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Hospitals and Doctors Use Health IT at Their Own Risk - Even if "Certified"

Due to my observations of confusion about health IT certification [1], and due to vague or incomplete seller language that could be misinterpreted by buyers (perhaps by design), I recently asked several ONC-ATCBs (HHS's Office of the National Coordinator for Health IT-Authorized Testing and Certification Bodies) the following. I sent this question via email to their "questions" email addresses: <blockquote>"Is EHR certification by an ATCB a certification of EHR safety, effectiveness, and a legal indemnification, i.e., certifying freedom from liability for EHR use of clinical users or organizations? Or does it signify less than that?"</blockquote> One ONC-ATCB provided the following in response to my request for information. <div style="margin-left: 40px;">From: Trivedi, Amit V (ICSA Labs) Sent: Thursday, February 16, 2012 11:22 AM To: Scot Silverstein Subject: RE: Form submission from: Contact Us Hello Scot, Thanks for your email. Certification by an ATCB signifies that the product or system tested has the capabilities to meet specific criteria published by NIST and approved by the Office of the National Coordinator. In this case the criteria are designed to support providers and hospitals achieve "Meaningful Use." A subset of the criteria deal with the security and patient privacy capabilities of the system. Here is a list of the specific criteria involved in our testing: <a href="http://healthcare.nist.gov/use_testing/effective_requirements.html" target="_blank">http://healthcare.nist.gov/use_testing/effective_requirements.html</a> In a nutshell, ONC-ATCB Certification deals with testing the capabilities of a system, some of them relate to patient safety, privacy and security functions (audit logging, encryption, emergency access, etc.). What was suggested in the email below (freedom from liability for users of the system, etc.) would be out of scope for ONC-ATCB testing based on the given criteria. [I.e., certification criteria - ed.] I hope that helps to answer your question. Thanks, Amit Amit Trivedi Program Manager - Healthcare ICSA Labs, an Independent Division of Verizon Business</div> Mar. 5, 2012 Addendum:  I also received a response from another ONC-ATCB, the Drummond Group: <blockquote>From: Joani Hughes (Drummond Group) Sent: Monday, March 05, 2012 1:06 PM To: Scot Silverstein Subject: RE: EHR certification question Per our testing team: It is less than that. It does not address indemnification although a certification could be used as a conditional part of some other form of indemnification function, such as a waiver or TOA, but that is ultimately out of the scope of the certification itself. Certification in this sense is an assurance that the EHR functions in way that could enable an eligible provider or eligible hospital to meet the CMS requirements of Meaningful Use Stage 1. Or to restate it more directly, CMS is expecting eligible providers or eligible hospitals to use their EHR in “meaningful way” quantified by various quantitative measure metrics and eligible providers or eligible hospitals can only be assured they can do this if they obtain a certified EHR technology. Please let me know if you have any questions. Thank you, Joani. Joani Hughes Client Services Coordinator Drummond Group Inc.</blockquote> These are direct and clear statements. My question was certainly answered. ONC cerification is not a safety validation, such as in a document from NASA on aerospace software safety certification, "<a href="http://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/20040014965_2004000657.pdf">Certification Processes for Safety-Critical and Mission-Critical Aerospace Software</a>" (PDF) which specifies at pg. 6-7: <blockquote>In order to meet most regulatory guidelines, developers must build a safety case as a means of documenting the safety justification of a system. The safety case is a record of all safety activities associated with a system throughout its life. Items contained in a safety case include the following: • Description of the system/software • Evidence of competence of personnel involved in development of safety-critical software and any safety activity • Specification of safety requirements • Results of hazard and risk analysis • Details of risk reduction techniques employed • Results of design analysis showing that the system design meets all required safety targets • Verification and validation strategy • Results of all verification and validation activities • Records of safety reviews • Records of any incidents which occur throughout the life of the system • Records of all changes to the system and justification of its continued safety </blockquote> Health IT testing conspicuously lacks attention to most of the aerospace software safety points above. I note that there appears to be no reasonable excuse for such omissions. IOM has recently studied the issue of HIT safety. IOM states in a Nov. 2011 report that HIT safety and safety testing is unsatisfactory, and has recommended HHS study it as well. IOM recommends HHS annually re-evaluate whether regulation is needed to improve safety, although IOM favors industry self-policing [2]. Thus, buyers and users of even "ONC certified" health IT are not indemnified from liability due to medical errors or problems caused by the health IT. Sellers who exaggerate the value of certification or imply its meaning is akin to FDA device approval, likewise, could be faulted for making false representations about their products. It would appear the sellers could potentially be sued for doing so by purchasers/users who themselves get into legal hot water due to EHR defects or other problems. -- SS Note: [1] I believe confusion about EHR "certification" is in part due to the term itself. I raised objections to this term when it was first proposed based on my experience in pharma, suggesting what I felt was the more accurate expression "features qualification" instead. [2] "Health IT and Patient Safety: Building Safer Systems for Better Care", Institute of Medicine of the National Academies, Nov. 2011, <a href="http://www.iom.edu/Reports/2011/Health-IT-and-Patient-Safety-Building-Safer-Systems-for-Better-Care.aspx">http://www.iom.edu/Reports/2011/Health-IT-and-Patient-Safety-Building-Safer-Systems-for-Better-Care.aspx</a>

Hospitals and Doctors Use Health IT at Their Own Risk - Even if "Certified"

Due to my observations of confusion about health IT certification [1] , and due to vague or incomplete seller language that could be misint...

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Logical Fallacies in Defense of Conflicts of Interest Employed by a Leader of Academic Medicine

We have repeatedly discussed the adverse effects of conflicts of interest on health care.  Recently, I <a href="http://hcrenewal.blogspot.com/2012/02/texas-tmap-trials-as-illustration-of.html">argued</a> that the most pernicious are conflicts of interest created as an incentive for trusted health care leaders, usually respected health care professionals or academics, to promote the vested interests of those who pay them, in the guise of the leaders' professional roles.  In this capacity, the leaders are often dubbed "key opinion leaders" by those who employ them, but may be regarded as mere "salesmen" by the corporate personnel who recruit them. (See posts <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>)  These relationships may be hidden, often behind confidentiality agreements, unless revealed by litigation.  Documents revealed by discovery in legal actions showed how companies planned other organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post <a href="http://hcrenewal.blogspot.com/2009/09/lexapro-marketing-plan-was-meant-to.html">here</a> about marketing of Lexapro, and <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a> about Neurontin). However, defenses of conflicts of interest continue to appear regularly.  The latest example, which incorporates an important twist, appeared <a href="http://online.wsj.com/article/SB10001424052970203686204577116374283814362.html">in yesterday's Wall Street Journal</a>.  It was in the form of a "Boss Talk"  interview with a leader of a major health care organization (whose identity we will discuss later.) The title of the interview indicated that the interviewee was not "worried about industry ties" of academia or of health care professionals.  Conflicts of interest were clearly its main focus.  For example, it began, <blockquote>Many universities are wringing their hands over the increasing coziness of medical schools and their corporate partners.</blockquote> Then it stated that the interviewee: <blockquote>has no such qualms.</blockquote> The defense of this lack of qualms was heavily based on logical fallacies. Biased Sample or Hasty Generalization The main reason for this lack of concern appeared to be complete disregard of the more serious kinds of conflict of interest briefly described above. The interviewer asked: <blockquote>What are the trickiest conflicts of interest to navigate?</blockquote> The answer was: <blockquote>Surgery is particularly challenging. Let's say you're a physician and you come up with a new hip replacement. You invented it so you're going to make a lot of money. But if you're going to do my surgery, I want you to put in the device you think is best. How do you separate that, when the person is the inventor and the great technician?</blockquote>This may be tricky, but is arguably not the most tricky kind of conflict of interest. The trickier example of the key opinion leader hired as a salesman was not raised by the interviewer or the interviewee. Such a case was graphically revealed by testimony of the aborted TMAP trial which implicated the former state mental health director as hired by Johnson and Johnson subsidiary Janssen to "promote Risperdal as a safe and effective medication." (See <a href="http://hcrenewal.blogspot.com/2012/02/texas-tmap-trials-as-illustration-of.html">this post</a>.) Industry spokespeople and key opinion leaders themselves tout KOLs as clinical, educational, and/or scientific experts chosen for their expertise to advance medicine, science and public health.  There have been  documented instances (e.g., see posts <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>) in which defectors from marketing departments of commercial health care corporations described KOLs as salespeople who could be more influential hidden within their professional or academic cloaks.  Even some physicians paid to be speakers on behalf of pharmaceutical corporations have acknowledged their role as salespeople in fancy dress (see post <a href="http://hcrenewal.blogspot.com/2010/11/of-drug-talks-deception-and-denial.html">here</a>).  There are cases of documents revealed by discovery in legal actions that show how companies planned organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post <a href="http://hcrenewal.blogspot.com/2009/09/lexapro-marketing-plan-was-meant-to.html">here</a> about marketing of Lexapro, and <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a> about Neurontin). Perhaps the interviewee was unaware of these issues.  Whether due to ignorance or deliberate avoidance, failing to consider the full spectrum of conflicts of interest, and specifically ignoring those with the greatest likelihood of adverse effects, appears to be a logical fallacy in this instance.  If deliberate, it appears to be reasoning from an (intentionally) <a href="http://www.nizkor.org/features/fallacies/biased-sample.html">biased sample</a>, if not, it appears to be a <a href="http://www.nizkor.org/features/fallacies/hasty-generalization.html">hasty generalization</a>. The interview also included a few other choice logical fallacies that went unchallenged by the interviewer. False Dilemma The interviewer asked: <blockquote>What do you tell professors who won't work with drug or biotech companies?</blockquote> The response was: <blockquote>I think that's a huge mistake. If you're a professor now, and you want to get your discovery to society, you either need to start a company or work with a company to commercialize a product.</blockquote> Of course, in the "good old days," academic researchers got their "discoveries to society" simply by publishing them. Developing and marketing products based on their discoveries, while worthwhile undertakings in their own rights, were not considered part of the academic mission. Professors could still do this, if their goal was not to get rich. Yet the Bayh-Dole act allowed academic institutions to make money from their professors' discoveries, and the rush to commercialize the university has been on ever since. So while professors and academic institutions who are motivated mainly by money might not consider just putting the knowledge they discover in the public domain, that course remains possible, just not so lucrative. The assertion that the only way to get a "discovery to society" is to start or work with a company is simply false, and using this assertion in an argument appears to be an example of a <a href="http://www.nizkor.org/features/fallacies/false-dilemma.html">false dilemma</a>. Straw Man The interviewee worked another argument into the same paragraph: <blockquote>When professors have told me they won't work with companies anymore because they feel they'll have this scarlet letter, I think: 'Wouldn't that be sad if all the best scientists and clinicians won't work with companies because the public has said they're evil?'</blockquote> I doubt that any of even the most vociferous critics of the conflicts of interest that now befog health care have claimed that those involved are evil, much less that they are have successfully convinced the whole public at large that anyone who "works with companies" is evil. Implying that this would be the result of criticism of conflicts of interest does not appear to be supported by evidence, and is probably flat wrong. Asserting it here appears to be an example of the <a href="http://www.nizkor.org/features/fallacies/straw-man.html">straw man fallacy</a>. Summary So the Wall Street Journal has added to our collection of defenses of conflicts of interest that seem mainly to be based on logical fallacies.  We have noted that logical fallacies are increasingly deployed to defend the status quo in health care, and particularly to defend the interests of those who are profiting the most from the current dysfunctional system.  We have noted that several defenses of the conflicts of interest generated by financial relationships between physicians and medical academics on one hand and commercial health care firms on the other, were based on logical fallacies.  (See examples <a href="http://hcrenewal.blogspot.com/2011/03/once-more-with-feeling-another-defense.html">here</a>, <a href="http://hcrenewal.blogspot.com/2010/11/there-you-go-again-richard-epstein-says.html">here</a>,  <a href="http://hcrenewal.blogspot.com/2009/09/latest-version-of-argument-that-we-are.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2011/09/using-logical-fallacies-to-scold.html">here</a>.)  I have yet to see a coherent, logical, fact-based argument that the benefits for patients' and the public's health of physicians and medical academics working part-time as consultants, advisers, speakers, and directors of health care corporations outweigh the obvious risks of biasing medical decision making, education and research in favor of vested interests. In 2011, I <a href="http://hcrenewal.blogspot.com/2011/09/using-logical-fallacies-to-scold.html">noted</a>, "I have also yet to see an argument in favor of conflicts of interest made by anyone who does not have such conflicts."At least, however, up to that point I had not noted any such arguments made by people who had much power to enforce their views, as opposed to the ability to just express them.  The interview discussed above, however, was a person who has such power. The interview was with Dr Susan Desmond-Hellmann, the relatively new Chancellor of the University of California- San Francisco, who was just <a href="http://www.fiercebiotech.com/special-reports/25-most-influential-people-biopharma-today/susan-desmond-hellmann-25-most-influentia">named</a> one of the "25 most influential people in biopharma."  She has recently been advocating a change of direction towards commercialization for her campus, one of the most prestigious health care oriented universities/ academic medical centers in the country.  She previously justified this redirection again using logical fallacies (look <a href="http://hcrenewal.blogspot.com/2011/10/logical-fallacies-to-support-putting.html">here</a>).  She also appears to yet another advocate for conflicts of interest who has her own conflicts.  As we noted <a href="http://hcrenewal.blogspot.com/2009/05/bio-tech-u.html">here</a>, Dr Desmond-Hellmann had little academic experience before she became Chancellor, but had worked her way up in the corporate pharmaceutical world, leaving her position as President for drug development at Genentech after it was taken over by Roche.  As we <a href="http://hcrenewal.blogspot.com/2011/10/logical-fallacies-to-support-putting.html">noted previously</a>, even after that, Dr Desmond-Hellmann apparently has not completely left the corporate world. - A <a href="http://www.athletepromotions.com/celebrity/Susan-Desmond-Hellmann-appearance-booking-agent.php">web-site</a> for a speakers' bureau in which she apparently still participates lists her as a current "Advisor of Genentech since April 2009." - In 2010, Dr Desmond-Hellmann joined the board of directors of Procter and Gamble, a company which makes many health related products, although it sold its global pharmaceutical business. Last year, the company made an agreement with Teva to market over-the counter medications (see<a href="http://www.reuters.com/article/2011/11/03/teva-pg-idUSN1E7A20BZ20111103"> this Reuters article</a>). Note that she got this position despite apparently not having any prior personal investment in P&G stock. However, per the company's <a href="http://www.pg.com/en_US/downloads/investors/annual_reports/2011/PG_2011_Proxy.pdf">2011 proxy statement</a>, she appears to be in line to collect over $250,000 a year in compensation for this position. It does not seem impossible that these ongoing commercial interests may influence how she acts in her role as Chancellor.  Yet while it may be unsurprising, it is very disappointing that conflicts of interest are now being uncritically and illogically publicly defended by people in positions to exert so much influence on health care. The noted cognitive psychologists George Loewenstein, Sunita Sah, and Daylian Cain just asserted in JAMA [Loewenstein G, Sah S, Cain DM. The unintended consequences of conflict of interest disclosure. JAMA 2012; 307: 669-670. Link <a href="http://jama.ama-assn.org/cgi/content/extract/307/7/669?etoc">here</a>.] <blockquote>Conflicts of interest, including fee-for-service arrangements, are at the heart of the astronomical increases in health care costs in the United States, and transparency is not substitute for more substantive reform.</blockquote> True health care reform requires such substantive reform of the financial arrangements among corporations that sell health care services or products and health care professionals and others who make decisions about patients' or the public's health. To decide how to accomplish such reform, we need a better discussion informed by logic and evidence, sans logical fallacies. Those who lead health care ought to be able to participate in this discussion under these conditions.

Logical Fallacies in Defense of Conflicts of Interest Employed by a Leader of Academic Medicine

We have repeatedly discussed the adverse effects of conflicts of interest on health care. Recently, I argued that the most pernicious are ...

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Congressman Darrell Issa: FDA's email monitoring of "whistleblowers" communicating with Congress was illegal

In followup to my post of Jan. 30, 2012 "<a href="http://hcrenewal.blogspot.com/2012/01/can-you-sue-government-fda.html">Can You Sue the Government? FDA Whistleblowers Sue Over Surveillance of Personal e-Mail</a>" I provide a link to a probing letter from Darrell Issa, Chairman, US House of Representatives Committee on Oversight and Government Reform to Margaret Hamburg MD, Commissioner of the FDA. The letter raises the issue that FDA's email monitoring of "whistleblowers" communicating with Congress was illegal ("unlawful, and will not be tolerated"), and the illegality was further compounded by harassment and retaliation against the "whistleblowers." Many probing "who? why? when?" questions are asked of FDA. I do not have free text of this letter, just a link to images of the letter. I cannot post the text (no access to OCR of a PDF at the moment), but the letter images are here: <a href="http://www.whistleblowers.org/storage/whistleblowers/documents/FDAComplaint/issaletter.fdaspying.pdf">http://www.whistleblowers.org/storage/whistleblowers/documents/FDAComplaint/issaletter.fdaspying.pdf</a> Worth reading in its entirety. -- SS

Congressman Darrell Issa: FDA's email monitoring of "whistleblowers" communicating with Congress was illegal

In followup to my post of Jan. 30, 2012 " Can You Sue the Government? FDA Whistleblowers Sue Over Surveillance of Personal e-Mail ...

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Death at Birth: A Tragedy Caused by Overwork and Undertraining - and Technology

As a result of my recent post "<a href="http://hcrenewal.blogspot.com/2012/02/those-goddamn-trial-lawyers-are-to.html">Plaintiff's Trial Lawyers Are to Blame for EHRs That 'Tattle' on Doctors - And Harm Patients</a>", a malpractice attorney, Patrick Malone in Washington, D.C., sent me a link to a tragic summary of a case his firm handled. The story illustrates the toxic effects that health IT and other technology, especially when not "done well", can have on patient care. I present it below with just a bit of comment, with permission of attorney Malone. Emphases also mine: <div class="bodytext"> <h3></h3></div><blockquote><div class="bodytext"> <div class="description"> <a href="http://www.patrickmalonelaw.com/lawyer-attorney-1838178.html">Death at Birth: A Tragedy Caused by Overwork and Undertraining</a>The Patrick Malone firm represented the family of Keren Kipoliongo, a baby girl who died in her mother’s womb just minutes before the successful Cesarean section delivery of her twin sister Gabrielle.This tragedy occurred at Virginia Hospital Center in Arlington, Virginia in July 2008. At midnight one evening, Mrs. Kipoliongo and her husband presented to the labor and delivery unit at the hospital, as scheduled per their obstetrician’s instructions. The plan was to induce labor with the drug Pitocin (oxytocin) and monitor both babies during the labor with fetal heart monitors, to make sure they could withstand the contractions and be safely delivered by the normal vaginal route.This was the first pregnancy for the couple, and they were excited about the prospects of having twins. They had set up their home in northern Virginia with a nursery with two cribs and two of everything else they would need.The obstetrician whom Mrs. Kipoliongo had seen regularly throughout her pregnancy checked them into the L&D unit and then went to sleep in the doctors’ lounge. He instructed the nurse and a resident physician (doctor in training) to call him if needed.Mrs. Kipoliongo was left alone for large stretches through the night. It wasn’t until a nursing shift change at 7 a.m. that she started to get close attention from the nurses. By that time, baby Keren was in bad shape as shown by fetal monitor patterns in which her heart beat was slowing ominously with the mother’s contractions. She had already shown throughout the overnight period a flattening or lack of variability from beat to beat. (The flattening of the heart rate often means the baby is not getting enough oxygen.) [Why was this not noted and acted upon promptly? Read on - ed.] They finally brought the obstetrician in, and he decided around 8:15 a.m. to do a Cesarean section. Baby Keren was still alive at that point. Unfortunately she died some time over the next hour, because when the doctor finally cut into the mother’s womb after 9 a.m., he found that she was dead, with the umbilical cord wrapped tightly around her neck.When our law firm investigated what had happened on behalf of the family, we found several disturbing facts. These included:<ul><li>Despite the lack of reassuring signs on baby Keren’s heartbeat, the nurses failed to do any of a number of standard things that can improve the baby’s condition, such as turning the mother, giving the mother oxygen, and giving extra fluids.</li><li>The hospital overworked the nurse assigned to Mrs. Kipoliongo’s labor, giving her a second patient for whom she was also primarily responsible. Standards require one-on-one nursing during a labor that is as involved as hers was. The stimulating drug Pitocin requires close monitoring. In addition, Keren was under-sized (a condition called “intrauterine growth restriction”), and that is why they were proceeding with a scheduled birth rather than wait for labor to start on its own. (At autopsy, Keren was found to have completely normal body organs; her only issue was being small.) [I note that the overwork might have included having to interact with an EHR presenting a <a style="font-weight: bold; font-style: italic;" href="http://www.tinyurl.com/hostileuserexper">mission hostile user experience</a>, as I've seen in critical care environments and have worked to specifically avoid when I was in charge <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story">as here</a> - ed.] </li><li>Inspection of the computerized hospital record showed that this nurse, Julie Bates Gilpin, made most of her entries in the record hours after the purported observation time, including a whole series of entries after her shift ended. [I have seen this phenomenon myself; some EHR's allow entries even without a time stamp, and the only way to ascertain when entries were made is via discovery of metadata (automatically generated audit trails and other data that shows who manipulated data, and when. Hospitals often resist providing full metadata, despite Federal Rules of Civil Procedure (FRCP) governing e-discovery enacted almost 6 years ago - ed.] </li><li>We asked the nurse at a deposition why her entries showed such regular times of observation, at exactly 15 minutes after the hour, 30 minutes, 45 minutes, etc. She told us that was because she “rounded” on her patients every 15 minutes. But later we discovered – after winning a “motion to compel” in which the judge required the hospital to turn over records of the other patients Ms. Gilpin was monitoring that night (with names blacked out) – that she was also recording the same exact pattern of observations on her other patient, at 15 past the hour, 30, 45, and so on. So when we compared our client’s record with the other patient, it was clear that Nurse Gilpin was making computer entries showing that she was in two places at once. Again, most of these entries were made hours later and back-timed. [I also wonder, during the actual clinical encounter time was the nurse treating the actual patients or the e-Patient, i.e., the 'virtual patient' represented by the computer screens? - ed.] </li><li>We also wanted to know why the alarm on the fetal monitor went off 12 times during the night but was answered only one of those times by Nurse Gilpin. We discovered that these monitors have alarm reset buttons like a snooze button on an alarm clock. You can hit the button and turn off the alarm without doing anything else for the patient. Most of the time, the “snooze button” was hit by a nurse at the nurse’s station. What did this mean? The monitor was supposed to be tracking two separate twin babies. [Not exactly what I would call a "state of the art" alert design - ed.] The alarm would go off when the signal was lost for one baby. The nurses are supposed to reposition the patient so they can pick up the signal again. They didn’t do that for most of the times that the signal was lost. So it turned out that hours went by during the night when nothing was tracked on baby Keren’s heartbeat.</li><li>Even worse, we found out that when we took Nurse Gilpin’s testimony, she no longer remembered how to do her job on the labor and delivery unit even though she had worked there up until a few months before the time of her deposition. We asked her how a nurse reads the fetal monitor and what are bad signs for the baby, and she said she didn’t know.</li><li>And even worse than that (the wrongdoing kept piling up in this case as we continued our investigation), the resident doctor, whose name was Dr. Sahardat Nurudeen, and who was the only physician monitoring our client’s labor progress for nearly eight hours, also claimed at her deposition that she couldn’t read a fetal monitor tracing even though she was in training to become an obstetrician. (In fact, she had completed her full obstetric residency and was preparing for her board certification test at the time of her deposition.) We say “claimed,” because it could be that she just wanted to avoid answering tough questions at the deposition about individual segments of Keren’s monitor strips. Either way, it wasn’t good for high quality, accountable patient care.</li></ul>We finally concluded that there were many chances during that night to save Keren’s life, but the understaffing and overwork and apparently poor training (how could a nurse or a young doctor forget how to read a fetal monitor, a basic part of their training?) [and the toxic effects of ill-conceived and ill-implemented technology - ed.] led to an unnecessary tragedy. </div> </div></blockquote> This story should give pause to technophiles in medicine who ignore technology's possible downsides, and the clinicians who are compelled to center their clinical lives around such technology (while the purveyors of that technology are often <a href="http://jama.ama-assn.org/content/301/12/1276.extract">held harmless</a> by hospital executives <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda">in violation of the latter's fiduciary responsibilities</a>). -- SS

Death at Birth: A Tragedy Caused by Overwork and Undertraining - and Technology

As a result of my recent post " Plaintiff's Trial Lawyers Are to Blame for EHRs That 'Tattle' on Doctors - And Harm Patient...

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Those Goddamn Plaintiff's Trial Lawyers Are to Blame for EHRs That 'Tattle' on Doctors - And Harm Patients

It seems the EHR technophiles are starting to notice one of the side effects of EHR technology: the liabilities EHRs impose on users. Interestingly, those liabilities are presented below as the fault not of a cavalier industry receiving extraordinary governmental and regulatory accommodation compared to other healthcare sectors that, among other issues, have allowed it to (see hyperlinks for more information): <ul><li>Disregard practices of <a href="http://sydney.edu.au/engineering/it/%7Ehitru/essays/Pt%206%20-%20Comparison%20between%20ERD%20and%20Relational%20Schemata.pdf">good software engineering</a>, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">product safety</a> and <a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html">human factors issues</a> (usability), </li><li>Ignore tenets of good information presentation yielding literal <a href="http://hcrenewal.blogspot.com/2011/02/electronic-medical-records-two-weeks.html">reams of 'legible gibberish'</a> masquerading as medical records that confuse attorneys on both sides of the Bar as well as clinicians, </li><li>Flout proper conduct of <a href="http://ohsr.od.nih.gov/guidelines/index.html">human subjects experimentation</a> e.g. without <a href="http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html">informed consent</a>,</li><li>Avoid appropriate methodologies for <a href="http://en.wikipedia.org/wiki/Randomized_controlled_trial">medical device trials</a> (all the while promoting the data these devices generate as 'revolutionizing healthcare'),</li><li>and more as covered on this site and at my Drexel University educational site <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">at this link</a>. </li></ul> Instead, the liabilities are presented as the fault of plaintiff trial lawyers, who need to be disempowered through yet another special accommodation for health IT. My comments are interspersed in [red italics]: <blockquote>Feb. 8, 2012 The Wall Street Journal MarketWatch <a style="font-weight: bold;" href="http://www.marketwatch.com/story/healthcare-it-expert-exposes-hidden-risks-of-lawsuits-due-to-electronic-health-record-2012-02-08">Healthcare IT Expert Exposes Hidden Risks of Lawsuits Due to Electronic Health Record </a> Spokesperson Says Electronic Health Records May Give Crippling Access to Physician's Actions and Increase the Need for Defensive Medicine [Crippling access to physician's actions? That is an odd combination of terms - ed.] DELRAY BEACH, Fla., Feb 8, 2012 (GlobeNewswire via COMTEX) -- Since the American Recovery and Reinvestment Act (ARRA) passed in February 2009 and caused a digital tsunami in the healthcare industry, physicians have been scrambling to comply with the requirement to switch to electronic health record systems. (EHRs) While many in the healthcare industry laud the use of EHRs to improve quality of care and analyzing patient outcomes, Dr. Sam Bierstock, founder of Champions In Healthcare, points out significant concerns regarding increased vulnerability to medical legal claims that may result from the use of EHRs without major tort reform that would relieve physicians of an onslaught of malpractice suits. "EHRs unquestionably have the potential to improve patient safety and the quality of care delivered, but what few people realize is that using an EHR exposes physicians to an Orwellian level of analysis of every single act while doing their job," said Bierstock, who has advocated and pioneered the use and benefits of EHRs for more than 30 years." EHRs, however, can also be audited to examine how long it took them to act after an abnormal lab result came in, if the doctor checked on on-line references before making a clinical decision, what was said in every email and how long the doctor took to respond, and even how long the doctor looked at a screen or scrolled down to read an entire document. [Why, exactly, this is a bad thing, I do not understand; it seems hypocritical. After all, any data collected that can help improve healthcare has been deemed golden - up to now - ed.] Physicians are exposing themselves to an unacceptable level of scrutiny and analysis of their use of computers that may serve to encourage malpractice suits. ["Unacceptable level of scrutiny" is largely a code phrase for <a href="http://library.ahima.org/xpedio/groups/public/documents/ahima/bok1_036537.hcsp?dDocName=bok1_036537">audit trails and other 'metadata'</a>, i.e., automatically generated computer data that shows who accessed or modified a document or other data, when, from where, etc. I ask - access to this data is unacceptable to whom? Injured patients? - ed.] Meaningful tort reform is essential to getting the maximal benefit from these wonderful systems. [Wonderful systems, when even the IOM admits we don't know the level of harm they cause, the NIST indicates they are poorly usable, and so forth <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">as here</a>? - ed.] According to Bierstock, the problem runs even deeper because during his career as an industry consultant with Champions in Healthcare, and as a speaker at healthcare events he has noticed that the vast majority of physicians are still not aware of the complex requirements imposed upon them by the Health Information Technology for Economic and Clinical Health (HITECH) Act even though it has been a law for more than two years. [I agree with the statement "imposed upon them", but this imposition was largely at the hands of the HIT pundits, the 'Ddulites' (technophiles who ignore technology's downsides, the opposite of 'Luddites', <a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-irrational.html">link</a>), and various species of non-medical profiteers - ed.] "I talk to many physicians who have no idea they can suffer financial, civil and even criminal penalties (i.e. jail) for non-compliance.," said Bierstock. "I have been asked to speak about this topic many times, but beyond HITECH, it's my opinion that similarly, doctors and hospitals don't yet fully realize their medical legal vulnerability associated with the use of EHRs. [They will learn, fast, with Medical Informatics specialists such as myself on patients' side instead of on the side of the health IT industry - ed.] This will be the case until there is major tort reform, which has unfortunately been thwarted by the influence of American Trial Attorneys and their associations." [You see, it's all the fault of the evil Plaintiff's Bar - ed.] Bierstock noted that in an effort to stimulate physicians and hospitals to install and use EHRs, The American Reinvestment and Recovery Act of 2009 also authorized the Centers for Medicare and Medicaid Services (CMS) to issue guidelines which define what is "Meaningful Use" of an EHR - guidelines which must be met in order for hospitals and doctors to receive financial incentive payments for using EHRs, or be penalized by having Medicare or Medicaid payments reduced for failure to meet the guidelines. [Unfortunately, they did not formulate guidelines for safety. Thus, as Sharona Hoffman, JD notes in <a style="font-weight: bold; font-style: italic;" href="http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1697587">MEANINGFUL USE AND CERTIFICATION OF HEALTH INFORMATION TECHNOLOGY: WHAT ABOUT SAFETY?</a>, "General system safety is a property that is attainable only through rigorous processes for development and evaluation. However, the regulations do not address certification of EHR vendors’ software development processes or even require vendors to analyze and mitigate potential safety hazards. Furthermore, ATCBs will use testing requirements developed by the National Institute of Standards and Technology (NIST) that are apparently intended only to determine whether systems include certain features. Passing such tests is not sufficient to ensure that those features function properly in the long term and under varied operating conditions." - ed.] Bierstock believes that if physicians are expected to embrace EHRS, they should be allowed to do so in a manner that maximizes the benefits of these systems to the delivery of care and to the benefit of their patients without worrying about giving unlimited ammunition to trial lawyers. [Perhaps the EHR pundits should have foreseen this eventuality before pushing the current administration to mandate national EHR rollout. It didn't take a rocket scientist to do so - ed.] "Quite simply, physicians may be in a situation that leaves them vulnerable to litigation and threatens loss of their professional standing and personal assets -- all because an external evaluator [e.g., a trial lawyer, judge or jury -ed.] may not think the physician lived up to arguable standards in the digital age," said Bierstock. "Overall, EHRs are the litigator's proverbial golden goose. They are to malpractice attorneys what the electron microscope is to microbiology." [In other words, EHRs deserve yet another special accommodation, this time regarding legal Discovery, in addition to the many other special accommodations this industry has received. In fact, EHRs make available only that which they are designed to, and discoverability of that information is a Federal matter under the <a style="font-weight: normal;" href="http://www.fiosinc.com/case-law-rules/e-discovery-federal-rules-civil-procedure-frcp.aspx">Federal Rules of Civil Procedure (FRCP) governing e-discovery </a>- "On December 1, 2006 the Federal Rules of Civil Procedure were revised to address numerous e-discovery issues. Rules 16,26,33,34,37 and 45 require attorneys to pay specific attention to electronic discovery issues. E-Discovery practices and strategies need to be reviewed and aligned with the updated rules to ensure compliance." - ed.] </blockquote> I find requests for additional special accommodations for EHR's over other medical devices and IT in other industries (e.g., airplane black boxes and cockpit recorders that monitor the every move of pilots) to be illustrative of the concept "be careful, you may get what you wish for." That plaintiff trial lawyers are blamed for quite properly using the Federal Rules of Civil Procedure to assure justice for victims of medical malpractice, including EHR-related medical malpractice, is outrageous. It seems the pundits might be starting to panic, after realizing the "data utopia" that is going to "revolutionize medicine" has a downside. -- <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm">S. Silverstein, MD</a> Feb. 14, 2012 Addendum: It seems the clinical data itself generated by today's health IT - garnered while putting patients at risk and costing many billions of dollars - might not be anywhere near as trustworthy as advertised by the technophiles. See "<a href="http://aushealthit.blogspot.com/2012/02/it-seems-we-are-not-only-ones-bumping.html">It Seems We Are Not The Only Ones Bumping Up Against EHR Data Quality Issues. PCEHR Implications Are Worth Considering</a>" at the Australian Health Information Technology blog by Dr. David More, MB PhD FACHI, and the <a href="http://jamia.bmj.com/">JAMIA</a> articles he references. Dr. More observes: <blockquote>... If ever there was an example of “garbage in, garbage out” in operation this has to be it. There has to be a great deal of care taken as we move from the most simplest data sharing to more complex efforts.</blockquote> -- SS

Those Goddamn Plaintiff's Trial Lawyers Are to Blame for EHRs That 'Tattle' on Doctors - And Harm Patients

It seems the EHR technophiles are starting to notice one of the side effects of EHR technology: the liabilities EHRs impose on users. Inter...

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"The Banks Can Do It, Why Can't Hospitals?"

I have often heard the refrain that while away from one's home in Terre Haute, one can withdraw money from an ATM machine in Timbuktu. So, why can't my medical records from birth be called up instantly from the Timbuktu Regional Hospital if I fall unconscious at the <a href="http://en.wikipedia.org/wiki/Festival_au_D%C3%A9sert" title="Festival au Désert">Festival au Désert</a> and forgot my wallet? In other words, computing in the banking industry is perfected, so why can't healthcare get its act together? (Irrespective of the sea change of difference between simple financial data and incredibly complex medical data.) Not so fast, health IT <a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-irrational.html">Ddulites</a>: <blockquote>New York Times February 9, 2012 <a href="http://dealbook.nytimes.com/2012/02/09/online-users-of-citibank-bill-pay-app-charged-twice/">Users of Citibank Bill-Pay App Charged Twice</a> By BEN PROTESS A program error at Citibank was not detected for months. Citigroup’s effort to become “the world’s digital bank” has encountered a snag. ["<a style="font-weight: bold; font-style: italic;" href="http://hcrenewal.blogspot.com/search/label/glitch">Glitch</a>" is the health IT-specific term - ed.] A technical bug caused Citi, the nation’s fourth largest bank by deposits, to double the charge for customer payments in recent months. Some customers using their iPads to settle their cable bill or mortgage payment, for example, actually paid twice, according to customers and a bank official. The problem, which began in July but went undetected by the bank until December, prompted bogus payments big and small. Some customers quickly spotted the redundant transaction and complained to Citi, while other consumers were caught off guard when the bank recently notified them of the discrepancy. The snag even led some unsuspecting customers to overdraw their accounts, though a bank spokesman said that was rare. Citi has traced the error to its nascent iPad application. Other mobile applications and the bank’s broader online bill payment system were immune from the problem, the bank said. But a few clients who were charged twice said they had not used an iPad to pay bills. And the Citi spokesman declined to disclose the number of customers caught up in the mishap, saying only that it amounted to “a limited number of clients.” [It would appear that Citi was not in complete control of its systems; the systems were in control of Citi - ed.] Instead, the spokesman said that fewer than 2 percent of Citibank transactions executed through an iPad were counted twice. The spokesman would not elaborate on the number of iPad transactions at Citi, citing concerns about releasing proprietary data. [2% of a very large number is still a large number - ed.] ... While Citi may be the first company to stumble with the iPad, it is far from the only bank to encounter electronic hiccups. Customers have long been befuddled by accidental A.T.M. withdrawals and so-called transaction gaps, where a customer pays online but the transaction fails to process. A number of regional banks have also double-dipped with customer payments and even JPMorgan Chase, the nation’s biggest bank, recently had a minor brush with duplicate online withdrawals. The mishaps, while minor, underscore the risks that customers face when banks wade into the fledgling world of online banking. [That's peanuts compared to the risks they face when hospitals wade into the fledgling world of electronic medical records and CPOE - ed.] While banks are scrambling to please customers who prefer clicking a mouse to dealing with tellers, the industry is learning that new technologies come with some growing pains. “It’s a challenge for banks to keep up with the device proliferation — everything is moving very fast,” said David Albertazzi, a senior analyst with Aite Group, which advises financial institutions on technology and regulatory issues. “It is very important that financial institutions balance speed-to-market versus safety and soundness.” [Healthcare seems immune from that wise caveat. 'Full steam ahead, icebergs be damned' seems the siren call for IT in that domain - ed.] ... Last year, JPMorgan Chase owned up to its gaffe, a technical hitch with an online cash transfer system, within a day. “People make mistakes. Unfortunately, we made one twice,” Ryan McInerney, Chase’s chief executive of consumer banking, told customers, who received a $25 cash bonus for their troubles. [Every excuse term in the book's been used here - growing pain, hiccup, snag, bug, hitch, flaw - except one - 'incompetence' - ed.] Citi’s response, however, appears to have been not nearly as prompt. The error began in July, within days of the bank introducing its gleaming new iPad application. The coming-out for the application included a press release announcing the “new standard for digital banking” with a “one-of-a-kind app.” ... “EBusiness professionals at retail banks — and other financial institutions — should pay close attention to what Citibank has done, particularly its willingness to experiment and try out new ideas in a brand-new channel,” Forrester Research, a technology research company, said in a report. [Healthcare IT is a big experiment, except it's not just dollars and cents that can get farkled - ed.] But almost immediately, a smattering of anonymous customers began posting concerned comments online, wondering whether it was their own fault — the product of double-clicking. Then fingers began to be pointed at the bank. One online commenter posting on the company’s Apple store Web site called the application “very unreliable.” In late December, the bank tracked the error to an internal flaw. A technical command on the bank’s iPad application, it turned out, was wrongly set to redo transactions that had initially failed. The bank began alerting customers to the snag in mid-January, and made another round of calls this week, including to clients who say they had not paid their bills through the iPad. ... Citi has had other technology problems in the last year. Last summer, the bank disclosed that hackers had stolen the names and addresses of hundreds of thousands of North American credit card customers. A week later, the bank revised its estimates, saying that about 80 percent more customers had been ensnared than previously thought. The breach, which did not include Social Security numbers or security codes, was a lesson for Wall Street firms. Big banks, experts say, are now more reluctant to estimate the scope of a problem in case the numbers grow. “It’s very challenging to really pinpoint the number of customers affected,” Mr. Albertazzi said. “It’s the nature of the beast.” </blockquote> If these growing pains, hiccups, snags, bugs, hitches, and flaws are the "nature of the beast" in electronic banking systems, one can only wonder why banking is held up to be the "gold standard" that healthcare has to equal. Healthcare has a long tradition and obligations to implement new technologies with the greatest of caution and care, using clinical trials based on the scientific method, and with informed consent. Banking lacks such traditions. The healthcare IT industry has largely abandoned them. While a bank's computing may make a mistake with a decimal point, a hospital's computer errors can injure or kill people. The current rush to universal health IT needs to slow down. Further, HIT industry pundits need to stop making comparisons to other industries that are both irrelevant and unwarranted. -- SS

"The Banks Can Do It, Why Can't Hospitals?"

I have often heard the refrain that while away from one's home in Terre Haute, one can withdraw money from an ATM machine in Timbuktu. ...

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The Texas TMAP Trial as Illustration of a Systematic Stealth Marketing Campaign

Before it was abruptly ended by a sudden settlement for $158 million, the trial in Texas of a suit alleging unethical marketing of the drug Respirdal (risperidone) by the Janssen subsidiary of Johnson and Johnson opened yet another window on organized stealth marketing campaigns in health care. (Note that we first discussed this case <a href="http://hcrenewal.blogspot.com/2006/12/guidelines-in-whose-interest.html">here </a>in 2006, and that this trial and the case was ably covered in detail on the <a href="http://1boringoldman.com/">1BoringOldMan blog</a>.)  Even so, given all the recent attempts to dismiss critics of the pharmaceutical industry as "pharmascolds," (e.g., <a href="http://hcrenewal.blogspot.com/2011/09/using-logical-fallacies-to-scold.html">here</a>), and to otherwise uphold the current status quo in our dysfunctional health care system, I thought it would be useful to rediscuss this case to show how systematic stealth marketing threatens the ideals of rational, evidence-based health care. <a href="http://hcrenewal.blogspot.com/search/label/evidence-based%20medicine">Evidence-based medicine</a> may simply be viewed as medicine based on evidence and logic tempered with humanity. A slightly longer definition is practice based on the best evidence from clinical research derived from systematic searches, critically reviewed, used to maximize individual patients' benefits and minimize their harms according to their values. In contrast, brief summaries of sworn testimony during the trial, and of a key report by an expert witness suggested how a commercial health care organization, in this case, the Jennssen subsidiary of Johnson and Johnson, could organize a stealth marketing campaign to promote practice based on deception and falsehoods, entangled in illogic and emotional and psychological manipulation. This was all done to market a product which could not so easily be supported by evidence and logic. Deception and Falsehoods: Suppression of Medical Research A Bloomberg <a href="http://www.businessweek.com/news/2012-02-01/j-j-hid-3-risperdal-diabetes-studies-from-fda-texas-jury-told.html">report</a> of the last day of the trial showed how the Respirdal stealth marketing campaign used the now classic mechanism of suppression of medical research: <blockquote>Johnson & Johnson officials hid three studies showing some patients using Risperdal developed diabetes while claiming the antipsychotic drug didn’t cause the disease, a witness testified. As early as 1999, Johnson & Johnson’s Janssen unit had researchers’ findings that about half the patients taking Risperdal in a study comparing its risks to those of Eli Lilly & Co.’s Zyprexa antipsychotic drug developed diabetes after a year on the medication, Joseph Glenmullen, a psychiatrist and Harvard Medical School instructor, told a Texas jury yesterday. That study concluded Risperdal caused 'medically serious weight gain' that led study subjects to develop diabetes, Glenmullen testified in the trial of the state of Texas’s lawsuit over Janssen’s marketing of the drug. At the same time, Janssen salespeople were telling doctors that researchers concluded the drug didn’t cause the disease, Glenmullen added.</blockquote> In particular, <blockquote>Glenmullen, testifying as an expert for the state, told jurors Janssen officials didn’t turn over Study 113, which found Risperdal posed a higher diabetes risk than Zyprexa, to the U.S. Food and Drug Administration when regulators began probing links between anti-psychotic medications and the disease in 2000. The drugmaker also didn’t turn over the results of two other later studies that found Risperdal and Zyprexa posed comparable diabetes risks to the FDA.</blockquote>Suppression of research is a severe threat to evidence-based medicine because it can severely bias the clinical evidence base on which it depends. Deception and Falsehood: Ghostwriting A summary of the 86 page report by Professor David Rothman commissioned by the Texas Attorney General <a href="http://www.houstonpress.com/2011-12-15/news/down-the-hatch-the-rothman-report/">published in the Houston Press</a> provided this example of ghostwriting: <blockquote>A member of J&J's Speakers Bureau, [University of Texas Professor of Psychiatry Dr Alexander] Miller collected at least $82,000 from Janssen and its contractors. He declined to comment for this story, saying he may be called as a witness in the lawsuit. Miller was a 'guest author' for one of Janssen's ghostwritten articles. Upon receiving the manuscript, Miller wrote, 'Yes, I am happy to be included as a co-author. I made a few minor edits and comments in the manuscript.'</blockquote>In addition, another <a href="http://www.houstonpress.com/2011-12-15/news/down-the-hatch/">article</a> in the Houston Press summarizing the issues before the trial provided this overview of the ghostwriting process: <blockquote>As described in the AG's expert witness report, a company called Excerpta Medica was hired to draft some of Janssen's Risperdal articles. In 2003, according to Rothman, Excerpta Medica issued 'Risperidone Publication Program Status Reports,' indicating that 30 of the 145 articles to be published had authors listed as 'to be determined.' Rothman also examined what he considered a signature ghostwritten piece meant to boost Risperdal's pediatric profile; the study is included in the 2010 parameters. Rothman cited a barrage of e-mails between Excerpta Medica and J&J in crafting the article. At one point, an Excerpta Medica employee wrote, 'It would be very helpful to receive some guidance in relation to the flow, format and subject in this paper and whether you think this is too marketing oriented or not, in order to prepare a next draft. Besides that we would like [to] have some suggestions for external authors on this paper. Maybe [a] U.S. and a European KOL? Your input will be much appreciated.'' The article eventually appeared in a 2007 volume of the European Journal of Child and Adolescent Psychiatry. For a lead author, J&J scored a heavy hitter: Dr. Peter Jensen, former associate director of child and adolescent research at the National Institute of Mental Health, and the founding director of the Center for the Advancement of Children's Mental Health at Columbia University. Now with the Mayo Clinic, Jensen declined to comment for this story.</blockquote> This indicates the scope of this particular ghostwriting initiative: 145 articles were planned.  Thus, ghostwritten articles could comprise a major proportion of the apparently scholarly literature relevant to Risperdal.  Ghostwriting is fundamentally deceptive because it allows marketing to appear in the guise of scholarly work.  Ghostwritten reviews can deceptively shift the focus from the questions that need to be addressed by the evidence-based process to benefit patients to those whose answers would benefit marketers. Deception and Falsehoods: Key Opinion Leaders Emotional and Psychological Manipulation: Creation of Conflicts of Interest An important element of most stealth marketing campaigns is the creation of <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">key opinion leaders</a>.  These are academics or professionals who can promote products in the guise of unbiased expertise.  A summary of the 86 page report by Professor David Rothman commissioned by the Texas Attorney General <a href="http://www.houstonpress.com/2011-12-15/news/down-the-hatch-the-rothman-report/">published in the Houston Press</a> provided the example of Dr Steven Shon: <blockquote>As the head of the state's mental health agency, Shon was perhaps Janssen's most crucial key opinion leader; his influence in pushing Risperdal was invaluable. He accepted at least $47,000 from Janssen and its medical ghostwriter, Excerpta Medica, and signed an agreement to be a member of Johnson & Johnson's Speakers Bureau. Rothman writes, 'The medical director of the state's mental health agency should not be serving as an official spokesperson for a pharmaceutical company whose product state agencies are purchasing.' The company paid for his trips across the country, and even overseas, to promote Risperdal as a safe and effective medication. (But the romance between Janssen and Shon was not without its bumps; Shon would get 'upset' if the checks he accepted from Janssen were made out to the MHMRA instead of directly to him. Apparently, those were more difficult to funnel into his personal account.) Shon retired in 2005, allowing him to collect his taxpayer-funded pension. He moved to Las Vegas, where he's the director of psychiatry for a mental health and substance abuse clinic called Harmony Healthcare. Shon was so influential that Janssen grew paranoid and possessive when it learned that other companies sought his partnership as well. When J&J employee Yolanda Roman heard that Eli Lilly had flown him to their headquarters on a private jet, she wrote, "Steve I suppose is enjoying the vast attention and response he can command from Industry...Obviously, Steve has the right to be served by all Industry, let's hope he remains fair [and] balanced and remembers who PLACED HIM ON THE 'TMAP' MAP." Meanwhile, another employee busted out the caps-lock to warn that "WE WILL NOT LET LILLY OR PFIZER PREVAIL WITH OUR MOST IMPORTANT PUBLIC SECTOR THOUGHT LEADER."</blockquote> Similarly, a Bloomberg <a href="http://www.bloomberg.com/news/2012-01-11/johnson-johnson-paid-texas-official-to-speak-around-the-u-s-jury-told.html">report</a> of Dr Shon's trial testimony included: <blockquote>Johnson & Johnson’s Janssen unit paid a Texas mental health official to speak around the U.S. about state guidelines on prescribing antipsychotic drugs that gave preference to medicines like the company’s Risperdal, the official said. Steven Shon accepted honorariums to fly to Arizona, Florida and New Jersey to discuss Texas guidelines developed in 1999 advising doctors that a newer class of drugs like Risperdal were a “first choice or option” for schizophrenia, he testified today in state court in Austin.</blockquote> Also, <blockquote>Attorneys for Jones questioned Shon, who served as medical director of the Texas Department of Mental Health and Mental Retardation until he involuntarily retired in 2006. Shon testified that he served on Janssen advisory boards, was a board member of a Janssen publication called 'Mental Health Issues Today' and was a continuing medical education speaker in programs sponsored by the company. Shon was asked about six trips in which he got honorariums of $3,000 from Janssen to discuss the TMAP project. In several cases, he kept those payments, he said. In testimony yesterday, a Texas Medicaid investigator said Shon signed several consulting agreements with Janssen, and the company paid him $47,587 over several years. </blockquote> Dr Shon's value to Janssen derived from his position as the respected leader of the state's mental health agency. While he was apparently paid by Janssen marketers who saw him as an ally, his marketing was all the more effective because it seemed to come from an unbiased expert. As such it was deceptive. The <a href="http://iom.edu/Activities/Workforce/ConflictOfInterest.aspx">Institute of Medicine report on conflicts of interest</a> defined them as "a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest." The report, and indeed much of the discussion of conflicts of interest in health care assumes that most secondary interests are "-within limits - legitimate and even desirable goals." For example, an academic physician who also was a basic scientist could be paid by a pharmaceutical company to do a specific assay on samples used in research. In that case, the payments could conceivably create a risk that the academic's professional judgment in a clinical setting would be unduly favorable to the products of the company. However, the relationship hardly seems intended to cause such a bias. Notions that conflicts of interest are "inevitable" but "manageable" may stem from consideration of conflicts of interest like this. However, conflicts of interest deliberately created as perverse incentives may be much more consequential, and as this example shows, perhaps not rare. It appears that Janssen paid Dr Shon not to do some task that was unrelated to how he fulfilled his primary entrusted responsibilities as director of mental health, but in order to influence how he fulfilled them. We have noted previous examples in which corporate marketers consider paid key opinion leaders as sales people (see posts <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>). Such conflicts are deliberately created so that the recipient of payments uses his or her entrusted responsibilities to serve the vested interests of the payer may be deceptive, as noted above.  Furthermore, by being intended to induce changes in how the payee performs his or her primary responsibilities, these conflicts are particularly likely to lead to abuse of these entrusted responsibilities. Given that the <a href="http://www.transparency.org/news_room/faq/corruption_faq">Transparency International definition of corruption</a> is abuse of entrusted power for private gain, we need a new and more incisive term to described this variety of conflicts of interest. The motivation of key opinion leaders by created conflicts of interest can result in powerful manipulation of the key opinion leaders, but more importantly of their audience.  Emotional and Psychological Manipulation: Intimidation Another Bloomberg <a href="http://www.bloomberg.com/news/2012-01-12/j-j-whistle-blower-recounts-firing-after-finding-payments.html">report</a> included testimony about how someone who attempted to blow the whistle about the Respirdal stealth marketing campaign was intimidated: <blockquote>Allen Jones testified yesterday in state court in Austin, Texas, that he was an investigator in the Pennsylvania Office of Inspector General in 2002 when he looked into an unregistered bank account run by Steven Fiorello, the pharmacist. Fiorello was on a Pennsylvania committee weighing whether to require doctors to give priority to newer, more expensive drugs like Risperdal in state-funded treatment of mental-health patients, Jones said. Jones, 57, said he found a $4,000 check from J&J’s Janssen unit to Harrisburg State Hospital that was sent “\'to the attention of' Fiorello. The check covered a Fiorello trip to New Orleans to discuss Pennsylvania’s drug guidelines. Another check for $1,766 to the hospital account was sent 'in care of' of Fiorello, Jones said. Fiorello controlled the account and didn’t register it with the state, Jones said. 'The account was used to deposit money from drug companies,' Jones said yesterday in the trial’s third day of testimony. 'There were real problems here. On many levels, the account was improper.' Janssen also paid $2,000 directly to Fiorello as an honorarium for his speaking at a company-sponsored event in 2002, Jones said. Jones said he followed the money trail and explored efforts by Janssen to promote, on a state-by-state basis, Texas guidelines favoring drugs like Risperdal. The funds sent to the hospital account helped pay travel expenses for programs related to setting up the Texas guidelines in Pennsylvania, he said. The state adopted the guidelines that favored Risperdal in 2003, Jones said. </blockquote> Note that this testimony appears to be about yet another KOL paid to promote guidelines that would in turn promote the marketing of Respirdal. So this is yet another case of a conflict of interest apparently deliberately created to influence the individual's primary responsibility. However, then <blockquote>Jones said his boss told him to ease off his probe. He said he was told, 'Stay away from the drug companies. This is a personnel issue. Stay away from the drug companies, stay away from TMAP. Jones said his boss said, 'Drug companies write checks to both sides of the aisle. Stay away from it.' His boss told him that 'morally and ethically I was correct, but politically, this was dead.' Jones said that later he was removed as the lead investigator from the case, and he was 'marginalized completely.' He continued to pursue the case on his own time, and spoke to the New York Times for a story that ran Feb. 1, 2004. He said he was fired for talking to the newspaper. </blockquote> So Jones was intimidated to the extent that he lost his job. Note further that the implication is that this intimidation stemmed from yet more conflicts of interest created by Janssen, payments to politicians. This underlines how stealth marketing campaigns become complex systems. Note further that in retrospect, Jones' complaints were deemed true by a court of law and a state commission: <blockquote>Fiorello, once the chief pharmacist for Pennsylvania’s public welfare department, was convicted in December 2008 of felony conflict-of-interest charges for taking payments from drug companies, including Janssen and Pfizer Inc. He was sentenced to 18 months of probation and fined $3,000. He also paid more than $27,000 in civil fines after the Pennsylvania Ethics Commission cited him. </blockquote>In a sense, intimidation and created conflicts of interest are two sides of the same coin.  Both involve the deliberate imposition of incentives, either positive or negative.  These incentives are designed to further marketing aims and organizational interests, not to improve patient care or public health, or advance science.  Thus they are powerful tools of emotional and psychological manipulation. Summary Note that even the brief summaries of trial evidence suggested how systematic the campaign was, and how within it, the elements of deception and falsehoods (instead of evidence), and emotional and psychological manipulation (instead of logic and humanity) were predominant. This should be added to previous discussion of <a href="http://hcrenewal.blogspot.com/search/label/stealth%20marketing">stealth marketing campaigns</a>, including such examples as that of Neurontin <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a>). Stealth marketing campaigns are complex examples of how behavior meant to further vested interests may directly threaten evidence-based practice, physicians' professionalism, and ultimately patients' and the public's health. There have been many calls (e.g., see recent posts <a href="http://hcrenewal.blogspot.com/2011/10/logical-fallacies-to-support-putting.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/11/if-medical-school-is-just-part-of.html">here</a>) for increased "collaboration" among health professionals and academics and industry.  Often they are justified by the need for "innovation," while resulting conflicts of interest are deemed "manageable."  The current examples show how the vested interests of health care organizations operating within a laissez faire, anything goes environment may make such collaboration poisonous.

The Texas TMAP Trial as Illustration of a Systematic Stealth Marketing Campaign

Before it was abruptly ended by a sudden settlement for $158 million, the trial in Texas of a suit alleging unethical marketing of the drug ...

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