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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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A Critical Review of a Critical Review of e-Prescribing ... Or Is It CPOE?

In PLoS medicine, the following article was recently published by researchers at the University of New South Wales in Australia: <blockquote>Westbrook JI, Reckmann M, Li L, Runciman WB, Burke R, et al. (2012) Effects of Two <a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001164">Commercial Electronic Prescribing Systems on Prescribing Error Rates in Hospital In-Patients: A Before and After Study</a>. PLoS Med 9(1): e1001164. doi:10.1371/journal.pmed.1001164</blockquote> The section I find most interesting is this: <blockquote>We conducted a before and after study involving medication chart audit of 3,291 admissions (1,923 at baseline and 1,368 post e-prescribing system) at two Australian teaching hospitals. In Hospital A, the Cerner Millennium e-prescribing system was implemented on one ward, and three wards, which did not receive the e-prescribing system, acted as controls. In Hospital B, the iSoft MedChart system was implemented on two wards and we compared before and after error rates. Procedural (e.g., unclear and incomplete prescribing orders) and clinical (e.g., wrong dose, wrong drug) errors were identified. Prescribing error rates per admission and per 100 patient days; rates of serious errors (5-point severity scale, those ≥3 were categorised as serious) by hospital and study period; and rates and categories of postintervention “system-related” errors (where system functionality or design contributed to the error) were calculated.</blockquote> Here is my major issue: Unless I am misreading, this research took place in hospitals (i.e., "wards" in hospitals) and does not seem to focus (if even refer to) discharge prescriptions. I think it would be reasonable to say that what are referred to as "e-Prescribing" systems are systems used at discharge, or in outpatient clinic/offices to communicate with a pharmacy selling commercially and not involved in inpatient care. From the U.S. Centers for Medicare and Medicaid Services (CMS), for example: <blockquote><a href="https://www.cms.gov/EPrescribing/">E-Prescribing</a> - a prescriber's ability to electronically send an accurate, error-free and understandable prescription [theoretically, that is - ed.] directly to a pharmacy from the point-of-care </blockquote> I therefore think the terminology used in the article as to the type of system studied is not well chosen. I believe it could mislead readers not experienced with the various 'species' of health IT. This study appears to be of an inpatient <a href="http://en.wikipedia.org/wiki/Computerized_physician_order_entry">Computerized Practitioner Order Entry</a> (CPOE) system, not e-Prescribing. Terminology matters. For example, in the U.S. the HHS term "certification" is misleading purchasers about the quality, safety and efficacy of health IT. HIT certification as it exists today (granted via <a href="http://healthit.hhs.gov/portal/server.pt?open=512&mode=2&objID=3120">ONC-Authorized Testing and Certification Bodies</a>) is merely a features-and-functionality "certification of presence." It is not like an Underwriter Labs (UL) safety certification of an electrical appliance that the appliance will not electrocute you. (This is not to mention the irony that one major aspect of Medical Informatics research is to remove ambiguity from medical terminology, e.g., via the decades-old <a href="http://www.nlm.nih.gov/research/umls/">Unified Medical Language System</a> project or UMLS. However, as I've often written, the HIT domain lacks the rigor of medical science itself.) I note that if this were a grant proposal for studying e-Prescribing, I would return it with a low ranking and a reviewer comment that the study proposed is actually of CPOE. That said, looking at the nature of this study: The conclusion of this paper was as follows. I am omitting some of the actual numbers such as confidence intervals for clarity; see the full article available freely at above link for that data: <blockquote>Use of an e-prescribing system was associated with a statistically significant reduction in error rates in all three intervention wards. The use of the system resulted in a decline in errors at Hospital A from 6.25 per admission to 2.12 and at Hospital B from 3.62 to 1.46. This decrease was driven by a large reduction in unclear, illegal, and incomplete orders. The Hospital A control wards experienced no significant change. There was limited change in clinical error rates, but serious errors decreased by 44% across the intervention wards compared to the control wards. Both hospitals experienced system-related errors (0.73 and 0.51 per admission), which accounted for 35% of postsystem errors in the intervention wards; each system was associated with different types of system-related errors.</blockquote> I note that "system related errors" were defined as errors "where system functionality or design contributed to the error." In other words, these were unintended adverse events as a result of the technology itself. The authors conclude: <blockquote>Implementation of these commercial e-prescribing systems resulted in statistically significant reductions in prescribing error rates. Reductions in clinical errors were limited in the absence of substantial decision support, but a statistically significant decline in serious errors was observed. </blockquote> The authors do acknowledge some limitations of their (CPOE) study: <blockquote>Limitations included a lack of control wards at Hospital B and an inability to randomize wards to the intervention.</blockquote> Thus, this was mainly a pre-post observational study, certainly not a randomized controlled clinical trial. Not apparently accounted for, either, were potential confounding variables related to the CPOE implementation process (as in <a href="http://www.blogger.com/comment.g?blogID=9551150&postID=5650114337316261515&isPopup=true">this comment thread</a>). In that thread I wrote to a commenter [<a href="http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html" style="font-style: italic;">a heckler, actually</a>, apparently an employee of HIT company <a href="http://www.meditech.com/" style="font-style: italic;">Meditech</a>] with a stated absolute faith in pre-post studies that: <blockquote>... A common scenario in HIT implementation is to first do a process improvement analysis to improve processes prior to IT implementation, on the simple calculus that "bad processes will only run faster under automation." There are many other changes that occur pre- and during implementation, such as training, raising the awareness of medical errors, hiring of new support staff, etc. There can easily be scenarios (I've seen them) where poorly done HIT's distracting effects on clinicians is moderated to some extent by process and other improvements. Such factors need to be analyzed quite carefully, datasets and endpoints developed, and data carefully collected; the study design and preparation needs to occur before the study even begins. Larger sample sizes will not eliminate the possible confounding effects of these factors and many more not listed here. The belief that simple A/B pre-post test that look at error rate comparisons are adequate is seductive, but it is wrong. </blockquote> Stated simply, in pre-post trials the results may be affected by changes that occur other than the intervention. HIT implementation does not involve just putting computers on desks, as I point out above. In other words, the study was essentially <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">anecdotal</a>. The lack of RCT's in health IT are, in general, one violation of traditional medical research methodologies for studying medical devices. That issue is not limited to this article, of course. Next, on ethics: CPOE has already been demonstrated in situ to create all sorts of new potential complications, such in at Koppel et al.'s "<a href="http://jama.ama-assn.org/content/293/10/1197.abstract">Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors</a>", <cite><abbr title="JAMA: The Journal of the American Medical Association" class="slug-jnl-abbrev">JAMA.</abbr> </cite>2005;293(10):1197-1203. doi: 10.1001/jama.293.10.1197 that concluded: <blockquote> In this study, we found that a leading CPOE system often facilitated medication error risks, with many reported to occur frequently. As CPOE systems are implemented, clinicians and hospitals must attend to errors that these systems cause in addition to errors that they prevent. </blockquote> CPOE technology, at best, should be considered experimental in 2012. In regards to e-Prescribing proper, there's this: <a href="http://hcrenewal.blogspot.com/2011/06/electronic-medication-prescribing-magic.html">Errors Occur in 12% of Electronic Drug Prescriptions, Matching Handwritten</a> and this: <a href="http://hcrenewal.blogspot.com/2011/07/eprescribing-assuming-issues-like-this.html"></a><a href="http://hcrenewal.blogspot.com/2011/07/eprescribing-assuming-issues-like-this.html">Upgrading e-prescribing system can bump up error risk</a> to consider; in other words, the literature is conflicting, confirming the technology remains experimental. This current study confirmed some (CPOE) errors that would not have occurred with paper did occur with cybernetics, amounting to "35% of postsystem errors in the intervention wards." In other words, patient Jones was now subjected to a cybernetic error that would not have occurred with paper, in the hopes that patients Smith and Silverstein would be spared errors that might have occurred without cybernetic aid. Even though the authors observe that "human research ethics approval was received from both hospitals and the University of Sydney", since patient Jones did not provide informed consent to the experimentation with what really are experimental medical devices as I've written often on this blog [see note 1], I'm not certain the full set of ethical issues have been well-addressed. It's not limited to this occasion, however. This phenomenon represents a pervasive, continual world-wide oversight with regard to clinical IT. Furthermore, and finally: of considerable concern is another common limitation of all health IT studies, which I believe is often willful. What really should be studied before justifications are given to spend tens of millions of dollars/Euros/whatever on CPOE or other clinical IT is this: The impact of possible non-cybernetic interventions (e.g., additional humans and processes) to improve "medication ordering" (either CPOE, or ePrescribing) that might be FAR LESS EXPENSIVE, and that might have far less IT-caused unintended adverse consequences, than cybernetic "solutions." Instead, pre-post studies are used to justify expenditures of millions (locally) and tens or hundreds of billions (nationally), with results sometimes like <a href="http://hcrenewal.blogspot.com/2011/09/npfit-programme-going-pffft.html">this</a> affecting an entire country. There is something very wrong with this, both scientifically and ethically. -- SS Note: [1] If these devices are not experimental, why are so many studying them to see if they actually work, to see if they pose unknown dangers, and to try to understand the conflicting results in the literature? More at this query link: <a href="http://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20experiment">http://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20experiment</a> Addendum Feb. 10, 2012: An anonymous commenter points out an interesting issue. They wrote: <blockquote>The study was flawed due to its failure to consider delays in care and medication administration as an error caused by these experimental devices. Delays are widespread with CPOE devices. One emergency room resorted to paper file cards and vacuum tubes to communicate urgency with the pharmacy. Delays were for hours.</blockquote> I agree that lack of consideration of a temporal component, i.e., delays due to technology issues, is potentially significant. I, for example, remember a more than five-minute delay in getting sublingual nitroglycerin to a relative with apparent chest pain due to IT-related causes. The problem turned out to be gastrointestinal, not cardiac; however, in another patient, the hospital might not be so lucky. Addendum Feb. 12, 2012: A key issue in technology evaluation studies is to separate the effects of the technology intervention from other, potentially confounding variables which always exist in a complex <a href="http://en.wikipedia.org/wiki/Sociotechnical_systems">sociotechnical system</a>, especially in a domain such as medicine. This seems uncommonly done in HIT evaluation studies. Not doing so will likely inflate the apparent contribution of the technology. A "control ward" where the same education and training, process re-engineering, procedural improvements, etc. were performed as compared to the "intervention ward" (but without actual IT use) would probably be better suited to pre-post studies such as this. A "comparison ward" where human interventions were implemented, as opposed to cybernetic, would be a mechanism to determine how efficacious and cost-effective the IT was compared to less expensive non-cybernetic alternatives. -- SS

A Critical Review of a Critical Review of e-Prescribing ... Or Is It CPOE?

In PLoS medicine, the following article was recently published by researchers at the University of New South Wales in Australia: Westbrook J...

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Health IT: Ddulites and Irrational Exuberance

The title is not a typo. I've often tried to explain the phenomenon of irrational exuberance where computers are concerned, especially in the domain of health IT. In face of the literature references provided throughout this blog, including at posts such as <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">this reading list</a> and at sites such as <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">here</a>, one would think rational people would temper their exuberance somewhat, at the very least towards rapid national rollouts - as opposed to constrained, controlled experiments until the industry learns how to get the technology "right." However, more than a decade of writing has had little effect. I've also attempted to explain the phenomenon of irrational exuberance on a belief in technological determinism, on industry propaganda, on unquestioning IT faith being a quasi-"religion", and on profiteering or other quid pro quo. (The latter, I'm certain, is operative to an extent.) I have now come across a term, though, that I believe accurately encapsulates the phenomenon of unquestioning beliefs that health IT + clinician automagically --> a "revolution" in medicine. It may be a character trait. The trait has been described by the term "Ddulite." (Pronounced, I would say, 'da-dew-light'.) It is obviously a play on "Luddite" with the fist four characters backwards. Apart from its historical meaning, a Luddite is "<a href="http://www.merriam-webster.com/dictionary/luddite">one who is opposed to change, especially technological change</a>" (Merriam-Webster). A Ddulite, on the other hand, is the opposite of a Luddite. A Ddulite is: <a href="http://www.thefacultylounge.org/2011/12/ddulites.html" style="font-style: italic;"></a> <blockquote><a href="http://www.thefacultylounge.org/2011/12/ddulites.html" style="font-style: italic;">A person who prefers new tech to old tech even when the old tech is better--more functional</a></blockquote> or alternately: <a href="http://alltopics.com/argument-favor-ddulites.html" style="font-style: italic;"></a> <blockquote><a href="http://alltopics.com/argument-favor-ddulites.html" style="font-style: italic;">A person with a preference for higher tech solutions even in cases where lower tech alternatives have greater and more appropriate functionality</a>. </blockquote> My own definition, especially in healthcare: <blockquote>Hyper-enthusiastic technophiles who either deliberately ignore or are blinded to technology's downsides, ethical issues, and repeated local and mass failures. [1]</blockquote> Such people ignore the downsides, even if the downsides are deadly - in which case I believe it justified to describe Ddulites as "radical technophiles." The Ddulite simply assumes if it's new technology, it has to be better, no matter the evidence because, well, it's new technology. In other words, irrational exuberance in IT in general, and HIT specifically, is not merely a belief, it's a character trait, perhaps an ideology. That could help explain why some otherwise very bright people, even people who promote evidence-based medical practice, seem to become blind and deaf in regard to HIT, as in the recent comment thread on my post "<a href="http://hcrenewal.blogspot.com/2012/02/kevinmd-how-algorithm-driven-medicine.html">KevinMD: How algorithm driven medicine can affect (make more dangerous, actually) patient care</a>." When it comes to evidence-based IT practice, a Ddulite is eager to provide extraordinary special accommodation towards IT flaws, ethics, known dangers, etc. Someone of this ideology finds it exceptionally easy to dismiss or ignore any and all evidence that could contradict the technology's powers to "transform" medicine, and perhaps even worse (for patients), that could contradict its infallible beneficence. Unfortunately, IT is not a magic bullet ... it can be just a bullet, period, unless "done well", an undertaking of almost <a href="http://en.wikipedia.org/wiki/Wicked_problem">wicked complexity</a>. Being a Ddulite can, in fact, lead to recklessness and negligence. A transition to IT must always respect the findings of <a href="http://rkcsi.indiana.edu/About/AboutDocs/SI_report.pdf">Social Informatics</a> (PDF): see especially Sec. 3.1 'Key Social Informatics Ideas' starting on pg. 117. The transition must be done - especially in a scientific domain - in a scientific manner. In medicine, that means applying the rigors of medical research, medical science and medical ethics to the conception, design, implementation and lifecycle of health IT, with all that implies. This is certainly not the state of the HIT enterprise in 2012, which is largely based on a management information systems, i.e. merchant-computing, paradigm. People who offer unquestioning loyalty to cybernetics, and who reflexively accuse those who are circumspect about commercial health IT of being "Luddites" who proffer "<a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">anecdotes</a>", perhaps need to look in the mirror. They then need to think critically as to whether their reflection demonstrates Ddulite characteristics. <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEifWfyKYjpgBz5Kk5fyAUpjjrSNaNoMjFL-QsYFvzzeS_npkxE4ZRSpq_vmQmJOeunGfDQnhUA-cuXpKKjgi5rxtJVGuRa3DwGHC7nPLeD9XyWFwnAn7yoP8aa3ZsA6kpYnW6ytagBI483a/s1600/In_a_Mirror%252C_Darkly_%2528ENT_episode%2529_Part_II.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5706894737912216594" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEifWfyKYjpgBz5Kk5fyAUpjjrSNaNoMjFL-QsYFvzzeS_npkxE4ZRSpq_vmQmJOeunGfDQnhUA-cuXpKKjgi5rxtJVGuRa3DwGHC7nPLeD9XyWFwnAn7yoP8aa3ZsA6kpYnW6ytagBI483a/s320/In_a_Mirror%252C_Darkly_%2528ENT_episode%2529_Part_II.jpg" style="cursor: pointer; display: block; height: 124px; margin: 0px auto 10px; text-align: center; width: 164px;" /></a>Unquestioning loyalty to the Empire: <a href="http://en.wikipedia.org/wiki/In_a_Mirror,_Darkly">In A Mirror, Darkly</a></div> -- SS Feb. 19, 2012 addendum: Also see my post "<a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-disregard-for.html">Health IT Ddulites and Disregard for the Rights of Others</a>" that adds another observation about the Ddulite mindset. Notes: [1] On mass IT failures repeatedly ignored, see "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Goldfinch_pessimism_PAR.pdf">Pessimism, Computer Failure, and Information Systems Development in the Public Sector</a>", Shaun Goldfinch, University of Otago, New Zealand, Public Administration Review 67;5:917-929, Sept/Oct. 2007.

Health IT: Ddulites and Irrational Exuberance

The title is not a typo. I've often tried to explain the phenomenon of irrational exuberance where computers are concerned, especially i...

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More cybernetic miracles: 14,000 patients failed to receive follow-up outpatient appointments

14,000 is a lot of patients to miss followup appointments. I do not think this feat could have been accomplished via paper: <a href="http://www.ehi.co.uk/news/acute-care/7519/morecambe-bay-missed-14000-outpatients"></a><blockquote><a href="http://www.ehi.co.uk/news/acute-care/7519/morecambe-bay-missed-14000-outpatients">Morecambe Bay missed 14,000 outpatients</a> E-Health Insider.com 7 February 2012 Lyn Whitfield University Hospitals of Morecambe Bay NHS Foundation Trust is working through a backlog of 14,000 patients who failed to receive follow-up outpatient appointments because of administrative and IT problems.</blockquote> And problems with disappearing ink and Fido, the office canine, chewing up charts, but mostly the IT. <blockquote> The report of an investigation into the backlog paints a damning picture of failures at the trust, which became the first to introduce the Lorenzo electronic patient record system as part of the National Programme for IT in the NHS.</blockquote> That would be, the failed National Programme for IT in the NHS, the <a href="http://hcrenewal.blogspot.com/2011/09/npfit-programme-going-pffft.html">NpfIT that went Pffft</a> (perhaps the world's most expensive onomatopoeia, at a mere £12.7bn). <blockquote>The report says the problems go back many years and have their roots in a ‘mismatch’ between demand and capacity at Morecambe Bay, as well poor management and risk practices and a culture of avoiding blame. However, it also says the trust missed a big opportunity to identify and tackle the problems when it introduced Lorenzo [a health IT system - ed.] in June 2010, and that staff work-arounds contributed to the ultimate size of the backlog.</blockquote> That is, workarounds to system flaws and 'glitches.' <blockquote>Eventually, there were 37,000 access plans on the Lorenzo system for which a guaranteed access date had been missed. Many of these plans were duplicates or had not been closed. However, 14,000 patients needed to be seen and were divided into cohorts so the trust could deal with them. All these patients should have been seen by the end of March. For the future, the report says the trust needs to establish better systems, find ways to make sure that the board knows what is going on, encourage staff to take responsibility for dealing with problems, and curb the “mal-use” of Lorenzo by imposing “sanctions” on staff if necessary. </blockquote> Once again, blaming the IT users and punishing them for not conforming to the diktats of the IT and its designers. <blockquote>It also says the findings of the report, and the importance of “electronic, standardised and systematic management of outpatient follow-ups” should be shared with all providers, in case others are suffering the same problems on a smaller scale.</blockquote> "In case?" It sounds like they don't even know. <blockquote>... when a backlog was identified during the data cleansing process for the introduction of Lorenzo, the trust failed to recognise it as a clinical problem. Instead, to try and solve another administrative problem – the constant cancellation of clinics – the trust introduced a ‘partial booking’ system. Patients who needed a follow-up in more than six weeks were asked to call for an appointment. “No arrangements were made to account for the 1,000 or so calls that the clinical clerks would receive per week, whilst still trying to man the reception desk and administer the clinics,” the report says. “This created chaos and confusion for patients and staff alike.” </blockquote> Sounds like a government operation to me. <blockquote>Patients were often offered late appointments – “some of which arrived with the patient only after the clinic had taken place.” All of this caused patient and GP complaints, but because they seemed to relate to administrative problems, their real, clinical nature was overlooked. In the middle of all this, outpatient staff complained that Lorenzo was slow – although the report says there is no evidence that it was slower than the system it replaced [ignore the users - their complaints are all 'anecdotal' - ed.] – and that it was more complicated to complete a booking. As a result, “many staff found ways around that were quicker, but these were responsible for patients having multiple access plans, which helped to label the problem as administrative.” </blockquote>You never have to work around something that is not in your way. <blockquote>Floor walkers initially monitored such “inappropriate” use, but this stopped once Lorenzo had stabilised. [The computer police...how charming. - ed.] Morecambe Bay is the first and most prominent of the ‘early adopter’ sites for Lorenzo, which was due to be implemented in the North, Midlands and East by CSC [an American management consulting firm - ed.] as local service provider. The problems at the trust, CSC’s failure to complete the ‘early adopter’ programme, and critical reports from watchdogs and MPs on progress, have thrown a new LSP deal into doubt.</blockquote> I presume they mean critical reports from MPs like <a href="http://hcrenewal.blogspot.com/2012/01/very-latest-health-it-glitch.html">this</a>, and other reports like <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">this</a> from Parliament's Public Accounts Committee a few years back that stated, among many other findings, that: <blockquote>... The [NPfIT] Programme is not providing value for money at present because there have been few successful deployments of the [U.S. Cerner] Millennium system and none of Lorenzo in any Acute Trust. Trusts cannot be expected to take on the burden of deploying care records systems that do not work effectively. Unless the position on care records system deployments improves appreciably in the very near future (i.e. within the next six months), the Department should assess the financial case for allowing Trusts to put forward applications for central funding for alternative systems compatible with the objectives of the Programme. </blockquote> Charming. <blockquote>CSC announced last week that it was going to lay off 500 staff, including 46 from iSoft, which developed Lorenzo, and which CSC bought last year.</blockquote> I'm sure that will help speed up software remediation. -- SS

More cybernetic miracles: 14,000 patients failed to receive follow-up outpatient appointments

14,000 is a lot of patients to miss followup appointments. I do not think this feat could have been accomplished via paper: Morecambe Bay m...

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Perhaps Hospitals Don't Care Much That EHRs Can Be Dangerous, Because EHRs Lets them Attract 'Good Paying Customers' And Exclude the Old and Poor

This comes as no surprise to me. I believe it may help explain hospital's cavalier attitudes towards the risks of today's commercial health IT. It's all about money. We already knew that (for example, see my Feb. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/02/does-emr-facilitated-upcoding-formely_15.html">Does EHR-Incited Upcoding (Also Known as 'Fraud') Need Investigation by CMS, And Could it Explain HIT Irrational Exuberance?</a>"), but the following news adds to the pecuniary motivations: <blockquote>Kaiser Health News <a href="http://www.kaiserhealthnews.org/Stories/2012/February/06/Hospitals-Mine-Patient-Records.aspx">Critics say hospitals cherry pick best-paying patients </a> By Phil Galewitz KHN Staff Writer Feb 05, 2012 When the oversized postcard arrived last August from Provena St. Joseph Medical Center promoting a lung cancer screening for current or former smokers over 55, Steven Boyd wondered how the hospital had found him. Boyd, 59, of Joliet, Ill., had smoked for decades, as had his wife, Karol. Provena didn't send the mailing to everyone who lived near the hospital, just those who had a stronger likelihood of having smoked based on their age, income, insurance status and other demographic criteria. The nonprofit center is one of a growing number of hospitals using their patients' health and financial records to help pitch their most lucrative services, such as cancer, heart and orthopedic care. As part of these direct mail campaigns, they are also buying detailed information about local residents compiled by consumer marketing firms — everything from age, income and marital status to shopping habits and whether they have children or pets at home. Hospitals say they are promoting needed services, such as cancer screenings and cholesterol tests, but they often use the data to target patients with private health insurance, which typically pay higher rates than government coverage. At an industry conference last year, Provena Health marketing executive Lisa Lagger said such efforts had helped attract higher-paying patients, including those covered by "profitable Blue Cross and less Medicare." </blockquote> Not to mention helping exclude those covered by Medicaid, or the uninsured. <blockquote>Strategy Draws FireWhile the strategies are increasing revenues, they are drawing fire from patient advocates and privacy groups, who criticize the hospitals for using private medical records to pursue profits. </blockquote>I don't recall anywhere on the releases at area hospitals saying they would be using their own clinical data for marketing purposes (which likely involve third party contractors). It might be in the fine print, however. I also don't recall any place to sign and give informed consent to the use of experimental medical devices such as the EHR's used to collect the marketing data, either, but that's addressed elsewhere on this blog such as <a href="http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html">here</a>. <blockquote> Doug Heller, executive director of <a href="http://www.consumerwatchdog.org/" target="_blank">Consumer Watchdog</a>, a California-based consumer advocacy group, says he is bothered by efforts to "cherry pick" the best-paying patients. "When marketing is picking and choosing based on people's financial status, it is inherently discriminating against patients who have every right and need for medical information," Heller says. "This is another example of how our health system has gone off the rails."</blockquote> I would go beyond "off the rails." How about, straight to perverse? EHR data is used to attract paying customers and then expose them to risk of being maimed due to the disruptive nature of the HIT itself. <blockquote>Deven McGraw, director of the health privacy project at the Center for Democracy and Technology in Washington, says federal law allows hospitals to use confidential medical records to inform patients about things that may help them. </blockquote> "If it's technically legal, we can do it, and who gives a damn about the ethics?" is what is being expressed here. <blockquote>"You want health providers to communicate to patients about health options that may be beneficial to their health," McGraw says. "But sometimes this is about generating business for a new piece of equipment that the hospital just bought." Using such information for marketing "creeps closer to the line," between what is legal and what is not, she says.</blockquote> And helping recoup the costs of that hundred-million dollar EHR setup, too. <blockquote> ... Tess Niehaus, vice president of marketing at St. Anthony’s Medical Center in St. Louis, says the approach has been quite successful and makes no apologies for going after the most lucrative business. "We are here to serve everybody but we market for good paying patients because it preserves our ability to serve everyone," she says. [And the ability to proffer generous executive salaries and raises - ed.] </blockquote> "Good paying patients?" Does that imply there are bad paying patients? (Might those "bad paying patients" be predominantly the elderly and/or minorities?) <blockquote> While the practice is legal, most people would be shocked to know their <a href="http://www.worldprivacyforum.org/pdf/TestimonyofPamDixonfs.pdf" style="font-weight: bold;" target="_blank">records may be shared</a> with nonmedical personnel and outside firms to help hospitals attract business, says Pam Dixon, executive director of the World Privacy Forum, an advocacy group based in California. "I am really bothered by the overabundance of information that is flowing that is unnecessary and risky," she says. </blockquote> As I've written before, <a href="http://hcrenewal.blogspot.com/2012/01/2011-closes-on-note-of-electronic.html">don't worry, your most sensitive data's safe in the hands of the extremely skilled health IT professionals</a> at most hospitals. <blockquote>While hospitals may profit from offering cholesterol tests and mammograms, the big payoff is in what those screenings may lead to – additional tests and procedures, including surgery. "It's all about downstream revenue," says Patrick Kane, senior vice president of marketing at Cape Cod Healthcare in Massachusetts who used such approaches at Wellmont Health System in Kingsport, Tenn. "The old adage in business is that it’s easier to sell an existing customer new services, rather than find a new customer."</blockquote> So much for medical professionalism and conservatism. At least Mr. Kane admits it's all about money. <blockquote>... Provena's Lagger says the approach boosted the system's bottom line so it could serve people regardless of insurance status. "This is a means to an end," she says. </blockquote> The ends don't always justify the means, but that may be a hard concept for some in today's amoral culture to understand. <blockquote>... Much of the expertise for such campaigns is provided by three consulting firms -- <a href="https://www.cpm.com/index.cfm/customers/testimonials/" target="_blank">CPM Marketing</a> of Madison, Wis., <a href="http://www.blogger.com/www.medseek.com" target="_blank">Medseek</a> of Birmingham Ala. and New York-based <a href="http://thomsonreuters.com/" target="_blank">Thomson Reuters</a>. They typically charge hospitals $100,000 a year or more. CPM, which merged in November with Denver, Colo.-based HealthGrades, a health ratings firm, added 100 new hospitals last year to give it a total of 400. Medseek works with more than 250 hospitals and Thomson Reuters, with 150.</blockquote> Remember Darrin Stevens on <a href="http://en.wikipedia.org/wiki/Bewitched">Bewitched</a>? "Larry, I've got a great idea for a new campaign! Let's troll for patients using their private data! Never mind that I have donkey ears today... that darn mother in law of mine, Endora!" <blockquote>The targeting worked in the case of Boyd, who called the number on the back and scheduled the CT scan a few days later. The $169 test showed his lungs were clear, but found potential blockages in coronary arteries that his Provena-affiliated doctor is monitoring."In hindsight, I’m glad I had the test," he says.</blockquote> No mention of patients who had unnecessary testing and interventions that led to bad outcomes ... or patients injured by the very EHR systems that make such marketing possible. -- SS

Perhaps Hospitals Don't Care Much That EHRs Can Be Dangerous, Because EHRs Lets them Attract 'Good Paying Customers' And Exclude the Old and Poor

This comes as no surprise to me. I believe it may help explain hospital's cavalier attitudes towards the risks of today's commercia...

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Rendering Unto Caesar - What the Abramson Family Cancer Research Institute vs Thompson Says About the Loss of the Academic Medical Mission

A case, <a href="http://www.nytimes.com/2012/02/06/health/cancer-center-in-lawsuit-says-a-doctor-appropriated-a-discovery.html">reported</a> by the New York Times as involving an intellectual property dispute, should create a lot of cognitive dissonance about the state of the academic medical mission. Litigation Involving the Abramson Family Cancer Research Institute and Dr Craig B Thompson Here is how the Times outlined the story: <blockquote>The president of Memorial Sloan-Kettering Cancer Center in New York is in a billion-dollar dispute with his former workplace, a cancer institute at the University of Pennsylvania, over accusations that he walked away with groundbreaking research and used it to help start a valuable biotechnology company. In a lawsuit, the Leonard and Madlyn Abramson Family Cancer Research Institute at Penn described its former scientific director, Dr. Craig B. Thompson, as 'an unscrupulous doctor' who 'chose to abscond with the fruits of the Abramson largess.' </blockquote> In particular, <blockquote>In the suit, the Abramson cancer institute, which has received more than $100 million from the philanthropist Leonard Abramson and his family, says that Dr. Thompson concealed his role in starting Agios, which has attracted investors with a potentially new way to treat cancer. The institute says Dr. Thompson’s actions deprived it of proceeds that could support future research, causing it damages that could exceed $1 billion.</blockquote> So presumably the Abramson Institute is alleging that Thompson took its intellectual property and put it into Agios, and the Institute therefore wants compensation. Note that the Institute does not appear to be alleging either that Thompson was supposed to be its employee, but actually was working for Agios at the time he was supposed to be working for the institute; or that Thompson hid a a conflict of interest created by his financial relationship with Agios that could have affected how he fulfilled his professional responsibilities there. Note further that certain other parties declared that they are not part of this dispute. These included Dr Thompson's current employer: <blockquote>Sloan-Kettering declined to comment, saying it was not a party to the lawsuit....</blockquote> These also included the University of Pennsylvania: <blockquote>Susan E. Phillips, senior vice president for Penn Medicine, said that the suit had been filed not by the university but by the research institute, a separate entity. She said the university was investigating the accusations. </blockquote> The nature of this dispute ought to generate several kinds of cognitive dissonance. Protecting Intellectual Property vs Upholding the Academic Mission at the University of Pennsylvania On <a href="http://www.afcri.upenn.edu/aboutus/ourhistory.html">one of its web pages</a>, the Abramson Family Cancer Research Institute describes its history: <blockquote>The Abramson Cancer center of the University of Pennsylvania provides each patient with exemplary care though a comprehensive team approach, personalized service, education and outreach, and nationally recognized cancer research programs.</blockquote> The web page describes the institute as simply part of the larger University of Pennsylvania cancer center, which came to be named for the Abramson family: <blockquote>Penn's Cancer Center was renamed in 2002 as the Abramson Cancer Center of the University of Pennsylvania, recognizing the Abramson family's $100 million commitment to support comprehensive cancer research and care.</blockquote> Thus it seems that the Abramson institute is simply a piece of a traditional academic medical center. The academic mission is traditionally described as the creation and teaching of knowledge. Thus, if an academic institution creates new knowledge, its should then disseminate it, not own it. Of course, in the US, since the Bayh-Dole act was passed, academic institutions were given the ability to patent their discoveries, and began to protect and sequester the knowledge they contained, rather than disseminating it. In this case, however, one part of a large university and a large academic medical center seems to be concentrating entirely on its right of ownership of intellectual property, not the traditional academic mission. The fact that this dispute has lead to litigation suggests that the academic organization is now intent on protecting, rather than disseminating knowledge. The dispute appears to be between a commercial research company and its allegedly errant former hired manager. The Abramson Institute: Part or Independent of the Academic Medical Center?   A little more digging suggests that the nature of the Abramson institute is not as clear as is described in its web-page. A GuideStar search revealed that the institute is actually legally independent from the university. It filed its own 990 form (latest version, covering 2009-2010, <a href="http://www.guidestar.org/FinDocuments/2010/232/929/2010-232929823-074d3257-9.pdf">here</a>.) The filing did list various entities, including the Clinical Care Associates of the University of Pennsylvania Health System, and the Trustees of the University of Pennsylvania as "related tax-exempt organizations." However, this filing should create cognitive dissonance about what the underlying nature of the Institute? Is it part of the University of Pennsylvania and its medical center, or is independent but cooperating? This dissonance is only enhanced by the ambiguous response of the University of Pennsylvania to the lawsuit. If the Institute is part of the University, then the University ought to be party to the lawsuit, it would seem. This filing with the US government did underline the Institute's commitment to disseminating research. A description of its tax "exempt purposes" included: <blockquote>Education - scientists at the Institute actively share their discoveries with the research community, physicians, and students.</blockquote> As above, this statement of purpose appears not to fit with the filing of a lawsuit to obtain damages due to the alleged taking of intellectual property. If this really were the Institute's mission, would not they want the intellectual property liberated so it could be actively shared? The cognitive dissonance about the mission of the Institute and of the University versus the protection and sequestration of intellectual property is thus increased. Upholding the Academic Mission vs Staying Uninvolved at Memorial Sloan-Kettering Cancer Center As an aside, note that Dr Thompson is now not just working for Agios. In fact, he has been President of the Memorial Sloan-Kettering Cancer Center since 2010 (look <a href="http://www.mskcc.org/news/magazine/october-2010/craig-thompson-named-president-msk">here</a>). Just like the Abramson Cancer Center, Sloan-Kettering is an academic medical center with the traditional mission of teaching, research, and patient care. Here is its <a href="http://www.mskcc.org/about">mission statement</a>: <blockquote>As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, and superb educational programs.</blockquote> So one would think that people there ought to be concerned by allegations that its current president took intellectual property without authorization, and that he is "an unscrupulous doctor." If these allegations were to be proven false, they seemingly would represent a major, unwarranted slur on its and his reputation. If they were to be proven true, they would indicate that current leadership might not have the character to uphold the mission. Either outcome would be serious and have serious implications. However, at the moment, this noted academic medical institution has expressed neither outrage about possibly false accusations nor resolve to investigate the matter and then weed out any leaders not devoted to the mission. Thus, the apparent intention of the leadership of Memorial Sloan-Kettering to stay uninvolved with this case ought to generate more cognitive dissonance. Summary The cognitive dissonances evoked by the case of the Abramson Institute vs Dr Thompson ought to inspire questions about what our academic medical institutions have become.  While they proclaim their devotion to research and teaching to improve health and health care, and advance science, they may increasingly act like commercial research organizations whose main goal is to generate increased revenue from products and services, and in this case, from intellectual property.  It is hard to see how this emphasis on holding onto rather than disseminating new knowledge will be good in the long run for science, learning, or patient care. We are now a good 30+ years into our ill-fated American experiment about the effects of turning medicine commercial and making health care a commodity. So far, it has yielded the highest costs in the world, but declining access, mediocre quality, and demoralized professionals.  Squabbling among top researchers and leading academic medical institutions over the ownership of intellectual property for the sake of revenue, not dissemination, is the latest symbol of the decline of our health care. I can only hope that all the parties involved suddenly remember that they are supposed to be creating and disseminating knowledge, not just getting rich.

Rendering Unto Caesar - What the Abramson Family Cancer Research Institute vs Thompson Says About the Loss of the Academic Medical Mission

A case, reported by the New York Times as involving an intellectual property dispute, should create a lot of cognitive dissonance about the...

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Just Business - Employee Control Fraud, Gresham's Dynamic, and the Race to the Bottom in Health Care

Since Enthoven called for the break up of the physicians' "guild," and handing over its supposed power to managers, (see post <a href="http://hcrenewal.blogspot.com/2006/03/consequences-of-breaking-physicians.html">here</a>) managers have taken over from physicians and other health care professionals as leaders of health care organizations.  Unfortunately, most of these managers are <a href="http://hcrenewal.blogspot.com/search/label/generic%20managers">generic</a>, often lacking knowledge and experience in health care, and understanding of its core values.  Instead, such generic managers may rely on the current management dogma.  The perils of doing so are illustrated by an analysis of the recent expose of conditions at Apple manufacturing plants in China. The Apple Expose The New York Times summarized in a <a href="http://www.nytimes.com/2012/01/26/business/ieconomy-apples-ipad-and-the-human-costs-for-workers-in-china.html">landmark article</a> how bad it is to work in factories building Apple products under contract in China.  Workers endure harsh conditions, toiling up to six days a week, 12 hours a day.  Meanwhile, banners remind them to "work hard on the job today or work hard to find a job tomorrow."  Workers may be exposed to hazardous, even poisonous materials (like n-hexane used to clean components).  Workers have died in explosions due to inadequate control of combustible dust. Over 18 workers at one factory attempted or committed suicide within two years. The article suggested that while Apple managers may be well-intentioned, and "want to improve conditions in factories," the bottom line is more important: <blockquote>that dedication falters when it conflicts with crucial supplier relationships or the fast delivery of new products.</blockquote> In fact, because of its rigid insistence on cost control, its suppliers are sorely tempted to push their workers too hard: <blockquote>Apple typically asks suppliers to specify how much every part costs, how many workers are needed and the size of their salaries. Executives want to know every financial detail. Afterward, Apple calculates how much it will pay for a part. Most suppliers are allowed only the slimmest of profits. So suppliers often try to cut corners, replace expensive chemicals with less costly alternatives, or push their employees to work faster and longer, according to people at those companies. 'The only way you make money working for Apple is figuring out how to do things more efficiently or cheaper,' said an executive at one company that helped bring the iPad to market. 'And then they’ll come back the next year, and force a 10 percent price cut.' </blockquote> So, <blockquote>'You can set all the rules you want, but they’re meaningless if you don’t give suppliers enough profit to treat workers well,' said one former Apple executive with firsthand knowledge of the supplier responsibility group. 'If you squeeze margins, you’re forcing them to cut safety.' </blockquote> William Black's Analysis: Employee Control Fraud and the Race to the Bottom Writing <a href="http://www.huffingtonpost.com/william-k-black/apples-ethical-blindness-_b_1244410.html">in the Huffington Post</a>, William K Black showed how Apple executives' relentless focus on cost could drive a race to the bottom. He began by analyzing Apple executives' explanation for out-sourcing their production: <blockquote>'We shouldn't be criticized for using Chinese workers,' a current Apple executive said. 'The U.S. has stopped producing people with the skills we need.' </blockquote> He noted that it is absurd to suggest that the US does not have workers with the technical skills necessary to build Apple products. He suggests, however, that these are not the skills that matter. <blockquote>The suppliers want engineers and managers who will selectively apply their substantive skills. American engineers and managers cannot be counted on to provide the necessary selectivity. Apple's suppliers' often seek managers willing to order their workers to exceed the lawful workweek, to refuse to pay them for significant portions of the wages they have earned, to unlawfully employ child labor, and even to coerce abortions.</blockquote> So, in the n-hexane example, <blockquote>The engineer did not order the workers to use the nerve poison because he hated the workers. It was 'just business.' The nerve poison reduced cleaning time, so an engineer knowingly ordered the workers to use it and scores of other engineers did nothing to prevent the usage. </blockquote> Note that Black calls this employee control fraud, deceiving the employee that he or she is working in a reasonably safe environment, and that employee health and safety is a concern, when in truth the only concern is the bottom line. So what Apple executives, and by analogy, other multi-national corporate executives want are underlings, particularly middle and line managers who will do anything, anything to cut costs and improve the bottom line. This will produce the race to the bottom: <blockquote>What we are observing is the essence of a Gresham's dynamic in which bad ethics drives good ethics out of the market. Two aspects of this Gresham's dynamic are obscene, and both are produced by neoclassical economics dogma. Calling this process 'creative destruction' is baseless and dishonest. It is the fraudulent destruction of honest businesses, professions, and labor.</blockquote> Black concluded: <blockquote>firms that are anti-employee control frauds are likely to commit other forms of control fraud. Apple and its Western counterparts have driven the creation of an Asian network of fraudulent firms that has distorted international trade, hollowed out U.S. manufacturing, and created a bizarre hybrid: quasi-communist crony capitalism. It boggles the mind that theoclassical economists celebrate the corrupt result as the essence of creative destruction. The network is corrupt. It will not play by the rules. Firms like Apple help create the perverse incentives that encourage the network to cheat. Surviving U.S. manufacturing firms are whipsawed by the powerful Gresham's dynamic that the frauds produce. U.S. firms and workers are constantly pressured to reduce wages and workforce to try to compete with the foreign frauds. This is the 'Road to Bangladesh' strategy that has caused U.S. working class wages to stall for decades. Europe is retreating along this same road at an even more rapid rate. The Gresham's dynamic tilts the world in favor of fraudulent firms operating in fraud-friendly nations. </blockquote>The Race to the Bottom in Health Care Note that we have written about numerous examples of executives of US health care organizations putting revenue ahead of the health care mission, ahead of workers' morale, ahead of patients' and the public's health. Some of these examples involve executives of nominally non-profit organizations that are supposed to have charitable purposes. (Look under our heading of <a href="http://hcrenewal.blogspot.com/search/label/mission-hostile%20management">mission-hostile management</a>.) In fact, just yesterday, Dr Carl Elliott, <a href="http://chronicle.com/blogs/brainstorm/working-the-assembly-line-at-the-human-experimentation-factory/43646">writing</a> for the Chronicle of Higher Education, summarized how pharmaceutical companies have out-sourced clinical research. The resulting commercial clinical research have generated conditions as bad for the research subjects as those endured by the Chinese electronics workers above: <blockquote>If the past decade had an emblematic moment for clinical research, it was probably November 12, 2005, the day when Bloomberg Markets published its cover story, “Big Pharma’s Shameful Secret.” In that issue, Bloomberg reporters laid out the story of SFBC International, a contract research organization in Miami that was paying undocumented immigrants to test the safety of new drugs in a seedy motel. The SFBC owners had converted the lobby into a large waiting area with plastic chairs, and they were housing their research subjects six to a room. The medical director of the research site was unlicensed to practice medicine; the Institutional Review Board that approved many of the studies was owned by the wife of the company vice-president; and the converted motel, which had been cited for fire and safety violations, was eventually demolished. Nonetheless, SFBC had become an astonishingly successful enterprise. Just a few years before the Bloomberg Markets report, Forbes had named SFBC one of the most admired small businesses in America. Virtually every major pharmaceutical company had tested drugs with the company. In fact, with 675 beds, the converted motel was the largest research facility in North America.</blockquote>Note: see our relevant posts here on <a href="http://hcrenewal.blogspot.com/search/label/SFBC%20International">SFBC International</a>, and on <a href="http://hcrenewal.blogspot.com/search/label/contract%20research%20organizations">contract research organizations</a>. Moreover, such out-sourcing has produced the sort of race to the bottom described by Black, but this time involving one of the US most important health care institutions, academic health care: <blockquote>the more important reason is money. In medical schools, faculty members are often expected to generate their own salaries, either by seeing patients or getting grants and contracts. Likewise, academic departments are often expected to be financially self-sufficient, with as little support as possible from central administration. 'Eat what you kill' is the phrase used, without irony, by medical school deans and department heads. And if you are not killing it with NIH grants, you probably need to be killing it with AstraZeneca or Pfizer. This system has not been good for human subjects, but it has not been good for academic physicians either. According to a recent study of over 5,000 faculty members at U.S. medical schools, 51 percent of respondents said that the administration is only interested in me for the revenue I generate.' Thirty-one percent said that their institution discourages altruism; 27 percent said that it does not reward clinical excellence; and over half said that it does not value teaching. Nearly half of respondents were considering leaving their current jobs; almost a third were considering leaving academic medicine altogether. Asked if their values lined up with the medical schools where they worked, over half said no. And just in case you are wondering why these physicians are not standing outside the building with picket signs, protesting the injustice of the system, the survey offers another clue. Thirty percent of respondents agreed with the statement, 'I am reluctant to express my opinion for fear of negative consequences.' [This was from an abstract by Pololi L et al.  See our relevant post <a href="http://hcrenewal.blogspot.com/2010/12/american-medical-schools-are-only-in-it.html">here</a>.] Of course, this survey does does not exactly match up with the happy propaganda disseminated by the media-relations offices at most medical schools. Instead, it offers a picture of alienated, demoralized physicians, unhappy in their jobs, pressed to work according to values that repel them in order to prop up an institution that views them primarily as instruments to generate profit. In this environment, contract research makes perfect sense. It may not require much intellectual work, but it pays the bills and keeps the authorities happy. And if medical schools don’t really value intellectual work anyway, that may well be enough.</blockquote>So the pressures on medical school faculty are little different from those on corporate middle management.  Their only role is to make money, mainly so that the top leaders can become multi-millionaires, and woe unto them if they object. Summary What is missing in all this is any organized opposition to the race to the bottom. As long as top executives can make<a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation"> nearly unlimited money</a>, as long as they can do so by making their subordinates put revenue ahead of all else, as long as there are no countervailing forces, the race to the bottom will continue. To stop it, we need some combination of efforts by honest government regulators, professional and trade organizations, civil society organizations including non-profit organizations and NGOs that really care about patients' and the public's health, and finally an activated, and properly outraged public. As long as we think that a laissez faire policy allowing continual market dysfunction to continue, the good times for executives will keep rolling, over all of the rest of us.

Just Business - Employee Control Fraud, Gresham's Dynamic, and the Race to the Bottom in Health Care

Since Enthoven called for the break up of the physicians' "guild," and handing over its supposed power to managers, (see post ...

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