healthy4u

WHO YOU GONNA BELIEVE?

WHO YOU GONNA BELIEVE? Ghostwriting Charges and Stonewalling at the American Psychiatric Association The American Psychiatric Association came under a searchlight this past December over allegations of ghostwriting. The story originated with a public <a href="http://www.pogo.org/pogo-files/letters/public-health/ph-iis-20101129.html">letter</a> from Project on Government Oversight (POGO) to the Director of NIH, and it was picked up by Duff Wilson writing in the <a href="http://www.nytimes.com/2010/11/30/business/30drug.html?_r=3">New York Times</a>. The book was Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care. The named authors were Charles Nemeroff, now chairman of psychiatry at the University of Miami, and Alan Schatzberg, formerly chairman of psychiatry at Stanford University. Both are well known for ethical controversy – see <a href="http://hcrenewal.blogspot.com/search?q=Nemeroff">here</a> and <a href="http://hcrenewal.blogspot.com/search?q=Schatzberg">here</a>. Soon, these allegations were being dissected in the blogosphere, with stellar contributions from <a href="http://carlatpsychiatry.blogspot.com/2010/11/its-textbook-its-ad-its.html">Daniel Carlat</a>, <a href="http://1boringoldman.com/index.php/2011/01/21/when-charlie-met-sally/">1boringoldman</a>, <a href="http://www.pharmalot.com/2010/11/ghostwriting-from-medical-journals-to-entire-books/">Ed Silverman</a>, and <a href="http://alison-bass.blogspot.com/2010/12/government-oversight-agency-calls-on.html">Alison Bass</a>. The APA and its publishing arm, known as American Psychiatric Press, Inc. or APPI, came to the defense of the two prominent academic authors over the ghostwriting charge. In particular, an APA employee named Mark Moran authored a <a href="http://pn.psychiatryonline.org/content/46/2/1.1.full">denial </a>of the charge in the January 2011 issue of the APA news magazine, Psychiatric News. As the controversy played out, letters from attorneys demanded retractions, and partial qualifications of the original story appeared in the New York Times and on the POGO weblog. There was never any doubt that the heavy lifting was done by a pair of professional writers employed by a medical communications company under a financial grant from a drug company. Nemeroff defended his role by averring that he ‘scrutinized’ the work product of the professional writers. Threatening letters from lawyers for Nemeroff and Schatzberg were publicized, and the APA weighed in. The coup de grâce was administered by blogger Daniel Carlat’s withering <a href="http://carlatpsychiatry.blogspot.com/2010/12/nemeroff-and-schatzbergs-textbook.html">review</a> of the book’s artful construction to highlight the use of the sponsoring company’s antidepressant and anti-anxiety drug in primary care, while muting important information about the drug’s liabilities. Nevertheless, the APA held to its legalistic stance in defense of the ‘authors.’ This behavior is counterproductive for professional medical organizations, as I have discussed <a href="http://hcrenewal.blogspot.com/2010/12/impeachment-its-about-institution-not.html">before</a>, because it misses the ethical forest for the legal trees. Now comes the good part. In response to the piece by Mark Moran in Psychiatric News, Leemon McHenry prevailed on Robert Rubin and myself to write with him to the magazine’s editors. Leemon is a faculty member in the Department of Philosophy at California State University, Northridge. He also has experience evaluating legal documents arising in litigation over antidepressant drugs. Robert Rubin has partnered with me in outing several notable ethics compromises involving Nemeroff and Schatzberg, going back as far as 2002, though we always call ourselves equal opportunity critics. Our letter sent in late January to Dr. Carolyn Robinowitz, the Interim Editor of Psychiatric News, has been <a href="http://pogoblog.typepad.com/pogo/letter-to-apa-20110128.html">posted</a> today on the POGO site. In our letter, we challenged much of Mr. Moran’s defense, and we called attention to what WASN’T in the public domain, despite all the claims and counterclaims. Essentially, the partial qualifications of the original reports that appeared in The New York Times and in the letter to NIH from POGO resulted from the inconclusiveness of some of the documents. We called on the APA to come clean with the release of all relevant materials, in the interest of transparency. For instance, what WASN’T known were the specifics of the contract involving the corporation, the (ahem) authors, the publisher (APPI), and the medical communications company. Or the money flow to the ‘authors’ from the contract in addition to their royalties. Or the legal release form transferring ownership of the work product to the ‘authors’ and APPI. Or the corporation’s planned marketing activities, given that the corporation ordered 10,000 copies of the book. Or the correspondence among all parties that might reveal who actually did what. Leemon McHenry’s perspective is that this hidden layer of documents may well be available if they could be unsealed in pending litigation. Naturally, corporations and their attorneys strive to keep the information hidden. But our general point is that the APA has a different duty – which is to transparency rather than to stonewalling. Did the APA do that? Sadly, no, they did not. Here is the curt <a href="http://pogoblog.typepad.com/pogo/apa-response-20110322.html">reply</a> from the Executive Editor Catherine Brown denying publication of our letter after a delay of almost 8 weeks. Now that’s what I call stonewalling.

WHO YOU GONNA BELIEVE?

WHO YOU GONNA BELIEVE? Ghostwriting Charges and Stonewalling at the American Psychiatric Association The American Psychiatric Association ca...

Đọc thêm »

Medicare/Medicaid Cuts? Spend Money on Patients - Not Computer Experiments

There has recently been much debate about how to save this country from European-style financial ruin. From "<a href="http://www.examiner.com/political-buzz-in-national/gop-2012-budget-proposal-cuts-taxes-on-rich-cuts-medicare-the-future">GOP 2012 budget proposal cuts taxes on rich, cuts Medicare in the future</a>", Examiner.com, April 3, 2011: <blockquote style="font-family:arial;">On Tuesday House Budget Committee Chairman Paul Ryan (R-WI) is expected to release the Republicans’ 2012 budget proposal. Currently Democratic and Republican leaders are trying to negotiate a compromise on the 2011 budget would make some cuts to discretionary spending. Republicans have said they would not be able to propose really significant cuts to lower the deficit until 2012. <a href="http://www.cnn.com/2011/POLITICS/04/02/house.gop.budget/" rel="nofollow">According to reports</a>, the GOP proposal would dramatically cut taxes on corporations and the rich, while also making significant cuts to Medicare and Medicaid.</blockquote> I propose the cuts to Medicare and Medicaid, which will directly affect medical care delivery to the elderly and poor, be traded for cutting extravagant expenditures for experimental medical computer technology. This could be accomplished through repeal of HITECH and diversion of those funds to patient care, where it's more urgently needed. Let scarce taxpayer dollars be spent on the health of human beings, not on machines of uncertain value and risk at their current state of evolution in 2011. At my Jan. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/01/us-house-of-representatives-proposes-to.html">US House of Representatives Proposes to Defund Largest Non-Consented Medical Experiment in U.S. History: HITECH</a>" I had written about H.R.408, the Spending Reduction Act of 2011 Introduced in the House of Representatives: <blockquote style="font-family:arial;">In a new bill in the House of Representatives, the ‘‘Spending Reduction Act of 2011’’ (<a href="http://rsc.jordan.house.gov/UploadedFiles/JORDAN_004_xml.pdf">link - PDF</a>), it is proposed to cut unobligated funds of, among others, division A of the "American Recovery and Reinvestment Act of 2009": <blockquote> ... Spending Reduction Act of 2011 DIVISION A—APPROPRIATIONS PROVISIONS ... TITLE XIII—HEALTH INFORMATION TECHNOLOGY </blockquote> Title XIII of the ARRA along with title IV of division B is better known as HITECH: <blockquote>SEC. 13001. SHORT TITLE; TABLE OF CONTENTS OF TITLE. (a) SHORT TITLE.—This title (and title IV of division B) may be cited as the ‘‘Health Information Technology for Economic and Clinical Health Act’’ or the ‘‘HITECH Act’’.</blockquote></blockquote> I commented that it looked like HITECH was one of a number of spending extravaganzas on the proposed chopping block. Health IT under the country's current financial condition is indeed an extravagance, especially considering the experimental nature of the technology and the doubts expressed by experts as to its true value in its current state of development (see "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">An Updated Reading List on Health IT</a>" at my Drexel Univ. Healthcare IT failures site). This recent revelation should also be considered: The quality of the technology is likely far, far worse than anyone, including the pessimists, imagined. The HIT problem reports in FDA's MAUDE database (<a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">link</a>) are child's play compared to the following. The unprecedented, recent, detailed analysis of a major American electronic health record system for use in Emergency Departments (of all places) by an Australian health IT expert at the following links is simply astonishing, if not downright frightening. See: <ul style="font-family:arial;"><li>Analysis of Cerner Problems Defined by ED Directors, <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=120&Itemid=116">http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=120&Itemid=116</a></li></ul><ul style="font-family:arial;"><li>A study of an Enterprise Health information System, <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146</a></li></ul> If even a fraction of this analysis is correct, we should simply take those billions of dollars and turn them into cigar wrappers. Or perhaps coffins. I will also repeat some of my rationale in my Jan. 2011 post for repeal of HITECH: <ul style="font-family:arial;"><li>This country cannot afford HITECH at this time. Put simply, we are broke, and the national deficit is ballooning far out of control. The money would be far better spent at this time on care of those who cannot afford that care. </li></ul><ul style="font-family:arial;"><li>HITECH appeared as if out of nowhere, with little to no input time from stakeholders. This suggests lobbying by those with conflicts of interest to push this bill onto the public, affecting their medical care without informed consent (see my March 2009 post "<a href="http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html">Draft Patient Rights Statement and Informed Consent on Use of HIT</a>"). The bill includes persuasion along with economic coercion for non-adopting organizations and physicians. ("Adoption" = adherence to government-set standards of "meaningful use" of <a href="http://www.tinyurl.com/hostileuserexper">poorly usable technology</a>.) I disapprove of the stealth process by which HITECH appeared. This is the U.S., not the old USSR.</li></ul><ul style="font-family:arial;"><li>Mass social experiments involving major systemic changes to our healthcare delivery system, with exceptional claims being made about IT, need to be backed by exceptional evidence. That evidence is lacking. In fact, the evidence might actually point in the negative direction. See my aforementioned post "<a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">An Updated Reading List on Health IT</a>." </li></ul><ul style="font-family:arial;"><li>The technology <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">is not ready</a>. It is dangerous in unqualified hands, which most every medical center and physician office is in 2011 (i.e., an <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">IT backwater</a>). The field of health IT was somehow transformed from an experimental field into the 'savior of medicine' without the proof of value and safety that would ordinarily be required to move an experimental technology from lab to national rollout. Per the Washington Post, this process appears to have been a highly politicized one, favoring the corporate elites. The Washington Post’s 2009 article on the influential HIT vendor lobby “The Machinery Behind Healthcare Reform” is <a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/05/15/AR2009051503667.html?hpid=topnews">at this link</a>. </li></ul> To these I will add a few more reasons to convert HITECH extravagance in time of financial distress and high unemployment to direct care provision: <ul style="font-family:arial;"><li>A similar experiment in the much smaller and strongly government-managed healthcare system of the UK didn't exactly have stellar results (<a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">link</a>, <a href="http://www.dh.gov.uk/en/MediaCentre/Pressreleases/DH_119293">link</a>). We also have been warned not to make the same multi-billion dollar errors (<a href="http://www.huffingtonpost.com/stephen-soumerai/dont-repeat-the-uks-elect_b_790470.html">link</a>). </li></ul><ul style="font-family:arial;"><li>The cavalier attitudes by the administration-appointed ONC director Blumenthal towards evidence of health IT-caused adverse effects, including deaths, reported to him by the FDA (see this Feb. 23, 2010 <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf">Internal FDA Memorandum on Health IT Safety Issues</a>, PDF). </li></ul> Despite the fact that the Director of FDA's Center for Device and Radiological Health Jeffrey Shuren (a physician and lawyer) testified these reports were likely just the "tip of the iceberg", ONC director Blumenthal glibly stated, per the Aug. 2010 Huffington Post Investigative Fund article <a href="http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight">FDA, Obama Digital Medical Records Team at Odds over Safety Oversight</a>, that FDA's reports of health IT related injuries and deaths were “anecdotal": <blockquote style="font-family:arial;">ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.” He told the Investigative Fund that he believed nothing in the report indicated a need for regulation. </blockquote> These exact cavalier attitudes about "anecdotes" just failed in the Supreme Court. (See my Mar. 27, 2011 post about the Zicam decision in "<a href="http://hcrenewal.blogspot.com/2011/03/those-who-dismiss-heathcare-and-healht.html">Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost - Supreme Court-Style</a>"). More reasons for diverting HITECH funds to patient care include government waste driven by irrational exuberance and idealism: <ul style="font-family:arial;"><li>The irrational exuberance and idealism about this technology purportedly saving money, a dreamer's dream explicitly refuted, for example, by notable figures at Wharton (<a href="http://knowledge.wharton.upenn.edu/createpdf.cfm?articleid=2260">link</a>) and Stanford (<a href="http://online.wsj.com/article/SB10001424052970204005504574235751720822322.html">link</a>). (Also see "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Goldfinch_pessimism_PAR.pdf">Pessimism, Computer Failure, and Information Systems Development in the Public Sector</a>", Shaun Goldfinch, Public Administration Review 67;5:917-929, Sept/Oct. 2007).</li></ul><ul style="font-family:arial;"><li>More on purported cost savings - Peter Orszag, former head of the Congressional Budget Office, said the use of electronic health records, without a major change in health care delivery, "would not significantly reduce overall health care costs" <a href="http://www.ihealthbeat.org/articles/2007/11/14/budget-office-downplays-ehrs-effect-on-reducing-health-costs.aspx?topic=ehrs%20and%20phrs">in the agency's 2007 report</a> on long-term health care spending. He also said that according to data from the report, the return on investment for EHR's "is not going to be as substantial as people think." The CBO concluded that predictions of cost savings from EHR's relied on "overly optimistic" assumptions and said much is unknown about the potential impact of health information technology. [That is, it is an experimental technology - ed.] Mass savings from health IT is an assertion that is both unproven and highly unlikely in my view. </li></ul><ul style="font-family:arial;"><li>Yet another irrationally exuberant dream about the use of the massive amounts of uncontrolled clinical data, entered by myriad observers in an infinite variety of situations into these systems, to be used for research. This is the antithesis of sound methods for data collection and management in medical research. It is a dreamer's concept of the "Randomized Controlled Clinical Trial Made Easy." (See my essay "<a href="http://www.jpands.org/vol14no2/silverstein.pdf">The Syndrome of Inappropriate Overconfidence in Computing: An Invasion of Medicine by the Information Technology Industry.</a>" Also see "<a href="http://hcrenewal.blogspot.com/2009/04/have-we-suffered-complete-breakdown-in.html">Have we suffered a complete breakdown in the scientific method with regard to EHR and clinical IT?</a>".)</li></ul> Finally, here's another reason to withdraw HITECH for now: <ul style="font-family:arial;"><li>As I'd written in a series of essays at <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">this blog query link</a>, we simply don't know how to make computerized medical information reasonably private and secure. (One might wonder whether the current administration, sponsors of the out-of-the-blue HITECH act, actually wants healthcare information to be private and secure.) </li></ul> I reiterate from my January 2011 post: I would not weep for the HITECH act's passing. It would allow the restoration of health IT back to an unrushed and careful experiment. It would also give time to work out the significant issues causing health IT difficulty (such as <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">raised in 2009 by our National Research Council</a>) before we embark on national health IT diffusion. In other words, its passing would <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">reduce risk</a> and help restore an essential level of sanity and due diligence to the healthcare IT sector, now afflicted by irrational exuberance bordering on <a href="http://hcrenewal.blogspot.com/2011/01/healthcare-it-delirium.html">delirium</a>. We would avoid the largest unconsented medical experiment in US history, which as I have repeatedly written I feel would be disastrous with current levels of understanding of this technology and how to design, deploy and manage it. (My relative's 2010 HIT-related injuries only strengthened my convictions in this regard.) Disclosure: I have no financial conflicts of interest regarding HITECH or health IT to weep about. Others do, and it's not hard to predict their financial interests will push them to oppose HITECH repeal "by any means necessary." A replacement HITECH act that's "HIGH" on research and caution, but not so high on stealth, coercion and idealistic euphoria would be welcomed. -- SS

Medicare/Medicaid Cuts? Spend Money on Patients - Not Computer Experiments

There has recently been much debate about how to save this country from European-style financial ruin. From " GOP 2012 budget proposal...

Đọc thêm »

With this device in your chest, an Elvis suit for the doc?

The April 3, 2011 NY Times has a nice <a href="http://www.nytimes.com/2011/04/03/health/03implant.html?nl=todaysheadlines&emc=tha25&pagewanted=print">piece </a>about pacemakers and AICDs from a little-known and low market share German device manufacturer, <a href="http://www.biotronik.com/portal/home">Biotronik</a>. Apparently this company's pacemakers have pretty much cornered the market among cardiologists at <a href="https://www.umcsn.com/">University Medical Center</a> in Las Vegas.<div> </div><div>(By the way, the Times has gone to a pay-wall, so the above link to it can't be counted on to work for too long after this posting comes out. Try a search engine. There's no permalink as one used to use to make sure the link stayed put.) <div> </div><div>In any case, how fitting it all seems in anything-goes Nevada. According to the article the Feds may or may not be going after this egregious example of conflict of interest. Let's hope they are. But at least we can make sure that what plays in Vegas doesn't stay in Vegas.</div><div> </div><div>Apparently some of the <a href="https://www.umcsn.com/Medical-Services-at-UMCSN/Heart-Center.aspx?intMenuID=132&intPageID=219">cardiologists at UMC</a> are (or were) pulling down up to 5k a month in consulting fees. That may or may not have anything to do with the fact that the small German device-maker went from having, oh, zero 2-3 years ago to 95% of all devices implanted there last year, by total number of patients.</div></div><div> </div><div>Good work, gentlemen. Let the word go out. Come to America and roll the dice in Las Vegas. It's almost enough to make me want to become a brimstone-spouting right wing pastor. "To gamble, it's of the devil."</div><div> </div><div>But this is a place where the state's new <a href="http://nv.gov/govsandoval.aspx">governor </a> is a former chair of the gaming commission.</div><div> </div><div>Of course, the real culprit here is, collectively, those cardiologists and the middle-man distributors who court them. According to the article, the cardiologists who didn't enroll their patients (and presumably take dough) were on what the sales guys called the "loser" list.</div><div> </div><div>Yes, "winning" in health care is about market share and effective sales. No surprise here. We knew that already, of course, from Wendell Potter's <a href="http://www.amazon.com/Deadly-Spin-Insurance-Corporate-Deceiving/dp/1608192814/ref=wl_it_dp_o?ie=UTF8&coliid=I12JO1SNO4S2R7&colid=27YYYBOMT031M">Deadly Spin</a>, with which most readers of this blog are no doubt already familiar.</div><div> </div><div>It sure as hell isn't about the patient winning. But last time I checked, professionalism and the Hippocratic Oath have something to say about the patient being the one who's supposed to win.</div><div> </div><div>One understands that these gotta-make-a-buck middle-men, and the device vendor-manufacturers, are interested in the almighty share. Birds gotta fly, fish gotta swim. But the doctors--a sad commentary indeed if, as this articles says, "[they] then did the rest."</div><div> </div><div>In this same vein, loss of meaning, clearly the word "university" in hospitals' names has ceased to have much real meaning. The article says the hospital CEO never bothered to ask the docs whether they had a conflict of interest.</div><div> </div><div>Alas, too often that's equally true across the rest of the country. "University" centers behave just like proprietary players, as anyone reading this blog can't have failed to notice.</div><div> </div><div>Maybe just a wee bit more glaring in Vegas, though, where guys in Elvis suits fall out of the sky and pay-to-play pacemakers fall into patients' chests.</div>

With this device in your chest, an Elvis suit for the doc?

The April 3, 2011 NY Times has a nice piece about pacemakers and AICDs from a little-known and low market share German device manufacturer,...

Đọc thêm »

Making a Stat Less Significant: Common Sense on "Side Effects" Lacking in Healthcare IT Sector

At my Mar. 27, 2011 post "<a href="http://hcrenewal.blogspot.com/2011/03/those-who-dismiss-heathcare-and-healht.html">Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost - Supreme Court-Style</a>" I wrote that the SCOTUS decided in MATRIXX INITIATIVES, INC., ET AL. v. SIRACUSANO ET AL. (<a href="http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf">link to PDF</a>) that: <blockquote>... We conclude that the materiality of adverse event reports cannot be reduced to a bright-line rule ... Because adverse reports can take many forms, assessing their materiality is a fact-specific inquiry, requiring consideration of their source, content, and context. </blockquote> Wall Street Journal author and "Numbers Guy" Carl Bialik adds to that point in an article today "<a href="http://online.wsj.com/article/SB10001424052748703712504576235683249040812.html" style="font-weight: bold;">Making a Stat Less Significant</a>" where he writes: <blockquote>To determine whether a medical side effect is significant in an experiment requires knowing that every incidence of that side effect is being reported. Researchers can feel confident that is happening in a controlled clinical trial of a drug, but they can't be sure when a drug is being sold to the general public, as was the case with Zicam.</blockquote> In other words, when one is not sure that every incident of a side effect is being reported, one should not cavalierly dismiss "anecdotal" reports of side effects, especially from reliable reporters. The practictioners of Medical Informatics, along with the HIT Industry and its customers, appear to have failed in that regard with respect to clinical IT (electronic medical records, CPOE etc.) For years they have argued that these medical devices should not be regulated because that would "stifle innovation" and that reports of device adverse events were "anecdotal." Many in the field still make these arguments. This view extends all the way up to the Director of the Office of the National Coordinator for Health IT, who glibly stated per the Aug. 2010 Huffington Post Investigative Fund article <a href="http://huffpostfund.org/stories/2010/08/fda-obama-digital-medical-records-team-odds-over-safety-oversight">FDA, Obama Digital Medical Records Team at Odds over Safety Oversight</a> that FDA's own reports of health IT related injuries and deaths were “anecdotal": <blockquote>ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.” He told the Investigative Fund that he believed nothing in the report indicated a need for regulation. </blockquote> Those "injury findings" appear in an FDA Internal Memo made available by the aforementioned Huffington Post Investigative Fund and archived at the following link: <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf"></a><blockquote><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf">Internal FDA memorandum on HIT risks</a> (PDF) to Jeffrey Shuren MD JD (Director, Center for Devices and Radiological Health). Health Information Technology (H-IT) Safety Issues. "This is an Internal Document Not Intended for Public Use." Feb. 23, 2010. (My description/summary of the memorandum is at my Aug. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun?</a>")</blockquote> That memorandum itself emphasizes how FDA's own knowledge of these events is partial due to reporting impediments and lack of knowledge of resources such as FDA's MAUDE database. The known reports were likely "<a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">the tip of the iceberg</a>" according to the Director of FDA’s Center for Devices and Radiological Health (CDRH) <a href="http://www.healthimaging.com/index.php?option=com_articles&view=article&id=20311:jeffrey-e-shuren-named-as-fda-cdrh-director">Jeffrey Shuren, MD, who also happens to be a lawyer</a>. As at the aforementioned "<a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">tip of the iceberg</a>" link, at an HHS meeting of the HIT Policy Committee's Adoption/Certification Workgroup on February 25, 2010, Shuren testified: <blockquote>... In the past two years, we have received 260 reports of HIT-related malfunctions with the potential for patient harm – including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist. Even within this limited sample, several serious safety concerns have come to light. The reported adverse events have largely fallen into four major categories: (1) errors of commission, such as accessing the wrong patient’s record or overwriting one patient’s information with another’s; (2) errors of omission or transmission, such as the loss or corruption of vital patient data; (3) errors in data analysis, including medication dosing errors of several orders of magnitude; and (4) incompatibility between multi-vendor software applications and systems, which can lead to any of the above.</blockquote> The problem with ignoring testimony and reports of health IT-related difficulties and dismissing them as "anecdotal" goes back to the issue of "knowing that every incidence of that side effect is being reported." While FDA itself admits significant doubt about completeness of reporting in its memo, what's worse is that Koppel and Kreda at University of Pennsylvania wrote a paper from which one might conclude that the healthcare and health IT industries are themselves aligned to conceal health IT adverse events reports. In their remarkable article <a href="http://jama.ama-assn.org/content/301/12/1276.extract">Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians</a>, Journal of the American Medical Association, 2009;301(12):1276-1278, we learn that there is little motivation for device safety in the health IT industry: <blockquote>Healthcare information technology (HIT) vendors enjoy a contractual and legal structure that renders them virtually liability-free—“held harmless” is the term-of-art—even when their proprietary products may be implicated in adverse events involving patients. This contractual and legal device shifts liability and remedial burdens to physicians, nurses, hospitals, and clinics, even when these HIT users are strictly following vendor instructions...HIT vendors are not responsible for errors their systems introduce in patient treatment because physicians, nurses, pharmacists, and healthcare technicians should be able to identify—and correct—any errors generated by software faults. [In other words, they are expected to be clairvoyant when presented with erroneous or missing data - ed.] </blockquote> We additionally learn that: <blockquote>The significant disparity between buyers and sellers in knowledge and resources [about healthcare IT problems] is profound and consequential. Vendors retain company confidential knowledge about designs, faults, software-operations, and glitches. Their counsel have crafted contractual terms that absolve them of liability and other punitive strictures while compelling users’ non-disclosure of their systems’ problematic, or even disastrous, software faults. </blockquote>In other words, health IT customers and users have a gag order imposed on them regarding software faults and defects. I think any reasonable person would conclude there is great doubt as to whether "every incidence of [HIT side effects] is being reported." I also pointed out in JAMA (<a href="http://jama.ama-assn.org/content/302/4/382.1.extract">link</a>) and on my Drexel website (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda">link</a>) how agreeing to these terms caused hospital executives to violate both their fiduciary duties to their organization's workers as well as Joint Commission safety standards obligations. (I've personally reported health IT defects I'd observed in hospitals where my relatives were patients to FDA's MAUDE database, discovering that the institution itself, whose officials I alerted to the problems, did not. An example is <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1729552">here</a>.) The above is all common sense. Thus, the dismissal of reports of health IT-related patient injury, deaths, and "near misses" represents a failure of common sense, as well as a massive abrogation of fiduciary responsibilities and legal and ethical obligations among the Medical Informatics, health IT vendor, healthcare delivery, and healthcare regulatory sectors. One end result is that it permits software <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=120&Itemid=116">like this</a> to be mandated by state governments on hundreds of hospitals. One can only imagine the public, press and legal reactions if mission-critical software issues of this magnitude were brought forth after an aviation or nuclear power plant disaster. The cavalier dismissals of HIT mishap reports clearly fall into the "knew, or should have known" category of negligence. Plaintiff attorneys for patients injured or killed via HIT-related mishaps should take note. -- SS Note: my WSJ comment on this issue appears <a href="http://online.wsj.com/article/SB10001424052748703712504576235683249040812.html#articleTabs%3Dcomments%26commentId%3D2294618">here</a>.

Making a Stat Less Significant: Common Sense on "Side Effects" Lacking in Healthcare IT Sector

At my Mar. 27, 2011 post " Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have L...

Đọc thêm »

Logical Fallacies in Support of Payments for Board Members of Non-Profit Health Insurers

The kerfuffle over the huge golden parachute given the departing CEO of an ostensibly non-profit Massachusetts health insurer/ managed care organization continues to evolve (see posts <a href="http://hcrenewal.blogspot.com/2011/03/massachusetts-blue-cross-blue-shield.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/03/some-dare-call-it-corruption.html">here</a>), providing some new insight into governance problems afflicting health care organizations.  One of the issues that aroused initially aroused concern was that Massachusetts Blue Cross Blue Shield paid the members of its board of trustees substantial amount, an unusual practice for a non-profit organization.  Board members who feel they owe their pay to the CEO they are supposed to be overseeing might be particularly inclined to over pay that same CEO. Nonetheless, the Boston Globe just <a href="http://www.boston.com/business/healthcare/articles/2011/03/31/two_health_insurers_boards_opt_to_keep_accepting_pay/">reported</a> that other non-profit Massachusetts health insurers were defending their payments to board members: <blockquote>The state’s second- and third-largest health insurers said yesterday their board members have decided to keep paying themselves five-figure annual fees despite objections from the state attorney general and an inquiry into directors’ compensation at nonprofit health plans.</blockquote>The rationales for these decisions were fascinating, amounting to four variations of special pleading, plus an appeal to tradition. Special pleading: Our board members are experienced and independent <blockquote>'Good governance is advanced by the recruitment and retention of experienced, independent, reasonably compensated directors,' Harvard Pilgrim said in its statement. 'In 2010, our board worked more than 2,000 hours.'</blockquote> I doubt any non-profit organization would admit to not wanting experienced, independent board members,  but very few other non-profits pay their board members. Asserting that board members of the Massachusetts insurance companies especially deserve pay because of characteristics they share with other members of other boards who are not paid amounts to <a href="http://www.nizkor.org/features/fallacies/special-pleading.html">a special pleading</a>. The second statement seems just to be a simple exaggeration, since 2000 hours a year implies that the board members work there full-time (40 hours/week * 50 weeks = 2000 hours).   Special Pleading: Our board members are skilled and experienced <blockquote>Wellesley-based Harvard Pilgrim, however, said in its statement that board members 'apply their specialized experience and skills in the areas of medicine, accounting, finance and law, to support our company and its mission. Our board serves as responsible, independent fiscal stewards for our members’ premium dollars.'</blockquote> Again, board members of all sorts of non-profit organizations could be described in similar terms. So using this as an argument for paying board members when members with the same attributes of other boards are not paid is another special pleading. Special Pleading: Our boards have great responsibility <blockquote>Tufts, based in Watertown, said its board believes there is 'an additional overlay of responsibility' for directors of a health insurance company. 'Unlike the directors of other nonprofits, they are subject to distinct regulatory considerations,' the Tufts statement said. 'Therefore, compensation for time, commitment and skill of top talent is a responsible approach for the oversight of an organization that provides health care coverage to hundreds of thousands' of members.</blockquote> Of course, boards of hospitals have their own "distinct regulatory considerations," as do boards of academic institutions  Boards of hospitals are also responsible for the health of their patients and boards of academic institutions are responsible for the education of their students. So this is a third example of a special pleading. Special Pleading: Our responsibility, our time, our effort Appeal to Tradition: Our tradition is to pay directors <blockquote>The history and tradition of nonprofit health plans is to pay [directors] in this state. These are people from various walks of life who bring a skill set. These are not political hacks. . . . It’s because of the responsibility, the time, the effort, and the work you have to put into it. It’s a lot of homework.</blockquote> It is true that the four non-profit Massachusetts health insurers all apparently did pay their board members, although in many other states, members of the boards of non-profit health insurers were not paid. But in the absence of any further argument that Massachusetts organizations were right when the others were wrong, this amounts to <a href="http://www.nizkor.org/features/fallacies/appeal-to-tradition.html">an appeal to tradition</a>.   The rest of this personal statement was again a special pleading.  Summary Board members of non-profit organizations generally are said to have three duties, as <a href="http://www.boardsource.org/Knowledge.asp?ID=3.364">per BoardSource</a>: - The Duty of Care: "a board member owes the duty to exercise reasonable care when he or she makes a decision as a steward of the organization." - The Duty of Loyalty: "a board member must give undivided allegiance when making decisions affecting the organization. This means that a board member can never use information obtained as a member for personal gain, but must act in the best interests of the organization." - The Duty of Obedience: "The duty of obedience requires board members to be faithful to the organization's mission. They are not permitted to act in a way that is inconsistent with the central goals of the organization." The notion that boards stewarding non-profit organizations, including health care organizations, have these core responsibilities seems to have become increasingly ignored and forgotten in an increasingly commercialized health care environment.  Simply fulfilling these duties should not be regarded as exceptional board service, and certainly not so exceptional as to require pay.  The fallacious arguments made on behalf of lucrative payments given to members of the boards of two of the more highly regarded non-profit health insurance corporations in the country indicate how low governance and stewardship of health care organizations has sunk. Again, we need governance of health care organization by people who understand their fundamental duties, who are willing to be accountable, and who put their organizations' mission ahead of personal gain.  Those who profess concern about the stewardship of health care need not go far to find examples of fundamental misconceptions about what such stewardship involves.  We need to restore core values of governance to our health care organizations.

Logical Fallacies in Support of Payments for Board Members of Non-Profit Health Insurers

The kerfuffle over the huge golden parachute given the departing CEO of an ostensibly non-profit Massachusetts health insurer/ managed care ...

Đọc thêm »

Wendell Potter on "Insurers’ Cynical Calculations on the Cost of Doing Business"

<a href="http://wendellpotter.com/2011/03/insurers%E2%80%99-cynical-calculations-on-the-cost-of-doing-business">On his blog</a>, Wendell Potter, former head of public relations for CIGNA, discussed big health insurance/ managed care organizations' attitudes toward paying financial penalties for wrong-doing: <blockquote>Having served as head of PR for two of the country’s largest health insurers — CIGNA and Humana — I know from personal experience that such fines are not widely considered newsworthy. Insurers know this, and so, annoying as being charged with breaking the law might be, they largely shrug off the fines and the threat of a day’s worth of bad publicity that occasionally accompany them. They are perfectly willing to risk being caught because they long ago realized that the fines are never severe enough to make them radically change the way they do business. Such a change would involve dealing more honestly with both their customers and the doctors who provide care to the people they insure.</blockquote> We have frequently discussed the parade of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> involving major health care organizations, including drug, device, biotechnology companies, and hospitals and health care systems as well as insurers and managed care organizations. We have repeatedly noted that fines or payments imposed on these organizations seem to have little deterrent effect. Now we have some documentation that this is true from someone who used to be in the belly of the beast. So I get to 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.

Wendell Potter on "Insurers’ Cynical Calculations on the Cost of Doing Business"

On his blog , Wendell Potter, former head of public relations for CIGNA, discussed big health insurance/ managed care organizations' att...

Đọc thêm »

How Large Health Care Organizations Set the "Rules of the Game" to Dominate Health Care

The notion that health care is increasingly "dominated by large, bureaucratic organizations which do not honor ... [its] core values"(1) just made it into a main-stream, large circulation US medical journal.  A brand new commentary in the American Journal of Medicine(2) by Supri and Malone declared: <blockquote>To explain why we have the most expensive health care system in the world and yet one of the lowest performing, we need to take a perspective that focuses on the US institution of medicine as a whole. We expose the hidden rules by which this institution operates and discuss how its powerful organizations shape, control and perpetuate this ailing system.</blockquote> The article then described the main types of large, powerful health care organizations: <blockquote>The US institution of medicine is not a single, comprehensive and cohesive system of health care. Instead, it is comprised of a myriad of large and powerful organizations, including <a href="http://hcrenewal.blogspot.com/search/label/health%20insurance">insurance companies</a>, <a href="http://hcrenewal.blogspot.com/search/label/managed%20care%20organizations">Health Maintenance Organizations</a> (HMOs), corporate for-profit hospital chains, and <a href="http://hcrenewal.blogspot.com/search/label/pharmaceuticals">pharmaceutical companies</a>. This institutional structure is large and vast, and has over the years become ever more labyrinthine. </blockquote> Note that there are even more kinds of large and powerful health care organizations, including non-profit <a href="http://hcrenewal.blogspot.com/search/label/hospitals">hospitals</a> and <a href="http://hcrenewal.blogspot.com/search/label/hospital%20systems">hospital systems</a>, <a href="http://hcrenewal.blogspot.com/search/label/employers">employers</a> acting as payers for health care, <a href="http://hcrenewal.blogspot.com/search/label/government">government agencies</a>, <a href="http://hcrenewal.blogspot.com/search/label/medical%20devices">device</a> and <a href="http://hcrenewal.blogspot.com/search/label/biotechnology">biotechnology</a> companies, <a href="http://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20failure">health care information technology companies</a>, <a href="http://hcrenewal.blogspot.com/search/label/public%20relations">public relations firms</a>, <a href="http://hcrenewal.blogspot.com/search/label/medical%20education%20and%20communication%20companies">medical education and communication companies</a>, <a href="http://hcrenewal.blogspot.com/search/label/contract%20research%20organizations">contract research organizations</a>, <a href="http://hcrenewal.blogspot.com/search/label/medical%20societies">professional societies</a>, <a href="http://hcrenewal.blogspot.com/search/label/patient%20advocacy%20groups">patient advocacy groups</a>, accrediting bodies, health care charities, etc, etc, etc.  But the point is that the large organizations, not the patients, the physicians, nor the public dominate. Supri and Malone suggested that each kind of organization sets the "rules of the game," that is, the priorities important to the organization, which are very different from the core values that many of us believe ought to guide health care: <blockquote>Not only is the institutional structure large, it is dynamic, and actively creates, shapes, and maintains the institution of medicine. It does this through what we call setting the “rules of the game”; that is, by imposing the terms by which the system operates.</blockquote> For example, <blockquote>Insurance companies have set the rule 'restrict choice and coverage.' They enact this through their elaborate system of copayments and deductibles, exclusion clauses and loopholes, each designed to deter patients from claiming the health care they need, and to override physicians' medical judgment.</blockquote> Similarly, it cited the rules for managed care, "manage care," that is, "restrict utilization of health care" regardless of patients' needs; the pharmaceutical industry, "charges as much as we want, because insurance will pay;" and "corporate hospital chains ... test as much as we want, because insurance will pay." Thus it made the point that US health care now is driven by the priorities of large organizations whose interests at best may disregard and at worst may conflict with providing the best possible care for individual patients. Further, the resulting complexity is to the benefit of the large organizations: <blockquote>As each organization has created its own 'rules of the game,' the institution of medicine has grown into a complex entity that few really understand. This very complexity actually works to the advantage of the organizations that comprise the system, creating an operating environment that allows them to siphon off billions of dollars. It is one of the main reasons why the cost of health care has spiraled out of control. </blockquote> This is very important, and suggests that the system will just become more bureaucratic, complex and opaque until it finally collapses. Finally, it raised the point that the organizations collude to promote their priorities at the expense of patients' and the public's health: <blockquote>Although each organization sets their 'own rules of the game,' they are also strongly and deeply interlinked, and cooperate and collaborate to protect the system of health care that they have devised, so that it remains intact and continues to serve their own interests.</blockquote> Although  Supri and Malone did not differentiate the leadership of large organizations from the organizations themselves, we have pointed out that the top leaders of various kinds of organizations seem to think alike, becoming a sort of de facto executives' guild, with a "<a href="http://hcrenewal.blogspot.com/search/label/superclass">superclass</a>" of oligarchs at its pinnacle.  The guild may be enabled by these leaders' often <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">huge compensation</a> and other benefits and corporate arrangements that keep them shielded from the vicissitudes of daily life that patients, health care professionals, and lower level organizational employees must face.  Furthermore, the leadership of these organizations is often interlinked, for example, by leaders of one organization serving on boards of <a href="http://hcrenewal.blogspot.com/search/label/boards%20of%20directors">directors</a> or <a href="http://hcrenewal.blogspot.com/search/label/boards%20of%20trustees">trustees</a> of others. It is so nice for us at Health Care Renewal to have some company. It is a very important blow to the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a> for these sorts of views to appear in a mainstream medical journal. When I interviewed a motley group of physicians and health care professionals in the early part of the 21st century, many expressed concerns about how medicine had been taken over by large organizations which did not honor its values. The article published in 2003(1) in Europe which tried to summarize their concerns probably could not have been published at that time in the US, but its publication remote from its main topic only made it more anechoic. It may be that an article published in a respected American journal will generate some more echoes. Here is hoping that Health Care Renewal can help create some such echoes.  Obviously, those who lead large organizations in health care will not be happy about that, so it is possible this article's appearance in a main-stream journal may incite some pushback, perhaps generated by the public relations machines of the large health care organizations (see <a href="http://hcrenewal.blogspot.com/2011/02/health-care-corporate-disinformation.html">this post</a> about how Wendell Potter's excellent <a href="http://wendellpotter.com/deadlyspin/">Deadly Spin</a> documented how large organizations use propaganda and disinformation to undermine viewpoints that threaten their domination.) In conclusion, I strongly support Supri and Malone's final sentiments: <blockquote>The sum of the 'rules of the game' devised by these organizations has resulted in a fragmented, haphazard and broken system of health care. Reform is long overdue, and demands root and branch transformation of the 'rules of the game' governing the US institution of medicine. This requires us to understand these rules, who is setting them, and how these rules are being used to exploit the system of medicine. Only then can we begin to heal our ailing health care system.</blockquote>Well said! But now almost 8 years since the publication of "A Cautionary Tale," we still have a long way to go. References 1.  Poses RM. A cautionary tale: the dysfunction of American health care.  Eur J Inte Med 2003; 14: 123-130.  Link <a href="http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6VSB-48D4VTD-D&_user=489286&_coverDate=03%2F31%2F2003&_rdoc=1&_fmt=high&_orig=gateway&_origin=gateway&_sort=d&_docanchor=&view=c&_searchStrId=1699586911&_rerunOrigin=google&_acct=C000022678&_version=1&_urlVersion=0&_userid=489286&md5=52787b7440a81ac69b0bffe22ddbe5ff&searchtype=a">here</a>. 2.  Supri S, Malone K. On the critical list: the US institution of medicine. Am J Med 2011; 124: 192-193.  Link <a href="http://www.ncbi.nlm.nih.gov/pubmed/21396498">here</a>.

How Large Health Care Organizations Set the "Rules of the Game" to Dominate Health Care

The notion that health care is increasingly "dominated by large, bureaucratic organizations which do not honor ... [its] core values...

Đọc thêm »