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Three Years Later, A Congressional Investigation of the Deadly Adulterated Heparin

Slightly more than three years ago, 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.   Three years later, how the heparin was adulterated, and who was responsible are still unknown. So now, it seems, there will actually be an official investigation.  As<a href="http://online.wsj.com/article/SB10001424052748703775704576162450111643240.html"> reported</a> by Alicia Mundy in the Wall Street Journal, <blockquote>The House Energy and Commerce Committee is conducting a formal investigation into the contaminated-heparin crisis of 2008, saying it wants regulators to figure out who was responsible for adulteration linked to 81 U.S. deaths. The panel's chairman, Rep. Fred Upton (R., Mich.), and two colleagues sent a letter Wednesday to the Food and Drug Administration asking for documents on whether the agency pursued possible culprits in China and pushed the Chinese government for more information. 'The committee is investigating the unsolved case of who contaminated the U.S. supply of heparin,' a blood thinner used by about 12 million Americans annually, said Mr. Upton, joined by Reps. Clifford Stearns (R., Fla.) and Michael Burgess (R., Texas).</blockquote> Better late than never, I suppose. <a href="http://hcrenewal.blogspot.com/2008/03/contaminated-heparin-where-is-outrage.html">In March, 2008</a>, I called the case "outrageous," and called for an investigation. You really did hear it here first on Health Care Renewal. So three years later, an investigation has actually begun. The latest WSJ article noted: <blockquote>'There is substantial public interest in solving this case' because more than 80% of the standard heparin supply in the U.S. today comes from China, the lawmakers wrote. About 16% of all pharmaceutical ingredients in the country are imported from China, they wrote.</blockquote> Also, <blockquote>'There is reason to believe all or some of the individuals responsible for the adulteration are still actively engaged in the Chinese pharmaceutical supply chain, and pose a continuing threat to pharmaceutical products imported to the U.S.,' the lawmakers wrote.</blockquote> However, why this "substantial public interest" and the existence of "a continuing threat" did not lead to an investigation earlier is still completely obscure. The article hinted at some partisan discord in the committee that will do the investigation: <blockquote>Over the last two years, Mr. Burgess and the Energy and Commerce Committee's then-top Republican, Rep. Joe Barton of Texas, pressed the FDA for information on the agency's inspections of Chinese heparin facilities and on the extent of cooperation from national and local Chinese authorities. At the time, Republicans were in the minority. Their inquiries didn't constitute a committee investigation, and they couldn't demand nonpublic information from the FDA or call hearings. They now are in the majority and have those powers. </blockquote> The implication is that the Democrats on the committee blocked the investigation. Why they would have blocked an investigation when the executive branch was in Republican hands, and why the matter could not have been investigated in another congressional committee, or by some other organization, is unknown. So, again, better late than never. An investigation could at least be the beginnings of accountability for the very well paid pharmaceutical company leaders who up to now have denied all responsibility for failing their most important responsibility, to provide pure, unadulterated drugs. As we have said again and again, 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>.) Hat tip to the <a href="http://postscript.communitycatalyst.org/?p=2234">Postscript blog</a>.

Three Years Later, A Congressional Investigation of the Deadly Adulterated Heparin

Slightly more than three years ago, we first posted about the case of the deadly adulterated heparin. (A case summary is appended to the e...

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Windows 7 Service Pack 1 "Glitches": Why Personal Computers are Problematic, and Perhaps Should Not Be Mission Critical Components in Hospitals

A technical note on computer unreliability, and a series of followup critical questions relative to health IT: I run Windows 7 Professional on one of my computers, a very unspecial 4-5 year old <a href="http://www.microcenter.com/">Micro Center</a> machine, the <a href="http://www.powerspec.com/systems/system_specs.phtml?selection=6001">PowerSpec 6001</a>, using conventional components. The machine was upgraded with 2 Gb RAM and an ATI Radeon 9600 series video card, to run the <a href="http://en.wikipedia.org/wiki/Windows_Aero">Aero</a> "eye candy." It has run satisfactorily since I installed Windows 7 Professional (32-bit version) on it last year. I am not a <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm">computer amateur</a>. [I do, however, admit to being a <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/medinformatic1/ham.htm">Radio Amateur</a> - Extra class - ed.] Further, I meticulously keep the machine current with Microsoft security patches, use Symantec anti-virus which I also keep updated, check my disk for errors, and only visit major well-known, nationally prominent websites using the machine. So yesterday, <a href="http://technet.microsoft.com/en-us/library/ff817622%28WS.10%29.aspx">Windows 7 Service Pack 1</a> appeared in my "Software updates" list from Microsoft, after being released to the general public. It was explained that this Service Pack improves performance, reliability and security [i.e., it is intended to update all the many, many bugs, unreliabilities and security holes of the operating system since its inception - ed.] I confirmed my machine met the specs for it, and allowed the computer to download and install Service Pack 1. That was my mistake. After installation, the machine could no longer reboot Windows. The flying color patches of the first screen appeared ... and then the machine suffered a hard reboot (going back to the BIOS-initiated memory checks and screens, etc.), as if I'd pressed the front panel hardware RESET button this machine has. An automated "wizard" that came up and tried to figure out why the machine would not restart failed to do so. I asked the machine, therefore, to roll back to the state it was in prior to the Service Pack 1 (SP1) "upgrade" via a "Restore Point", a feature Windows permits using the "system restore" capability. The SP1 installation automatically creates a Restore Point (image of the prior state of the OS) on the machine just before installing itself. The machine works again, but ... (and that is a big "but"): <ul><li>The Service Pack is not installed. Therefore I am not running the latest protections, and do not know what will happen in the future with respect to patches and upgrades. Maybe the Service Pack will get its own Service Pack at some point to fix it, so it can fix my computer; </li></ul><ul><li>The Service pack installation, without warning and rather rudely, erased my prior computer Restore Points of the past few weeks, leaving only the Restore Point it created just before inflicting itself on my machine. Just to thumb its nose at me, it also left two Restore Points from back in November, which would require me to then re-install a lot of software and updates at the very least. I cannot even try a Restore Point of, say, last week after other updates;</li></ul><ul><li>I attempted to view the system error logs to determine what caused the failed Service Pack Install. Surprise! The Event Viewer and Task Scheduler management consoles I use to review system operation no longer operated, instead producing this lovely, extremely explanatory message: "MMC cannot initialize the snap-in", followed by hexadecimal gibberish that any doctor or citizen can easily decipher:</li></ul> <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEipsrNjV6W0ounPrqZiWBK-To0gEljWXmtc6AGgXhgHy9AO8hoI5b1W0cOeDs_KFXhH4mMkEL02pVhp7fDGZIzJ17BdRymASYeIkadc4VSU4_BoHBEiyWHBa-TkM8yFpdYeLCisPp_-Y4BW/s1600/mmc.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5577303822912380578" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEipsrNjV6W0ounPrqZiWBK-To0gEljWXmtc6AGgXhgHy9AO8hoI5b1W0cOeDs_KFXhH4mMkEL02pVhp7fDGZIzJ17BdRymASYeIkadc4VSU4_BoHBEiyWHBa-TkM8yFpdYeLCisPp_-Y4BW/s320/mmc.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 320px; height: 224px;" /></a>Such explanatory error messages! "MMC cannot initialize the snap-in. The snap-in might not have been installed correctly. Name: Event viewer. CLSID: FX: {b05566ad-fe9c-4363-be05-7a4cbb7cb510}." Click to enlarge. </div> <ul><li>Attempts to look up the error on the Web produce gobs and gobs of amateurish "legible gibberish", indirection, misdirection, guesswork, and speculation, some of it from Microsoft itself;</li></ul><ul><li>To add insult to injury, typical of poor user interaction design, I could not copy-and-paste the error, but had to type it (partially, fortunately, thanks to Google); </li></ul><ul><li>Much of the material was in very broken English (where's those language translators promised to us for some 50 years now by computer scientists?)</li></ul><ul><li>My attempts at repairing the damage by running the command "SFC /scannow" (system file check) to check and repair critical windows files showed that the Service Pack "Upgrade" also corrupted a number of critical Windows system files - despite the "Restore Point" rollback. Great Scott! </li></ul><ul><li>SFC repaired the files and produced a log of gibberish that's thousands of pages long for me to ferret out what got damaged (ironically, just like the records from a few weeks of a relative's EMR-error-related hospitalization, at appx. 2,900 pages of legible gibberish); </li></ul><ul><li>The repair did not restore the missing functionality;</li></ul><ul><li>Attempts to reinstall supporting packages such as .Net framework also do not restore the functionality;</li></ul><ul><li>Attempts to reinstall the Service Pack produce the same results, a crash on initial restart after the installation and need to roll back, erasure of several Restore Points I manually created, along with re-corruption of the critical system files previously repaired by the SFC /scannow command. </li></ul><ul><li>I have no way of knowing what else is broken or may malfunction; </li></ul><ul><li>While not rigorous, reports on the web show a significant percentage of <a href="http://downloadsquad.switched.com/2011/02/23/ask-dls-how-did-your-windows-7-sp1-upgrade-go/">others having problems with the "Service Pack"</a> as well. Russian Roulette, anyone? </li></ul> <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEipL1D9biQcJq6e-TiLm6QnxoMKHg9o9_h4i864qw7g-V6kzjlzi8DkwmpWebiiAS3M0Xnw2cNWfTfvI3C_B5pnLDee6oRjtj7wzaKX8KI0iNyeKLDNMB4ir1xdNIVMD48t02E88FAtzjjf/s1600/russian-roulette.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5577305996290114098" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEipL1D9biQcJq6e-TiLm6QnxoMKHg9o9_h4i864qw7g-V6kzjlzi8DkwmpWebiiAS3M0Xnw2cNWfTfvI3C_B5pnLDee6oRjtj7wzaKX8KI0iNyeKLDNMB4ir1xdNIVMD48t02E88FAtzjjf/s320/russian-roulette.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 219px; height: 124px;" /></a>Russian Roulette, anyone? </div> All this was after many months of Microsoft "Beta testing" the Service Pack. (Perhaps it was really "Alpha testing?") Similar issues occurred with the former Microsoft OS, Windows XP (now in its third major service pack since its release in 2002, with patches still coming on an almost weekly basis). Fortunately, I have backup images of my entire disk, but the inconvenience and time wasted is quite irritating - and I will still not have the latest security patches after I roll back my machine to my latest disk image. <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjeSaa1WOoygz87TemZb4uPh1FuYD2Yi8yhOcNDLSH0_JQzFQ6fWuvaB8H6eGHxmDDFtWNkslzbtWNABRsXvr98W33cPpILBu6JoynOZUFt_VtKsJBcWhtc27kyIVqkpSznDWRpB_5Wi5NF/s1600/bang_head_here.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5577345249233565298" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjeSaa1WOoygz87TemZb4uPh1FuYD2Yi8yhOcNDLSH0_JQzFQ6fWuvaB8H6eGHxmDDFtWNkslzbtWNABRsXvr98W33cPpILBu6JoynOZUFt_VtKsJBcWhtc27kyIVqkpSznDWRpB_5Wi5NF/s320/bang_head_here.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 229px; height: 244px;" /></a> One should note that these "glitches" are just in the Operating System (OS) itself. Third-party applications (such as EMR and CPOE sytems, middleware, interfaces, etc.) suffer the same type of problems...for instance, the life-and-limb-threatening "glitches" that occurred at <a href="http://hcrenewal.blogspot.com/2010/08/huffington-post-investigative-fund-fda.html">Trinity Healthcare after an EMR "upgrade."</a> Further, OS "glitches" can cause unexpected application "glitches", and vice versa. Complexity on top of complexity... Note that machines running similar software are on the "servers" that are the heart of major enterprise systems such as EMR's and CPOE's, that communicate with enduser workstations. Now, several simple questions: <ul><li>Who knows what other "glitches" the Service Pack introduced to my machine, that will "bite me" (or patients) later?</li></ul><ul><li>Are these the machines we want our doctors and nurses to depend upon, since they increasingly regulate every medical transaction that occurs?</li></ul><ul><li>Has the software become too complex to be entirely reliable, maintainable and secure?</li></ul><ul><li>Does the average hospital have the staff to effectively deal with issues such as the above?</li></ul><ul><li>Do these "glitches" raise the risk and the cost - therefore reducing the ROI, already low (see <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">reading list</a>) - of experimental health IT to even more unsatisfactory levels?</li></ul> Finally: <ul><li>Would the average person tolerate such behavior from their car? In their aircraft? (Oops, the brakes don't work properly in 13.5% of cars after the parts upgrade, and that altimeter is simply crazy ...) </li></ul>-- SS Feb. 24 late night addendum: Deciding to play with this mayhem, and knowing I was going to be wasting a lot of time, I first backed up my deranged machine to an external disk (~ half an hour) to preserve my files. I then restored my machine from an external disk backup image to its condition in mid-Nov. 2010 [thinking perhaps something more recent caused the SP1 to fail]. That took another half an hour. I then attempted to install the SP1 again. That took another hour or more. Same results - machine crash after the "circling window panes" display. I let the "Startup Repair" wizard run. It failed with the following informative messages. In a superb example of poor user design, I had to jot the messages down on paper, as it made no offer to print them, or load them into a thumb drive, etc. - although it did offer to send the error messages to Microsoft, a neat trick as the software components to drive the computer's wireless network adapter were not loaded: <blockquote>Problem details - System Repair Problem signature: 1- 6.1.7600.16385 2- 6.1.7600.16385 3 - unknown 4 - 21201077 5- AutoFailure 6 - 3 7 - BadPatch OS version - 6.1.7600.2.0.0 Local ID - 1033256.1 Root cause - a patch is preventing the system from starting [no fooling - ed.] Repair Action System file integrity check and repair Result = Failed. Error code = 0xa</blockquote> Then for added fun, I started the machine up in 'Safe Mode' (using the F8 key at startup). It came up, but told me it was doing a System Restore due to the failure to configure the Service Pack. After about 20 minutes of frantic disk activity, the machine rebooted - and immediately crashed as before. I am rerunning the Startup Repair wizard again, asking it to restore my system, but I predict it will do so with the original remaining problems of non-functioning components that started this whole mess - if it works at all. This is all absurd. It is a massive waste of time, a result of poor programming, uninformative, cryptic error messages (what? computers don't have enough storage for useful error messages?), poor (nonexistent) documentation, inadequate attention to the user experience, condescension of the user, inability to report the problems back to HQ automatically due to lack of forethought about a compromised machine's ability to access the network, software unreliability, and probably a host of other issues I haven't thought of yet because I'm tired after all this fritter. Not to mention, it is potentially destructive of data to those who suffer this problem but did not keep backups. They warn you beforehand - but the installation agreement you "sign" is of the Ross Koppel/David Kreda "<a href="http://jama.ama-assn.org/content/301/12/1276.extract">hold the vendor harmless</a>" variety. This experience is a metaphor for the state of health IT (with "glitches", "workarounds", unexplained errors, etc.), and of the dangers of computer worship. -- SS Feb 25 addendum - further experimentation based on web comments about SP1, such as running a pre-SP1 readiness checking utility by Microsoft, emptying the /temp folders, renaming the "software distribution" folder, clean booting, etc. all produce the same result: crash of the machine on reboot. And there's no computer doctor to call for an appointment to fix the problem. -- SS

Windows 7 Service Pack 1 "Glitches": Why Personal Computers are Problematic, and Perhaps Should Not Be Mission Critical Components in Hospitals

A technical note on computer unreliability, and a series of followup critical questions relative to health IT: I run Windows 7 Professional ...

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Wendell Potter's "Deadly Spin"

We recently <a href="http://hcrenewal.blogspot.com/2011/02/health-care-corporate-disinformation.html">discussed how</a> Wendell Potter, author of <a href="http://wendellpotter.com/deadlyspin/">Deadly Spin</a>, has provided a chilling picture of health care corporate disinformation campaigns and the tactics used therein.  I finally had a chance to read the whole book, which should be read by anyone interested in concentration and abuse of power in health care. Let me summarize some of its main points. The Unholy History of Public Relations Mr Potter set "PR" in its historical context, and noted parallels among the modern deceptions he recounts and how the father of PR white-washed tobacco companies, and with the propaganda and disinformation used by 20th century totalitarian states to cement their rule. How Deceptive PR Changed the Course of Health Care As noted earlier, Mr Potter recounted how deceptive PR campaigns subverted the health care reform plans of US President Bill Clinton, reduced the impact of Michael Moore's movie, "Sicko," and helped to remodel the recent health care reform bill to reduce its threat to commercial health insurers.  He further noted how PR distracted public attention from the growing faults of a health care system based on commercial health insurance, and how practical and legal safeguards against abuses by insurance companies were eroded.  Making More by Providing Less Care Mr Potter catalogued the tactics insurance companies use to reduce care and increase revenue, such as rescision, elimination of coverage for groups with high costs, the use of high deductibles disguised as "consumer choice," etc. The Tactics of Stealth Health Policy Advocacy As noted in our earlier post, Mr Potter described "charm offensives;" the deliberate creation of distractions, including the planting of memes for short-term goals that went on to have long-term adverse effects; fear mongering; the use of front groups, including "astroturf," (faux disease advocacy and/or grass roots organizations), public policy advocacy groups, and tame (and conflicted) scientific/professional groups; and intelligence gathering.  He provided some practical advice for detecting such tactics. For example, be very suspicious of policy advocacy by groups with no apparent address or an address identical to that of a PR firm, or with anonymous leaders and/or anonymous financial backing. Why Good People Do Bad Things Mr Potter provides some insight into the rationalization and compartmentalization that allow apparently upstanding people to peddle deceptive PR. Memes Metastasizing Mr Potter noted how memes are created to fit short term goals.  My observation is that these memes may then acquire lives of their own that then may have long term adverse effects.  Think about "the best health care system in the world," fears of "government bureaucrats," but not corporate bureaucrats running health care, to what the label "junk science" may be applied, and where fears of the "nanny state" came from. Summary Mr Potter seems to be the only known example of a defector from the ranks of the leadership of modern corporate health care prompted by conscience.  Anyone who finds this blog useful should find his book at least equally useful.  (To those from outside the US:  although most of Mr Potter's experience was with the US system, the role of PR in society here is likely not that different from its role in other developed countries.) I hope to return to some of the issues he raises in more detail from time to time. Bravo, Wendell Potter, for returning from the "dark side."  Note that I have added Mr Potter's blog to our blog-roll.

Wendell Potter's "Deadly Spin"

We recently discussed how Wendell Potter, author of Deadly Spin , has provided a chilling picture of health care corporate disinformation c...

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The face of postmodern medicine: lying

The face of postmodern medicine, where what is moral is context-sensitive, and outright clinical fabrications about "illness" (a.k.a lies) are fair game. I don't remember anything like this in the Oath of Hippocrates: <blockquote><a href="http://en.wikipedia.org/wiki/Postmodernism">Postmodernism</a> is a movement away from the viewpoint of modernism. More specifically it is a tendency in contemporary culture characterized by the problem of objective truth and inherent suspicion towards global cultural narrative or meta-narrative. It involves the belief that many, if not all, apparent realities are only social constructs, as they are subject to change inherent to time and place.</blockquote> <div style="text-align: center;"><a href="http://www.youtube.com/watch?feature=player_embedded&v=ipqEzJpeqis"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5575608602360929682" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgtWvVMZEaxwAR2KTxSMo5Kicpa_imLxaNLSTDIF_2FwgESWDcBxps3Jw83eS-2VUet5MJlWDIoUoMFHJH_adK8x0R0Ef8OP4ImU_Cqg-4p4FHn-j4lHh0poFlOClU_ddCs2syHQ-cF0HF8/s320/dr_lie.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 253px; height: 141px;" /></a>Lying with a smile. This alleged physician seems to have no qualms with lying, in writing medical "out sick notes" for political purposes. Click to play video. </div> If this person is truly a physician, I cannot condone such behavior, that is, lying about clinical matters to suit one's own agenda, whatever that agenda might be. I saw too much of that when I worked for the regional transit authority's medical department in a large city. Community physicians lied about injuries to support continued, fraudulent "therapy" (from which the physician - and the involved attorney - profited), and to support continued receipt of worker's compensation by the employees. Example: months of treatment for back "strain and sprain and myofasciitis" from a 30,000-lb bus (excluding passengers!) being rear ended by a 3,000 pound car at minor fender-bender speeds. This was not uncommon. Defying known laws of physics, the force from the impact somehow traveled the considerable length of the bus, took a 90 degree turn up into the driver's air spring-cushioned seat, and strained their back. Many of these folks failed the typical exams used to detect fakery. Example: elevating their legs to 90 degrees while sitting to remove their shoes, at which time they'd have no complaints, but then screaming loudly of back pain when in the same relative position, but supine. <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiL6fHFFB84B4EBl4pEsWiUQ2ngnHvsl3KQDEyU0WNlPvEWk7ptzm0BZo2YuRB_snj0jkVk6OAprBm9Eje9RBWS9-cMRT0RP_ZUyXcYKZIc4IJuaURtnGLeejXb_OVNHR6xP0EvD87qFJRg/s1600/backpain.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5575619449541333218" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiL6fHFFB84B4EBl4pEsWiUQ2ngnHvsl3KQDEyU0WNlPvEWk7ptzm0BZo2YuRB_snj0jkVk6OAprBm9Eje9RBWS9-cMRT0RP_ZUyXcYKZIc4IJuaURtnGLeejXb_OVNHR6xP0EvD87qFJRg/s320/backpain.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 302px; height: 262px;" /></a>Click to enlarge. A maneuver to detect exaggerated response for back pain. Somehow, the dishonest "injury clinic" docs certifying these folks as "disabled" never seemed to perform this test. All in the patient's best interest, of course... </div> Often, passengers on the bus would go to the same type of doctors with the same claims of injury. Sometimes as well, <a href="http://books.google.com/books?id=NjjnfWxLE8sC&pg=PA29&lpg=PA29&dq=septa+injury+fraud&source=bl&ots=JEYkYJGk1T&sig=tUM4jQiZHLLC5athUBLN7STuqB4&hl=en&ei=opdgTY7xIYKclgfg0LCwDA&sa=X&oi=book_result&ct=result&resnum=3&ved=0CCQQ6AEwAjgK#v=onepage&q=septa%20injury%20fraud&f=false">there would be more people claiming injury than people on the vehicle </a>known as "ghostriders" (as opposed to ghostwriters, a frequent topic on this blog). The dishonest community physicians would certify them "injured" nonetheless. And you wonder why your bus fare is several dollars... Ultimately, physician dishonesty-on-an-agenda leads to a <a href="http://en.wikipedia.org/wiki/Tuskegee_syphilis_experiment">medical slippery slope</a> that, as history proves, is not a path the profession wants to emulate. One wonders what other lies physicians with attitudes like this proffer. <a href="http://hcrenewal.blogspot.com/2011/02/does-emr-facilitated-upcoding-formely_15.html">Lies in their billing</a>, perhaps, to "<a href="http://en.wikipedia.org/wiki/The_Man">stick it to the Man</a>?" -- SS Addendum Feb. 27, 2011: Along comes this story at AOL news: <a href="http://www.aolnews.com/2011/02/27/horrific-us-medical-experiments-come-to-light/">"Horrific US Medical Experiments Come to Light</a>." It seems the medical slippery slopes of the not-too-distant-past, as recent as the 1960's, were more slippery than most knew. -- SS

The face of postmodern medicine: lying

The face of postmodern medicine, where what is moral is context-sensitive, and outright clinical fabrications about "illness" (a.k...

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EHR as Molestation Candidate Selector: What was this Resident looking for in the EHR before "examining" female patients?

As I was the Director of Clinical Informatics/CMIO (Chief Medical Informatics Officer) at Christiana Care Health System in Delaware back in the mid to late 1990's, and was the physician-architect of their EHR systems then, I find this story particularly disturbing: <blockquote><a href="http://www.myfoxphilly.com/dpp/news/local_news/Christiana_Hospital_Sex_Assault_Charges_021811">First-Year Resident Accused Of Fondling 6 Patients</a> FoxPhilly.com, Feb. 18, 2011 Warrants Issued, Police Searching For Suspect NEWARK, Del. - Delaware State Police are trying to find a former first-year resident at Christiana Hospital who they have identified as a suspect in alleged sexual contact with six patients. According to state police, [the former Medical Resident] has been charged with six counts each of third-degree unlawful sexual contact and abuse, mistreatment or neglect of a patient or resident of a facility. ... The incidents were reported between Oct. 1 and Nov. 15 at the hospital in Newark. <div class="fontStyle4"><div class="story last"> The female patients were between the ages of 20 and 32, police said. Authorities interviewed victims and hospital staff, reviewed patient charts, and audited access to computer records, which led to the identification of [the Resident] as a suspect, according to state police. ... State police said investigators found [the Resident] accessed the computerized hospital records of the six victims prior to the incidents, performed "physical exams" on the victims and failed to provide clinical documentation of the examinations in the victims' hospital charts. Scheduling records also indicated that [the Resident] was working when the incidents occurred. ... In three of the incidents, it was determined that the victims were identified as "non- teaching" patients for whom [the Resident] had no direct patient care responsibilities and had no authority to conduct physical exams or access their hospital records. </div></div></blockquote><div class="fontStyle4"><div class="story last"> Also noted in another account of the story <a href="http://www.delawareonline.com/article/20110218/NEWS01/110218012/Former-resident-sought-in-Christiana-Hospital-assaults?odyssey=tab%7Cmostpopular%7Ctext%7CFRONTPAGE">in the Delaware News Journal</a> (a newspaper) is this:<blockquote>... State police initially released details about three of the assaults on Nov. 12 and said at the time that they were investigating why hospital officials did not report the incidents to police until after the third assault, some two weeks after the first victim reported the incident to hospital staff. During the subsequent police investigation, three additional women contacted state police to report similar incidents.</blockquote>One could ask, then, why the Medical Resident was able to access these medical records, and why the unauthorized accesses apparently took some time to discover by "investigators" (presumably law enforcement officers), only after complaints were made.It is also reasonable to assume this Resident did not abuse the first woman's records he found in a search. There was likely a larger series of unauthorized chart accesses as he searched the EMR system. In other words, I don't think he was peeking at an individual record, and then going in to a room to do his nasty work, one at a time. He was likely looking at a number of potential "candidates" before each incident; i.e., he was likely "trolling around" for potential victims. It would be interesting to see the electronic "footprint" he left. I had horrifying firsthand experience with abuse of electronic medical information in an earlier role in the public sector. Specifically, I had observed the events in John Doe vs. the Southeastern Pennsylvania Transportation Authority (<a style="font-weight: bold;" href="http://www.aegis.com/law/fedapp/3d/1995/1995c03329.html">link</a>). In this situation a gay co-worker, the SEPTA Employee Assistance Program liaison John Eakes (now deceased of AIDS) with whom I had worked extensively in the SEPTA Medical Department, was discriminated against by administration after peeks at his prescription records. His medications included those used in treating HIV-positive patients:<blockquote>...[After the disclosure to SEPTA Chief Administrative Officer (and Deputy General Manager - ed.) Judith Pierce, Doe - a.k.a. Eakes] testified that he felt as though he were being treated differently. A proposal he had made for an in-house employee assistance program met with scant interest; he felt that this was because of his HIV condition. In addition, an administrator who reported to Pierce did not call on Doe to assist in the same way that he had called on Doe earlier. Doe testified that he felt as though there was less social chitchat, co-workers ate less of the baked goods he brought to the office to share, and that his work space seemed more lonely than before. He also became fearful of Pierce, who never told Doe that she knew of his illness. Doe alleges that he became depressed and requested a prescription for Zoloft, an antidepressant, from his physician. Later, another antidepressant called Elavil was added to the medications Doe was taking. </blockquote>John Eakes was a good and conscientious employee and deserved none of this, in these relatively early years of HIV+ intolerance. Therefore, when I was CMIO at Christiana Care Health System just a few years later, and as Chair of the committee on compliance with the then-new Health Insurance Portability and Accountability Act of 1996 (HIPAA), I recommended strongly that chart audits for unauthorized access be performed on a regular basis by a dedicated person or team, and rapid action taken if it occurred. (Then again, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story">my counsel on healthcare IT</a> was <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU">not infrequently ignored</a>.)Multiple accesses by a resident (trainee) to EHR records of non-teaching (private) patients should have sent up a very large and immediate cybernetic red flag.<a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi-Mgv1rMyxIAyhZglmpRG_QL8-Tf3KEGDzHCndqG4Yu0YGvvh2GNip5i6Ba1YhNXUnUOLuC9DVAntiYWfmmb-LRAwfI4EDGWc_WHqjroFXedkqYDQCpe7_lROX2fZjVmBQPPhXI6VxRKnI/s1600/Red_Flag_Logo_med.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5578083552944692690" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEi-Mgv1rMyxIAyhZglmpRG_QL8-Tf3KEGDzHCndqG4Yu0YGvvh2GNip5i6Ba1YhNXUnUOLuC9DVAntiYWfmmb-LRAwfI4EDGWc_WHqjroFXedkqYDQCpe7_lROX2fZjVmBQPPhXI6VxRKnI/s320/Red_Flag_Logo_med.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 134px; height: 136px;" /></a>Ding! Ding! Ding! Warning! Unauthorized accesses detected... I am also concerned about the characteristics this former trainee was seeking in reviewing the EHR. A history of gynecological or breast disease to serve as a ploy for performing an intrusive exam? Was he looking for a psychiatric history? A history of prior sexual abuse? While the EHR proved helpful in post hoc forensics, are we now seeing another potential abuse of EHR's for the identification of patients who may be preyed upon by the disturbed? It would be helpful to know if there was a common medical theme regarding the patients affected in this rather shocking affair. -- SS Feb. 19 Addendum: This affair reminds me of a saying that became news in the election of President Barack Obama: "The Chickens Have Come Home To Roost" - Rev. Jeremiah Wright Feb. 21 Addendum: It appears that the corporate PR folks are monitoring the airwaves in planning their responses to this scandal. From the blog viewing logs: <blockquote>IP Address 167.112.160.# (Christiana Care Health Services) ISP Christiana Care Health Services Time of Visit Feb 21 2011 9:36:32 am Last Page View Feb 21 2011 9:42:03 am Visit Length 5 minutes 31 seconds Page Views 5 Referring URL <a style="font-weight: bold;" href="http://us.cisionpoint.com/NewsItemDetail.aspx?id=1671771040">http://us.cisionpoint.com/NewsItemDetail.aspx?id=1671771040</a> Visit Entry Page <a href="http://hcrenewal.blogspot.com/2011/02/what-was-this-medical-resident-looking.html">http://hcrenewal.blogspot.com/2011/02/what-was-this-medical-resident-looking.html</a> Visit Exit Page <a href="http://hcrenewal.blogspot.com/2011/02/what-was-this-medical-resident-looking.html">http://hcrenewal.blogspot.com/2011/02/what-was-this-medical-resident-looking.html</a></blockquote> On the "Cisionpoint" company, <a href="http://us.cisionpoint.com/">us.cisionpoint.com</a>, the "referring" URL that led to this post: <blockquote style="margin-right: 0px;" dir="ltr"> CisionPoint brings together - in one integrated customized dashboard - the on-demand tools you need to create, execute and evaluate superior campaigns from start to finish.Log in to plan your campaign, connect with the media directly, monitor news coverage and analyze campaign results. </blockquote> It will be interesting to see how this horrifying episode is "managed" by the corporate spin doctors. -- SS Feb. 21 addendum #2: Here is a message posted by the organization: <blockquote>Message from the chief operating officer Posted today Christiana Care is steadfast in our commitment to the safety and well-being of our patients, employees and all visitors to our campuses. The Delaware State Police have issued a press release identifying a suspect in the case of inappropriate touching first reported late last year. The suspect is a former first year medical resident at Christiana Care. The prompt and thorough work of our Department of Public Safety when the allegations first surfaced, and information we shared with the State Police from our robust health information technology system, was instrumental to the process. We quickly identified the medical resident as a person of interest, and took swift action to prevent any further patient contact. As a result of our preliminary investigation, he was suspended and upon further investigation dismissed from employment. Our rapid response when the allegations were first reported revealed no systemic issues contributed to this incident. As an organization guided by learning, we are continuing a thorough review of best practices in hospital security to determine if there are any new security measures we should adopt. [Hopefully in the intervening years since I was CMIO, they've become even more of a learning organization compared to <a style="font-style: italic; font-weight: bold;" href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU">here</a>, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cultures%20of%20mismanagement%20toxic%20to%20healthcare%20quality">here</a> and <a style="font-style: italic; font-weight: bold;" href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story">here</a>, where under the prior "C" level leadership they learned so much from me and made me feel so at home, I felt compelled to leave to maintain my sanity - ed.] We remind and encourage all patients and family to always ask health care providers to identify themselves, explain why they are there to see the patient, and explain the care provided to them. All Christiana Care employees are required to prominently display their identification badges. [One wonders if they now permit PhD holders to use that credential on the badge, not permitted when I was there - ed.] We deeply regret the alleged incidents and our concern for the affected patients is shared throughout our health system. Gary Ferguson Chief Operating Officer </blockquote> <div>As I knew Mr. Ferguson in a prior role, and as he is a good person, I with some regret point out that this appears to be corporate spin control. A truly "robust" HIT security system, in my opinion, would have flagged the perpetrator after the first victim. It might even have prevented the molestation if there was a time delay between when he, as a trainee, trolled for a victim by viewing the records of a private patient, and then saw the patient, without some medical emergency that could have justified the records breach. <blockquote>Merriam-Webster dictionary <a style="font-weight: bold;" href="http://www.merriam-webster.com/dictionary/robust">ro·bust</a> adj \rō-ˈbəst, ˈrō-(ˌ)bəst\ a : having or exhibiting strength or vigorous health b : having or showing vigor, strength, or firmness [a robust debate] [a robust faith] c : strongly formed or constructed : sturdy [a robust plastic] d : capable of performing without failure under a wide range of conditions [robust software]<robust> </robust></blockquote> This "robust" system, after all, is a system critical to human life and well-being, not an inventory system of medical data. Let an unauthorized person access, say, government intelligence files, and see how far that flies... (Notwithstanding the Wikileaks affair, where the <a href="http://en.wikipedia.org/wiki/Bradley_Manning">low-level person</a> who accessed the diplomatic files did have authorization to access the servers, through managerial complacency.) </div>-- SS Feb. 26 Addendum: This story was picked up by the Newark Post, the local newspaper in Newark, Delaware, where Christiana Hospital is located. <a style="font-weight: bold;" href="http://www.newarkpostonline.com/articles/2011/02/24/news/doc4d65787e4758e501313769.txt"></a><blockquote><a style="font-weight: bold;" href="http://www.newarkpostonline.com/articles/2011/02/24/news/doc4d65787e4758e501313769.txt">Questions raised about access to hospital medical records</a> By Doug Rainey, Newark Post Published: Thursday, February 24, 2011</blockquote> -- SS </div></div>

EHR as Molestation Candidate Selector: What was this Resident looking for in the EHR before "examining" female patients?

As I was the Director of Clinical Informatics/CMIO (Chief Medical Informatics Officer) at Christiana Care Health System in Delaware back in ...

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Pharmacia, or Maybe Pfizer Settles, Only Eight Years Later

Didn't somebody say "justice delayed is justice denied?"*  Here is a story for a Friday afternoon, via a press release from the New York state Attorney General's office, <a href="http://www.bloomberg.com/apps/news?pid=conewsstory&tkr=PFE:US&sid=atVb2W5YOIaE">per Bloomberg</a>: <blockquote>Attorney General Eric T. Schneiderman today announced a multimillion dollar settlement with a pharmaceutical company that inflated the cost of drugs sold to state health programs. The company, Pharmacia Corporation, has paid $2.5 million to the New York Medicaid program and to the Elderly Pharmaceutical Insurance Coverage Program (EPIC), and also to cover the costs of the investigation.</blockquote> Here is more information about the lawsuit: <blockquote>The lawsuit, filed in 2003, charged that Pharmacia failed to report real and accurate prices, and did not take into account discounts, rebates, chargebacks and other price concessions to their wholesalers. As a result, New York's Medicaid Program and the EPIC program paid more for certain drugs manufactured by Pharmacia than those state programs should have. </blockquote> This is an unusual entrant into our march of legal settlements. As noted above, this lawsuit took eight years to settle. The entity that made the settlement, Pharmacia, is actually long gone as an independent company. It merged into Pfizer in 2003 (see <a href="http://www.pfizer.com/about/history/pfizer_pharmacia.jsp">this</a>). Despite the eight years of waiting, the settlement is extremely paltry compared to the size of the company to which the settlement now applies. According to Google Finance, in 2010, Pfizer's annual revenues were more than $67 billion. This settlement adds in a small way to a series of settlements Pfizer has recently made.  Pfizer paid a $2.3 billion settlement in 2009 (see post <a href="http://hcrenewal.blogspot.com/2009/09/pfour-legal-settlements-for-pfizer-why.html">here</a>), and three other major settlements from then to early 2010 (see post <a href="http://hcrenewal.blogspot.com/2010/03/settlement-and-conviction-round-up.html">here</a>).  The company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post <a href="http://hcrenewal.blogspot.com/2010/12/drug-companies-are-now-no-1-when-it.html">here</a>).  For other discussions of Pfizer on Health Care Renewal, look <a href="http://hcrenewal.blogspot.com/search/label/Pfizer">here</a>.  The New York Attorney General's press release claimed, "These are hard financial times for our state, and my office will do its part by uncovering every dishonestly claimed dollar, and holding those who take advantage of New York accountable."  Begging his pardon, but could he really have been serious that nicking Pfizer for $2.5 million eight years after the lawsuit was filed is really holding this giant company accountable?  Will this settlement make the company any more accountable than all those that came before, some almost one thousand times bigger?  Meanwhile, as is usually the case in these stories about the march of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements </a>in health care, no person who authorized, directed or implemented the questionable activity apparently paid any penalty or suffered any sort of negative consequences. This week, Matt Taibi asked "<a href="http://www.rollingstone.com/politics/news/why-isnt-wall-street-in-jail-20110216">why isn't Wall Street in jail?"</a> in the title of his most recent Rolling Stone article.  I should also ask, why aren't some leaders of pharmaceutical, device, biotechnology, and managed care corporations in jail?  Just as the leaders of big financial service firms seem to be completely unaccountable for the havoc they created in the global economy, and despite bluster by various government officials, the leaders of big health care corporations seem to be completely unaccountable for the unethical behavior of their companies that continue to inflate the health care bubble. So for the nth time I will repeat:  we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich. Meanwhile, the continued unwillingness of government leaders to take on corporate leaders suggests how corporatist the US has become. Government for the corporations, by the corporations, and of the corporations, bodes no good for the people whose rights are increasingly being displaced. Mr Taibi encapsulated the problem in a more colorful way, and I will end with his version, somewhat edited for this family publication: <blockquote>Over drinks at a bar on a dreary, snowy night in Washington this past month, a former Senate investigator laughed as he polished off his beer. 'Everything's f***ed up, and nobody goes to jail,' he said. 'That's your whole story right there. Hell, you don't even have to write the rest of it. Just write that.'</blockquote> * - the quote has been attributed to William Gladstone in a 1868 speech. but may be older than that (link <a href="http://freakonomics.blogs.nytimes.com/2010/06/17/quotes-uncovered-justice-delayed/">here</a>)

Pharmacia, or Maybe Pfizer Settles, Only Eight Years Later

Didn't somebody say "justice delayed is justice denied?"* Here is a story for a Friday afternoon, via a press release from th...

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After Manufacturing Problems, Genzyme CEO's Golden Parachute Means "Failure = Success"

In late 2009, I <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> I asked why a company that could afford to make its CEO very rich could not afford to adequately maintain its manufacturing facilities. In May, 2010, I <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.  And in August, 2010, I <a href="http://hcrenewal.blogspot.com/2010/08/golden-parachute-for-making.html">posted</a> about how this series of management missteps could lead to the company's CEO becoming even richer because they lead to a declining stock price, which increased the likely that the company would be bought out, which could trigger the CEO's golden parachute.  I suggested then that were this to happen, it would be a gross example of 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. Now it  looks like this will happen.  Yesterday, the Boston Globe <a href="http://www.boston.com/business/healthcare/articles/2011/02/16/genzyme_agrees_to_201b_sale_to_drug_giant">reported</a>: <blockquote>Ggenzyme Corp., the largest biotechnology company in Massachusetts and one of the industry’s historic pioneers, has struck a definitive agreement to be bought by French pharmaceutical giant Sanofi-Aventis SA, in a deal valued at about $20.1 billion.</blockquote> As a result of this deal, <blockquote>Genzyme’s high-profile president and chief executive, Henri A. Termeer, who has run the company for 28 years, will resign following the close of the transaction. But he will advise Sanofi on integrating the two companies. Termeer built the company into a global operation with 10,000 employees worldwide and a business model that has been the envy of the biotechnology industry. He turns 65 on Feb. 28. Termeer, though fiercely proud of Genzyme’s independence, stands to make more than $23 million when the sale is completed, according to a 'change of control' clause in his employment contract. In addition, as a major Genzyme shareholder, he would be in a position to cash out shares that last year were worth more than $275 million.</blockquote> That and several other articles s noted that it was Genzyme's manufacturing problems that lead to the buy-out: <blockquote>the string of events that made Genzyme vulnerable to a takeover began in the summer of 2009 when workers discovered viral contamination at Genzyme’s Allston Landing plant overlooking the Charles River. Genzyme was forced to temporarily shut down and clean up the plant and ration shipments of its best-selling Cerezyme and Fabrazyme drugs, both of which treat enzyme deficiencies. The events created an opening for competitors such as Shire and Israel’s Protalix Biotherapeutics and sent Genzyme’s stock tumbling on the Nasdaq. The dip in Genzyme’s share price drew activist investors, including Carl C. Icahn of New York and Ralph Whitworth of San Diego, who accumulated shares they hoped to sell at a rich premium. They pressured management to take steps to boost shareholder value, including a stock buyout and the elimination of 1,000 jobs worldwide. Ultimately, the company gave Whitworth a seat on its board, and, after Icahn threatened to unseat Genzyme directors in a proxy battle, it granted two seats to his associates. In many ways, industry watchers said, an acquisition became inevitable once Genzyme stumbled at its Allston plant.</blockquote> A Bloomberg <a href="http://www.bloomberg.com/news/2011-02-16/genzyme-s-termeer-may-follow-health-care-ceo-path-to-private-equity-firms.html">article</a> noted that this sequence of events would lead to <blockquote>The departure package [which] makes him 'one of the biggest all- time winners in biotech,' said [University of Michigan business professor Erik] Gordon, who has studied the pharmaceutical industry for three decades. </blockquote> Our criticism of the Genzyme CEO's potential for reaping hugely perverse incentives was paralleled by Jim Edwards' <a href="http://www.bnet.com/blog/drug-business/genzyme-ceo-earns-300m-for-running-company-into-the-ground/7447">critique</a> of what actually happened: <blockquote>Here’s how crazy CEO incentive compensation is: Genzyme (GENZ) CEO Henri Termeer walked away from his company with a payout that may be worth $300 million yesterday when Sanofi-Aventis (SNY) acquired his company. But the only reason Genzyme was acquired — triggering Termeer’s gargantuan change-of-control package — is because Termeer nearly ran his company into the ground, making his stock cheap enough for Sanofi to buy. In other words, failure = success when it comes to change-of-control packages for CEOs.</blockquote> So let me just repeat my conclusion from last August: 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.

After Manufacturing Problems, Genzyme CEO's Golden Parachute Means "Failure = Success"

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

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