to perform more poorly as caseloads increase and clinicians have less time for computer fritter. <blockquote class="tr_bq"> Unauthorized drug dispensation and improper dose of medication decreased post-CPOE, but drug omission and administration at the wrong time were responsible for the increase.</blockquote> Those seem to match the expressed concerns of another large group of "anecdote-profferers", e.g., the nurses at my Nov. 17, 2013 post "Another 'Survey' on EHRs - Affinity Medical Center (Ohio) Nurses Warn That Serious Patient Complications 'Only a Matter of Time' in Open Letter" at <a href="http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html">http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html</a>: From those nurses' Open Letter to management on health IT risks: <blockquote class="tr_bq">... Some of the concerns that nurses have brought to the attention of management include: <ul><li>Medication errors/scanning issues - perhaps the biggest concern of all RNs</li><li>RNs unable to access patient records for hours at  a time</li><li>Incorrect descriptors and inaccurate drop-down menus</li><li>Incorrect calculations in the I&O and MAP [mean arterial pressure - ed.] portions of the chart </li><li>Inaccurate medication times and the inability of RNs to ensure medications are scheduled correctly</li><li>Endless loops of computer prompts that are unable to be dismissed by RNs in an emergency</li></ul></blockquote> Back to the current Med Page Today.com article: <blockquote class="tr_bq">The use of CPOE software created a time cut-off issue that explained the wrong time of administration increase, the study authors told MedPage Today. If drugs were ordered 5 minutes after the cut-off for the morning medication administration, they would not make it to the patient until the evening rounds unless a special alert was sent to the nurse staff.</blockquote> That is, a time-eating and fragile (and thus potentially dangerous} workaround.  I note that one does not have to work around something that is not standing in their way. <blockquote class="tr_bq">Balasubramanian and colleagues suggested that the lack of flexibility in the CPOE software was responsible for the drastic increase in medication errors, despite the fact that they thought it would improve error rates across the board.</blockquote> In other words, the software is not truly fit for purpose.  See definition of "bad health IT" below. <blockquote class="tr_bq">... The authors suggested that electronic prescribing would be better with electronic medical records. "[E]lectronic prescribing alone may fail to increase medication list accuracy to the extent we would like," Covyeou wrote.</blockquote> Replace "may fail" with "in our case, did fail." The point about adding an EHR is certainly in the category of "wishful thinking." If the EHRs are bad health IT, I opine the situation would likely get even worse (cf. Affinity Health, above). From my site at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases">http://cci.drexel.edu/faculty/ssilverstein/cases</a>/:  <blockquote class="tr_bq">Bad Health IT ("BHIT") is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.</blockquote> In summary, the technology is not a panacea, and can in fact be worse than paper.  Those who blindly ignore that reality and push for mass rollout of this still-experimental technology "no matter what" do not share, in my opinion, the ethics I was taught in Medical School. -- SS

Yet Another "Anecdote" - Inpatient Results of Electronic Prescribing "Disappointing"

Many of those in the Medical Informatics community, especially the academics in the upper echelons of the American Medical Informatics Ass...

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BLOGSCAN - US Supreme Court Turns Down Pfizer Appeal of RICO Conviction

Pfizer Inc, which boasts of being the world's largest research based pharmaceutical company, also seems to be one of the world's largest examples of health care corporations that have withstood an amazing number of settlements, fines, and at times convictions for misbehavior without major apologies, significant changes in leadership or corporate culture, or bankruptcy.  (Look <a href="http://hcrenewal.blogspot.com/2013/07/pfizers-umpteenth-settlement-for-491.html">here</a> for a list of the cases, and <a href="http://hcrenewal.blogspot.com/search/label/Pfizer">here</a> for all we have written about Pfizer).   Pfizer, amazingly, has the malodorous distinction of having been convicted by a US jury as a RICO - a racketeering influenced corrupt organization in 2010 (look <a href="http://hcrenewal.blogspot.com/2010/03/settlement-and-conviction-round-up.html">here</a>).  Pfizer executives, of course, kept their office of counsel busy by appealing the conviction, all the way up to the US Supreme Court. As <a href="http://1boringoldman.com/index.php/2013/12/11/r-i-c-o/">discussed</a> on the 1BoringOldMan blog, the court has now turned down the appeal and let the conviction, which had been affirmed by lower federal court, stand.   So Pfizer is now officially a racketeering influenced corrupt organization.   Yet although the description of the RICO statute that 1BoringOldMan quoted notes the law can be used to go after the leaders of organized crime, no individual at Pfizer who authorized, directed, or implemented the relevant misbehavior, which was in this case the promotion of Neurontin for off-label uses, for which its benefits were at best unproven, at worse nonexistent, even if its harms are well-documented.  Thus even this RICO conviction has not affected the impunity of top health care corporate leaders.  As we have said endlessly, true health care reform will not occur until the leaders of large health care organizations are made accountable for their actions, and are prevented from becoming amazingly rich while their organizations repeatedly commit unethical or illegal acts that harm patients' and the public's health.    ADDENDUM (14 December,2013) - The <a href="http://hcrenewal.blogspot.com/2013/12/blogscan-us-supreme-court-turns-down.html">followup post</a> at 1BoringOldMan on this topic includes some optimism that now that the validity of the RICO concept applied to a large health care corporation has been affirmed, more stringent law enforcement may follow.   Roy M. Poses MD for Health Care Renewal

BLOGSCAN - US Supreme Court Turns Down Pfizer Appeal of RICO Conviction

Pfizer Inc, which boasts of being the world's largest research based pharmaceutical company, also seems to be one of the world's lar...

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JOBSCAN - Project Officer to Address Corruption in the Pharmaceutical and Health Care Sector in the UK

It is extremely rare that I see a job posting relevant to Health Care Renewal, but amazingly saw one today: <div align="left"> Job Opportunities at Transparency International </div> <div align="left"> <div> <h3>Project Officer, Corruption in Pharmaceutical & Healthcare Sector, Transparency International UK</h3> Application Closing Date - 03 Jan 2014 Job Start Date - February 2014 or as soon as possible thereafter Duration - This appointment is for one year initially Pay Scale - £26,000-30,000 pa depending on experience Location - Transparency International UK, London, UK <a href="http://www.transparency.org/whoweare/work/project_officer_corruption_in_pharmaceutical_healthcare_sector_transparency" target="_blank">View the whole posting</a></div><div> </div><div>I would urge anyone interested to apply soon.  The deadline is coming up.  I am glad to see that Transparency International in the UK is addressing corruption in health care.  </div><div> </div><div>Roy M. Poses MD on Health Care Renewal </div></div>

JOBSCAN - Project Officer to Address Corruption in the Pharmaceutical and Health Care Sector in the UK

It is extremely rare that I see a job posting relevant to Health Care Renewal, but amazingly saw one today: ...

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44% of hospitals reported to HHS that they can delete the contents of their EHR audit logs whenever they'd like?

Modern Healthcare published an article "Feds eye crackdown on cut-and-paste EHR fraud" on Dec. 10, 2013 by <a href="mailto:jcarlson@modernhealthcare.com" target="_blank">Joe Carlson.</a> The article is about federal efforts to reduce the amount of clinician cut-and-paste from prior notes of a patient - which can even be done between charts of different patients.  This practice can result in overbilling for work not actually performed.  The practice can also result in no-longer-accurate data being carried forward; I have been consultant to cases where that phenomenon, in my opinion, contributed to grave patient injury in cases that have settled out of court. It is at this link:  <a href="http://www.modernhealthcare.com/article/20131210/NEWS/312109965/feds-eye-crackdown-on-cut-and-paste-ehr-fraud?utm_source=articlelink&utm_medium=website&utm_campaign=TodaysHeadlines#">http://www.modernhealthcare.com/article/20131210/NEWS/312109965/feds-eye-crackdown-on-cut-and-paste-ehr-fraud?utm_source=articlelink&utm_medium=website&utm_campaign=TodaysHeadlines#</a> Subscription required, but googling the article title may allow reading it in its entirety. The article begins: <blockquote class="tr_bq">Federal officials say the cut-and-paste features common to <a href="http://www.modernhealthcare.com/section/articles?tagID=975" target="_blank">electronic health records</a> invite fraudulent use of duplicated clinical notes and that there is a need to clamp down on the emerging threat. That concern is enhanced by the fact that it's too easy to turn off features of EHR systems that allow tracking of sloppy or fraudulent records. <div> In an <a href="http://www.modernhealthcare.com/assets/pdf/CH92135129.PDF" target="_blank">audit report released Tuesday morning (PDF)</a>, [HHS Office of Inspector General, "NOT ALL RECOMMENDED FRAUD SAFEGUARDS HAVE BEEN IMPLEMENTED IN HOSPITAL EHR TECHNOLOGY"], HHS agencies confirmed that they are developing comprehensive plans to deter <a href="http://www.modernhealthcare.com/section/articles?tagID=687" target="_blank">fraud</a> and abuse involving EHRs, including guidelines for cut-and-paste features. The issue arises at a time when critics say federally subsidized digital patient record systems are sometimes being used inappropriately by providers to drive up reimbursement.</div> “Certain EHR documentation features, if poorly designed or used inappropriately, can result in poor data quality or fraud,” according a report from HHS' Office of the Inspector General.</blockquote> None of this is a surprise to me, and to readers of this blog. However, the real "money quote" in the article, I believe, is this: <div style="margin-left: 40px;">"In addition, only 44% of hospitals' “audit log” systems could record whether cut-and-paste was used to enter data, and an identical percentage of hospitals reported [to OIG] that they can delete the contents of their internal audit logs whenever they'd like."</div> From page 11 of the HHS OIG Report linked above (<a href="http://www.modernhealthcare.com/assets/pdf/CH92135129.PDF">http://www.modernhealthcare.com/assets/pdf/CH92135129.PDF</a>): [In 2006, ONC contracted with RTI International (RTI) to develop recommendations to enhance data protection; increase data validity, accuracy, and integrity; and strengthen fraud protection in EHR technology.] <blockquote class="tr_bq">... Hospitals' control over audit logs may be at odds with their RTI- recommended use as fraud safeguards: RTI recommends that EHR users not be allowed to delete the contents of their audit log so that data are always available for fraud detection, yet nearly half of hospitals (44 percent) reported that they can delete their audit logs. Although these hospitals reported that they limit the ability to delete the audit log to certain EHR users, such as system administrators, one EHR vendor noted that any software programmer could delete the audit log. RTI recommends that the ability to disable the audit log be limited to certain individuals, such as system administrators, and that EHR users, such as doctors and nurses, be prevented from editing the contents of the audit log because these actions can compromise the audit log's effectiveness. Hospitals reported they have the ability to disable (33 percent) and edit (11 percent) their audit logs, although they reported restricting those abilities to certain EHR users, such as system administrators or EHR vendors. All four EHR vendors we spoke with reported that the audit logs cannot be disabled in their products, but one vendor again noted that a programmer could disable the audit log.</blockquote> I further note that, being voluntarily provided, i.e., not part of a formal investigation of any specific organization, those numbers are likely low, perhaps very low considering this issue. An audit log or audit trail is an automatically-generated dataset, invisible to most users, containing items such as who viewed records, the date/time/location of viewing, and indication of actions they may have performed on the records such as editing/changes/additions/deletions, etc. As an EHR itself is a collection of magnetized or optically encoded bits on some computer storage medium, it cannot be authenticated as complete and free from alteration by humans. The audit trail is the only way to authenticate an EHR printout, however (as well as EHR screenshots or any other electronic data turned into a tangible form from those bits) as complete and free from alteration. If an EHR printout cannot be authenticated as complete and free from alteration, its trustworthiness and perhaps even court admissibility as a business record under an exception to the hearsay rules regarding evidence may be damaged or invalidated. My concern is that, if true, and considering the conflict of interest a hospital has regarding hiding potential fraud or malpractice that could cost them millions of dollars, a capability to "delete the contents of their internal audit logs whenever they'd like" and to edit audit trails (which based on the capabilities of relational databases also implies an ability to delete sections of audit logs selectively and/or to substitute false data) is simply alarming. I don't think the EHR pioneers intended EHRs to be used for purposes of allowing evidence spoliation without traceability ... -- SS Dec. 13, 2013 Addendum: I received the following reply from EHR compliance expert Dr. Reed D. Gelzer.  Re-posted with permission: <blockquote class="tr_bq"> Good morning Dr Silverstein, Thank you yet again for the illumination that you bring to matters of truth in Healthcare Information Technology. Regarding the OIG report’s source document, the 2007 report to the ONC, I was the Fraud Prevention Workgroup Chair for that project, working under Principal Investigators Dr. Don Simborg and Susan Hanson, former Chair of AHIMA.  For anyone who is interested in this subject matter, I would recommend that you go to the source document and, among other things, review the list of contributors.  These were all individuals who volunteered time to attempt to mitigate harms of defective HIT, in their capacities of records management systems, nearly 8 years ago now.   Many have gone on into leadership roles in related organizations and domains, some still working towards trustworthy health information technology systems. I believe that I can say that none of those working on the report then would have believed that it was conceivable that even our most basic recommendations regarding the fitness of audit functions would remain "novel" in the industry in 2013.  One cannot be surprised at the low level of authenticity supports in hospitals’ EHRs systems given that fitness as record management systems for patient care has, to date, been either neglected or presumed, not tested or attested.   I am gratified that our 2007 work was utilized for the OIG report to illuminate the deplorable state of integrity supports in these patient care information systems.  This will undoubtedly spur interest in supportive resources such as the HL7 EHR System Functional Model Standard and the HL7 Records Management and Evidentiary Support Profile Standard. All of us who worked on that ONC report are, I hope, as gratified as I am that the OIG removed our work product from its designated obscurity.   We developed the guidelines via methods that were more qualitative than quantitative, entirely intended to guide initial implementation backed by more methodical research.   We represented the most informed at that time, including those like myself and my ADIC associate Patricia Trites who had performed compliance testing on over 30 among the leading EHRs at the time and found extraordinary ranges of deficiencies, including audit functions that could be disabled at will.   Standards and tools existed then to support mitigation of risks and those Standards and tools have expanded since.  Now that the events and ONC decisions that led to inactions on the report are now in the past, we can more rapidly achieve the potentials nascent in HIT by rendering it more trustworthy, usable, and safe. Thank you again for your ongoing vigilance. Sincerely, Reed D. Gelzer, MD, MPH, CHCC Trustworthy EHR, LLC Co-Facilitator, HL7 Records Management and Evidentiary Support Workgroup</blockquote> To this I add that I also would not have found it conceivable that my concerns about bad health IT and the risks of patient harm it poses, as well as common healthcare IT project mismanagement, of which I started writing about in 1998 (<a href="http://cci.drexel.edu/faculty/ssilverstein/cases/">http://cci.drexel.edu/faculty/ssilverstein/cases/</a>) would remain "novel" ideas in the industry in 2013. The Obamacare healthcare exchange website debacle has made the latter issue mainstream.  The former issues still need more sunlight. -- SS 2/4/14 addendum: HHS is apparently starting to pay attention to the importance of robust and secure EHR audit trails. I note in the HHS document "Meaningful Use Stage 2, 2014 Edition EHR CERTIFICATION CRITERIA 45 CFR 170.314", page 7, regarding audit trails, available at this writing at <a href="http://www.healthit.gov/sites/default/files/meaningfulusetablesseries2_110112.pdf">http://www.healthit.gov/sites/default/files/meaningfulusetablesseries2_110112.pdf</a>: <div style="margin-left: 40px;">§170.314(d)(2) Auditable events and tamper-resistance. (i) Record actions. EHR technology must be able to: </div><div style="margin-left: 80px;">(A) Record actions related to electronic health information in accordance with the standard specified in § 170.210(e)(1); (B) Record the audit log status (enabled or disabled) in accordance with the standard specified in § 170.210(e)(2) unless it cannot be disabled by any user; and (C) Record the encryption status (enabled or disabled) of electronic health information locally stored on end-user devices by EHR technology in accordance with the standard specified in § 170.210(e)(3) unless the EHR technology prevents electronic health information from being locally stored on end-user devices (see 170.314(d)(7) of this section). </div><div style="margin-left: 40px;"> (ii) Default setting. EHR technology must be set by default to perform the capabilities specified in paragraph (d)(2)(i)(A) of this section and, where applicable, paragraphs (d)(2)(i)(B) or (d)(2)(i)(C), or both paragraphs (d)(2)(i)(B) and (C). (iii) When disabling the audit log is permitted. For each capability specified in paragraphs (d)(2)(i)(A), (B), and (C) of this section that EHR technology permits to be disabled, the ability to do so must be restricted to a limited set of identified users. (iv) Audit log protection. Actions and statuses recorded in accordance with paragraph (d)(2)(i) must not be capable of being changed, overwritten, or deleted by the EHR technology. (v) Detection. EHR technology must be able to detect whether the audit log has been altered.  </div> From a posting at <a href="http://healthcaresecprivacy.blogspot.com/2012/09/meaningful-use-stage-2-audit-logging.html">http://healthcaresecprivacy.blogspot.com/2012/09/meaningful-use-stage-2-audit-logging.html</a>: <blockquote class="tr_bq">... The Information that needs to be recorded: § 170.210(e)(1)(i):  These rules [in a column I did not show here - ed.] identify “sections 7.2 through 7.4, 7.6, and 7.7 of the standard specified”. This is simply the list of attributes that an audit log entry should contain that <a href="http://www.astm.org/Standards/E2147.htm" target="_blank">ASTM E2147</a> says are mandatory, and excludes the values it outlines as important but not mandatory. Below is about 90% of what is in section 7, I didn't want to copy all of it out of respect for the copyright. But, the part missing is just a one-line definition of each item, nothing more than that. </blockquote><blockquote class="tr_bq">7. Audit Log Content 7.1 Audit log content is determined by regulatory initiatives, accreditation standards, and principles and organizational needs. Information is needed to adequately understand and oversee access to patient identifiable data in health information systems in order to perform security oversight tasks responsibly. Logs must contain the following minimum data elements: 7.2 Date and Time of Event 7.3 Patient Identification 7.4 User Identification 7.5 Access Device (optional) 7.6 Type of Action (additions, deletions, changes, queries, print, copy) 7.7 Identification of the Patient Data that is Accessed(optional) 7.8 Source of Access (optional unless the log is combined from multiple systems or can be indisputably inferred) 7.9 Reason for Access (optional) 7.10 If capability exists, there should be recognition that both an electronic “copy” operation and a paper “print” operation are qualitatively different from other actions.</blockquote> I am not sanguine about the "optional" components, especially 7.7 - the actual data that was accessed and acted upon. I also note it is stunning that these audit trail 'rules' have only been promulgated recently.  It will be interesting to see how rigorous the EHR "certification" process will be regarding audit trails. -- SS

44% of hospitals reported to HHS that they can delete the contents of their EHR audit logs whenever they'd like?

Modern Healthcare published an article " Feds eye crackdown on cut-and-paste EHR fraud " on Dec. 10, 2013 by Joe Carlson. The arti...

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For Whom the Door Revolves - from For-Profit Contract Research Organization Leadership to Surgeon General?

The new nominee to be US Surgeon General is Dr Vivek Murthy, as <a href="http://www.boston.com/lifestyle/health/blogs/white-coat-notes/2013/11/14/obama-nominating-vivek-murthy-harvard-and-brigham-and-women-surgeon-general/eo6mit1nNtLpUxE6VrizLJ/blog.html">announced</a> in the Boston Globe White Coat Notes blog in November.  A Boston Globe <a href="http://www.bostonglobe.com/metro/2013/11/15/murthy-obama-choice-for-surgeon-general-who-likes-practice-outside-hospital-walls/KwrWaarq2lkrDMy1vXLNEP/story.html">article</a> a few days described not only his "healthy lifestyle" which included ingestion of "unflavored almond milk, raw carrots, and high-protein grains," as well as the practice of yoga, but how he has <blockquote class="tr_bq">strived to use his medical degree to help patients beyond the hospital walls through starting health care companies and nonprofits. His supporters hope that his record stands out....</blockquote> While the US Surgeon General has little power, occupants of the office have tried to use it as a bully pulpit, often for public health issues.  For example, <a href="http://www.surgeongeneral.gov/about/previous/biokoop.html">Dr C Everett Koop</a> was known for his campaign against smoking, and his advocacy for public health measures to combat HIV.   Most previous Surgeons General came from academic, public health, and/or practice backgrounds (Dr Koop was Physician-in-Chief of the Childrens Hospital in Philadelphia; his successor, Dr Antonia Caremello was in academic pediatrics, private practice, and at the NIH; then Dr M Jocelyn Elders also came from academic pediatrics, etc.) Dr Murthy superficially seems to come from this tradition.  The Globe article noted his "professional life as a Brigham and Women's Hospital [a prestigious Harvard teaching institution] physician." However, Dr Murthy was also described by the official statement nominating him to be surgeon general as "Co-Founder and Chairman of the Board of TrialNetworks, formerly known as Epernicus, since 2007."  The Globe called it a "software start-up company in Needham ... to help drug developers efficiently collect information from clinical trials." But wait, an <a href="http://www.usatoday.com/story/opinion/2013/12/03/obama-health-care-surgeon-general-murthy-column/3863603/">op-ed</a> in early December in USA Today called him a "self described passionate entrepreneur" and "a part-time physician and a full-time businessman."  In fact, the TrialNetworks web-site describes a company that <blockquote class="tr_bq">provides sponsors and CROs the industry's only <a href="http://www.trialnetworks.com/platform/overview">Clinical Trial Optimization System</a>. Using this modern and intuitive cloud-based technology, customers such as Merck & Co. and Infinity Pharmaceuticals are able to transform the quality and efficiency of clinical operations at each stage of a trial from feasibility through closeout. Companies ranging from biotechs to Top-10 pharmas have implemented the TrialNetworks platform for use in Phase I-IV trials by more than 25,000 site staff in 60 countries.</blockquote>Thus, TrialNetworks is a form of for-profit contract research organization in that it is apparently paid by drug and biotechnology companies to help them do clinical trials and other clinical research. Its website includes <a href="http://www.trialnetworks.com/customers/overview">customer testimonials</a> from  Merck, Biogen Idec, Infinity Pharmaceuticals, and Ariad Pharma. So apparently Dr Murthy, if approved, may be the first US Surgeon General to come through the revolving door from a leadership position in a company that is a variant on the for profit contract research organization theme, an organization that supports clinical research by the pharmaceutical industry, and has major pharmaceutical and biotechnology corporate clients.  As we have discussed, most clinical research is now sponsored, and effectively run by for-profit drug, biotechnology and device companies, and is devoted to efforts by these companies to assess their own products, often ostensibly as required for regulatory approval, but often influenced by marketing considerations.  Unfortunately, the domination of clinical research by those with vested interests in having the research turn out in favor of their own products has resulted in many examples of <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation of the research</a>, and <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression </a>when that manipulation has failed to produce the desired results. So the obvious concern about Dr Murthy would be whether he would use his bully pulpit only to support patients' and the public's health,  or would his prior experience in a leadership position in commercially sponsored pharmaceutical research influence him in favor of that industry's priorities? As we have discussed, US health care is now dominated by for-profit corporations, and these organization can command the effort of multi-million or billion dollar marketing and public relations divisions to sell their products and the policy positions they favor.  These organizations hardly are in need of more bully pulpits.  Yet it seems that this new appointment will further increase the influence in government of big health care business, rather than that of health care professionals, patients, and the people in general. Sadly, it seems that Dr Murthy's nomination is just the latest example of how leadership of health care in government and in the corporate world now overlaps, and how the role of "pure" health care practitioners and health care academics in government has waned.  As we <a href="http://hcrenewal.blogspot.com/2013/10/former-fda-commissioner-cms.html">previously noted,</a>  the system in which government and big corporations largely overlap in terms of their leadership and presumably goals is called <a href="http://hcrenewal.blogspot.com/search/label/corporatism">corporatism</a>.  One can argue that such systems end up being run primarily for the benefit of corporate and government insiders.  Until we dispel the fog of corporatism that has spread over the government that was once supposed to be of the people, by the people, and for the people, expect no real health care reform, and expect continuing rising costs, declining access, and worsening patient care. Obviously, true health care reform would start with the government and its officials putting patients' and the public's health first, way ahead of the financial comfort of corporate leaders. I would note that neither the currently controversial and now operational Affordable Care Act, nor any of its opponents schemes for alternatives addresses this issue. by Roy M. Poses MD for Health Care Renewal

For Whom the Door Revolves - from For-Profit Contract Research Organization Leadership to Surgeon General?

The new nominee to be US Surgeon General is Dr Vivek Murthy, as announced in the Boston Globe White Coat Notes blog in November. A Boston ...

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