healthy4u

Physician Pleads Guilty to Fraud for Fabricating Celebrex (and Other) Study Data

As reported <a href="http://www.masslive.com/chicopeeholyoke/republican/index.ssf?/base/news-25/1263545132168150.xml&coll=1">by the Springfield, MA, Republican</a>: <blockquote>A former chief of acute pain at Baystate Medical Center has agreed to plead guilty to falsifying medical research and must pay $420,000 in restitution to pharmaceutical companies, federal court records show. Dr. Scott S. Reuben, of Longmeadow, was charged on Thursday with health care fraud. He signed a plea agreement with prosecutors a week earlier. Reuben prompted a furor in the medical community in March, when he was accused of making up research results in at least 21 published studies and inventing patients in certain instances. </blockquote> In one notable instance, <blockquote>In 2005, Reuben received a $74,000 research grant from pharmaceutical giant Pfizer, agreeing to test Celebrex as a component of the multimodal therapy. He claimed to have treated 200 patients, 100 with Pfizer's product and 100 with a placebo. 'In fact, Reuben had not enrolled any patients into that study and the results reported both to Pfizer and to the Anesthesia and Analgesia Journal and in turn to the public were wholly made up by Reuben,' the charge states. Albert said the fabrications were discovered by medical staff within the hospital during a routine review at the hospital's 'research week,' when clinicians design poster displays of their studies. </blockquote> A <a href="http://www.theday.com/article/20100116/BIZ02/301169909/1044">report </a>in the New London, CT, Day indicated the scope of Reuben's fake research: <blockquote>Anesthesia & Analgesia later had to retract 10 papers authored by Reuben, and medical experts at the time said at least 21 journal articles by the anesthesiologist appeared to have been fabricated. The agreement calls for Reuben to pay restitution of $296,557 to Pfizer and $16,000 to Wyeth Pharmaceuticals, two companies that merged last fall. Merck & Co. would receive $49,375 from the agreement, according to documents. In addition to his fabricated Celebrex studies, Reuben had pretended to do research that backed the effectiveness of other pain drugs, including Pfizer's Bextra and Merck's Vioxx, according to prosecutors. Bextra and Vioxx later were pulled from the market because studies showed they increased the risk of death from heart attacks and strokes. In addition, Reuben published data showing that Pfizer's antidepressant Effexor had exhibited painkilling properties. Reuben's studies had been considered pioneering at the time they were published. His data had supported the use of two of Pfizer's major products - Celebrex and Lyrica - in combination to treat certain types of post-operative pain. Reuben 'was a regular on the medical lecturing circuit,' according to court documents, and 'had become a well known figure in the anesthesia and pain management medical communities.' Pfizer said previously that it had supported five of Reuben's research initiatives. Pfizer, which declined at the time to reveal how much it paid Reuben over the years to be part of its speakers' bureau, said the company played no part in the fraud. Asked for a comment Friday, Pfizer was not able to provide a timely response. </blockquote> Note that we usually do not post about stories of individual's clinical research misconduct, not because it is unimportant, but because individual misconduct may be related more to an individual's motives and character than to concentration and abuse of power in health care. However, in this case it appears that Dr Reubens was enabled, at least in the psychological and logistical senses, by pharmaceutical companies happy to sponsor research which suggested the effectiveness of their products.  Since Dr Reubens apparently fabricated most of his data, notice that he apparently deliberately fabricated data that made Pfizer's Celebrex, Bextra, Lyrica, and Effexor, and Merck's Vioxx look good.  Perhaps there was careerism here.  Positive studies about "innovative" effective drugs are more likely to get published than negative studies or studies of old drugs.  However, we have <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">noted before</a> that pharmaceutical (and biotechnology and device) companies like to sponsor studies with results that make their products look good.  One bit of good news in this story is that Reuben's colleagues at the hospital apparently were able to uncover the fabrications when they had an opportunity to critically look at data from several of his studies. Certainly some Pfizer employees had easy access to the same data.  But perhaps they would not have thought to look at it critically as long as it was so unrelentingly positive about their company's products.  As we have said before, health care professionals, policy makers and patients ought to be extremely skeptical of clinical studies sponsored (and often deeply influenced) by those with vested interests in the studies' turning out in certain ways.  We ought to reconsider national research policies that have turned over sponsorship of the majority of clinical research to those with such vested interests. Hat tip to Prof Margaret Soltan <a href="http://www.margaretsoltan.com/?p=20778">on the University Diaries blog</a>. ADDENDUM (19 January, 2010) - see also <a href="http://alison-bass.blogspot.com/2010/01/why-fda-is-more-pro-business-than-ever.html">comments</a> on the Alison Bass Blog.

Physician Pleads Guilty to Fraud for Fabricating Celebrex (and Other) Study Data

As reported by the Springfield, MA, Republican : A former chief of acute pain at Baystate Medical Center has agreed to plead guilty to falsi...

Đọc thêm »

Not Just an American Disease

We have written about attacks on rigorous evidence-based medicine, and particularly on comparative effectiveness research from those with vested interests in having clinical research come out a certain way (e.g., see<a href="http://hcrenewal.blogspot.com/2009/11/no-free-speech-for-comparative.html"> this</a> most recent relevant post). Those who see such research primarily as a marketing opportunity tend to be offended by the notion of rigorous, unbiased research that may not be so easily turned to marketing purposes. Since I, like the other current <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> bloggers, am based in the US, we tend to focus on local examples. But it turns out that the American malady described above has spread to Germany. From the Science blog, <a href="http://blogs.sciencemag.org/scienceinsider/2010/01/pharma-lobbies.html">ScienceInsider</a>: <blockquote>A long-running feud between pharmaceutical companies and the German institute that evaluates the effectiveness of medical treatments could cost the institute director his job. Although the post is supposed to be apolitical, members of Germany’s new coalition government have called for Peter Sawicki, founding director of the Institute for Quality and Efficiency in Health Care (known by its German acronym IQWiG, pronounced ICK-vig), to be replaced with someone who is friendlier to the pharmaceutical industry. The institute’s board of directors are expected to decide on 20 January whether Sawicki, a clinical researcher and diabetes expert, will be replaced when his contract runs out later this year. Sawicki’s supporters say the move would endanger the institute’s reputation for impartial and rigorous science, and earlier this month a petition signed by 600 doctors and clinical researchers called on the health minister and the board to keep Sawicki on. Gerd Antes, director of the German Cochrane Centre in Freiburg, a not-for-profit organization that analyzes health care effects, says that replacing Sawicki would significantly undermine IQWiG and its work. Antes views the anti-Sawicki push as 'part of the political game to soften and to weaken rigorous procedures for new drugs and medical devices in Germany.' </blockquote> And it turns out that the American-based pharmaceutical industry has jumped right in. <blockquote>Big pharma’s attacks have even come from outside Germany. In March 2009, the Pharmaceutical Research and Manufacturers of America petitioned the Obama Administration to put Germany on a trade and intellectual property 'priority watch list' chiefly because of IQWiG’s influence on the German drug market. The petition complained that the institute has 'inadequately taken into account the value of innovative pharmaceuticals,' among other complaints. The Obama Administration declined to put Germany on its watch list. </blockquote> Parenthetically, "innovation" seems to be a favorite term that those with vested interests in selling products or services use to describe those products, sometimes in the absence of any data that shows them to be superior to the alternatives in terms of important clinical outcomes, that is, outcomes that patients may care about.  "Innovative" was also how complex financial products which contributed to the global economic meltdown were described by those who stood to make money selling, or sometimes simultaneously short-selling them, - but maybe that's guilt by association.  I hope the Germans are able to preserve their stake in honest, comparisons of tests and treatments that are not influenced by those with vested interests in selling those tests and treatments.

Not Just an American Disease

We have written about attacks on rigorous evidence-based medicine, and particularly on comparative effectiveness research from those with ve...

Đọc thêm »

Electronic Medical Records and Going For Broke: Jackson Health System's Financial Future Appears Grim

<div style="text-align: justify;">I have written on numerous occasions that health IT in its present form, often poorly designed and implemented under current IT leadership structures, is often a waste of precious healthcare resources. The resources might be better spent on essentials such as patient care for the poor or improved human staffing, until this experimental technology is perfected. As at my site on <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/">health IT difficulties and mismanagement</a> I observed: <blockquote> Healthcare information technology (HIT) holds great promise towards improving healthcare quality, safety and costs. As we enter the second decade of the 21st century, however, this potential has been largely unrealized. A significant factor impeding HIT achievement has been mismanagement of the technology. Mismanagement of HIT is largely due to false assumptions and naïveté concerning the challenges presented by this still-experimental technology, and underestimations of the expertise essential to achieve the potential benefits of HIT. This results in mission-hostile HIT design, and HIT leaders and stakeholders operating outside (often far outside) the boundaries of their professional competencies. Until these issues are acknowledged and corrected, HIT efforts will waste precious healthcare resources, will not achieve claimed benefits for many years to come, and may actually cause harm. Numerous reports in the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=2009">2009 articles link</a> corroborate this view, including those from the U.S. Joint Commission and National Research Council. </blockquote> The following may bring my observations to life. This from 2007: <blockquote>RedOrbit.com/News <a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=228e92552e6e49c0bb70ebaa5010067a&URL=http%3a%2f%2fwww.redorbit.com%2fnews%2fhealth%2f1057193%2fjackson_memorial_hospital_uses_stateoftheart_technology_to_drive_improved_patient%2findex.html">Jackson Memorial Hospital Uses State-of-the-Art Technology to Drive Improved Patient Outcomes for South Florida Families</a> Posted on: Thursday, 6 September 2007, 09:11 EDTJackson Memorial Hospital (JMH), part of Jackson Memorial Health System, South Florida's leading/largest healthcare provider, recently implemented 11 Cerner Millennium® solutions. [Including EMR, nursing, pharmacy, radiology, HIM, Eligibility Management, Master Person Index, Registration Management, Scheduling Management, Emergency Department, etc. - ed.] This marks the hospital's first step in a multi-stage healthcare information technology implementation. With Cerner Millennium® solutions, JMH clinicians now have access to real-time resources to better manage patient care with improved access to cross-department information, evidence-based clinical decision support and streamlined hospitals operations. "Cerner is pleased to partner with Jackson Memorial Hospital, an institution continually ranked as one of the best hospitals in America," said Trace Devanny, Cerner -- president. "JMH's decision to implement a solution-oriented information technology system reinforces its vision to improve healthcare communitywide. Cerner worked together with JMH to implement multiple Cerner Millennium solutions specifically designed for various roles, venues and conditions that will ultimately improve the patient experience."</blockquote></div><div style="text-align: justify;"> These implementations, a mere "first step" towards "streamlining operations," and their maintenance, modification, remediation, and staffing were undoubtedly multimillion-dollar expenses and are likely still ongoing. (See other examples of mass hospital IT expenditures <a href="http://hcrenewal.blogspot.com/2006/10/70-million-for-electronic-medical.html">here</a> and <a href="http://sacramento.bizjournals.com/sacramento/stories/2006/03/06/story3.html">here</a>.) Now, fast forward to 2010. This is stunning: <blockquote> <a href="http://www.miamiherald.com/business/breaking-news/story/1422477.html">Jackson Health System's financial future appears grim</a> Miami Herald BY JOHN DORSCHNER Posted on Wednesday, 01.13.10 Looking forward and back, Jackson Health System's grim financial picture just keeps getting worse. Members of the Public Health Trust, the system's governing board, are being told: • Patient volume has dropped by 6.5 percent recently, meaning that with all the cost cutting and new revenue plans, Jackson is facing an $88 million loss this fiscal year, and this estimate is likely to get worse. • The government system may have lost much more money last year than the $56 million it reported in unaudited statements. That loss could conceivably go as high as $150 million. • Cash on hand to pay bills -- the measure of how the three-hospital system is doing at this moment -- continues to be awful. ``Perhaps a cash hemorrhage,'' PHT member Marcos Lapciuc called it. The bad news came at PHT committee hearings late Tuesday afternoon. ``Very drastic measures need to happen'' to stem the growing losses, said Chief Executive Eneida Roldan. She said the losses were likely to increase, because considerable funding for poor patients comes from Tallahassee, and the Legislature is expected to cut back on healthcare funding programs as it deals with its own budget crisis. ``We're making very drastic decisions that no hospital wants to do,'' Roldan told the board, including ending contracts for 175 unfunded patients to receive dialysis at out-patient centers.</blockquote> Ending contracts for unfunded patients to receive dialysis after spending tens of millions of dollars on IT to "streamline operations?" Could this be an example of "Blood for Computers?" <blockquote>Board members were upset in particular about how the institution, with 12,000 employees and $1.9 billion in revenue, could be so uncertain about its financial performance last year. The central issue appears to be the proper amount of accounts receivable -- money that the system expects to collect from insurers -- as contrasted with bad debts that are unlikely to be collected. As of Nov. 30, Jackson was listing its accounts receivable at $431.8 million. ``It just doesn't tie in,'' said board member Martin Zilber. ``We talk about $400 million or $500 million like it's buying lunch.'' Ernst & Young, Jackson's auditors, are expected to present the official audited returns within the next month. ``We know there's going to be a sizable adjustment,'' Chief Financial Officer Frank Barrett told the board. But he's uncertain how much.</blockquote> Uncertain how much money will be "adjusted" in accounts receivable? Apparently all this computerization has not realized a ROI on basic financial management. Could problems with the IT (e.g., mismanaged design, mission hostile user experience, bugs, etc.) and/or mismanagement of its implementation actually be responsible for the chaos, I ask? <blockquote>... Perplexed board members heard several explanations. One is that the system has switched computer systems, and the old financial software may have been calculating bills as accounts receivable from years ago, when those items should be listed as uncollectable bad debts.</blockquote> If that was the case (and I note the "may have", implying the organization is not even certain of this explanation), why was this discrepancy not noted before or during the transition? Who, exactly, was managing this project? This would be a stunning example of IT mismanagement making what happened at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=Insufficient%20IT%20management">Yale some years ago</a> look like a cakewalk, and on par with the mismanagement at another Miami hospital, Mt. Sinai, as I posted <a href="http://hcrenewal.blogspot.com/2008/04/pearls-before-swine-hospital-gets-f-on.html">here</a>. <blockquote>... On Monday, the board was shown a presentation on bill collecting with a complex grid of flow charts and time lines. Still, some board members expressed concern about why Jackson's financial people didn't have a better handle on key measures of the system's condition.</blockquote> A question arises regarding whether the massive IT implementations are causing data irregularities, confusion, or are not functioning properly in other ways affecting financial management. <blockquote>``I don't totally understand the reasons,'' said [board member] Ernsto de la Fé. ... The fiscal 2009-2010 budget had calculated a loss of $6.5 million. Of that, $107 million was the baseline loss, reduced by $59.8 million in new revenue building ventures and $41.5 million in cost-cutting.</blockquote> "Cost cutting" usually is synonymous with "layoffs." How many millions were spent on computing instead of jobs, I wonder? Additional information on these financial difficulties are available at the Miami Herald: <blockquote> <div id="mlt_item">•<a href="http://www.miamiherald.com/living/health/costs/story/1423837.html?storylink=mirelated" alt="Jackson Health System faces more financial losses" tooltipid="mi_tt1"> Jackson Health System faces more financial losses</a></div> <div id="mi_tt1" style="display: none;"><h4>Jackson Health System faces more financial losses</h4> Looking forward and back, Jackson Health System's grim financial picture just keeps getting worse. Members of the Public Health Trust, the system's governing board, are being told: Patient volume has dropped by 6.5 percent recently, meaning that with all the cost cutting and new revenue plans, Jackson is facing an $88 million loss this fiscal year. This estimate is likely to get worse.</div> <div id="mlt_item">•<a href="http://www.miamiherald.com/living/health/costs/story/1327064.html?storylink=mirelated" alt="Donna Shalala tries to mend fences with Jackson Health" tooltipid="mi_tt2">Donna Shalala tries to mend fences with Jackson Health</a></div> <div id="mi_tt2" style="display: none;"><h4>Donna Shalala tries to mend fences with Jackson Health</h4> While Jackson Health System's governing body struggled Tuesday to find more ways to cut costs and increase revenue, University of Miami President Donna Shalala made a rare appearance before the Public Health Trust to ``personally apologize for statements by members of the university leadership team last week.'' She was referring to UM Board of Trustees Chairman Phillip George's comments to Jackson leaders that he was disturbed about the quality of doctors that Jackson had been hiring in recent years. ``I wouldn't send my family to many of them,'' George said. Shalala noted that the Jackson doctors, all fully credentialed, were often approved by UM department heads to practice at Jackson. ``If they are good enough for Jackson patients, let me tell you, they are good enough for me and my family.''</div> <div id="mlt_item">•<a href="http://www.miamiherald.com/living/health/healthcare-reform/story/1237386.html?storylink=mirelated" alt="Jackson Health System may close clinics, nursing homes" tooltipid="mi_tt3">Jackson Health System may close clinics, nursing homes</a></div> <div id="mi_tt3" style="display: none;"><h4>Jackson Health System may close clinics, nursing homes</h4> Needing to present a balanced budget for Miami-Dade Commission's approval Thursday, the Jackson Health System is proposing to close two primary care centers, both of its nursing homes, outsource inmate healthcare and reduce support to other entities that care for the poor and uninsured. ``We are in an extremely unique position,'' Chief Executive Eneida Roldan said Wednesday. The public health system is having to cut services to meet an estimated budget deficit of $133 million for its next fiscal year at a time when the commission must also deal with filling a shortfall of more than $400 million in other county programs. Some doctor services at Jackson Memorial may also be curtailed, Roldan said. ``Because Jackson has been forced to reduce its funding for the annual operating agreement with the University of Miami,'' she wrote in a message to employees, ``the university is also planning to reduce its services offered at our facilities.''</div> <div id="mlt_item">•<a href="http://www.miamiherald.com/1374/story/1402578.html?storylink=mirelated" alt="Jackson Health System's cash pot falls to dangerous levels" tooltipid="mi_tt4">Jackson Health System's cash pot falls to dangerous levels</a></div> <div id="mi_tt4" style="display: none;"><h4>Jackson Health System's cash pot falls to dangerous levels</h4> Even after plans to reduce staff and close units, Jackson Health System is getting dangerously close to its bare minimum for cash-on-hand -- a key indication of financial health. As of Oct. 31, Miami-Dade's public hospital system had 20.8 days of cash to pay its bills, including payroll and keeping the lights on. Its governing body, the Public Health Trust, has set 20 days as the lowest Jackson should go. ``When it gets below 20 days, that's when I declare an emergency,'' said Frank Barrett, chief financial officer. He said he is already talking to county administrators about getting an advance to fund payroll if the system runs out of cash.</div> <div id="mlt_item">•<a href="http://www.miamiherald.com/business/breaking-news/story/1402083.html?storylink=mirelated" alt="Jackson Health's finances continue to deteriorate" tooltipid="mi_tt5">Jackson Health's finances continue to deteriorate</a></div></blockquote></div><div style="text-align: justify;"> While IT is not a definite cause or contributor to these problems, I sense familiar patterns. Perhaps forensics related to hospital computing, the decisions to spend so many millions on the technology, and the actual impact of the implementations might shed additional light on the reasons for this apparent financial debacle. Perhaps the hospital system would have better spent that money on buttressing its financial stability, and hiring smart people to have kept better track of its finances. An analysis of these issues might likely provide a cautionary tale for hospital executives planning on massive new HIT expenditures to "streamline operations." Addendum: This is a good time to once again call attention to this paper by a perspicacious author from Down Under: <blockquote>Pessimism, Computer Failure, and Information Systems Development in the Public Sector. (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, <st1:place st="on"><st1:city st="on">University of Otago</st1:city>, <st1:country-region st="on">New Zealand</st1:country-region></st1:place>). Cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Goldfinch_pessimism_PAR.pdf">link</a> to pdf</blockquote> Feb. 11, 2010 Addendum: <a href="http://www.healthcarefinancenews.com/news/cfo-miami-health-system-resigns"></a><blockquote><a href="http://www.healthcarefinancenews.com/news/cfo-miami-health-system-resigns">CFO at Miami health system resigns</a> MIAMI – Frank Barrett, chief financial officer and executive vice president at Miami's Jackson Health System, has resigned after five years in the position. The health system's board of directors criticized Barrett strongly last week after he reported miscalculated financial losses. Barrett had revealed to the board that Jackson Health lost $203.8 million in fiscal 2009, although he had originally reported a $46.8 million loss. The projected loss for fiscal 2010 rose $87 million to $229 million.</blockquote> -- SS </div>

Electronic Medical Records and Going For Broke: Jackson Health System's Financial Future Appears Grim

I have written on numerous occasions that health IT in its present form, often poorly designed and implemented under current IT leadership ...

Đọc thêm »

The Syndrome of Useless Information

<div style="text-align: justify;">I occasionally elevate comments and replies to the level of full posts if I feel they better illustrate and clarify significant points I raise. In my Jan. 9, 2010 post "<a href="http://hcrenewal.blogspot.com/2010/01/does-ceo-of-google-use-google.html">Does the CEO of Google Use Google? - And: Platform, Platform, Who's Got The Platform?</a>" I lamented the intrusion of ill-informed, reductionistic, "database platform"-centric views of non-clinical IT personnel into healthcare. I received the following feedback from an anonymous commenter: <blockquote>Anonymous wrote: Or then again, there's this: "Non-physicians may reach correct diagnoses by using Google: a pilot study." <a href="http://www.ncbi.nlm.nih.gov/pubmed/19130327">http://www.ncbi.nlm.nih.gov/pubmed/19130327</a> "Researchers found that almost six-in-10 difficult cases can be solved by using the world wide web as a diagnostic aid." <a href="http://www.dailymail.co.uk/news/article-415562/Doctors-using-Google-diagnose-illnesses.html">http://www.dailymail.co.uk/news/article-415562/Doctors-using-Google-diagnose-illnesses.html</a> I think this post [i.e., my HC Renewal post about Google's CEO and "platforms" - ed.] misses the larger point that Gawande and Schmidt were addressing (and to some extent agree on) - the "art" of the practice of medicine must be transformed to the science of the practice of medicine. And today, science and IT are necessarily intertwined in practical terms. The future will no doubt involve ever more sophisticated and useful clinical DSS. Historically speaking, invoking the complexity argument is fraught with issue as technological advances provide better and better ways to represent and manage it. January 16, 2010 10:03:00 AM EST</blockquote> Anonymous apparently meant these article references to exemplify the coming Age of Cybernetic Miracles in medicine. My response to this anonymous feedback was placed in the <a href="http://hcrenewal.blogspot.com/2010/01/does-ceo-of-google-use-google.html#c3758917515516282280">comment thread</a> of the "Does the CEO use Google" post and covered a number of bases. I've reproduced my response, and added additional explanatory notes not in my original response in bold red italics below: <blockquote><a href="http://www.blogger.com/profile/03994321680366572701" rel="nofollow" onclick="window.open(this.href);return false;">MedInformaticsMD</a> wrote: Re: Anonymous Jan 16 @ 10:03 AM- The article [the first, at nlm- ed.] you cite reports the following: Non-physicians may reach correct diagnoses by using Google: a pilot study. OBJECTIVE: We endeavoured to determine whether individuals who are not physicians are likely to arrive at correct diagnoses [note the stated objective carefully -- "are likely to arrive at correct diagnoses" - ed.] by using Internet resources. METHODS: In this prospective study four non-physicians used Google to search for diagnoses. They reviewed the 26 diagnostic cases presented in the case records of the New England Journal of Medicine during 2005; they were blind to the correct diagnoses. The main measurement was the percentage of correct diagnoses arrived at by non-physicians by using Google. The diagnostic success of the four non-physicians was compared to that of four young physicians. RESULTS: The average diagnostic success of non-physicians was 22.1% (95% confidence interval [CI] 4.5-39.7%). There was no statistically significant difference between the non-physicians regarding this outcome (p = 0.11). They took 8.9 +/- 6.7 (mean +/- standard deviation) minutes for case record reading and 17.4 +/- 7.9 minutes for Google searching per case. Non-physicians performed worse than physicians (50.9% [95% CI 37.4-64.5%]) in regard to diagnostic success (p <0.001). CONCLUSION: Non-physicians, at least those who have similar characteristics to the participants in the present study, may occasionally reach correct diagnoses by performing a brief web-based search. Doctors should realise that patients may assume a more active role in their health decision-making process and take this development into consideration in physician-patient interaction. -------------------------- This article suffers from what can be termed "the syndrome of useless information." [It is, in fact, a failure or negative finding with regard to its stated objective - ed.] Let's see: The average diagnostic success of non-physicians was 22.1% They omit the opposite semantic: that the google-armed nonphysicians got more than three quarters of the diagnoses WRONG. Will you trust your grandmother to them? Non-physicians performed worse than [young, a.k.a. inexperienced] physicians (50.9% [95% CI 37.4-64.5%]) in regard to diagnostic success (p <0.001). Young, inexperienced physicians (trainees or residents?) arriving at 51% of the diagnoses correctly using ONLY google (not, for example, Harrison's, and other standard medical texts that would not be highly usable to most non-physicians lacking background to fully understand it) is not unexpected. What is surprising is that the article omitted an essential control group: *experienced* physicians. It's not that they're hard to find. The article concludes: Non-physicians, at least those who have similar characteristics to the participants in the present study, may occasionally reach correct diagnoses by performing a brief web-based search. Occasionally reach correct diagnoses? How about "most often reach incorrect diagnoses?" Cf. a broken clock is still occasionally correct. [I repeat, the article is, in fact, a failure or negative finding with regard to its stated objective of "determining whether individuals who are not physicians are likely to arrive at correct diagnoses." They are in fact unlikely to get it right, with only a 22% hit rate, although the authors appear to have de-emphasized that fact. This will only make physicians' work harder as they "take this development into consideration", i.e., deal with patients armed with search engine-gleaned misdiagnoses - ed.] I do not view this article as revealing anything of practical value other than perhaps the dangers of allowing non-physicians armed with search engines to think they can perform medical diagnosis to any meaningful extent. Anonymous wrote: the "art" of the practice of medicine must be transformed to the science of the practice of medicine. And today, science and IT are necessarily intertwined in practical terms. Reductionist views of non-medical IT personnel spouting off about 'database platforms' will not advance the science or the art of medicine. Also, yes, IT is a tool of science; however, it and its designers and implementers facilitate science; the enablers of science are: scientists, using their insight, creativity, ingenuity, experience and expertise. Concerning the second article [at dailymail.co.uk - ed.], I note: "But they [the authors] stress the efficiency of the search and the usefulness of the retrieved information depend on the searchers' knowledge base." [The 'searchers' in this case were apparently - experienced physicians - ed.] In other words, search engines can facilitate experts. That is not exactly new knowledge. The 'art' of medicine, i.e., judgment, likewise is both indispensible, and irreproducible via "database platforms." Perhaps one day with advances in <a href="http://news.bbc.co.uk/2/hi/sci/tech/7740484.stm" rel="nofollow">cognitive computing</a> we will get to that point, but at present we can't even do as well as a cat. Note the statement from the IBM P.I. that "there are no computers that can even remotely approach the remarkable feats the mind perform." Until we get there, I think it's not unreasonable to hold off on non-clinicians touting reductionist information retrieval-centric views. Anonymous wrote: Historically speaking, invoking the complexity argument is fraught with issue as technological advances provide better and better ways to represent and manage it. You must not have read my original post. It is advances in information science (i.e., in informatics) that will provide those advances, not advances in [information] technology. IT is a tool; information science is an activity of the mind. Your statements clearly demonstrate a conflation of information technology and information science. Computers facilitate information science research, but they are certainly not its sine qua non.</blockquote> I should also add that the second article referenced by "Anonymous" refers to "obscure conditions such as Cushing's syndrome." I'm not exactly sure to whom Cushing's disease is an obscure disease. A non-medical IT person, perhaps? Now, back to reality. Computers serve as aids to clinicians, when the IT is "done well." However, there is no substitute -- except in sci fi -- for expertise. Medical expertise can only come from ~4 years of premed and then 4+ years of <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/transcript_busm.JPG">hard medical study in a wide variety of preclinical and clinical sciences</a> leading to the M.D. degree, 3-4 years of postgraduate residency, and often 2+ additional years of <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/transcript_yale.jpg">postdoctoral fellowship training</a> beyond residency for specialists (it should be noted, unfortunately, that there are no additional medical degrees beyond M.D., although residency and fellowship training often makes pursuing a Ph.D. in most fields seem like a cakewalk). Add to all that years of additional clinical experience in actual practice. <div style="text-align: justify;">I am quite disturbed that this study and experience has become so casually regarded outside of medicine, for example in the IT sector. I think it reflects poorly on the IT culture specifically, and on our current culture as a whole. </div></div><div style="text-align: justify;">Medical judgment is borne of that study and experience, not of healthcare computer dabbling typical of the business IT/MIS world in hospitals, and the all-too-often technical bachelor's degrees held by leaders in that domain. Google CEO Schmidt at least is a true computer scientist with a doctorate in CS; that does not, however, qualify him to comment on medical and medical informatics-related issues as in my <a href="http://hcrenewal.blogspot.com/2010/01/does-ceo-of-google-use-google.html">prior post</a>. Stated frankly: he and many others with similar views are venturing far outside their competencies and as a result are talking nonsensically. Incidentally, I believe it's time to move on from continually responding to the non-medical, IT-personnel proffered platformorrhea on how IT databases, decision support, artificial intelligence etc. will transform medicine from an art to a science, revolutionize medicine, and similar positions trafficked for at least several decades now. They are largely manifestations of the Syndrome of Inappropriate Overconfidence in Computing (SICC syndrome), a term I coined in the 1990's and described is some detail <a href="http://hcrenewal.blogspot.com/2008/12/21st-century-plague-syndrome-of.html">here</a> in a post entitled "A 21st Century Plague? The Syndrome of Inappropriate Over-Confidence in Computing." At that post I stated that: <blockquote>I, for one, would welcome a cessation of claims that IT will "revolutionize" any field that depends primarily on cognition, such as biomedicine, and a return to more temperate attitudes instead of the almost bellicose grandiosity about HIT we see today. That is to say, that HIT - with proper contributions from the aforementioned specialties [e.g., social science, social informatics, biomedical informatics, HCI, etc.] will facilitate better health care, not "revolutionize" it.</blockquote> In the future, similar comments as those from "Anonymous" will simply get referred back to the post you are now reading and the bolded one on SICC above. </div> Finally, I will not hold my breath for <a href="http://en.wikipedia.org/wiki/Emergency_Medical_Hologram" title="Emergency Medical Hologram" class="mw-redirect">Emergency Medical Hologram</a> Mark I, or R2D2 and C3PO to appear anytime soon. -- SS

The Syndrome of Useless Information

I occasionally elevate comments and replies to the level of full posts if I feel they better illustrate and clarify significant points I rai...

Đọc thêm »

Why Are Health Care Organizations' Ethics Codes News?

This just in <a href="http://www.orlandosentinel.com/news/local/os-blood-bank-senate-20100113,0,7104369.story">from the Orlando Sentinel</a>, <blockquote>The head of Central Florida's largest blood bank told Florida senators Wednesday that she has completely overhauled the operation — from the boardroom to the bloodmobile. 'Believe me, I get it,' an apologetic Anne Chinoda told members of a committee investigating the business ways of Florida's Blood Centers and other blood banks across the state. Chinoda said FBC now prohibits board members from doing business with the agency, has instituted nine-year term limits for board members and has put together a group to review executive compensation. She also unveiled a blood-donor bill of rights she promised to publicize. Sen. Don Gaetz, chairman of the health regulation committee that asked Chinoda to appear, said he was pleased by her testimony. 'What we saw today was an admission of inappropriate practices in the past and a promise they will be fixed,' he said. </blockquote> These new ethical standards were a response to a past controversy, <blockquote>Gaetz's committee has been investigating FBC, which generates $100 million in revenues annually, and the statewide industry since the summer. The inquiry was triggered in part by a series of stories in the Orlando Sentinel that showed FBC board members have sold millions of dollars in goods and services to the agency each year; that board members had no term limits; and that Chinoda was compensated nearly $600,000 annually. Her salary was not discussed at the hearing. Like others in the industry, FBC gets its blood for free from donors, tests and repackages it. FBC then sells the blood to 70 hospitals and medical facilities in 21 counties in Central and South Florida. </blockquote> How often do you hear pleas from local blood banks about urgent shortages?  How often do you donate blood, or feel bad because you did not or could not donate?  Many people who selflessly donate blood were likely unpleasantly surprised to find out that blood banks sell (at a high price) the blood they donated, and used the proceeds to pay their executives generous salaries, and pay vendors run by their board members. Here was another example of a previously revered local, not-for-profit health care institution run apparently for the personal benefit of its top insider leaders. Why was it news when the organization in question adopted a code of conduct that limited self-dealing by board members, limited board members to only(?) nine-year terms, and put in place some sort or organized process to set the CEO's compensation?  Do those not seem like they ought to be standard, and not  newsworthy practices? Similarly, an article<a href="http://www.nj.com/news/index.ssf/2009/11/hackensack_hospital_tightens_e.html"> in the Newark Star-Ledger</a> back in November recounted how  Hackensack University Medical Center in New Jersey, whose board members had been accused of self-dealing (see<a href="http://hcrenewal.blogspot.com/2009/04/hospital-board-members-with-juice-in.html"> this post</a>), and to which a New Jersey state legislator had been convicted of selling his services (see <a href="http://hcrenewal.blogspot.com/2009/04/new-jersey-legislator-found-guilty-of.html">this post</a>), had instituted "tightened ethics rules," including a provision that "board members will no longer be allowed to do business with the hospital."  Again, why should a rule like this be news?  One of the duties of board members of all not-for-profit organizations is the <a href="http://www.boardsource.org/Knowledge.asp?ID=3.364">duty of loyalty</a>, "a standard of faithfulness; a board member must give undivided allegiance when making decisions affecting the organization."  Overpaying crony executives and authorizing business dealings with one's own business seem to obviously violate this duty. We have noted how the business culture of health care organizations has increasingly come to resemble the larger business culture in an era of laissez-faire capitalism and the rise of new oligarchs and robber barons.  So it is telling that it was also news when UBS, a large international bank enacted a code of ethics for its employees that required them to actually comply with "foreign tax reporting rules," (<a href="http://www.businessweek.com/news/2010-01-12/ubs-asks-workers-to-sign-code-pledging-tax-compliance-secrecy.html">per Bloomberg</a>.) One would have once thought that health care organizations, given their responsibilities for human life and health, and their formerly sterling reputations, would have clear, comprehensive codes of ethics that are actually enforced.   But it is news when a health care organization develops such a code (and it still may be news when such a code is enforced.)  <a href="http://hcrenewal.blogspot.com/2009/10/organisational-ethics-policies-primer.html">This post</a> summarized some current thinking on organizational ethics policies.  In conclusion, I asked readers to think about whether their own health care organization had anything resembling such a policy.  I suspect few could identify such policies.  Health care professionals need to inquire why health care organizations, including drug, device, biotechnology and health care information technology companies,  health care insurers, to hospitals, academic medical centers, and medical schools, etc, almost never have real organizational ethics policies.  Of course, the suspicion is that lack of such policies makes it easier for insiders to direct the organization for their personal benefit.  At least if we could make such policies the norm, we could remind organizational leaders that they are supposed to be upholding the mission, not lining their pockets.

Why Are Health Care Organizations' Ethics Codes News?

This just in from the Orlando Sentinel , The head of Central Florida's largest blood bank told Florida senators Wednesday that she has c...

Đọc thêm »

Yet Another Service Profession to be Revolutionized by IT

As in healthcare, here is yet another claim -- of the 'bellicose grandiosity' variety -- that IT will "revolutionize" a service profession.From TheHill.com:<blockquote><div class="title"> </div> <div> <a href="http://thehill.com/blogs/hillicon-valley/technology/75965-white-house-blames-inefficient-government-on-outdated-technologies">White House budget director blames old computers for ineffective government</a> By Ian Swanson - 1/14/2010 A big reason why the government is inefficient and ineffective is because Washington has outdated technology, with federal workers having better computers at home than in the office. This startling admission came Thursday from Peter Orszag, who manages the federal bureaucracy for President Barack Obama. The public is getting a bad return on its tax dollars because government workers are operating with outdated technologies, Orszag said in a statement that kicked off a summit between Obama and dozens of corporate CEOs. ... “It’s time to bring government into the 21st century,” Orszag said. “Information technology has the power to transform how government works and revolutionize the ease, convenience and effectiveness by which it serves the American people."</div></blockquote> I really wish that claims of IT and revolutions would cease. Perhaps the word "increase" (as in "increase the ease, convenience and effectiveness by which government serves the people") would be more accurate and indeed less hysterical. When you do hear the "R" word in association with computers, though, think very big bucks for the industry and for the management consultants, and a massive amount of uncompensated clerical work and aggravation for the profession to be "revolutionized." -- SS

Yet Another Service Profession to be Revolutionized by IT

As in healthcare, here is yet another claim -- of the 'bellicose grandiosity' variety -- that IT will "revolutionize" a se...

Đọc thêm »

Meaningfully Experimental Protocols and Interfaces to Nowhere? Nagging Questions On Healthcare IT Remain

Despite a massive push in our (yet-unnamed) U.S. national program for health IT in the past year (which I shall christen as the NPfIT in the HHS), nagging questions about healthcare IT remain. The first regards the Public Comment period on the "Meaningful Use" criteria for HIT, part of the <a href="http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a7c4a8">Medicare and Medicaid Programs; Electronic Health Record Incentive Program</a> Proposed Rule: <blockquote> This proposed rule would implement the provisions of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) that provide incentive payments to eligible professionals (EPs) and eligible hospitals participating in Medicare and Medicaid programs that adopt and meaningfully use certified electronic health record (EHR) technology. The proposed rule would specify the initial criteria an EP and eligible hospital must meet in order to qualify for the incentive payment; calculation of the incentive payment amounts; payment adjustments under Medicare for covered professional services and inpatient hospital services provided by EPs and eligible hospitals failing to meaningfully use certified EHR technology; and other program participation requirements. </blockquote> Perhaps submitting comments in the public forum of a blog will spread the message further than through the method above... As I wrote in Oct. 2009 at "<a href="http://hcrenewal.blogspot.com/2009/10/washington-post-article-electronic.html">Washington Post Article: Electronic medical records not seen as a cure-all</a>", there is a major problem with the term "meaningful use" itself: <blockquote> This [term "meaningful use"] is an example of putting the cart before the horse, and is a semantically-based, self contained logical fallacy of sorts. If a health IT system is harmful, the term "meaningful use" is itself Orwellian. If we don't know if HIT is beneficial, or have doubts, then such as term presupposes that health IT is inherently beneficial. A better term would have been "good faith use" - use based on the faith or hope that health IT will have an overall positive effect. The term "meaningful use" jumps the gun and is more a political slogan than a "meaningful term."</blockquote> I go further. Use of a term that a priori assumes some outcome reflects the antithesis of science. The term "meaningful use" in the domain of technology implies that those following the recipe for use of some technology, as well as their subjects, will experience meaningful outcomes. A parallel is in the logical fallacy of <a href="http://www.logicalfallacies.info/presumption/begging-the-question/">begging the question or circular argument</a>, where the conclusion of an argument is among its premises. 'A priori knowledge' is knowledge known independently of experience, i.e., from reason alone; 'a posteriori knowledge' is knowledge proven through experience. To say we as a society have a priori knowledge of the benefits of health IT would unarguably be an absurdity; to say we have uncontested a posteriori knowledge of same is, quite simply, a lie. Evidence of the portable, healthcare-improving qualities of health IT in its current form has been <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=other">weak</a>, and the literature challenging this often technologically-deterministic position <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=2009">is growing</a>. In scientific research, an <a href="http://en.wikipedia.org/wiki/Experiment">experiment</a> (Latin: ex- periri, "to try out") is a method of investigating causal relationships among variables, or to test a hypothesis. An experiment is a cornerstone of the empirical approach to acquiring data about the world and is used in both natural sciences and social sciences. The truth is that healthcare IT remains an experiment, using virtual medical IT devices that are entirely unregulated. The "meaningful use" criteria, basically arrived at by opinions and committee consensus, must be viewed in that framework. (I note that some NPfIT experiments in <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">other lands</a> have not been very successful). When the criteria are viewed in, say, the framework of a NIH grant proposal for testing some new technology, the correct term is not "meaningful use", it is "experimental protocol" or "research protocol." The government is paying for physicians to follow an experimental protocol, reimbursing them for part of the expense and labor, in the hope that the experiment will have beneficial effects and no major adverse side effects on the practice and financing of medicine. If one accepts the premise that HIT -- and our collective understanding of how to design and implement it -- is fully proven and ready for societal rollout (which is the operative assumption of our government - witness the duress of penalties), then one is not following the methodologies of science. If, on the other hand, one accepts that it *is* an experimental technology, then one should also accept that the current rollout plans are nonscientific in the extreme. This is simply not how ethical biomedical research is conducted, e.g, without the consent of the subjects (patients) -- indeed, with actual coercion of the healthcare professionals -- and without regulation of the experimental technologies. I therefore ask the following nagging but important question: why is the term "meaningful use" even in the lexicon of the U.S. NPfIT in the HHS? Why should physicians buy into this program? Why should they not instead refuse to participate in an experiment that could waste their time or cause adverse consequences for which they are liable? Why should those who do participate not calculate the person-hours required to perform the experimental tasks as specified by the experimental protocol, and charge for their time and labor accordingly? (See some related points at the vendor post "<a href="http://blog.srssoft.com/2010/01/readers-respond-the-exorbitant-cost-of-meaningful-use/">Readers Respond: The Exorbitant Cost of Meaningful Use</a>" at the <a style="font-weight: bold;" href="http://blog.srssoft.com/">EMR Straight Talk</a> site. Note: I have no relationships with, or connections to, this vendor.) Further, what is missing in the experiment of unregulated IT medical devices is robust risk assessment, adverse events reporting, and perhaps most importantly, patient informed consent. It is also unclear if the <a href="http://hcrenewal.blogspot.com/2009/03/health-it-hold-harmless-and-defects-gag.html">"hold harmless" and "defects nondisclosure" clauses</a> traditional in IT contracting, and that likely violate healthcare leadership fiduciary responsibilities and joint commission safety standards, will be forbidden in this grand experiment. A second nagging question arises regarding a somewhat perplexing announcement: a HIT vendor's product that provides data interchange (i.e., an interface apparatus) between EMRs and other medical devices has received <a href="http://money.cnn.com/news/newsfeeds/articles/globenewswire/181482.htm">FDA pre-marketing clearance</a>, making it available for sale. On an Interface to Nowhere:<blockquote> Thousands of medical devices are used in hospitals, physician offices and homes to help clinicians provide better care to patients. Medical devices are used to monitor patient vital signs, infuse medication and even help patients breathe. These devices capture important information about patient health, but oftentimes that information resides in disparate systems outside of the patient's electronic health record (EHR). To solve this problem, [vendor] created the CareAware device connectivity architecture to connect medical devices to the EHR, enabling bi-directional data sharing between medical devices and the patient record. The[vendor] CareAware iBus, a solution that connects medical devices to the EHR to support the entire care process, recently received 510(k) pre-market clearance from the U.S. Food and Drug Administration and is now available in the United States and all U.S. territories. </blockquote> Here is the question: How is it possible that an intermediary apparatus to interface medical devices to an EHR can be subject to FDA approval, but the EHRs themselves that this intermediary apparatus interfaces the devices to can be entirely unregulated? EHRs are not subject to FDA approval or any other regulatory agency's evaluation and approval whatsover. Further, why is the FDA marginalized to the point where the only component of HIT they evaluate and approve are interfaces? This is a somewhat jarring violation of common sense and first principles of systems thinking: that systems should be evaluated in their entirety, as unexpected adverse consequences are often the result of system-related failures exacerbated by the "weak links" in the system. This probably also violates the principles of resilience engineering, a term I first learned after <a href="http://www.scribd.com/doc/12392282/To-The-Moon-In-A-Hot-Air-Balloon-Why-Is-Clinical-IT-Difficult">presenting on IT difficulties to the IEEE Medical Technology Policy Committee</a> a few years ago. With regard to these nagging questions, I'm just asking. Let the reader decide if these are reasonable questions regarding their medical care. I doubt I will receive official answers to my <a href="http://en.wikipedia.org/wiki/L%C3%A8se_majest%C3%A9">lèse majesté</a>. -- SS

Meaningfully Experimental Protocols and Interfaces to Nowhere? Nagging Questions On Healthcare IT Remain

Despite a massive push in our (yet-unnamed) U.S. national program for health IT in the past year (which I shall christen as the NPfIT in the...

Đọc thêm »