Amgen Settles, Pleads Guilty to Misbranding Aranesp

Now it's Amgen's turn to settle and plead.  <a href="http://www.nytimes.com/2012/12/19/business/amgen-agrees-to-pay-762-million-in-drug-case.html">Per the New York Times,</a><br /><br /><blockquote class="tr_bq"><i>The biotechnology giant Amgen marketed its anemia drug Aranesp for unapproved uses even after the Food and Drug Administration explicitly ruled them out</i>, federal prosecutors said on Tuesday.<br /><br /><div itemprop="articleBody"> The federal charges were made public as <i>Amgen pleaded guilty to illegally marketing the drug and agreed to pay <b>$762 million</b> in criminal penalties and settlements of whistle-blower lawsuits.</i> </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Amgen was '<i>pursuing profits at the risk of patient safety</i>' Marshall L. Miller, acting United States attorney in Brooklyn, said in a telephone news briefing on Tuesday. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">David J. Scott, Amgen’s general counsel, entered the guilty plea at the United States District Court in Brooklyn to <i>a single misdemeanor count of misbranding the drug, Aranesp</i>, meaning selling it for uses not approved by the F.D.A. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Amgen agreed to pay $136 million in criminal fines and forfeit $14 million, with about $612 million going to settle civil litigation. </div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">The article noted the key charge against Amgen,</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody"> In court on Tuesday, prosecutors charged that <i>Amgen had promoted the use of Aranesp to treat anemia in cancer patients who were not undergoing chemotherapy, even though the drug’s approval was only for patients receiving chemotherapy. </i></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><i>A subsequent study sponsored by Amgen showed that use of Aranesp by those nonchemotherapy cancer patients had actually increased the risk of death</i>, and the off-label use diminished. </div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Also,</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody"> The federal charges also say Amgen promoted using larger but less frequent injection of Aranesp than stated in the label as a way of making the drug more attractive to doctors and patients than Procrit, a rival anemia drug from Johnson & Johnson. </div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">As is typical of such cases, the prosecutors could not figure out how to charge any individuals who might have authorized, directed, or implemented the bad behavior,</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody"> Mr. Miller said that the<i> evidence in the Amgen case was not sufficient to charge individuals</i>. However, he said, Amgen agreed to sign a corporate integrity agreement that requires executives and board members to personally certify compliance with regulations. That would make it easier to prosecute individuals should violations occur again, he said. </div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><b>The Charges in Context</b></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">In some reports of the settlement, the issue appeared to be money.  For example, Pharmalot <a href="http://www.pharmalot.com/2012/12/amgen-to-plead-guilty-in-marketing-probe/">reported</a> that after a whistle-blower filed suit against Amgen, "a subsequent investigation by the Justice Department found that these practices induced physicians to use Amgen medications unnecessarily when lower cost alternatives were available." </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">However, Amgen's practices could have had much worse effects than just removing money from the US Treasury.</div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Consider the context.  Only a few of the not very numerous articles in the media on this case noted that the key complaint was that Amgen was pushing use of Aranesp for patients with cancer, specifically those not receiving chemotherapy.   (<a href="http://news.yahoo.com/amgen-pleads-guilty-misbranding-charges-pay-762-million-161356503--finance.html">Reuters</a> made this explicit, for example, but not so the <a href="http://www.latimes.com/business/la-fi-amgen-plea-20121219,0,7120268.story">Los Angeles Times,</a> or <a href="http://www.bloomberg.com/news/2012-12-18/amgen-expected-to-plead-guilty-to-charges-u-s-says.html">Bloomberg's initial coverage</a>.)</div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"> In fact, there has been concern about the adverse effects of Aranesp for patients with cancer for a while.  In 2007, Khuri noted in a commentary in the New England Journal of Medicine(1) that "concern about a detrimental effect of ESAs [erythropoiesis stimulating agents, a class of drugs of which Aranesp is a prominent member] in patients with cancer arose" after results of a small clinical trial of epoetin beta in patients with oral, pharyngeal or laryngeal cancer receiving radiation therapy showed worse survival in patients receiving that drug.  Subsequently, in 2008, a meta-analysis of multiple randomized clinical trials showed that patients with cancer receiving ESAs, including Aranesp, had an increased risk of venous thromboembolism (drug clots) and death.(2)  In 2009,  another meta-analysis showed that ESAs lead to decreased survival in patients with cancer.(3)</div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Recall, though, that Aranesp is meant to improve anemia.  It was not meant to cure cancer, or even put the disease into remission.  Its use therefore was mainly adjunctive.  Thus, it appears its benefits for cancer patients (improved anemia, and possibly decrease in such symptoms as fatigue) could not outweigh its harms (including hastening death).</div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">So the issue was not merely that Amgen was promoting a drug in an instance in which its use had not been improved by the US Food and Drug Administration (FDA), or that such use of the drug was unnecessarily costly.  The issue was that Amgen was promoting a drug that had no proven benefits for the patients, but could hasten their death.  It appears that Amgen was pursuing profits at the expense of lives.</div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><b>Summary</b></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">So it is particularly disturbing that no individual apparently will be held responsible for the promotion of Aranesp for patients for whom its use might prove fatal.  The assurance that the proposed corporate integrity agreement will prevent further abuse is notably hollow.  I can recall no recent case in which the government authorities have used such an agreement to pursue charges against individuals.  The likely deterrent effect of the monetary settlement will likely be minimal.  $762 million may look just like a cost of doing business when the drug in question was bringing in over $2 billion a year (<a href="http://www.latimes.com/business/la-fi-amgen-plea-20121219,0,7120268.story">per the Los Angeles Times</a>).  </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">So the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> march on and on.  The government continues to extract fines from health care organizations whose actions endanger not only the federal budget, but patients' well being and lives, without even trying to hold individuals responsible.  The impunity of health care corporate executives thus also continues.</div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">As we have said far too many times, we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.</div><div itemprop="articleBody"></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><b>References</b></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">1.  Khuri FR. Weighing the hazards of erythropoiesis stimulation in patients with cancer.  N Engl J Med 2007; 356: 2445-2447.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMp078101">here</a>.</div><div itemprop="articleBody">2.  Bennett CI, Silver SM, Djulbegovic B et al.  Venous thromboembolism and mortality associated with recombinant erythropoietin and darbepoetin administration for the treatment of cancer-associated anemia.  JAMA 2008; 299: 914-924.  Link <a href="http://jama.jamanetwork.com/article.aspx?articleid=181533">here</a>.</div><div itemprop="articleBody">3.  Bohlius J, Schmidlin K, Brillant C et al.  Recombinant human eryhtropoiesis-stimulating agents and mortality in patients with cancer: a meta-analysis of randomised trials.  Lancet 2009; 373: 1532-1542.  Link <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2809%2960502-X/abstract">here</a>.</div>

Amgen Settles, Pleads Guilty to Misbranding Aranesp

Now it's Amgen's turn to settle and plead.  Per the New York Times, The biotechnology giant Amgen marketed its anemia drug Aranesp ...

Đọc thêm »

A Significant Additional Observation on the PA Patient Safety Authority Report "The Role of the Electronic Health Record in Patient Safety Events" -- Risk

At a Dec. 13, 2012 post "<a href="http://hcrenewal.blogspot.com/2012/12/pennsylvania-patient-safety-authority.html" target="_blank">Pennsylvania Patient Safety Authority: The Role of the Electronic Health Record in Patient Safety Events</a>" I alluded to <i>risk</i> in a comment in red italics: <br /><br /><blockquote class="tr_bq"><span style="font-family: Arial,Helvetica,sans-serif;"><span class="ms-rteCustom-text-PSASubhead1-H"><span class="ms-rteCustom-text-PSABody-P">... Reported events were categorized by their reporter-selected harm score (see Table 1). Of the 3,099 EHR-related events, 2,763 (89%) were reported as “event, no harm” (e.g., an error did occur but there was no adverse outcome for the patient) <span style="color: red;"><i><b>[a risk best avoided to start with, because luck runs out eventually - ed.]</b></i></span>, and 320 (10%) were reported as “unsafe conditions,” which did not result in a harmful event.  </span></span></span></blockquote><br />The focus of the report is on how the "events" <i>did not </i>cause harm.  Thus the relatively mild caveat:<br /><blockquote class="tr_bq"><br /><span style="font-family: Arial,Helvetica,sans-serif;">"<span class="ms-rteCustom-text-PSASubhead1-H"><span class="ms-rteCustom-text-PSABody-P">Although the vast majority of EHR-related reports did not document actual harm to the patient, analysts believe that further study of EHR-related near misses and close calls is warranted as a proactive measure."</span></span></span> </blockquote><br />It occurs that if the title of the paper had been "<b><i>The Role of the Electronic Health Record in</i> <i>Patient Safety <span style="color: red;"><u>Risk</u></span></i></b>", the results might have been interpreted far differently:<br /><br />In essence, from from June 2, 2004, through May 18, 2012 (the timeframe of the Pennsylvania Patient Safety Reporting System or PA-PSRS database), from a dataset <b>highly limited in its comprehensiveness</b> as written in the earlier post, <u>there were approximately 3,000 "events" where an error did occur that potentially put patients at risk</u>.<br /><br />That view - risk - was not the focus of the study.  Should it have been?<br /><br />These "events" really should be called "risk events." <br /><br />It is likely the tally of <b>risk events</b>, if the database were more comprehensive (due to better recognition of HIT-related problems, better reporting, etc.) would be much higher.  So would the reports of "harm and death" events as well.<br /><br />That patient harm did not occur from the majority of "<b>risk events</b>" was through human intervention, which is to say,<i> luck</i>, in large part<br /><br />Luck runs out, eventually.<br /><br />I have personally saved a relative several times from computer-related "risk events" that could have caused harm if I were not there personally, and with my own medical knowledge, to have intervened.  My presence was happenstance in several instances; in fact a traffic jam or phone call could have caused me to have <b>not </b>been present.<br /><br />What's worse, the report notes:<br /><br /><blockquote class="tr_bq">Analysts noted that EHR-related reports are increasing over time, which was to be expected as adoption of EHRs is growing in the United States overall.</blockquote><br />In other words, with the current national frenzy to implement healthcare information technology, these "risk events" - and "harm and death events" - counts will increase.  My concern is that they will increase significantly.<br /><br />I note that health IT is likely the only mission-critical technology<b> that receives special accommodation regarding risk events</b>.  "If the events didn't cause harm, then they're not that important an issue" seems to be the national attitude overall.<br /><br />Imagine aircraft whose avionics and controls periodically malfunction, freeze, provide wrong results, etc., but most are caught by hyper-vigilant pilots so planes don't go careening out of control and crash.  Imagine nuclear plants where the same occurs, but due to hypervigilance the operators prevent a nuclear meltdown.<br /><br />Then, imagine reports of these "risk events" - based on fragmentary reporting of pilots and nuclear plant operators reluctant to do so for fear of job retaliation - where the fact of their occurrence takes a back seat to the issue that the planes did not crash, or Three Mile Island or Chernobyl did not reoccur.<br /><br />That, in fact, seems to be the culture of health IT.<br /><br />I submit that<i> the major focus that needs addressing in health IT is <b>risk</b> </i>- not just confirmed body counts. <br /><br />-- SS<br /><br />

A Significant Additional Observation on the PA Patient Safety Authority Report "The Role of the Electronic Health Record in Patient Safety Events" -- Risk

At a Dec. 13, 2012 post " Pennsylvania Patient Safety Authority: The Role of the Electronic Health Record in Patient Safety Events &qu...

Đọc thêm »

The "King of Pain" Recants - Pharmaceutical Paid Key Opinion Leader Admits It Was All "Misinformation"

This may be a first.  A Wall Street Journal <a href="http://online.wsj.com/article/SB10001424127887324478304578173342657044604.html">story</a> announced that the "key opinion leader" who played a pivotal role in the promotion of  aggressive use of narcotics to treat non-malignant chronic pain has had a change of heart.   <br /><br /><b>Background - Embracing Narcotics</b><br /><br />In the long ago time when I was in medical school, the wisdom was then that narcotics (that is, drugs like morphine or heroin, the latter not legal) should only be used in severe acute pain, like that due to bad trauma or occurring post-operatively, or for the pain of terminal illnesses, like cancer.  The reason their use was so restricted was that the drugs were believed to cause frequent adverse effects, from severe constipation, to addiction, to respiratory depression and death.<br /><br />However, starting in the 1990s, the conventional wisdom changed.  Suddenly, the focus was on the under-treatment of chronic, but not malignant pain, and it became permissible, or even preferable, to use potent narcotics for this purpose.  Physicians like me who were very conservative in their use of narcotics were chastised for under-treating pain.<br /><br />The Wall Street Journal <a href="http://online.wsj.com/article/SB10001424127887324478304578173342657044604.html">article</a> explained how this radical change in approach was apparently engineered by a few key opinion leaders, particularly Dr Russell Portenoy.  It opened, <br /><br /><blockquote class="tr_bq">Two decades ago, the prominent New York pain-care specialist drove a movement to help people with chronic pain. He <i>campaigned to rehabilitate a group of painkillers derived from the opium poppy that were long shunned by physicians because of their addictiveness</i>.<br /><br /><i>Dr. Portenoy's message was wildly successful.</i> Today, drugs containing opioids like Vicodin, OxyContin and Percocet are among the most widely prescribed pharmaceuticals in America. </blockquote><br />The article provided graphics showing that per capita prescription narcotic use has more than tripled since 1999,  <br /><br /><b>A Change Driven by Wishful Thinking, not Evidence</b><br /><br />Unfortunately, as the article made clear, the radical change that seemed so odd to some of us physicians who were trained before the 1990s was not driven by any good evidence from clinical research.<br /><br />Per the WSJ,<br /><br /><blockquote class="tr_bq">Because doctors feared they were dangerous and addictive, opioids were long reserved mainly for cancer patients. But Dr. Portenoy argued that they could be also safely be taken for months or years by people suffering from chronic pain. Among the assertions he and his followers made in the 1990s: <i>Less than 1% of opioid users became addicted, the drugs were easy to discontinue and overdoses were extremely rare in pain patients.</i> </blockquote><br /><br />However, Dr Portenoy's contention seemed to be based only on a small case-series of patients, lacking any sort of control group, and too small and likely too selective to generalize, particularly to patients with chronic, non-malignant pain.(Portenoy RK, Foley KM.   Chronic use of opioid analgesics in non-malignant pain: report of 38 cases. Pain 1986; 25:171-86.  This article does not seem to be available online.)<br /><br /><blockquote class="tr_bq">In 1986, at the age of 31, he co-wrote a seminal paper arguing that opioids could also be used in the much larger group of people without cancer who suffered chronic pain. The<i> paper was based on just 38 cases</i> and included several caveats. Nevertheless, it opened the door to much broader prescribing of the drugs for more common complaints such as nerve or back pain. </blockquote><br /> Dr Portenoy also cited <br /><br /><blockquote class="tr_bq">the statistic that less than 1% of opioid users became addicted.<br /><br />Today, even proponents of opioid use say that figure was wrong. 'It's obviously crazy to think that only 1% of the population is at risk for opioid addiction,' said Lynn Webster, president-elect of the American Academy of Pain Medicine, one of the publishers of the 1996 statement. 'It's just not true.'<br /><br />The figure came from<i> a single-paragraph report in the New England Journal of Medicine in 1980 describing hospitalized patients briefly given opioids</i>.</blockquote><br />The reference here appears to be a letter to the New England Journal of Medicine ( Porter J, Jick H. Addiction rate in patients treated with narcotics. New England Journal of Medicine 1980; 302:123.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJM198001103020221">here</a>.)  This was literally one paragraph long, so the methods of the research it reported cannot be rigorously evaluated.  In any event, the letter appears to have retrospectively documented an observation of hospitalized patients who were given at least a single dose of narcotics, and thus appears not relevant to the effects of long-term narcotics on patients with chronic pain.  <br /><br />Thus, Dr Portenoy's enthusiasm for aggressive use of narcotics in non-malignant chronic pain was never based on any good evidence from well designed and performed randomized controlled trials with long-term followup that showed that narcotics were safe and effective in this setting.  At best, Dr Portenoy's and colleagues' contentions that narcotics should be liberally utilized for such patient were based on wishful thinking, not good evidence.<br /><br /><br /><b>A Change Driven by Stealth Marketing</b> <br /><br />The WSJ article documented how Dr Portenoy was a prime mover in what appeared to be deceptive stealth campaigns to market narcotics for chronic, non-malignant pain.  Dr Portenoy's 1986 case-series<br /><br /><blockquote class="tr_bq">opened the door to much broader prescribing of the drugs for more common complaints such as nerve or back pain.<br /><br />Charming and articulate, <i>he became a sought-after public speaker. He argued that opioids are a 'gift from nature' that were being forsaken because of 'opiophobia' among doctors. 'We had to destigmatize these drugs,'</i> said Dr. Portenoy. <br /><br />He rose to chairman of pain medicine and palliative care at Beth Israel Medical Center in New York. His small office is <i>studded with awards</i> and evidence of his offbeat sense of humor. He prominently displays a magazine mock-up that jokingly dubs him 'The King of Pain.'<br /><br />At medical conferences, <i>his confident, knowing manner helped smooth the way for his message.</i> Before an audience of government regulators, he once joked that he might tell a patient at low risk of abuse: 'Here, [have] six months of drugs. See you later,' he said, according to a Food and Drug Administration transcript. Amid laughter, he added, 'It's just hyperbole. I don't actually do that.' <br /><br />Steven Passik, a psychologist who once worked closely with Dr. Portenoy and describes him as his mentor, says their message <i>wasn't based on scientific evidence so much as a zeal to improve patients' lives. 'It had all the makings of a religious movement at the time</i>,' he says. 'It had that kind of a spirit to it.' </blockquote><br />So Dr Portenoy became a respected opinion leader.  His influence was demonstrated by how he generated disciples<br /><br /><blockquote class="tr_bq"> <i>Dr. Portenoy's ideas about opioids reached into mainstream medicine and attracted outspoken advocates</i>. In a 1998 talk in Houston, Alan Spanos, a South Carolina pain specialist, said patients with chronic noncancer pain could be trusted to decide themselves how many painkillers to take without risk of overdose. According to a recording, Dr. Spanos said he understood that a patient would simply 'go to sleep' before stopping breathing. While asleep, he said, the patient 'can't take a dangerous dose. It sounds scary, but as far as I know, nobody anywhere is getting burned by doing it this way.'</blockquote><br />Dr Portenoy was affiliated with organized efforts that facilitated the marketing of narcotics for chronic malignant pain.  The marketing used clinical practice guidelines to push narcotics<br /><br /><blockquote class="tr_bq"><i>Dr. Portenoy helped write a landmark 1996 consensus statement by two professional pain societies that said there was little risk of addiction or overdose among pain patients</i>. </blockquote><br />The campaign enlisted government regulators, and thus seemed to include an element of regulatory capture,<br /><br /><br /><blockquote class="tr_bq">One of Dr. Portenoy's chief complaints was that <i>doctors were reluctant to prescribe opioids because they feared scrutiny by regulators or law enforcement. In the second half of the 1990s, he and his followers campaigned successfully for policies to change that.</i><br /><br /><a href="http://www.blogger.com/blogger.g?blogID=9551150" name="U90171026145MLH"></a>In 1998, the Federation of State Medical Boards released <i>a recommended policy reassuring doctors that they wouldn't face regulatory action for prescribing even large amounts of narcotics, </i>as long as it was in the course of medical treatment. In 2004 the group <i>called on state medical boards to make undertreatment of pain punishable for the first time.</i></blockquote><br />This case demonstrated the direct involvement of pharmaceutical companies who sold narcotics, <br /><br /><blockquote class="tr_bq">That policy was drawn up with the help of <i>several people with links to opioid makers, including David Haddox, a senior Purdue Pharma executive</i> then and now. The <i>federation said it received nearly $2 million from opioid makers since 1997</i>. The federation says it derives the majority of its funding from administering medical licensing exams, credential verification, and data services.<br /><br />A <i>federation-published book outlining the opioid policy was funded by opioid makers including Purdue Pharma, Endo Health Soluttions Inc, and others, with proceeds totaling $280,000 going to the federation.</i> . </blockquote><br /> The campaign also involved an important hospital accrediting organization<br /><br /><blockquote class="tr_bq">In 2001,<i> the Joint Commission, [JCAHO] which accredits U.S. hospitals, issued new standards telling hospitals to regularly ask patients about pain and to make treating it a priority. </i>The now-familiar pain scale was introduced in many hospitals, with patients being asked to rate their pain from one to 10 and circle a smiling or frowning face.<br /><br /><i>The Joint Commission published a guide sponsored by Purdue Pharma</i>. 'Some clinicians have inaccurate and exaggerated concerns" about addiction, tolerance and risk of death, the guide said. "This attitude prevails despite the fact there is no evidence that addiction is a significant issue when persons are given opioids for pain control.'</blockquote><br /><br /><b>A Change Leading to Personal Enrichment</b><br /><br />Meanwhile, Dr Portenoy was personally profiting from his relationships with pharmaceutical companies<br /><br /><br /><blockquote class="tr_bq">Over his career, <i>Dr. Portenoy has disclosed relationships with more than a dozen companies, most of which produce opioid painkillers.</i> 'My viewpoint is that I can have those relationships, they would benefit my educational mission, they benefit in my research mission, and to some extent, they can benefit my own pocketbook, without producing in me any tendency to engage in undue influence or misinformation,' he said.<br /><br />Dr. Portenoy and Beth Israel declined to provide details of their funding by drug companies. A 2007 fundraising prospectus from Dr. Portenoy's program shows that <i>his program received millions of dollars over the preceding decade in funding from opioid makers including Endo, Abbott Laboratories, Cephalon, Purdue Pharma and  Johnson & Johnson. </i> </blockquote><br />He currently also appears to be on the advisory boards of  <a href="http://www.insideview.com/directory/zars-pharma-inc">Zars Pharma Inc</a>,  <a href="http://www.relevarepharma.com/index.php?option=com_content&view=article&id=11&Itemid=13">Relevare Therapeutics</a>, and <a href="http://www.cytogelpharma.com/board-of-managers.html">Cytogel Pharma</a>.<br /><br />Thus, it seems that Dr Portenoy fit the usual definition of <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">key opinion leader</a>.  He was regarded as an authority in his area and his opinions were obviously influential.  He was paid by health care corporations with interests in selling their goods or services, in this case, narcotic drugs, and was using his influence to promote individual patient care decisions and policy decisions that facilitated the widespread use of these drugs.  <br /><br /><b>A Change Leading to Sick and Dead Patients</b><br /><br />Since the campaign to "destigmatize" narcotics began, the US has seen what many have called an epidemic of narcotic adverse effects.  The WSJ article provided graphs showing that narcotic related deaths and hospital admissions both increased more than five times since 1999.   As the WSJ put it,<br /><br /><blockquote class="tr_bq"> some specialists now question whether the drugs should be prescribed so freely for months or years to people with chronic pain that isn't related to cancer, as Dr. Portenoy proposed 25 years ago. "People lost sight of the fact that <i>these are dangerous drugs that are highly addictive,</i>" said Jane Ballantyne, a pain specialist at the University of Washington. She once agreed with Dr. Portenoy and proponents of broad opioid use but now believes they need to be used more selectively.</blockquote><br /><br /><b>Dr Portenoy Recants</b><br /><br />What is most remarkable about this case is that it seems to be the first in which a highly influential industry paid key opinion leader has publicly had a change of heart. <br /><br /><blockquote class="tr_bq">Now, Dr. Portenoy and other pain doctors who promoted the drugs <i>say they erred by overstating the drugs' benefits and glossing over risks. 'Did I teach about pain management, specifically about opioid therapy, in a way that reflects misinformation? Well, against the standards of 2012, I guess I did,'</i> Dr. Portenoy said in an interview with The Wall Street Journal. 'We didn't know then what we know now.'</blockquote><br /><br />I would note there is some sophistry there.  There was never good evidence for narcotics' effectiveness or safety for patient with chronic, non-malignant pain.<br /><br />In fact, Dr Portenoy also admitted that, sort of,<br /><br /><blockquote class="tr_bq">'<i>Data about the effectiveness of opioids does not exist,' </i>Dr. Portenoy said in his recent Journal interview. To get a painkiller approved, companies must prove that it is better at reducing pain than a sugar pill during short trials often lasting less than 12 weeks. 'Do they work for five years, 10 years, 20 years?' Dr. Portenoy said in the Journal interview. 'We're at the level of anecdote.'</blockquote><br /><br />Again, it is not that the data that supported the use of the drugs has disappeared, or that new data has been developed that contradicts the old data.  There never has been any good data, that is, from well designed and performed randomized controlled trials that demonstrate that the benefits of narcotics outweigh their harms for patients with chronic, non malignant pain.  It does not exist now and it never existed. <br /><br />Dr Portenoy also admitted, <br /><br /><blockquote class="tr_bq">'<i>I gave innumerable lectures in the late 1980s and '90s about addiction that weren't true,'</i> Dr. Portenoy said in a 2010 videotaped interview with a fellow doctor. The Journal reviewed the conversation, much of which is previously unpublished. </blockquote><blockquote class="tr_bq">In it, Dr. Portenoy said<i> it was 'quite scary' to think how the growth in opioid prescribing driven by people like him had contributed to soaring rates of addiction and overdose deaths</i>. 'Clearly, if I had an inkling of what I know now then, I wouldn't have spoken in the way that I spoke. It was clearly the wrong thing to do,' Dr. Portenoy said in the recording. </blockquote><br />So not only did the Wall Street Journal article describe how the overuse of narcotics for chronic, non-malignant pain came from wishful thinking energized by the possibility of corporate and personal profit, it showed how the chief medical cheer leader for these drugs now admits he was wrong.<br /><br /><br /><b>Summary</b><br /><br />In summary, it appears that the huge increase in the use of narcotics to treat chronic, non-malignant pain was never based on clear convincing evidence from well-designed studies.  At best it was based on irrational enthusiasm and wishful thinking by some very vocal and persuasive advocates.  These advocates seemed to become "key opinion leaders," that is, influential people who promoted the use of pharmaceuticals while they were being paid by pharmaceutical companies, and were likely involved in what appears to be systematic stealth marketing campaign by the pharmaceutical companies that make narcotics.  These campaigns included production of clinical practice guidelines promoted as authoritative, and enlistment of accrediting organizations and government regulatory agencies.<br /><br />One particularly disturbing part of this story was the involvement of numerous people and organizations  entrusted by society to promote good medical care.  It shows how physicians, other health professionals, and the public at large must be very skeptical of vocal advocates of new, aggressive, "innovative" approaches, of clinical practice guidelines even those developed by apparently prestigious professional societies, of accrediting organizations, and of government regulators.  That is discouraging, and could lead to the cynical approach of simply not trusting anyone.<br /><br />I would note, however, that two ways the headlong rush to over-use of narcotics could have been derailed would have been:<br />-  employment of extreme skepticism of people paid by narcotics manufacturers advocating increased use of these drugs, no matter how distinguished, scholarly, or influential these people appear to be.  This suggests the need for general skepticism of people with financial relationships with health care corporations pushing the goods or services these corporations provide, or pushing policies that would aid the selling of those goods or services <br />-  a rigorous evidence-based medicine approach, meaning making clinical and policy decisions based on the best evidence found by systematic search from rigorously evaluated clinical research about the benefits and harms of these decisions, informed by patients' values.  Such an approach would have revealed there was never any good clinical evidence to support long-term use of narcotics for chronic, non-malignant pain, the particular "innovation" being pushed in this case.<br /><br />So I would argue that the case of the legal narcotics pushers underlines the need for utmost transparency about conflicts of interest affecting people and organizations that advocate for particular approaches to health care, and to the management of individual patients; continuing movement to bar at least the most egregious conflicts, as per the Institute of Medicine report on the topic (look <a href="http://hcrenewal.blogspot.com/2009/04/institute-of-medicine-report-on.html">here</a>); and the need for the very skeptical, rigorous application of true evidence-based medicine approaches.   <br /><br />Finally, I must note that this seems to be the first time that a prominent, highly influential key opinion leader  has recanted.  Maybe he will write an article entitled "Dr Drug Pusher?" - just joking, but at least one former  key opinion leader did write the confessional  "<a href="http://hcrenewal.blogspot.com/2007/11/most-popular-dr-drug-rep.html">Dr Drug Rep</a>."  Maybe this is the beginning of a movement toward health care based on logic and evidence rather than wishful thinking, irrational enthusiasm, or ideology, or even worse, on deception or personal enrichment.      <br /><br />

The "King of Pain" Recants - Pharmaceutical Paid Key Opinion Leader Admits It Was All "Misinformation"

This may be a first.  A Wall Street Journal story announced that the "key opinion leader" who played a pivotal role in the promot...

Đọc thêm »

Pfizer's 13th Legal Settlement - Will it be Enough to End the Impunity?

It has been almost two months since we lasted <a href="http://hcrenewal.blogspot.com/2012/10/when-clinical-trials-are-meant-for.html">noted</a> misbehavior by giant global pharmaceutical firm Pfizer Inc. With little fanfare, however, a few small news items noted the corporation's latest legal settlements.<br /><br /><b>Deceptive Marketing of Protonix </b><br /><br />The first settlement merited only a few paragraphs <a href="http://www.reuters.com/article/2012/12/12/us-pfizer-settlement-idUSBRE8BB19O20121212">from Reuters</a>.  The gist was:<br /><br /><blockquote class="tr_bq"><span id="articleText"><span class="focusParagraph"><span class="articleLocatio</span>n"><i>Pfizer Inc will pay $55 million plus interest to settle charges that Wyeth promoted its acid reflux drug Protonix for unapproved uses and made unproven claims</i> about the medicine, the U.S. Department of Justice said on Wednesday.  </span></span></span><br /><br /><span id="articleText">The infractions took place between February 2000 and June 2001, long before the world's largest drugmaker acquired Wyeth in 2009 for $68 billion.</span></blockquote><br /><span id="articleText">A <a href="http://www.examiner.com/article/pfizer-agrees-to-pay-55m-for-illegally-promoting-protonix">report</a> in the examiner explained that Wyeth did not merely go beyond the label in promoting Protonix, it went beyond the evidence.</span><br /><br /><blockquote class="tr_bq">Wyeth allegedly promoted Protonix as the 'best PPI for nighttime heartburn' <i>even though there was never any clinical evidence that Protonix was more effective</i> than any other PPI for nighttime heartburn. </blockquote><br />Furthermore, the charges were that systemic efforts to mislead were sanctioned by top management:<br /><br /><blockquote class="tr_bq"> The allegations in the complaint are that this superiority slogan was formulated <i>at the highest levels of the company</i>. Wyeth retained an outside market research firm, at the cost of tens of thousands of dollars, to ensure that sales representatives delivered that misleading superiority message.</blockquote><br />Finally, the government asserted that Wyeth corrupted physicians' continuing medical education in the process:<br /><br /><br /><blockquote class="tr_bq">Finally, the government alleges that Wyeth<i> used continuing medical education (CME) programs to promote Protonix for unapproved uses. </i>CME programs are sponsored by accredited independent providers, such as universities, nonprofit organizations, or specialty societies. Pharmaceutical companies are permitted to provide financial support for CME programs, but they are not permitted to use CME programs as promotional vehicles for off-label indications.<br /><br />According to the complaint, Wyeth spent millions of dollars providing 'unrestricted educational grants' to CME providers, and <i>these grants invariably included promises that Wyeth would not attempt to influence the content of the program in any way. Nevertheless, the government alleges that one of Wyeth’s core marketing tactics for Protonix was to use CME programs to drive off-label use of the drug. According to the complaint, the Protonix 'brand team' influenced virtually every aspect of these CME programs: program topics, speaker selection, organization, and content.</i> In addition, the government alleges that <i>Wyeth even insisted that the CME program materials use the same color and appearance as Protonix promotional materials</i>–a tactic that Wyeth and the vendor called 'branducation.'</blockquote><br />So it seemed that the company put on quite an effort to promote what we have called elsewhere pseudo-evidence based medicine, yet, like many other legal settlements involving large health care organizations, this one involved no penalties of any type against the people within the organization who authorized, directed, or implemented the bad behavior.  <br /><br /><span id="articleText"> <b>Misleading Marketing of Zyvox, Lyrica</b></span><b><span id="articleText"> </span></b><br /><br /><span id="articleText">Another settlement, for a few dollars less, got even less attention.  Fox Business news did <a href="http://www.foxbusiness.com/news/2012/12/12/pfizer-will-pay-42-million-to-settle-unfair-marketing-charges-related-to-zyvox/">repor</a>t this:</span><br /><br /><blockquote class="tr_bq"><span id="articleText"> </span><i>Pfizer Inc. (PFE) agreed to pay a combined $42.9 million to North Carolina and 32 other states in a settlement of allegations that the drug maker used unfair and deceptive practices in the marketing of antibiotic Zyvox and nerve-pain medicine Lyrica.</i></blockquote><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">I could find no detail about the sorts of deception allegedly involved in the news media.  What little more Fox provided did suggest that this case also involved pitching drugs in instances in which their use was unsupported by good evidence:</div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><blockquote class="tr_bq"><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">The states had alleged that Pfizer had marketed Zyvox as superior to another antibiotic in fighting certain types of infections, though there allegedly <i>wasn't substantial evidence to support superior results </i>for some uses that Pfizer claimed.<br /><br />The states also alleged that Pfizer marketed Lyrica for some off-label, or unapproved, uses. </div></blockquote><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">There was no hint that again any individual would suffer any negative consequences for this particular set of deceits either.</div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><b>Avoiding Impunity as a Topic of Polite Discussion</b></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">We have discussed a seemingly endless parade of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> by large health care organizations.  In almost none was there any consequence beyond a fine paid by the company, and sometimes a pledge that the company would thereafter behave better.  While these relatively small costs were diffused throughout the organizations, almost never did the people who authorized, directed, or implemented the bad behavior pay any price or suffer any penalty.  Thus we have opined again and again (e.g., most recently <a href="http://hcrenewal.blogspot.com/2012/11/phony-consulting-and-royalty-agreements.html">here</a>) that these settlements have become just another cost of doing business, and have no power to deter future bad behavior.<br /></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">In addition, we have noted not only have multiple organizations made such settlements, some organizations have settled again and again.  Yet even in the cases of these multiple organizational offenders, the individuals involved maintain their immunity from any negative consequences.  Thus these are examples of impunity.  </div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Transparency International declared 23 November, 2012, as the <a href="http://www.transparency.org/news/feature/international_day_to_end_impunity">International Day to End Impunity</a>, explained as follows:</div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><blockquote class="tr_bq"><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">At Transparency International we view <i>impunity as getting away with bending the law, beating the system or escaping punishment. <b>Impunity is anathema</b> to the fight against corruption</i>.</div></blockquote><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br />However, impunity is one of those concepts which never seems to be a subject of polite conversation in health care, or, as we say, it has become <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>.  </div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br />Therefore, it is fascinating that while these two Pfizer settlements were announced almost simultaneously, each was discussed, such as it was, as if it occurred in a vacuum.  Moreover, it also seems that each settlement was crafted by law enforcers without any attention to the record of the company making the settlement.  Thus, any implications about impunity were avoided.</div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><b>Pfizer's Multiple Ethical Opfenses</b></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">In fact, during the time we have been posting on Health Care Renewal, Pfizer has become one of the great repeat ethical offenders in the health care arena.  Its track record since the beginning of the 21st century, (with yello colored background below, compiled from <a href="http://hcrenewal.blogspot.com/2012/08/pfizers-pforeign-pfiasco.html">this post</a>), is remarkable.</div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><span style="background-color: #fff2cc;">In the beginning of the 21st century, <a href="http://articles.philly.com/2009-09-03/business/25267571_1_pfizer-employee-pfizer-sales-representatives-zyvox">according to the Philadelphia Inquirer</a>, Pfizer made three major settlements,</span> <br /><blockquote><span style="background-color: #fff2cc;">October 2002: Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor.</span></blockquote><blockquote><span style="background-color: #fff2cc;">May 2004: Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000.</span> </blockquote><blockquote><span style="background-color: #fff2cc;">April 2007: Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug.</span></blockquote><span style="background-color: #fff2cc;"><br />Thereafter, Pfizer paid a $2.3 billion settlement in 2009 of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post <a href="http://hcrenewal.blogspot.com/2009/09/pfour-legal-settlements-for-pfizer-why.html">here</a>).  Pfizer was involved in two other major cases from then to early 2010, including one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post <a href="http://hcrenewal.blogspot.com/2010/03/settlement-and-conviction-round-up.html">here</a>).  The company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post <a href="http://hcrenewal.blogspot.com/2010/12/drug-companies-are-now-no-1-when-it.html">here</a>).  Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York in early 2011 (see post <a href="http://hcrenewal.blogspot.com/2011/02/pharmacia-or-maybe-pfizer-settles-only.html">here</a>).   In March, 2011, a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see <a href="http://www.bloomberg.com/news/2011-03-22/pfizer-reaches-asbestos-settlement-that-may-end-quigley-unit-s-bankruptcy.html">this story</a> in Bloomberg).  In October, 2011, Pfizer settled allegations that it illegally marketed bladder control drug Detrol (see this <a href="http://hcrenewal.blogspot.com/2011/10/what-pfizer-v-few-consequences-for-long.html">post</a>). Finally, in August, 2012, Pfizer settled allegations that its subsidiaries bribed foreign (that is, with respect to the US) government officials, including government-employed doctors (see this <a href="http://hcrenewal.blogspot.com/2012/08/pfizers-pforeign-pfiasco.html">post</a>).  </span></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">By my count, the two current settlements would be numbers twelve and thirteen.  Of course, while I believe this list is accurate, it may be incomplete.</div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Since none of these posts involved any negative consequences for any individuals who authorized, directed, or implemented the bad behavior, or who profited from it, and none involved any changed in the leadership or organization of the company, this becomes an amazing record of the impunity of Pfizer leadership over time and space. <br /></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><b>Will Impunity Finally Lead to Outrage? </b></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br />Impunity, though, is a concept that is beginning to command some attention.</div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">The <a href="http://15iacc.org/about/declarations/the-brasilia-declaration/">Brasilia Declaration</a> which was published at the conclusion of the 15th International Anti-Corruption Conference (hosted by <a href="http://www.transparency.org/">Transparency International</a>) included:</div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><blockquote class="tr_bq"><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">it is clear <i>we all face a common challenge in our work: impunity for those who abuse positions of power. </i></div></blockquote><blockquote class="tr_bq"><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">If impunity is not stopped, <i>we risk the dissolution of the very fabric of society and the rule of law, our trust in our politics and our hope for social justice.</i><br /><br />Activists, businesspeople, politicians, public officials, journalists, academics, youth and citizens who gathered in Brasilia to discuss the threat of corruption made it clear that <strong>impunity undermines integrity everywhere. </strong><br /><br />Whether we are investing collective efforts and resources in fighting poverty, human rights violations, climate change or bailing out indebted economies, <i>we need to give the people a reason to believe that impunity will be stopped.</i></div></blockquote><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">While the two latest Pfizer settlements barely got media coverage, maybe a $1.9 billion dollar settlement in the US by international banking giant will get more attention.  The charges in this case were not merely deceiving some doctors and patients about drug efficacy and safety.  The company was accused of aiding money laundering by drug cartels, and facilitating rogue regimes get around international sanctions.  As the New York Times <a href="http://dealbook.nytimes.com/2012/12/10/hsbc-said-to-near-1-9-billion-settlement-over-money-laundering/">reported</a>, </div><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><blockquote class="tr_bq"><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">State and federal authorities decided against indicting HSBC<a class="tickerized" href="http://dealbook.on.nytimes.com/public/overview?symbol=HBC&inline=nyt-org" title="More information about HSBC Holdings PLC"></a> in a money-laundering case over concerns that criminal charges could jeopardize one of the world’s largest banks and ultimately destabilize the global financial system.<br /><br />Instead, HSBC announced on Tuesday that it had <i>agreed to a record $1.92 billion settlement with authorities. The bank, which is based in Britain, faces accusations that it transferred billions of dollars for nations like Iran and enabled Mexican drug cartels to move money illegally through its American subsidiaries.</i></div></blockquote><div style="background-color: white; border-bottom: medium none; border-left: medium none; border-right: medium none; border-top: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><span id="articleText">Unlike Pfizer's slow-motion impunity, this example got attention.  The Los Angeles Times <a href="http://articles.latimes.com/2012/dec/11/business/la-fi-hsbc-fine-20121212">noted</a>,</span><br /><br /><blockquote class="tr_bq">The massive penalty still was not enough to appease some critics. No bank executives were charged as part of the investigation, leading some analysts to question the government's willingness to hold powerful Wall Street firms accountable.<br /><br />'<i>It's mind-boggling how they think you can have a financial system and allow this kind of impunity</i>,' said William Black, a former banking regulator who aided federal prosecutors during the savings and loan crisis of the 1980s and 1990s. <i>HSBC 'put the world at enormous risk.'</i></blockquote><span id="articleText"><br /></span><span id="articleText">A NY Times <a href="http://www.nytimes.com/2012/12/12/opinion/hsbc-too-big-to-indict.html">editorial</a> opened,</span><br /><br /><blockquote class="tr_bq"><span id="articleText"><i>It is a dark day for the rule of law. </i>  Federal and state authorities have not to indict HSBC, the London-based bank, on charges of vast and prolonged money laundering, for fear that criminal prosecution would topple the bank and, in the process, endanger the financial system.  They have also not charged any top HSBC banker in the case, though it boggles the mind that a bank could launder money as HSBC did without anyone in a position of authority making culpable decisions.</span><br /><br /><span id="articleText">Clearly, the government has bought into the notion that too big to fail is too big to jail.  When prosecutors choose not to prosecute to the full extent of the law in a case as egregious as this, the law itself is diminished.  The deterrence that comes from the threat of criminal prosecution is weakened, if not lost.</span></blockquote><br /><span id="articleText">So maybe this huge financial case will prove to be the straw that breaks impunity's back.  So I will close by quoting the end of the Brasilia Declaration, in the hope that a few people will take it to heart in the context of health care, as well as in finance.</span><br /><br /><br /><blockquote class="tr_bq">To take this important struggle forward the international anti-corruption community should promote greater people engagement and find ways to provide greater security for anti-corruption activists.<br /><br />Reducing impunity also requires independent and well-resourced judiciaries that are accountable to the people they serve.<br /><br />We call on leaders everywhere to embrace not only transparency in public life but a culture of transparency leading to a participatory society in which leaders are accountable.<br /><br />We call on the anti-corruption movement to support and protect the activists, whistleblowers and journalists who speak out against corruption, often at great risk.<br /><br />It is up to all of us in government, business and society to embrace transparency so that it ensures full participation of all people, bringing us together to send a clear message: <i>We are watching those who act with impunity and we will not let them get away with it.</i></blockquote>

Pfizer's 13th Legal Settlement - Will it be Enough to End the Impunity?

It has been almost two months since we lasted noted misbehavior by giant global pharmaceutical firm Pfizer Inc. With little fanfare, howeve...

Đọc thêm »

Pennsylvania Patient Safety Authority: The Role of the Electronic Health Record in Patient Safety Events

<span style="font-family: Arial,Helvetica,sans-serif;">The <a href="http://patientsafetyauthority.org/Pages/Default.aspx" target="_blank">Pennsylvania Patient Safety Authority</a> has released a report "<b>The Role of the Electronic Health Record in Patient Safety Events</b>."  A press release is <a href="http://www.patientsafetyauthority.org/NewsAndInformation/PressReleases/2012/Pages/pr_December_12_2012.aspx" target="_blank">at this link</a>, and the full report in PDF is <a href="http://www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2012/Dec;9%284%29/documents/113.pdf" target="_blank">at this link</a>.  In the report, the Pennsylvania Patient Safety Authority analyzed reports of EHR-related events from a state database of reported medical errors and identified several major themes.</span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;">The report was prepared with the assistance <span class="ms-rteCustom-text-PSABody-P"><span class="ms-rteCustom-text-PSABody-P"><span class="ms-rteCustom-text-PSAByline-P">of Erin Sparnon, Senior Patient Safety Analyst the <a href="https://www.ecri.org/Pages/default.aspx" target="_blank">ECRI Institute</a> near Philadelphia.  The ECRI Institute is an independent organization renowned for its safety testing of medical technologies and reporting on same, and that "</span></span></span><span class="UserContent">researches the best approaches to improving the safety, quality, and cost-effectiveness of patient care."  I've mentioned it and its bylaws in this blog in the past as a model for independent, unbiased testing and reporting of healthcare techonlogies.</span></span> <br /><br /><span style="font-family: Arial,Helvetica,sans-serif;">Regarding the Patient Safety Authority:</span><br /><span style="font-family: Arial,Helvetica,sans-serif;"><br /></span><br /><blockquote class="tr_bq"><span style="font-family: Arial,Helvetica,sans-serif;">The Pennsylvania Patient Safety Authority was established under Act 13 of 2002, the Medical Care Availability and Reduction of Error ("Mcare") Act, as an independent state agency. It operates under an 11-member <a href="http://patientsafetyauthority.org/PatientSafetyAuthority/Pages/BoardofDirectors.aspx" title="">Board of Directors</a>, six appointed by the Governor and four appointed by the Senate and House leadership. The eleventh member is a physician appointed by the Governor as Board Chair.  Current membership includes three physicians, three attorneys, three nurses, a pharmacist and a non-healthcare worker.<br /><br />The Authority is charged with taking steps to reduce and eliminate medical errors by identifying problems and recommending solutions that promote patient safety in hospitals, ambulatory surgical facilities, birthing centers and certain abortion facilities. Under Act 13 of 2002, these facilities  must report what the Act defines as "Serious Events" and "Incidents" to the Authority. </span></blockquote><br /><span style="font-family: Arial,Helvetica,sans-serif;">The Authority maintains a database of serious events and incidents:</span><br /><br /><blockquote class="tr_bq"><span style="font-family: Arial,Helvetica,sans-serif;">Consistent with Act 13 of 2002, the Authority developed the Pennsylvania Patient Safety Reporting System (PA-PSRS, pronounced "PAY-sirs"), a confidential web-based system that both receives and analyzes reports of what the Act calls Serious Events (actual occurrences) and Incidents (so-called "near-misses"). </span></blockquote><br /><span style="font-family: Arial,Helvetica,sans-serif;">Cutting right to the chase, the paper's summary:</span><br /><blockquote class="tr_bq"><span style="font-family: Arial,Helvetica,sans-serif;"><br /></span><span style="font-family: Arial,Helvetica,sans-serif;"><i><span class="ms-rteCustom-text-PSAAbstract-P">As adoption of health information technology solutions like electronic health records (EHRs) has increased across the United States, increasing attention is being paid to the safety and risk profile of these technologies. However, several groups have called out a lack of available safety data as a major challenge to assessing EHR safety, and <b>this study was performed to inform the field about the types of EHR-related errors and problems reported to the Pennsylvania Patient Safety Authority and to serve as a basis for further study.</b> Authority analysts queried the Pennsylvania Patient Safety Reporting System for reports related to EHR technologies and performed an exploratory analysis of 3,099 reports using a previously published classification structure specific to health information technology. The majority of EHR-related reports involved errors in human data entry, such as entry of “wrong” data or the failure to enter data, and a few reports indicated technical failures on the part of the EHR system. This may reflect the clinical mindset of frontline caregivers who report events to the Authority.</span></i></span></blockquote><br /><span style="font-family: Arial,Helvetica,sans-serif;">Results:</span><br /><br /><blockquote class="tr_bq"><span style="font-family: Arial,Helvetica,sans-serif;"><span class="ms-rteCustom-text-PSASubhead1-H"><span class="ms-rteCustom-text-PSABody-P">... Reported events were categorized by their reporter-selected harm score (see Table 1). Of the 3,099 EHR-related events, 2,763 (89%) were reported as “event, no harm” (e.g., an error did occur but there was no adverse outcome for the patient) <span style="color: red;"><i><b>[a risk best avoided to start with, because luck runs out eventually - ed.]</b></i></span>, and 320 (10%) were reported as “unsafe conditions,” which did not result in a harmful event. Fifteen reports involved temporary harm to the patient due to the following: entering wrong medication data (n = 6), administering the wrong medication (n = 3), ignoring a documented allergy (n = 2), failure to enter lab tests (n = 2), and failure to document (n = 2). Only one event report, related to a failure to properly document an allergy, involved significant harm.</span></span> </span></blockquote><br /><span style="font-family: Arial,Helvetica,sans-serif;">A significant "study limitations" section was included that addressed: </span><br /><br /><ul><li><span style="font-family: Arial,Helvetica,sans-serif;">Issues regarding reporting statutes of the PA-PSRS errors database; </span></li></ul><ul><li><span style="font-family: Arial,Helvetica,sans-serif;">lack of awareness of EHRs as a potential contributing factor to an error;</span></li></ul><ul><li><span style="font-family: Arial,Helvetica,sans-serif;">limitations of narrative reporting affecting both the types of reports queried </span><span style="font-family: Arial,Helvetica,sans-serif;"><span style="font-family: Arial,Helvetica,sans-serif;">and the tags applied </span>(the study used textual data mining methodolgies);</span></li></ul><ul><li><span style="font-family: Arial,Helvetica,sans-serif;">query design of the study; and</span><span style="font-family: Arial,Helvetica,sans-serif;"> </span></li></ul><ul><li><span style="font-family: Arial,Helvetica,sans-serif;">the need for further refinement of the machine learning tool used in creating the working dataset, which may have missed relevant cases.</span></li></ul><br /><span style="font-family: Arial,Helvetica,sans-serif;">Some of these impediments to knowing the magnitude of extant HIT issues are also present in the 2008 <a href="http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html" target="_blank">Joint Commission Sentinel Events Alert on HIT</a>, the <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">2010 FDA internal memorandum on HIT Safety</a>, and the <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">2011 IOM report</a> on the same topic.</span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;">(The IOM report specifically observed that t</span><span style="font-family: Arial,Helvetica,sans-serif;">he<span style="font-weight: bold;"> </span>"barriers to generating evidence pose unacceptable risks to safety.") </span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;">The major obstacle to this study in my view, though, was the nature of the dataset.  The database is for general reporting of medical errors, and it contains no specific fields or reminders about EHRs or the known ways in which they can contribute to, or cause, medical mistakes.  </span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;">The attempt was made, as acknowledged in the study, to glean information about EHR-related events from, in large part, textual analysis of narrative in the hopes that the reporter recognized the role of IT, and reported it using terms that could be detected by the search algorithms.  <i>In other words, the data was not "purposed" for this type of study.  </i></span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;"><b>It is axiomatic that one cannot find data that is simply not present, no matter how fancy the search algorithm.</b>  Further, passive analysis of clinical IT risk/harms data in an industry where lack of knowledge of causation and misconceptions abound will produce only partial results that suggest further study is needed, and not give an indicator of just how incomplete the results are. </span><span style="font-family: Arial,Helvetica,sans-serif;"><!--[if !mso]><style>v\:* {behavior:url(#default#VML);} o\:* {behavior:url(#default#VML);} p\:* {behavior:url(#default#VML);} .shape {behavior:url(#default#VML);} v\:textbox {display:none;} </style><![endif]--></span><span style="mso-spacerun: yes;"></span><span style="font-family: Arial,Helvetica,sans-serif;"><!--[if !ppt]--><!--[endif]--> </span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;">Thus, this cautionary statement was made in the new PA Patient Safety Authority report:</span><br /><br /><blockquote class="tr_bq"><span style="font-family: Arial,Helvetica,sans-serif;"><b>"<span class="ms-rteCustom-text-PSASubhead1-H"><span class="ms-rteCustom-text-PSABody-P">Although the vast majority of EHR-related reports did not document actual harm to the patient, analysts believe that further study of EHR-related near misses and close calls is warranted as a proactive measure."</span></span></b></span> </blockquote><span style="font-family: Arial,Helvetica,sans-serif;"></span><br /><span style="font-family: Arial,Helvetica,sans-serif;">My comments:</span><br /><span style="font-family: Arial,Helvetica,sans-serif;"><br /></span><span style="font-family: Arial,Helvetica,sans-serif;">The report is welcome.</span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;"></span><span style="font-family: Arial,Helvetica,sans-serif;">The most important part of the paper, I point out, is the “Limitations” section. FDA, IOM and others have made similar observations – we don’t know the true magnitude of the problem due to systematic limitations of the available data. </span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;"></span><span style="font-family: Arial,Helvetica,sans-serif;">Therefore, at best what is available must be deemed as risk management-relevant case reports, a “red flag” that could represent (using the words of FDA CDRH director Jeffrey Shuren regarding HIT safety), the tip of the iceberg.</span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;"></span><span style="font-family: Arial,Helvetica,sans-serif;">It is imperative far more work be done in post-market surveillance as this technology is deployed nationally and internationally.  This is to ensure that good health IT (GHIT) prevails and bad health IT (BHIT) is either remediated or removed from the marketplace.  I had defined those in other writings as follows:</span><br /><br /><blockquote class="tr_bq"><b><span style="color: black; font-family: Arial;">Good Health IT</span></b><span style="color: black; font-family: Arial; mso-bidi-font-weight: bold;"> ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps <span class="SpellE">eHealth</span>information secure, protects patient privacy and facilitates better practice of medicine and better outcomes.<span style="mso-spacerun: yes;">  </span></span></blockquote><br /><blockquote class="tr_bq"><span style="color: black; font-family: Arial; mso-bidi-font-weight: bold;"><b>Bad Health IT</b> ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for <span class="SpellE">hypervigilance</span> (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.<span style="mso-spacerun: yes;">  </span></span></blockquote><br /><span style="font-family: Arial,Helvetica,sans-serif;"></span><span style="font-family: Arial,Helvetica,sans-serif;"><b>An additional major factor</b> that also contributes to lack of knowledge of EHR-related adverse events is hospital reporting non-compliance. For instance, I know of cases from my own legal consulting work and personal experience that I would have expected to appear in the database, but apparently do not.</span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;"></span><span style="font-family: Arial,Helvetica,sans-serif;">But don’t take it from me alone. Here is PA Patient Safety Authority Board Member Cliff Rieders, Esq. on this.</span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;"></span><span style="font-family: Arial,Helvetica,sans-serif;">From “Hospitals Are Not Reporting Errors as Required by Law, Phila. Inquirer”, pg. 4,</span><span style="font-family: Arial,Helvetica,sans-serif;"><a href="http://articles.philly.com/2008-09-12/news/24991423_1_report-medical-mistakes-new-jersey-hospital-association-medication-safety" rel="nofollow" target="_blank">http://articles.philly.com/<wbr></wbr>2008-09-12/news/24991423_1_<wbr></wbr>report-medical-mistakes-new-<wbr></wbr>jersey-hospital-association-<wbr></wbr>medication-safety:</a></span><br /><span style="font-family: Arial,Helvetica,sans-serif;">   </span><br /><span style="font-family: Arial,Helvetica,sans-serif;"> </span><br /><blockquote class="tr_bq"><span style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;"><i>... Hospitals don’t report serious events if patients have been warned of the possibility of them in consent forms, said Clifford Rieders, a trial lawyer and member of the Patient Safety Authority’s board.</i></span></span><br /><span style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;"><br /></span></span><span style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;"><i>He said he thought one reason many hospitals don’t want to report serious events is that the law also requires that patients be informed in writing within a week of such problems. So, if a hospital doesn’t report a problem, it doesn’t have to send the patient that letter. <span style="color: red;"><b>[T<span style="font-size: small;">h<span style="font-size: small;">us reducing <span style="font-size: small;">risk of </span>litigation<span style="font-size: small;">, and, incidentally, <span style="font-size: small;">potentially </span>infr<span style="font-size: small;">inging on</span> <span style="font-size: small;">patient<span style="font-size: small;">s'</span> rights</span></span> to legal recourse - ed.]</span></span></b></span></i></span></span><i><br /><br /> Rieders says the agency has allowed hospitals to determine for themselves what constitutes a serious event and the agency has failed to come up with a solid definition in six years.<br /><br /> </i><span style="font-size: small;"><i>Fixing this “is not a priority,” he added.</i></span></blockquote><br /><span style="font-family: Arial,Helvetica,sans-serif;"></span><span style="font-family: Arial,Helvetica,sans-serif;">This coincides with my own personal experience precisely.  In a case where my relative was permanently injured as a result of EHR-related medication error, and then died of the injuries, I never received the required report in writing from the hospital.  I also do not believe the case was reported to the Safety Authority, at least not as IT-related.</span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;"></span><span style="font-family: Arial,Helvetica,sans-serif;">I suspect the true rates of EHR-related close calls, reversible injuries, permanent injuries and deaths is significantly higher than the limited data available suggests. That data is merely a red flag <b>that much more education, stringent reporting requirements,  templates of known causes of error, and enforcement are needed</b>.  (An April 2010  "thought experiment" on this issue I wrote about at "<a href="http://hcrenewal.blogspot.com/2010/04/if-benefits-of-hit-can-be-guesstimated.html" target="_blank">If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers</a>" certainly suggested as much.) </span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;"></span><span style="font-family: Arial,Helvetica,sans-serif;">Slides where I made those types of recommendations to the Patient Safety Authority, at a presentation I gave in July 2012 at their invitation, are at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/PA_patient_safety_Jul2012.ppt" rel="nofollow" target="_blank">http://www.ischool.drexel.edu/<wbr></wbr>faculty/ssilverstein/PA_<wbr></wbr>patient_safety_Jul2012.ppt</a></span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;">A major concern I have is that the HIT industry will use this new report in a manner that ignores its limitations.</span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;">(Disclosure: I was an invited reviewer of this new PPSA report.)</span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;">-- SS </span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;"><b>Addendum Dec. 13:  </b> </span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;">Also worth review is "<a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3243129/" target="_blank">Patient Safety Problems Associated with Heathcare Information Technology: an Analysis of Adverse Events Reported to the US Food and Drug Administration</a>", Magrabi, Ong, Runciman, and Coiera, AMIA Annu Symp Proc. 2011.  </span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;">Data here came from FDA's voluntary (i.e., also tip of the iceberg) </span><span style="font-family: Arial,Helvetica,sans-serif;"><a class="l" href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm">Manufacturer and User Facility Device Experience</a> (MAUDE) database.  Ironically, the study was done in Australia using Australian grant funds.</span><br /><br /><span style="font-family: Arial,Helvetica,sans-serif;">-- SS </span><span class="citation-flpages"></span>

Pennsylvania Patient Safety Authority: The Role of the Electronic Health Record in Patient Safety Events

The Pennsylvania Patient Safety Authority has released a report " The Role of the Electronic Health Record in Patient Safety Events .&...

Đọc thêm »

Health Care Hired Managers Not Playing by the Same Rules - the Example of Lancaster General Health

That all people in the US do not play by the same rules, and that more specifically the richest people do not play by the same rules as the somewhat or a lot less rich, became a topic of discussion after the 2008 global financial collapse/ great recession.  A powerful discussion of this theme appeared in <i><a href="http://www.randomhouse.com/book/213722/predator-nation-by-charles-h-ferguson">Predator Nation</a></i>, the book by Charles Ferguson that followed his award winning documentary, <a href="http://www.sonyclassics.com/insidejob/">Inside Job</a>:<br /><br /><blockquote class="tr_bq">Ponder the toxic effects of too much wealth, too much power, the new culture of American investment banking, and a <i>life conducted within the cocoon of America's new oligarchy</i>. [p 112]</blockquote><br />He focused on the culture of <a href="http://hcrenewal.blogspot.com/search/label/finance">finance</a>, but as we have seen, this culture has overlapped the culture of health care.  Thus we have shown <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">multiple examples</a> of those who have become rich due to their positions in health care, almost always positions as high-ranking hired managers of health care organizations.  They get paid according to different rules than apply to other hired employees, and <a href="http://hcrenewal.blogspot.com/search/label/executive%20life%20style">live by different rules</a> than their less-favored fellow employees, again by virtue of their positions.<br /><br />Some of these examples were of CEOs of huge, for-profit health care corporations,  However, we have increasingly seen hired managers of moderate size non-profit organizations who also appear to play by different rules than their fellow employees.<br /><br /><b>The Executives of Lancaster General Health </b><br /><br />The latest example appeared through <a href="http://lancasteronline.com/article/local/790929_Healthy-paychecks-for-LGH-executives.html">reporting</a> found in LancasterOnline, the web presence of several newspapers in Lancaster, Pennsylvania, about a regional community health care system, Lancaster General Health.  The <a href="http://www.lancastergeneralhealth.org/LGH/About-Lancaster-General-Health.aspx">system</a> includes one major hospital, Lancaster General, an obstetrics hospital, and a variety of satellites and out-patient facilities.     <br /><br />The system was facing challenges in 2010:<br /><br /><blockquote class="tr_bq">In 2010, times were getting tougher for Lancaster General Health.<br /><br />The mammoth [sic] health care system would notch record revenues of nearly $1 billion that year. But its <i>annual surplus fell</i> for the fourth straight year. Though destitute by no means, <i>galloping expenses and uncertainty in the marketplace</i> were hammering LGH's business model, prompting changes. <i>Two units were closed, some positions were eliminated, and 170 employees were reassigned.</i></blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">However, despite these difficulties, </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq">Two executives — CEO Tom Beeman, who was on military leave part of the year, and Executive Vice President Jan Bergen, who helped fill in for Beeman in his absence — <i>earned <b>more than $1 million</b> in total compensation; another six got at least $500,000.</i><br /><br />And those top 21 executives collectively received more than $2 million in bonuses and incentives.</blockquote><br />That lavish total compensation included "perks" that were likely not furnished to lesser employees, for example<br /><br /><br /><blockquote class="tr_bq">The IRS form lists few explicit perks, save one: LGH paid $1,044 in <i>social club dues</i> for Beeman in 2010.<br /><br />Said Regina Mingle, LGH's executive vice president of human resources: 'In this community, if you need to do business, you do it at the Hamilton Club or Lancaster Country Club. We decided ... we would pay those fees.'</blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">It seems doubtful, however, that any other employees who felt that they did "business" at country clubs or similar establishments were entitled to subsidized dues.</div><br />This relatively lavish pay was part of a pattern.  Executive compensation had been increasing out of proportion to any obvious benchmark for a while.<br /><br /><blockquote class="tr_bq"><i> In fiscal year 2005-06, CEO Tom Beeman earned a comparatively modest total compensation of <b>$646,094</b>. By 2010, that had more than doubled, to <b>$1.35 million</b>.</i> That figure included a base compensation of $606,728, along with $345,000 in bonuses and incentives and $279,511 in retirement and other deferred compensation. <br /><br />Bergen, who along with Executive Vice President Marion A. McGowan took on some of Beeman's duties when he left in October 2010 for a nine-month military leave of absence, saw her compensation rise from<b><i> $332,823</i></b> in 2005-06 to a total of <b><i>$1.1 million</i></b> in 2010. The latter figure included $425,967 in base pay, $177,752 in bonuses and incentives, $111,383 in retirement and other deferred compensation, and $320,208 in what the IRS calls 'other reportable compensation' such as employee contributions to 401(k) or 403(b) retirement plans.<br /><br />The third highest-paid LGH executive in 2010 was McGowan, whose compensation package totaled <b><i>$772,978,</i></b> including $456,789 in base pay and $192,226 in bonuses and incentives. Fourth on the list was  </blockquote><blockquote class="tr_bq">Dr. Lee M. Duke II, senior vice president and chief physician executive, whose compensation totaled<b><i> $746,830,</i></b> including $405,083 in base pay and $140,377 in bonuses and incentives.<br /><br />Fifth was Chief Financial Officer F. Joseph Byorick Sr., whose total compensation of <b><i>$652,667</i></b> included $397,160 in base pay and $140,500 in bonuses and incentives.</blockquote><br />So note that CEO Beeman's compensation was for less than one full year's worth of work.  His annualized rate would have been even more.<br /><br />A <a href="http://lancasteronline.com/article/local/790937_25-execs---2-1-million-in-bonuses-at-LGH.html">companion article</a> noted that part of CEO Beeman's bonus for 2010 was justified by his efforts to keep in touch with the institution while he was physically not present, and was, in fact off-site for an extended period fulfilling a military reserve commitment<br /><br /><blockquote class="tr_bq"> In October 2010, Lancaster General Health had a problem.<br /><br />Its <i>CEO, Tom Beeman, was shipping out for a military tour of duty</i>, to serve as deputy director of the National Intrepid Center of Excellence in Bethesda, Md. <i>Two other administrators —  Executive Vice Presidents Jan Bergen and Marion W. McGowan — would step into Beeman's shoes while he was away.</i><br /><br />Yet Beeman stayed involved. '<i>We had regular Skype [video-conferencing] calls,' </i>said Alex Henderson, chairman of the LGH Board of Trustees.<br /><br /><i>That, LGH officials believed, merited a bonus</i>. So Beeman got nearly $90,000 for his efforts in absentia.</blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br />Note that this verified that Beeman got more than $1 million in compensation despite not having worked a whole year, since it was necessary for two other executives to take over his work.<br /><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Furthermore, while US law does mandate employers to re-hire employees who take leaves to fulfill military reserve commitments (look <a href="http://www.dol.gov/vets/programs/userra/userra_fs.htm">here</a>),  I suspect that very few employers pay employees anything while they are away (although reservists are certainly paid by the government for their reserve duty).  However, Beeman got a bonus merely for keeping in touch while he was away doing another job.  I further suspect it is extremely unusual to pay an employee a bonus for trying to keep in touch during his or her military service.<br /><br />So the reporting on compensation given to top hired managers at Lancaster General emphasized that executive pay is set using very different rules than are used to set the pay of other employees. <br /><br /><b>The Talking Points Reappear as Justifications for Exceptional Compensation of Hired Managers </b></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Furthermore, the justifications made for the Lancaster General top executives' large compensation packages echoed talking points used to support such largess for top hired managers in other health care settings, but did not explain why hired managers merit exceptional treatment.   We first listed the talking points <a href="http://hcrenewal.blogspot.com/2011/09/talking-points-sans-original-thought-to.html">here</a>, and then provided additional examples of their use <a href="http://hcrenewal.blogspot.com/2011/09/more-repeats-of-talking-points.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2012/03/example-of-how-complex-takes-control.html">here</a>.   The talking points are:<br />-  we pay what everyone else pays<br />-  CEOs work hard and are brilliant, and so deserve high pay<br />-  high pay is needed to attract and retain competent, if not brilliant people.<br /><br />None of the examples of these talking points we have seen so far explain why these apply to CEOs and other top hired managers, but not to other kinds of employees.  .<br /><br /><u>We Pay What Everyone Else Pays</u><br /><br />A <a href="http://lancasteronline.com/article/local/790930_Compensation-for-LGH-executives-has-nowhere-to-go-but-up.html">third article</a> in the LancasterOnline series noted that executive compensation was based on information on what everyone else pays,<br /><br /><blockquote class="tr_bq">nonprofits must hire consultants to study how similarly sized nonprofits pay their executives.<br /><br />LGH's consultant is a firm called Mercer, headquartered in New York City with an office in Philadelphia. Charlie Scott, of Mercer, has in recent years helped LGH determine what to pay its highest-compensated executives.<br /><br /> 'Our role is to be [an] <i>independent source of market norms</i>,' said Scott, determining '<i>levels of compensation available in the market for executive positions</i>, as well as how compensation is paid.</blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><br /><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><a href="http://lancasteronline.com/article/local/790930_Compensation-for-LGH-executives-has-nowhere-to-go-but-up.html#ixzz2Em2365eC" style="color: #003399;"></a>This is an interesting variant of this talking point, because it essentially blames the reasoning on the Internal Revenue Service.  The article did not explain how Mercer determined the extent of the appropriate market, nor how it obtained a representative sample of data about that market.</div><br /><u>CEOs Work Hard and Are Brilliant, and So Deserve High Pay</u><br /><br /><u>High Pay is Needed to Attract and Retain Competent, if not Brilliant People</u></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">These justifications are often combined.  In the case of Lancaster General, the examples <a href="http://lancasteronline.com/article/local/790929_Healthy-paychecks-for-LGH-executives.html">included</a></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq">At LGH, officials say the <i>generous compensation is necessary to attract and retain the top talent.</i> Said Lancaster attorney Alex Henderson III, chairman of the Lancaster General Health board of trustees and its compensation committee, which decides what to pay top execs: 'Demand for top-notch hospital executives has grown, and we have to respond to that.'<br /><br />'<i>We're not looking to be average.'</i></blockquote><br />I seriously doubt that the hospital system is committed to "generous" pay to get "top talent" for all of its job openings.  Again, I doubt the generosity includes full pay for leaves taken for military service, or, for that matter country club dues.<br /><br />Another version was offered by the chair of the system's board of trustees:<br /><br /><blockquote class="tr_bq"> Trustee Henderson said that as LGH's goal<i> isn't to maximize revenue but save lives</i>, executives can be doing a fantastic job — worthy of six-figure bonus and incentive pay — even when the system's financial performance slips.<br /><br />Consider an executive who devises a way to shorten stays for patients, Henderson said: 'That's great for the patients, for insurance companies, for nurses who don't have to take care of people who don't need to be here' — but it's bad for LGH's bottom line.</blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Left out of the first part of the statement was how one could attribute lives saved to the work of a hired manager, especially, as in the case of CEO Beeman, a manager with no direct experience caring for patients.  Mr Beeman's <a href="http://www.lancastergeneralhealth.org/LGH/About-Lancaster-General-Health/About-LGH/Executive-Leadership.aspx">official hospital bio</a> listed this educational background,</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><blockquote class="tr_bq"><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Prior to joining Lancaster General Health, he served at Saint Thomas Health Services as its President and Chief Executive Officer, and the Senior Vice President for Hospital Operations and Executive Director of the Hospital of the University of Pennsylvania. </div></blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">It did not include any former positions that would have involved direct patient care.  </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Health care actually does not save lives that often, but hopefully does often ameliorate disease and injury, reduce suffering and improve function.  However, the people who actually directly accomplish this are health care professionals, nurses, doctors, therapists, etc, not managers who sit in offices.  </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">I will merely note that Mr Henderson's second example apparently was theoretical.  There was no example given of an executive who actually did shorten length of stay.  </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">In a <a href="http://lancasteronline.com/article/local/790930_Compensation-for-LGH-executives-has-nowhere-to-go-but-up.html">third article</a> in the LancasterOnline series, the compensation consultant employed by Lancaster General Health reiterated the argument that one must pay top dollar for scarce managerial talent:</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><blockquote class="tr_bq"><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">[Mercer consultant Charlie] Scott said that the law of supply and demand that applies 'to any type of talent pool applies to health care executives. There's normally a lack of supply of <i>what's considered blue-chip talent</i> ... [and] the increasing complexity of the health care industry requires an increasing level of talent and capability.'</div></blockquote></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br />Note that no one who defended the compensation given to CEO Beeman or other top managers provided evidence that they are "top" or "blue chip" talent, or that they, rather than the health care professionals who work at or for the system save lives.<br /><br /><b>Summary</b></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br /></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">In our last US election campaign season, a few candidates pledged to level the playing field so that rich and poor would play by the same rules.  Other candidates scoffed at the importance of the problem, or called its invocation class warfare.  Meanwhile, in health care, we just accumulate more examples that different people play by different rules. <br /><br />So we have yet another particular example of how top hired managers, particularly CEOs, of even modestly sized, non-profit health care organizations get to play by different rules than those affecting other employees, and other people who work in health care.  As in previous cases, the justifications provided for these different rules were basically a repeat of poorly conceived arguments that have been cited often by defenders of executive exceptionalism. <br /><br />The "we pay what everyone else pays" is basically an<a href="http://www.nizkor.org/features/fallacies/appeal-to-common-practice.html"> appeal to common practice fallacy</a>.  Why we have to do so is never stated.  In any case, the argument did not include why the limited selection of comparator hospitals and executives used is a representative sample of "everyone."  Furthermore, as we noted <a href="http://hcrenewal.blogspot.com/2012/10/more-reasons-to-doubt-how-ceos-are.html">here</a>, what evidence there is suggests that skills required to run one organization do not necessarily transfer to another, suggesting the comparison to "everyone" makes no sense.<br /><br />As is usual, the "CEOs are brilliant" argument is basically an <a href="http://www.nizkor.org/features/fallacies/appeal-to-authority.html">appeal to authority fallacy</a>, and provided no evidence that the particular CEO is brilliant.  In fact, it seems that everyone who has used this talking point before claims his or her CEO is brilliant. (Look <a href="http://hcrenewal.blogspot.com/2011/09/talking-points-sans-original-thought-to.html">here</a> for example.) Obviously, all CEOs cannot be above average. <br /><br />Finally, as noted <a href="http://hcrenewal.blogspot.com/2012/10/more-reasons-to-doubt-how-ceos-are.html">here</a>, there is no evidence that without high pay worthy leaders could not be hired or retained.</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><br />Unfortunately, the otherwise excellent articles on Lancaster General did not challenge any of the defenders of executive exceptionalism to better justify their assertions.  Nor were they asked to consider its adverse effects. <br /><br />As we have frequently said, current policies about paying hired health care managers leave the managers unaccountable for the effects of their actions on patients' and the public's health, and worse, fail to deter and may even encourage ignorance of the health care mission, frankly mission-hostile behavior, self-interest, conflicts of interest, and outright corruption.  Meanwhile, paying nearly all top managers as if they were brilliant, while setting much harsher standards for the employees who actually take care of patients, including health professionals, demoralizes those on whom patients actually depend for care.<br /><br />As we have said endlessly,....   Health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior.<br /><br />If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses. </div></div>

Health Care Hired Managers Not Playing by the Same Rules - the Example of Lancaster General Health

That all people in the US do not play by the same rules, and that more specifically the richest people do not play by the same rules as the ...

Đọc thêm »