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Annals of Electronic Information Security

Annals of Electronic Information Security

At The Hill , former House Speaker Newt Gingrich raises a good point about the leak of hundreds of thousands of diplomatic cables and other ...

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Professors at Harvard and Nottingham Medical School (UK): Are we repeating the UK's clinical IT failures in the US?

In the opinion piece "<a href="http://www.huffingtonpost.com/stephen-soumerai/dont-repeat-the-uks-elect_b_790470.html" title="Permalink" id="title_permalink">Don't Repeat the UK's Electronic Health Records Failure"</a> (Huffington Post, Dec. 5, 2010), <a href="http://www.populationmedicine.org/content/personnelDetail.asp?PID=164&CID=1&Sub=Y">Dr. Stephen B. Soumerai</a>, Professor of Population Medicine at Harvard Medical School and <a href="http://www.nottingham.ac.uk/News/ExpertiseGuide/Experts/A/DrTonyAvery.aspx">Dr. Anthony Avery</a>, Professor of Primary Care at the University of Nottingham Medical School, UK share familiar themes on health IT. These themes will be especially familiar to HC Renewal readers and to my students and other readers of my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">Medical Informatics teaching website</a>. The professors wrote: <blockquote>Fueled by the economic stimulus passed by Congress in 2008 [The ARRA a.k.a. "American Recovery and Reinvestment Act" and the HITECH legislation it contained - ed.], the federal government has embarked on a controversial $30 billion program to induce doctors throughout the country to adopt electronic health records (EHRs) by 2014. The purpose is to create an interconnected system of electronic health records to improve safety and reduce medical costs. But the United Kingdom has spent the last 6 years working on the same idea, and it's proven to be a colossal failure -- so much so that the government is drastically cutting its program. What happened to their plan? Should we be paying attention before rushing ahead with our own?</blockquote> My response to that question is clear, such as at my Nov. 2008 post "<a href="http://hcrenewal.blogspot.com/2008/11/should-us-call-moratorium-on-ambitious.html">Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans</a>?" and the followup Jan. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/01/i-ask-again-should-us-call-moratorium.html">I Ask Again: Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?</a>" where I wrote: <blockquote> $50 billion a year is big money that might be better spent elsewhere - such as providing care for the poor and for disadvantaged children - until we know how to get HIT right. I suggest it may be best not to go all-out for HIT under the current paradigm. It is my belief, in fact, based on the above issues [UK and US issues - ed.] plus a chronic influx of HIT difficulty and mismanagement stories I hear from colleagues, ex-colleagues, recruiters, etc., that healthcare organizations not contractually obligated should consider a postponement of plans to purchase clinical IT (i.e., systems for direct use by clinicians such as EHR's). This postponement should last at least until the issues that lead to ineffective and counterproductive HIT can be better understood and corrections initiated in the industry.</blockquote> The professors further write: <blockquote>In 2005 the United Kingdom embarked on the largest investment ($18 billion) in health information technology in the world. Yet despite expectations that the system would increase efficiency and reduce medical errors, their efforts neither improved health nor saved money -- in fact in some cases, they may have led to patient harm. Britain's government-run medical system is obviously different from our complex public-private insurance system. [I had written that a smaller, socialized healthcare system should be far easier to automate than our own in the US - ed.] However, its electronic health record project bears an uncanny resemblance to the program President Obama is starting. </blockquote> They then delineated a number of problems: <blockquote>Too large and ambitious: The UK project tried to accomplish too much, too fast, attempting to digitize health records for the whole population in a period of four years. This massive undertaking is years behind schedule and has delivered only a fraction of what it promised. Despite all the money poured into the system, the vast majority of hospitals in the UK still don't have integrated electronic health records. </blockquote> Why? The reasons sound familiar: <blockquote> ... Because non-clinicians developed the system, the electronic forms they designed have little to do with how doctors treat patients -- making it unworkable for many physicians. As the Chair of the British House of Commons Public Accounts Committee recently stated, "This is the biggest IT [Information Technology] project in the world and it is turning into the biggest disaster."</blockquote> The "biggest IT disaster in the world" is not an honor I wish to see repeated in the U.S. On another familiar problem: <blockquote>Too dependent on commercial, proprietary companies: Rather than create one system and beta-test it, the UK government depended on four companies to build the system, two of which quit or were fired for missing deadlines. So the health records were never developed in the south of England. The computer software was secret and proprietary. There was no accountability to the public, and the vendors did not provide enough technical support to clinicians having trouble using the records. The resulting software errors and crashes caused missing or incorrect clinical information and sometimes threatened patient safety, for example by causing surgical delays and the cancellation of hundreds of operations.</blockquote> The inquiring mind would want to know about actual patient injuries and deaths that likely resulted from such problems... The professors observe: <blockquote>If a country like Britain -- which already has a national health system and is a fraction of the size of the US -- had so many problems with electronic health records, imagine the problems America would face.</blockquote> This sounds like my comments in a public comment letter of March 9, 2010 to HHS/ONC (<a href="http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html">Re: RIN 0991-AB59, "Proposed Establishment of Certification Programs for Health Information Technology</a>") where I wrote, among many other things: <blockquote>... We ignore the UK experience at our peril, an experience in a medical environment smaller and far more government-controlled than our own. ... I believe that a rushed National Program for HIT in the United States will suffer the same fate as the aforementioned National Programme for IT in the UK, and perhaps even a worse fate as the UK’s socialized medicine system is certainly a smaller, more homogeneous and more controllable testbed environment for experimenting with HIT.</blockquote> The professors relate: <blockquote> Even our partial adaption of electronic health records is causing problems. Over the last couple of years, doctors and hospitals have reported to the FDA dozens of medical injuries -- including six deaths and preventable heart attacks -- caused by problems related to computerized health records such as software errors and unreadable computer screens. Some errors resulted in drug doses that were 10 times higher than intended. FDA officials called this the "tip of the iceberg." </blockquote>I wrote about the FDA's findings <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=FDA_iceberg">here</a>, and conducted a "thought experiment" regarding what those numbers might extrapolate out to in my April 2010 post "<a href="http://hcrenewal.blogspot.com/2010/04/if-benefits-of-hit-can-be-guesstimated.html">If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers</a>."They continue: <blockquote>... More than 50 medical organizations, including the AMA, have called on the Secretary of Health and Human Services to delay the program. In response, the administration delayed some of the required health IT functions, but kept the same 2014 deadline.</blockquote> Indeed. They are courting disaster in my opinion, both clinically and financially, as I wrote in a Feb. 2009 Wall Street Journal letter to the editor entitled “<a href="http://online.wsj.com/article/SB123492035330205101.html">Digitizing Medical Records May Help, but It's Complex</a>”: <blockquote>Dear WSJ, You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill. I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants. For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors. HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine. The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker. I can only hope patients get something worthwhile for the $20 billion.</blockquote> The professors then note: <blockquote>How do we avoid the UK's failure? The administration or Congress should slow down the program and delete those parts of the legislation that fine doctors for not using this technology. There's no need to have this system in place by 2014. Instead, we should conduct rigorous studies of the cost-effectiveness of electronic health records systems before mandating their use. Rather than force doctors to choose from dozens of commercial software products developed in secret, we should take a hint from the non-commercial sector, such as the Veterans Administration, which uses "open-source" coding so people can work collaboratively to continuously improve the system. </blockquote> Slowing down the program and performing rigorous studies of HIT before wide scale rollout are themes I raised, among other places, in my Dec. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/12/healthcare-it-as-cybernetic-miracle.html">Tensions and Paradoxes in Electronic Patient Record Research: Critical Thinking on Health IT</a>" where I wrote: <blockquote>In conclusion, I believe this literature review supports the notion expressed in other studies and opinion pieces here and elsewhere that we really need to SLOW DOWN the current HIT stampede, largely promoted by the HIT industry lobby. We need to take the appropriate time to better understand how to "do HIT well" before plunging in as if we actually know what we're doing</blockquote> as well as at my Oct. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/10/washington-post-article-electronic.html">Washington Post Article: Electronic medical records not seen as a cure-all</a>" where I wrote: <blockquote>... The literature is indeed conflicting, and the need for rigorous scientific study has never been more essential considering the commitment of tens of billions of dollars towards health IT. The time for story telling, marketing based on opinion, name calling, leap-of-faith extrapolations of light year dimensions, and other forms of pseudoscience and non-science are over. The time for objective study is now.</blockquote> The professors conclude: <blockquote> The Obama administration wants government programs to be based on evidence of effectiveness. Simply following the lead of "IT believers" and salesmen without the requisite evidence will repeat the UK's failures. Now is the time to proceed carefully, consider existing research and the British experience, and chart a more rational course into the digital age of medicine.</blockquote> I do not know if these two professors were familiar with my writings, but I am happy to see these themes (once treated as verboten and as grounds for marginalization by the HIT industry) increasingly going mainstream. Patient well being - which includes you, dear readers - depends on that. -- SS

Professors at Harvard and Nottingham Medical School (UK): Are we repeating the UK's clinical IT failures in the US?

In the opinion piece " Don't Repeat the UK's Electronic Health Records Failure" (Huffington Post, Dec. 5, 2010), Dr. Step...

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Is Healthcare IT a Solution to the Wrong Problem?

In a study published in the Nov. 25, 2010 New England Journal of Medicine entitled "<a href="http://www.nejm.org/doi/full/10.1056/NEJMsa1004404">Temporal Trends in Rates of Patient Harm Resulting from Medical Care</a>", Landrigan N Engl J Med 363;22, it was found that medical error rates were not dropping: <blockquote>In a study of 10 North Carolina hospitals [from January 2002 through December 2007], we found that harms remain common, with little evidence of widespread improvement. Further efforts are needed to translate effective safety interventions into routine practice and to monitor health care safety over time. </blockquote> Unfortunately, I don't believe that the article differentiated between computerized hospitals and paper-based ones. Nor were the subject hospitals selected on the basis of computerization or non-computerization: <blockquote>We conducted a retrospective study of a stratified random sample of 10 hospitals in North Carolina ... ... All acute care North Carolina hospitals listed in the American Hospital Association (AHA) database except those providing exclusively pediatric, rehabilitation, or psychiatric care were eligible for selection for the study. These hospitals were stratified according to the AHA’s definition of the facility as small, medium, or large; urban or rural; and teaching or nonteaching. The number of hospitals that underwent randomization for inclusion in each stratum reflected the proportion of national discharges from that type of hospital. If an invited hospital declined to participate, another closely matched hospital was randomly invited to participate in its stead.</blockquote> While the extent of EHR/CPOE and other clinical IT adoption was not measured, some of the hospitals studied would likely have adopted and/or been using clinical IT in various capacities during the study period. The IT might have been expected to contribute to lower error rates over time. Although that is admittedly speculation, there is a more important point to be made. Many of the identified errors seem to have little to do with record keeping, but instead with human factors. From the New York Times article "<a href="http://www.nytimes.com/2010/11/25/health/research/25patient.html?_r=1&hp=&pagewanted=print">Study finds No Progress in Safety at Hospitals</a>" covering the NEJM article: <blockquote>... Landrigan’s study reviewed the records of 2,341 patients admitted to 10 hospitals — in both urban and rural areas and involving large and small and teaching and nonteaching medical centers ... Among the preventable problems that Dr. Landrigan’s team identified were severe bleeding during surgery, serious breathing trouble caused by a procedure being performed incorrectly, a fall that dislocated a patient’s hip and damaged a nerve and vaginal cuts caused by a vacuum extraction device used to help deliver a baby. The findings were a disappointment but not a surprise, Dr. Landrigan said. Many of the problems were caused by the failure of hospitals to use measures that had been proved to avert mistakes and prevent infections from urinary catheters, ventilators and lines inserted into veins and arteries. </blockquote> The chart of "harms" in the article, both those deemed "non-preventable" and those deemed "preventable" reads like a textbook of medicine, e.g.: <blockquote>Cardiac arrest, shock, myocardial ischemia, acute respiratory failure, acute renal failure, hemorrhage, thromboembolic venous event, hematoma, pancreatitis, ileus, stroke or intracerebral hemorrhage, withdrawal symptoms, catheter-related bloodstream infection, urinary tract infection, surgical-site infection, clostridium difficile colitis, surgical anastomosis failure, wound dehiscence, failed procedure, unplanned return to surgery, fetal neonatal complication associated with delivery, hypothermia, pressure ulcer, catheter complication, etc.</blockquote> It seems unlikely a missing or illegible chart was the cause of many of these adverse events. (In fact, the study was done retrospectively from the patient charts.) Thus, expectations for major quality improvements in healthcare from the hundreds of billions spent on health IT might be vastly overstated based on false assumptions about the causes of adverse events. Many of the above adverse events seem not highly amenable to correction via cybernetic information retrieval systems. They might be amenable, though, to improved nursing and ancillary staffing (perhaps I should say 'elimination of understaffing'), decreased work hours, improved CME, and better supervision of trainees ($100's of billions of dollars being spent for IT would surely buy a lot of those items). What I found striking was this: <blockquote> “A third of the errors in the intensive care unit disappear when residents work 16 hours or less,” Dr. Landrigan said, although he noted that senior residents often work longer hours.</blockquote> That being the case, health IT that created heavier workloads and cognitive overload of residents already struggling under sleep deprivation might actually increase the risk of error. It would seem national healthcare IT may be a 'solution' to the wrong problems in 2010. We perhaps should better be focusing on human problems not amenable to cybernetic intervention before we start a national medical IT experiment, in the hope that major changes will somehow be effected by the magic of computers. -- SS

Is Healthcare IT a Solution to the Wrong Problem?

In a study published in the Nov. 25, 2010 New England Journal of Medicine entitled " Temporal Trends in Rates of Patient Harm Resulting...

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Health Insurers Sanctioned, Fined

It has not been a good few weeks for big US health insurance companies.  First was a report (e.g., <a href="http://online.wsj.com/article/BT-CO-20101122-708949.html">per</a> the Wall Street Journal) that three companies had been suspended from selling Medicare Advantage plans: <blockquote>The U.S. government's Medicare program has ordered three health insurers--Universal American Corp. (UAM), Health Net Inc. (HNT) and Arcadian Health--to stop marketing to and enrolling new members in their Medicare Advantage health and prescription-drug plans, saying the companies violated regulations. </blockquote> In particular, <blockquote>Universal American was told to stop marketing to and enrolling people in its Medicare Advantage plans effective Dec. 5. The action doesn't affect current members or the enrolling of beneficiaries in the company's stand-alone Medicare prescription-drug plans. Health Net had to suspend the marketing of and enrollment in its Medicare Advantage plans and stand-alone Medicare prescription-drug plans as of Friday, as the government said the company's conduct poses a 'serious threat' to enrollees. The sanction doesn't affect the status of current enrollees, however. In a letter Friday to Theodore Carpenter, head of Universal American's Medicare Advantage business, the Centers for Medicare and Medicaid Services alleged the company has a 'longstanding pattern of prohibited marketing practices targeted to highly vulnerable populations in violation' of federal law and guidelines as well as contractual terms with CMS. Universal American is a 'chronic poor performer' with respect to the regulations, according to CMS, which said the company's agents engaged in aggressive sales tactics and abusive behavior, and misled or confused beneficiaries or misrepresented the plan. The agency's letter to Health Net government-programs executive Scott Kelly said the company's conduct 'poses a serious threat to the health and safety of its enrollees,' as a result of the company's 'intractable failure to provide its enrollees with prescription drug benefits in conformance" with laws, guidelines and contract terms.' CMS cited a 'history of non-compliance.' </blockquote> Then, the state of California fined and ordered restitution from multiple companies, as <a href="http://articles.sfgate.com/2010-11-30/business/24951943_1_health-insurers-san-francisco-insurer-dmhc">reported</a> by the San Francisco Chronicle: <blockquote>State regulators Monday fined seven of California's largest health insurers nearly $5 million for systematically failing to pay doctors and hospitals fairly and on time. The California Department of Managed Health Care issued the fines following an 18-month audit in which investigators looked at a small but statistically significant sample of claims. The investigation found the plans were paying on average about 80 percent of the claims correctly, far below the legal threshold of 95 percent. 'Our clear and consistent message is that California's hospitals and physicians must be paid fairly and on time,' said Cindy Ehnes, director of the Department of Managed Health Care, which is charged with regulating the states' health maintenance organizations, or HMOs. In addition to the fines, the companies must pay the doctors and hospitals restitution that is expected to run into the "tens of millions of dollars," Ehnes said. The plans will also be required to come up with a plan to correct the problem and submit to future audits. Failing to pay providers properly makes it tougher for them to survive in the struggling economy, Ehnes said. 'If providers are not paid, patient care and access suffer,' she said. Regulators fined Anthem Blue Cross and Blue Shield of California $900,000 each. United/PacifiCare was fined $800,000 and Kaiser Foundation Health Plan and Health Net were both hit with fines of $750,000. The fines for Cigna and Aetna were $450,000 and $300,000, respectively, for a total of $4.85 million.</blockquote> Please note that some of these companies have become "frequent flyers" on the Health Care Renewal blog.  Anthem Blue Cross in California is a subsidiary of WellPoint. WellPoint, in particular, just appears again and again on Health Care renewal.  A list of all posts about that company is <a href="http://hcrenewal.blogspot.com/search/label/WellPoint">here</a>, and see <a href="http://hcrenewal.blogspot.com/2010/04/what-me-worry-leaders-prosper-despite.html">this post</a> for a list of past ethical and management missteps.  Health Net appeared in both stories above, and appeared on Health Care Renewal <a href="http://hcrenewal.blogspot.com/search/label/Health%20Net">here</a>.  Posts on Aetna are <a href="http://hcrenewal.blogspot.com/search/label/Aetna">here</a>. Having been writing for this blog now for several years, I am struck by how often the conduct of particular health care organizations has been discredited, without any discernible effect on the organization's leadership or course.  It is particularly striking how the attention paid and pay given to the leaders of some health care organizations contrasts with the public record of their organization's bad behavior. In particular, contrast the long catalog of misbehavior by WellPoint, noted above, with the enormous earnings of the company's CEO (more than $13 million in 2009), and her status as a prominent speaker on health care policy (see post <a href="http://hcrenewal.blogspot.com/2010/11/prominent-health-care-policy-advice.html">here</a>).  In the laissez faire, anything goes, wild, wild west economy of today, spearheaded by the financial service companies that lead us to the global economic collapse, it seems that ethical leadership counts for nothing.  This is bad when it applies to the leadership of financial services, whose bad leadership can cost us all a lot of money.  It is worse when it applies to health care, whose bad leadership can cost us our health and our lives. As I have said ad infinitum, to really reform health care, we will need to get accountable, ethical, transparent leadership of health care organizations.

Health Insurers Sanctioned, Fined

It has not been a good few weeks for big US health insurance companies. First was a report (e.g., per the Wall Street Journal) that three ...

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When Robo-Medicine Replaces Dr. Welby, Watch Out

<div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;">At "<a href="http://online.wsj.com/article/SB10001424052748704658204575610770240874674.html?mod=WSJ_article_related">The Trouble With Robo-Lending</a>", WSJ, Nov. 13, 2010 Amir Bhidé wisely notes, contrary to the seductive memes of statistical model religionists, that: <blockquote>"High-touch gave way to high-tech. Statistical models that took no heed of specific circumstances replaced the bankers' on-the-spot judgments" </blockquote> and that: <blockquote>"Robo-lending and the securitization it facilitates lead to the misallocation of capital and economic instability." </blockquote> Wait until "Robo-Medicine" hits, where on-the-spot judgments about medical care get replaced with statistical models of treatment, for example, in the form of electronic medical records-hosted "decision support" based on "comparative effectiveness research." We apparently have not yet learned our lessons from the financial crisis regarding statistical legerdemain in fields where statistics should never replace human judgment. It's only money. However, the fundamental truths within the adage "there are three kinds of lies: lies, damned lies, and statistics" will become exceedingly and painfully clear from the medical mayhem that results when Robo-Medicine replaces Dr. Welby. -- SS </div>

When Robo-Medicine Replaces Dr. Welby, Watch Out

At " The Trouble With Robo-Lending ", WSJ, Nov. 13, 2010 Amir Bhidé wisely notes, contrary to the seductive memes of statis...

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Academic Medical Center Crime Wave?

Every large group or organization has a few bad apples.  My web searches constantly turn up stories of individuals working in health care who behave unethically or commit crimes.  I do not generally discuss these cases on Health Care Renewal, since they seem unavoidable, and their sporadic appearance does not necessarily have anything to do with systemic problems in health care. However, in the last week, I noted four cases of rather exceptionally bad behavior by individuals working in large hospital systems, and the severity and proximity of these cases made me wonder if they reflect some new trend. Pennsylvania State University Faculty Member Charged with Rape As <a href="http://www.pennlive.com/midstate/index.ssf/2010/11/doctor_accused_of_using_painki.html">reported</a> by PennLive.com, <blockquote>Former Derry Township, Dauphin County, doctor Dr. Robert L. Yarwood stands accused of using his position and influence to addict two of his patients to painkillers and raping them multiple times. Yarwood, 56, has been charged with more than 42 criminal counts, including rape and sexual assault, stemming from allegations made in 2008 by two women, ages 40 and 45. He is accused of giving narcotics to the women to 'exert psychological force,' said Fran Chardo, Dauphin County first assistant district attorney. 'The case, speaking abstractly, is very disturbing because of the trust relationship between the patient and the doctor,' Chardo said. 'It’s a violation of trust.' In an interview with The Patriot-News, one of the women said she had visited Yarwood several times over the course of a year. He was prescribing her pain medication, which she eventually became addicted to. Then, she said, he raped her. 'I was paralyzed. I was in shock,' she said. 'I trusted him.' At the time of the allegations, Yarwood was an obstetrician and gynecologist at the Penn State Milton S. Hershey Medical Center, which he joined in the late 1990s. In August 2008, the medical center was apprised of the investigation and immediately suspended Yarwood from having contact with patients. </blockquote> $5 Million Embezzlement from Columbia University Medical Center As <a href="http://online.wsj.com/article/SB10001424052748704584804575645152197487616.html">reported</a> by the Wall Street Journal, <blockquote>A 48-year-old Bronx man has been arrested and charged with grand larceny for allegedly stealing nearly $4.5 million from Columbia University over the course of two months, authorities said Monday. George Castro is accused of adding a TD Bank account belonging to him as a payee in the Columbia University Medical Center's accounts payable system, netting payments of $3.4 million in October and $1 million in November, authorities said. Mr. Castro, whose relationship with the university is unclear, was arrested Wednesday. A law-enforcement official familiar with the case said Mr. Castro had $200,000 in cash in his possession when he was arrested and had withdrawn $140,000 the day before his arrest. According to a criminal complaint, Mr. Castro told investigators the money 'just appeared' in his bank account and that he had gotten 'greedy.'</blockquote> Duke Surgeon and Surgical Department Business Manager Accused of Embezzlement As <a href="http://www.wral.com/news/local/story/8700929/">reported</a> by WRAL.com, <blockquote>A former Duke University surgeon and manager have been charged with stealing $267,000 from the university, police said Tuesday. Dr. Eric Joel DeMaria, 51, of 1101 Tacketts Pond Drive in Raleigh, and John William Cotton, 39, of 7228 Loblolly Pine Drive in Raleigh, were each charged with embezzlement of more than $100,000. Cotton also was charged with obtaining property by false pretense. Cotton was arrested last Wednesday, and DeMaria surrendered to police Tuesday morning. Both have been released on $25,000 bonds. DeMaria was director of Duke's bariatric surgery program, while Cotton was a business manager in the surgical department at Duke University Hospital, according to Michael Schoenfeld, Duke's vice president for public affairs.</blockquote> Office Worker Accused of Stealing $3.8 Million from Memorial Sloan-Kettering Cancer Center As <a href="http://www.nypost.com/p/news/local/manhattan/clerk_mil_rip_off_yqCRPJkkPQelySq0vY6oCO">reported</a> by the New York Post, <blockquote>A former worker at Memorial Sloan-Kettering stole nearly $4 million from the cancer center in a massive scheme that involved ordering a boatload of unnecessary printer cartridges and reselling them, authorities said. The loot from the elaborate scam was used to fund a lavish lifestyle that allowed $37,000-a-year receiving clerk Marque Gumbs to move from a Bronx housing project to a luxurious Trump high-rise in the suburbs. Gumbs, 32 -- who was arraigned yesterday in Manhattan Criminal Court on charges of grand larceny and criminal possession of stolen property -- allegedly began his scheme in 2004 by ordering extra toner cartridges and reselling them. In one astounding stretch from October 2009 through August 2010, Gumbs ordered $1.2 million worth of toner that wasn't usable for any machine at the hospital, authorities said. His alleged ruse cost the hospital $3.8 million.</blockquote> Summary So here is the box-score. Reported in one week were three alleged theft/ embezzlement schemes with values from $267,000 to $5 million, and one alleged series of multiple rapes. The alleged perpetrators included two academic physicians (one in surgery, one in obstetrics-gynecology), two hospital staff, one in management, and a person with an unclear relationship to the hospital. All involved large, prestigious academic medical centers. So, again, maybe these were just coincidences. However, it may be that there is a real trend toward bigger and more spectacular thefts and embezzlements from big, not for profit health care institutions.  The most likely explanation is simply that the increasingly huge amounts of money flowing through such institutions attracts those who go to where the money is, and that the increased complexity of the bureaucracy of ever-growing health care institutions makes it easier to hide such thefts.  At least, this odd string of cases should prompt more questions about the conventional wisdom that it is good for health care organizations to grow ever larger.  However, just to be speculative, note that three of these incidents occurred at institutions whose leadership has attracted our attention before.  We discussed conflicts of interest affecting one Columbia academic leader <a href="http://hcrenewal.blogspot.com/2006/08/more-entangled-web-unitedhealth-case.html">here</a>, and the prevalence of leaders of failed financial services companies on the New York-Presbyterian board <a href="http://hcrenewal.blogspot.com/2009/12/with-leaders-like-these.html">here</a>.  We discussed a leader of two of the firms most involved in the global financial collapse who was also the chairman of the board of Duke University<a href="http://hcrenewal.blogspot.com/2009/10/trustee-of-what-caliber-for-hospital.html"> here</a>.  A quick skim of Memorial Sloan-Kettering's Board of Overseers (in its <a href="http://www.mskcc.org/annualreport/2009/pdfs/FullReport_AR09.pdf">2009 annual report</a>) showed the presence of at least two leaders of failed financial services firms heavily involved in the global financial collapse (E Stanley O'Neal, former CEO of Merrill Lynch, and Sanford I Weill, former CEO of Citigroup).  The speculation is that as academic medical centers and hospital systems and their parent universities have increasingly been recipients of the "stewardship," and hence immersed in the culture of the financial services industry, particularly firms which contributed to the global financial collapse, the culture of health care became increasingly laissez faire, anything goes, wild, wild west, and so it got easier for the wrong people to be hired, and for the wrong people to pull off truly spectacular capers. I submit that the first criterion for being a trustee or director, and hence ostensibly a steward of an academic medical institution should be devotion to the mission of the organization, not size of one's contribution.

Academic Medical Center Crime Wave?

Every large group or organization has a few bad apples. My web searches constantly turn up stories of individuals working in health care wh...

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"Unreasonably Dangerous" Heparin

It is time for an update on the case of the deadly contaminated heparin sold by Baxter International, which has received much less attention than seems warranted given its human costs (81 lives).  How the heparin was contaminated, and how the contaminated heparin ended up being sold as a US Food and Drug Administration approved American product are still unknown.  Despite the fact that the outcome of this case were so bad, it received disproportionately little attention when it was first made public, and now seems to have become nearly anechoic. Case Summary  Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China. That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label. The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small "workshops" operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA. The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many patients who received got seriously ill or died. While there have been investigations of how the adulteration adversely affected patients, to date, there have been no publicly reported investigations of how the OSCS got into the heparin, and who should have been responsible for overseeing the purity and safety of the product. Despite the facts that clearly patients died from receiving this adulterated drug, no individual has yet suffered any negative consequence for what amounted to poisoning of patients with a brand-name but adulterated pharmaceutical product.  (For a more detailed summary of the case, look <a href="http://hcrenewal.blogspot.com/2010/05/more-questions-no-answers-about-case-of.html">here</a>, and for all our posts on this topic, look <a href="http://hcrenewal.blogspot.com/search/label/heparin">here</a>.) Civil Cases Plod Forward If there is any ongoing official investigation of this case, it has not been made public.  Civil cases filed by patients allegedly injured by the heparin, or by relatives of patients who died allegedly from the heparin, seem to be proceeding at a glacial pace.  However, there is one development in one set of civil cases worthy of note.  As <a href="http://online.wsj.com/article/SB10001424052748703374304575623013312191090.html">reported</a> two weeks ago by Alicia Mundy in the Wall Street Journal: <blockquote>A state court in Illinois has granted a partial summary judgment to two plaintiffs suing Baxter International Inc. over contaminated blood thinner, saying that some of the company's heparin was 'unreasonably dangerous.' The suit involves tainted imported heparin ingredients from China that caused a public health crisis in 2008, and were linked to more than 80 deaths in the U.S. and many other serious allergic reactions. Some 300 cases nationwide against Baxter and its main ingredient supplier, Wisconsin-based Scientific Protein Laboratories LLC, were consolidated in Chicago in Cook County Circuit Court. Both companies have said that they weren't negligent and weren't responsible for the deadly reactions among patients. The Illinois judge's ruling, dated Wednesday, involved a motion for partial summary judgment that named only Baxter. The motion was filed on behalf of two plaintiffs in the consolidated cases, one of whom died. The ruling cites statements by Baxter's corporate quality vice president and the president of the company's medication delivery division that the heparin was defective. Baxter argued in its defense that a jury should address the question of whether a product is 'unreasonably dangerous.' The company noted that the two Baxter executives who agreed in depositions that the heparin was defective aren't doctors or scientists. However, Judge Jennifer Duncan-Brice wrote that the issue before her wasn't whether heparin actually caused the death or injury to the plaintiffs, but just whether the product was, as a matter of fact, contaminated. </blockquote>The most basic responsibility of a pharmaceutical company is to produce pure, unadulterated product.  As the current director of the US Food and Drug Administration <a href="http://healthpolicyandreform.nejm.org/?p=13270">wrote</a> in this week's New England Journal of Medicine, the agency's "modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law, more than a quarter of a century in the making, that prohibited interstate commerce in adulterated and misbranded food and drugs."  However, in the 21st century, drug companies are increasingly failing to produce unadulterated products, and the FDA is having increasing difficulty assuring patients that the drugs they take meet even the most basic safety standards.  I submit that corporate cultures increasingly influenced by the arrogant, greedy, amoral leadership of the financial services industry that lead us to the brink of another depression are also leading us to the brink of a poisonous era in health care.  Corporate leaders intent on cutting costs, and paying themselves as much of the resulting proceeds as possible, may see quality and safety as just another cost cutting target.  Corporate leaders brought up in the culture of finance, but untrained and inexperienced in engineering, science, and medicine find it all too easy to ignore quality and safety and focus on the bottom line.  (It is ironic that in the quote above, Baxter International's attorneys made light of the judgments of the company's own executives because they are not physicians or scientists.) Meanwhile, society seems to have been so mesmerized by the mantra that laissez faire capitalism will lead to miraculous "innovation" that we do not even attend to instances in which it lead instead to death. As we have said until being blue in the face, as long as the leaders of health care organizations are not held accountable for the results of their decisions on health care quality, cost, and access (even in such extreme quality violations as those resulting in multiple patient deaths), we can expect continuing decisions that sacrifice quality, increase costs, and worsen access, but that are in the self-interest of the people making them. To really reform health care, we must hold health care organizations and their leaders accountable (and not blame all the problems on doctors, other health care professionals, patients, and society at large).

"Unreasonably Dangerous" Heparin

It is time for an update on the case of the deadly contaminated heparin sold by Baxter International, which has received much less attention...

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