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Drug Discovery and Reductionism for Physicists ... And Others

Having worked both in health IT and in pharma drug discovery, I read numerous pharma-related blogs. From the blog of medicinal chemist Derek Lowe, "<a href="http://pipeline.corante.com/archives/2012/03/06/drug_discovery_for_physicists.php">In the Pipeline</a>" about reductionism in drug discovery. I believe the observations are more widely applicable to health IT, and to medicine itself. Emphases mine: -------------------------------- <h4>March 6, 2012 </h4><h3><a href="http://pipeline.corante.com/archives/2012/03/06/drug_discovery_for_physicists.php">Drug Discovery for Physicists</a></h3><a href="http://pipeline.corante.com/archives/2012/03/06/drug_discovery_for_physicists.php#zemail"></a> Posted by Derek <div class="img"> There's a <a href="http://wavefunction.fieldofscience.com/2012/03/why-its-hard-to-explain-drug-discovery.html">good post</a> over at the Curious Wavefunction on the differences between drug discovery and the more rigorous sciences. I particularly liked this line: <blockquote>The goal of many physicists was, and still is, to find three laws that account for at least 99% of the universe. But the situation in drug discovery is more akin to the situation in finance described by the physicist-turned-financial modeler Emanuel Derman; we drug hunters would consider ourselves lucky to find 99 laws that describe 3% of the drug discovery universe.</blockquote> That's one of the things that you get used to in this field, but when you step back, it's remarkable: so much of what we do remains relentlessly empirical. I don't just mean finding a hit in a screening assay. It goes all the way through the process, and the further you go, the more empirical it gets. Cell assays surprise you compared to enzyme preps, and animals are a totally different thing than cells. Human clinical trials are the ultimate in empirical data-gathering: there's no other way to see if a drug is truly safe (or effective) in humans other than giving it to a whole big group of humans. We do all sorts of assays to avoid getting to that stage, or to feel more confident when we're about to make it there, but there's no substitute for actually doing it. There's a large point about reductionism to be made, too: <blockquote>Part of the reason drug discovery can be challenging to physicists is because they are steeped in a culture of reductionism. Reductionism is the great legacy of twentieth-century physics, but while it worked spectacularly well for particle physics it doesn't quite work for drug design. A physicist may see the human body or even a protein-drug system as a complex machine whose understandings we can completely understand once we break it down into its constituent parts. But the chemical and biological systems that drug discoverers deal with are classic examples of emergent phenomena. A network of proteins displays properties that are not obvious from the behavior of the individual proteins. . .Reductionism certainly doesn't work in drug discovery in practice since the systems are so horrendously complicated, but it may not even work in principle.</blockquote> And there we have one of the big underlying issues that needs to be faced by the hardware engineers, software programmers, and others who come in asking why we can't be as productive as they are. There's not a lot of <a href="http://en.wikipedia.org/wiki/Algorithmic_information_theory">algorithmic compressibility</a> in this business. Whether they know it or not, many other scientists and engineers are living in worlds where they're used to it being there when they need it. But you won't find much here.--------------------------------I personally like the conclusion of Dr. Lowe's source article at Curious Wavefunction:<div></div><blockquote><div> </div><div>... All this can only be a good augury if it means that more physicists are going to join the working ranks of drug discoverers. And it will all work out splendidly as long as they are willing to occasionally hang their reductionist hats at the door, supply pragmatic solutions and not insist on getting answers right to twelve decimal places.</div></blockquote><div></div> </div> The reductionistic ideas prevalent in medicine today, where EHRs and Watson-like computers are <a href="http://hcrenewal.blogspot.com/2011/01/ibms-watson-jeopardy-and-revolutioning.html">supposed to be able to work miracles</a> real soon now, is likely worse than reductionism in drug discovery, as they lead to the current mess with EHR's (see for instance <a href="http://ctlab.org/documents/Hiding%20in%20plain%20sight.pdf">this article</a>) and threats to patients. -- SS

Drug Discovery and Reductionism for Physicists ... And Others

Having worked both in health IT and in pharma drug discovery, I read numerous pharma-related blogs. From the blog of medicinal chemist Derek...

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AMA News Article Offers Incomplete (and Thus Misleading) Advice on the Legal Risks of EHRs and other Clinical IT

An article was published in the AMA News by Alicia Gallegos, AMA Medical News staff, entitled "Legal risks of Going Paperless." While it is not clear if these are the official views of the AMA leadership, the article is interesting nonetheless. It should perhaps have been entitled "Some of the Legal Risks of Going Paperless, excluding the ones that make the health IT industry look bad:" <a style="font-weight: bold;" href="http://www.ama-assn.org/amednews/2012/03/05/prsa0305.htm"> </a><blockquote><a style="font-weight: bold;" href="http://www.ama-assn.org/amednews/2012/03/05/prsa0305.htm">Legal Risks of Going Paperless</a> AMA News March 5, 2012 Electronic medical records are meant to save time and money, but they also can create liability issues for doctors. By Alicia Gallegos, amednews staff. Defense attorney Catherine J. Flynn knows how electronic medical records can overwhelm — and often change — the course of a medical liability lawsuit. In one of her cases, a New Jersey doctor being sued for medical negligence has been accused by a plaintiff’s attorney of modifying a patient’s electronic history. A printing glitch caused the problem, Flynn said, but the accusation has meant extra time and defense costs. Computer screen shots were reviewed, more evidence was gathered and additional arguments were made. “This has taken a life of its own, and we’ve done virtually no discovery on the medical aspects of the case,” she said. “The cost of the e-discovery alone is in excess of $50,000.”</blockquote> This is a variation on the theme of plaintiff's lawyers being the cause of EHR problems as I wrote at "<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>." <blockquote>System breaches. Modification allegations. E-discovery demands. These issues are becoming common courtroom themes as physicians transition from paper to EMRs, legal experts say. Not only are EMRs becoming part of medical negligence lawsuits, they are creating additional liability.</blockquote> Missing is the problem that is most important of all: health IT system defects, poor user interfaces, unreliability, data loss, etc. causing or contributing to medical malpractice that results in patient harm or death. (An example that I personally observed and reported to the FDA MAUDE database is <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/Detail.CFM?MDRFOI__ID=1729552">here</a>; there are numerous others in this blog.) <blockquote>Data breaches are among the most common reasons that electronically stored information lands doctors in court, said Lisa Gallagher, senior director for privacy and security at the Health Information and Management Systems Society, which advocates health information technology</blockquote> Most common perhaps (a big problem unto itself), but not the most clinically significant problem. Yet the AMA article goes on about this issue for many paragraphs; it's the prime focus of the article. <blockquote>A 2011 ruling in New York highlights how e-discovery creates a burden for doctors. During a lawsuit against St. Luke’s Hospital Roosevelt Center, a debate arose about whether the plaintiff should be allowed access to screen shots from a doctor’s computer. Joan Bowman, who sued the hospital for wrongful death on behalf of her husband, wanted to see a computer template used to aid physicians in diagnoses. The hospital said the request was overly broad and oppressive. But the Supreme Court of the State of New York ordered the release of the screen shots. “Defendant doctors testified that they utilized these materials in coming to their diagnosis,” Judge Alice Schlesinger wrote. “It is not a stretch to allow counsel to see and understand these materials.” At this article’s deadline, the hospital’s attorney had not returned messages seeking comment. The case sets a precedent, said Susan Dennehy, Bowman’s attorney. “If others want to see screen shots from records, I think they’ll rely on this case,” she said. “It was important to see where the template led you if you put in an inaccurate chief complaint.”</blockquote> Note the "spin" about the "burden for doctors" of eDiscovery. To the pundits and voluntary adopters: you have gotten what you asked for. To the non-pundit clinicians forced to use health IT: I hate to say this, but you've gotten screwed. The article then offers a laundry list of how to avoid EHR-related liability: <blockquote>... As the number of electronic medical records increases, so do certain legal risks, medical liability experts say. Common mistakes doctors make with EMRs and how attorneys recommend that physicians reduce their liability risks: Mistake: EMRs allow users to move quickly through patient records, but cutting and pasting information makes it easy to paste incorrect information. Recommendation: Refrain from copying and pasting EMR data, and be cautious when moving from one patient’s record to the next. Mistake: Computer programs can help doctors make a differential diagnosis, but the templates don’t often include every possible symptom and corresponding medical condition. Recommendation: Doctors should not become overly dependent on electronic diagnosis aids. Electronic systems are no substitute for hands-on diagnosis. Mistake: Because EMRs allow physicians to move through patient charts much more quickly than paper charts, attorneys are noticing that some doctors are not being thorough when writing notes electronically. Recommendation: Physicians should keep meticulous electronic notes on each patient and take time to document each chart. Mistake: Some practices can fail to safeguard electronic patient data. Recommendation: Practices should encrypt all information on computer devices and have policy that discourages employees from taking portable devices out of the office. Mistake: A system may not clearly indicate changes to records. Recommendation: Physicians should install systems that show transparency when modifications are made and/or have a program lockout period where no more modifications can be made to a record. Mistake: Doctors may fail to follow notification requirements in the event of a data breach. Recommendation: Be clear on what your state law requires when a data breach occurs, and make sure employees follow the rules immediately. Mistake: Doctors may destroy or delete electronic records when a lawsuit is possible. Recommendation: If doctors suspect they are being sued, they must preserve all electronic data related to the patient in question, including emails, phone messages and computer records.</blockquote> Missing is this, as is well-covered by almost 8 years of posts on this blog, and elsewhere: <blockquote> Big mistake: Doctors and hospitals buy and implement experimental technology approved by nobody, of uncertain quality to the point of <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">losing or corrupting data</a>, often with glass-tube black-and-white TV user interface modernity. Such technology is "errorgenic", i.e., it promotes "use error", can mislead, and can promote medical errors. Recommendation: Hold off until the industry has gotten its act together.</blockquote> Also missing from the AMA News article is the fact that physicians and hospitals use health IT at their <a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html">own risk</a>, even if the IT is "certified." This article is clearly pregnant with omissions and spin that reveal a pro-health IT bias. -- SS

AMA News Article Offers Incomplete (and Thus Misleading) Advice on the Legal Risks of EHRs and other Clinical IT

An article was published in the AMA News by Alicia Gallegos, AMA Medical News staff, entitled "Legal risks of Going Paperless." W...

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Another Health IT Mythbuster: Doctors order more X-rays, not fewer, with computer access

This piece is in the Washington Post about a just-released piece in Health Affairs (<a href="http://content.healthaffairs.org/content/31/3/488.abstract">at this link</a>) by Danny McCormick, David H. Bor, Stephanie Woolhandler and David U. Himmelstein of Harvard Medical School. (Woolhandler and Himmelstein have written on such topics before, such as in the Nov. 2009 article “<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/AJM-Himmelstein-Hospital-Computing.pdf">Hospital Computing and the Costs and Quality of Care: A National Study</a>”, Amer J Med 123:1; 40-46.) In the abstract of the new article, the researchers note: <blockquote>Giving Office-Based Physicians Electronic Access To Patients’ Prior Imaging And Lab Results Did Not Deter Ordering Of Tests Health Aff March 2012 vol. 31 no. 3 488-496 Abstract <div id="p-1">Policy-based incentives for health care providers to adopt health information technology are predicated on the assumption that, among other things, electronic access to patient test results and medical records will reduce diagnostic testing and save money.</div>To test the generalizability of findings that support this assumption, we analyzed the records of 28,741 patient visits to a nationally representative sample of 1,187 office-based physicians in 2008. Physicians’ access to computerized imaging results (sometimes, but not necessarily, through an electronic health record) was associated with a 40–70 percent greater likelihood of an imaging test being ordered. The electronic availability of lab test results was also associated with ordering of additional blood tests. The availability of an electronic health record in itself had no apparent impact on ordering; the electronic access to test results appears to have been the key. These findings raise the possibility that, as currently implemented, electronic access does not decrease test ordering in the office setting and may even increase it, possibly because of system features that are enticements to ordering. We conclude that use of these health information technologies, whatever their other benefits, remains unproven as an effective cost-control strategy with respect to reducing the ordering of unnecessary tests. </blockquote><div id="p-1"></div> The WaPo offered these observations in their article: <a href="http://www.washingtonpost.com/national/health-science/doctors-order-more-x-rays-not-fewer-with-computer-access/2012/03/05/gIQATghCtR_story.html"> </a><blockquote><a href="http://www.washingtonpost.com/national/health-science/doctors-order-more-x-rays-not-fewer-with-computer-access/2012/03/05/gIQATghCtR_story.html" style="font-weight: bold;">Doctors order more X-rays, not fewer, with computer access</a> By <a href="http://www.washingtonpost.com/lena-h-sun/2011/03/03/ABUvPGP_page.html" rel="author">Lena H. Sun</a>, Published: March 5 <div class="module byline"><h3> </h3></div><div class="article_body"> <article> In the debate over the high cost of health care, federal policymakers have always claimed that one way to cut costs is for doctors to use <a href="http://www.washingtonpost.com/national/despite-incentives-doctors-are-wary-about-switching-to-electronic-health-records-/2011/02/24/ABvRCuV_story.html" xslt="_http">electronic medical records </a>and other information technology. <a href="http://www.washingtonpost.com/national/one-doctors-digital-journey/2011/02/18/ABZrMSW_story.html" xslt="_http">Doing so</a>, they say, avoids duplication and saves money. But new research suggests that may not be the case.</article> </div>Doctors who have easy computer access to results of X-rays, CT scans and MRIs are 40 to 70 percent more likely to order those kinds of tests than doctors without electronic access, according to a study to be published in the March issue of the journal Health Affairs.</blockquote> This is not surprising to me. Click a button, order an test, click a button, get the results. What could be easier? What the pundits failed (and continually fail) to take into account is the social context of health IT. It is not used on a robotic assembly line. There are incentives, both proper and perverse (e.g., "defensive medicine", profits, patient demands) that figure into how any IT will "play out" in healthcare. Making the blanket statement that "IT in healthcare will save money" without solid, sustained evidence (as opposed to the anecdotal evidence that now exists), while simultaneously ignoring contrary evidence is simply promoting an industry-created meme, a.k.a. wishful thinking. <blockquote>“On average, this is comparing doctors who had electronic medical records and those who didn’t,” said lead author Danny McCormick, a physician and assistant professor of medicine at Harvard Medical School. Researchers say the findings challenge a key premise of the nation’s multibillion-dollar effort to promote the widespread adoption of health information technology. “This should give pause to those making the argument,” McCormick said. Instead of saving money, that effort could drive costs higher, he said. For the study, researchers at the Cambridge Health Alliance, a health system in Cambridge, Mass., and the City University of New York analyzed data from a 2008 federal government survey. The data included information collected from 28,741 patient visits to 1,187 office-based doctors. The information included the type of doctor, their office computerization and the tests ordered at each visit. About half of the doctors’ offices surveyed had computerized access to results of X-rays and other imaging tests. Researchers found that doctors who did not have computerized access ordered imaging tests in 12.9 percent of visits, while doctors with electronic access ordered imaging in 18 percent of visits, a 40 percent greater likelihood. Doctors with computerized access were even more likely — about 70 percent more likely — to order advanced imaging tests, such as PET scans, which experts said are most commonly used to detect cancer, heart problems, brain disorders and other central nervous system disorders. The study found the results hold true even after taking into account other factors, such as patient demographics, doctor specialty and physician self-referral. </blockquote> Unfortunately, nothing up to and including HIT-related patient deaths will give pause to health IT pundits pushing national rollout. They have too much skin in the game in the health IT bubble, psychologically (<a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-irrational.html">link</a>) and financially. The pundits need to be opposed by medical and legal professionals in an organized, systematic fashion until such time as this industry follows the National Academies' <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">direct recommendations on getting health IT "right."</a> <blockquote>... Researchers were not able to determine why physicians ordered the imaging tests, or whether in those cases, physicians had looked at patients’ prior chest X-rays. Nor were they able to assess whether the increased imaging helped or harmed patients.</blockquote> That needs to be followed up upon, obviously. Will it? Probably not. <blockquote>At some flagship hospitals with customized health information technology systems, for example, doctors get specific feedback about diagnostic tests that can result in ordering fewer tests.</blockquote> Note the word "can." (After decades there is no rigorous, unopposed proof, yet we are embarking on a national rollout with penalties for non-adopters?) This rationalization is both the "it will be better in version 2.0" and wishful thinking combined. <blockquote>Michael Furukawa, a health economist in the Office of the National Coordinator for Health Information Technology, the administration’s health IT czar, said the researchers’ focus was not deep enough to support the study’s conclusions. “The data are sound, the methods are appropriate, but the focus is limited,” he said. “They only looked at one piece of health IT.”</blockquote> "But the focus is limited?" So what? That was all they intended to look at, and the result was concerning. Moving the goalposts is not a valid refutation of research. On the other hand, coming from a political office that clearly does not understand how to conduct qualitative research and creates political promotion pieces masquerading as "research", such a statement is not surprising. See "ONC: "The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results" <a href="http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html">at this link</a>, where essential research methodologies were thrown under the bus for publication in Health Affairs. At least the deviations from rigorous research methodologies were admitted: <blockquote>“... Our findings must be qualified by two important limitations: the question of publication bias [e.g., bias in evidence selection - ed.], and the fact that we implicitly gave equal weight to all studies regardless of study design or sample size.”</blockquote> Unfortunately, the media, politicians, financial decisionmakers and others are likely not to really comprehend, in-depth, the full significance of that sentence. I can only imagine the reaction to such an excuse made by pharma for the mainstreaming of a risk-prone drug. I personally take with the greatest of skepticism anything coming from ONC, an increasingly politicized government office in my observation. You should, too, in my opinion. -- SS

Another Health IT Mythbuster: Doctors order more X-rays, not fewer, with computer access

This piece is in the Washington Post about a just-released piece in Health Affairs ( at this link ) by Danny McCormick, David H. Bor, Stepha...

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Gentiva's Odyssey Healthcare Settles Again, Signs Yet Another Corporate Integrity Agreement

The Milwaukee Journal-Sentinel <a href="http://www.jsonline.com/news/milwaukee/whistleblower-case-on-hospice-fraud-settled-for-25-million-e54d9un-141143483.html">reported</a> a legal settlement worth noting.  Here are the basics: <blockquote>One of the nation's largest providers of hospice care has agreed to pay $25 million to settle a Medicare fraud case initiated after a former company nurse in Milwaukee filed a whistle-blower suit. It was the second such settlement in six years for Odyssey Healthcare Inc., which paid the federal government $12.5 million in 2006 after another Wisconsin-based employee sued.</blockquote> Also, <blockquote>Medicare provides a benefit meant to cover hospice care for the terminally ill. It covers 24-hour in-home nursing service only during limited crisis periods. But from 2006 to 2009, Odyssey practiced a pattern of enrolling and recertifying non-terminal patients, and billing for continuous care that wasn't necessary or reasonable, according to the False Claims Act suit filed in 2008 but just unsealed Thursday.</blockquote> As is usual in such cases, Odyssey's parent company denied that it did anything wrong: <blockquote>Odyssey, which operates in 26 states, is now part of Atlanta-based Gentiva Health Services, which runs hospice offices in West Allis and Burlington. Gentiva officials declined to comment, but referred to an announcement it posted on its investor relations website last month. 'Gentiva cooperated fully with this investigation, which covered a period prior to our acquisition of Odyssey, and the settlement is consistent with our efforts to instill Gentiva's culture of compliance throughout the company,' said John Camperlengo, general counsel and chief compliance officer. The statement said the firm is proud of the care its thousands of hospice clinicians provide, and of Gentiva's efforts to ensure strict compliance with all regulatory requirements.</blockquote> The Implications of the Need for a New Corporate Integrity Agreement However, there are some disturbing aspects of this case that require a bit more explanation. First, as noted by the Associated Press (in a story available <a href="http://www.thonline.com/news/iowa-illinois-wisconsin/article_d2a4d2d0-8f73-53c2-86dc-e6ff3c7e2ab5.html">here</a> from the Dubuque [Iowa] Telegraph-Herald), <blockquote>Besides agreeing to pay the $25 million settlement, Odyssey entered a five-year corporate integrity agreement with the federal government.</blockquote> Now corporate integrity agreements are not known for their effectiveness. In fact, as we noted in <a href="http://hcrenewal.blogspot.com/2011/07/executives-get-rich-despite-ethical-and.html">this blog post</a>, according to <a href="http://files.shareholder.com/downloads/GTIV/1338648526x0x456437/CEA1782E-FB2C-4850-A530-9CF06AA6C55B/Gentiva_AR_2010.pdf">Gentiva's 2010 annual report</a>, its Odyssey subsidiary had been subject to a corporate integrity agreement arising from its 2006 settlement, one which was apparently not effective in preventing its misbehavior from 2006 to 2009. However, corporate integrity agreements do serve as markers for the need to improve the integrity of the corporations who need to make them. In this case, why would Gentiva be asked to sign such an agreement if its integrity were already beyond reproach? So Gentiva's current "culture of compliance" is open to question. The Implications of "Enrolling and Recertifying Non-Terminal Patients" A quick read of the Journal-Sentinel and Associate Press stories above might give the impression that what Odyssey did wrong involved a billing technicality, admittedly, one that allowed it to collect more money that that to which it would otherwise be entitled. This story actually goes beyond the issue of fraud, and raises important concerns about patient care. The enrollment  by a hospice of patients who are actually not terminally ill could have serious adverse effects on such patients. As we noted in <a href="http://hcrenewal.blogspot.com/2011/07/prepare-them-to-die-for-profit-hospices.html">this post</a>, hospices are meant for patients with very limited life expectancies. The goal of hospice is to provide comfort and palliation, not active treatment of illnesses. So if patients who actually do not have such severely limited life expectancies are admitted to a hospice, they might be denied therapy that could actually make them feel better, or even cure acute illnesses or prolong their lives. For example, a hospice patient who developed an open wound might not get maximal wound therapy, as in an example (allegedly involving a different commercial hospice provider) in the post above. So it is possible that Odyssey's enrolling and re-certifying of non-terminally ill patients could have lead to failure to provide some of these patients with the care they should have had. Whether this did or did not occur in individual cases, and what adverse effects may have been produced is not clear from the coverage of this case.   Summary As I wrote in 2011, .... There has been a lot of blather from politicians in the US about "death panels" in debates about health care reform. Many such politicians seem worried that the US government has or will have death panels under the new health care reform legislation. We have criticized that legislation for not addressing many important health care problems. No one, however, has convincingly demonstrated how its provisions would convene "death panels." Wendell Potter argued in his book, <a href="http://wendellpotter.com/deadlyspin">Deadly Spin</a>, (see <a href="http://hcrenewal.blogspot.com/2011/02/wendell-potters-deadly-spin.html">this post</a>) that for-profit insurance companies had their own "death panels." The Bloomberg article strongly suggests that for-profit hospices may also act like death panels. In search of more revenue, for-profit hospices may enroll patients who are not at the end of life, but then provide them only "comfort care," so that if they develop new conditions that are treatable, they are likely to die in the absence of treatment. I am waiting for the politicians who so enthusiastically condemned the supposed "death panels" to be found in health care reform legislation to condemn for-profit hospices for behaving like death panels. In my humble opinion, the case discussed above are the strongest argument yet that we need to reconsider our headlong rush to turn health care, particularly the direct care of patients, over to relatively unregulated, for-profit corporations. The cases above suggest that the pursuit of revenue ahead of patients' welfare by such organizations may lead to sick and dead patients. I cannot see how for-profit direct patient care can be made safe for patients without intense government regulation. If any of those vocal advocates of "free market" health care (in the absence of any good explanation of how health care can ever be an ideal free market, see <a href="http://hcrenewal.blogspot.com/2010/08/how-fallacy-of-perfect-health-care.html">this post</a>) can explain to me how for-profit hospices can be made safe for patients without such regulation, I would welcome their attempts. Meanwhile, this just calls out for legislative and legal investigation, and urgent policy changes.   By the way, the case above also shows how the current approach used by the government to address misbehavior in health care does not work.  We have noted previously how these <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> often only lead to financial penalties imposed on companies, not individuals, which diffuses their impact, and provides no disincentives to future bad behavior by individuals.  Sometimes <a href="http://hcrenewal.blogspot.com/search/label/corporate%20integrity%20agreement">corporate integrity agreements</a> are added, but as in the current case, they also seem not to deter future bad behavior.   So, I further conclude, de rigueur, to really deter bad behavior, those who authorized, directed or implemented bad behavior must be held accountable. As long as they are not, expect the bad behavior to continue. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

Gentiva's Odyssey Healthcare Settles Again, Signs Yet Another Corporate Integrity Agreement

The Milwaukee Journal-Sentinel reported a legal settlement worth noting. Here are the basics: One of the nation's largest providers of...

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Courses and Conferences on Health Care Ethics, Corruption, Marketing

Two courses and two conferences of interest to Health Care Renewal readers are coming soon. Short Course: Why Do Physicians Not Make Rational, Evidence Based Decisions? A full-day course at the <a href="http://smdm2012.com/">14th Biennial European Meeting of the Society for Medical Decision Making</a> on Sunday, 10 June, 2012 in Oslo, Norway. Taught by bloggers Dr Roy Poses and Dr Wally Smith, the course will address both the effects of cognitive psychological limitations and of external influences by vested interests leading to less than optimal decisions. A full description of the course is <a href="http://smdm2012.com/course_proposals">here</a>.   Online Course: Corruption in the Health Sector A 30 hour online course given by the <a href="http://www.u4.no/">U4 Anti-Corruption Resource Center</a>, offered in collaboration with the Boston University School of Public Health.  The course is "on causes and consequences of corruption in the health sector; vulnerabilities in drug supply systems, informal payments, and strategies to minimise the problems."  A full description is <a href="http://www.u4.no/training/online-training/corruption-in-the-health-sector">here</a>.  Conference: Deception, Incentives and Behavior A two-day conference given by the Rady School of Management, University of California - San Diego, on 20-21 April, 2012 in San Diego, California, USA.  This will be a multidisciplinary meeting to facilitate "research of deception and related unethical behavior in the fields of economics and psychology/judgment and decision making (JDM)." The conference web-site is <a href="http://rady.ucsd.edu/dib-symposium">here</a>.  Conference: Third Annual PharmedOut Conference on How Patient Harms May Result from Industry Promotion A two-day conference given by <a href="http://www.pharmedout.org/">PharmedOut</a> at Georgetown University in Washington, DC on 14-15 June, 2012.  The conference will focus on the how industry promotion may lead to under-use, over-use, or mis-use of drugs and devices. The conference web-site is <a href="http://pharmedout.org/2012Conference.htm">here</a>.

Courses and Conferences on Health Care Ethics, Corruption, Marketing

Two courses and two conferences of interest to Health Care Renewal readers are coming soon. Short Course: Why Do Physicians Not Make Rationa...

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Why Health Care Leaders Remain Unaccountable: How the Family Invisibly Promoted the "Divine Right of CEOs"

We have frequently discussed the lack of <a href="http://hcrenewal.blogspot.com/search/label/accountability">accountability</a> of health care leaders, which we sometimes have described as CEO exceptionalism. We have noted how health care leaders almost never seem to need to take responsibility for their organizations' misbehavior and its outcomes, (look <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">here</a>) and in fact can command ever increasing <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">compensation</a>, no matter how badly they or their organizations do.  Some of the more recent examples of this phenomenon were: <div></div><div></div><ul><li>William Weldon, soon to retire as CEO of Johnson and Johnson, has commanded eight-figure yearly compensation despite severe manufacturing problems leading to 30 product recalls since 2009, and multiple ethical lapses leading to legal settlements and guilty pleas (see<a href="http://hcrenewal.blogspot.com/2012/02/semi-retirement-of-salesman-weldon-to.html"> this post</a>).</li><li>Non-profit hospital system CEOs got bonuses and raises, or departed with golden parachutes as their systems faced financial losses and laid off employees, or after their medical staff questioned their management (see <a href="http://hcrenewal.blogspot.com/2012/01/three-golden-parachutes-and-some.html">this post</a>).</li><li>A non-profit hospital CEO got a golden parachute ostensibly because he engineered a successful merger.  However, the merger never took place (see <a href="http://hcrenewal.blogspot.com/2011/11/new-low-hospital-ceo-got-golden.html">this post</a>.) </li></ul>Others examples can be found <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">here</a>.  Moreover, such executive compensation is almost never justified with anything approaching evidence or logic.  When health care organizations can be bothered to try to explain executive compensation, they revert to rote compliments (executives are called "brilliant" or "visionary") without further explanation, e.g., look <a href="http://hcrenewal.blogspot.com/2011/10/peer-benchmarking-lake-wobegone-effect.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/09/more-repeats-of-talking-points.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/09/talking-points-sans-original-thought-to.html">here</a>), or even fall back to <a href="http://hcrenewal.blogspot.com/search/label/logical%20fallacies">logical fallacies</a> (e.g.look <a href="http://hcrenewal.blogspot.com/2011/12/more-tales-of-hospital-ceo-compensation.html">here</a>). Why Does Unaccountable Leadership Persist Unchallenged? Why this absurd state of affairs persists and is getting worse, and why it is so little noticed outside of this blog, is a real question.  One explanation we just <a href="http://hcrenewal.blogspot.com/2012/03/golden-calf-explains-how-economism-lead.html">raised</a> is that society has gotten used to "the divine rights of CEOs," partially because of the success of an ideology that has been called "economism," that in turn is based on some old and now rarely accepted religious teachings that have somehow infiltrated what is supposed to be a science. The Family as a Supporter of the "Divine Right of CEOs" A related explanation comes from <a href="http://jeffsharlet.com/content/about-the-family/">The Family</a>, published in 2008, written by<a href="http://jeffsharlet.com/"> Jeff Sharlet</a>.  It suggests that such outmoded beliefs have been promoted by an extreme, nearly invisible, but influential religious sect called "The Family" that has been around since the 1930s.  The Family has powerfully promoted its fringe religious beliefs to influence policy and politics.  I strongly recommend reading the book for further details, or at least a summary article, <a href="http://www.harpers.org/archive/2003/03/0079525">Jesus Plus Nothing</a>, Shalet published in 2003 in Harpers. Let me summarize the relevant points.  Because many will seem far-fetched, I will provide quotes from the book to back each up, with page references from the Harper Paperback edition.  Italics were added for emphasis. Secrecy The Family, formerly the Fellowship, is secretive, and functions behind a variety of front organizations. <blockquote>The family has operated under many guises, some active, some defunct: National Committee for Christian Leadership, International Christian Leadership, National Leadership Council, the Fellowship Foundation, the International Foundation. (P 20-21)</blockquote> Extreme Theology While nominally Christian, the Family is at the far extreme of the spectrum, and embraces beliefs that many would find far-fetched, or worse. It discounts the Bible and the Holy Trinity, and hence is hardly fundamentalist in the usual sense of the word. The Family’s <blockquote>origins lie not in the New Testament, which is ultimately little more than a fabric from which the Family constructs contemporary realities....” (P 61)</blockquote><blockquote>Not Jesus plus scripture, since scripture, after all, contains a great deal besides Jesus. No burning bush, no voice in the whirlwind, no Daniel, no lions. (P 252).</blockquote> It discounts the Holy Trinity. <blockquote>[Current Family leader Douglas] Coe and his inner circle do believe in the trinity; a Washington fundamentalist activist told me,’ but they’ll given the Father and the Holy Ghost the weekend off. Because they clutter the conversation. Jesus is so easily presented. (P 252)</blockquote> Some call it a dominionist sect, that is, one that seeks a return to the very earliest Christianity, before any organized churches.   <blockquote>The Family’s beliefs appear closer to a more marginal set of theologies sometimes gathered under the umbrella term of dominionism, characterized ... by William Martin, a religious historian at Rice University, and Billy Graham’s official biographer.... Dominionist theologies hold the Bible to be a guide to every decision, high and low, from whom God wants you to marry to whether God thinks should buy a new lawn mower. Unlike neo-evangelicals, who concern themselves chiefly with getting good with Jesus, dominionists want to reconstruct early Christian society, which they believe was ruled by God alone. (P 44)</blockquote> (Note, however, that the emphasis on the Bible as guide appears to contradict the discounting of scripture above.) Links to the Powerful The Family has had ties to numerous powerful politicians. <blockquote>The Family is in its own words an ‘invisible’ association, although it has always been organized around public men. Senator Sam Brownback (R., Kansas), chair of a weekly off-the-record meeting of religious right groups called the Values Action Team (VAT) is an active member, as is Representative Joe Pitts (R., Pennsylvania),... Others referred to as members include senators Jim DeMint of South Carolina,...; Pete Dominici of New Mexico...; Chuck Grassley (R., Iowa); James Inhofe (R., Oklahoma); Tom Coburn (R., Oklahoma); John Thune (R., South Dakota); Mike Enzi (R., Wyoming); and John Ensign.... ‘Faith-based Democrats’ Bill Nelson of Florida and Mark Pryor of Arkansas,... are members.... (P18)</blockquote> Many other politicians, some very well known, from both major parties appear as Family members or friends in the book. Since the 1950s, the Family has supported the National Prayer Breakfast. (P 195).  The "Divine Right" of Leaders The Family believe that those who are powerful are those chosen by God to be powerful, and hence must obeyed. Family founder Abraham Vereide, better known as Abram <blockquote>“would become an exponent of religion for the elite - the ‘up and out,’ as he called them.... He termed this trickle-down faith the Idea, and it was really the only idea he ever had - the only one, he believed, God gave him. In one sense, it was nothing more than a defense of the status quo. It neither challenged power nor asked for anything from the powerful but their good intentions. ( P 91)</blockquote><blockquote>“Power lies in things as they are. God has already chosen the powerful, his key men. ( P 96)</blockquote><blockquote>‘We work with power where we can, build new power where we can’t.’ The words belong to Doug Coe, who seized the Fellowship’s top spot in a succession struggle following Abram’s death in 1969 and began transforming it into what I eventually encountered as the Family. ( P 121.)</blockquote> The "Divinely Chosen" Leaders Need Not be Accountable to Any Man The powerful, because they are chosen by God and are instruments of God’s will, need not be accountable, at least to any other humans. <blockquote>This, Abram decided, was what it meant to die to the self: to turn all responsibility over to God. That such a transfer meant the abdication of any accountability for one’s actions, that it provided justification for any ambition, did not occur to him. (P 125)</blockquote><blockquote>A Fellowship tract titled Studies for Public Men, 10,000 of which were printed up by a Chevron Oil executive, claimed that such abuses [refers to an Army General who worked with Coe and was subsequently jailed for selling surplus weapons to 'Third World gangs'] are inevitable, but not attributable to the piety with which such men cloaked their misdeeds. When pious men committed crimes, went the thinking, godlessness was to blame - ‘secularism in its worst form!’ In a Section titled ‘Accountablity,’ the tract explained why the Fellowship should not be held accountable for the actions of its individual members.... ‘Persisting in the accusation of collective guilt immobilizes a society,’ advised the tract. Perhaps, but the Fellowship denied the very concept of guilt for the powerful. That was a legalistic notion, an encroachment on God’s sovereignty.... (P 220)</blockquote><blockquote>We’re all sinners, and thus shouldn’t judge those whom God places in authority. (P 241)</blockquote> The "Divine Right" Extends Even to Dictators The Family’s support of powerful, unaccountable leadership is suggested by how it tolerated, and sometimes supported vicious dictatorships. <blockquote>Understand Abram’s weirdly ambivalent relationship with fascism.... (P 124)</blockquote><blockquote>In Frankfurt, Abram claimed, God personally revealed to Abram a key man to quietly help manage the internal affairs of Germany’s elite: Dr Otto Fricke, an austere German churchman with an uncomfortable past. ‘You are God’s man for this hour in Germany,’ Abram told him. Had Abram asked about Fricke’s role in Germany’s previous hour, Fricke would have begged off explaining his activities during the Third Reich. As a radio preacher, he’d been recruited by Goebbels to propagandize,.... (P 159)</blockquote><blockquote>Coe counseled a Haitian senator and then Haiti’s ambassador to the United States, easing both into commitments to a Christ-led nation, with the understanding the Christ Coe preached led not toward the socialism that tempts any bitterly poor people but toward an economics of ‘key men’ who would share their wealth as God instructed them. Senators Frank Carlson and Homer Capehart, both members of the Foreign Relations Committee, did the follow-up work, leading a Fellowship delegation of twelve businessmen to instruct the Haitian parliament in prayer cell politics. Francois ‘Papa Doc’ Duvalier, who would declare himself president for life but also the nation’s official ‘Maximum Chief of the Revolution’ and ‘Electrifier of Souls’ - he was the weirdest and most vicious dictator in the Western Hemisphere - impressed the senators with his spirituality.</blockquote><blockquote>Not only did South Korea hold a prayer breakfast, but its dictator, General Park Chung Hee, tried to use the Fellowship to channel illegal funding to congressional candidate’s of [President Richard] Nixon’s selection. (P 216)</blockquote><blockquote>In 1968, Abram declared [Indonesian dictator] Suharto’s coup a ‘spiritual revolution,’ and Indonesia under his rule an especially promising nation, hope for the future in Abram’s later years. (P 245)</blockquote> The family also had cordial relationships with South Vietnamese leader General Nguyen Van Thieu (P 248) and Filipino dictator Ferdinand Marcos (P 249)   Summary   Sharlet's book suggests how the Family's increasing influence has led to the infiltration into the general society of the notion that all current leaders, including and particularly corporate CEOs, have a "divine right," and can thus not be held accountable by mortal men, even though that notion, if expressed this clearly, would seem ridiculous to a vast majority of the population.  It is possible that the major reason that most health care leaders have become unaccountable is some sort of subconscious acquiescence to the notions of economism (as discussed <a href="http://hcrenewal.blogspot.com/2012/03/golden-calf-explains-how-economism-lead.html">here</a>), and promulgated by the Family.  However, this acquiescence then is largely by people who would likely reject the bizarre religious beliefs that underpin these notions if those beliefs and their origin were made clear.   All those who do not believe that all earthly leaders are divinely chosen need to challenge the leaders chosen by human to be accountable to humans.    As a society we need to wake up from our dazed acquiescence to ideas that border on crazy.  We need to challenge rote justifications and talking points for that which makes no sense, but serve to make the powerful more powerful.

Why Health Care Leaders Remain Unaccountable: How the Family Invisibly Promoted the "Divine Right of CEOs"

We have frequently discussed the lack of accountability of health care leaders, which we sometimes have described as CEO exceptionalism. We...

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Rerun: Health Information Technology Basics From Calif. Nurses Association and National Nurses Organizing Committee

I think this post <a href="http://hcrenewal.blogspot.com/2010/04/health-information-technology-basics.html">from two years ago</a> on IT realities in healthcare merits a repeat appearance. --------------------------- I have never before seen a document like the one entitled "Health Information Technology Basics", by the Institute for Health & Socio-Economic Policy, California Nurses Association and the National Nurses Organizing Committee. It is available <a href="http://www.calnurses.org/research/pdfs/ihsp_tech_basics_sept_2009.pdf">at this link</a> (PDF). [Note- now at archive.org <a href="http://web.archive.org/web/20100202074048/http://www.calnurses.org/research/pdfs/ihsp_tech_basics_sept_2009.pdf">here</a> - ed.] It is long but contains rather interesting views on the issue of health IT, management and clinicians (nurses). <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj2kPMNq2zuprs2la92q9jJFG3VU5EB9TYmXG1TJUCE-fc6BX0hfDmvzTnZayFxED27w7lFQkE3rmvehts9-hBnHn3bOjPJoYZMF219p7p1rvHUXdvEiAsYfy9u7pgPuYWp6sSY0MH5dgrE/s1600/whereispatient.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5715319571018970930" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj2kPMNq2zuprs2la92q9jJFG3VU5EB9TYmXG1TJUCE-fc6BX0hfDmvzTnZayFxED27w7lFQkE3rmvehts9-hBnHn3bOjPJoYZMF219p7p1rvHUXdvEiAsYfy9u7pgPuYWp6sSY0MH5dgrE/s320/whereispatient.jpg" style="display:block; margin:0px auto 10px; text-align:center;cursor:pointer; cursor:hand;width: 320px; height: 233px;" /></a>From the PDF, this cartoon is satirical but touches on a most serious issue - distraction due to technology. Click to enlarge. </div> I find the following passages of particular interest as they reflect views we express on this blog, and attack the notion of cybernetic miracles being wrought: <blockquote>Skill is the ability, drawn from education and experience, to do something expertly. It can also be defined as the effective exercise of professional judgment in non-routine situations. Following prescribed rules, as a machine would, makes an employee competent to perform tasks, but it doesn’t make the employee skilled. They can do their job as long as there are no surprises. But when something unexpected happens, the rules break down, and caring for patients means facing the unexpected every day. Only skilled health professionals can cope with the unexpected. To know what to do, they have to rely on their own judgment. The exercise of judgment is the essence of skill. ... Much health information technology is skill-degrading. As the work of health professionals becomes increasingly automated, they lose the ability to do their jobs without HIT. To make matters worse, they’re expected to keep pace with machines. They serve the machines rather than doing the more gratifying work of patient care, and ultimately they’re compensated less well. </blockquote> And this: <blockquote>Displacement [of people by machines] is hard to spot because it’s unlikely to appear as a one-to one correspondence; that is, you probably won’t find a robot sitting in your colleague’s chair tomorrow. It’s more likely to happen piecemeal, over an extended period, and through attrition. <ul><li>The job of patient care will be redefined, privileging technical over clinical skills.</li><li>The hospital will begin to hire more HIT specialists and fewer RNs.</li><li>Functions performed in the past by health professionals will be fragmented and reallocated between machines and less-skilled employees.</li><li>Increased technical efficiency will enable the hospital or HMO to expand without expanding its workforce.</li></ul></blockquote> And this: <blockquote>Use of any hospital technology must be consistent with safe, therapeutic, and effective patient care. Health information technology is a complete unknown in this regard. It’s an enormous social experiment designed by computer scientists and implemented by hospital administrators. HIT hasn’t grown organically from the needs of patients but has been imported from other industries. Known as enterprise resource planning, it’s adapted from similar technology designed to manage business operations on a massive scale and already being used to run the world’s largest corporations. Caring for patients isn’t business. It requires compassion, judgment, and advocacy. Because RNs have the moral right and legal duty to advocate for patients, they have to be able to override the automated decision-making of HIT designed to serve business interests. RNs have to work collectively to control health information technology rather than trying to fix it. It’s important to recognize that tinkering can’t fix HIT because its primary purpose is to mechanize, or routinize, patient care. It’s designed to quantify the unquantifiable, to replace the patient with an imaginary statistical norm. High-quality healthcare can’t be mechanized because it depends on people—on patients and caregivers—and people are infinitely more complex and capable than computers can ever be.</blockquote> Amen to that. Read the entire document for a union-oriented view of health IT. It contains many truisms regarding HIT irrational exuberance and the control issues of the healthcare management class. -- SS

Rerun: Health Information Technology Basics From Calif. Nurses Association and National Nurses Organizing Committee

I think this post from two years ago on IT realities in healthcare merits a repeat appearance. --------------------------- I have never bef...

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