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Doctors' Dubious Excuses for Taking Pharmaceutical Companies' Money

Pro Publica has updated their database of payments by pharmaceutical payments to physicians and organizations.  It now has data from 15 companies totaling more than $2 billion from 2009 to 2012. To accompany <a href="http://www.propublica.org/article/dollars-for-docs-mints-a-millionaire">Pro Publica's report</a>, a number of news outlets wrote about payments given to local or regional doctors.  These included, in semi-random order, the Los Angeles Daily News (<a href="http://www.dailybulletin.com/breakingnews/ci_22751458/california-doctors-report-prescription-drug-company-payments-speaking-engagements">via the Inland Valley Daily Bulletin</a>), the <a href="http://www.sltrib.com/sltrib/news/55962410-78/drug-research-drugs-industry.html.csp">Salt Lake (City, Utah) Tribune</a>, the <a href="http://www.mercurynews.com/breaking-news/ci_22776326/drug-companies-pay-millions-california-doctors-speaking-meals">San Jose (California) Mercury News</a>, <a href="http://www.newschannel5.com/story/21592977/nashville-psychiatrist-paid-more-than-1m-by-drug-companies">NewsChannel5</a> in Nashville, Tennessee, the <a href="http://www.pasadenastarnews.com/news/ci_22769057/city-hope-area-doctors-receive-funding-from-drug">Pasadena (California) Star-News</a>, the Bergen and Passaic, New Jersey Record Herald via<a href="http://www.northjersey.com/news/Drug_firms_paid_2B_to_doctors_to_pitch_products_and_conduct_research_study_says.html"> NorthJersey</a>, the <a href="http://articles.philly.com/2013-03-14/news/37654205_1_joseph-pharmaceutical-giants-foot-doctor">Philadelphia Inquirer</a>, and the <a href="http://www.dispatch.com/content/stories/local/2013/03/17/prescription-for-conflict.html">Columbus (Ohio) Dispatch</a>. The combined reports showed that many physicians, including prominent academics and community practitioners, are still getting a lot of money from pharmaceutical firms.  Since Pro Publica was only able to get data from some US drug companies, albeit those who accounted for 47 percent of US drug sales, it is likely that many more doctors than those in the data base got such payments, and the doctors in the data base may have gotten more money from companies that do not report their payments.  In addition, it is likely that many more doctors get similar payments from medical device companies, health care information technology companies, and other for-profit corporations that promote health care products and services.   We had discussed Pro Publica's initial reporting from its database <a href="http://hcrenewal.blogspot.com/2010/10/not-best-and-brightest-drug-marketers.html">here</a>.  While there is evidence that most payments to doctors by pharmaceutical companies are intended to promote marketing, we discussed <a href="http://hcrenewal.blogspot.com/2010/11/of-drug-talks-deception-and-denial.html">here</a> how some doctors rationalized their payments as fully professional and proper. Now the updated reporting has provided many examples of - not to put too fine a point on it - physicians making dubious excuses for their acceptance of payments, often large, from pharmaceutical companies. Their themes included It's Education, What Could Possibly Go Wrong? From Pro Publica, <blockquote class="tr_bq">[Dr Rakesh] Jain, of Lake Jackson, Texas, has earned $582,049.  [Dr Vladimir] Maletic, of Greer, SC, made $527,850<a href="http://projects.propublica.org/docdollars/search?utf8=%E2%9C%93&term=Vladimir+Maletic&state%5Bid%5D=&services%5B%5D=&period%5B%5D=">,</a> according to Dollars for Docs.</blockquote> So, <blockquote class="tr_bq">Jain said he loves teaching and delivers the same lectures about drugs and medical conditions regardless of whether a drug company is paying him. 'I am not a marketer, I am an educator,' Jain said.</blockquote> Also <blockquote class="tr_bq">Maletic said he speaks about treatments for mood disorders, schizophrenia and sleep-wakefulness disorders because he believes that 'good quality education about pharmaceutical products may be beneficial to both physicians and their patients.'</blockquote> The LA Times found someone with a similar opinion. <blockquote class="tr_bq">'Pharmaceutical companies used to take doctors to dinner, but that was banned years ago,' said Dr. Arthur Chanzel Jeng, an infection control specialist at UCLA-Olive View Medical Center in Sylmar.  'Now they must provide some educational content.' Jeng was paid $80,500 by Pfizer last year for several speaking engagements. As an infection control specialist at Olive View, he and others in his field are concerned about drug resistant diseases and the limited number of antibiotics. Drug companies have little incentive to produce new antibiotics, he said, so if they do, physicians in his field want to know more about the drugs. That's why he agrees to speak. 'We (speakers) provide education when a new antibiotic does get released,' he said. 'There needs to be education among doctors on how to use this new antibiotic.'</blockquote> In addition, the Salt Lake Tribune noted that  <blockquote class="tr_bq"><div class="TEXT_w_Indent">[Dr Eliot] Brinton received two of the single largest payments in Utah, both in excess of $85,000, for promoting drugs by GlaxoSmithKline, ProPublica’s database shows. He describes the lectures as educational and based on science.</div><div class="TEXT_w_Indent"> </div><div class="TEXT_w_Indent">'I love the science and I love to teach. And doctors are glad to better understand the drugs and how to use them. I’m careful not to act as a cheerleader,' he said. 'If I’m a shill for the drug company I lose my integrity and integrity is really all I have to offer my patients and the drug companies.'</div></blockquote> The physicians above all asserted that since their activities were "educational," they must be worthwhile. Note that the ostensibly educational activities described above all appear to be "drug talks," that is talks sponsored by the drug companies, probably through speakers' bureaus, and given probably not as part of formal, accredited continuing medical education.  Since the publication of "Dr Drug Rep" in the New York Times in 2007, the public has learned that such talks mainly include content provided by the pharmaceutical companies, and are meant by the companies as marketing exercises.  From that case we also learned that physicians who deviate from the marketing message do not last long on speakers' bureaus.  (See posts <a href="http://hcrenewal.blogspot.com/2007/11/is-it-medical-education-or-is-it.html">here</a> and <a href="http://hcrenewal.blogspot.com/2007/11/most-popular-dr-drug-rep.html">here</a>.)  In addition, pharmaceutical companies often pay physicians deemed to be "<a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">key opinion leaders,</a>" whose opinions are promoted supposedly for their brilliance and erudition.  However, as noted <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/10/not-best-and-brightest-drug-marketers.html">here</a>, the companies buying their services believe they have bought the services of sales people.    Evidence about key opinion leaders actually performing like marketers has come from documents revealed during litigation (e.g., see this <a href="http://hcrenewal.blogspot.com/2012/07/giant-gsk-settlement-provides-reminder.html">recent example</a> of a huge monetary settlement made of charges that GlaxoSmithKline, a major multinational drug company committed fraud among other things, and in the course of its unethical activities used key opinion leaders as marketers).   Also, see the Neurontin marketing plan (see post <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a>), and the Lexapro marketing plan (see post <a href="http://hcrenewal.blogspot.com/2009/09/lexapro-marketing-plan-was-meant-to.html">here</a>) for examples of how company keaders view key opinion leaders as marketers. Given the volume of evidence about drug talks, speakers' bureaus, and the marketing purposes of key opinion leaders, the assertion that because they were in some sense educational, these doctors' corporate financed talks were worthwhile is at best a silly excuse. More formally, it may arise from a logical fallacy.  The doctors appeared to be arguing that education is an unalloyed good.  However, obviously not all education is good education, or unbiased education. Specifically in this case, logic, and evidence from several cases in which pharmaceutical companies' intentions as documented in communications revealed in litigation (see examples <a href="http://hcrenewal.blogspot.com/search/label/stealth%20marketing">here</a>) suggest that these companies pay physicians for education that they believe serves marketing purposes.Thus the doctors seem to be using the <a href="http://www.nizkor.org/features/fallacies/composition.html">composition fallacy</a>, the logical fallacy that an entire class (in this case, all of education) can be judged by some of its members (examples of unbiased, accurate, good education.)  <div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">It's Research, What Could Possibly Go Wrong?  </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Similarly, the doctors who get paid to do research say it's all about the research.  The Salt Lake Tribune reported on</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote class="tr_bq"><div class="TEXT_w_Indent">CRI LifeTree Research, which has received at least $3.4 million in drug company payments since 2009, according to ProPublica. </div><div class="TEXT_w_Indent"> </div><div class="TEXT_w_Indent">Co-founder <a href="http://www.crilifetree.com/lynnwebster" target="_blank">Lynn Webster</a>, an anesthesiologist, is listed as having received the single largest payment in the state: $1,687,771 from Cephalon, a big maker of pain medications. Only three other doctors in the country received more from Cephalon. </div><div class="TEXT_w_Indent"> </div><div class="TEXT_w_Indent">Nationally, Webster is among the top 50 for single largest payments received, behind marquee hospitals, such as the Mayo Clinic, Cleveland Clinic and Duke and Harvard Universities.</div><div class="TEXT_w_Indent"> </div><div class="TEXT_w_Indent">A nationally recognized expert in pain management, Webster <a href="http://www.sltrib.com/sltrib/news/55905155-78/pain-webster-patients-deaths.html.csp" target="_blank">is under investigation</a> by the U.S. Drug Enforcement Administration, which is looking into opioid overdose deaths of patients of his former pain clinic. A Senate Committee is probing his financial ties to Big Pharma.</div></blockquote><div class="TEXT_w_Indent"> </div><div class="TEXT_w_Indent">Webster insisted,</div><div class="TEXT_w_Indent"> </div><blockquote class="tr_bq"><div class="TEXT_w_Indent">Research payments to him cover overhead and other costs, including his salary as a lead researcher, he said. </div><div class="TEXT_w_Indent"> </div><div class="TEXT_w_Indent">'Research inevitably leads to better education, better systems and better therapies — things that are indispensable for medical advancement and quality care,' he said. </div></blockquote><div class="TEXT_w_Indent"> </div><div class="TEXT_w_Indent">The Pasadena Star-News provided this version,</div><div class="TEXT_w_Indent"> </div><blockquote class="tr_bq"><div class="TEXT_w_Indent"></div>Pasadena-based plastic surgeon John Edward Gross received more than $770,000 from Allergan, the maker of Botox and some breast implants. In 2011-12, Allergan paid Gross to conduct research, consult, serve on health care panels and business travel. 'What I'm doing for Allergan is to advance breast surgery,' said Gross, a board certified surgeon and a former chemical engineer. 'Much of the research you do is industry-supported. They have a motivation to make better and new products.' </blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">It is pretty amazing to see the notion that all clinical research is irreproachable in print.  We and others have documented huge numbers of cases and volumes of evidence that clinical research may be <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulated</a>, and, if necessary, <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed</a> to support the commercial goals of those who make products or provide services assessed by such research.  In fact, the prestigious Institute of Medicine's <a href="http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx">report </a>on Conflict of Interest in Medical Research, Education and Practice included the recommendation (4.1) that "individuals may not conduct research with human participants if they have significant financial interest in an existing or potential product or a company that could be affected by the outcome of research."  Given the volume of this evidence, the assertion that all pharmaceutical company clinical research should be irreproachable is just plain silly. Again, formally the physicians' arguments, if they should be dignified with that name, seem to arise from the same logical fallacy discussed above.  The underlying argument seems similar to that made above about education: "I am doing research.  All research is good, unbiased, helpful to patients.  So what I am doing is good, unbiased, helpful research."  So it appears the composition fallacy again was in play.</div><div class="TEXT_w_Indent"> </div></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">It's Not Really My Money</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">The San Jose Mercury News provided this example,</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><blockquote class="tr_bq"><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">The database links Dr. Gurkirpal Singh to more than $248,000 in Pfizer payments it lists for speaking, consulting, travel and meals since 2009. He said all the money went to Institute of Clinical Outcomes Research and Education in Palo Alto, where he is the chief scientific officer. Singh said the money paid for research. </div></blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote>'I receive nothing -- let me be very clear on that,' said Singh, who is an adjunct clinical professor at Stanford University.</blockquote> The Columbus Dispatch added, <blockquote class="tr_bq"> Dr. Henry Nasrallah, a psychiatrist at the University of Cincinnati, netted $647,341 in speaking and consulting fees from drug companies, ranking him as Ohio’s top recipient of such payments over that four-year period. Cincinnati’s College of Medicine put that money toward his $222,232 annual salary. 'The (pharmaceutical) companies have a signed agreement with the university for my activities, not with me personally,' Nasrallah wrote in an email to The Dispatch. 'This is another reason why I maintain scientific and clinical impartiality about the various drugs I teach, because I do not have a direct personal gain,' wrote Nasrallah, a former chairman of Ohio State University’s psychiatry department.</blockquote></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Really, the boss doesn't care whether he brings in any money? </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"></div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">These doctors seem to be denying that money is fungible.  In other words, they seem to be arguing that money going to the organizations that pays them is different from money going directly to them, and that their bosses do not in fact care whether their activities bring any revenues to the organization.  This just flies in the face of common sense. </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">Someone Needs to Pay</div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">NewsChannel5 was able to interview the top earner on the Pro Publica list, Dr Jon W Draud, who said among other things,  </div><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"> </div><blockquote class="tr_bq"><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;">it was only fair to accept payments for his speaking engagements because it makes up for what he would otherwise make while working at his practice.</div></blockquote><div style="background-color: white; border: medium none; color: black; overflow: hidden; text-align: left; text-decoration: none;"><blockquote> 'It's not essential, I suppose, but I consider it a reasonable, fair compensation for being gone and traveling, and spending time away from my home and family,' Draud said.</blockquote>If Dr Draud was providing education, a useful service, it seems reasonable that someone should pay for it.  However, he appears to <a href="http://www.nizkor.org/features/fallacies/begging-the-question.html">beg the question</a> of who should pay for it?  Underlying this question is the concern that since it was pharmaceutical companies, not students, who were paying, the education was being done primarily to benefit the former, through marketing, rather than the latter.  The apparent argument, that because it is not reasonable to get paid for services, any source of payment is acceptable, is again just plain silly.  Who Cares About Money? NewsChannel5 also reported that Dr Draud said <blockquote class="tr_bq"> accepting so much money did not create a conflict of interest between him and his patients. He said the information he gives out was not biased towards the drug companies.</blockquote> However, the Institute of Medicine<a href="http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx"> report </a>on Conflict of Interest in Medical Research, Education and Practice defined conflict of interest as "circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest."  Asserting that receiving over $1 million could not create even a risk that his educational presentations were biased towards the interests of those who gave him that money seems like simple denial.   The FDA Said it Was True Top earner Dr Draud also said according to NewsChannel5, <blockquote class="tr_bq"> It has to be vetted by the FDA as being fair, balanced and non-biased toward the pharmaceutical company....</blockquote> From the Philadelphia Inquirer, re Dr Warren S Joseph, a podiatrist who received over $650,000 <blockquote class="tr_bq">Joseph acknowledged the payments in an email to Philly.com. 'All of my lectures given for the Pharma industry follow strict FDA guidelines and are consistent with the corporate integrity agreements entered into between the companies and the government,' Joseph said. 'There is full disclosure of this fact at all lectures.'</blockquote> These justifications appear to be just plain wrong.  As far as I know, the US Food and Drug Administration does not pre-approve "drug talks" given by physicians for pharmaceutical companies. By the way, the statement by Dr Joseph approaches self parody.  As we have discussed, <a href="http://hcrenewal.blogspot.com/search/label/corporate%20integrity%20agreements">corporate integrity agreements</a> are usually the products of legal settlements of charges of wrongdoing.  Drug companies do not sign such agreements because of previous good behavior.  Moreover, I have never heard of such an agreement that required pre-approval of drug talks, either.   Trust Me, I'm an Expert  As reported by NorthJersey, <blockquote class="tr_bq">One of the top recipients in North Jersey was Thomas Dayspring, an internist and expert in cholesterol management, who earned just under $400,000 from Merck and GlaxoSmithKline. Dayspring said he was paid for lectures at conferences for doctors arranged by the drug companies, as well as continuing medical education programs. 'I’ve logged over 2 million miles, all over the world and in all 50 states,' said Dayspring, who served as the director of the North Jersey Institute of Menopausal Lipidology in Wayne until last summer. 'Guys like me who are nationally known attract a big audience. Not every speaker can trot out a CV like mine.'</blockquote>New Jersey, you gotta love it.  The most charitable characterization of this is an <a href="http://www.nizkor.org/features/fallacies/appeal-to-authority.html">appeal to authority</a>, albeit an amazingly egotistical one.  Summary  Two years after Pro Publica's report, pharmaceutical companies are continuing to pay substantial sums to physicians and other health professionals, nominally for education and research.  Because these arrangements are financially beneficial to the professional recipients of the money, and likely financially beneficial via their marketing effects  to the companies that provide the money , it should be no surprise that they are continuing in the absence of any regulatory restrictions. What is saddest about the latest reporting is the silliness of the excuses made by the conflicted physicians.  Professionals with four years of education post-college, and multiple years of experience, and who are often respected as academics or practitioners ought to be able to reason and argue better than they did in the examples above.  Of course, people who make a lot of money often come to believe they really deserve it.  And conflicts of interest produce conflicted thinking.  As Joe Collier wrote in the BMJ, " people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult." (Look<a href="http://hcrenewal.blogspot.com/2006/06/british-medical-journal-highlights.html"> here</a>.) The IOM  <a href="http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx">report </a> on conflicts of interest suggested full disclosure of all payments that could be considered conflicts of interest, banning clinical research by conflicted individuals, prohibiting academic physicians from giving "drug talks" whose content was provided by industry, and developing methods to fund continuing medical education independent from industry.  This report, and its recommendations have gotten scant attention, maybe because they would threaten a status quo that enriches conflicted health professionals and the companies that create these conflicts.  However, in my humble opinion, implementing all the report's recommendations would only be a beginning down the road of restoring the integrity of clinical care, teaching, and research.   </div>

Doctors' Dubious Excuses for Taking Pharmaceutical Companies' Money

Pro Publica has updated their database of payments by pharmaceutical payments to physicians and organizations. It now has data from 15 comp...

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Bad Science (and Perhaps Conflict of Interest) At ONC / HHS

This article recently appeared, quoting <a href="http://www.healthit.gov/newsroom/jacob-reider-md" target="_blank">Jacob Reider, M.D.</a>, chief medical officer at ONC on an upcoming Health IT Safety Plan: <blockquote class="tr_bq">Health Data Management <a href="http://www.healthdatamanagement.com/news/HIMSS13-ONC-HIT-safety-plan-45809-1.html" target="_blank">http://www.healthdatamanagement.com/news/HIMSS13-ONC-HIT-safety-plan-45809-1.html</a>  ONC Sets Early Summer for Release of HIT Safety Plan The Office of the National Coordinator for Health Information Technology anticipates releasing a final health information technology safety plan by early summer, officials announced on March 5 at HIMSS13 in New Orleans. ONC released a draft plan in December and accepted public comment until February 4. The draft followed an Institute of Medicine report that ONC commissioned that highlighted the need for better understanding of the HIT impacts on safety, as well as shared responsibilities among all stakeholders to improve safety, Jodi Daniel, director of the ONC office of policy and planning, said during an educational session. There is little doubt that use of I.T. results in fewer medical errors, particularly medication-related because of electronic prescriptions and clinical decision support, noted Jacob Reider, M.D., chief medical officer at ONC. “It’s obvious that in many areas there will be fewer errors, but at the same time, in other areas there will be more errors.” Consequently, a priority of the plan will be implementing a framework to help the industry better understand what the trouble areas will be as I.T. use increases. Less than 1 percent of patient safety events are related to HIT, Reider contended, but the industry needs more data to better understand the level of harm from such events and how to improve the technology. HIT-related errors, he reminded the audience, are not always the fault of vendors; providers can introduce risk when customizing their systems. </blockquote> The upcoming safety plan release is fine and good, but I, for one, wonder if it can be trusted. The level of bias and lack of knowledge of the domain, evidence of incomplete research, and/or poor scientific judgement inherent in the statements I bolded above are disturbing.  They are also  reminiscent of the problems in the ONC-authored paper discussed <a href="http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html" target="_blank">at this link</a>. First: <ul><li>There is little doubt that use of I.T. results in fewer medical errors</li></ul> On the contrary, there is significant well-researched doubt in that the evidence is quite contradictory.  Let's cite the IOM's 2012 report on health IT risk: <blockquote class="tr_bq">… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect.   </blockquote><blockquote> IOM (Institute of Medicine) 2012. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">Health IT and Patient Safety: Building Safer Systems for Better Care</a> (PDF). Washington, DC: The National Academies Press.</blockquote> Let's quote one of the IOM study panel members, an international authority on safety, <a href="http://hcrenewal.blogspot.com/2013/03/dr-richard-cook-on-health-it-sectors.html" target="_blank">Dr. Richard Cook</a>: <blockquote class="tr_bq">... HIT's cornucopia has been promised repeatedly since the 1960's. Nothing like the promises has materialized.  Indeed, the IOM committee that was commissioned to evaluate the best evidence on this subject found no persuasive evidence that HIT improved patient safety. I know because I was there.  </blockquote> The body of literature <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist" target="_blank">here</a> also contains relevant studies contradicting Dr. Reider's quoted, dispositive statement. Next: <ul><li>It’s obvious that in many areas there will be fewer errors</li></ul> This statement requires no response, but I'll respond anyway.   In science, stating something is "obvious" (i.e., what is referred to at the site "<a href="http://www.themathlab.com/geometry/funnyproofs.htm" target="_blank">36 Humorous Methods of Proof</a>" as "Proof by obviousness") is, on its face, bad science. Next: <ul><li>Less than 1 percent of patient safety events are related to HIT</li></ul> The aforementioned IOM report was quite clear on the following: <blockquote class="tr_bq">... Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety. ... The magnitude of the risk associated with health IT is not known.</blockquote> Likewise, FDA has concluded that what they know on HIT-related patient safety events is likely "<a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html" target="_blank">t</a><a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html" target="_blank">he tip of the iceberg</a>"  due to systematic impediments to knowing, as has the ECRI Institute who has only now begun to study the issue with any degree of rigor.  (The results are of great concern to anyone who should know, or should have made it their business to know, as <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html" target="_blank">at this lin</a><a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html" target="_blank">k</a>.) Perhaps Dr. Reider needs a lesson on basic <a href="http://plato.stanford.edu/entries/epistemology/" target="_blank">epistemology</a>:  "We simply don't know what we don't know." Finally: <ul><li>HIT-related errors, he reminded the audience, are not always the fault of vendors; providers can introduce risk when customizing their systems. </li></ul> I find it remarkable that a government official uses a public/industry platform HIMSS to defend an industry, while at the same time stating more study is needed to understand the causative factors of harm from the industry's products. This raises the question of conflict of interest, and the possibility this official is not impartial or trying to be "fair" but aiming towards protecting an industry he once worked for - and to where he's likely to return at some point.  (See Roy Poses' posts on "<a href="http://hcrenewal.blogspot.com/search/label/revolving%20doors" target="_blank">revolving doors</a>" for examples of that.) From his government biography <a href="http://www.healthit.gov/newsroom/jacob-reider-md" target="_blank">her</a><a href="http://www.healthit.gov/newsroom/jacob-reider-md" target="_blank">e</a>: <blockquote class="tr_bq">Dr. Jacob Reider Director, Office of the Chief Medical Officer Jacob Reider, MD is a family physician with 20 years of experience in health information technology and special interest in clinical innovation, user experience, and clinical decision support. His background includes leadership roles in nearly all facets of the health IT domain – from small start-up companies to academic facilities, primary care medical groups, and large health IT development organizations. Dr. Reider has served as a member of the Board of Trustees of the American Medical Students Association, the Society of Teachers of Family Medicine, and has served in directorial positions on boards of several innovative health IT companies. </blockquote>   I note I do not find evidence of formal medical informatics education, which selfsame ONC recommends for leadership roles in health IT (see my Dec. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/12/onc-defines-taxonomy-of-health-it.html" target="_blank">ONC Defines a Taxonomy of Robust Healthcare IT Leadership</a>"), but I do find roles <a href="http://www.linkedin.com/in/jacobr" target="_blank">such as</a>: <blockquote class="tr_bq">Chief Medical Informatics Officer <a href="http://www.allscripts.com/" target="_blank">Allscripts</a> June 2009 – January 2011 (1 year 8 months) Medical Director <a href="http://www.allscripts.com/" target="_blank">Allscripts</a> March 2007 – June 2009 (2 years 4 months) Chief Medical Officer MedRemote (Now <a href="http://www.nuance.com/healthcare/services/dragon-CertifiedEHRs/dragon-works.asp" target="_blank">Nuance</a>) November 1999 – December 2002 (3 years 2 months) </blockquote> One might reasonably wonder what personal gains might accrue to Dr. Reider from the promotion of health IT - which includes downplaying its current risks - from an influential government perch.  (I for example held many Merck stock options after my late 2003 departure.  They remained underwater until expiration, but even a a $10 or $20 increase in stock price could have bought me, say, a new sports car or even house.) I also note that the former CEO of Allscripts, Glen Tullman was, in fact, a close confidant of our current President and <a href="http://www.allscripts.com/en/company/about-us/leadership/bio-tullman.html" target="_blank">advisor on health IT</a> during his first campaign: <blockquote class="tr_bq">A tireless advocate of technology in medicine, Tullman has been featured in virtually every major news outlet. An early supporter of fellow Chicagoan Barack Obama, Tullman introduced him to the Electronic Health Record (EHR) and served on his finance and healthcare committees during the 2008 presidential campaign. </blockquote> Is it any wonder, then, that my expectation is that the forthcoming ONC HIT safety plan will be biased towards industry, reflect poor science and incomplete/selective research, and overall be a <a href="http://en.wikipedia.org/wiki/Whitewash_%28censorship%29" target="_blank">whitewash</a>? I'll be presenting on issues such as this to the Plaintiff's Bar.  They seem to be the last protectors of people's/patient's rights where clinical IT is concerned - a role they seem most familiar with in other sectors. I emailed Dr. Reider a link to this post with a request that if he has robust evidence to support his assertions that is not publicly available, to please release it. -- SS Mar. 16, 2012 Addendum:  A correspondent asked me the following that I thought deserved mention beyond the comments section: <blockquote class="tr_bq">"How would he know, exactly, when we know, that they never tallied the thousands of e-Rx errors from a national Siemens defect that was disclosed only at the Brown Medical Center Hospitals (Lifespan) but was a systemwide defect; nor from the Cerner convert to e-Rx defect that was evident at the Trinity Health System; and millions of other errors from when the e-Rx system was unavailable. Or, do they simply do not count those?"</blockquote> My response?  No, they probably consider those "anecdotal."  -- SS

Bad Science (and Perhaps Conflict of Interest) At ONC / HHS

This article recently appeared, quoting Jacob Reider, M.D. , chief medical officer at ONC on an upcoming Health IT Safety Plan : Heal th Da...

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IRS faces class action lawsuit over theft of 60 million medical records

Try this with paper records.  This is spectacular (as in, spectacularly alarming) if true: <blockquote class="tr_bq"><a href="http://www.healthcareitnews.com/news/irs-face-lawsuit-over-theft-60-million-patient-health-records?topic=08%2C18" target="_blank">IRS faces class action lawsuit over theft of 60 million medical records</a> The Internal Revenue Services is now facing a class action lawsuit over allegations that it improperly accessed and stole the health records of some 10 million Americans, including medical records of all California state judges. According to a <a href="http://www.courthousenews.com/2013/03/14/55707.htm">report</a> by Courthousenews.com, an unnamed HIPAA-covered entity in California is suing the IRS, alleging that some 60 million medical records from 10 million patients were stolen by 15 IRS agents. The personal health information seized on March 11, 2011, included psychological counseling, gynecological counseling, sexual/drug treatment and other medical treatment data. "This is an action involving the corruption and abuse of power by several Internal Revenue Service agents," the complaint reads. "No search warrant authorized the seizure of these records; no subpoena authorized the seizure of these records; none of the 10,000,000 Americans were under any kind of known criminal or civil investigation and their medical records had no relevance whatsoever to the IRS search. IT personnel at the scene, a HIPPA facility warning on the building and the IT portion of the searched premises, and the company executives each warned the IRS agents of these privileged records," it continued.   According to the case, the IRS agents had a search warrant for financial data pertaining to a former employee of the John Doe company, however, "it did not authorize any seizure of any healthcare or medical record of any persons, least of all third parties completely unrelated to the matter," the complaint read. The class action lawsuit against the IRS seeks $25,000 in compensatory damages "per violation per individual" in addition to punitive damages for constitutional violations.  Thus, compensatory damages could start at a minimum of $250 billion.</blockquote> According to the linked Courthousenews.com piece, the class is represented by attorney Robert E. Barnes of Malibu, California.   The Complaint is reported to state that the IRS' data theft was so enormous it affects "roughly one out of every twenty-five adult American citizens." If a government agency decides to steal medical records, I'd rather the records be on paper than electronic. I think it's inarguable that it is a lot harder for 15 people to haul 60,000,000 paper charts away than a few hard disks. Mass theft of records must be factored into the risk/benefit ratio of electronic health records.  See other posts on this topic at the label index terms below. Addendum:  the Complaint is <a href="http://www.phiprivacy.net/wp-content/uploads/37-2013-00038750-CU-CR-CTL_roa1_03-11-13_.pdf" target="_blank">here</a> (PDF). -- SS

IRS faces class action lawsuit over theft of 60 million medical records

Try this with paper records. This is spectacular (as in, spectacularly alarming) if true: IRS faces class action lawsuit over theft of 60 m...

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Minimizing Legal Liability or Upholding the Mission? - the Markingson Case Redux

There are new, and troubling developments in the long running case of Dan Markingson, the psychiatric patient and research subject who committed suicide while enrolled in a trial of anti-psychotic drugs at the University of Minnesota nearly 10 years ago. Summary of the Case A good quick summary of this case just <a href="http://blogs.law.stanford.edu/lawandbiosciences/2013/03/14/the-markingson-case-investigate-the-university-of-minnesota/">appeared </a>in the Center for Law and Bioscience blob out of the Stanford Law School.  <blockquote class="tr_bq">Dan Markingson – a vulnerable, psychotic young man – was forced to choose between enrolling in a Pharma-funded drug study or being involuntarily committed (in other words, locked up).  A UMN [University of Minnesota]  doctor enrolled him in the study despite having just determined that Dan 'lack[ed] the capacity to make decisions regarding [his] treatment,' rendering it highly unlikely that Dan could have given valid informed consent to participate.  As Dan's mother, Mary Weiss, observed his mental condition deteriorating, she repeatedly tried to have Dan removed from the trial – at one point asking  'Do we have to wait until he kills himself or someone else before anyone does anything?'  But the UMN co-investigators in the drug study refused to terminate his participation.  Shortly after Ms. Weiss made her desperate plea, Dan Markingson killed himself by cutting his own throat.</blockquote> Our most recent (2011) post on the case was <a href="http://hcrenewal.blogspot.com/2011/02/university-of-minnesota-where-nothing.html">here</a>.  In it we also noted that there was reason to think: -  The design of the controlled trial was flawed. -  Financial conflicts of interests may have influenced the trial investigators' actions, particularly their questionable enrollment of Mr Markingson in the trial and their retention of him in it despite his apparent clinical deterioration. Despite that, when bioethicists and the University of Minnesota called for a new investigation of the trial and what happened to Mr Markingson, the university rebuffed them. Worse, as detailed in a 2012 <a href="http://blogs.law.stanford.edu/lawandbiosciences/2012/12/14/how-not-to-run-a-drug-study-the-university-of-minnesota-puts-on-a-clinic/">post</a> in the Center for Law and Bioscience blog, not only did university officials rebuff this call, but the university general counsel, who had been operating at the heart of this case, appeared to threaten the leading bioethicist dissident, Dr Carl Elliott: <blockquote class="tr_bq"> After Carl Elliott, the University of Minnesota bioethicist, refused to drop the matter, Rotenberg asked the university’s Academic Freedom and Tenure Committee to take up the question of '[w]hat is the faculty[’s] collective role in addressing factually incorrect attacks on particular university faculty research activities?' – a question that appeared both to accuse Elliott of 'factually incorrect attacks' and to call for some unspecified action to 'address' them.  Other faculty, including the president of the Minnesota chapter of the American Association of University Professors, viewed this as an attempt to intimidate Elliott into silence.  If so, it backfired.  The story <a href="http://goo.gl/4BIuM">ended up in the press</a>, putting the Markingson case back in the public eye and once again making the University of Minnesota look really bad.</blockquote> New Evidence Unearthed In 2013, Dr Elliott made public what may be important new evidence in the case.  As <a href="http://www.startribune.com/local/193447511.html">summarized</a> by the Minneapolis Star-Tribune, <blockquote class="tr_bq">The professor, Carl Elliott, says he has obtained consent documents for two separate schizophrenic patients that appear to be exact copies — not just in the subjects’ apparent replies, but in the positions of the lettering on the pages. Elliott said it is improbable that separate patients would provide identical responses to the questionnaire, which includes open-ended questions about the risks and requirements of clinical research. And that, he said, raises questions about whether the university was really examining patients to determine their ability to consent to research.</blockquote>  One crucial question about the case is how a patient who was actively psychotic - out of touch with reality - could give true informed consent to participation in a drug trial.  These new documents suggest major irregularities in the process used in the trial to assure that patients did give informed consent.  Furthermore, as <a href="http://www.mndaily.com/news/campus/2013/03/14/10-years-study-scandal-lives">reported</a> by the Minnesota Daily, other documents that Dr Elliott found suggested problems with records that related to whether study investigators would have had legal authority to access Mr Markingson's medical records, also suggesting major problems with trial administration.  These documents, unknown until recently, suggest new concerns with how the study in which Mr Markingson was enrolled, and during which he died, was run.  Yet, the University of Minnesota's official response to them, once again orchestrated by university counsel Mark Rotenberg, attacked the legitimacy of the documents (and indirectly, attacked Prof Elliott again), as reported by the Star-Tribune, <blockquote class="tr_bq">the university’s general counsel, Mark Rotenberg, challenged the authenticity of the documents and disagreed that study recruiters failed to obtain proper and independent consent from mentally ill patients. 'I am challenging these allegations directly,' he said. 'We have no reason to believe the consent forms were prepared inappropriately.'</blockquote> As Matt Lamkin <a href="http://blogs.law.stanford.edu/lawandbiosciences/2013/03/14/the-markingson-case-investigate-the-university-of-minnesota/">wrote</a> in the Stanford Law and Bioscience blog,  the University's responses all through this case have been focused  not on the welfare of patients, maintaining the trust of research participants, or the integrity of clinical trials, but on the legal defense of  the University and its leaders <blockquote class="tr_bq">Despite all this (<a href="http://blogs.law.stanford.edu/lawandbiosciences/2012/12/14/how-not-to-run-a-drug-study-the-university-of-minnesota-puts-on-a-clinic/">and much more</a>), the University has never acknowledged any errors or taken any disciplinary action related to the Markingson case and has repeatedly rejected calls for an independent investigation.  That’s probably because from the start the University has handled this case as a litigation matter.  Rather than trying to determine whether there were problems with the way its personnel treated Markingson, the University has focused on minimizing its potential liability.  Accordingly, the University appears to run every inquiry related to the case through the office of its General Counsel, Mr. Rotenberg.  When Carl Elliott (my mentor as a grad student at UMN) wrote <a href="http://www.motherjones.com/environment/2010/09/dan-markingson-drug-trial-astrazeneca">a damning article about the case</a> in Mother Jones, the University’s response came from Rotenberg.  When <a href="http://www.scribd.com/doc/49659724/U-of-M-Board-of-Regents-Markingson-Letter">UMN bioethicists called on the University’s Board of Regents to launch an independent investigation</a>, the Regents deferred to Rotenberg.  Not surprisingly, he declined. When you turn to your lawyer, you’re going to get a particular kind of response.  The GC isn’t in a position to take an objective look at the circumstances.  He’s an advocate.  His role is not to make sure the client has conducted itself ethically, but to minimize the client’s risk.  Asking your lawyer to respond to allegations of wrongdoing is like asking your PR flacks to do so.  Their job is to make their clients look good, not to make sure they’ve acted properly.</blockquote>Note that this still begs the question of who the client is.  Is it the university, or the university's leaders? Furthermore, as Mr Lamkin pointed out, the general counsel would appear to have a conflict of interest.  It may be he has an interest in defending his own actions, as well as those of his client(s), whether they are the university, its leaders, or both.  <blockquote class="tr_bq">In addition to Mr. Rotenberg’s role as the University’s top defender and advocate, there is another reason he cannot impartially consider requests for an investigation: the General Counsel’s Office is an important player in some of the disturbing events at issue.  As noted above, Rotenberg himself has been accused of attempting to intimidate and silence the bioethicist who has most doggedly sought an investigation.  The University’s lawyers are also responsible for the disgraceful silencing of Markingson’s mother, Mary Weiss.  After avoiding liability by arguing the University was immune from suit, these lawyers then threatened to force Weiss – whose son had died in a University doctor’s 'care – <a href="http://blogs.law.stanford.edu/lawandbiosciences/2011/09/15/academic-health-centers-bare-knuckled-litigation-tactics/">to pay the University’s legal costs</a> of some $57,000.  The University used that threat as leverage to get Weiss to forgo an appeal of the trial court’s decision.</blockquote> So as the University continues to refuse any new consideration of this this seemingly never-ending case, Dr Elliott has posted an <a href="https://www.change.org/petitions/governor-mark-dayton-of-minnesota-investigate-psychiatric-research-misconduct-at-the-university-of-minnesota-2">online petition</a> calling for an outside investigation.   We will see how Mr Rotenberg reacts to this. Summary A very troubling aspect of this case is that it has shown that the university leadership has seemed to care, at best, more about fending off litigation than upholding the university's mission.  The mission of the university is supposed to be discovering and disseminating the truth in a spirit of free inquiry.  Added to the mission of medical schools and university teaching hospitals is taking good care of patients, and putting the patients' interests ahead of all other concerns.  Yet, in this case, university leaders have not seemed to care whether in their haste to push back legal liability they were stepping on their faculty's academic freedom and free speech, the integrity of the medical research done at the university, and most importantly the rights of their patients and research subjects.  Furthermore, it is not clear whether they mainly feared the impact of litigation on the university, or how litigation might actually end up holding them accountable. As Dr Judy Stone <a href="http://blogs.scientificamerican.com/molecules-to-medicine/2013/03/12/a-clinical-trial-and-suicide-leave-many-questions-part-5-the-case-of-the-mysteriously-appearing-documents/">wrote</a> in her Scientific American blog, <blockquote class="tr_bq">  it appears that UMN believes, as do many other institutions, that protecting itself from scandal and its consequences comes first and foremost and that, like the big banks, that it is too big to be punished.</blockquote> Again, note that UMN cannot itself believe or protect.  People acting ostensibly on its behalf may have been protecting themselves from scandal, and believing that the size and status of their institution gave them, the leaders, impunity. The case of Mr Dan Markingson is a continuing reminder that to reform health care, health care organizations need to be lead by people who put the health care mission first and are willing to be accountable for that mission.   I hope that eventually there is an honest investigation of this case, and a commitment to reform based on its conclusions. See additional thoughts from Dr Howard Brody <a href="http://brodyhooked.blogspot.com/2013/03/latest-on-markingson-case-at-u-minn.html">on the Hooked: Ethics, Medicine and Pharma blog</a>, on the <a href="http://1boringoldman.com/index.php/2013/03/13/intrinsically-flawed-and-dangerous/">1BoringOldMan blog</a>, <a href="http://ptable.blogspot.com/2013/03/online-petition-requesting-governor.html">on the Periodic Table blog</a>, and last but certainly not least, many comments by Dr Carl Elliott on the <a href="http://loathingbioethics.blogspot.com/">Fear and Loathing in Bioethics blog.  </a>

Minimizing Legal Liability or Upholding the Mission? - the Markingson Case Redux

There are new, and troubling developments in the long running case of Dan Markingson, the psychiatric patient and research subject who commi...

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JAMA: "Improving the Electronic Health Record—Are Clinicians Getting What They Wished For?" - No, But Utopia Arrives Soon

At a new JAMA piece "Improving the Electronic Health Record—Are Clinicians Getting What They Wished For?", former Columbia U. and now NIH medical informaticist <a href="http://www.cc.nih.gov/about/SeniorStaff/james_cimino.html" target="_blank">James J. Cimino, MD</a> points out issues with the documentation that results from health IT systems. A preview of the first page of this short Viewpoint piece is available free <a href="http://jama.jamanetwork.com/article.aspx?articleID=1667100" target="_blank">at t</a><a href="http://jama.jamanetwork.com/article.aspx?articleID=1667100" target="_blank">his lin</a><a href="http://jama.jamanetwork.com/article.aspx?articleID=1667100" target="_blank">k</a>.  It includes the observation that: <blockquote class="tr_bq">... There is no question that computerization has made patients’ records more available and legible. With respect to completeness, however, there are now complaints that the record is too complete: electronic notes are deemed by many clinicians as being full of extraneous details and obscuring important aspects of a patient’s condition</blockquote> Dr. Cimino goes on to state that: <blockquote class="tr_bq">Empirical observational studies of clinicians have shown ways to improve EHR functionality ... Similar research on clinical documentation processes is needed to advance this crucial EHR component. </blockquote> These are excellent observations. The issue I have with the piece is - and I am finding this true of many articles critical of today's health IT - the ending, which I'm finding to often be PR.  Or, perhaps it would be more accurate to call the endings of late a "salvage operation-style" attempt to save face for the informatics community, who let this domain be overrun by the corporate IT sector and terrible products that violate many of the precepts of design of good health IT learned during five decades of research. Cimino concludes an otherwise constructive piece with this statement: <blockquote class="tr_bq">... Rather than complain about the challenges [a euphemism if ever I saw one - ed.] they have introduced, clinicians should recognize that current EHRs are illuminating the opportunities for the next generation of systems that will support clinicians as active partners across the spectrum of health care settings and tasks. The resulting improvements in documentation will, in turn, support patients, administrators, and researchers as we move towards a true learning health system. </blockquote> I note this assertion is at complete odds with the dictum I was taught from my earliest medical mentors, and that no amount of wishful thinking will banish: <blockquote class="tr_bq">"Critical thinking always, or your patient's dead." (Cardiothoracic surgery pioneer Victor P. Satinsly, M.D., Hahnemann Medical College, Philadelphia, early 1970s.)</blockquote> Translating the statement into plainer English, it seems to me that Cimino is saying this: <blockquote class="tr_bq"> "Doctors, shut up, stop complaining about the chaos and patient/professional risk today's bad health IT is causing, take the medicine your betters have prescribed for you, and don't be uncompromising patient advocates as patients are secondary in this quest to reach IT-based Healthcare Utopia - which we will reach come version 2.0."</blockquote> (This comes, ironically, at a time when physicians are starting to get a voice, e.g., Twitter's <a href="http://hcrenewal.blogspot.com/2013/03/twitter-ehr-revolt-ehrbacklash.html" target="_blank">#EHRbacklash</a>.) It appears articles with even a faint tinge of anti-health IT sentiment - in addition to the traditional methods, results, limitations etc. sections - have an "appeasement" section as well.  Perhaps this it what it takes to get past peer review and/or industry ire. In my view, this salvage mentality sprinkled with euphemisms and Utopian rhetoric spoils an otherwise constructive piece.  This type of language and utopian predictions about HIT have also appeared in other major medical publications by informatics and healthcare leaders (including top governmental office holders), as for example <a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html" target="_blank">here</a>. Now, I know Jim Cimino and he is a good scientist.  However, I truly wish the non-scientific, "wait for version 2.0", utopian P.R. would stop.  As a member of the Medical Informatics profession myself, it's actually become embarrassing. -- SS

JAMA: "Improving the Electronic Health Record—Are Clinicians Getting What They Wished For?" - No, But Utopia Arrives Soon

At a new JAMA piece " Improving the Electronic Health Record—Are Clinicians Getting What They Wished For? ", former Columbia U. a...

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But don't worry, your EHR information is secure

My last reminder of this issue was almost a half-year ago, but I think a repeat is in order. More bugs squashed: <a href="http://www.zdnet.com/microsoft-fixes-critical-windows-ie-flaws-for-patch-tuesday-7000012352/" target="_blank">Microsoft fixes critical Windows, IE flaws for Patch Tuesday</a> <blockquote class="tr_bq">Microsoft has released four critical security updates for Windows and Internet Explorer, along with a bevy of other products, in order to <a href="http://technet.microsoft.com/en-us/security/bulletin/ms13-mar">protect against at least 19 vulnerabilities</a> identified in its software. On deck this month, there are four "critical" vulnerabilities that affect Windows, Internet Explorer, Office, and Windows Server, including one for Silverlight that affects both Windows and Mac machines. The most severe Internet Explorer flaw affected all versions of Windows XP (Service Pack 3) and above, including Vista, Windows 7, and Windows 8 — including tablets running Windows RT — running Internet Explorer 6 and above. The flaw could have allowed a hacker to access the vulnerable system with the same user rights. ... The <a href="http://technet.microsoft.com/en-us/security/bulletin/ms13-mar">other vulnerabilities rated as "important"</a> could allow data and information disclosure, or an elevation of privileges on affected machines. These affect SharePoint, OneNote, Outlook for Mac, and kernel-mode drivers in Windows-based machines. </blockquote> I note that Windows XP is now more than a decade old, but Windows RT is brand-spanking new. In a Nov. 2012 post somewhat vexatiously entitled "<a href="http://hcrenewal.blogspot.com/2012/11/why-its-crazy-to-want-your-most.html" target="_blank">Why It's Crazy to Want Your Most Confidential Information Put into An Electronic Medical Records System</a>" about Windows 8 flaws, I had indicated how common Microsoft products were in hospital IT. I stand by that vexatious title. But don't worry, your confidential medical information is secure, and your safety against malfunctioning IT that loses your critical medical information after hackers invade is assured, in our current rushed national health IT rollout. What is the answer?  Until this technology has significantly been secured and debugged, this old triad applies: <ul><li>If you want your information secure, don't put it on a computer.</li><li>If you must put it on a computer but still want some degree of security, don't put the computer on a network.</li><li>If you must put the computer on a network, especially a network connected to the Internet, your information is no longer secure.  </li></ul>It's premature in my view to be building and operationalizing national health records networks.  Unless, that is, patient information privacy, security and confidentiality are secondary considerations. (In my view, they are seen by the national IT builders and promoters as secondary considerations, but the builders and promoters will never admit it, perhaps even to themselves.) <ul></ul>-- SS

But don't worry, your EHR information is secure

My last reminder of this issue was almost a half-year ago, but I think a repeat is in order. More bugs squashed: Microsoft fixes critical Wi...

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The Dangers of Big Corporate Health Care: Deceptive Marketing of Cancer Treatments

A series of articles over the last few months, culminating in an <a href="http://www.reuters.com/article/2013/03/06/us-usa-cancer-ctca-idUSBRE9250L820130306">investigative report </a>by Reuters, provided the newest example of what can go wrong when corporations provide direct care to vulnerable patients.  In this case, the vulnerable patients had cancer, and the corporation that provided them care was the Cancer Treatment Centers of America (CTCA).  I will try to go through the case chronologically. As Rueters reported, CTCA "was founded in 1988 by Richard J. Stephenson, who has been chairman ever since." The Founder's Checkered Past A Misdemeanor As Reuters noted, <blockquote class="tr_bq">A graduate of Northwestern University Law School, Stephenson started out as an investment banker. In 1966 he became a trustee of Americans Building Constitutionally, an organization that helped wealthy individuals set up not-for-profit corporations and personal trusts to avoid paying federal income and inheritance taxes. In 1969, a California state court found the group's top official and six others guilty of grand theft or conspiring to commit grand theft. Stephenson had pleaded no contest to false advertising, a misdemeanor, and testified for the state, according to media reports at the time.</blockquote> Allegations of Use of Unproven Cancer Treatments Stephenson seemingly stayed out of trouble until 1975, but <blockquote class="tr_bq">Stephenson ventured into healthcare in 1975, when he and partners bought Zion-Benton Hospital in Zion, Illinois, renaming it American International Hospital. By the late 1980s, American International was facing financial problems and its 'reputation had been severely damaged' by local press reports about its use of unproven cancer treatments, according to a 2004 court opinion on a successful petition by a former CTCA president seeking an increased valuation for his share of the company.</blockquote> CTCA: No More Unsubstantiated Claims Apparently around the time American International Hospital starting having major troubles, Stephenson branched out, <blockquote class="tr_bq">In 1988, Stephenson founded CTCA. He was motivated, said CEO Bonner, by the difficulty he had identifying and obtaining the best therapies for his mother after she developed bladder cancer. She died in 1982.</blockquote> By 1996, CTCA got into trouble too,   <blockquote class="tr_bq">Cancer Treatment Centers of America got in trouble with regulators in 1996, when the Federal Trade Commission accused it of, among other things, presenting survival claims it couldn't support. The company entered into a consent decree with the FTC and, without admitting any of the allegations, agreed not to make unsubstantiated outcomes claims.</blockquote> "Unscientific Therapies" As far as I can tell, all was then quiet until 2012.  Late that year, a Forbes columnist <a href="http://www.forbes.com/sites/stevensalzberg/2012/12/31/making-a-profit-from-offering-ineffective-therapies-to-cancer-patients/">wrote</a>, <blockquote class="tr_bq"> Alongside standard, science-based cancer therapies, CTCA also offers an array of questionable, unscientific therapies, which it proudly labels as part of its 'integrative cancer treatment.'  <a href="http://www.cancercenter.com/cancer-treatments.cfm">CTCA advertises many such treatments</a>, including: <div style="padding-left: 30px;">* Acupuncture * Acupressure * Chiropractic * <a href="http://www.cancercenter.com/complementary-alternative-medicine/naturopathic-medicine.cfm">Naturopathy</a> * <a href="http://www.cancercenter.com/complementary-alternative-medicine/naturopathic-medicine.cfm">Homeopathy</a> * Mind-Body medicine (including Reiki and Qi Gong)</div> None of the treatments in this list has any scientific support showing that they provide a benefit to cancer patients.  Some of them carry a real risk of harm, as I’ve written about previously.</blockquote> He further charged, <blockquote class="tr_bq">CTCA makes multiple unsupported, unscientific claims for its alternative treatments, such as: <ul><li>'<a href="http://www.cancercenter.com/brain-cancer/naturopathic-medicine.cfm">Naturopathic medicine can help</a> reduce these [cancer-related] symptoms, strengthen the immune system and support the healing process throughout your brain cancer treatment.'</li><li>'<a href="http://www.cancercenter.com/complementary-alternative-medicine/acupuncture.cfm">Acupuncture may help</a> to alleviate [cancer] treatment-related side effects, such as nausea and vomiting.'</li><li>'<a href="http://www.cancercenter.com/leukemia/chiropractic-care.cfm">When used during your leukemia treatment</a>, our chiropractic care services can help correct bone, muscle and joint problems and restore nerve function.' </li></ul>These are just a few examples. These claims, and CTCA’s marketing of the therapies involved, present a huge ethical problem. </blockquote> Manipulated Survival Statistics Then, in March 2012, the Reuters investigative reporters <a href="http://www.reuters.com/article/2013/03/06/us-usa-cancer-ctca-idUSBRE9250L820130306">charged</a> that CTCA manipulated its survival statistics to make its results look better. <blockquote class="tr_bq">CTCA reports on its website that the percentage of its patients who are alive after six months, a year, 18 months and longer regularly tops national figures. For instance, 60 percent of its non-small-cell lung cancer patients are alive at six months, CTCA says, compared to 38 percent nationally. And 64 percent of its prostate cancer patients are alive at three years, versus 38 percent nationally. Such claims are misleading, according to nine experts in cancer and medical statistics whom Reuters asked to review CTCA's survival numbers and its statistical methodology. The experts were unanimous that CTCA's patients are different from the patients the company compares them to, in a way that skews their survival data. It has relatively few elderly patients, even though cancer is a disease of the aged. It has almost none who are uninsured or covered by Medicaid - patients who tend to die sooner if they develop cancer and who are comparatively numerous in national statistics. Carolyn Holmes, a former CTCA oncology information specialist in Tulsa, Oklahoma, said she and others routinely tried to turn away people who 'were the wrong demographic' because they were less likely to have an insurance policy that CTCA preferred. Holmes said she would try to 'let those people down easy.' Equally significant, CTCA includes in its outcomes data only those patients 'who received treatment at CTCA for the duration of their illness' - patients who have the ability to travel to CTCA locations from the get-go, without seeking local treatment first. That means excluding, for example, those who have exhausted treatment options closer to home and arrive at a CTCA facility with advanced disease. Accepting only selected patients and calculating survival outcomes from only some of them 'is a huge bias and gives an enormous advantage to CTCA,' said biostatistician Donald Berry of MD Anderson Cancer Center in Houston.</blockquote> Furthermore, <blockquote class="tr_bq">CTCA also appears to exclude the vast majority of its patients when it calculates survival data. In survival results from 2004 to 2008 posted on its website, CTCA reported 61 patients with advanced prostate cancer, 97 with advanced breast cancer, 434 with advanced lung cancer, and 165 with advanced colon or rectal cancer. These are the four most common solid tumors. In the same period, CTCA treated thousands of patients at its Zion facility alone, according to filings with state regulators. 'We agree that some of our sample sizes' are small 'and have always stated this as a limitation of our study,' said Xiong, the consultant to CTCA. 'I'd have some concerns about why and wonder if some cherry-picking was going on,' said Spectrum Health's Campbell. Moreover, while the standard reporting period for cancer survival is five years after diagnosis, CTCA on its website doesn't go that far; for the four most common tumors, it reports survival up to four years at most. And as Reuters found, the company's advantage often diminishes as the five-year mark approaches </blockquote>  The Founder's Checkered Present By the way, also in the last few months, watchdog groups have asked for an investigation of CTCA's founder for possible deceptive actions that might have violated US election laws.  In December, 2012, the Washington Post <a href="http://www.washingtonpost.com/politics/freedomworks-tea-party-group-nearly-falls-apart-in-fight-between-old-and-new-guard/2012/12/25/dd095b68-4545-11e2-8061-253bccfc7532_story.html">reported </a> <blockquote class="tr_bq">In the weeks before the election, more than $12 million in donations was funneled through two Tennessee corporations to the FreedomWorks super PAC after negotiations with [CTCA Founder Richard J] Stephenson over a preelection gift of the same size, according to three current and former employees with knowledge of the arrangement. </blockquote>Then, <blockquote class="tr_bq"> Two watchdog groups last week asked the Federal Election Commission and the Justice Department to investigate the donations from the two Tennessee companies. The groups, Democracy 21 and the Campaign Legal Center, say the arrangement could violate federal laws that prohibit attempting to hide the true source of a political contribution by giving it under another name.</blockquote> Summary In summary, there are now charges in the media that Cancer Treatment Centers of America manipulated its survival data to makes its advertised results appear better, while it also advertises unproven complementary and alternative medicine treatments  as effective.  In the past the company had signed a consent decree not to make (presumably any more) unsubstantiated claims.  Meanwhile, the company's founder, who has a past history of a no contest plea to false advertising, and who had previously run a hospital system also charged with making unsupported survival claims, has been accused of hiding political donations. Thus this organization, run by someone who has his own history of deception, has been found to make exaggerated and/or unsubstantiated advertising claims of several types and at different times.  These claims could attract vulnerable patients who perhaps could get better care elsewhere, possibly leading to excess morbidity and even early mortality.  So Cancer Treatment Centers of America seems to be the latest reason to worry about the laissez faire US system which allows lightly regulated for-profit corporations to provide direct "care" to our most vulnerable patients.   We have recently discussed how a for-profit hospital chain may have been over treating some patients and under treating others, possibly risking patients' health to increase revenues (look <a href="http://hcrenewal.blogspot.com/2012/08/paging-doctor-ebdita-how-private-equity.html">here</a>);  how for-profit hospice corporations by enrolling patients who do not actually have terminal illness for palliative care only  could be denying potentially curative treatment to curable patients (look<a href="http://hcrenewal.blogspot.com/search/label/hospices"> here</a>); and how for-profit mental health clinics and drug treatment centers could be providing shoddy, and potentially dangerous care to boost revenues (look <a href="http://hcrenewal.blogspot.com/2012/07/private-equity-vs-patient-care-bainful.html">here</a> and <a href="http://hcrenewal.blogspot.com/2013/03/deadly-over-doses-and-private-equity.html">here</a>). We will see if the newest part of the pattern of news reports about CTCA and its founder, coupled with reports about other for-profit health care corporations that provide direct care to vulnerable patients provoke any official action.  However, the pattern is substantial enough so that it should make all health care professionals and all patients  reconsider whether ever to trust a for-profit hospital system, hospital, clinic or other site providing direct health care to patients. On a policy level, as I have said before,....   In my humble opinion, before the health care bubble bursts, we need to challenge the notion that direct health care should ever be provided, or that medicine ought to be practiced by for-profit corporations. Before market fundamentalism became so prominent, many states prohibited the corporate practice of medicine, and the American Medical Association <a href="http://hcrenewal.blogspot.com/2007/12/relman-in-jama-on-threats-to-physicians.html">forbade the commercialization of medicine.</a>  It is time to heed that wisdom. I submit that we will not be able to have good quality, accessible health care at an affordable price until we restore physicians as independent, ethical health care professionals, and until we restore small, independent, community responsible, non-profit hospitals as the locus for inpatient care.

The Dangers of Big Corporate Health Care: Deceptive Marketing of Cancer Treatments

A series of articles over the last few months, culminating in an investigative report by Reuters, provided the newest example of what can go...

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