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Prosecuting Doctors for Importing IUDs from Canada, but Still No Penalties for Selling Adulterated Heparin from China

Here in Rhode Island, the big health care story recently was the use of unapproved intra-uterine devices (IUDs) by some local obstetrician-gynecologists (OB-GYNs).  The first nuanced summary of the story which just appeared <a href="http://www.projo.com/news/content/IUDS_07-18-10_RDJ7DC7_v22.14cd6b6.html">in the Providence Journal</a>, written by Felice Freyer, suggested how the consequences of possible misconduct in health care depend on the clout of those involved. The Unapproved IUDs Here are the main points. The issue that caused so much local controversy was the use of unapproved IUDs: <blockquote>Ten Rhode Island medical groups with 28 doctors told the Health Department that they bought IUDs, a form of birth control, from a foreign source, at prices about half what they had to pay for IUDs approved for use in the United States. Many had stopped using the unapproved devices long before the Health Department began its investigation in June.</blockquote> Here is what we know about the actual devices they implanted: <blockquote>An IUD is a T-shaped device that can fit in the palm of a woman’s hand. To prevent pregnancy, doctors insert it into the uterus, where it can stay for years. There are two types available in the United States: the ParaGard copper IUD and the Mirena hormonal IUD. Mirena, the more costly and more popular brand, has a coating of a progesterone-like drug that reduces heavy menstrual bleeding. </blockquote>Unapproved IUDs Made by an American Company in Finland and Sold in Canada Most of the "unapproved devices" the doctors were using were apparently made in Finland by an American company. <blockquote>In most cases, the doctors were using Mirena, which is made at a factory in Finland by an American company, Bayer Healthcare Pharmaceuticals. Only when it comes through approved channels can doctors and patients be assured that a product meets FDA standards. But it is unclear whether Bayer –– or anyone –– makes a version of Mirena that does not meet those standards. </blockquote>The doctors imported the devices from far-away, exotic Canada. <blockquote>Most of the devices apparently came from Canada, where the government negotiates with drug and device makers to keep prices low.</blockquote> There is no reason to suspect the devices were counterfeit, or defective. <blockquote>'If they’re really from Canada and from a reputable pharmacy, it should be exactly the same thing [as the FDA-approved version],' said Sheryl Ruzek, a retired public health professor at Temple University and vice chair of the board of the ECRI Institute, a nonprofit organization that evaluates medical procedures and products. 'My hunch is the patients were not harmed,' she said. </blockquote>Potential Negative Consequences for the Physicians However, the RI physicians are in big trouble for importing them: <blockquote>In Rhode Island, the state boards that regulate physicians, nurses and nurse-midwives are investigating all those involved. If any are found guilty of unprofessional conduct, they could face disciplinary action such as a reprimand or license suspension. The state attorney general’s office has a Medicaid fraud unit, but declined to comment. The U.S. Attorney also had no comment. </blockquote>US doctors in other states have also been importing IUDs, and also are in big trouble: <blockquote>So many doctors were importing IUDs or considering doing so that the American College of Obstetricians and Gynecologists recently took an official stand, issuing an advisory opposing the use of imported devices. In 2006, the California Department of Health found that eight doctors had used imported IUDs in some 850 women. In October 2009, an Arkansas doctor was indicted by a federal grand jury for using non-FDA-approved versions of Mirena. He was charged with violation of the Food, Drug & Cosmetic Act, health-care fraud (for allegedly billing Medicaid for the unapproved devices) and money-laundering (for the way he allegedly handled Medicaid reimbursements). The doctor, Kelly Dean Shrum, has not yet come to trial, but potential penalties include fines and imprisonment. </blockquote> Summary, and the Contrast with the Case of the Adulterated, Fatal Heparin So to summarize, doctors who imported IUDs from Canada that appeared to be identical to those sold with FDA approval in the US, and were made in Finland by an American company at the same factory in which the US approved IUDs were made have gotten into major trouble with state and federal authorities. There is no clear evidence that the IUDs caused any harm to patients. I am not defending the doctors' actions. However, contrast the treatment they are likely to receive with another case we have frequently discussed. We last blogged about the case of Baxter International's adulterated heparin <a href="http://hcrenewal.blogspot.com/2010/05/more-questions-no-answers-about-case-of.html">here</a>.  In summary, Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China.  That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label.  The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small "workshops" operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA.  The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many patients who received got seriously ill or died.  While there have been investigations of how the adulteration adversely affected patients, to date, there have been no publicly reported investigations of how the OSCS got into the heparin, and who should have been responsible for overseeing the purity and safety of the product.  Despite the facts that clearly patients died from receiving this adulterated drug, no individual has yet suffered any negative consequence for what amounted to poisoning of patients with a brand-name but adulterated pharmaceutical product. Yet everyone from state health departments to the federal authorities have jumped into the case of the unapproved IUDs imported, but from Canada, and apparently identical to the IUDs sold in the US.  There is, at least so far, no evidence that the IUDs were defective or dangerous, and no evidence they have harmed patients.  One doctor has been prosecuted for violating the Food, Drug and Cosmetic Act, and for health care fraud and money-laundering.  No one working for Baxter International (or for the identified organizations within its supply chain) has been prosecuted for anything. What the...?   I do not object to discipline and prosecution of individual doctors who appear to have broken the law.  But why are we so vigorously pursuing individual doctors for an apparently technical violation of laws that did patients no apparent harm, when we are not pursuing health care corporate executives for selling adulterated drugs that likely killed patients?  F Scott Fitzergald wrote that the "very rich are different from you and me," and it appears that very rich health care leaders have impunity when it comes to conduct that let patients be harmed and die.  Real health care reform would make top health care leaders as accountable as we now make individual doctors.

Prosecuting Doctors for Importing IUDs from Canada, but Still No Penalties for Selling Adulterated Heparin from China

Here in Rhode Island, the big health care story recently was the use of unapproved intra-uterine devices (IUDs) by some local obstetrician-g...

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The Avandia Spin Cycle Continues Even After the FDA Safety Hearings

We have posted multiple times about Avandia (rosiglitazone), GlaxoSmithKline's star-crossed glucose-lowering drug.  While Avandia has received considerable media coverage, we focused on two questions: 1 - what are the benefits and harms of rosiglitazone as a treatment of type 2 diabetes, and therefore for which patients under what circumstances should this drug be used? 2 - what barriers have prevented physicians and patients from getting the best possible answer to the first question, and what can be done about them?  (See recent post <a href="http://hcrenewal.blogspot.com/2010/02/bring-back-dsi-avandia-case-as-spy.html">here</a>.)  In particular, the Avandia case has illustrated how those with vested interests in the success of a health care product have done their best to obscure information that might threaten its success, even when doing so obscures the information that physicians and patients need to make the best possible decisions.  At one point, (in 2007, no less) we called this the "<a href="http://hcrenewal.blogspot.com/2007/06/avandia-spin-cycle-continues.html">Avandia spin cycle</a>." Avandia once again has been in the news after the US Food and Drug Administration's hearings on the safety of the drug.  These hearings were so well covered in the media that a lengthy summary would be superfluous.  However, their main points demonstrated the persistence of the Avandia spin cycle: - An FDA reviewer felt that "the company's misreadings of the ... Record trial ... were so profound, he concluded, that they 'suggest serious flaws with trial conduct.'" (per Gardiner Harris <a href="http://www.nytimes.com/2010/07/10/health/10diabetes.html">writing</a> in the New York Times) -A former FDA reviewer "withheld from regulators a study showing its Avandia diabetes drug may cause heart attacks." (<a href="http://www.bloomberg.com/news/2010-07-09/glaxo-withheld-avandia-study-former-fda-manager-said-to-testify-in-suit.html">per Bloomberg News</a>) - GlaxoSmithKline's forerunner SmithKline Beecham "secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda."  However, "the study also provided clear signs that it [Avandia] was riskier to the heart.  But instead of publishing the results, the company spent the next 11 years trying to cover them up." (per Gardiner Harris <a href="http://www.nytimes.com/2010/07/13/health/policy/13avandia.html">writing</a> in the New York Times. - "Government experts and a panel of medical advisers repeatedly voiced skepticism on Tuesday about the trustworthiness of GlaxoSmithKline, which makes the controversial diabetes drug Avandia." (per Gardiner Harris again <a href="http://www.nytimes.com/2010/07/14/health/policy/14diabetes.html">writing</a> in the New York Times.) So the Avandia saga has brought to the front pages the concerns we have had with <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression</a> and <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> of clinical research, especially when pursued by health care organizations with vested interests in the results of specific research projects coming out a certain way, and how they have been enabled by those with <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a>.  Doctors thus should be worried whether those of us who try to practice evidence-based medicine have been fooled into practicing <a href="http://hcrenewal.blogspot.com/search/label/pseudo-evidence%20based%20medicine">pseudo-evidence-based-medicine</a>. Those commenting on the story focused on the need for transparency when clinical research is funded and run by the corporations whose products are being evaluated. -  "GlaxoSmithKline, the maker of Avandia, can't be trusted to report adverse clinical results fairly.  The company must be watched like a hawk as additional trials that it sponsors go forward."  (<a href="http://www.nytimes.com/2010/07/15/opinion/15thu1.html">NY Times editorial</a>) -  "What America should demand in return for ... [generous patent] protection is that the FDA be able to make an honest evaluation of the efficacy of drugs.  When drug companies make this impossible by suppressing test results, not only do they violate their fundamental obligation of honesty with the public, their customers and their regulator, but they also break the bargain they have struck in return for the protection of their intellectual capital."  (Former NY Attorney General Eliot Spitzer<a href="http://www.slate.com/id/2260470/"> in Slate</a>.) Instead, as I have written before, maybe we ought to consider whether those with vested interests in drugs or devices ought to be running clinical research meant to evaluate their own products.  Ironically, while this discussion of how the Avandia spin cycle first began to revolve were going on, others were still trying to add revolutions (per minute).  In particular, a Reuters <a href="http://www.reuters.com/article/idUSN1511649320100715">story</a> noted: <blockquote>Three influential groups of doctors who treat diabetes urged patients not to stop taking Avandia, saying on Thursday that while news about the controversial drug may be frightening, it would be worse to suddenly stop taking it.</blockquote> That is odd, given that Avandia has never been shown to improve clinical outcomes for patients with diabetes, and that there are many other drugs that control blood sugar which appear to be safer. But wait, there is more, <blockquote>The Endocrine Society, American Diabetes Association and the American Association of Clinical Endocrinologists worried that patients may be afraid to take Avandia. 'Patients should continue taking all currently prescribed medications unless instructed otherwise by their health care provider,' Dr. Robert Vigersky of the Endocrine Society said in a statement. 'Stopping diabetes medications can cause significant harm and result in higher levels of blood glucose that may cause severe short term health problems and could increase the risk of diabetes-related complications in the long term.'</blockquote> Would not it make more sense to advise patients still on Avandia to consult with their doctors urgently about possible alternatives?  Meanwhile, it does not seem irrational to be afraid of taking Avandia, given the increasing evidence about its harms, and increasing evidence that what we know about its harms may be an under-estimate. So I wondered why these august medical societies seemed so unaffected about the doubts about Avandia's safety, and about the evidence offered to support its use that the latest news ought to generate. It turns out that all three of the medical societies get financial support from, -- wait for it --, GlaxoSmithKline. The Endocrine Society lists GSK as one of its <a href="http://www.endo-society.org/industry/CLB_about.cfm">Corporate Liaison Board Members</a>. The American Diabetes Association lists GSK as one of its <a href="http://www.diabetes.org/donate/sponsor/our-corporate-supporters.html">Banting Circle Supporters</a>, that is, those that give at least $1,000,000 a year. The American Association of Clinical Endocrinologists lists GSK as a member of its <a href="http://www.aace.com/org/cap/capdirectory.php">Corporate AACE Partnership</a>. (I was not able to find out the total amount contributed by GSK to either the Endocrine Society or the AACE.) So once again, the loudest voices in support of the product come from those used to, and perhaps dependent on financial support from its manufacturer. As a physician, I have been particularly disappointed that our medical societies, whose missions are ostensibly to support our professional values, seem to act more and more like marketers for the companies whose contributions, rather than members' dues increasingly support them. The cycle keeps spinning. For further thoughts on the latest in the Avandia case, see <a href="http://brodyhooked.blogspot.com/2010/07/side-trip-into-diabetes-selling-wrong.html">this post</a> by Howard Brody on the Hooked: Ethics, Medicine and Pharma blog, and <a href="http://alison-bass.blogspot.com/2010/07/when-will-big-pharma-learn-story-of.html">this</a> by Alison Bass on the Alison Bass Blog.

The Avandia Spin Cycle Continues Even After the FDA Safety Hearings

We have posted multiple times about Avandia (rosiglitazone), GlaxoSmithKline's star-crossed glucose-lowering drug. While Avandia has re...

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The New York Times Reports A University President's Conflict of Interest

Three months ago, we <a href="http://hcrenewal.blogspot.com/2010/04/smoke-screen-how-conflict-of-interest.html">discussed</a> the controversy at the University of Michigan about  the university president's position on the board of directors of the big pharmaceutical, medical device and medical supply company Johnson and Johnson as a potential conflict of interest that could have influenced her decision to make the campus smoke-free.  (Johnson and Johnson makes drugs to aid in smoking cessation.)  I argued that by the Institute of Medicine definition, President Coleman did have a conflict of interest, and while it was not possible to tell whether it influenced the smoke-free decision, the issue with conflicts is that they constantly raise the possibility of undue influence on decisions. Now this issue has made it to the big time.  New York Times reporter Duff Wilson, <a href="http://prescriptions.blogs.nytimes.com/2010/07/13/university-presidents-outside-board-seat-poses-questions-of-conflict/">wrote</a> in the Times' Prescriptions Blog <blockquote>The University of Michigan medical school became the first in the nation last month to say it would refuse any funding from drug companies for its continuing medical education classes. The decision could cost it as much as $1 million a year, but it was worth it, the medical school dean said, for education to be free from potential bias. At the same time, Mary Sue Coleman, president of the entire University of Michigan, sits on the board of directors for the pharmaceutical giant Johnson & Johnson. Last year, the company paid her $229,978 — roughly half in stock and half in cash — for attending a limited number of meetings, corporate filings show. Conflict of interest? Conflict of policies? If the med school and mere professors could be tainted by drug money, what about the university president? She says no. Responding to questions on Ms. Coleman’s behalf Monday, Kelly E. Cunningham, a spokeswoman for the university, said the president satisfied the policy by disclosing her outside work. Ms. Coleman has never had to recuse herself from any discussion or action at the university because medical purchasing and investment decisions are so remote from her, Ms. Cunningham said. 'The same is true at J&J,' she added. 'There has never been a discussion or decision at the board level that involved something related to the UM. But, of course, if there were, she would recuse herself.'</blockquote> The <a href="http://www.freep.com/article/20100715/NEWS05/7150385/University-of-Michigan-s-Mary-Sue-Coleman-should-quit-firm-s-board-students-say">story</a> was picked up by the Detroit Free Press, which reiterated the official line that President Coleman's role on the Johnson and Johnson board did not pose a conflict: <blockquote>A student group at the University of Michigan is calling on President Mary Sue Coleman to resign from her seat on the Johnson & Johnson board of directors, saying it's a conflict of interest. But Coleman has no plans to resign, and university officials say her role on the board is not in conflict with university operations. Last year, she earned nearly $230,000 for her board duties. Coleman's U-M salary is about $550,000. 'It's essential that U-M have a voice and interact with the business world,' said Rick Fitzgerald, a U-M spokesman. 'She thinks it's her duty to understand what the commercial world is doing.'</blockquote> So, as I did last time, let us turn to the Institute of Medicine's definition of conflict of interest (in a health care context) found in its report, <a href="http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx">Conflict of Interest in Medical Research, Education, and Practice</a>. <blockquote>Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest. Primary interests include promoting and protecting the integrity of research, the quality of medical education, and the welfare of patients. Secondary interests include not only financial interests....</blockquote> I asserted then that President Coleman has a conflict of interest. Her primary interests as President of a university are to uphold the university's academic mission, and as President of a university that includes a medical school, a school of public health, and an academic medical center, also to uphold the integrity of patient care and public health practice. Her secondary interest as a member of the board of directors of a public, for-profit corporation is her fiduciary duty to that corporation and its stockholders, which means she must "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. <a href="http://www.amazon.com/Corporate-Governance-Robert-G-Monks/dp/1405116986">Corporate Governance</a>, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.] Such unyielding loyalty to the shareholders of a pharmaceutical and medical device company clearly creates a risk of influencing judgments or actions that could affect the corporations' sales or operations, economic or health policy, or the general environment in which it operates. Many of the judgments of or actions performed by the leader of a medical school, public health school, and academic medical center could so so, and are thus at risk of being so unduly influenced. As the IOM report said, though, <blockquote>a judgment that someone has a conflict of interest does not imply that the person is unethical. Such judgments assume only that some situations are generally recognized to pose an unacceptable risk that decisions may be unduly influenced by considerations that should be irrelevant.</blockquote> However, note that the sorts of decisions that may be influenced by a conflict of interest go beyond just those that involve the specific secondary interest causing the conflict. So the University spokesperson's statement that the president would recuse herself from any decision at the university that directly involved Johnson and Johnson, but that no such decision has ever been necessary, missed the point. Meanwhile, the university's insistence that the president's part-time position at Johnson and Johnson is justified by the need to "have a voice and interact with the business world" rings hollow. There are many ways a president could do that which do not involve getting corporate pay (and for "unyielding loyalty"). It rings especially hollow at a university that has identified corporate funding for continuing medical education as an unacceptably bad conflict of interest. But then again, conflicts of interest are known to create confused thinking, and such confused thinking is likely to be prevalent at an institution that has one set of rules for the little people, and another for the top leaders. Maybe this story in the New York Times will lead to some discussion about whether it is good for academic medical institutions to tolerate this previously "<a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html">new species of conflict of interest</a>" (as we termed it in 2006).

The New York Times Reports A University President's Conflict of Interest

Three months ago, we discussed the controversy at the University of Michigan about the university president's position on the board of...

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FDA MAUDE Database: Patient Outcome - Death

I present another health IT problem case from the FDA's voluntary <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm">MAUDE</a> (Manufacturer and User Facility Device Experience) database below. From FDA's description of MAUDE: <ul style="font-style: italic;"><li>MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19. </li><li>The on-line search allows you to search CDRH database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE is scheduled to be updated monthly and the search page reflects the date of the most recent update. FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed by technical or clerical difficulties.</li><li>MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester. </li></ul> I somehow missed the following case when I wrote the Oct. 2009 post '<a href="http://hcrenewal.blogspot.com/2009/10/out-policy-is-to-always-have-unabashed.html" style="font-weight: bold;">Our Policy Is To Always Have Unabashed Faith In The Computer ... Except When It Screws Up, And Then It's The Doctor's Fault</a>' but I have added it there as well: <blockquote> <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656460">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656460</a> CERNER MILLENIUM POWERCHART CPOE Event Date 11/19/2006 Event Type: Death Patient Outcome: Death The medication review screen of the subject device does not specify the exact dose in milligrams of combination medications. For example, narcotics are combined with tylenol in at least two strengths. Liquid narcotic tylenol-oxycodone combination is reported in ml, not mg. The exact dose of tylenol is not specified and requires knowledge of the combination medication dose in the volume specified. Certain fields of the grid do not specify the volume, but rather state "date/time" requiring another click or pop up screen. The immediate knowledge of tylenol dosage in mg is directly related to understanding and preventing excessive doses. In the subject, 10 ml of acetaminophen-oxycodone is indicated as having been given 3 times over 4 hours. That means that 1950 mg of tylenol was administered in 4 hours while the patient was in a state of starvation and receiving other medication that increase the effects of tylenol. This dose would equate to 11,700 mg of tylenol over 24 hours, nearly 3 times the maximum daily dose in otherwise health people. In the ensuing days, the patient developed acute renal failure, presumably acute tubular necrosis, and died. In the absence of other etiology, the excess tylenol was the culprit. This was not considered as etiology ante-mortem. The counterintuitive screen impaired the professionals. The pharmacist did not recognize and stop the medication, the nurses administered it, and the excessive dose, clinically meaninglessly listed as a volume of 10 ml -given 3 times in 4 hours- of acetaminophen-oxycodone, was missed by the physicians. Adverse events have been ascribed to "user error" by vendors. The device offers a potent propensity to life endangering oversights. There are other screens on this device which present information that interfere with clinically useful visualization of data. [Who designed these screens, I ask? Clinicians, or business IT personnel used to designing inventory systems for widget control? - ed.] The data does not flow to the professionals. It is not represented in a meaningfully useful manner. The professionals need to hunt for it. As such, the user unfriendly screens [see <a href="http://www.tinyurl.com/hostileuserexper">this link</a> on mission hostile HIT - ed.] impair safe medical care consistent with the impediment to expedient professional understanding of what, exactly, is the dose of medication and how much was administered to the patient. This sentinel case of death is directly attributed to user unfriendly screens on this device.</blockquote> How many cases like this, as well as "near misses" related to health IT go unreported, nationwide and worldwide? As in my paper "<a href="http://www.scribd.com/doc/28747771/Remediating-an-Unintended-Consequence-of-Healthcare-IT-A-Dearth-of-Data-on-Unintended-Consequences-of-Healthcare-IT">Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT</a>", nobody really knows; these devices are unregulated with no requirements for reporting. However, let's roll it out nationally anyway, because HIT will deterministically "revolutionize" medicine. Just ignore those spoil-the-party, man-behind-the-curtain prattle from writers <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">like these</a>. We can safely ignore all contrarian research and literature, of course, as we all know HIT will revolutionize medicine from the definitive certainty of HHS in "<a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html">The 'Meaningful Use' Regulation for Electronic Health Records</a>", NEJM, Blumenthal and Tavenner (10.1056/NEJMp1006114, July 13, 2010): <blockquote>The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice. [Except for those who <a href="http://archinte.ama-assn.org/cgi/content/short/167/13/1400">haven't</a> - ed.] </blockquote> And our government's called <a href="http://www.bp.com/sectiongenericarticle.do?categoryId=3&contentId=2006926">BP Energy Company</a> cavalier? I offer no additional comments. -- SS

FDA MAUDE Database: Patient Outcome - Death

I present another health IT problem case from the FDA's voluntary MAUDE ( Manufacturer and User Facility Device Experience ) database b...

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NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks"

The Insurance Industry is catching on that EMR's and other clinical IT are not exactly the cybernetic miracles they're sometimes held out to be, for example as implied in <a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html" style="font-family: arial;">this statement from HHS</a> in the July 13, 2010 NEJM that- <blockquote style="font-family:arial;">... EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. </blockquote> <a href="http://www.norcalmutual.com/about/" style="font-family: arial;">NORCAL Mutual Insurance Company</a>, for example, produces a near-monthly publication entitled "<a href="http://www.norcalmutual.com/publications/claimsrx.php" style="font-family: arial;">Claims Rx</a>." Its purpose: <blockquote style="font-family:arial;"> The goal of Claims Rx is to help physicians better recognize their medical professional liability risks and implement strategies to minimize those risks. The topics addressed here are derived from numerous sources including closed malpractice claims analyses, emerging liability trends and current medical literature. Each issue is meticulously reviewed by an editorial board consisting of physicians, nurses, risk management specialists and attorneys with a mind toward optimal patient safety and proactive risk management.</blockquote> The October 2009 issue, found <a href="http://www.norcalmutual.com/publications/claimsrx/oct_09.pdf" style="font-family: arial;">at this link </a>in PDF, is entitled "Electronic Health Records: Recognizing and Managing the Risks." It contains advice to physicians to limit their liability, reduce errors, and presents de-identified examples of HIT-related horror stories. Some of the advice offered includes: <blockquote style="font-family:arial;"> Electronic health records (EHRs) hold great promise of improving patient safety and decreasing medical liability exposure, but their use is creating a variety of new risk management and patient safety issues. </blockquote>For some reason, the "great promises" made over the past fifty years still seem elusive...but we'll get it right some day...(perhaps when <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" style="font-family: arial;">these issues</a> among others are solved). <blockquote style="font-family:arial;">Some of these issues are directly associated with EHRs (e.g., providers disregard warnings generated by the EHR), but many of the risk concerns associated with EHRs are analogous to problems that currently exist in paper documentation systems.</blockquote> The marketing puffery that today's EMR's are vastly superior to paper might be just that - marketing puffery. <blockquote style="font-family:arial;">In this month’s Claims Rx we present a number of shorter-than-usual case studies that exemplify various aspects of unsafe EHR documentation and communication practices. The scenarios are based on NORCAL closed claims, facts presented in appellate opinions, research findings and the observations of NORCAL Risk Management Specialists. What many of the examples show is that EHRs do not eliminate many of the dangerous documentation and communication practices that have historically led to patient injury and malpractice lawsuits. </blockquote> I would add "EHR's in their present form do not eliminate dangerous practices", designed as if they were clinical data inventory systems by business-IT eggheads rather than as clinical tools "of, by and for clinicians." (One might ask why we are about to spend 100+ billion dollars on them in national rollout the next few years.) <blockquote style="font-family:arial;"> Consequently, while it is important to address new issues that arise with EHRs, many of the risk management recommendations that apply to a paper-based documentation system remain valid. This Claims Rx will discuss the risks associated with various aspects of EHRs and will provide guidance for instituting policies and procedures designed to enhance the quality and safety of patient care, while diminishing professional liability risk. </blockquote> A number of case examples then follow. I will reproduce two, but all can be read via downloading the PDF at the link above. <blockquote style="font-family:arial;">Saving Images in the Wrong Patient’s Chart Just as an image can be misfiled or lost in a paper system, it can be misfiled in an electronic one. However, as the following case shows, it can be less obvious that an image has been misfiled in an electronic system. Case Study Patient #1 and patient #2 both presented to the Emergency Department (ED) complaining of abdominal pain. CT scans of the abdomen and pelvis were completed for both patients. A radiology tech mistakenly gave patient #2’s images the identification number assigned to patient #1 and uploaded the images into the Picture Archiving Computer System (PACS). A short time later, the tech realized his mistake and called the on-duty teleradiologist to tell him about the mistake and request that the mislabeled images be deleted from the system. However, the on-duty teleradiologist did not have access to delete images from the PACS; this had to be done by the PACS administrator. The tech then corrected the labeling problem and sent the images out to the teleradiology service for a preliminary review and resent the correctly labeled images to the PACS. Patient #1’s PACS file now contained both his own and patient #2’s images. A few days later the tech told his supervisor about the mislabeling, and assumed that the supervisor would remedy the problem. Pursuant to hospital policy, the tech should have immediately contacted the PACS administrator. The teleradiology service reported that patient #1’s CT scan was normal. Patient #2’s CT scan, however, showed a large tumor (about the size of a grapefruit) on the patient’s kidney. The service faxed the reports to the radiology department at the hospital. The next morning, the on-duty radiologist reviewed the PACS images from the night before. He disregarded the teleradiology service reports because they did not correspond to what he saw in the PACS. Because patient #2’s scan had been completed before patient #1’s, patient #2’s images were the first series in his file. The on-duty radiologist noted the large tumor and dictated a note. Because patient #2’s images still carried patient #1’s identification number, the radiologist’s report was assigned to patient #1. Patient #1 was subsequently seen by a number of specialists for the supposed tumor on his kidney. Seven days after the CT scan, he underwent a nephrectomy [lovely- ed.]. During the surgery, no mass could be positively identified on his kidney by his surgeons. Postoperatively, no tumor was identified in the removed kidney and pathology returned benign. (Please note, once the filing mistake was recognized, patient #2 was notified and underwent a timely and successful nephrectomy.) [In other words, through serendipity only one person was harmed, not two - ed.]</blockquote> One wonders how many "cases" like this will arise out of the major-vendor EHR upgrade flaw that is claimed to have led patient data to go into wrong charts at not one, but several hospitals: <a href="http://histalk2.com/2010/07/10/monday-morning-update-71210/" rel="bookmark" title="Article about: Monday Morning Update 7/12/10"></a><blockquote style="font-family:arial;"><a href="http://histalk2.com/2010/07/10/monday-morning-update-71210/" rel="bookmark" title="Article about: Monday Morning Update 7/12/10">HIStalk Monday Morning Update 7/12/10</a> From Holy Smoke: “Re: Cerner. Misidentification incidents have been reported with Cerner PowerChart and Millenium in hospitals in Indiana, Michigan, and others after a Cerner upgrade. Entries are placed in the wrong electronic chart and reviewed data is for the wrong patient.” Unverified. I saw nothing in the FDA’s <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm" target="_blank">Maude database</a>, so if it’s happening, customers should file an experience report. </blockquote> (See my July 11, 2010 post '<a href="http://hcrenewal.blogspot.com/2010/07/health-it-and-highest-regulatory.html" style="font-family: arial;">Health IT and 'High Regulatory Standards': Criminal Negligence for Implementing Defective Systems That Put Data in the Wrong Charts?</a>'). Next from NORCAL: <blockquote style="font-family:arial;">Checking the Wrong Box In the following case, the appearance of the computer screen probably played a role in the medication error. Case Study A patient presented to his primary care physician (PCP) for the treatment of headaches and episodes of altered consciousness. The PCP prescribed amitripyline at 10 mg nightly. The PCP told the patient to escalate the dosage by 10 mg every three to four days until the pain was relieved, but not to exceed 50 mgs without consulting him. When creating the prescription, the PCP intended to check off the 10-mg box in the computerized physician order entry (CPOE), but inadvertently checked the 100-mg box, which was right above it. In the medication instructions section, he indicated that five pills could be taken per night, so the patient would not have to return to the pharmacy and pay an additional co-pay if he ultimately needed the larger dose. The pharmacist had noticed that the dose seemed high and requested that a call be made to the PCP prior to it being dispensed. A nurse at the PCP’s office picked up the call, and because she was very busy that day, told the pharmacy to dispense the medication as it had been ordered — she did not check the dose. Three days later, the patient took five of the 100-mg pills together. Early the next morning, the PCP was contacted by an emergency department (ED) physician who reported that the patient was in the ED reporting dizziness, an altered state of consciousness, an inability to coordinate his movements and a rapid heartbeat. He was further informed by the ED physician that the patient had taken five 100-mg amitripyline tablets. The PCP then checked the patient’s record and realized his mistake. [It's serendipitous that the patient was not in the morgue when the mistake was realized - ed.]</blockquote> Read the rest of the cases and the explanations at the Electronic Health Records: Recognizing and Managing the Risks "Claims Rx" document from NORCAL <a href="http://www.norcalmutual.com/publications/claimsrx/oct_09.pdf" style="font-family: arial;">here</a> (PDF). In these cases, both technological and "people" issues were responsible for the malpractice events. However, healthcare is an extremely complex endeavor requiring exquisite attention to detail (or your patient's dead). These IT systems could have been designed to provide cognitive, ease-of-use, and known-error revision (or at least known-error flagging) support to clinicians that could have helped prevent these errors. HIT designers need to do their part if they want to be considered part of the clinical team. If they don't do their part voluntarily and stop with the <a href="http://www.tinyurl.com/hostileuserexper">mission-hostile</a>,1970's-paradigm "inventory system of widgets" health IT, as I've written before, they will increasingly find themselves part of that team in an involuntary manner - as defendants in litigation. Finally, due to issues such as: an utter lack of governmental regulation of the HIT industry and a lack of defect and error reporting requirements; contractual gag and hold-harmless clauses (as raised by Penn researchers Koppel and Kreda in JAMA <a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">here</a>); physician fear of hospital retaliation such as <a href="http://www.aapsonline.org/peerreview/epidemic.php">sham peer review</a> for HIT whistleblowing especially now that more physicians are becoming hospital employees; and other causes, there is no reliable data on the incidence of EHR-related medical errors and malpractice. As in my paper "<a href="http://www.scribd.com/doc/28747771/Remediating-an-Unintended-Consequence-of-Healthcare-IT-A-Dearth-of-Data-on-Unintended-Consequences-of-Healthcare-IT">Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT</a>", there is also no reliable data on "near misses" or potential IT related mishaps that were averted by serendipity. These near misses expose patients to risk. With no reporting, there is no systematic data that can be used for remediation and prevention. I thus present once again the following thoughts from my post <a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html" style="font-family: arial;">Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records"</a>: I believe we should hold off national Health IT roll outs until we: <ul style="font-family:arial;"><li>learn sufficiently from failures such as the UK CfH and our own military's AHLTA debacle on how to avoid same, which can injure and kill patients and wastes massive money and resources healthcare can ill afford, and more importantly that can be better used elsewhere - such as care of the poor;</li></ul><ul style="font-family:arial;"><li>improve the technology's usability, safety and efficacy through the years of Medical Informatics and other disciplinary research needed, that was short circuited through the invention of the ONC office by Bush (although national HIT then remained a goal, not a mandate), and the 'militarization' of ONC under Obama whereby HIT was unilaterally declared a proven technology and mandated for national rollout;</li></ul><ul style="font-family:arial;"><li>end the contractual and fear-based censorship of information on health IT problems, and patient injuries and deaths related to the devices; and</li></ul><ul style="font-family:arial;"><li>meaningfully regulate these devices that have increasingly become governors of care delivery.</li></ul>I have written extensively on these topics at this blog, at my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">academic website on health IT failure</a>, and other sources (see list at end of my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm">bio</a>). When there are significant doubts about a medication or medical device, we ought not push for national rollout. Health IT devices have gotten special accommodation, and it's not on the basis of any rigorous science I am familiar with. -- SS

NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks"

The Insurance Industry is catching on that EMR's and other clinical IT are not exactly the cybernetic miracles they're sometimes hel...

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Eli Lilly CEO on “America’s Growing Innovation Gap”

In “<a href="http://online.wsj.com/article/SB10001424052748704111704575354863772223910.html" style="font-weight: bold;">America’s Growing Innovation Gap</a>”, WSJ, July 9, 2010, Eli Lilly CEO John C. Lechleiter, Ph.D. writes that: <blockquote> “…the most important elements are the seeds of innovation, which equate to talented people and their ideas.” </blockquote> He then suggests these people are “highly skilled immigrants” abroad. In my own circle of friends, I know American pharma industry cast-offs who are both brilliant and talented. One with dual MS degrees in mathematics and computer science from a major university, one a skilled bioinformaticist I've had teach my healthcare informatics students as guest lecturer, one a brilliant programmer who could be considered the grandfather of computer image manipulation, another with years of expertise in pharma knowledge discovery. Then there's me – former Director of a Merck R&D support group and of The Merck Index - with degrees in medicine and post-doctoral specialization in biomedical informatics and information science, plus I'm an extra-class amateur radio licensee who understands complex technology at a level far beyond that of the usual pharmaceutical company worker.Yet no donuts for us. In recent years the pharmaceutical industry won’t grant any of us the courtesy even of an interview. However, in Mar. 2009 as I documented <a href="http://hcrenewal.blogspot.com/2009/03/lilly-i-were-referred-to-me-as-person.html">here</a>, I did receive an email solicitation from Lilly that read as follows ("sic's" are mine): <blockquote>“Your Help Is Requested for a Eli Lilly Career Opportunity! (sic) I am a member of the Staffing Team at Eli Lilly. I were referred to me (sic) as person who specializes in pharmaceutical based informatics. I wanted to reach out to me (sic), to see if you maybe able (sic) to recommend anyone that could qualify for the below position (sic)." </blockquote> I was not exactly inspired by this solicitation, perhaps written by one of the "highly skilled immigrants" Lechleiter covets.Nor was I inspired by the earlier solicitation I documented at my Jan. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/01/what-me-worry-lilly-fined-over-zyprexa.html">What, Me Worry? Lilly Fined Over Zyprexa, Should Be Fined For eRecruitment Inanity As Well?</a>" I suggest if Mr. Lechleiter wishes to close America’s purported "innovation gap", he spend some time away from the executive castle and perhaps review some resumes – and the job solicitations his company proffers – in his HR department. A cause of the "innovation gap" may be leadership <a href="http://www.thefreedictionary.com/xenophilia">xenophilia</a>, at the expense of the American born-and-raised scientists the pharma industry is so fond of discarding. -- SS

Eli Lilly CEO on “America’s Growing Innovation Gap”

In “ America’s Growing Innovation Gap ”, WSJ, July 9, 2010, Eli Lilly CEO John C. Lechleiter, Ph.D. writes that: “…the most important...

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Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records"

<div class="PlainText" style="font-family:arial;">In the NEJM article "The 'Meaningful Use' Regulation for Electronic Health Records", David Blumenthal, M.D., M.P.P. (ONC Chair) and Marilyn Tavenner, R.N., M.H.A. (10.1056/NEJMp1006114, July 13, 2010) available <a href="http://healthcarereform.nejm.org/?p=3732&query=home">at this link</a>, the opening statement is (emphases mine): </div><blockquote dir="ltr" style="margin-right: 0px;font-family:arial;"><div class="PlainText">The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.</div></blockquote><div class="PlainText" style="font-family:arial;"> I think it fair to say those are grandiose statements and predictions presented with a tone of utmost certainty in one of the world's most respected scientific medical journals. </div><div class="PlainText" style="font-family:arial;"></div><div class="PlainText" style="font-family:arial;"> Even though it is a "perspectives" article, I once long ago learned that in writing in esteemed scientific journals of worldwide impact, statements of certainty were at best avoided, or if made should be exceptionally well referenced. </div><div class="PlainText" style="font-family:arial;"></div><div class="PlainText" style="font-family:arial;">I note the lack of footnotes showing the source(s) of these statements. </div><div class="PlainText" style="font-family:arial;"></div><div class="PlainText" style="font-family:arial;">I also note the lack of mention of literature refuting or potentially refuting these statements of certainty. I can think of more than a few examples of the latter just off the top of my head [ref. 1-15 below, certainly not a comprehensive list but merely skimming the surface]. </div><div class="PlainText" style="font-family:arial;"></div><div class="PlainText" style="font-family:arial;">In politics, however, no such sourcing is necessary. It's easy for a politician <a href="http://www.powerlineblog.com/archives/2010/07/026720.php" target="_blank">to say</a> "Free markets will not give us the healthcare system we want" or, conversely, "I <a href="http://www.powerlineblog.com/archives/2010/07/026746.php" target="_blank">never heard about</a> the DOJ's selective dismissal of charges against people intimidating voters at a voting site in Philadelphia." </div><div class="PlainText" style="font-family:arial;"></div><div class="PlainText" style="font-family:arial;">So, did the NEJM publish fact, or political platitude? </div><div class="PlainText" style="font-family:arial;"></div><div class="PlainText" style="font-family:arial;">Can someone provide a list of peer reviewed, rigorous studies that back the assertions of certainty in 10.1056/NEJMp1006114, and override the body of literature that could cast doubt on these assertions of certainty? Since it's people's lives at stake, not an inventory of widgets, I've promoted the idea of holding off on national roll outs until we: <ul style="font-family:arial;"><li>learn sufficiently from failures such as the UK's <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">NPfIT</a> (National Programme for IT) in the NHS and our own military's <a href="http://hcrenewal.blogspot.com/2010/07/4-billion-military-emr-ahlta-to-be-put.html">AHLTA debacle</a> on how to avoid same, which can injure and kill patients and wastes massive money and resources healthcare can ill afford, and more importantly that can be better used elsewhere - such as care of the poor;</li></ul><ul style="font-family:arial;"><li>improve the technology's usability, safety and efficacy through the years of Medical Informatics and other disciplinary research needed, that was short circuited through the invention of the ONC office by Bush (although national HIT then remained a goal, not a mandate), and the 'militarization' of ONC under Obama whereby HIT was unilaterally declared a proven technology and mandated for national rollout;</li></ul><ul style="font-family:arial;"><li>end the contractual "hold vendor harmless clauses" (see Koppel and Kreda's 2009 JAMA article <a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">here</a>), and fear-based censorship of information on health IT problems, patient injuries and deaths related to the devices; and</li></ul><ul><li>meaningfully regulate these devices that have increasingly become governors of care delivery. </li></ul> I have written extensively on these topics at this blog, at my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">academic website on health IT failure</a>, and other sources (see list at end of my <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm">bio</a>). When there are significant doubts about a medication or medical device, we ought not push for national rollout. Health IT devices have gotten special accommodation, and it's not on the basis of any rigorous science I am familiar with. <style title="owaParaStyle">P { MARGIN-TOP: 0px; MARGIN-BOTTOM: 0px } BODY { SCROLLBAR-HIGHLIGHT-COLOR: #cecfce; SCROLLBAR-ARROW-COLOR: #3f52b8; SCROLLBAR-TRACK-COLOR: #fffbff; SCROLLBAR-DARKSHADOW-COLOR: #fafafa; SCROLLBAR-BASE-COLOR:-- S</style>-- SS </div> References: (hyperlinks to these and others can be found at my medical informatics teaching sites <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=other">here</a> and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">here</a>): <div class="PlainText" style="font-family:arial;"></div> <blockquote dir="ltr" style="margin-right: 0px;font-family:arial;"><div class="PlainText" style="font-family:arial;"></div><div class="PlainText" style="font-family:arial;">1. Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop by Bonnie Kaplan and Kimberly D. Harris-Salamone. From the May/June 2009 issue of JAMIA. 2. "E-Health Hazards: Provider Liability and Electronic Health Record Systems.” Hoffman and Podgurski’s followup paper on EHR medical and legal risks 3. Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. Ross Koppel, PhD, et al, Journal of the American Medical Association, 2005;293:1197-1203 4. Electronic Health Record Use and the Quality of Ambulatory Care in the United States. Arch Intern Med. 2007;167:1400-1405. The authors examined electronic health records (EHR) use throughout the U.S. and the association of EHR use with 17 basic quality indicators. They concluded that “as implemented, EHRs were not associated with better quality ambulatory care.” 5. Pessimism, Computer Failure, and Information Systems Development in the Public Sector. (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand) 6. <a href="http://www.blogger.com/redir.aspx?C=cd79bb9ef239435c91597828510ff401&URL=http%3a%2f%2fiig.umit.at%2fefmi%2fbadinformatics.htm" target="_blank"></a>Bad Health Informatics Can Kill. his site contains summaries of a number of reported incidents in healthcare where IT was the cause or a significant factor. It comes from the Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI). </div><div class="PlainText" style="font-family:arial;"></div><div class="PlainText">7. The U.S. National Research Council’s "Current Approaches to U.S. Health Care Information Technology are Insufficient." 8. The UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program. 9. Gateway reviews of the UK National Programme for IT from the Office of Government Commerce (OGC) (released under the UK’s Freedom of Information Act). 10. A report on the serious problems with the Department of Defense’s AHLTA system, Electronic Records System Unreliable, Difficult to Use, Service Officials Tell Congress. (This system, as I <a href="http://hcrenewal.blogspot.com/2010/07/4-billion-military-emr-ahlta-to-be-put.html">wrote here</a>, is slated for abandonment. I cannot imagine it was greatly improving outcomes). 11. A New York Times report “Little Benefit Seen, So Far, in Electronic Patient Records” on Jha’s research at the Harvard School of Public Health, that compared 3,000 hospitals at various stages in the adoption of computerized health records and found little difference in the cost and quality of care. 12. An American Journal of Medicine paper “Hospital Computing and the Costs and Quality of Care: A National Study” by Himmelstein and Woolhandler at Harvard Medical School, that also concluded “as currently implemented, hospital computing might [very] modestly improve process measures of quality but not administrative or overall costs." 13. A Milbank Quarterly article “Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" by Greenhalgh, Potts, Wong, Bark and Swinglehurst at University College London. 14. Health Affairs, 29, no. 4 (2010): 639-646 Electronic Health Records’ Limited Successes Suggest More Targeted Uses, Catherine M. DesRoches et al. 15. NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks" (PDF <a href="http://www.norcalmutual.com/publications/claimsrx/oct_09.pdf">here</a>) </div></blockquote><blockquote dir="ltr" style="margin-right: 0px;font-family:arial;"><div class="PlainText"> </div><div class="PlainText"> </div><div class="PlainText"></div></blockquote> Addendum 7/14: I think this statement at "The Road to Hellth" blog in a post entitled "<a href="http://roadtohellth.com/index.php?option=com_content&view=article&id=146:meaningful-ruse&catid=37:dapblog&Itemid=175">Meaningful Ruse</a>" that cites my posts is apropos: <blockquote>... Meaningful use entered our vocabulary in early 2009 as part of a $20+ billion gift from doctors, hospitals and the taxpayers to the needy folks at Cerner, GE, Siemens, Allscripts, Epic and other purveyors of complex, expensive and difficult-to-use and potentially even dangerous medical software products. </blockquote> -- SS

Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records"

In the NEJM article " The 'Meaningful Use' Regulation for Electronic Health Records ", David Blumenthal, M.D., M.P.P. (ONC...

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