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"Proprietary Information," Confidentiality Motions, and the Anechoic Effect; the Case of the Contaminated Heparin

The case of the deadly contaminated heparin sold by Baxter International 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.  Our most recent post, <a href="http://hcrenewal.blogspot.com/2010/07/more-about-what-we-dont-know-about.html">here</a>, noted that an investigation into the contamination of the active pharmaceutical ingredient (API - actually the heparin itself) in China failed to produce any results, apparently because the Chinese government did not see fit to pursue it.  (Note that a brief summary of the whole case is at the end of this post.) Now a new <a href="http://online.wsj.com/article/SB10001424052748704868604575433960537183170.html">story</a> in the Wall Street Journal by Alicia Mundy explains even more about why we do not know more about the contaminated heparin: <blockquote>Baxter International Inc. faces a new challenge in federal court in its bid to block disclosure of documents about the 2008 contaminated-heparin crisis. Baxter and Scientific Protein Laboratories LLC are fighting a civil mass tort lawsuit alleging deaths and injuries from imported Chinese heparin in 2007 and 2008. A company that isn't party to that lawsuit says some of the information Baxter and SPL want to keep confidential is important to public health and drug safety, and could reveal information about the sources of toxic heparin in the Chinese supply chain. The two companies want to keep under seal portions of depositions taken in the case, including those related to Momenta Pharmaceuticals Inc., which helped the U.S. government investigate the contamination. Baxter and SPL say they will be hurt if forced to disclose proprietary information. They have denied that they were negligent in the deaths linked to the blood-thinning drug, widely used in cardiovascular and other conditions. </blockquote> So, <blockquote>On Aug. 3, federal Judge James Carr in Toledo, Ohio, ruled in favor of the confidentiality motion by Baxter and SPL.</blockquote> On the other hand, there are arguments, admittedly by parties with relevant financial interests, for making more information public: <blockquote>Last Friday, another company entered the fray, contending that the information in the depositions shouldn't be sealed. Amphastar Pharmaceuticals Inc. said public health could benefit if the depositions shed light on circumstances in China. Amphastar, which has been competing with Momenta for approval to make a newer and more expensive form of heparin, said the information is also important to a congressional investigation into the Food and Drug Administration's handling of the heparin crisis. Republican leaders of a House committee say the FDA failed to trace the contamination in the Chinese heparin supply chain. On July 23, the FDA granted approval to Momenta to make the special heparin called enoxaparin, while Amphastar's application remains on hold. Amphastar said in its court filing that the 'serious safety concerns' involving heparin are relevant to enoxaparin because heparin is the starting material of enoxaparin's active ingredient. Most U.S. heparin supplies come from China.</blockquote> Of course, the companies who want to keep as much about the case secret as they can are not talking about it: <blockquote>Lawyers for Baxter and SPL declined to comment on their efforts to restrict information related to Momenta. They referred inquiries to Baxter, whose spokeswoman declined to comment.</blockquote> So here is more about what we do not know about the deadly contaminated heparin from China. One reason that this case has remained so <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a> is that the companies that sold and processed the contaminated heparin, and are now defendants in lawsuits have used that situation as a rationale for keeping "proprietary" information secret.  There clearly may be reasons that Baxter International, the company that sold the heparin under their (formerly?) prestigious US label  wants to keep secret the details about what efforts it did or did not make to assure that the heparin it sold was pure and unadulterated. There clearly also may be reasons that Scientific Protein Laboratories LLC, the US based company that sold the heparin API to Baxter wants to keep secret the details about what efforts it did or did not make to assure that the heparin API was pure and unadulterated.  The ability of participants in lawsuits to keep "proprietary" information secret clearly adds to the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>.  Ironically, it may be that civil legal action, which is sometimes the only way to impose negative consequences on health care organizations that have misbehaved, may have the adverse effect of further hiding information about the events in question.  However, to promote the safety of individual patients and the health of public, and to prevent another deadly case of drug contamination, understanding details about what happened is absolutely vital. The private pecuniary interests of Baxter International and Scientific Protein Laboratories LLC seem to be directly opposite to those of patients, physicians, and the public at large in this case. It is therefore disquieting to learn that the companies' wishes to keep information they declare is "proprietary" seem to have trumped individual patient safety and public health concerns. (Note that these concerns go beyond the commercial concerns of Amphastar Pharmaceutical, although in this case the pecuniary interests of that company do not seem to be opposed to patient safety and the public health.) If we really want a health care system that improves the health of individuals and the public, we need it to put health and safety concerns ahead of the incomes of health care corporations.  That such a statement seems not a platitude, but revolutionary is a mark of how our health care system has been turned on its head. Case Summary In 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>.)

"Proprietary Information," Confidentiality Motions, and the Anechoic Effect; the Case of the Contaminated Heparin

The case of the deadly contaminated heparin sold by Baxter International has received much less attention than seems warranted given its hum...

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St. Vincent's Goes Bankrupt, Executives Earn Millions

St. Vincent's Hospital in the Greenwich Village section of New York City was a landmark institution which filed for bankruptcy in April, 2010, and then closed its doors.  Background A New York Times <a href="http://www.nytimes.com/2010/02/03/nyregion/03vincents.html">article</a> written earlier this year described an institution "threatened with extinction" because it stuck to its mission of "compassionate care" in a health care environment that values "fancy equipment and celebrity doctors."  Thus, "officials blamed a high rate of poor and uninsured patients as well as cuts in Medicare and Medicaid and the hospital's inability to negotiate favorable contracts with health insurance companies...."  Painting Another Picture However, a <a href="http://www.nypost.com/p/news/local/manhattan/doctored_books_Vz0s07aQjbaZW2pix1N85M">story</a> this week in the grittier New York Post painted a different picture: <blockquote>St. Vincent's Hospital was looted by execs and consultants in the two years before it closed, then grossly exaggerated its debt, according to blockbuster papers set to be filed tomorrow in Manhattan Supreme Court. The filing, a petition that seeks to force the state Health Department to turn over documents on the closing, says the defunct medical center blew through millions in 'highly questionable' expenses, including $278,000 for a golf outing, while paying its top 10 executives a combined $10 million a year. It also shelled out $17 million for 'management consultants,' $3.8 million on 'professional fund-raising' and a staggering $104 million on unspecified costs it listed simply as 'other' on its federal tax returns, the petition says. But even with all that money going out, St. Vincent's wasn't nearly as cash strapped as it claimed, say the court papers, prepared by a law firm working for doctors and nurses formerly employed there and the hospital's West Village neighbors. Its crushing debt of about $1 billion, which the hospital blamed for having to close its doors in April, was bloated by hundreds of millions of dollars in loans dumped on St. Vincent's from other medical entities run by the Archdiocese of New York, starting in 2001, after the other institutions merged with the hospital, the papers say. 'The debt of the hospital was specifically exaggerated by numerous factors, including the transfer of debt from other Catholic medical centers and mismanagement by the board of directors,' the documents say. 'These transfers . . . remain undisclosed to the public.'</blockquote> Historical Parallels These accusations parallel themes that appeared towards the end of the February, 2010, NY Times piece. First, regarding the transfer of debt: <blockquote>To remain competitive, in 2000 St. Vincent’s merged with several other Catholic hospitals to form St. Vincent Catholic Medical Centers. Along with the flagship hospital in the Village, it ran seven other hospitals: Bayley Seton and St. Vincent’s on Staten Island; Mary Immaculate, St. John’s and St. Joseph’s in Queens; St. Mary’s in Brooklyn; and St. Vincent’s Westchester, in Harrison, N.Y. It was also affiliated with St. Vincent’s Midtown, formerly St. Clare’s, in Midtown Manhattan. The merger was conceived as a way to streamline management and give the hospitals pricing leverage, but it was troubled from the beginning. After closings and sales, the network was left with just one New York City hospital, the flagship; a psychiatric and substance abuse treatment hospital in Westchester; and several nursing homes and other outpatient facilities. Some of St. Vincent’s debt was inherited from the closed hospitals. </blockquote> Second, regarding mismanagement: <blockquote>In 2004, St. Vincent’s turned over management to Speltz & Weis, the first in a series of turnaround consultants. It paid the firms millions of dollars a year to run the hospital and hired their officials as hospital executives. The system filed for Chapter 11 bankruptcy protection in early July 2005, when it appeared, according to court papers filed by hospital creditors, that it would be unable to make its payroll. In a lawsuit filed in 2007, some of the hospital’s creditors painted a picture of a hospital system trapped between unscrupulous consultants and a passive or gullible board. The lawsuit accused David E. Speltz and Timothy C. Weis, the hospital system’s former chief executive and chief financial officer, of delaying the bankruptcy organization while they and their consulting firm collected millions of dollars in fees. The lawsuit accused them of hiring high-priced contractors and padding their fees, instead of using hospital employees to do work. And it says they leveraged their positions with the hospital to negotiate the sale of their consulting company to Huron Consulting Group, in Chicago, also a defendant in the case. </blockquote> The outcome of that earlier lawsuit was unclear.  It does suggest that St. Vincent's may have been chronically bled by greedy managers and consultants. Contrasting Financial Health and Executive Compensation Of course, as one of our unofficial legal consultants noted, anyone can file a lawsuit. However, perusal of the latest <a href="http://www.guidestar.org/FinDocuments/2008/134/077/2008-134077996-057ea950-9.pdf">990 form</a> filed with the Internal Revenue Service by St Vincent Catholic Medical Centers for calendar year 2008 did reveal a disquieting contrast. That form stated that the the hospital lost over $65 million in 2008, and over $34 million in 2007. However, in 2008, here were the compensation of its highest paid managers - Brian Fitzsimmons, Executive Director, $2,135,401 - Bernadette Kingman-Bez, Senvior Vice President, CCO (?), $1,520,841 - Paul Rosenfeld, Executive Director, CC, $1,196,458 - Henry Amoroso, CEO, $1,081,592 In addition, seven current and former executives at the Senior Vice President of Vice President level earned over $500,000 that year, and another 13 earned over $250,000. Summary So clearly, while the hospital was hemorrhaging money, and a little more than a year away from bankruptcy, this not-for-profit hospital whose mission emphasized serving the poor served a large corps of  executives very large amounts of money.  So we see again the pattern of top managers rewarding themselves disproportionately (here, grossly so) given the mission and financial status of their organizations.  The picture is of pay entirely independent of performance, and leaders who are ultimately only in it for the money. How many more examples like this do we need until there is resolve that real health care reform will make top health care leaders accountable for their performance, and provide them incentives that are fair and rational, rather than perverse? Post-Script Of course, if we regard the fall of institutions whose mission was to do good as inevitable in our Darwinian world, an explanation that earlier coverage of this story suggested, all we can do is to throw our hands up.  However, the inevitability argument is often made by those who are benefiting from the current way of doing things.  A more skeptical view of this case, and related health policy issues, may suggest a different approach.

St. Vincent's Goes Bankrupt, Executives Earn Millions

St. Vincent's Hospital in the Greenwich Village section of New York City was a landmark institution which filed for bankruptcy in April,...

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EPIC's outrageous recommendations on healthcare IT project staffing

<div dir="ltr" style="font-family:arial;"><div style="text-align: center;">"Critical thinking always, or your patient's dead" - Victor Satinsky, MD, NSF-funded summer science training program (SSTP) for high school students, Hahnemann Medical College, early 1970's. </div>Health IT projects are incredibly complex undertakings in equally complex, mission-critical medical environments. They are definitely not an area for novices. From conception to design to implementation, faulty systems can endanger patients. Further, one astute author of an article entitled "Faulty Construction" in the journal ForTheRecord.com (<a href="http://www.fortherecordmag.com/archives/080210p10.shtml">link</a>) observes that: <blockquote>Critics wonder what good it is to invest in EHR technology if it fails to engender itself to users who feel betrayed by its lack of intuitiveness.</blockquote> Inexperience is a critical factor in creating and implementing HIT that "betrays" users in many ways (see, for example, <a href="http://www.tinyurl.com/hostileuserexper">here</a> on mission hostile HIT). With these issues in mind, here is how the major HIT vendor, EPIC, recommends hospitals staff their clinical IT projects. It also follows that they staff their own development teams in the same manner. The recommendations are largely outrageous, especially in the context of medical environments where uninformed, unconsenting patients are subjected to IT experimentation in clinical matters. </div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> From <a href="http://histalk2.com/2010/08/14/monday-morning-update-81610/" target="_blank">this link</a> at the "Histalk" site on staffing of health IT projects, Aug. 16, 2010. Emphases mine: </div> <div> <div dir="ltr"> <blockquote dir="ltr" style="margin-right: 0px;font-family:arial;"> Epic Staffing Guide A reader sent over a copy of the staffing guide that Epic provides to its customers. I thought it was interesting, first and foremost in that Epic is so specific in its implementation plan that it sends customers an 18-page document on how staff their part of the project. Epic emphasizes that many hospitals can staff their projects internally, choosing people who know the organization. However, they emphasize choosing the best and brightest, not those with time to spare. Epic advocates the same approach it takes in its own hiring: don’t worry about relevant experience, choose people with the right traits, qualities, and skills, they say. The guide suggests hiring recent college graduates for analyst roles. Ability is more important than experience, it says. That includes reviewing a candidate’s college GPA and standardized test scores. I bet many readers were taught by their HR departments to do behavioral interviewing, i.e. “Tell me about a time when you …” Epic says that’s crap, suggesting instead that candidates be given scenarios and asked how they would respond. They also say that interviews are not predictive of work quality since some people just interview well. Don’t just hire the agreeable candidate, the guide says, since it may take someone annoying to push a project along or to ask the hard but important questions that all the suck-ups will avoid.Epic likes giving candidates tests, particularly those of the logic variety. </blockquote> While there's some good here, the part about "not worrying about relevant experience" and about "hiring recent college graduates as HIT project analysts" is downright frightening. Medical environments and clinical affairs are not playgrounds for novices, no matter how "smart" their grades and test scores show them to be. These practices as described, in my view, represent faulty and dangerous advice on first principles. The advice also is at odds with the taxonomy of skills published by the Office of the National Coordinator I outlined at the post "<a href="http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html">ONC Defines a Taxonomy of Robust Healthcare IT Leadership</a>."One wonders if these recommendations are simply the idiosyncratic opinions of EPIC's leadership. They certainly deviate wildly from medicine's culture (e.g., of rigorous domain-specific training, and certification where the test cannot even be taken without prerequisite, very specific experience).One could also look at these recommendations from an economic perspective. The word "cheap" and a corollary concept, "age discrimination" come to mind regarding a stated preference for recent graduates over experienced personnel. Finally, from a personal perspective, my grades and test results out of high school and college were very high, e.g., a perfect 800 in math on the SAT, high grades in advanced courses in the 'hard sciences' - not to mention, advanced computer courses such as in IBM mainframe assembly language programming. Yet the ‘modern me’ (after medical, further IT and informatics education and hard earned applied experience) knows that I would not have wanted the ‘young me’ to have been involved in critical clinical IT functions on that basis. -- SS </div></div>

EPIC's outrageous recommendations on healthcare IT project staffing

"Critical thinking always, or your patient's dead" - Victor Satinsky, MD, NSF-funded summer science training program (SSTP) fo...

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Being a Health Insurance Executive Means Never Being Able to Say You Are Sorry

WellPoint, the largest US for-profit health care insurance company, has provided a steady stream of examples of poor management and bad behavior for the edification of Health Care Renewal readers.  Most recently, a company whose core functions include reliably and confidentially managing electronic data on policy-holders allowed what should have been private data from nearly half a million people to appear on-line (see post <a href="http://hcrenewal.blogspot.com/2010/06/wellpoint-dont-know-much-about-computer.html">here</a>.  For other examples, look <a href="http://hcrenewal.blogspot.com/search/label/WellPoint">here</a>.) This week, the Los Angeles Times <a href="http://www.latimes.com/health/la-fi-anthem-president-20100810,0,3943650.story">recounted</a> what happened to a highly placed WellPoint executive who tried to improve the company's behavior.  <blockquote>Leslie Margolin was the public face of Anthem this year when it sought to raise individual insurance rates as much as 39%. The move triggered a backlash in Washington and Sacramento, where lawmakers accused Margolin and her corporate bosses at insurance giant WellPoint Inc. of trying to gouge unknowing policyholders. Margolin, 55, generated headlines statewide when she was called to testify before angry lawmakers in the state capital. With television cameras rolling, the hearing's chairman stared her down and asked bluntly: 'Have you no shame?' Now, speaking publicly for the first time since her departure, Margolin says she had been chagrined over the rate hikes for the last year and had worked internally to get Indianapolis-based WellPoint to rescind them or scale them back, and to apologize. 'I thought the rates were too high,' she said. 'I thought the impact on our membership was too significant.' Margolin did not object to the rates in her Sacramento testimony this February. But in the months that followed, she repeatedly voiced her objections to WellPoint and in appearances outside the company, remarks that went largely unnoticed by the public. In a March talk at Pepperdine University's business school, for instance, she told a gathering of students and business leaders that she wasn't responsible for rate increases she believed were ill-timed and ill-advised. 'We have impacted individual consumers in ways that were so significant for those individuals,' she said. 'And for that, I personally feel very, very sorry.' As she made the Pepperdine appearance and others, Margolin said, she privately pressed WellPoint to abandon the company's get-tough approach to longtime adversaries — doctors and hospitals — and instead collaborate as part of a new 'healthcare transformation strategy' to cut costs and improve patient safety and the quality of care.</blockquote> So what happened to Ms Margolin? Did she get a big raise and an award for doing the right thing? Is the moon made of green cheese? In fact, here is what happens to a health insurance executive who says she is sorry for excessively high insurance rates: <blockquote>Last month, WellPoint replaced her. At the time, Margolin said her departure was a mutual decision. Interviews with company insiders, insurance industry leaders and others familiar with the situation now make clear that she was pushed out. 'Her undoing was that she rocked the boat and wanted to do things a different way,' said one person familiar with the events who declined to be identified for fear of retribution. 'She wasn't a good corporate soldier.' Margolin herself spoke cautiously about her resignation, but said: 'There is no question I needed to leave.'</blockquote> In fact, her exit was quite inglorious: <blockquote>Margolin vividly recalls her last day. Even though her Anthem team was exceeding its financial goals and membership numbers, she said, she was ushered from the doors of Anthem's Woodland Hills headquarters. She didn't have a chance to send a farewell message to her 400 employees.</blockquote>So it seems that being a top health insurance corporate executive means never admitting a mistake, and never, ever saying you are sorry. In contrast, in the <a href="http://media.corporate-ir.net/media_files/irol/13/130104/WellPoint_2009_AR.pdf">2009 WellPoint Annual Report</a>, CEO Angela Braly boasted: <blockquote>As you can see throughout this report, we’re focused on making health benefits more affordable, improving access to care, and simplifying interactions with the delivery system. We believe that we have to favorably impact the value equation in health care while improving the experience of members, doctors, and employers.</blockquote> So presumably at WellPoint, "making health benefits more affordable" means raising premiums 39%.  As we <a href="http://hcrenewal.blogspot.com/2010/04/what-me-worry-leaders-prosper-despite.html">mentioned</a> earlier this year, for this and other bits of legerdemain, Angela Braly's 2009 compensation increased 51 percent to $13.1 million. This seems more like pay for propaganda than pay for performance. In a <a href="http://www.dismountingourtiger.com/business-health/oil-executives-produce-vacuous-disaster-response-plans/">post</a> in the Dismounting Our Tiger blog, Edwin Lee addressed the origins of the BP oil spill by noting how most big corporations have come to promote leaders distinguished mainly for their careerism, tribal attitude, and disinclination to question received wisdom.  He wrote that the result was promoting "mediocre, short term thinkers with similar work experiences, outlooks, temperaments and personal incentives. Disaster response, creative thinking and fundamental changes are outside their limited range of interests or competencies."  Thus we can expect that at some point, WellPoint, and many similarly lead health care organizations, will create their own disasters.  We can only hope that our health care system survives them. Meanwhile, kudos to Ms Margolin for trying to put the interests of policy-holders and the public ahead of following the company line.  If only more such people were able to lead health care organizations rather than being unceremoniously fired, we might have a fighting chance to have health care that really is high quality, affordable, and accessible.    PS - For those old enough to have been forced to watch <a href="http://www.imdb.com/title/tt0066011/">Love Story</a>, the original quote was "love means never having to say you're sorry."

Being a Health Insurance Executive Means Never Being Able to Say You Are Sorry

WellPoint, the largest US for-profit health care insurance company, has provided a steady stream of examples of poor management and bad beha...

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A Golden Parachute for Making Contaminated Drugs?

In late 2009, we <a href="http://hcrenewal.blogspot.com/2009/11/genzymes-remarkable-businessstrategy.html">posted</a> about problems at a Genzyme plant that manufactured some fabulously expensive drugs, e.g. Cerezyme whose cost to patients approximated $160,000 a year. We thought then that for a drug costing that much, the company ought to have figured out a conservative process to provide pure and unadulterated product. In a later <a href="http://hcrenewal.blogspot.com/2009/11/was-is-worst-biotech-ceo-worth.html">post</a> we also why a company that could afford to make its CEO very rich could not afford to adequately maintain its manufacturing facilities.  In May, 2010, we <a href="http://hcrenewal.blogspot.com/2010/05/genzyme-settles.html">posted</a> about a legal settlement of charges related to its manufacturing problems requiring Genzyme to pay a $175 million fine and function under US government supervision. Recent news articles suggest that the fix of the company's inabilities to manufacture pure, unadulterated drug remained remote.  Reuters <a href="http://www.reuters.com/article/idUSTRE67A20Q20100811">reported</a> that it had to discard "additional inventories of drugs ... for failure to the meet the company's quality control standards."  Bloomberg<a href="http://www.bloomberg.com/news/2010-08-10/sanofi-target-genzyme-says-contamination-fix-at-plant-may-take-four-years.html"> reported</a> that it "may take three to four years to complete changes requested by U.S regulators after plant contamination." Meanwhile, however, the company continues to talk to Sanofi-Aventis about being bought out, and the Boston Globe<a href="http://www.boston.com/business/healthcare/articles/2010/08/11/if_genzyme_is_acquired_termeer_gets_23m/"> reported</a> just how much Genzyme CEO Henri A Termeer would stand to make if the buyout takes place: <blockquote>Under the 'hange of control' agreement currently worth $23 million, Termeer would receive several payments. He would receive a lump sum of $11 million, a figure representing three times his base salary plus a bonus. He would also get $356,000 in benefits, including health, life, accident, and disability insurance, outplacement and relocation services, and legal fees. And he could cash out 175,137 shares through accelerated equity awards. Those shares are now worth $11.9 million, but almost certainly would be worth more if the company is acquired at a premium.</blockquote> Furthermore, <blockquote>Apart from the golden parachute, Termeer could reap huge stock gains if the company is sold. The 4.1 million Genzyme shares he owns represented about 1.5 percent of its stock as of April 9, the most recent regulatory filing. At the current share price, Termeer’s stake is worth more than $275 million.</blockquote> So riddle me this: over the last 5 years, Genzyme stock-holders have seen their investment lose 5.7% of its value (<a href="http://www.google.com/finance?q=NASDAQ%3AGENZ">according</a> to Google Finance),  while patients have paid outlandish prices for contaminated medicine, or have had to reduce their medication dosages after the defective manufacturing plant was shut down.  So why should the CEO who presided over all this, whose has already become rich as a hired employee of Genzyme, get even richer?  Once again we demonstrate how massively perverse incentives stupendously reward the top brass of health care organizations for mediocre, or worse leadership and bad results for both patients/ clients/ customers and stock-holders alike.  As long as being a health care CEO is effectively a license to loot the company, is it any wonder that health care organizations continue to be badly lead, and health care costs soar while quality and access suffer?  Once more with feeling: real health care reform would require us to make health care executives truly accountable for their actions, and penalize them for those that are ill-informed, contemptuous of health care values, self-interested, or corrupt.

A Golden Parachute for Making Contaminated Drugs?

In late 2009, we posted about problems at a Genzyme plant that manufactured some fabulously expensive drugs, e.g. Cerezyme whose cost to pa...

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Deceptive Marketing, For-Profit Universities, and Health Care Education

Last week, reports about deceptive marketing and other questionable practices used by the growing for-profit higher education industry in the US appeared in the news.  For example, <a href="http://www.bloomberg.com/news/2010-08-03/for-profit-colleges-deception-uncovered-by-u-s-investigation-into-aid.html">per Bloomberg</a>: <blockquote>Recruiters at U.S. for-profit colleges lied to entice students and encouraged them to commit fraud to qualify for aid, a report by the Government Accountability Office found. Recruiters at all 15 colleges studied by the GAO, Congress’s investigational arm, misled potential students about the costs, duration and quality of their programs, according to a report obtained by Bloomberg News....</blockquote> Other deceptions include: <blockquote>“'college representatives exaggerated undercover applicants’ potential salary after graduation and failed to provide clear information about the college’s program duration, costs, or graduation rate,' the report said. 'Admissions staff used other deceptive practices, such as pressuring applicants to sign a contract for enrollment before allowing them to speak to a financial advisor about program cost and financing options.' </blockquote> Also, <blockquote>In one case cited by the report, a GAO investigator posing as an applicant was told to lie on an aid application about the number of household members to qualify for grants. When the investigators told college employees that they had $250,000 in savings, officials at three colleges told them to hide their savings in order to qualify for financial aid. </blockquote> In addition, <blockquote>For-profit colleges overstated the quality of their programs and the organizations overseeing their accreditation, the report said. One recruiter told an investigator posing as an applicant that his school was accredited by the same one that accredits Harvard University. 'It’s the top accrediting agency,' the recruiter said, according to the report. 'Harvard, University of Florida --they all use that accrediting agency.' Recruiters exaggerated their colleges’ benefits and graduation rates, the report said. A beauty college recruiter said barbers earn as much as $250,000 a year, while the Bureau of Labor Statistics said 90 percent of barbers make less than $43,000 annually, according to the report. </blockquote> A later <a href="http://online.wsj.com/article/BT-CO-20100804-712937.html">report</a> by the Dow Jones news service named some of the corporate players whose educational "institutions" were involved in dubious schemes. <blockquote>Colleges operated by Apollo Group Inc. (APOL), Corinthian Colleges Inc. (COCO) and Washington Post Co.'s (WPO) Kaplan Higher Education unit were among the schools the U.S. Government Accountability Office found provided 'deceptive and otherwise questionable information' to agents who posed as prospective students in an undercover investigation of for-profit student recruitment tactics. </blockquote> It is tempting to look for parallels with health care, once a calling like higher education, but now increasingly an "industry," often run, as we have documented endlessly, by people with little experience or knowledge about how health care is actually done on the ground, with little sympathy for the values of health care professionals, and given strong incentives to maximize the money coming in, whatever it takes. However, the issue goes beyond these parallels. In fact, many of the bigger for-profit education corporations provide considerable health care education, including the three named above. The University of Phoenix, a subsidiary of the Apollo Group Inc, offers a <a href="http://www.phoenix.edu/colleges_divisions/nursing/master-of-science-in-nursing.html">Masters of Science in Nursing </a>degree. Several of the <a href="http://www.cci.edu/brands">"brands"</a> of Corinthian Colleges Inc offer offer "diploma and/or degree programs in health care." Kaplan University, a subsidiary of Kaplan Higher Education Corporation, has a <a href="http://online.kaplanuniversity.edu/health_sciences/Pages/Schools_Of_Health_Sciences.aspx">School of Health Sciences</a>.  So it seems likely that many health care professionals, or would-be health care professionals, have been enticed by the sorts of sales practices documented in the report.  There are no known for-profit US medical schools.  However, as we have <a href="http://hcrenewal.blogspot.com/2010/01/to-whom-does-leading-off-shore-medical.html">discussed</a>, many US students go to for-profit "off-shore" medical schools, often in the Caribbean, who mainly "educate" US citizens who want to practice here (as opposed to all the schools in countries other than the US whose main goal is to educate doctors for their own countries.)  Some of these off-shore schools are owned by big US corporations.  One can only wonder whether their recruitment tactics are similar to those of the for-profit "universities" located in the US.  We have discussed <a href="http://hcrenewal.blogspot.com/search/label/deception">deceptive</a> marketing of hospitals, drugs and devices, but now it seems that deceptive marketing is even more widespread in health care than we originally thought, along with the take the money and run ethos that has infected so much of the business world. If we truly want to reform health care to improve quality and access, and control costs, we need to restore the focus to care, the care of the patient, and away of the false pursuit of economic efficiency that only seems to benefit the quick buck artists.

Deceptive Marketing, For-Profit Universities, and Health Care Education

Last week, reports about deceptive marketing and other questionable practices used by the growing for-profit higher education industry in th...

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UK: ISO draft standards for the development, manufacture and deployment of healthcare IT focus on SAFETY

The UK's NHS has not had the best of success to date implementing national health IT, as indicated by reports <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">here</a> and <a href="http://www.connectingforhealth.nhs.uk/about/foi">here</a>, for example. However, they have appeared to have learned from their mistakes and in fact are on the way to being far ahead of the U.S. in terms of understanding what it truly takes for HIT to be efficacious - and perhaps even more importantly, as safe as possible. From an informatics colleague who informed me of these developments: <blockquote>The UK has recently adopted the ISO draft standards for the development and deployment of HIT. They don't go as far as premarket approval, but do require vendors to develop and deliver to healthcare organizations a formal hazard assessment for their products, require both to continually update their risk assessments, and require care delivery organizations to have an explicit process for identifying & mitigating risks, and formally accepting (or not) the residual risks that remain. The thinking is these standards will be adopted across the EU once the ISO approval process is completed.</blockquote> These two remarkable documents are available from the UK's NHS: <div class="PlainText"><blockquote><a href="http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009">http://www.isb.nhs.uk/documents/isb-0160/dscn-18-2009</a> "Health informatics — Guidance on the management of clinical risk relating to the deployment and use of health software" Formerly ISO/TR 29322:2008(E) DSCN18/2009 and <a href="http://www.isb.nhs.uk/documents/isb-0129/dscn-14-2009">http://www.isb.nhs.uk/documents/isb-0129/dscn-14-2009</a> "Health Informatics — Application of clinical risk management to the manufacture of health software" Formerly ISO/TS 29321:2008(E) DSCN14/2009 </blockquote> From the first of these, the overall intro: <blockquote>ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.</blockquote> Then on to matters at hand: <blockquote>Introduction The threat to patient safety There is mounting concern around the world about the substantial number of avoidable clinical incidents which have an adverse effect on patients, of which a significant proportion result in avoidable death or serious disability, see references [1], [2], [3], [4], [5] and [6]. A number of such avoidable incidents involved poor or "wrong" diagnoses or other decisions. A contributing factor is often missing or incomplete information, or simply ignorance, e.g. of clinical options in difficult circumstances or of the cross-reaction of treatments (a substantial percentage of clinical incidents are related to missing or incomplete information). It is increasingly claimed that information systems such as decision support, protocols, guidelines and pathways could markedly reduce such adverse effects. [As I have written in many places such as <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">here</a> and <a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html">here</a>, this may or may not be true regarding today's commercial healthcare IT as it is currently designed and deployed. Evidence supporting the assertion, especially robust studies such as randomized controlled clinical trials, is scarce, and evidence contradicting it is growing. The technology remains experimental - ed.] If for no other reason – and there are others – this is leading to increasing deployment and use of increasingly complex health software systems, such as for decision support and disease management. It can also be anticipated that, due to pressures on time and to medico-legal aspects, clinicians will increasingly rely on such systems, with less questioning of their "output", as a "foreground" part of care delivery rather than as a "background" adjunct to it. Indeed, as such systems become integrated with medical care, any failure by clinicians to use standard support facilities may be criticised on legal grounds. Increased use of such systems is not only in clinical treatment but also in areas just as important to patient safety, such as referral decision-making. Failure to make a "correct" referral, or to make one "in time", can have serious consequences. Economic pressures are also leading to more decision support systems. The area of generic and/or economic prescribing is the most obvious, but achieving economy in the number and costs of clinical investigative tests is another. Thus the use of health software and medical devices in increasingly integrated systems, e.g. networks, can bring substantial benefit to patients. However unless they are proven to be safe and fit for purpose they may also present potential for harm or at least deter clinical and other health delivery staff from making use of them, to the ultimate detriment of patients. Annex A provides some examples of the potential for harm. Harm can of course result from unquestioning and/or non-professional use, although the manufacturers of health software products, and those in health organizations deploying and using such products within systems, can mitigate such circumstances through, for example, instructions for use, training and on-screen presentation techniques, guidance, warnings or instructions. Some of these system deficiencies are insidious, may be invisible to the end user [an obviously perilous situation - ed.] and are typically out of the sole control of either the manufacturer or the deploying health organization.</blockquote> The reports note the obvious, something that the health IT vendors' <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda">contractual gag clauses</a> and secrecy in the health IT industry make difficult to rigorously evaluate: <blockquote>A necessary pre-cursor for determining and implementing controls to minimize risks to patients, from a health software systems that is manufactured and then deployed and used within a health organization, is a clear understanding of the risks which the deployed system might present to patients if malfunction or an unintended event were to occur, and the likelihood of such a malfunction or event causing harm to the patient.</blockquote> These risks cannot be properly evaluated in an industry where the flows of information are dominated by the vendors. Some examples of potential for harm, from annex (appendix) A, will likely sound quite familiar to readers of Healthcare Renewal: <ul><li>Patient (mis)identification</li><li>Inadvertent accidental prescribing of dangerous drugs (such as methotrexate)</li><li>Incorrect patient details retrieved from radiology information system</li><li>CT and MRI images could not be seen after being moved to PACS</li><li>Drug mapping error</li><li>Pre-natal screening risk computation errors</li><li>Radiotherapy errors</li><li>Slack security</li></ul> I especially note the following in the first document (on deployment): <blockquote>5.3 Competencies of personnel Persons performing risk management tasks will need to have the knowledge, experience and competencies appropriate to the tasks assigned to them. This will need to include, where appropriate, knowledge and experience of the particular health software systems (or similar health software products) and applications, the technologies involved and risk management techniques. This should include appropriate registered clinical input throughout the process. Appropriate competency and experience records will need to be maintained. Clinical risk management tasks can, and should, be performed by a project team that contains representatives of each of the functions that are involved in deploying and subsequently using the health software systems or system, with each contributing their specialist knowledge to build both awareness and consensus. Of particular importance will be clinical input from clinicians who are familiar with the practical realities of the environments within which the software system will be used and the clinical processes to which the software system is directed. </blockquote> Emphasis on the last sentence is mine. At a time when U.S. CIOs and health IT "talking heads" still find the need to write touchy-feely "Master of the Obvious" articles extolling the virtues of permitting clinicians 'input' into health IT projects, usually under the aegis of unempowered "Directors of Informatics" or "Chief Medical Information Officers" (a.k.a. Directors of Nothing and Chiefs of Nothing, with no true executive presence or authority), the latter direct, definitive sentence is refreshing. Miracle of miracles, even postmarketing surveillance is covered (the pharma and medical device industries have been mandated by regulators to conduct such studies on their products for decades): <blockquote>11 Post-deployment monitoring Both manufacturers and organizations deploying and using health software and other products within systems, have a business need to establish, document and maintain a process to collect and review information about the clinical safety performance of the products and system in the post-deployment phase, at least to help manage their liabilities but also to enable them to optimize their products and systems.</blockquote> There is much more in these documents. Download and read the PDF's. I will have more to say in future posts, but thank god someone is considering the risks to patients of this technology, touted as universally beneficent by health IT exceptionalists, in a serious manner. Now if only we can import this thinking into the United States. -- SS </div>

UK: ISO draft standards for the development, manufacture and deployment of healthcare IT focus on SAFETY

The UK's NHS has not had the best of success to date implementing national health IT, as indicated by reports here and here , for examp...

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