healthy4u: mission-hostile management

To Die in Texas - Dr Mahmood's Apparently Fatal Stealth Hospital System Collapses Nearly Anechoically

I would bet that most people in the US still think our health care system is highly regulated.  Some may thus conclude that the system is basically safe, because, for example, drugs have to be proven safe and effective to be approved by the government, and hospitals must be licensed and run by competent people who are thoroughly vetted.  Of course, some people still think that the US has, or had until recently, the best health care system in the world (look <a href="http://www.nbcnews.com/health/health-care/best-health-care-system-really-john-boehner-f2D11598594">here</a>). Furthermore, the view that less regulation is always better is no quite popular in the US and elsewhere.  For example, after the chemical spill threatened water supplies in the capitol of West Virginia, the Dallas News <a href="http://www.dallasnews.com/news/west-explosion/headlines/20131221-despite-crises-from-salmonella-outbreak-to-west-blast-rick-perry-s-pushed-freer-rein-for-business.ece">reviewed</a> Texas Governor Rick Perry's consistent attacks on government regulation.    <blockquote class="tr_bq">'American business in general, and American agriculture specifically, have had enough of bureaucracy at both the federal and state levels, but especially bureaucracy out of Washington,' Perry said at a congressional hearing. 'The men and women who feed and clothe this nation are suffocating under the weight of mounting federal regulations.' That was back in 1993, when Perry was Texas’ agriculture commissioner. Now Texas’ longest-serving governor, Perry has remained steadfast in his opposition to government regulations. </blockquote> Some who take such a neoliberal stance may say the health care system is over-regulated, and thus is inefficient and not innovative, leading to our high costs and poor access. However, an amazing case out of Governor Perry's Texas that was made public last year, and I regret I just heard about recently, suggests how little health care may be regulated, and how unregulated health care, whether or not it is efficient, may be deadly. As <a href="http://www.dallasnews.com/investigations/patient-safety/headlines/20130713-patients-died-amid-federal-state-regulatory-inaction.ece">reported</a> in the Dallas News, July, 2013, in the last few years there seems to have been an epidemic of quality problems in a number of seemingly unrelated small rural Texas hospitals.  The report focused first on one hospital, Renaissance Hospital Terrell After for-profit hospital corporation Renaissance Healthcare declared bankruptcy in 2008 (look <a href="http://www.bizjournals.com/houston/stories/2008/09/08/story6.html">here</a>), it sold its hospital in Terrell, Texas to RH Terrell Management LLC owned by one Dr Tariq Mahmood.  Almost immediately, however, there was trouble.  First Edwina Henry, the quality director, spied a doctor making questionable entries in patients' charts: <blockquote class="tr_bq">from her office, she had a clear view of doctors’ foot traffic through the medical records department. When she saw [Dr Tariq] Mahmood jotting in patient charts, she knew he wasn’t seeing patients. Mahmood himself had not been credentialed to treat patients — a process in which management vets backgrounds and competencies of doctors. Part of Henry’s job was tracking such evaluations. She also knew it was a breach of privacy laws to review patients’ medical records. 'I immediately questioned some of the clerks and [insurance billing] coders,' she said. They were deeply concerned, saying he was altering the patients’ records to help boost reimbursements for insurance claims, Henry said.</blockquote> When Ms Henry complained, things did not go well, <blockquote class="tr_bq">Henry made her confidential call to the bankruptcy court in early November 2008, alleging potential fraud and threats to patient care that were eluding government notice [Ed - note that the hospital was going through bankruptcy proceedings and had just been acquired by a new owner]. The court forwarded her complaint to the U.S. Justice Department, the Texas attorney general’s office and the state health department, officials confirmed. Later that month, the state health department sent an inspector to the hospital. However, the visit was brief, Henry said, and the inspector didn’t interview her or seek her help in obtaining records. Williams, the health department spokeswoman, told The News her agency’s records show the inspector was unable to substantiate violations at the time. Henry was terminated from Renaissance as part of a 'restructuring'.... </blockquote>Then the hospital was cited for turning patients away from the emergency department, <blockquote class="tr_bq">At Renaissance, two women in labor, one bleeding, were refused treatment. The inspection reports don’t reveal whether the women suffered complications because of the delays. A Renaissance employee told one of the women that if she 'could stand there and have a conversation with them then (she) wasn’t about to have a baby,' reports say.</blockquote> Then there were problems with infection control, <blockquote class="tr_bq">At Renaissance, no supervision over infection control could be found. For three months in the summer of 2010, no one was in charge of tracking infectious diseases or preventing their spread.</blockquote> The next year, the problem was blood transfusions <blockquote class="tr_bq">Inspectors returned to Renaissance in September 2011 to investigate a botched blood transfusion procedure. They found that a registered nurse had not supervised the patient’s care. In another case, an inspector witnessed an unsupervised vocational nurse administering blood to a patient, despite no evidence that she was competent to do so — another violation.</blockquote> In 2012, <blockquote class="tr_bq">During the summer, the Texas secretary of state had revoked Renaissance’s business charter for failure to pay franchise taxes. That office didn’t share the information with the health department; it isn’t required to do so. In September, state health regulators notified Renaissance that they were proposing a $35,050 fine for 13 violations, including the nursing supervision failures, dating as far back as 2010. Williams, the health department spokeswoman, could not explain why the fine process took nearly two years since the first violation. </blockquote> Finally, in 2013, patients started to die, <blockquote class="tr_bq">In January of this year, when state inspectors returned to Renaissance, they found nursing supervision failures yet again. This time, the failures had led to three deaths: All ER patients. All with severe breathing difficulties. All receiving little to no intervention as their conditions worsened.</blockquote> In particular, <blockquote class="tr_bq">[Eve] McCallum sought her own care after complaining of shortness of breath during a family dinner. McCallum had chronic obstructive pulmonary disease. When she was admitted, nurses were ordered to monitor her vital signs and oxygen levels. Her breathing soon improved, said her niece, Lou Ann Sims. 'We were fully expecting to pick her up the next morning,' Sims said. Instead, they watched helplessly as her condition deteriorated. On Christmas Day, a physician explained to McCallum’s family that she had to be transferred to the intensive care unit. Later, Sims witnessed a scene she can’t let go of: Her aunt lay connected to a ventilator while a nurse stood smoking a cigarette just outside the door. The nurse had propped open the door with an IV pole. The family immediately sought to have McCallum transferred to another hospital. But hospital officials told them 'this would be a lateral move and was not allowed,' according to a transcript of an interview the family later conducted with state officials. McCallum died two days later. Inspectors wrote that a licensed vocational nurse had been left in charge of her treatment, without a registered nurse’s oversight. There was no evidence an RN had assessed her condition on admission or was watching over her in the ICU. They could find no doctor orders to place her on oxygen, no order for medications administered to her, 'nor evidence of communication with the M.D.' Suspecting more than just care breakdowns at Renaissance, McCallum’s family reported her death to the Texas attorney general’s fraud-control unit.</blockquote> So partially in response to this egregious case, <blockquote class="tr_bq">By February, the state health department had moved to revoke Renaissance’s operating license, and CMS had ordered its federal funding terminated — only the ninth time nationally in the last three years CMS had taken such a step.</blockquote> Even those steps could not shut down the hospital, but city officials took that last step due to the failure to pay taxes. Other Hospitals Dallas News reporter Miles Moffeit found several other cases of severe problems at small hospitals owned by Dr Mahmood, with at least one patient death apparently resulting, . Shelby Regional Medical Center This hospital was owned by Tenet Healthcare, but was sold to another of Dr Mahmood's companies, Shelby Medical Holdings, in 2007 (look <a href="http://www.beckershospitalreview.com/hospital-management-administration/shelby-regional-medical-center-in-texas-closes-its-doors.html">here</a>).  In 2009, this hospital was also cited for providing insufficient treatment in the emergency department. In 2012, things were really falling apart, <blockquote class="tr_bq">In October 2012, inspectors were at Shelby chronicling dirty, clogged air-conditioners and failures to prevent ceiling plaster 'from falling into the patient food service line and contaminating food.' Those problems put patients’ safety in 'immediate jeopardy,' they wrote. As inspectors roamed Shelby’s halls in December, the power suddenly went out in four buildings, though not in the main hospital facility itself. The electric bill hadn’t been paid. They found other debts stacking up, too — as much as $190,442 owed to as many as 79 service providers. Signs of neglect were everywhere. Only three of 20 patient rooms inspected were 'fully functional for patient care,' they wrote. They found holes in walls, dirty and tattered curtains, and patients complaining of heat pouring from the faulty A/C system.</blockquote> Finally, in 2013, another patient died, <blockquote class="tr_bq">On Wednesday, CMS cut off federal funding to ... Shelby Regional Medical Center in Center in East Texas after regulators said a patient rushed there by ambulance never received treatment from a doctor. The ER physician wouldn’t leave his 'sleep room,' the inspection report said, resulting in the patient’s death. Regulators also cited the hospital for failing to vet backgrounds of doctors and nurses. </blockquote>Apparently soon thereafter Dr Mahmood shut the hospital down due to "legal issues that ... [he] is facing," <a href="http://lightandchampion.com/article/003856-mahmood-closes-shelby-regional-medical-center-staff-volunteers-time-until-doors-shut">per</a> the Shelby Light and Champion. Lake Whitney Medical Center Dr Mahmood apparently purchased this hospital from a struggling local hospital authority in 2007.   In 2009, it was cited for inadequate care in the emergency department, <blockquote class="tr_bq">At Lake Whitney, a nurse acknowledged to inspectors that she had shredded records of a patient who was denied care following a fall, according to a report. The 'patient wasn’t going to pay anyway,' the nurse was quoted as saying in the document.</blockquote> In 2010, there was evidence of major infrastructure problems, <blockquote class="tr_bq">At Lake Whitney, patients were served food on rusty 'over-the-bed tables that were a source of possible infections for open wounds.' Bulging ceiling tiles exposed pipes. Pavement outside a main hospital door was 'cracked and unlevel,' putting patients at risk of injury. </blockquote>As Dr Mahmood's legal troubles mounted, the hospital was sold to Frontier Hospitals Inc (look <a href="http://watchdogblog.dallasnews.com/2013/08/florida-company-takes-over-lake-whitney-medical-center-effectively-dissolving-embattled-owners-troubled-chain.html/">here</a>). Cozby-Germany Hospital  I have been unable to discover when Dr Mahmood purchased this hospital.  In 2010, it became apparent that the hospital was not properly licensed, <blockquote class="tr_bq">'The administrator reported the new owner had not notified (CMS) … and has not applied for hospital licensure with the state licensing agency,' a report said. [The owner] ... also was found to have appointed his own employees to the hospital’s governing board of directors, instead of independent outsiders.</blockquote> And there were more severe problems with credentialing, <blockquote class="tr_bq">At Cozby-Germany hospital, hospital inspectors discovered that the chief of staff and another doctor had expired medical licenses. There were no 'functional' nurse and doctor credentialing processes, and clinical policies had not been updated since 2008, they said. The hospital pledged reforms.</blockquote> But in May 2011, records show, Cozby hired one of Texas’ most notorious doctors, Rolando Arafiles. <blockquote class="tr_bq">At the time, Arafiles had been placed on probation by the medical board for allegations of harming nine patients, overbilling and improper coding at a Winkler, Texas, facility, according the board. He also was disciplined for intimidating the Winkler nurses who blew the whistle on his practices. In November, Arafiles would be convicted of two felonies linked to the retaliation and would surrender his license.</blockquote> In 2013, two local doctors purchased the hospital. The Vanishing Owner What made this series of cases all the more amazing is that it was really one interlinked case.  All these hospitals, plus a few more, had the same owner.  Yet no one, especially  no one in state or federal government knew that until 2013 when the facts were uncovered by Mr Moffeit. <blockquote class="tr_bq">[Dr Tariq] Mahmood, a Pakistan-trained doctor, obtained his Texas medical license in 1978. Since 2008, he has practiced medicine only at his Central Texas Hospital in Cameron, south of Waco, records with the Texas Medical Board show. Older documentation is not available. Over the last two decades, he has purchased at least six hospital companies and two home-health care agencies, according to filings with the Texas secretary of state. He also has invested his money outside health care, acquiring the historic Hotel Lawrence in downtown Dallas, property records show. In addition to Renaissance, Shelby and Central Texas Hospital, Mahmood owns the Lake Whitney Medical Center in Whitney and Cozby-Germany Hospital in Grand Saline. He sold Community General Hospital in Dilley around the time of his arrest in April. The hospitals have no common corporate identity and little or no website presence, making it difficult for anyone to know they are owned by Mahmood or are part of a chain.</blockquote> However, much bout Dr Mahmood was mysterious, and the deliberate cultivation of mystery might have slowed the response to this case. <blockquote class="tr_bq">Mahmood is rarely seen in the communities where his hospitals are located, say business associates and city officials. Sometimes they catch a glimpse of him passing by in a chauffeur-driven car. 'He’s almost impossible to track down' to discuss business matters, said Tom Elliott, a director for a nonprofit company that owns the hospital building in Grand Saline. 'He lets his people do the talking.' Mahmood is a mystery to many of his own employees. He works almost entirely behind the scenes, they say, focusing largely on the business side of his operations. He often is traveling or spending time at his 10,000-square-foot gated estate in Cedar Hill, they say. 'We see him maybe once a year,' said one of his hospital physicians. 'The employees say he doesn’t like confrontation. I say he just doesn’t like to communicate. He seems to live in a different world.'</blockquote> Aftermath  At some point, the shadowy Dr Mahmood may have to answer for all this, at least to some extent, <blockquote class="tr_bq">In April, federal authorities charged the 62-year-old Cedar Hill resident with defrauding Medicare and Medicaid programs through $1.1 million in false billings. Mahmood is accused of directing employees at his Central Texas Hospital in Cameron to alter underlying information in insurance claims from his other hospitals. 'In many cases,' the indictment alleges, these were 'for patients he had never seen.' Mahmood pleaded not guilty, and his attorney said he denies all charges. He has declined repeated interview requests from The Dallas Morning News. </blockquote> Note, however, that these are charges of financial fraud.  They do not obviously have to do with poor quality care, risks to patients' safety, or the deaths of at least three patients as discussed above. This case was so bad that even the current Governor of Texas, Rick Perry, a politician known for taking a small government, minimal regulation stance, at least said he was going to take some action, as <a href="http://www.dallasnews.com/investigations/patient-safety/headlines/20130719-perry-orders-investigation-into-oversight-of-troubled-rural-hospital-chain.ece">reported</a> again in the Dallas News, <blockquote class="tr_bq">The governor’s office has ordered a 'deep and comprehensive look' at health care facilities owned by Dr. Tariq Mahmood, whose chain of rural Texas hospitals avoided serious regulatory action despite years of endangering patients. The inspector general for the state Health and Human Services Commission and one of the agencies it oversees, the state health department, will conduct separate investigations, officials said Friday.</blockquote> And in February, 2014, the Dallas News <a href="http://www.dallasnews.com/investigations/20140206-texas-hospitals-chief-faces-fraud-charges-over-use-of-stimulus-grants.ece">reported</a> that the chief financial officer of the Dr Mahmood's stealth hospital chain was also in hot water, <blockquote class="tr_bq">The top administrator of a chain of hospitals that collapsed under the ownership of a North Texas physician faces charges that he defrauded the federal government of nearly $800,000 in stimulus funds. Joe White of Cameron rose from maintenance man to head administrator and chief financial officer over hospitals once owned by Dr. Tariq Mahmood. Now he joins Mahmood in facing the possibility of prison time. Like Mahmood, who pleaded not guilty, White is accused of identify theft and bilking the federal government of health care dollars. White has yet to enter a plea.</blockquote> Note that the CFO and apparently COO was not even a professional generic manager.  He was a former maintenance man  and operator of a Radio Shack store..  Dr Mahmood has not yet come to trial.  Many questions about the case remain unanswered:  -  Did Mahmood the only person besides his CFO cum maintenance man in charge of all this, or did he have other backers,  cronies, associates? -  What happened to the rigorous state investigation promised by Rick Perry? -  Given that what went on harmed patients, and hence was not just financial manipulation, are there any civil lawsuits pending?  Are there any other criminal investigations?\ Furthermore, despite its egregious nature, this case was amazingly <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>  The only national recognition I could find was i<a href="http://runningahospital.blogspot.com/2013/07/hospital-slumlord.html">n Paul Levy's Not Running a Hospital blog.</a>  Seven months later, I could find nothing in the national media, nothing in medical and health care literature.  Despite the amazingly poor quality of care in evidence, despite the fact that patients died, I could find no cries of outrage from those who proclaim to support quality health care or patient safety.  Summary Dr Mahmood and his chief operating and financial officer collectively displayed leadership that was ill-informed (the COO/ CFO was a former maintenance man), incompetent (see the egregious health quality problems listed above), self-interested (note the size of Dr Mahmood's mansion versus how little was obviously spent on his hospitals), opaque and dishonest (note how Dr Mahmood's ownership of the hospitals was obscured), and allegedly criminal.  This leadership persisted over at least eight years until it culminated in cases of apparently needless patient deaths.   The amazing case of the stealth for-profit hospital system run by Dr Mahmood, and how its combined problems failed for so long to get systemic regulatory notice hardly suggest that our health care system is heavily regulated, or that current regulation can be relied upon to reassure patients that all is well and that the system is safe. In fact, in the case of Dr Mahmood, government regulators did not seem to even want to know too much about hospital ownership, <blockquote class="tr_bq">Top health regulators weren’t even aware Mahmood owned several hospitals until The News sought information about them earlier this year. Regulatory agencies aren’t set up to track problem hospital owners or hold them accountable. Nor do they look for patterns of care breakdowns inside hospital chains. 'We just don’t have that authority,' said David Wright, deputy regional administrator for CMS. The federal agency oversees the state health department’s inspections of federally funded hospitals. 'We can only address problems in stand-alone facilities.'</blockquote> Furthermore, it appears that modern regulators have decided to become hospital managers' and owners' best friends, <blockquote class="tr_bq">The process allows hospitals to avoid sanctions if they cooperate. Hospitals submit “corrective action plans” to remedy failures. It can take months for state regulators to bring penalties such as fines against a facility. In the case of Renaissance, it took years. 'We want to do what’s in the best interest of the patients, and our regulatory philosophy is to get hospitals into compliance,' said Carrie Williams, spokeswoman for the Texas Department of State Health Services. 'We’re not in the business of shutting down hospitals. We will give them some leeway and work with them.'</blockquote> Of course, this minimalist, light touch regulatory methodology may have made some sense in an earlier era when nearly all hospitals were small community not-for-profit organizations, non-profit academic institutions, or were run by local governments.  It seems quaint, and hopelessly out of date in an era when most hospitals are part of <a href="http://hcrenewal.blogspot.com/search/label/hospital%20systems">ever larger systems,</a> now often owned for-profit corporations, and when hospital system CEOs who are professional, and thus <a href="http://hcrenewal.blogspot.com/search/label/generic%20managers">generic managers</a>, not health care professionals, in an era of <a href="http://hcrenewal.blogspot.com/search/label/financialization">financialization</a> and "maximizing shareholder value," that is, making short-term revenue the most important outcome. Instead, the current minimalist regulatory system seems insufficient to prevent patients from dying of poor care allowed by poor leadership of health care organizations.  Much of the content of this blog has been about bad health care leadership, i.e., leadership that is <a href="http://hcrenewal.blogspot.com/search/label/ill-informed%20management">ill-informed</a>, incompetent, unsympathetic or <a href="http://hcrenewal.blogspot.com/search/label/mission-hostile%20management">hostile to health care professionals' values</a>, self-interested, <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicted</a>, dishonest, or even <a href="http://hcrenewal.blogspot.com/search/label/health%20care%20corruption">corrupt</a>.  In my humble opinion, health care regulation ought to be sufficient to promote competent, caring, unconflicted, honest leadership that is accountable for putting patients' interests ahead of self-interest.  Regulation needs to be more intense, and much smarter, geared to the reality of a health care system that is now largely for-profit in an era when management dogma puts revenue ahead of all other concerns. Maybe the deaths of some patients in Dr Mahmood's Texas hospital will finally let the air out of the mindlessly anti-regulatory bubble, and start some discussion of intelligent regulation to improve patient safety. However, that cannot happen if this case remains anechoic.  I regret it took me so long to find it, but now I have done my part to start some echoes.  But where are the media, where are the journal editors, and where are those who so loudly proclaim their interest in patient safety and health care quality? In particular, there are several prominent organizations that claim to promote health care quality and patient safety.  These organizations make these claims- <a href="http://www.jointcommission.org/topics/patient_safety.aspx">Joint Commission</a> <blockquote class="tr_bq"> For more than 60 years, The Joint Commission has been a champion of patient safety by helping health care organizations to improve the quality and safety of the care they provide. </blockquote> <a href="http://www.leapfroggroup.org/about_leapfrog">Leapfrog Group</a> <blockquote class="tr_bq"> The Leapfrog Group is a voluntary program aimed at mobilizing employer purchasing power to alert America’s health industry that big leaps in health care safety, quality and customer value will be recognized and rewarded.</blockquote> <a href="http://www.qualityforum.org/who_we_are.aspx">National Quality Forum</a> <blockquote class="tr_bq"> Transforming our healthcare system to be safe, equitable, and of the highest value will take time and the work of many, but the potential rewards are great. The National Quality Forum (NQF) is a nonprofit, nonpartisan, public service organization committed to this transformation. </blockquote> <a href="http://www.rwjf.org/en/about-rwjf/our-mission.html">Robert Wood Johnson Foundation</a> <blockquote class="tr_bq">Our efforts focus on improving both the health of everyone in America and their health care—how it's delivered, how it's paid for, and how well it does for patients and their families. </blockquote> These  organizations should the ones to start the conversation about improving rather than forever shrinking regulation.   I have not heard anything from them about the deadly hospitals of Dr Mahmood.  Are they listening now?  Will we ever hear from them?  Time will tell....   Note: the entire Dallas News series on the Mahmood hospitals can be found <a href="http://res.dallasnews.com/interactives/collapseofcare/">here</a>.

To Die in Texas - Dr Mahmood's Apparently Fatal Stealth Hospital System Collapses Nearly Anechoically

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18 Feb 2014

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

Legal and regulatory actions unfavorable for giant pharmaceutical, biotechnology and device company Johnson and Johnson just keep coming.  We last discussed such a story only two weeks ago <a href="http://hcrenewal.blogspot.com/2013/12/how-many-straws-johnson-and-johnson.html">here</a>.  The Latest Case This latest story got only desultory US coverage from the wire services.  The most complete version is in the European Commission <a href="http://europa.eu/rapid/press-release_IP-13-1233_en.htm">press release</a>.  The basics were: <blockquote class="tr_bq">The European Commission has imposed fines of € 10 798 000 on the US pharmaceutical company Johnson & Johnson (J&J) and € 5 493 000 on Novartis of Switzerland. In July 2005, their respective Dutch subsidiaries concluded an anticompetitive agreement to delay the market entry of a cheaper generic version of the pain-killer fentanyl in the Netherlands, in breach of EU antitrust rules.</blockquote> In more detail, <blockquote class="tr_bq"><div class="A_Standard__35__20_Normal">J&J initially developed Fentanyl and has commercialised it in different formats since the 1960s. In 2005, J&J's protection on the fentanyl depot patch had expired in the Netherlands and Novartis' Dutch subsidiary, Sandoz, was on the verge of launching its generic fentanyl depot patch. It had already produced the necessary packaging material. </div><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">However, in July 2005, instead of actually starting to sell the generic version, Sandoz concluded a so-called 'co-promotion agreement' with Janssen-Cilag, J&J's Dutch subsidiary. The agreement provided strong incentives for Sandoz not to enter the market. Indeed, the agreed monthly payments exceeded the profits that Sandoz expected to obtain from selling its generic product, for as long as there was no generic entry. Consequently, Sandoz did not offer its product on the market. The agreement was stopped in December 2006 when a third party was about to launch a generic fentanyl patch. </div><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">The agreement therefore delayed the entry of a cheaper generic medicine for seventeen months and kept prices for fentanyl in the Netherlands artificially high - to the detriment of patients and taxpayers who finance the Dutch health system.</div></blockquote><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">The obligatory colorful bits,</div><div class="A_Standard__35__20_Normal"> </div><blockquote class="tr_bq"><div class="A_Standard__35__20_Normal"> Why did J&J and Novartis conclude that agreement? According to internal documents Sandoz would abstain from entering the Dutch market in exchange for 'a part of [the] cake'. Instead of competing, Janssen-Cilag and Sandoz agreed on cooperation so as 'not to have a depot generic on the market and in that way to keep the high current price'. Janssen-Cilag did not consider any other existing potential partners for the so-called 'co-promotion agreement' but just focused on its close competitor Sandoz. Sandoz engaged in very limited or no actual co-promotion activities.</div></blockquote><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">So, </div><div class="A_Standard__35__20_Normal"> </div><blockquote class="tr_bq"><div class="A_Standard__35__20_Normal"> The Commission therefore concluded that the object of this agreement was anticompetitive and infringed Article 101 of the Treaty on the functioning of the European Union (TFEU). </div></blockquote><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">Johnson and Johnson's Ever Lengthening Unhappy Legal History There have been so many settlements made by, fines assessed against, and other adverse legal actions affecting Johnson and Johnson in the recent past that we must make a major revision of our summary of such cases (see same appended at the end of this post.)</div><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">Yet despite all these actions, there is no hint that anything will change at the company.  After all, it is extremely profitable, and all the fines, while they individually appear large, are not a big fraction of the money it brings in.  And, as we have noted far too often, not one of these actions actually provides any negative consequences, much less severely punishes anyone at the company who authorized, directed, or implemented the bad behavior.  </div><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">Instead, the leadership of the company continues to make itself very rich. As we wrote <a href="http://hcrenewal.blogspot.com/2013/07/johnson-and-johnson-settles-suit.html">here</a>,  Mr William Weldon, the outgoing CEO on whose watch most of the misbehavior resulting in the legal actions listed in the appendix below occurred, retired with a huge retirement package, after receiving extremely generous compensation prior to that.  The new CEO as of April, 2012,  Mr  Alex Gorsky, per<a href="http://www.investor.jnj.com/common/download/download.cfm?companyid=JNJ&fileid=644762&filekey=44D6D309-4972-4DAE-97C5-60157E6C6CD1&filename=JNJ_2013_Proxy_Statement.PDF"> the company's 2013 proxy statement</a>, already owns more than 190,000 Johnson and Johnson shares,  and received $10,977,109  total compensation in 2012.  Mr Weldon received over $29 million in total compensation just for 2012, the year in which he retired.  Other top executives received from over $3.5 million to over $8 million. One can only imagine how much top executives are making this year.</div><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">So Johnson and Johnson, once admired for proclaiming in its famous <a href="http://www.jnj.com/about-jnj/jnj-credo">credo</a> to "put the needs and well-being of the people we serve first," now seems to put its own hired managers first.  It boggles the mind that despite this amazing record of bad behavior, the executives who presided over it still have jobs, have made no obvious changes in how they manage the company, and in fact continue to get ridiculously rich.  The <a href="http://www.investor.jnj.com/governance/board.cfm">board of directors</a>, which includes the <a href="http://www.investor.jnj.com/governance/biodetail.cfm?bioid=4341">President of the University of Michigan</a>, a <a href="http://www.investor.jnj.com/governance/biodetail.cfm?bioid=4341">Professor and Emeritus Chancellor and Vice President of Health Affairs at Emory</a>, a <a href="http://www.investor.jnj.com/governance/biodetail.cfm?bioid=5191">Professor at MIT</a>, a <a href="http://www.investor.jnj.com/governance/biodetail.cfm?bioid=44646">former FDA Commissioner, and Senior Fellow at the Brookings Institute</a>, and the <a href="http://www.investor.jnj.com/governance/biodetail.cfm?bioid=40456">Vice Chancellor of Health Sciences, Dean of the David Geffen School of Medicine at the University of California, Los Angeles (UCLA); Chief Executive Officer of the UCLA Health System</a>, who seemingly ought to care about the integrity of evidence, protecting patients from harm, and the need for simple honesty, have not obviously done anything about the apparent massive violation of the company credo that has made its managers wealth.   Other than the stockholder lawsuit discussed below, the supposed owners of the company seem to be mute.</div><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">When will the straws break the camel's back?  In the absence of such a fracture, I repeat like an old, broken record... </div><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">Many of largest and once proud health care organizations now have recent records of repeated, egregious ethical lapses. Not only have their leaders have nearly all avoided penalties, but they have become extremely rich while their companies have so misbehaved. These leaders seem to have become like nobility, able to extract money from lesser folk, while remaining entirely unaccountable for bad results of their reigns. We can see from this case that health care organizations' leadership's nobility overlaps with the supposed "royalty" of the leaders of big financial firms, none of whom have gone to jail after the global financial collapse, great recession, and ongoing international financial disaster (look <a href="http://hcrenewal.blogspot.com/2012/08/duchess-of-wellpoint-abdicates-likely.html">here</a>). The current fashion of punishing behavior within health care organization with fines and agreements to behave better in the future appears to be more law enforcement theatre than serious deterrent.  As Massachusetts Governor Deval Patrick exhorted his fellow Democrats, I exhort state, federal (and international, for that  matter) law enforcement to "<a href="http://www.washingtonpost.com/blogs/election-2012/wp/2012/09/04/patrick-it-is-time-for-democrats-to-grow-a-backbone/">grow a backbone</a>" and go after the people who were responsible for and most profited from the ongoing ethical debacle in health care. Again, true health care reform would make leaders of health care organization accountable for their organizations' bad behavior.</div><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal">Appendix - Johnson and Johnson Recent Legal Record</div><div class="A_Standard__35__20_Normal"> </div><div class="A_Standard__35__20_Normal"></div><div class="A_Standard__35__20_Normal">2010 </div><div class="A_Standard__35__20_Normal">- Convictions in two different states in 2010 for misleading marketing of Risperdal - A guilty plea for misbranding Topamax in 2010 2011</div><div class="A_Standard__35__20_Normal">- Guilty pleas to bribery in Europe in 2011 by Johnson and Johnson's DePuy subsidiary - A guilty plea for marketing Risperdal for unapproved uses in 2011 (see <a href="http://hcrenewal.blogspot.com/2011/08/why-cultivate-weldons-confidence-ceo.html">this link</a> for all of the above) - A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post <a href="http://hcrenewal.blogspot.com/2011/09/johnson-and-johnson-pleads-guilty.html">here</a>) 2012 </div><div class="A_Standard__35__20_Normal">- In 2012, testimony in a trial of allegations of unethical marketing of the drug Risperdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers. After these revelations, the company abruptly settled the case (see post <a href="http://hcrenewal.blogspot.com/2012/02/texas-tmap-trials-as-illustration-of.html">here</a>). -  Also in 2012,  Johnson & Johnson was fined $1.1 billion by a judge in Arkansas for deceiving patients and physicians again about Risperdal (look <a href="http://hcrenewal.blogspot.com/2012/04/once-more-with-feeling-johnson-and.html">here</a>). -  Also in 2012, Johnson & Johnson announced it would pay $181 million to resolve claims of deceptive advertising again about Risperdal (see this <a href="http://hcrenewal.blogspot.com/2012/09/how-many-legal-settlements-does-it-take.html">post</a>). </div><div class="A_Standard__35__20_Normal">2013 </div><div class="A_Standard__35__20_Normal">-  In 2013, Johnson & Johnson settled case by shareholders alleging that management made misleading statements and withheld material information about manufacturing problems (see this <a href="http://hcrenewal.blogspot.com/2013/07/johnson-and-johnson-settles-suit.html">post</a>)</div><div class="A_Standard__35__20_Normal">-  In 2013, Johnson & Johnson Janssen subsidiary pleaded guilty to a charge of misbranding Risperdal, and settled for a total of $2.2 billion allegations that it promoted the drug for elderly demented patients and adolescents without an indication, and despite evidence of its harms (see this <a href="http://hcrenewal.blogspot.com/2013/11/another-and-huge-22-billion-settlement.html">post</a>).  </div><div class="A_Standard__35__20_Normal">-  In 2013, Johnson & Johnson DePuy subsidiary agreed to settle with multiple plaintiffs for $2.5 billion allegations that it sold defective mental-on-metal artificial hip, and hid evidence of its harms .</div><div class="A_Standard__35__20_Normal">- In 2013, Johnson & Johnsonn Janssen subsidiary was found by two juries to have concealed harms of its drug Topamax (see this <a href="http://hcrenewal.blogspot.com/2013/11/there-they-go-again-again-johnson-and.html">post</a> for this and above case).</div><div class="A_Standard__35__20_Normal">- In 2013, Johnson & Johnson Ethicon subsidiary's Advanced Surgical Products and two of its executives agreed to settle charges by US FDA that is sold mislabeled products used to sterilize equipment such as endoscopes (see this <a href="http://hcrenewal.blogspot.com/2013/12/how-many-straws-johnson-and-johnson.html">post</a>). </div><div class="A_Standard__35__20_Normal">- In 2013, Johnson & Johnson fined by European Commission for anticompetitive practices, that is, collusion with Novartis to delay marketing generic version of Fentanyl (in the current post above).  </div>

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

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17 Dec 2013

Why Trust Drug Company Executives After One Admits Commercially Sponsored Clinical Research Is All About "Competitive Advantage?"

Mickey, the semi-anonymous blogger on 1BoringOldMan, wrote a <a href="http://1boringoldman.com/index.php/2013/09/12/right-on-the-money/">righteously angry post</a> in support of transparent clinical research.  As we have noted frequently, clinical trials done on human subjects are often <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulated</a> to increase the likelihood of results favorable to commercial sponsors, or <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed</a> when even such manipulation does not produce the desired results. Note that such suppression and manipulation degrade the scientific value of the studies, impede the <a href="http://hcrenewal.blogspot.com/search/label/evidence-based%20medicine">evidence-based medicine</a> process to rationally apply clinical research evidence to improve the health of patients and the public, and violate the trust of research subjects who volunteer to participate based on the assumption that clinical research is meant to improve patient care and public health, and contribute to science, not just secure commercial advantage.   A European initiative to combat suppression of clinical research has been opposed by a lawsuit from US pharmaceutical manufacturers AbbeVie, spun off from Abbott Laboratories, and Intermune.  The European Medicines Agency had been willing to to make public unpublished patient level data from commercially sponsored clinical trials.  The lawsuit has shut down the process, and is meant to shut it down permanently, claiming that the clinical data, obtained from volunteer research subjects, includes "trade secrets." As <a href="http://1boringoldman.com/index.php/2013/09/12/right-on-the-money/">summarized </a>by Mickey, their motivation seems to be to conceal how pharmaceutical manufacturers and other commercial sponsors of human research use this research for promotional, rather than scientific purposes. An AbbeVie lawyer asserted that some adverse effects data should be kept confidential, and that "internal tactical decisions on how we are going to run a study, engage with regulators, and confront and solve problems and challenges we have uncovered during clinical trials" should also be kept secret because revealing them could "give other companies a tremendous competitive advantage," never mind whether keeping secrets could undermine science, decrease the study's usefulness to aid clinical and policy decision making, and break the implicit contract between researchers and study subjects. It is becoming more obvious that many drug company executives, and other leaders of large health organizations, may care more about "competitive advantage" than patients, science or the public good, as Mickey points out.  So much for that advertising puffery  about drug development to improve patient health.  Thus it may be ridiculous to think that these executives they will negotiate to improve transparency of clinical research in good faith when doing so could decrease such advantage, again no matter what the effect on patients, public health, or science. On this case there is an opportunity to speak out, Dr David Healy has a <a href="http://www.change.org/petitions/richard-gonzalez-of-abbvie-and-daniel-welch-of-intermune-drop-your-legal-action-blocking-access-to-ema-clinical-trial-data?utm_source=guides&utm_medium=email&utm_campaign=petition_lonely">petition up on Change.org</a> to oppose the AbbeVie and Intermune lawsuit which might get some notice if there are enough signatures.

Why Trust Drug Company Executives After One Admits Commercially Sponsored Clinical Research Is All About "Competitive Advantage?"

Mickey, the semi-anonymous blogger on 1BoringOldMan, wrote a righteously angry post in support of transparent clinical research. As we have noted frequently, clinical trials done on human subjects ar…

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12 Sep 2013

The Long Con - "Charitable" Hospitals Make Multimillionaires out of Their CEOs

The CEOs of ostensibly charitable hospitals founded to serve the poor continue to become rich.   The latest reminders are in two articles from Maryland, f<a href="http://www.delmarvanow.com/article/20130812/WIC01/308110024/Inside-Maryland-hospital-CEO-pay">rom DelMarVaNow,</a> and <a href="http://articles.baltimoresun.com/2013-08-17/health/bs-hs-health-compensation-20130817_1_hospital-ceos-health-care-executives-compensation">from the Baltimore Sun</a>,.and one <a href="http://www.bostonglobe.com/business/2013/08/15/top-executives-earned-million-boston-teaching-hospitals-according-filings/story.html">from the Boston Globe.</a> All this diligent reporting showed multimillion dollar <a href="http://articles.baltimoresun.com/2013-08-17/health/bs-hs-health-compensation-20130817_1_hospital-ceos-health-care-executives-compensation">executive compensation</a>,  as usual not justified by evidence or logic, but also how executive compensation is becoming divorced from the ostensible charitable mission of non-profit hospitals.   Most Hospital CEOs are Paid a Lot So jin Maryland, we found via DelMarVaNow, <blockquote class="tr_bq">Peninsula Regional Medical Center paid its top executive and her immediate predecessor a total of $2.37 million in compensation in 2011 as the nonprofit hospital gained millions of dollars in profit.</blockquote> In particular, <blockquote class="tr_bq"> The analysis shows that R. Alan Newberry was the third-highest paid hospital chief in Maryland, even though he has not run PRMC since 2009. In the year after formally stepping down from the hospital’s top job, Newberry received $1.57 million, about $600,000 more than he had while still working full time.</blockquote> The Baltimore Sun summarized compensation given to multiple executives, <blockquote class="tr_bq"> Eleven executives earning seven-figure compensation packages including salary, bonus, retirement and other pay saw their total pay rise from as little as 0.13 percent to as much as 308 percent in the fiscal year that ended in 2012, according to tax filings. Another executive earning more than $1 million saw a pay cut.</blockquote> In particular, <blockquote class="tr_bq"> The state's highest-compensated hospital executive that fiscal year was Kenneth A. Samet, the CEO of the 10-hospital MedStar Health system, who earned $6.3 million. More than half — $3.5 million — was money earned in a supplemental retirement plan during his 23 years of service. He won't get the money until he retires. His base pay was $1.2 million, and he received $1.5 million as a bonus and incentives. The other top five highest-paid executives in Maryland are James Xinis, CEO at Calvert Memorial Hospital in Prince Frederick; Ronald A. Peterson, CEO of the Johns Hopkins Health Center Corp.; Robert A. Chrencik, CEO of the University of Maryland Medical System; and Thomas Mullen, CEO of Mercy Medical Center. Xinis saw his compensation package jump 307.8 percent to $3.5 million, $2.8 million of which was a required distribution of vested retirement funds from a plan he begin contributing to in 2003, the hospital said in a statement. Xinis has served as CEO for 26 years and plans to retire in the next 18 months, the hospital said. His base salary in fiscal 2012 was $309,557. <div class="mod-baltsunarticletext mod-articletext" id="mod-a-body-first-para">Peterson, who oversees six hospitals, earned a $3.5 million compensation package. Peterson's 86.5 percent pay increase largely reflected pension benefits he'd earned during 40 years at Hopkins. His annual base salary increased about $49,500 to $1.1 million in fiscal 2012. Chrencik, whose system has 12 hospitals, earned about $2.3 million. Chrencik's total pay grew 23.4 percent. Mercy's Mullen saw his pay rise 24 percent to $1.6 million for the fiscal year ending in 2012.</div><div class="float" style="clear: both; height: 1px; line-height: 1px;"><img alt="" height="1" src="http://articles.baltimoresun.com/images/pixel.gif" width="1" /></div><div class="float" style="clear: both; height: 1px; line-height: 1px;"><img alt="" height="1" src="http://articles.baltimoresun.com/images/pixel.gif" width="1" /></div> The one CEO earning more than $1 million who saw his compensation fall was Edward D. Miller, who retired in June 2012 as CEO of Johns Hopkins Medicine and dean of the university's medical school. His reported pay dropped to just over $1 million in fiscal 2012 from nearly $2.3 million the prior year, when he took a one-time retirement payout.</blockquote> Also, <blockquote class="tr_bq">According to Saint Agnes tax filings, [CEO Bonnie] Phipps received $1.9 million in the 2012 fiscal year, 4.4 percent more compensation than a year earlier.</blockquote>  Per the Boston Globe, local hospital executives also did really well <blockquote class="tr_bq">Chief executives at the Boston area’s largest nonprofit teaching hospitals drew pay packages of $1 million to $2.1 million in 2011, including salaries, bonuses, and compensation such as health and life insurance and retirement benefits. Topping the list locally was Gary L. Gottlieb, chief executive of Partners HealthCare System, the state’s largest hospital and physicians organization, who received total compensation of $2.1 million in 2011, according to federal tax documents released Thursday by the nonprofits.</blockquote> And, <blockquote class="tr_bq">The presidents of Partners-owned Massachusetts General and Brigham and Women’s hospitals also drew seven-figure packages in 2011, with Peter L. Slavin at Mass. General receiving a total of $1.7 million and Elizabeth G. Nabel at Brigham and Women’s a total of $1.9 million.</blockquote> Also, <blockquote class="tr_bq">Tufts Medical Center reported that Ellen M. Zane, who served as chief executive through September 2011, had total pay of $1.6 million that year. Eric J. Beyer, who took over from Zane in October, had total compensation of $744,722 that included pay for work as chief executive and at his previous job as president of the Tufts Medical Center Physicians Organization. James Mandell, chief executive at Boston Children’s Hospital, was paid a total of $1.5 million in 2011. That was down from the $2 million he earned the prior year when he received two separate incentive awards, according to a hospital spokeswoman. Mandell plans to retire next month and will be succeeded by Sandra Fenwick, the hospital’s president and chief operating officer. Total compensation for Boston Medical Center chief executive Kate Walsh was listed at nearly $1.4 million in 2011, an increase from $1.3 million in 2010. At Dana-Farber Cancer Institute, chief executive Edward J. Benz Jr. received total compensation of nearly $1.3 million in 2011, up from $1.1 million in 2010. Beth Israel Deaconess Medical Center paid three different top executives in 2011. Eric Buehrens, who served as interim chief executive from February to October, drew total compensation of just over $1 million for that role and other executive jobs. </blockquote> The Justification for this Pay is Stereotyped (and not Supported by Logic or Evidence) The Usual Talking Points The articles in combination provided the usual talking points as justification.  It seems nearly every attempt made to defend the outsize compensation given hospital and health system executives involves the same arguments, thus suggesting they are talking points, possibly crafted as a public relations ploy.   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>, <a href="http://hcrenewal.blogspot.com/2012/03/example-of-how-complex-takes-control.html">here</a> <a href="http://hcrenewal.blogspot.com/2012/12/health-care-hired-managers-not-playing.html">here,</a> <a href="http://hcrenewal.blogspot.com/2013/05/executive-compensation-as-legal.html">here</a>, <a href="http://hcrenewal.blogspot.com/2013/06/no-blues-but-lots-of-green-for-st-louis.html">here,</a> and <a href="http://hcrenewal.blogspot.com/2013/08/should-we-cry-for-non-profit-hospital.html">here</a>..    They are: - We have to pay competitive rates - We have to pay enough to retain at least competent executives, given how hard it is to be an executive - Our executives are not merely competitive, but brilliant. As we have <a href="http://hcrenewal.blogspot.com/2013/08/should-we-cry-for-non-profit-hospital.html">noted before</a>, there is little evidence in support of these talking points.  What evidence there is on the topic suggests there is no real free market in interchangeable CEOs, and that CEOs are not very mobile, especially not across different kinds of organizations (look <a href="http://hcrenewal.blogspot.com/2012/10/more-reasons-to-doubt-how-ceos-are.html">here</a>).  There is little evidence that hospital (or other health care) executives are particularly brilliant, or any more brilliant than multitudes of physicians, nurses, and other health care professionals who work hard to make their institutions run. True to form, the reporting from Maryland and Boston found that defenders of executive pay cited the talking points, but without any further logic or evidence.  Competition Re PRMC (from DelMarVaNow), <blockquote class="tr_bq"> 'We’ve looked at about 17 like institutions. Eight are smaller than we are; eight are larger. Every hospital is different, so you have to always take into account there’s some variation, but we’ve always stayed in the middle. Our goal has been to stay in that 60 percent level as far as compensation goes,' said Martin Neat, chairman of PRMC’s board of directors, which oversees executives’ salaries.</blockquote>Note that in this case, no justification was provided for constantly setting the CEOs pay above the median. Re Maryland, via the Baltimore Sun <blockquote class="tr_bq"> Hospitals argue that they have to offer competitive compensation to attract talent to run a complicated business.</blockquote> Re Maryland and particularly UMMS, via the Sun, <blockquote class="tr_bq"> The medical institutions say they hire independent consultants and look at the pay of executives at comparable health systems when making their decisions. </blockquote> Also, <blockquote class="tr_bq">UMMS hospital executives are compensated in line with national benchmarks,' [UMMS spokeswoman Mary Lynn] Carver said. </blockquote> Note that there was no justification for the comparability of these institutions, or why a national versus regional comparison was made. Retention Re PRMC <blockquote class="tr_bq"> Above all, PRMC’s board of directors seeks to ensure that the hospital attracts and retains the best leaders.</blockquote> Note that there was no evidence given that current leaders might leave were their compensation reduced.  Brilliance Re PRMC, <blockquote class="tr_bq">[Board Chairman Neat]  added: 'These are high-paid positions, but these are very capable people who could go elsewhere.'</blockquote> Re Maryland, from the Baltimore Sun <blockquote class="tr_bq"> Executives need to understand everything from the latest health technologies to regulatory changes, including health reform.</blockquote>So do doctors and nurses, so why do they not not get similar pay? Also, <blockquote class="tr_bq"> [Carmela Coyle, CEO of the Maryland Hospital Association, said,] 'Hospital executives are in charge of incredibly complex organizations,' she said. 'They are organizations that are open 24 hours a day and are highly regulated. These are really difficult, difficult jobs'.</blockquote> Note again the lack of comparison with the doctors and nurses who must staff the hospitals 24 hours a day, and make difficult decisions while caring for patients with sometimes life-threatening conditions.  How often does a hospital CEO get a call in the middle of the night, and how often does it require a decision in a life-and-death situation? Re Mercy Medical Center, <blockquote class="tr_bq"> 'As a result of Mr. Mullen's leadership, vision and skillful stewardship, Mercy has been an economic engine for the city, infusing additional jobs into the local economy,' the hospital said in a statement.</blockquote> When in doubt, use the v (for visionary) word.  Note that this begs the questions of how many other people were responsible for the economic benefits, and whether such benefits, rather than, say ability to provide good care to patients, should be the main consideration. Should Brilliance be Measured by Revenue? At best, some defenders of high CEO pay seem to argue that the main measure of CEO brilliance ought to be their hospitals' financial performance. For example, the DelMarvaNow article included, <blockquote class="tr_bq">Fiscal health is one of the most important considerations in determining [new CEO Peggy] Naleppa's pay, [board chairman] Neat said. </blockquote> Also, he was quoted, <blockquote class="tr_bq">'There's no question that the financial performance of the institution is going to affect what you're going to pay', Neat said.</blockquote> While, <blockquote class="tr_bq">Nationwide, hospital boards subscribe to a similar philosophy.  Financial health was cited by 100 percent of multi-hospital organizations in a 2006 survey as a factor in determining bosses' incentive plans.</blockquote> Similarly, the Baltimore Sun quoted Dr Stephen F Jencks, "who serves on the board of the cost review commission," <blockquote class="tr_bq">executives should be judged by whether they are running cost-efficient organizations</blockquote> However, CEO pay seems to increase even at financially challenged institutions,  as the Baltimore Sun noted, <blockquote class="tr_bq">The CEO pay question — always a hot-button issue — is generating debate again this year after a state panel spurned a push by hospitals for higher rates, instead approving smaller increases and calling on them to do more to curb expenses. Hospitals have sought rate increases in each of the past three years, and this year at least one Baltimore-area hospital responded with layoffs in an effort to trim labor costs.</blockquote> So, <blockquote class="tr_bq">'If they are laying off staff and decreasing what they invest in the community and executive compensation is increasing, that is a real question,' said Jessica Curtis, project director of the hospital accountability project at Community Catalyst, a national advocacy group that promotes wider access to affordable health care.</blockquote>Even if one accepts that the compensation of leaders of organizations that take care of sick and injured patients ought to mainly depend on the brilliance of their leadership as measured by how much money the organizations make, rather than the quality of that care, it is not clear that all these leaders are brilliant in that sense. The Charitable Mission and CEO Compensation Essentially all US non-profit hospitals and hospital systems have a history of a charitable mission to improve the health of their patients and communities, even if that means taking care of poor people who cannot pay for these services.  Nearly all justify their legal status as non-profit corporations by stating this mission.  For example, Peninsula Regional Medical Center, the main subject of the DelMarVaNow article, describes its mission thus in its <a href="http://www.guidestar.org/FinDocuments/2012/520/591/2012-520591628-094036fd-9.pdf">US tax filing</a>, <blockquote class="tr_bq">Peninsula Regional Medical Center is a not-for-profit 501 (c) 3 non-stock corporation founded in 1897 to serve the health care needs of the community.  The Hospital's primary purpose is to provide the highest [sic] primary, secondary, and selected tertiary health care services to residents of and visitors to the Mid-Delmarva Peninsula in a competent, compassionate, and cost effective manner designed to elicit a high degree of consumer satisfaction.  The Hospital's mission is to improve the health of the communities we serve....</blockquote> Yet it appears that this mission is honored mainly in the breach, at least when it comes to CEO compensation.  The DelMarVaNow article emphasized that hospitals' charitable functions are not seen as relevant by hospital boards when setting CEO compensation, <blockquote class="tr_bq">Despite the nonprofit status of the organizations they oversee, hospital boards don't appear to put weight toward the amount of free medical services and community outreach activities, good deeds collectively known as charity care, [executive vice president of Integrated Healthcare Strategies Kevin] Talbot</blockquote> Also, <blockquote class="tr_bq">The head of the consulting firm that helps PRMC's board establish [current CEO] Naleppa's pay said community benefit shouldn't be part of the equation. 'In my over 25 years of consulting on hospital compensation, I have never seen community benefit used as a factor in determining executive pay,' Rian Yaffe said.  'Community benefit has nothing to do with how difficult a hospital is to manage and lead.'</blockquote> However, community benefit is the mission of the hospital, and is justification for most US hospitals' non-profit status, which allows them to escape certain kinds of taxation, and for donors to make charitable, tax-advantaged contributions to the hospitals.   The Baltimore Sun listed financial but not charitable performance as a justification for the compensation of a particular executive, the CEO of Johns Hopkins Medical Center, who is <blockquote class="tr_bq">'held responsible for stringent qualitative measures,'  in such areas as financial performance, patient safety and service excellence, [Johns Hopkins] spokeswoman Kim Hoppe said in a statement.</blockquote> When asked by the Sun to comment, the advocacy group Community Catalyst stated <blockquote class="tr_bq">One of the factors that should be considered, it says, is the role of non-profit hospitals in the community and in providing charity care.  </blockquote> Meanwhile, while the hospitals gain advantages from ostensibly focused on the mission of providing community care and benefit, not only are there leaders not given incentives to uphold this mission, they are explicitly compared to leaders of for-profit organizations who have no such missions, and who are primarily tasked with increasing short term revenue in this era of "<a href="http://hcrenewal.blogspot.com/search/label/financialization">financialization</a>."  In the Baltimore Sun, <blockquote class="tr_bq">Hospitals note that they compete with private sector businesses where their executives could choose to work instead.</blockquote>Again, as noted above, there is little evidence that top hired managers are really that mobile, and less that a manager from one sector, e.g., non-profit hospitals, would be in great demand in another, e.g., a for-profit corporation. The Boston Globe noted an argument made that implied no one should complain about how much non-profit hospital executives make, since executives of for-profit corporations make even more. <blockquote class="tr_bq"> 'In a big successful teaching hospital, it’s very rare to see anything less than $1 million in total compensation for the chief executive, and $1.5 million to $2 million is the norm,' [managing director of consulting firm Compensation Resources Paul R] Dorf said. 'Executives at publicly traded pharma or medical device companies can make 10 times as much.' </blockquote>So if there is little evidence for the mobility of top hired managers, there is less for the desirability of managers of non-profit hospitals as heads of large pharmaceutical or medical device companies.  But furthermore, in trying to justify, albeit illogically, outsize CEO compensation, the defenders of this compensation have provided evidence that the leaders and stewards of non-profit hospitals may no longer care about the hospitals' fundamental mission.  This suggests that hospitals' overt declarations of their mission, especially when used to obtain more donations and tax benefits, may amount to the ethical equivalent of a "long con," that is, a long-term confidence scheme. Summary While F Scott Fitzgerald noted that the very rich are different from you and me, it may now be more appropriate to say that top hired managers are very different from you and me.  Again and again we see that they play by very different sets of rules than do other people who work in health care.  Notably, while they often emphasize cost cutting, and may be quick to lay off or outsource other employees, their compensation increases year by year no matter how well their organizations are doing.  While other employees, increasingly now including doctors as well as other health care professionals, have to answer to the hired managers, the hired managers only answer to boards of directors or trustees who often act like their cronies, perhaps because they are often also current or retired hired managers. Hired managers are subject to incentives that seem designed not to improve patients' and the public's health, but at best to improve the short-term revenue of health care organizations, and at worst to increase the wealth of hired managers.  Such perverse incentives risk promoting ill-considered, mission-hostile, or even corrupt management.  The sorts of people who aspire to be hired managers in such conditions are likely not the sort of people one would expect to really advance the health of patients or of the population. As a first step to restoring health care leadership to some state of reasonable accountability and responsibility, we need to challenge the rules that only hired managers play by.  It would be nice to see articles in the media about health care CEO compensation that at least attempt to question the usual talking points.  All of us could think about how we could challenge our local million dollar plus hospital CEOs to justify why they should be treated so differently from all other hospital employees. Since it seems that many hospitals no longer fit at least the spirit of the definition of not-for-profit organizations, even though they use this designation for financial advantage, we need policies to encourage them to uphold their mission, and that provide negative consequences if they do not.

The Long Con - "Charitable" Hospitals Make Multimillionaires out of Their CEOs

The CEOs of ostensibly charitable hospitals founded to serve the poor continue to become rich. The latest reminders are in two articles from Maryland, from DelMarVaNow, and from the Baltimore Sun,.a…

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23 Aug 2013

Guest Post: Incompetent Management Breeds Demoralized Physicians

Health Care Renewal presents a guest post by <a href="http://imh.utmb.edu/about-us/faculty/howard-brody">Dr Howard Brody,</a> John P McGovern Centennial Chair of Family Medicine, Director of the Institute for Medical Humanities at University of Texas - Medical Branch at Galveston, and blogger at <a href="http://brodyhooked.blogspot.com/">Hooked: Ethics, Medicine and Pharma</a>.  Danielle Ofri, a prominent internist/author at Bellevue in New York, started a recent <a href="http://danielleofri.com/an-epidemic-of-disillusioned-doctors/">op-ed</a> piece, “Last week I was ready to quit medicine."  <div class="MsoNormal">She described an encounter most physicians can relate to—a 15-minute appointment slot, a new patient who spoke only Bengali, a long and complicated problem list, a bag containing 18 different medicines, two forms that had to be filled out by the doctor on this day’s visit, and a computer that froze while she was trying to keep up with the electronic charting. She described how, 45 minutes into the supposedly 15-minute visit, she had a phone in one ear with the Bengali translator and tech support on hold in the other ear.</div><div class="MsoNormal"> </div><div class="MsoNormal">Ofri’s plaint caught my attention because I had recently put up a <a href="http://hcrenewal.blogspot.com/2013/05/guest-post-physician-rebels-against.html">guest post on Health Care Renewal</a> about another highly skilled, caring physician who was seriously considering quitting practice. This led me to write a <a href="http://www.utmb.edu/newsroom/article8763.aspx">column</a> for some of our local newspapers about demoralized doctors</div><div class="MsoNormal"></div> <div class="MsoNormal"> </div><div class="MsoNormal">In the space allowed in an op-ed column, you can’t go into great depth in analyzing a complicated situation. So here’s what I would have wanted to say.</div><div class="MsoNormal"> </div><div class="MsoNormal">We can list all the management failures that this encounter represents. I won’t even start with the electronic record as that’s such a frequent theme in this blog. Who scheduled such a patient for a 15-minute visit? Where is the pharmacist who could have done a better job of going through all the lady’s medicines? Where is the staffer who could have filled out the forms for Dr. Ofri to sign? This is just to scratch the surface.</div><div class="MsoNormal"> </div><div class="MsoNormal">There are two things worrisome about this long list of management failures. If the goal of the health care system is actually to take good care of patients, then it seems obvious that Dr. Ofri, who wanted to try to provide high-quality care, had roadblock after roadblock thrown in her way.</div><div class="MsoNormal"> </div><div class="MsoNormal">Cynics will protest that this system obviously has no interest in quality patient care and seeks only to maximize revenue. If that’s so, is it really true that a board-certified MD is the most efficient labor source for keyboarding data into a computer, filling out paper forms, and doing all the other busy-work tasks that Dr. Ofri had to juggle? Can anyone really believe that this management structure supports either quality care orefficient resource use?</div><div class="MsoNormal"> </div> If the management of U.S. hospitals was severely understaffed or underpaid, then we could perhaps forgive such lapses. But we know that while the growth of physicians in the U.S. has been slow, the number of administrators has grown by leaps and bounds [The number of health care managers increased by 726% from 1983-2000 while physician numbers increased by 39%, look <a href="http://hcrenewal.blogspot.com/2005/04/growing-proliferation-of-managers.html">here</a> - Ed]  . And we know that at least at the high end, these managers are paid <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">munificent sums</a>, and are lauded for their supposed genius (look <a href="http://hcrenewal.blogspot.com/2013/06/no-blues-but-lots-of-green-for-st-louis.html">here</a> for example).    <div class="MsoNormal">So we appear to have a system that is slowly (in some cases rapidly) driving the best doctors out of practice, and yet somehow imagines that everything is going all right and there’s no problem—or if there’s a problem, it’s those whining doctors.</div><div class="MsoNormal"> </div><div class="MsoNormal">All us medical educators know that when we ask the first-year class how may of them have been told by practicing physicians that they’re making a big mistake coming to medical school, the majority will raise their hands. Yet the managers of America’s health systems apparently believe that they can go on demoralizing good practitioners and nothing bad will happen.</div><div class="MsoNormal"> </div><div class="MsoNormal">This may sound as if I am saying that health care managers are all evil people, but that’s an unfair characterization. These folks are simply trying to do what our society tells them. As I <a href="http://hcrenewal.blogspot.com/2012/03/golden-calf-explains-how-economism-lead.html">explained</a> some time ago, most of our popular and political discourse has been captured by a belief system that can be variously called neoliberalism, market fundamentalism, or <a href="http://hcrenewal.blogspot.com/search/label/economism">economism</a>. The ideology can be summarized as a quasi-religious faith in the so-called “free market,” steadfast opposition to government regulation of the market, and opposition to just about any form of taxes (for more on the nature of economism, look <a href="http://theeconomismscam.blogspot.com/2012/09/economism-primer.html">here</a>.)</div><div class="MsoNormal"> </div><div class="MsoNormal"></div><div class="MsoNormal"> </div><div class="MsoNormal"> Among other things, this ideology teaches us that everything important in our society can be accurately captured in objective measures of “productivity” and “efficiency.”  [This is akin to the "shareholder value" theory of management (look <a href="http://hcrenewal.blogspot.com/2012/04/health-care-dysfunction-explained-by.html">here</a>), or "<a href="http://hcrenewal.blogspot.com/search/label/financialization">financialization</a>." - Ed]  Once one has mastered the basic concepts taught in MBA school, there’s no need to learn anything about health care and what makes it a unique activity; there’s no basic difference between providing health care and flipping burgers at McDonalds or making widgets. [We have called this <a href="http://hcrenewal.blogspot.com/search/label/generic%20management">generic management</a>. - Ed.]. And so we get the crazy style of management well documented on this blog, not because of personal nastiness or ill will, but due to the ideological Kool-Aid everyone has been drinking for several decades now. </div><div class="MsoNormal"> </div><div style="margin-bottom: .0001pt; margin: 0in;">Today’s physicians seem to be like the proverbial frog being boiled in the pot of water because the heat was turned up so gradually the frog never figured out it needed to jump. [That is, they are suffering from "<a href="http://hcrenewal.blogspot.com/search/label/learned%20helplessness">learned helplessness</a>." - Ed] Dr. Ofri herself seems to represent a typical frog. Why? Perhaps it’s the style of the blog or op-ed writer to start off with a downer and then try to end on an upbeat note. Or perhaps it’s the natural physician’s tendency to stay away from policy questions. I’m not sure.</div><div style="margin-bottom: .0001pt; margin: 0in;"> </div><div style="margin-bottom: .0001pt; margin: 0in;">After starting us off with this hard-hitting description of a dysfunctional system, Dr. Ofri ends by opining that things are going to be better in the future because more women are entering medicine and because today’s medical students are more tech savvy. She gives herself credit for managing to forge a bond with the patient because they sat together and faced this adversity. She cites an upbeat study, “when asked what was the most satisfying aspect of medical practice, the number one answer was relationships with patients. This is what keeps us going on even the most trying of days.”</div><div style="margin-bottom: .0001pt; margin: 0in;"> </div>Dr. Ofri gets full credit for remembering the importance of relationships, and feels that she bonded more firmly with her patient because they went through all this together. How about a word, though, about the people behind the curtain, who are responsible for all that she and her patient had to go through, and who don’t seem to have a clue how bad it is and what it all means?  <div class="MsoNormal"> </div><div class="MsoNormal">Dr Howard Brody </div>

Guest Post: Incompetent Management Breeds Demoralized Physicians

Health Care Renewal presents a guest post by Dr Howard Brody, John P McGovern Centennial Chair of Family Medicine, Director of the Institute for Medical Humanities at University of Texas - Medical Br…

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30 Jul 2013

Pfizer May No Longer be Able to Delay Paying Its Asbestos Claims of Nearly $1 Billion

Pfizer, which claims to be the "world's largest research-based pharmaceutical company," is one step closer to paying a nearly one billion dollar settlement of legal claims of harms due to the asbestos products it used to manufacture. Pfizer Settles - More or Less - Some of its Asbestos Liability Most people would not think of Pfizer as a producer of asbestos.  However, the back-story, as <a href="http://www.philly.com/philly/business/20130627_Drug-maker_Pfizer_fails_to_escape_costly_asbestos_case.html">reported</a> in the Philadelphia Inquirer, and as we discussed <a href="http://hcrenewal.blogspot.com/2011/01/curious-case-of-pfizers-asbestos-claims.html">here</a> in 2011, is that <blockquote class="tr_bq">Pfizer used to have a minerals, pigments and metals division and, in 1968, it bought Quigley Company Inc., which made insulation for heavy industry. Quigley's Insulag contained asbestos.</blockquote> So, <blockquote class="tr_bq">Quigley stopped production at its facility in Old Bridge, N.J., in 1992.  When it filed for bankruptcy in 2004, Quigley faced more than 160,000 lawsuits, most related to asbestos product liability.</blockquote> By apparently holding out the legal fiction that Quigley was an independent entity, Pfizer seemed to use to use the bankruptcy filing to delay making any payment of these claims, most of which likely involved illnesses due to asbestos exposure.  As the Inquirer article said, <blockquote class="tr_bq">Pfizer has spent the nine years since arguing that bankruptcy law protects it from such lawsuits.</blockquote> notwithstanding the fact that Pfizer itself is hardly bankrupt. But now, as Bloomberg reported (<a href="http://www.theday.com/article/20130627/BIZ03/306279581/1044">via</a> the New London [CT] Day), <blockquote class="tr_bq"> Pfizer Inc.'s non-operating Quigley Co. won permission to end almost nine years in bankruptcy under a plan that resolves most asbestos claims against the former insulation maker and its parent, the world's largest drugmaker. U.S. Bankruptcy Judge Stuart Bernstein in Manhattan Wednesday approved a Chapter 11 plan under which Pfizer will contribute assets worth $964 million. He rejected a prior plan almost three years ago, saying Pfizer was improperly using Quigley's bankruptcy to shield itself from asbestos claims.</blockquote> Note that Pfizer has consistently argued that it should bear no responsibility for the effects of the asbestos made by its subsidiary: <blockquote class="tr_bq">'Pfizer has never been found derivatively or directly liable for injuries allegedly caused by Quigley's asbestos- containing products,' [Pfizer spokesman Christopher] Loder said.</blockquote> <div id="r1PostCPBlock" style="background-color: white; border: medium none; color: black; left: -99999px; overflow: hidden; position: absolute; text-align: left; text-decoration: none;">Pfizer used to have a minerals, pigments and metals division and, in 1968, it bought Quigley Company Inc., which made insulation for heavy industry. Quigley's Insulag contained asbestos. Read more at <a href="http://www.philly.com/philly/business/20130627_Drug-maker_Pfizer_fails_to_escape_costly_asbestos_case.html#AltGBB8oXa8YPkAC.99" style="color: #003399;">http://www.philly.com/philly/business/20130627_Drug-maker_Pfizer_fails_to_escape_costly_asbestos_case.html#AltGBB8oXa8YPkAC.99</a></div>Furthermore, <blockquote class="tr_bq">Pfizer has said throughout the case that it never made or sold Quigley's products and it doesn't have liability for them. Asbestos, once widely used as an insulator, was later shown to cause cancer.</blockquote> Convenient Fictions This case received little notice in 2011 and is receiving little notice now, and mainly for its business implications.  Yet the reporting does suggest  dots to connect to reveal some larger hypocrisies. Dedicated to improving health and well being? Pfizer asserts <a href="http://www.pfizer.com/about/history/history.jsp">on its website</a> that it <blockquote class="tr_bq">has remained dedicated to discovering and developing new, and better, ways to prevent and treat disease and improve health and well being for people around the world.[italics added]</blockquote> Yet despite this supposed dedication to health and well-being, it has long delayed any possible compensation to people who may have acquired severe, if not fatal disease from contact with one of its products. As per Bloomberg, note the examples of <blockquote class="tr_bq">people like Brenda Hagerich, 62, of Hot Springs, Ark., may get payments on their claims. Hagerich, whose father died in 1999 of mesothelioma, said she has been waiting for a second distribution of a $125,000 payment.</blockquote> Ownership without responsibility According to current media reports,  Pfizer attorneys repeatedly contended that because Quigley was a subsidiary of Pfizer, Pfizer could not be held accountable for its actions.  Yet Pfizer owned, and presumably thus gained all revenue from and chose the leadership of Quigley.  At best, maintaining this fiction seems heartless given Pfizer's stated interest in peoples' "health and well being." Who knew asbestos was dangerous? The current reports seem to imply that Pfizer's accountability should be mitigated because at the time it acquired Quigley, no one knew that asbestos was hazardous.  The Bloomberg report stated, <blockquote class="tr_bq">Quigley made asbestos-containing products from the 1940s to the 1970s, including Insulag, a powdered insulation. Pfizer, based in New York, bought the company in 1968.</blockquote> But, <blockquote class="tr_bq">Pfizer has said throughout the case that it never made or sold Quigley's products and it doesn't have liability for them. Asbestos, once widely used as an insulator, was later shown to cause cancer.</blockquote> The last sentence implies that asbestos was only shown to cause cancer after Pfizer acquired Quigley in 1968.  However, this suggests a lack of knowledge of medical history. In fact, evidence that asbestos was dangerous would have been readily available in 1968. Pulmonary asbestosis was recognized in 1927.(1, noted in 2).  Furthermore, by 1952, as per Dr Richard Doll(3), <blockquote class="tr_bq">The majority of workers (cited by Hueper, 1952) consider that a causal relationship between asbestosis and lung cancer is either proved or is highly probable and the reality of the relationship was agreed at the recent International Symposium on the Epidemiology of Lung Cancer.</blockquote> Doll reported further data in 1954 and concluded, <blockquote class="tr_bq">lung cancer was a specific industrial hazard of certain asbestos workers....</blockquote> Summary So while Pfizer officials ought to have known that in 1968 it was acquiring a company that made products that likely caused lung cancer, for more than 40 years, they have managed to stall payments to now mainly the heirs of people who acquired severe disease due to those products.  This clearly suggests that in this matter the company leadership has consistently put its revenue ahead of its ostensible dedication to peoples' health and well being.  Then again, this is hardly the first example of dubious ethical conduct by Pfizer.  See <a href="http://hcrenewal.blogspot.com/2013/01/pfizers-pfourteenth-settlement-small.html">this post </a>for a list of the 14 legal settlements of allegations of misconduct made by Pfizer since 2000, only one of which was related to the current case. Furthermore, dedication to short-term revenue over everything else has resulted in huge wealth for Pfizer's hired managers.  <a href="http://online.wsj.com/article/BT-CO-20130314-712087.html">Per</a> the Wall Street Journal, only the latest example is, <blockquote class="tr_bq">The total 2012 compensation for Pfizer Inc. (PFE) Chief Executive Ian C. Read was valued at $25.6 million, up 2.5% from 2011, as the drug maker hit two out of three key financial objectives last year.  Mr. Read's compensation was based partly on the company exceeding targets for total revenue and adjusted earnings-per-share, while missing its target for cash flow in 2012, Pfizer said in a proxy statement filed Thursday with the U.S. Securities and Exchange Commission.</blockquote> Presumably, the total revenue target would have been a bit lower if Pfizer had managed to set aside assets to pay the asbestos related claims discussed above in 2012 rather than in 2013. This relatively <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a> example shows how hollow ring most of the claims by leaders of big health care organizations that they value patients' and the public's health.  That may be convenient public relations puffery, but again and again the bottom line seems to matter more to them.  We have shown numerous examples of <a href="http://hcrenewal.blogspot.com/search/label/mission-hostile%20management">mission-hostile management</a>, and of leaders <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">compensated outrageously</a> out of proportion to their contributions to patients' and the public's health.  Thus, why should health care professionals, or patients believe that anything they do puts patients ahead of money? As we have said so often, health care professionals and society at large needs to hold large health care organizations' leadership accountable for their missions, and push out leaders who put their own pocketbooks and their organizations' revenue ahead of patients' and the public's health.  References 1.  Cooke WE.  Pulmonary asbestosis.  Br Med J 1972; 2: 1024. 2.  Hasan FM, Nash G, Kazemi H. Asbestos exposure and related neoplasia: the 28 year experience of a major urban hospital.  Am J Med 1978, 65: 649-654. Link <a href="http://www.ncbi.nlm.nih.gov/pubmed/707524">here</a>. 3.  Doll R. Mortality from lung cancer in asbestos workers.  Br J Indust Med 1955; 12: 81-86.  Link <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1035472/">here</a>.

Pfizer May No Longer be Able to Delay Paying Its Asbestos Claims of Nearly $1 Billion

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28 Jun 2013

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