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The Managers' Coup: How the "Hired Hands" Got "Paychecks as Big as Tajikistan"

We have frequently discussed the perverse incentives provided to the leaders of health care organizations.  They almost never pay a penalty for presiding over organizational actions that are unethical, harmful to patients, or even <a href="http://hcrenewal.blogspot.com/search/label/crime">criminal </a>(e.g., see posts <a href="http://hcrenewal.blogspot.com/2011/06/ucb-settles-pleads-guilty.html">here </a>and <a href="http://hcrenewal.blogspot.com/2011/06/two-more-settlements-one-more-corporate.html">here</a> for some very recent examples.)  However, they often collect outrageously huge <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">compensation</a> disproportionate to any reasonable measure of their organizations' performance.  (e.g., see posts <a href="http://hcrenewal.blogspot.com/2011/04/johnson-and-johnson-runs-afoul-of.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/03/despite-poor-financial-results.html">here</a> for relevant recent examples.) Now two news articles, based in turn on research studies, further illuminate how hired managers and executives have become so wealthy and unaccountable. The <a href="http://www.nytimes.com/2011/06/19/business/19gret.html">first news article</a> was in the New York Times, and was in turn based on an accounting study.  In summary, <blockquote>a recent, <a href="http://www.accountingobserver.com/Home/tabid/36/Default.aspx">immensely detailed report </a>in The Analyst’s Accounting Observer, a publication of R. G. Associates, an independent research firm in Baltimore. Jack Ciesielski, the firm’s president, and his colleague Melissa Herboldsheimer have examined proxy statements and financial filings for the companies in the Standard & Poor’s 500-stock index. In a report titled 'S.& P. 500 Executive Pay: Bigger Than ...Whatever You Think It Is,' they compare senior executives’ pay with other corporate costs and measures. </blockquote> Here are some of the major comparisons the report makes: - Paid More than the GDP of Tajikistan <blockquote>Total executive pay increased by 13.9 percent in 2010 among the 483 companies where data was available for the analysis. The total pay for those companies’ 2,591 named executives, before taxes, was $14.3 billion. That’s some pile of pay, right? But Mr. Ciesielski puts it into perspective by noting that the total is almost equal to the gross domestic product of Tajikistan, which has a population of more than 7 million. </blockquote> Again, note that all comparisons below refer only to these 2591 most highly paid executives of 483 companies, not all the companies' executives. - Paid More than Audit Expenses <blockquote>158 companies paid more in cash compensation to their top guys and gals last year than they paid in audit fees to their accounting firms.</blockquote> - Paid More than Income Taxes <blockquote>Thirty-two companies paid their top executives more in 2010 than they paid in cash income taxes. </blockquote> - Pay Rises While Stock Prices Fall <blockquote>The report calculated that at 179 companies in the study, the average value of stockholders’ stakes fell between 2008 and 2010 while the top executives at those companies received raises. </blockquote> - Paid a Substantial Fraction of Total Operating Revenue <blockquote>It identified 24 companies where cash compensation last year amounted to 2 percent or more of the company’s net income from continuing operations. </blockquote> The article used a health care example to illustrate this one: <blockquote>Topping this list is Allergan Inc., the health care concern whose top executives received, after taxes, an estimated $2.6 million in salaries last year. That amounted to 50 percent of what the company earned from continuing operations, the report said. </blockquote> Further details made this a particularly telling example of perverse incentives given to executives: <blockquote>Caroline Van Hove, an Allergan spokeswoman, said that the salaries were large when compared with net income in 2010 because one-time charges reduced earnings significantly that year; in previous years, she noted, earnings were far higher than executives’ pay. She also said the company’s C.E.O. had not received an increase in salary over the past three years. </blockquote> Parenthetically, some of the charges that affected Allergan's earnings were clearly due to a $375 million fine after a guilty plea to a federal misbranding charge and $225 million related civil penalties the company paid in 2010. As we noted in <a href="http://hcrenewal.blogspot.com/2010/09/at-end-of-summer-everybody-well-nearly.html">this post</a>, the US Department of Justice alleged that Allergan paid kickbacks to promote a drug for unapproved uses. Thus, what cost the company a major piece of its revenues were costs related to unethical behavior including one federal misdemeanor, and allegedly paying kickbacks to doctors to promote a drug for unapproved uses. However, while this behavior caused a marked drop in earnings, the research above showed the impunity of the executives who presided over this behavior, whose compensation held steady or rose. - Paid a Substantial Proportion of Research and Development Expenses <blockquote>Moving on to R.& D. costs, the report examined the 62 technology companies in its sampling that reported such an expense, excluding certain costs associated with acquisitions. Mr. Ciesielski found that the median level of executive pay was equal to 5.3 percent of these companies’ R.& D. expenditures. </blockquote> - Pay Equal to a Substantial Proportion of Market Capitalization <blockquote>Finally, there’s the comparison of executive pay with market capitalization. As Mr. Ciesielski noted, this calculation provides the biggest shock value. Eleven companies analyzed in the report gave top executives a combined pay package amounting to 1 percent or more of the companies’ average market value over the course of the year. </blockquote> To put it a different way, for a few corporations, the pay of the top five executives was equal to at least one percent of the total value of the corporations as measured by the value of all stock shares outstanding. In summary, the R. G. Associates' report suggests that the salaried executives, who the NY Times article reminded us are "hired hands," were generally paid amounts that seemed outrageously disproportionate to every metric used. Furthermore, a <a href="http://www.washingtonpost.com/business/economy/with-executive-pay-rich-pull-away-from-rest-of-america/2011/06/13/AGKG9jaH_story.html">second article </a>in the Washington Post provided an even more astonishing comparison. - Paid Enough to Become a Majority of the Richest Americans <blockquote>The largest single chunk of the highest-income earners, it turns out, are executives and other managers in firms, according to a landmark analysis of tax returns by economists Jon Bakija, Adam Cole and Bradley T. Heim. These are not just executives from Wall Street, either, but from companies in even relatively mundane fields such as the milk business. The top 0.1 percent of earners make about $1.7 million or more, including capital gains. Of those, 41 percent were executives, managers and supervisors at non-financial companies, according to the analysis, with nearly half of them deriving most of their income from their ownership in privately-held firms. An additional 18 percent were managers at financial firms or financial professionals at any sort of firm. In all, nearly 60 percent fell into one of those two categories.</blockquote> Summary So now it appears that the disproportionate compensation given to hired executives of large corporations, including health care corporations, have made them the majority of the very rich.  Most of the very rich are thus hired corporate employees, not company owners, not entrepreneurs, not even those who inherited wealth, or who are sports stars or rock musicians. This transformation of the face of the very wealthy has occurred at a time when the other employees of those corporations have generally stagnant incomes, and when those who have invested in those corporations, including many in the middle-class who have invested their retirement savings, have barely made money. So it turns out that in large corporations, including large health care corporations, it has become all about the top bosses.  The top bosses are likely to be paid enough to make them some of the richest US citizens.  Their pay likely comes off the top, so it has priority over profits and stock-holders gains, much less the pay of the lesser employees.  So it is clear that hired executives of large corporations have engineered perverse incentives for themselves that means never having to say they're sorry, never having to be accountable for anything the company does wrong.  Hence, there should be no mystery why US health care is the most expensive in the world, and despite its expense, is not very accessible and not of good quality.  The main culprit is a peculiar perversion of laissez faire capitalism in which the top managers have staged a coup, and have become the new oligarchs and plutocrats, and thus put their interests ahead of all others.  So to reform health care, we must reverse the managers' coup d'etat, and restore leadership of health care organizations that puts the mission, and the health of patients and the population first, and is accountable to corporate owners (when applicable) and to patients and the public.  But that will mean now going up against those who have made themselves the richest and most powerful people in the country and the world, who will not lightly give up their oligarchy.

The Managers' Coup: How the "Hired Hands" Got "Paychecks as Big as Tajikistan"

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20 Jun 2011

EMRUpdate's thoughts on health IT

I had posted about my relative's travails at the EMRupdate.com site where I have written or cross-posted a number of essays over the years. The site's proprietor Nick Harrington of the U.K. replied. In <a href="http://www.emrupdate.com/members/Nick-Harrington/default.aspx">his bio</a>: <blockquote> Managing Director of UK based document management software vendor Ambay Software providing hosting and support to <a href="http://www.emrupdate.com/">emrupdate.com</a></blockquote> I recognized a number of familiar themes in his reply. In turn, I replied to his reply as follows: <a href="http://www.emrupdate.com/members/Nick-Harrington/default.aspx"></a><blockquote><a href="http://www.emrupdate.com/members/Nick-Harrington/default.aspx">Nick Harrington</a> <a href="http://www.emrupdate.com/forums/p/30458/118187.aspx#118187">replied on</a> Mon, Jun 20 2011 10:12 AM Dr. Silverstein, We're sorry for your loss. Genuinely. However, I don't think this is the right place for you to start a campaign against EMR. The Healthcare industry is making big progress in the quality of patient care directly as a result of using Information Technology. The single act of providing computerized Electronic Health Record for a patient - whatever shape or form from many vendors - makes available important medical information to the whole team involved in patient care. It allows information to be readily available, to be carried with the patient as they move within the health system, it allows Doctors to be more aware of previous treatments, drug regimes and how best to care for this patient now in this consultation or emergency. Unfortunately laying blame at the door of IT and Electronic Medical Records isn't at all reaslistic and is unlikely to win your anything more than genuine sympathy. Certinaly no support for your premise that EHR is a direct cause of death, however unfortunate its circumstances. I do wish you peace and strength in your sad bereavement. Nick</blockquote> My reply: Nick Harrington wrote: <blockquote> Dr. Silverstein, We're sorry for your loss. Genuinely. However, I don't think this is the right place for you to start a campaign against EMR.</blockquote> Thanks for the expression of sympathy. It is appreciated. A few clarifications though: I have never maintained a "campaign" against EMR. I merely hold views that experimentation on patients with problematic, poorly engineered, unregulated medical devices (that are deliberately given special accommodation with regard to the federal FD&C act per Jeff Shuren at CDRH, see <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">FDA Decides Regulating Implantable Defibrillator Medical Devices a "Political Hot Potato"; Demurs</a>), and without informed consent, is unethical. As per <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/regulation_and_oversight_hoffman.pdf">Hoffman & Podgurski</a> at Case Western School of Law, what I am against is the lawlessness of the industry today. Nick Harrington wrote: <blockquote>the Healthcare industry is making big progress in the quality of patient care directly as a result of using Information Technology</blockquote> Much current and emerging literature refutes that (such as the sampling <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">at this link</a>). In consideration of this literature, today's commercial health IT is not yet ready for large scale rollout from an ethical perspective. Doing so is experimentation by definition. Doing s, especially without patient awareness or consent, is in violation of decades of policy on human experimentation (e.g., see HHS "<a href="http://answers.hhs.gov/ohrp/categories/1562">Human Research Protections Frequent Questions</a>.") These are first principles, not open to debate. Even modest NIH research grant proposals involving health IT undergo strict review for human subjects (and researcher) protections. I know first hand, as a sat on a Study Section on health of the population and provided Medical Informatics expertise to such proposals. Nick Harrington wrote: <blockquote>"The single act of providing computerized Electronic Health Record for a patient - whatever shape or form from many vendors - makes available important medical information to the whole team involved in patient care. It allows information to be readily available, to be carried with the patient as they move within the health system, it allows Doctors to be more aware of previous treatments, drug regimes and how best to care for this patient now in this consultation or emergency."</blockquote> Ideally, yes. However, we're still quite far from the ideal. At present, what we have is an unknown level of "health IT roadkill" on the way to perfecting the technology. As predicted by the field of <a href="http://rkcsi.indiana.edu/">Social Informatics</a>, there are also other unanticipated and likely adverse side effects (such as at <a href="http://hcrenewal.blogspot.com/2011/06/blogscan-uk-unencrypted-laptop-health.html">link</a>), outcome unknown. Nick Harrington wrote: <blockquote>Unfortunately laying blame at the door of IT and Electronic Medical Records isn't at all reaslistic </blockquote>That depends in what setting, and to whom, the blame is laid. In any case, regarding my relative: may she rest in peace, and may my efforts [i.e., at whistleblowing on health IT problems] result in others not having to suffer similar mistakes at the hands of IT. Nick Harrington wrote: <blockquote>I do wish you peace and strength in your sad bereavement. Nick</blockquote> Thanking you kindly. -- SS

EMRUpdate's thoughts on health IT

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20 Jun 2011

A Biomedical Informatics Manifesto

Note: this essay was originally posted in Oct. 2008. In view of my relatives's injuries due to interference of EHR's in clinical processes, I think it worthy of reposting. <h3 style="text-align: center;" class="post-title entry-title">A Biomedical Informatics Manifesto </h3> <div class="post-header"> </div> <div style="text-align: center; font-style: italic;"><blockquote>"We need to recognize that in our society's efforts to improve healthcare, we are attempting to create virtual clinical tools for complex and unforgiving medical settings that happen to involve computers, and that facilitate healthcare, not information systems that happen to involve doctors and clinicians that (in line with the bellicose grandiosity characteristic of IT marketing) will "revolutionize" healthcare. - S. Silverstein (me - ed.) </blockquote></div><div style="text-align: center;"> </div>The American Medical Informatics Association is moving towards <a href="http://www.digitalhcp.com/hitw/newsletters/2007/03/13/amia-clinical-informatics/">having the field of Biomedical Informatics formally declared a medical subspecialty</a> with the help of a $300,000 grant from the Robert Wood Johnson Foundation. While this is good, it is a long time in coming. I have been thinking a great deal about the recent Joint Commission Sentinel Events Alert on the potential dangers of poorly conceived and implemented healthcare IT. I wrote on this issue at the post "<a href="http://hcrenewal.blogspot.com/2008/12/joint-commission-sentinel-events-alert.html">Joint Commission Sentinel Events Alert On Healthcare IT</a>". Noteworthy is the fact that the research of current Biomedical Informatics specialists and allies figure heavily in the Alert’s references. I can only wonder what motivated the Joint Commission to issue such a potentially industry-adverse advisory (adverse to common and profitable health IT industry practices that create these issues, that is) at this time. President-elect Obama, after all, has made HIT a significant part of his agenda. Perhaps as cases of HIT difficulty and patient harm become more commonly known, the Commission does not wish to appear to have been caught unaware as have other regulatory agencies in the face of recent turmoil in the housing and financial sectors. I have heard rumors from my readers, in fact, of major stories about HIT malfunction that might in fact reach a wide public audience in the coming years. Considering the turmoil in the housing, economic and investment sectors, perhaps the Joint Commission does not want to be seen in the same light as a Fannie Mae or an SEC. In any case, the alert's appearance raises a meta-issue: <blockquote style="font-weight: bold;">Why was such an alert even necessary?</blockquote> None of the issues the alert raises, ranging from safety risks, unintended and preventable adverse events that these implementations can create or perpetuate via fundamental errors of either commission or omission, ill conceived human-machine interfaces and organization/system design, etc. would be very commonplace if the teachings of 40+ years of Biomedical Informatics research was heeded. Some of those researchers could probably have written the Joint Commission alert on HIT in the 1960's. In fact, they largely did. Biomedical informatics research goes back to the pioneers such as the writings in 1968-9 of Dr. Donald Lindberg, (now director of the U.S. National Library of Medicine at NIH and a key figure in funding for Bioemedical Informatics postdoctoral training), the "Ten Commandments" of Octo Barnett regarding HIT in 1970, the five major reasons for lack of HIS success by Morris Collen in 1972, the four reasons for lack of HIT diffusion by Friedman and Gustafson in 1977, and many others [1]. Why has it taken forty years for this research to be reinvented and regurgitated by a major healthcare regulatory agency? How many billions of dollars have been wastefully spent, and how many patients have been adversely affected by <a href="http://iig.umit.at/efmi/badinformatics.htm">bad informatics</a>, in all those years? Biomedical informatics research currently includes the work of the formal departments and centers in the field such as <a href="http://www.nlm.nih.gov/ep/GrantTrainInstitute.html">these</a> funded by the NIH in the U.S. and others funded by their own universities, departments of Biomedical Informatics in <a href="http://www.amia.org/informatics/acad&training/international.asp">other countries</a>, sociologists (e.g., <a href="http://www.ssc.upenn.edu/soc/People/koppelross.html">Ross Koppel</a>, <a href="http://oldwww.bmg.eur.nl/personal/j.aarts/">Jos Aarts</a> to name just a few), <a href="http://rkcsi.indiana.edu/">social informatics</a> experts, the <a href="http://www.ischools.org/">iSchool</a> consortium, and many others working in a cross-disciplinary manner. In my own case, I have been <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm">writing on these issues</a> since my eye-opening experiences as a Chief Medical Informatics Officer (CMIO) in the mid-1990's at Delaware's largest healthcare organization. I am astonished that the issues I wrote of then are current today; I often hear the exact same stories from current CMIO's over a decade later. I can say that none of the Joint Commission warnings were necessary on my watch as CMIO; I was cognizant of all these problems as a result of several years of studying the issues in the time I spent in the deep cave known as the <a href="http://www.med.yale.edu/library/">Yale Cushing/Whitney Medical Library</a> during my Biomedical Informatics fellowship and faculty time, as well as by direct observation using the simple skills of a medical internist but applied to IT. My writings have been widely viewed (see my 2006 AMIA poster "Access Patterns to a Website on HIT Failure", ppt file at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/content/documents/FINAL_Healthcare%20IT%20Failure_Oct_19_2006.ppt">this link</a>). Yet, as a Google or other search engine search on "healthcare IT failure", "healthcare IT difficulty" or similar concepts demonstrates, explicit information on this topic remains curiously limited. On the contrary, a search on "medical malpractice" brings up literally millions of "hits." Why do the healthcare IT dangers that are the subject of the JC alert occur at all? A clue can be found in the following observations. The problem can be summed up like this: <blockquote style="font-weight: bold;">Biomedical Informatics as a specialty might as well be invisible. Amateurs rule HIT.</blockquote> (Note: I use the term "amateur" not in a pejorative sense, but in the sense that I am a <a href="http://www.arrl.org/">radio amateur or “ham”</a> with formal licensure after governmental examinations and significant technical and applied telecommunications experience. I am not a telecommunications professional, however, who should be, say, leading a critical telecommunications initiative for a hospital or large business.) Here is my most recent and indeed most personal evidence Biomedical Informatics is still largely invisible. My former chair of medicine from my residency, a consummate clinician trained at Yale and now Chief of Staff of an 800+ bed hospital complex, opined regarding an opening for a Director of Clinical IT at his organization (in reference to my application, which was summarily ignored by the IT department other than the typical form letter reply) that "I do not believe it is a Sine qua non that a physician be at the helm of the clinical informatics enterprise". He knew of my career path since my residency in the mid 1980's. Now, this same person wrote a letter of recommendation in 1992 to Yale's Center for Medical Informatics about my qualifications for a Biomedical Informatics postdoctoral fellowship at his alma mater. The letter indeed mentioned the evening in 1986 when I went "way outside the box" as a resident at his hospital and used my IT expertise to repair a CT scanner's computer that was malfunctioning and that had been abandoned for the evening by the vendor. My repair brought the CT scanner online, and changed the intervention on a mid 20's unknown male brought to the ED with profound mental status changes from a potentially catastrophic lumbar puncture to the appropriate neurosurgical intervention - to manage a huge hydocephalus caused by a benign obstruction within his brain. The patient survived. The statement directed towards me that "a physician is not a Sine qua non of a healthcare informatics initiative" thus clearly identifies me as "a physician", not a "formally trained and experienced biomedical informatics professional who is also a physician." (One would hopefully never hear that "a surgeon is not a Sine qua non of major abdominal surgery.") That the field of biomedical informatics could have been so invisible to such a person suggests to me the field is simply a Black Hole to others even less well informed about its practitioners: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj3K4lYjCXbg50q4TJL2Mc7qb2GnTGsqYtRJzTwm8eIvfGybtehlfBX3kkVwjuFeqMI_ZLz7fku2eyvWwM7XANIwcBuoPNf4lJ1EVQPXIhLhOyDestfCBQVNTCr26AWQNUjEC99xXNDdtte/s1600-h/Black_Hole.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5283808971247560578" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj3K4lYjCXbg50q4TJL2Mc7qb2GnTGsqYtRJzTwm8eIvfGybtehlfBX3kkVwjuFeqMI_ZLz7fku2eyvWwM7XANIwcBuoPNf4lJ1EVQPXIhLhOyDestfCBQVNTCr26AWQNUjEC99xXNDdtte/s200/Black_Hole.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 200px; height: 160px;" /></a>The environment around an invisible Black Hole. Is this how the healthcare industry sees the field of Biomedical Informatics? </div> Other occupations (I've personally seen IT personnel, MBA's, business consultants, "process re-engineers", 'techie' docs and nurses with just enough IT knowledge to be dangerous, social workers, and a cadre of others) are thus free to commit what I term "cross-occupational piracy" upon HIT. They do not do a stellar job of it. Thus, the Joint Commission alert becomes necessary. This phenomenon was also apparent in pharma. I note the following essay at the excellent blog "<a href="http://www.corante.com/pipeline/">In the Pipeline</a>" by medicinal chemist Derek Lowe, PhD, in a Dec. 19, 2008 post entitled "<a href="http://pipeline.corante.com/archives/2008/12/19/my_compound_goes_where_the_wild_goose_goes.php">My Compound Goes Where the Wild Goose Goes</a>" that: <blockquote style="font-family: arial;">A colleague and I got to talking yesterday about something that I'm sure many chemists have noticed. Have you ever chased down some reaction or compound in the literature, only to find yourself wild-goosing back to some obscure journal that no one has ever read - just because no one can be bothered to publish a modern procedure? Here's how that typically works. You run a SciFinder search on Molecular Structure X. A list with a dozen references comes up. There's a Tet. Lett. from 2002, but what are the chances it'll have any spectral data (or anything useful at all?) Ah, there's one from Tetrahedron in 1995, that should do. So you look over the PDF, search for your compound. . .there it is, number 17. Now to the experimental. . .and you find in the first paragraph that "Compound 17 was prepared according to a published procedure", footnote thirty-eight. And the footnote is to. . .ay, it's to a Chem. Ber. paper from 1932. Ausgezeichnet! Oh-kay. Back to that SciFinder reference list. How about that Tet. Lett. paper? Nope, on inspection, it turns out to reference the 1995 paper you just looked at. What else? There's a JOC from 1984, let's try that. Good ol' JOC, solid stuff. Well, digging up that PDF, you find that it refers to a 1980 paper from the same group from Synthesis. Hrm. So you chase that one down, there it is, compound 9, and the experimental for it is. . . footnoted to the 1932 paper. Again.</blockquote> What he is referring to is the "wild goose chase" that often plagues medicinal and other chemists in performing syntheses, essential to the drug discovery process. He is pointing out the use of the cheminformatics resource known as "<a href="http://en.wikipedia.org/wiki/Chemical_Abstracts_Service">SciFinder</a>" by the American Chemical Society. An ACS division provides the largest databases of publicly disclosed chemistry-related information and makes the information accessible through search and retrieval software such as SciFinder, along with links to the original literature and patents. SciFinder is an essential tool to the modern research chemist. Some pharmas (e.g., Pfizer) made this tool widely available to its scientists. Which makes my experience in Big Pharma astonishing, in that I as a science library director in a company with a declining pipeline of new drugs had to fight a long battle with a non medical, non science-background IT VP over ending rationing of said tool, among others, to save a few million $ per annum. I was dumbfounded. This in a drug giant boasting $60 billion in market clout and 60,000 employees. In the end, my department received only a fraction of what I asked for, and that was soon taken away (not from me personally, but from the scientists, ultimately) as budgets declined. My appeals to senior management as a Biomedical Informatics professional, a.k.a. information scientist, might as well have been invisible as well. I was ultimately laid off by the VP for my efforts, leaving laggards who had tolerated this mind-boggling, truly absurd situation that impaired drug discovery behind. Black hole <a href="http://en.wikipedia.org/wiki/OJ_287">OJ287</a>, mass of 18 billion Suns. Unfortunately, I <a href="http://hcrenewal.blogspot.com/2007/03/computer-debacle-broken-down-process-at.html">doubt FDA will issue a similar</a> alert about the dangers of research IT leadership by non scientists. In effect, the Joint Commission Sentinel Alert affords an opportunity for a return to some sanity in healthcare IT endeavors. It is my view that the Biomedical Informatics community and its allies need to leverage this perhaps first-ever acknowledgment from an organization with clout that HIT is not a harmless panacea and needs to be subject to informed discipline and rigor (as medicine itself). They need to leverage it to end the "black hole of invisibility", irrespective of the bureaucratic and prolonged process of having the field declared a medical subspecialty, the outcome of which is uncertain. The alert needs to be leveraged each and every time a Biomedical Informatics professional finds themselves being marginalized. It needs to be leveraged as a hammer. "Political correctness" (aptly abbreviated "PC", pun intended) on these matters ultimately gets patients killed. You know you're afflicted with the terminal PC bug when you feel reluctance to tell your CIO and IT personnel who lack training, knowledge and experience in clinical medicine, and who've just concluded contracts for the world's worst clinical IT without sufficient end user involvement, that they, in fact ... lack training, knowledge and experience in clinical medicine. When told that the CIO or IT people or the COO or the CFO or the MBA process re-engineers "know better" than informatics experts what clinicians should be doing and what they need to care for patients; that informatics experts don't have enough project management or other mundane experience; that they are too academic; that doctors don't do things with computers; that a biomedical informatics expert is not the "Sine qua non" of a major healthcare informatics initiative; that the vendor whose products impaired a national HIT initiative overseas has assured us their products are just dandy, and so forth ... ... the reply should itself be a well-justified bit of bellicosity. Biomedical informatics professionals should stand up, speak out, and make it count: <blockquote> "What part of 40+ years of Biomedical Informatics research and experience don't you understand?"</blockquote> -- SS Reference: [1] A History of Medical Informatics in the United States 1950-1990 (pp. 167-175), Morris F. Collen B.E.E., M.D., 1995, American Medical Informatics Association, ISBN 0-9647743-0-5.

A Biomedical Informatics Manifesto

Note: this essay was originally posted in Oct. 2008. In view of my relatives's injuries due to interference of EHR's in clinical processes, I think it worthy of reposting.A Biomedical Informatics Man…

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18 Jun 2011

Blogscan: UK unencrypted laptop health breach affects more than 8.6 million records

From the blog "<a href="http://aushealthit.blogspot.com/2011/06/who-needs-hackers-when-there-are.html">Australian Health Information Technology</a>": <blockquote>Who Needs Hackers When There Are Accidents Like This? The PCEHR [Personally Controlled Electronic Health Record - ed.] Won’t Avoid Hacker Attention I Suspect. <div class="post-header"> </div> The following popped up a little while ago. By <a href="http://blogs.hcpro.com/hipaa/author/dnicastro/" title="Posts by Dom Nicastro">Dom Nicastro</a> Think the United States has its problems with securing patient health information? We’re not alone. London Health Programmes, a medical research organization based at the NHS North Central London health authority, has reported missing an unencrypted laptop containing information of 8.63 million patients and 18 million hospital visits, operations and procedures, according to today’s issue of <a href="http://www.thesun.co.uk/sol/homepage/news/3637704/Missing-Laptop-with-86million-medical-records.html">The Sun</a>. The data does not include names, “but patients could be identified from postcodes and details such as gender, age and ethnic origin,” according to the newspaper. Information on the laptop included records of cancer, HIV, mental illness and abortions. The computer was one of 20 lost, and officials have since recovered eight. The research organization “only just” reported the missing laptops to police although they went missing three weeks ago, according to the newspaper. The Information Commissioner’s Office, Great Britain’s independent authority that promotes data privacy for individuals, has issued a <a href="http://www.ico.gov.uk/%7E/media/documents/pressreleases/2011/ncl_statement_20110615.pdf">statement regarding the laptop theft</a>: “Any allegation that sensitive personal information has been compromised is concerning and we will now make inquiries to establish the full facts of this alleged data breach.” More here with a gruesome list of UK breaches. <a href="http://blogs.hcpro.com/hipaa/2011/06/unencrypted-laptop-health-breach-affects-more-than-8-million-records/">http://blogs.hcpro.com/hipaa/2011/06/unencrypted-laptop-health-breach-affects-more-than-8-million-records/</a> Clearly this sort of incident is made more significant when material like this is appearing regularly.</blockquote> We've posted numerous times at Healthcare Renewal on the impossible dream of electronic medical record privacy, security and confidentiality. See blog query links <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20confidentiality">here</a> and <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">here</a>. -- SS

Blogscan: UK unencrypted laptop health breach affects more than 8.6 million records

From the blog "Australian Health Information Technology":Who Needs Hackers When There Are Accidents Like This? The PCEHR [Personally Controlled Electronic Health Record - ed.] Won’t Avoid Hacker Atten…

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17 Jun 2011

UCB Settles, Pleads Guilty

Tromp, tromp, tromp.... the legal settlements keep marching along.  This latest story was reported by <a href="http://www.reuters.com/article/2011/06/09/ucb-settlement-idUSN0914441720110609">Reuters</a> and <a href="http://www.bloomberg.com/news/2011-06-09/ucb-pleads-guilty-to-illegal-off-label-marketing-of-epilepsy-drug-keppra.html">Bloomberg</a>.  The basics were, per Reuters: <blockquote>The American unit of Belgian pharmaceutical company UCB SA (UCB.BR) pleaded guilty on Thursday and will pay $34.4 million to settle criminal and civil charges that it illegally promoted a drug for migraines. The company pleaded guilty to one count of promoting the epilepsy treatment drug, Keppra, in the United States in 2004 for migraine treatment without the necessary approval from the Food and Drug Administration, the U.S. Department of Justice said.</blockquote> One atypical element here is that the company actually pleaded guilty to a crime. Another slightly off-key note came from the description of the activities constituting the illegal marketing, per Reuters: <blockquote>The company was accused of promoting Keppra with posters that claimed it was safe and effective for migraines and cited studies that it also claimed were independent -- but in fact were sponsored by UCB, according to the Justice Department. In those posters, UCB failed to disclose that its own trials had failed to demonstrate the drug was effective for migraines or that it had backed the studies, the agency said.</blockquote> Furthermore, per Bloomberg, <blockquote>UCB’s marketing included sponsorship of doctor-paid 'studies,' posters, publications and oral presentations about the supposed benefits of using Keppra to treat migraines. Prosecutors said UCB failed to disclose that a 2000 study showed that Keppra was not effective in preventing migraine. </blockquote> So the company did not deny accusations of deceptive marketing, and the suppression of a clinical study that failed to conform to marketing objectives. But most of the rest followed the usual routine. The settlement involved some sort of promises of better corporate behavior in the future, per Reuters: <blockquote>As part of the settlement, the company agreed to implement procedures and reviews to avoid and detect any future similar conduct. As a result, UCB will not face probation, according to the plea agreement filed in court.</blockquote> The penalty for the company was a fine that appeared to be big: <blockquote>UCB will pay about $8.6 million in criminal fines and forfeiture and another $25.8 million to settle parallel civil allegations involving false claims submitted to U.S. federal healthcare programs, according to the plea agreement.</blockquote> However, it was a pittance compared to the revenues generate by the product whose marketing was illegal, per Bloomberg: <blockquote>Keppra, with 942 million euros ($1.37 billion) in sales last year, is the company’s top-selling drug, according to data compiled by Bloomberg. </blockquote> The spokesperson for the government basically said, "that ought to teach them," again per Bloomberg, <blockquote>'UCB put its pursuit of profits ahead of its obligations to patients,' Ronald C. Machen Jr., U.S. attorney for the District of Columbia, said in an e-mailed statement. 'Today’s guilty plea and UCB’s $34 million payout should remind drug companies that try to cleverly design off-label marketing schemes that we will not allow them to compromise patient safety.' </blockquote> However, the company's leaders did not seem the least bit fazed, or contrite for that matter, per Reuters, <blockquote>'We are pleased to have resolved this matter and look forward to continuing to work with the many organizations with whom we partner to advance our mission of transforming the lives of people living with severe diseases,' said Greg Duncan, UCB's president for North American Operations.</blockquote> The contrast between the crime his company admitted, involving deceptive marketing and the suppression and a study that failed to fit marketing objectives, and the high minded mission seemed to cause Mr Duncan no cognitive dissonance. Or perhaps "transforming the lives of people" was meant more ironically? Left unsaid in the brief news reports was whether any individual who authorized, directed, or implemented the bad behavior, including, in this case, the deceptive marketing and suppression of clinical research, would pay any sort of penalty. It seems safe to assume that no one will go to jail, pay a fine, lose a job, or even be demoted.  Why the US Department of Justice thought that a small fine and no individual penalties would change corporate behavior, when the profits to be made are so large, in the absence of even a little bit of contrition by corporate leaders, was not exactly clear. So on and on the march goes. The <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">parade of settlements</a>, sometimes even involving guilty pleas of criminal convictions, now indicates how low the ethical standards of health care organizations have fallen. However, the lack of any consequences to individuals suggests that they have no incentive to rise. Again, despite promises of tougher treatment of individuals involved in health care corporate misbehavior from the government (see posts <a href="http://hcrenewal.blogspot.com/2011/05/fresenius-fined-82-million-for-false.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/06/attempt-to-hold-health-care-leaders.html">here</a>), the same old script plays out again and again. So I get to say twice in two days,,,, pervasive bad behavior by large health care organizations has got to be a major cause of our ongoing health care dysfunction. So, to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable. As long as they are not, expect the bad behavior to continue.

UCB Settles, Pleads Guilty

Tromp, tromp, tromp.... the legal settlements keep marching along. This latest story was reported by Reuters and Bloomberg. The basics were, per Reuters:The American unit of Belgian pharmaceutical c…

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15 Jun 2011

Two More Settlements, One More Corporate Integrity Agreement for Novo Nordisk

And the legal settlements for health care organizations keep right on marching along.  Here are the basics, <a href="http://online.wsj.com/article/SB10001424052702304259304576377430323510242.html">per</a> the Wall Street Journal, starting with the outline of the first settlement for Novo Nordisk: <blockquote>Drug maker Novo Nordisk A/S's U.S. affiliate has agreed to pay more than $25 million to end investigations by U.S. authorities related to the marketing of NovoSeven and several diabetes drugs. In one settlement, Novo Nordisk Inc., the U.S. affiliate, agreed to pay $25 million to end a probe and settle a civil lawsuit related to alleged improper marketing practices regarding Novo Seven, which is used to treat patients suffering from rare bleeding disorders. The complaint had alleged that Novo Nordisk promoted NovoSeven for unapproved uses. </blockquote>Here is the outline of the second settlement: <blockquote>Separately, the U.S. affiliate also agreed to pay $1.73 million in a settlement with the U.S. government to resolve allegations that its sales representatives accessed confidential patient information and submitted false Medicaid claims related to the marketing of diabetes drugs, including Novolin and Novolog. Federal prosecutors in Brooklyn, N.Y., had alleged Novo Nordisk representatives made payments to pharmacists in exchange for recommendations for Novolin and Novolog products. As part of their activities, the pharmacists, or Novo Nordisk sales representatives, accessed confidential patient information, according to the settlement agreement. </blockquote>Here is the usual pro forma denial by a company spokesperson that the company had done anything wrong: <blockquote>'We are committed to running our business according to high legal and ethical standards and have been cooperating with the government since the investigation began,' said Jim Shehan, corporate vice president and U.S. general counsel for Novo Nordisk Inc. 'With this settlement, we avoid the distraction and costs of a lengthy legal battle, which would not have been in the best interest of the company or its stakeholders.' Novo Nordisk denies any wrongdoing related to NovoSeven marketing....</blockquote>Also, <blockquote>Novo Nordisk didn't admit wrongdoing in the Novolin pact. </blockquote>By the way, here is the brief mention of the corporate integrity agreement: <blockquote>[Novo Nordisk] agreed to enter a five-year corporate integrity agreement with the U.S. Department of Health and Human Services in which it will add additional reporting and other procedures to its compliance program. </blockquote>Why would a company that professes "high ethical and legal standards" not contest allegations that it engaged in improper marketing, paid health care professionals to recommend its products, and instigated breaches of patient confidentiality?  Setting that aside, however, the coverage of this story <a href="http://articles.baltimoresun.com/2011-06-10/news/bs-md-factor-vii-20110610_1_factor-vii-novoseven-novo-nordisk">in the Baltimore Sun </a> raises further questions. First, how Novo Nordisk allegedly promoted Novo Seven, and the uses for which it was promoted are disturbing: <blockquote>the government [did not] back down from its charge that the company engaged in unlawful marketing that helped persuade the Army to treat combat casualties with a largely experimental drug that was not approved for such use by the Food and Drug Administration. Beginning in 2000, according to the government's claims, Novo Nordisk promoted the drug, also known as NovoSeven, to military doctors and entered into research agreements with Army hospitals. It provided funding for trials in which military officers participated, and gave 'donations and other gifts' to nonprofit foundations on behalf of military physicians. Those practices 'caused the military to use NovoSeven in its trauma patients,' the agreement states.</blockquote> There was no evidence that Novo Seven decreased the morbidity and mortality of battlefield trauma, but there were reasons to believe the drug increased thrombosis risk: <blockquote>Numerous clinical studies have since shown, however, that Factor VII is ineffective at controlling traumatic bleeding and can potentially cause blood clots that lead to heart attacks and strokes. </blockquote>This was not just paying physicians and institutions to market an expensive, but innocuous drug.  It was paying US military physicians and institutions to market a drug that put injured soldiers at risk, but gave them no benefit.  Given the degree of deference public officials give to the brave soldiers that serve the country on the battlefield, one would think that putting them at risk, and putting the honor of their officers and military institutions at risk ought to be a big deal, maybe a big deal requiring more than even a $25 million fine. On the other hand, although $25 million seems like a lot of money, it pales beside the amounts Novo Nordisk were making from Novo Seven: <blockquote>Last year Novo Nordisk reported annual sales of NovoSeven of almost $1.6 billion — mainly for treatment of hemophilia. Company officials say roughly 15 percent of its sales are for unapproved uses, or as much as $250 million last year.</blockquote> So while the settlement seems expensive compared to the cost of defending the suit in court, and it trades the distraction of a corporate integrity agreement for avoiding the "distraction" of further legal action, maybe a settlement equal to only one-tenth of the yearly sales of the relevant drug seemed a good deal for the company. Since the company was already laboring under a deferred prosecution agreement in the US related to charges of illegal foreign kickbacks (see <a href="http://hcrenewal.blogspot.com/2009/05/novo-nordisk-accepts-deferred.html">this post</a>), maybe adding a corporate integrity agreement did not seem like all that much distraction. On the other hand, the big question is: why was this deal a good one for the US government, or the people which it is supposed to protect? The amount involved only seems like a cost of doing business, and seems disproportionately small given that the allegations involved unlawful marketing that apparently threatened to corrupt US military doctors and hospitals, and were made against a company already under a deferred prosecution agreement for illegal kickbacks. Finally, since the impact of even the relatively small financial payment could be spread among all corporate employees and stockholders, and the deal involved no negative consequences for any individual who authorized, directed or implemented the bad behavior, why would it defer corporate insiders from authorizing or directing future bad behavior?  . We have heard a series of threats from US government officials that they are about to crack down on big health care companies that misbehave, and, in particular, actually try to impose some negative consequences on the people in those companies that authorized, directed, or implemented bad behavior (see <a href="http://hcrenewal.blogspot.com/2011/05/fresenius-fined-82-million-for-false.html">this post</a>). However, we continue to see settlements like this, involving relatively small financial penalties imposed on rather large corporations, and corporate integrity agreements and/or deferred prosecution agreements that do not obviously seem to change how the companies operate. Although a year ago we <a href="http://hcrenewal.blogspot.com/2010/06/attempt-to-hold-health-care-leaders.html">discussed</a> threats by the US government to hold health care leaders accountable using the "Responsible Corporate Officer Doctrine," which has been available since 1943, so far there is no evidence that this concept has been made operational. The continuing <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements</a> now seems to have included most of the previously well reputed commercial health care firms in the US. The length of this march is an indication of how pervasive is bad behavior by such health care organizations, especially when the marchers were accused of behavior that appeared clinically, not just financially unethical. I assert again that pervasive bad behavior by large health care organizations has got to be a major cause of our ongoing health care dysfunction. So, to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable.    As long as they are not, expect the bad behavior to continue.

Two More Settlements, One More Corporate Integrity Agreement for Novo Nordisk

And the legal settlements for health care organizations keep right on marching along. Here are the basics, per the Wall Street Journal, starting with the outline of the first settlement for Novo Nord…

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14 Jun 2011

The First Contaminated Heparin Case Verdict: Making Money by Giving Patients "the Cheap Stuff"

In February, 2008, we first <a href="http://hcrenewal.blogspot.com/2008/02/in-middle-of-all-those-pigs-in-china.html">posted</a> about the case of the deadly adulterated heparin.  (A case summary is appended to the end of this post, and nearly all our posts are <a href="http://hcrenewal.blogspot.com/search/label/heparin">here</a>.)  The case is of fundamental importance because it involves the failure of pharmaceutical companies to fulfill their core mission, to supply pure, unadulterated drugs.  It is also of fundamental importance because it may be about how this failure to fulfill core mission was not due to accident, or even simple incompetence, but due to putting financial goals ahead of patient safety.  The latest event in the very slowly unfolding aftermath of this case was the first verdict against the sellers of the heparin in a civil trial in a US court room.  As <a href="http://www.chicagotribune.com/business/breaking/chi-baxter-loses-first-heparin-case-20110609,0,1020947.story">reported</a> by the Chicago Tribune, <blockquote>A Cook County Circuit Court jury Thursday awarded $625,000 to the estate of a man who his attorneys say was given a dosage of a blood thinner made by Baxter International Inc. that contained a contaminated ingredient found in the company's supply chain in China. The verdict is the first from a case against Baxter and its supplier, Wisconsin-based Scientific Protein Laboratories, from hundreds of lawsuits filed against the Deerfield-based medical product giant. A mountain of litigation has been leveled against the companies after U.S. regulators determined in 2008 that Baxter's heparin was contaminated, from fake ingredients sourced in China.</blockquote> A statement by the (winning) plaintiff's attorneys underscored that this case may have been about cutting costs winning out over patient safety: <blockquote>'The active pharmaceutical ingredient in the contaminated heparin received by Mr. Johansen and other Americans was obtained from Baxter (and its supplier Scientific Protein Laboratories') Changzhou SPL,' Johansen estate attorneys Don Nolan of Chicago and David Zoll of Toledo, Ohio said in a statement this afternoon. 'This crude heparin was referred to in the companies' own internal records as 'the cheap stuff.' The contaminant was determined to be a man-made 'fake heparin' called over-sulfated chondroitin sulfate, causing among other effects, potentially fatal allergic-like reactions.'</blockquote> As explained in <a href="http://postscript.communitycatalyst.org/?p=2770">this post</a> in the Postscript blog: <blockquote>Baxter and its ingredient supplier, Scientific Protein Laboratories (SPL), announced in 2008 that the OSCS contaminant was introduced intentionally by their suppliers in China. Financial motives are presumed, because Heparin costs 100 times more to make than OSCS. In addition, Heparin which is harvested and purified from the intestines of pigs, was even harder to obtain in 2007-08 because a global pig disease epidemic had created an unexpected shortage in China and elsewhere. The timing was right, and seems the chemistry was, too. The OSCS contaminant was not initially discovered because it mimics some chemical properties of Heparin, suggesting that it was introduced by suppliers in China who possessed the biochemical savvy to fool the standard chemical purity tests then in use by Baxter and the FDA. (The assay test has since been improved by the US Pharmacopeia.)</blockquote>So it appeared in their haste to cut costs, Baxter International, and its US based supplier, Scientific Protein Laboratories, failed to consider that heparin chosen because it was "the cheap stuff" might not turn out to be safe. In particular, they seemed to be wilfully blind to the prospect that pushing for the cheapest price without inquiring too deeply into the details of the supply chain might tempt those down the chain to cheat, and in doing so, to disregard the safety of those patients (in another country) who would be infused with the resulting adulterated product.  This thus appears to be a vivid, and fatal case of mission-hostile management. Meanwhile, we still await the result of the investigation that was supposed to have started in February, 2011 (see <a href="http://hcrenewal.blogspot.com/2011/02/three-years-later-congressional.html">this post</a>.) To reiterate, 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). Case Summary - We have posted several times, recently <a href="http://hcrenewal.blogspot.com/2011/02/fda-to-scientific-protein-laboratories.html">here</a>, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International. - We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart. - We found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post <a href="http://hcrenewal.blogspot.com/2008/03/fake-heparin-then-sick-and-dead.html">here</a>.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post <a href="http://hcrenewal.blogspot.com/2008/03/who-was-responsible-for-purity-of.html">here</a>.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there. - The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops." - Leaders of all organizations involved, Baxter International, Scientific Protein Laboratories, Changzhou SPL, the Chinese government, and the US Food and Drug Administration, and the US Congress assigned blame to each other, but none took individual or organizational responsibility. (See post <a href="http://hcrenewal.blogspot.com/2008/05/blaming-some-dude-for-contaminated.html">here</a>.)  Note that SPL was recently bought out and taken private, making its current leadership even less transparent (see post <a href="http://hcrenewal.blogspot.com/2010/10/more-contaminated-heparin-but-who-leads.html">here</a>).  A 2010 inspection of an SPL facility by the FDA revealed ongoing manufacturing problems (see post <a href="http://hcrenewal.blogspot.com/2011/02/fda-to-scientific-protein-laboratories.html">here</a>). - Researchers (who turned out to have financial ties to a company which is developing an anti-coagulant drug that could compete with the heparin made by Baxter International) investigated the biological mechanisms by which the contamination of the heparin lead to adverse effects, but no one investigated further how the contamination occurred, or who was responsible. (See post <a href="http://hcrenewal.blogspot.com/2009/08/who-investigated-case-of-deadly.html">here</a>.) - Hundreds of lawsuits against Baxter have now been filed, so far without resolution. (See post <a href="http://hcrenewal.blogspot.com/2010/01/blog-post.html">here</a>.)  Efforts to make documents to be used in these cases public so far have not succeeded (see post <a href="http://hcrenewal.blogspot.com/2010/08/proprietary-information-confidentiality.html">here</a>). - A government report which attracted little attention warned of the dangers of pharmaceutical ingredients made in China and subject to virtually no oversight. (See post <a href="http://hcrenewal.blogspot.com/2010/04/another-echo-of-case-of-deadly-heparin.html">here</a>.) -  Despite requests from the US, the Chinese government did not investigate the production of the heparin that lead to the deaths (see post <a href="http://hcrenewal.blogspot.com/2010/07/more-about-what-we-dont-know-about.html">here</a>.) -  In February, 2011, a congressional investigation of the case was announced, but results are so far unavailable (see post <a href="http://hcrenewal.blogspot.com/2011/02/three-years-later-congressional.html">here</a>.)

The First Contaminated Heparin Case Verdict: Making Money by Giving Patients "the Cheap Stuff"

In February, 2008, we first posted about the case of the deadly adulterated heparin. (A case summary is appended to the end of this post, and nearly all our posts are here.) The case is of fundament…

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13 Jun 2011

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