healthy4u

The National Program for Healthcare IT in the U.S., and the Elephant in the Living Room

<div dir="ltr">The <a href="http://www.nist.gov/index.html">National Institute of Standards and Technology</a> (NIST) has begun to address deficient clinical IT usability. A PDF with presentations on the topic from the recent NIST conference on HIT usability is <a href="http://www.nist.gov/itl/upload/Final-Agenda-Usability-in-Health-IT-2-2.pdf">here</a> (warning: very large, 26 MB). There is a critical "meta-issue" that's being ignored regarding usability, though, yet it is the elephant in the living room. First, I will detail the elephant, then ask the simple, logical question that arises (the "inconvenient" question that nobody seems to be able to give a straight, non-marketing-spin answer to). </div> <div dir="ltr"> </div> <div dir="ltr">Here are the details of the elephant. First, poor usability ---> increased risk to patients. This is a first principle; it is not open to debate. Now: </div> <div dir="ltr"> </div> <div dir="ltr">If NIST is just now getting involved in "improving HIT usability" (the improvement of which should have occurred at least two decades ago); </div> <div dir="ltr"> </div> <div dir="ltr">While HIMSS's former Chairman of the Board admits the <a href="http://hcrenewal.blogspot.com/2010/07/barry-chaiken-md-mph-lets-be-patient.html" target="_blank">technology remains experimental</a>: </div> <div dir="ltr"> </div> <blockquote dir="ltr" style="margin-right: 0px;"> <div dir="ltr">... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better; </div></blockquote> <div dir="ltr"> </div> <div dir="ltr">While HIMSS itself admits <a href="http://www.himss.org/content/files/HIMSS_DefiningandTestingEMRUsability.pdf"> </a><a href="http://www.himss.org/content/files/HIMSS_DefiningandTestingEMRUsability.pdf" target="_blank">in this 2009 PDF</a> that </div> <blockquote dir="ltr" style="margin-right: 0px;"> <div dir="ltr">"Electronic medical record (EMR)!adoption rates have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available"; </div></blockquote> <div dir="ltr"> </div> <div dir="ltr">While the National Research Council (the highest scientific authority in the U.S.) last year <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572" target="_blank">reported that</a> : </div> <div dir="ltr"> </div> <blockquote dir="ltr" style="margin-right: 0px;"> <div dir="ltr">"Current Approaches to U.S. Health Care Information Technology are Insufficient" and that the technology "does not support clinicians' cognitive needs." The study was chaired by Medical Informatics pioneers Octo Barnett (Harvard/MGH) and William Stead (Vanderbilt); </div></blockquote> <div dir="ltr"> </div> <div dir="ltr">While it's not just the user experience that's the problem, either... </div> <div dir="ltr"> </div> <div dir="ltr">Insurers are starting to recognize this, e.g., <a href="http://hcrenewal.blogspot.com/2010/07/norcal-mutual-insurance-company.html" target="_blank">"NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks"</a> ; While hospitals and vendors cannot yet manage the technology reliably - how many medical mistakes have/will occur as a result of screw ups <a href="http://hcrenewal.blogspot.com/2010/07/health-it-and-highest-regulatory.html" target="_blank">like this one</a>, now confirmed to have occurred at a religious-denomination hospital chain headquartered in the Great Lakes region of the U.S.? <a href="http://hcrenewal.blogspot.com/2010/07/maude-database-patient-outcome-death.html" target="_blank">This patient</a> won't get a second chance, either. </div> <div dir="ltr"> </div> <div dir="ltr">The above issues are the elephant in the living room. Or, shall I say, in the Boardrooms and meeting rooms where health IT is planned and discussed? <div style="text-align: center;"><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="http://4.bp.blogspot.com/_8YphtkAHyDU/TEcCt1HDUkI/AAAAAAAAAWE/wEFz3aww_XE/s1600/elephant-in-the-room.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5496364856603005506" src="http://4.bp.blogspot.com/_8YphtkAHyDU/TEcCt1HDUkI/AAAAAAAAAWE/wEFz3aww_XE/s320/elephant-in-the-room.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 320px; height: 244px;" /></a>Health IT is great stuff, guys; it might actually work well one day! Let's roll it out nationally and penalize those Luddite doctors who refuse to "use it meaningfully" because it's not very usable. Oh, just ignore that strange creature over there in the corner ... </div></div> <div dir="ltr"> </div> <div dir="ltr"> </div> <div dir="ltr"> </div> <div dir="ltr"> Considering the size and weight of the elephant, here is my question: </div> <div dir="ltr"> </div> <div dir="ltr">Why are we rolling out this technology nationally under penalty of Medicare garnishment? I cannot get a straight, unspun answer to that question. Perhaps we need Bill O'Reilly to ask these questions of health IT officials on his <a href="http://www.foxnews.com/">FOX News</a> program, <a href="http://books.google.com/books?id=b9GRPXrYDPUC&printsec=frontcover&dq=no+spin+zone&hl=en&ei=8ANHTP3CAYL_8Abk6bXhBA&sa=X&oi=book_result&ct=result&resnum=1&ved=0CCkQ6AEwAA#v=onepage&q&f=false">The O'Reilly Factor</a>, where spin is attacked relentlessly (the "No Spin Zone.") -- SS </div>

The National Program for Healthcare IT in the U.S., and the Elephant in the Living Room

The National Institute of Standards and Technology (NIST) has begun to address deficient clinical IT usability. A PDF with presentation...

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Barry Chaiken, MD, MPH: "Let's be patient" with experimental devices that harm patients

At an <a href="http://histalk2.com/2010/07/19/histalk-interviews-barry-chaiken/">interview</a> of Barry Chaiken, MD, MPH, FHIMSS, former Chairman of the Board of health IT trade group <a href="http://www.himss.org/">HIMSS</a> and chief medical officer of <a href="http://www.imprivata.com/">Imprivata</a>, a company specializing in healthcare IT security, Chaiken pleads for the following special accommodations for Health IT relative to other medical sectors: <blockquote>... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better. [Why are the health IT applications bad to begin with, I ask? - ed.] </blockquote> I note the following. <ul><li>If 'we're' still learning (and I don't include people with genuine clinical computing expertise in that subgroup, but it does include the plethora of amateurs in the commercial health IT industry), then the technology is experimental.</li><li>Worse, it's unregulated - a major special accommodation in and of itself. </li><li>These sentiments about "being patient" would be appropriate - if the subjects of this experimental technology that vendors need to be "given a chance" to make better were experimental lab rats.</li></ul> Instead, the subjects of the experimental technology are unwitting, unconsenting human beings, who are being used as experimental test subjects for software development, and being put at risk, injured and indeed <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=maude_death">killed</a> by the disruptions these experimental technologies cause. Under these realities, the position presented by Chaiken is, in my opinion, ethically perverse. That such sentiments come from someone who holds the MD degree and who I assume took the Hippocratic oath in some form is stunning. In the health IT industry, "<a href="http://en.wikipedia.org/wiki/Primum_non_nocere">Primum non nocere</a>" seems to have been replaced with "Kybernetik über alle." Further, the commercial health IT vendors have had the good part of five decades to "get it right." How long is long enough? Their software is unavailable for detailed evaluation and open critique of the user experience by impartial experts, unlike open source EHR's like VistA CPRS, demo version available <a href="http://www.ehealth.va.gov/EHEALTH/CPRS_demo.asp">at this link</a> where anyone can: <ul><li>Download the latest version of CPRS today and get access to new features including graphing functionality</li><li>Use the software as if you were a provider by entering orders, entering documentation, retrieving reports (and graphs) and viewing alerts and notifications that help with decision support</li><li>Learn first hand how VA’s electronic health record system works</li></ul> Personally, I've had to use stealth simply to obtain and post graphical representations of some simply inexcusable commercial HIT interface sins (<a href="http://www.tinyurl.com/hostileuserexper">link</a>). Why should a secretive industry be given additional special accommodation? Dr. Chaiken goes on to state: <blockquote>Let’s hold them accountable if they don’t [make the applications better]. Absolutely, hold them accountable if they don’t; and the marketplace, I hope, will be able to make those choices and hold them accountable when they don’t. But, we’re still learning.</blockquote> Again, I'm not sure who the "we're" refers to, but "holding companies accountable" will not really help victims of the experiments who are seriously injured or killed. A better solution, as I have written on this blog (such as at my Nov. 2008 post "<a href="http://hcrenewal.blogspot.com/2008/11/should-us-call-moratorium-on-ambitious.html">Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans</a>?" and at other sites as well: Protect patients. Constrain the health IT experiment temporally and geographically, and apply the laws, customs and regulations of medical experimentation until this industry "has learned" whatever lessons Chaiken thinks they need to learn, e.g., from decades of Medical Informatics, Social Informatics, Computer Science, HCI and other research. None of these fields - last time I looked - are classified or protected intellectual property. Share information on patient adverse outcomes and near misses, instead of concealing them and contractually gagging users from openly speaking about problems. That would be the ethical approach. Further, how many more decades should we wait for the health IT industry to figure out how to look for better leaders beyond the "school of hard knocks" bias that's existed for at least the past decade? How many substandard health IT leaders were placed in hospitals the past few decades as a result of outrageous attitudes like these below from the major recrutiers, centered on spreading the wealth? <blockquote>I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of Hersher Associates, Northbrook, Illinois, agreed, stating "There's nothing like the school of hard knocks." In seeking out CIO talent, recruiter Lion Goodman "doesn't think clinical experience yields [hospital] IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues," according to Goodman. Healthcare Informatics, "Who's Growing CIO's." [No, that line about 'being consumed with patient care issues' as a strike against health IT leadership didn't come from a Scott Adams business-idiot parody cartoon - ed.] </blockquote> As in clinical medicine itself, if you're going to be anywhere near patient care and making decisions affecting its delivery, a degree damn well "gets you something." At about the same time the above appeared in Healthcare Informatics, a generalist IT recruiter wrote me <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/informaticsmd/opinions1.htm#anon1">this</a>: <blockquote> ... What is happening to MDs trying to change careers is providing a window into broader issues about professionals in society today - narrow training, pigeonholing in the marketplace, difficulty making lateral and cross-industry transition, what a handicap it is to be creative, entrepreneurial, or cross-disciplinary in the current marketplace, and the wasted intellectual capital represented by the high caliber of individuals who can't find ways to fruitfully plug themselves into the marketplace. I continue to be amazed at this general phenomenon...the remarkable quality of a number of candidates I've met, and the lack of recruiters' ability to get them in the door of good companies. The interesting part of the story is that when I am able to get access to high level execs in some of these companies (not just IT, but devices, pharmaceuticals, etc. also) they are dismayed at the quality of those that they hire. They know that something is wrong in how the recruitment process is working. (eg, one of the major device cos. just devoted the time of 1 FTE in Human Resources to 'finding innovative ways of identifying and recruiting good talent into the company.')</blockquote> Whose fault were the outrageous, deleterious hiring practices prevalent in this industry that contributed materially to its production of substandard products, hiring practices that persist to this day? (See example <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=leadership">here</a>.) Why should we be "patient", and "give them [yet more chances] to figure out the right way to do this", and why should patients permit themselves to continue to be guinea pigs to such a sloppy, cavalier industry? I note that Chaiken's credentials appear to fit the template, as colleague Roy Poses describes at various posts including <a href="http://hcrenewal.blogspot.com/2010/07/not-your-average-joes-health-plan.html">here</a>, of an "executive isolated from the real world of health care" and member of the <a href="http://hcrenewal.blogspot.com/search/label/superclass">superclass</a>. From the interview linked above: <blockquote> ... According to your LinkedIn profile, you’re CMO for Imprivata, CMIO for Symphony Corporation, and CMO of DocsNetwork. You’re on a couple of advisory boards, you own a vineyard, and you just finished your term as chair of the HIMSS board.</blockquote> Perhaps that helps explain the mantra of "computers [and profit] first, patients second." Finally, in answer to my own question above "Why are the health IT applications bad to begin with", I suggest complacency, incompetence, willful ignorance, and negligence (including <a href="http://legal-dictionary.thefreedictionary.com/Criminal+Negligence">criminal negligence</a>) as possible answers. -- SS Addendum: The following in today's WSJ caught my eye ("<a href="http://online.wsj.com/article/SB10001424052748703720504575377061515304900.html">What we've learned from the Gulf spill</a>", Michio Kaku, July 20, 2010): <blockquote>The nagging question is: Why did it take so long? Why couldn't they have capped the leak months ago? For three agonizing months, BP's engineers and executives were essentially making things up as they went along, conducting a billion dollar science project with the American people as guinea pigs. The basic science of stopping oil leaks at 5,000 feet below sea level should have been done years ago.</blockquote> Concepts are similar. With just a few edits, we have this: <blockquote>The nagging question is: Why is it taking so long? Why couldn't they have learned to create useful health IT decades ago? For at least thirty agonizing years, Health IT vendors' engineers and executives were essentially making things up as they went along, conducting a multibillion dollar science project with the American people as guinea pigs. The basic science of producing safe, effective, usable health IT should have been done years ago.</blockquote> -- SS

Barry Chaiken, MD, MPH: "Let's be patient" with experimental devices that harm patients

At an interview of Barry Chaiken, MD, MPH, FHIMSS, former Chairman of the Board of health IT trade group HIMSS and chief medical officer o...

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Not Your Average Joe's Health Plan

A <a href="http://www.denverpost.com/business/ci_15533672">Denver Post article</a> offered a brief glimpse into the health benefits of corporate leaders, on the unusual occasion of a former CEO now in legal fight for the health benefits in the style to which he had become accustomed: <blockquote>Poor Joe. He's not getting the health-care benefits he was promised. His former employer merged with another company, and then another, and then another. And, you know how it goes after a slew of mergers. Suddenly the new, conglomerated monster just doesn't care about retirees any more. Joe isn't going to sit back and take it like an average Joe. He's suing his former employer in U.S. District Court in Manhattan for breach of contract, breach of faith, breach of fiduciary duty and even promissory estoppel.</blockquote> The Joe in question was really: <blockquote>Lord & Taylor's CEO. Joseph E. Brooks of Greenwich, Conn., lorded over a fourfold increase in sales at Lord & Taylor, expanding to 46 from 19 locations. </blockquote> His career and Lord and Taylor's course after that were checkered, perhaps contributing to the current dispute: <blockquote>But that was a long time ago. And Macy's Inc., the current parent company, is resisting some of his medical claims.</blockquote> <blockquote>Brooks didn't get a deal like this from Filene's, where he served as president before joining Lord & Taylor. Or Ann Taylor, where he went on to generate shareholder lawsuits and shopper hate mail after demanding lower prices from suppliers and higher prices from customers, destroying both quality and value at the same time. Brooks also made his son president of Ann Taylor, sparking cries of nepotism. And then his son got snagged trying to slip by U.S. Customs without paying duties on pricey watches and was forced to resign. The senior Brooks subsequently resigned as well. A 1992 Newsday article called him 'as egotistical and extravagant as he was brilliant.'</blockquote>What Health Care Benefits Do CEOs Get? What had Brooks been promised as CEO of Lord and Taylor? <blockquote>In 1983, Lord & Taylor's corporate parent told Brooks it sought to provide 'great comfort to executives knowing that their medical costs are fully reimbursed by the Corporation.' The company told Joe it was a lifetime guarantee. CEOs should never, ever, have to worry about health care.</blockquote> Here are some details about his benefits: <blockquote>And for nearly 27 years, substantially all medical costs have been fully covered, even premiums. We're not just talking doctors' visits, hospitals, medications and tests. We're talking all travel and ancillary expenses associated with care, too. We're talking first-class transportation, accommodations and meals while being treated at the Mayo Clinic and the Duke Diet and Fitness Center. We're talking expenses for a companion or personal aide, too. We're also talking 'cosmetic services (surgery, medications, injections, creams and the like)' dental care, gym memberships, personal trainers, vitamins, massages — all paid by Joe's former employer for the rest of Joe's life. Oh, and if any of these benefits have tax consequences, we're talking gross-up payments to cover that, too.</blockquote>Why should we be concerned about the extravagant health plans given to top corporate executives?  The Implications We <a href="http://hcrenewal.blogspot.com/2009/07/are-health-plans-of-very-rich-different.html">noted in 2009</a> that the Goldman Sachs 2009 proxy statement indicated that top executives of that now controversial company received health plans worth about $40,000 each.  My concern then were not how much the costs of the plans contribute to top corporate leaders' compensation packages. Such packages are generally already so outrageously huge that providing $40,000 rather than $13,000 worth of health insurance is a trivial increase. My concern was not that plan recipients' demands for health care will collectively increase health care costs, because they likely include only a tiny portion of the population. My main concern, instead, was how much these plans further insulate already cocooned top executives from the vicissitudes of daily life, particularly related to coping with our current dysfunctional health care system. What benefits executive health care plans provided were not clear from the 2009 story about Goldman Sachs.  However, this year's case of Joe Brooks does suggest that the plans paid for every expense that could be conceivably health related.  As I worried then, it now does appear that such plans could completely insulate executives from having to deal with the managed care/ health insurance bureaucracy which frustrates patients seeking particular services, but not necessarily the most expensive, or least beneficial services. Furthermore, such plans may completely insulate executives from the various other vicissitudes of managing our currently dysfunctional health care system.  (By the way, that is why it seemed amazing that the CEO of Pfizer had to put up with some of the common vicissitudes when he went to a hospital for an elective procedure, an experience he publicly talked about with an almost charming naivete, given that he runs such a powerful health care organization which has been so influential in shaping our US "health care reform," see post <a href="http://hcrenewal.blogspot.com/2010/06/finding-out-about-health-care.html">here</a>.) Such executives isolated from the real world of health care might thus not have gut level appreciation of how dysfunctional the health care system has become for even insured patients. Since top executives often are disproportionately influential members of the "<a href="http://hcrenewal.blogspot.com/search/label/superclass">superclass</a>," their disconnection from the realities of dysfunctional health care is likely to translate into little real support by the powers that be for meaningful health care reform. There support may be further retarded by the influence of their fellow superclass members whose personal fortunes depend on the status quo in health care. Real improvement of health care may depend on finding leaders who have better understanding of the plight of real people.   Two Postscripts   Note: the <a href="http://www2.goldmansachs.com/our-firm/investors/financials/current/proxy-statements/2010-proxy-doc.pdf">Goldman Sachs 2010 proxy</a> indicates that the executive health plans given to the five most highly paid executives cost up to $56,927.     Also note that despite the effect that executive health plans may have on the thinking of those with the most power to influence health care policy, the plans have been of little interest to health care services and policy researchers.  I have not been able to find a single article in these literatures on the subject.  This appears to be yet another version of the anechoic effect, that certain inconvenient truths (to borrow from former US Vice President Al Gore) are not subjects of polite discussion of health care, lest the results excessively disturb the powers that be.

Not Your Average Joe's Health Plan

A Denver Post article offered a brief glimpse into the health benefits of corporate leaders, on the unusual occasion of a former CEO now in...

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Prosecuting Doctors for Importing IUDs from Canada, but Still No Penalties for Selling Adulterated Heparin from China

Here in Rhode Island, the big health care story recently was the use of unapproved intra-uterine devices (IUDs) by some local obstetrician-gynecologists (OB-GYNs).  The first nuanced summary of the story which just appeared <a href="http://www.projo.com/news/content/IUDS_07-18-10_RDJ7DC7_v22.14cd6b6.html">in the Providence Journal</a>, written by Felice Freyer, suggested how the consequences of possible misconduct in health care depend on the clout of those involved. The Unapproved IUDs Here are the main points. The issue that caused so much local controversy was the use of unapproved IUDs: <blockquote>Ten Rhode Island medical groups with 28 doctors told the Health Department that they bought IUDs, a form of birth control, from a foreign source, at prices about half what they had to pay for IUDs approved for use in the United States. Many had stopped using the unapproved devices long before the Health Department began its investigation in June.</blockquote> Here is what we know about the actual devices they implanted: <blockquote>An IUD is a T-shaped device that can fit in the palm of a woman’s hand. To prevent pregnancy, doctors insert it into the uterus, where it can stay for years. There are two types available in the United States: the ParaGard copper IUD and the Mirena hormonal IUD. Mirena, the more costly and more popular brand, has a coating of a progesterone-like drug that reduces heavy menstrual bleeding. </blockquote>Unapproved IUDs Made by an American Company in Finland and Sold in Canada Most of the "unapproved devices" the doctors were using were apparently made in Finland by an American company. <blockquote>In most cases, the doctors were using Mirena, which is made at a factory in Finland by an American company, Bayer Healthcare Pharmaceuticals. Only when it comes through approved channels can doctors and patients be assured that a product meets FDA standards. But it is unclear whether Bayer –– or anyone –– makes a version of Mirena that does not meet those standards. </blockquote>The doctors imported the devices from far-away, exotic Canada. <blockquote>Most of the devices apparently came from Canada, where the government negotiates with drug and device makers to keep prices low.</blockquote> There is no reason to suspect the devices were counterfeit, or defective. <blockquote>'If they’re really from Canada and from a reputable pharmacy, it should be exactly the same thing [as the FDA-approved version],' said Sheryl Ruzek, a retired public health professor at Temple University and vice chair of the board of the ECRI Institute, a nonprofit organization that evaluates medical procedures and products. 'My hunch is the patients were not harmed,' she said. </blockquote>Potential Negative Consequences for the Physicians However, the RI physicians are in big trouble for importing them: <blockquote>In Rhode Island, the state boards that regulate physicians, nurses and nurse-midwives are investigating all those involved. If any are found guilty of unprofessional conduct, they could face disciplinary action such as a reprimand or license suspension. The state attorney general’s office has a Medicaid fraud unit, but declined to comment. The U.S. Attorney also had no comment. </blockquote>US doctors in other states have also been importing IUDs, and also are in big trouble: <blockquote>So many doctors were importing IUDs or considering doing so that the American College of Obstetricians and Gynecologists recently took an official stand, issuing an advisory opposing the use of imported devices. In 2006, the California Department of Health found that eight doctors had used imported IUDs in some 850 women. In October 2009, an Arkansas doctor was indicted by a federal grand jury for using non-FDA-approved versions of Mirena. He was charged with violation of the Food, Drug & Cosmetic Act, health-care fraud (for allegedly billing Medicaid for the unapproved devices) and money-laundering (for the way he allegedly handled Medicaid reimbursements). The doctor, Kelly Dean Shrum, has not yet come to trial, but potential penalties include fines and imprisonment. </blockquote> Summary, and the Contrast with the Case of the Adulterated, Fatal Heparin So to summarize, doctors who imported IUDs from Canada that appeared to be identical to those sold with FDA approval in the US, and were made in Finland by an American company at the same factory in which the US approved IUDs were made have gotten into major trouble with state and federal authorities. There is no clear evidence that the IUDs caused any harm to patients. I am not defending the doctors' actions. However, contrast the treatment they are likely to receive with another case we have frequently discussed. We last blogged about the case of Baxter International's adulterated heparin <a href="http://hcrenewal.blogspot.com/2010/05/more-questions-no-answers-about-case-of.html">here</a>.  In summary, Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China.  That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label.  The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small "workshops" operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA.  The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many patients who received got seriously ill or died.  While there have been investigations of how the adulteration adversely affected patients, to date, there have been no publicly reported investigations of how the OSCS got into the heparin, and who should have been responsible for overseeing the purity and safety of the product.  Despite the facts that clearly patients died from receiving this adulterated drug, no individual has yet suffered any negative consequence for what amounted to poisoning of patients with a brand-name but adulterated pharmaceutical product. Yet everyone from state health departments to the federal authorities have jumped into the case of the unapproved IUDs imported, but from Canada, and apparently identical to the IUDs sold in the US.  There is, at least so far, no evidence that the IUDs were defective or dangerous, and no evidence they have harmed patients.  One doctor has been prosecuted for violating the Food, Drug and Cosmetic Act, and for health care fraud and money-laundering.  No one working for Baxter International (or for the identified organizations within its supply chain) has been prosecuted for anything. What the...?   I do not object to discipline and prosecution of individual doctors who appear to have broken the law.  But why are we so vigorously pursuing individual doctors for an apparently technical violation of laws that did patients no apparent harm, when we are not pursuing health care corporate executives for selling adulterated drugs that likely killed patients?  F Scott Fitzergald wrote that the "very rich are different from you and me," and it appears that very rich health care leaders have impunity when it comes to conduct that let patients be harmed and die.  Real health care reform would make top health care leaders as accountable as we now make individual doctors.

Prosecuting Doctors for Importing IUDs from Canada, but Still No Penalties for Selling Adulterated Heparin from China

Here in Rhode Island, the big health care story recently was the use of unapproved intra-uterine devices (IUDs) by some local obstetrician-g...

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The Avandia Spin Cycle Continues Even After the FDA Safety Hearings

We have posted multiple times about Avandia (rosiglitazone), GlaxoSmithKline's star-crossed glucose-lowering drug.  While Avandia has received considerable media coverage, we focused on two questions: 1 - what are the benefits and harms of rosiglitazone as a treatment of type 2 diabetes, and therefore for which patients under what circumstances should this drug be used? 2 - what barriers have prevented physicians and patients from getting the best possible answer to the first question, and what can be done about them?  (See recent post <a href="http://hcrenewal.blogspot.com/2010/02/bring-back-dsi-avandia-case-as-spy.html">here</a>.)  In particular, the Avandia case has illustrated how those with vested interests in the success of a health care product have done their best to obscure information that might threaten its success, even when doing so obscures the information that physicians and patients need to make the best possible decisions.  At one point, (in 2007, no less) we called this the "<a href="http://hcrenewal.blogspot.com/2007/06/avandia-spin-cycle-continues.html">Avandia spin cycle</a>." Avandia once again has been in the news after the US Food and Drug Administration's hearings on the safety of the drug.  These hearings were so well covered in the media that a lengthy summary would be superfluous.  However, their main points demonstrated the persistence of the Avandia spin cycle: - An FDA reviewer felt that "the company's misreadings of the ... Record trial ... were so profound, he concluded, that they 'suggest serious flaws with trial conduct.'" (per Gardiner Harris <a href="http://www.nytimes.com/2010/07/10/health/10diabetes.html">writing</a> in the New York Times) -A former FDA reviewer "withheld from regulators a study showing its Avandia diabetes drug may cause heart attacks." (<a href="http://www.bloomberg.com/news/2010-07-09/glaxo-withheld-avandia-study-former-fda-manager-said-to-testify-in-suit.html">per Bloomberg News</a>) - GlaxoSmithKline's forerunner SmithKline Beecham "secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda."  However, "the study also provided clear signs that it [Avandia] was riskier to the heart.  But instead of publishing the results, the company spent the next 11 years trying to cover them up." (per Gardiner Harris <a href="http://www.nytimes.com/2010/07/13/health/policy/13avandia.html">writing</a> in the New York Times. - "Government experts and a panel of medical advisers repeatedly voiced skepticism on Tuesday about the trustworthiness of GlaxoSmithKline, which makes the controversial diabetes drug Avandia." (per Gardiner Harris again <a href="http://www.nytimes.com/2010/07/14/health/policy/14diabetes.html">writing</a> in the New York Times.) So the Avandia saga has brought to the front pages the concerns we have had with <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression</a> and <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> of clinical research, especially when pursued by health care organizations with vested interests in the results of specific research projects coming out a certain way, and how they have been enabled by those with <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a>.  Doctors thus should be worried whether those of us who try to practice evidence-based medicine have been fooled into practicing <a href="http://hcrenewal.blogspot.com/search/label/pseudo-evidence%20based%20medicine">pseudo-evidence-based-medicine</a>. Those commenting on the story focused on the need for transparency when clinical research is funded and run by the corporations whose products are being evaluated. -  "GlaxoSmithKline, the maker of Avandia, can't be trusted to report adverse clinical results fairly.  The company must be watched like a hawk as additional trials that it sponsors go forward."  (<a href="http://www.nytimes.com/2010/07/15/opinion/15thu1.html">NY Times editorial</a>) -  "What America should demand in return for ... [generous patent] protection is that the FDA be able to make an honest evaluation of the efficacy of drugs.  When drug companies make this impossible by suppressing test results, not only do they violate their fundamental obligation of honesty with the public, their customers and their regulator, but they also break the bargain they have struck in return for the protection of their intellectual capital."  (Former NY Attorney General Eliot Spitzer<a href="http://www.slate.com/id/2260470/"> in Slate</a>.) Instead, as I have written before, maybe we ought to consider whether those with vested interests in drugs or devices ought to be running clinical research meant to evaluate their own products.  Ironically, while this discussion of how the Avandia spin cycle first began to revolve were going on, others were still trying to add revolutions (per minute).  In particular, a Reuters <a href="http://www.reuters.com/article/idUSN1511649320100715">story</a> noted: <blockquote>Three influential groups of doctors who treat diabetes urged patients not to stop taking Avandia, saying on Thursday that while news about the controversial drug may be frightening, it would be worse to suddenly stop taking it.</blockquote> That is odd, given that Avandia has never been shown to improve clinical outcomes for patients with diabetes, and that there are many other drugs that control blood sugar which appear to be safer. But wait, there is more, <blockquote>The Endocrine Society, American Diabetes Association and the American Association of Clinical Endocrinologists worried that patients may be afraid to take Avandia. 'Patients should continue taking all currently prescribed medications unless instructed otherwise by their health care provider,' Dr. Robert Vigersky of the Endocrine Society said in a statement. 'Stopping diabetes medications can cause significant harm and result in higher levels of blood glucose that may cause severe short term health problems and could increase the risk of diabetes-related complications in the long term.'</blockquote> Would not it make more sense to advise patients still on Avandia to consult with their doctors urgently about possible alternatives?  Meanwhile, it does not seem irrational to be afraid of taking Avandia, given the increasing evidence about its harms, and increasing evidence that what we know about its harms may be an under-estimate. So I wondered why these august medical societies seemed so unaffected about the doubts about Avandia's safety, and about the evidence offered to support its use that the latest news ought to generate. It turns out that all three of the medical societies get financial support from, -- wait for it --, GlaxoSmithKline. The Endocrine Society lists GSK as one of its <a href="http://www.endo-society.org/industry/CLB_about.cfm">Corporate Liaison Board Members</a>. The American Diabetes Association lists GSK as one of its <a href="http://www.diabetes.org/donate/sponsor/our-corporate-supporters.html">Banting Circle Supporters</a>, that is, those that give at least $1,000,000 a year. The American Association of Clinical Endocrinologists lists GSK as a member of its <a href="http://www.aace.com/org/cap/capdirectory.php">Corporate AACE Partnership</a>. (I was not able to find out the total amount contributed by GSK to either the Endocrine Society or the AACE.) So once again, the loudest voices in support of the product come from those used to, and perhaps dependent on financial support from its manufacturer. As a physician, I have been particularly disappointed that our medical societies, whose missions are ostensibly to support our professional values, seem to act more and more like marketers for the companies whose contributions, rather than members' dues increasingly support them. The cycle keeps spinning. For further thoughts on the latest in the Avandia case, see <a href="http://brodyhooked.blogspot.com/2010/07/side-trip-into-diabetes-selling-wrong.html">this post</a> by Howard Brody on the Hooked: Ethics, Medicine and Pharma blog, and <a href="http://alison-bass.blogspot.com/2010/07/when-will-big-pharma-learn-story-of.html">this</a> by Alison Bass on the Alison Bass Blog.

The Avandia Spin Cycle Continues Even After the FDA Safety Hearings

We have posted multiple times about Avandia (rosiglitazone), GlaxoSmithKline's star-crossed glucose-lowering drug. While Avandia has re...

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The New York Times Reports A University President's Conflict of Interest

Three months ago, we <a href="http://hcrenewal.blogspot.com/2010/04/smoke-screen-how-conflict-of-interest.html">discussed</a> the controversy at the University of Michigan about  the university president's position on the board of directors of the big pharmaceutical, medical device and medical supply company Johnson and Johnson as a potential conflict of interest that could have influenced her decision to make the campus smoke-free.  (Johnson and Johnson makes drugs to aid in smoking cessation.)  I argued that by the Institute of Medicine definition, President Coleman did have a conflict of interest, and while it was not possible to tell whether it influenced the smoke-free decision, the issue with conflicts is that they constantly raise the possibility of undue influence on decisions. Now this issue has made it to the big time.  New York Times reporter Duff Wilson, <a href="http://prescriptions.blogs.nytimes.com/2010/07/13/university-presidents-outside-board-seat-poses-questions-of-conflict/">wrote</a> in the Times' Prescriptions Blog <blockquote>The University of Michigan medical school became the first in the nation last month to say it would refuse any funding from drug companies for its continuing medical education classes. The decision could cost it as much as $1 million a year, but it was worth it, the medical school dean said, for education to be free from potential bias. At the same time, Mary Sue Coleman, president of the entire University of Michigan, sits on the board of directors for the pharmaceutical giant Johnson & Johnson. Last year, the company paid her $229,978 — roughly half in stock and half in cash — for attending a limited number of meetings, corporate filings show. Conflict of interest? Conflict of policies? If the med school and mere professors could be tainted by drug money, what about the university president? She says no. Responding to questions on Ms. Coleman’s behalf Monday, Kelly E. Cunningham, a spokeswoman for the university, said the president satisfied the policy by disclosing her outside work. Ms. Coleman has never had to recuse herself from any discussion or action at the university because medical purchasing and investment decisions are so remote from her, Ms. Cunningham said. 'The same is true at J&J,' she added. 'There has never been a discussion or decision at the board level that involved something related to the UM. But, of course, if there were, she would recuse herself.'</blockquote> The <a href="http://www.freep.com/article/20100715/NEWS05/7150385/University-of-Michigan-s-Mary-Sue-Coleman-should-quit-firm-s-board-students-say">story</a> was picked up by the Detroit Free Press, which reiterated the official line that President Coleman's role on the Johnson and Johnson board did not pose a conflict: <blockquote>A student group at the University of Michigan is calling on President Mary Sue Coleman to resign from her seat on the Johnson & Johnson board of directors, saying it's a conflict of interest. But Coleman has no plans to resign, and university officials say her role on the board is not in conflict with university operations. Last year, she earned nearly $230,000 for her board duties. Coleman's U-M salary is about $550,000. 'It's essential that U-M have a voice and interact with the business world,' said Rick Fitzgerald, a U-M spokesman. 'She thinks it's her duty to understand what the commercial world is doing.'</blockquote> So, as I did last time, let us turn to the Institute of Medicine's definition of conflict of interest (in a health care context) found in its report, <a href="http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx">Conflict of Interest in Medical Research, Education, and Practice</a>. <blockquote>Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest. Primary interests include promoting and protecting the integrity of research, the quality of medical education, and the welfare of patients. Secondary interests include not only financial interests....</blockquote> I asserted then that President Coleman has a conflict of interest. Her primary interests as President of a university are to uphold the university's academic mission, and as President of a university that includes a medical school, a school of public health, and an academic medical center, also to uphold the integrity of patient care and public health practice. Her secondary interest as a member of the board of directors of a public, for-profit corporation is her fiduciary duty to that corporation and its stockholders, which means she must "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. <a href="http://www.amazon.com/Corporate-Governance-Robert-G-Monks/dp/1405116986">Corporate Governance</a>, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.] Such unyielding loyalty to the shareholders of a pharmaceutical and medical device company clearly creates a risk of influencing judgments or actions that could affect the corporations' sales or operations, economic or health policy, or the general environment in which it operates. Many of the judgments of or actions performed by the leader of a medical school, public health school, and academic medical center could so so, and are thus at risk of being so unduly influenced. As the IOM report said, though, <blockquote>a judgment that someone has a conflict of interest does not imply that the person is unethical. Such judgments assume only that some situations are generally recognized to pose an unacceptable risk that decisions may be unduly influenced by considerations that should be irrelevant.</blockquote> However, note that the sorts of decisions that may be influenced by a conflict of interest go beyond just those that involve the specific secondary interest causing the conflict. So the University spokesperson's statement that the president would recuse herself from any decision at the university that directly involved Johnson and Johnson, but that no such decision has ever been necessary, missed the point. Meanwhile, the university's insistence that the president's part-time position at Johnson and Johnson is justified by the need to "have a voice and interact with the business world" rings hollow. There are many ways a president could do that which do not involve getting corporate pay (and for "unyielding loyalty"). It rings especially hollow at a university that has identified corporate funding for continuing medical education as an unacceptably bad conflict of interest. But then again, conflicts of interest are known to create confused thinking, and such confused thinking is likely to be prevalent at an institution that has one set of rules for the little people, and another for the top leaders. Maybe this story in the New York Times will lead to some discussion about whether it is good for academic medical institutions to tolerate this previously "<a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html">new species of conflict of interest</a>" (as we termed it in 2006).

The New York Times Reports A University President's Conflict of Interest

Three months ago, we discussed the controversy at the University of Michigan about the university president's position on the board of...

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FDA MAUDE Database: Patient Outcome - Death

I present another health IT problem case from the FDA's voluntary <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm">MAUDE</a> (Manufacturer and User Facility Device Experience) database below. From FDA's description of MAUDE: <ul style="font-style: italic;"><li>MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19. </li><li>The on-line search allows you to search CDRH database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE is scheduled to be updated monthly and the search page reflects the date of the most recent update. FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed by technical or clerical difficulties.</li><li>MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester. </li></ul> I somehow missed the following case when I wrote the Oct. 2009 post '<a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2009/10/out-policy-is-to-always-have-unabashed.html">Our Policy Is To Always Have Unabashed Faith In The Computer ... Except When It Screws Up, And Then It's The Doctor's Fault</a>' but I have added it there as well: <blockquote> <a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656460">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656460</a> CERNER MILLENIUM POWERCHART CPOE Event Date 11/19/2006 Event Type: Death Patient Outcome: Death The medication review screen of the subject device does not specify the exact dose in milligrams of combination medications. For example, narcotics are combined with tylenol in at least two strengths. Liquid narcotic tylenol-oxycodone combination is reported in ml, not mg. The exact dose of tylenol is not specified and requires knowledge of the combination medication dose in the volume specified. Certain fields of the grid do not specify the volume, but rather state "date/time" requiring another click or pop up screen. The immediate knowledge of tylenol dosage in mg is directly related to understanding and preventing excessive doses. In the subject, 10 ml of acetaminophen-oxycodone is indicated as having been given 3 times over 4 hours. That means that 1950 mg of tylenol was administered in 4 hours while the patient was in a state of starvation and receiving other medication that increase the effects of tylenol. This dose would equate to 11,700 mg of tylenol over 24 hours, nearly 3 times the maximum daily dose in otherwise health people. In the ensuing days, the patient developed acute renal failure, presumably acute tubular necrosis, and died. In the absence of other etiology, the excess tylenol was the culprit. This was not considered as etiology ante-mortem. The counterintuitive screen impaired the professionals. The pharmacist did not recognize and stop the medication, the nurses administered it, and the excessive dose, clinically meaninglessly listed as a volume of 10 ml -given 3 times in 4 hours- of acetaminophen-oxycodone, was missed by the physicians. Adverse events have been ascribed to "user error" by vendors. The device offers a potent propensity to life endangering oversights. There are other screens on this device which present information that interfere with clinically useful visualization of data. [Who designed these screens, I ask? Clinicians, or business IT personnel used to designing inventory systems for widget control? - ed.] The data does not flow to the professionals. It is not represented in a meaningfully useful manner. The professionals need to hunt for it. As such, the user unfriendly screens [see <a href="http://www.tinyurl.com/hostileuserexper">this link</a> on mission hostile HIT - ed.] impair safe medical care consistent with the impediment to expedient professional understanding of what, exactly, is the dose of medication and how much was administered to the patient. This sentinel case of death is directly attributed to user unfriendly screens on this device.</blockquote> How many cases like this, as well as "near misses" related to health IT go unreported, nationwide and worldwide? As in my paper "<a href="http://www.scribd.com/doc/28747771/Remediating-an-Unintended-Consequence-of-Healthcare-IT-A-Dearth-of-Data-on-Unintended-Consequences-of-Healthcare-IT">Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT</a>", nobody really knows; these devices are unregulated with no requirements for reporting. However, let's roll it out nationally anyway, because HIT will deterministically "revolutionize" medicine. Just ignore those spoil-the-party, man-behind-the-curtain prattle from writers <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">like these</a>. We can safely ignore all contrarian research and literature, of course, as we all know HIT will revolutionize medicine from the definitive certainty of HHS in "<a href="http://hcrenewal.blogspot.com/2010/07/new-england-journal-on-meaningful-use.html">The 'Meaningful Use' Regulation for Electronic Health Records</a>", NEJM, Blumenthal and Tavenner (10.1056/NEJMp1006114, July 13, 2010): <blockquote>The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice. [Except for those who <a href="http://archinte.ama-assn.org/cgi/content/short/167/13/1400">haven't</a> - ed.] </blockquote> And our government's called <a href="http://www.bp.com/sectiongenericarticle.do?categoryId=3&contentId=2006926">BP Energy Company</a> cavalier? I offer no additional comments. -- SS

FDA MAUDE Database: Patient Outcome - Death

I present another health IT problem case from the FDA's voluntary MAUDE ( Manufacturer and User Facility Device Experience ) database b...

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