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BLOGSCAN - Are electronic medical records a health care cure or a disease?

This doctor writing at Cleveland.com <a href="http://www.cleveland.com/opinion/index.ssf/2010/12/are_electronic_medical_records.html">really doesn't like EMR</a>: <blockquote style="color: rgb(0, 153, 0); font-weight: bold;">... Our practice implemented EMR about three months ago, and it has not been a downhill sleigh ride thus far. Here's the scorecard. • It saves time. It doesn't. • It saves money. It hasn't. • It promotes office flow and efficiency. Hardly. • It improves staff morale. Are you joking? • Patients prefer it. None that I know. • It's been a bonanza for document-scanning companies. Bingo! What I find most troubling about EMR is that it is "point and click" medicine. It radically disrupts the doctor-patient relationship. Taking the patient's medical history -- the bedrock of doctoring -- is reduced to a sterile data-entry process. Taking the history, the conversation that physicians and patients have had since Hippocrates tended to the sick, is our opportunity to reach out and bond with our patients. During this time, we forge human-to-human connections with patients who are seeking our help. This is the scaffold upon which a sturdy doctor-patient relationship develops. EMR is taking a chainsaw to this structure. Those who champion the technology are usually not practicing physicians. They are the insurance industry, billing personnel, medical coding specialists, the government, various bean counters and, of course, EMR vendors. Because these folks are not physicians, they do not appreciate how EMR affects doctoring at ground zero in our exam rooms ... </blockquote> Read the whole thing. -- SS

BLOGSCAN - Are electronic medical records a health care cure or a disease?

This doctor writing at Cleveland.com really doesn't like EMR : ... Our practice implemented EMR about three months ago, and it has not...

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Inpatient or outpatient and the battle to control costs: The truth about the push for electronic medical records?

Electronic health records have been pushed like opiates on a run-down inner city street corner for some years now; yet the evidence does not support the aggressive national push currently underway. I'd thought wishful thinking, hope, government naivete, industry aggression and lobbying, and other similar factors were a major explanation. A candid article today, however, in my local newspaper, about the ER of a hospital where I did my residency years ago (pre-EHR), seems to offer the most potent driver behind the current push - real-time money games: <blockquote><a href="http://www.philly.com/inquirer/health_science/daily/20101226_Inpatient_or_outpatient__The_battle_to_control_costs.html" style="font-weight: bold;">Inpatient or outpatient? The battle to control costs</a> By Michael Vitez Inquirer Staff Writer Sun, Dec. 26, 2010 Randy Klein had a lovely vacation, three weeks in Europe with her husband, Stephen, for their 36th anniversary. They went to Paris, Rome, Venice, even took a cruise to Monte Carlo. On the last day, they ate oysters in Normandy. Her stomach started cramping on the airplane. The diarrhea didn't hit, thank God, until she got home, in Rydal, on Oct. 17, but it landed with a fury. "Doesn't even give you a shot to get to the bathroom," she said. She went to the emergency room at Abington Memorial Hospital, where they took cultures and she spent the night. She began to feel better and went home the next day. A few days later, a violent diarrhea slammed her even worse than before. She went back to the ER and soon was on a gurney and hooked to a morphine drip. Klein, 56, was too sick to know or care, but she was the subject of a conversation taking place down the hall between her ER doctor and an admission review nurse: Should Klein be admitted to the hospital or treated there but as an outpatient, in what is known as observation? [That is, "short-stay", or "one-day" fast-tracked admissions - ed.] This may sound bureaucratic, even benign. But this question - and where it leads - tells a lot about the state of health care today, the tension between hospitals and insurers, the impact on patients.</blockquote> The tension is strong indeed: <blockquote>Abington wants to avoid treating Klein as an inpatient, then getting paid only an outpatient rate from the insurer - half as much.Insurers see themselves as good citizens, responsible parents [I think their principle motivation is, rather, to be good parents to their profits - ed.], doing the difficult job of holding down health-care costs, in part by refusing to pay for what they view [from a distance, post hoc - ed.] as unnecessary care.Doctors see this as second-guessing by insurers and an erosion of the doctor's role.[I don't "see it" as second guessing. It *IS* second guessing, on first principles - ed.] And hospital finance people say these cuts in reimbursement will affect the care of Randy Klein, thousands like her, and eventually all of us.</blockquote> And some will be injured and die as a result...but it's all for money: <blockquote>... These skirmishes over reimbursement take place gurney by gurney, patient by patient, like a thousand paper cuts, but the dollars add up.Abington says it will lose $12 million a year because of this. Hospitals around the state and nation are feeling the same financial pressure.Observation status, created by Medicare, has existed for years, but was infrequently used by area hospitals until last year, after a crackdown by Medicare auditors.The idea is basic: If a patient arrives in the emergency room, and it isn't immediately clear whether the patient should be admitted, the patient can be placed in observation - treated in the hospital but as an outpatient.</blockquote> The statement "treated in the hospital but as an outpatient" shows George Orwell's concepts of language manipulation are alive and well. <blockquote> ... Steve Fisher is one of 40 emergency-room doctors at Abington. He likes to say, "I'm paid to be paranoid."On Monday, Oct. 25, before he went to see Randy Klein, he saw that she had been in a few days earlier for the same problem, and that immediately raised concern.The results of cultures taken the previous week showed she had two parasites, campylobacter and giardia, infections one gets from contaminated food and fecally contaminated water. Fisher knew giardia, which he felt was causing her trouble, is rarely life-threatening, but he is paid, as he says, to be paranoid.On examination, Fisher felt Klein's belly was incredibly tender, and he contemplated a CT scan of her colon, but decided against subjecting her to the radiation.He didn't think she had a blockage or anything that would need surgery. But considering the extreme inflammation, a rupture was possible, and he was confident she would need subsequent abdominal exams in the hospital, in the days to come.</blockquote> ER doctors need to be "paranoid" because they ultimately are responsible for outcomes. They also develop a keen sense of judgment towards potential trouble. This patient was admitted for several days, but soon the claim for inpatient care was denied. Based on a cookbook known as "<a href="http://www.mckesson.com/en_us/McKesson.com/Our%2BBusinesses/McKesson%2BHealth%2BSolutions/Solution%2BAreas/InterQual%2BDecision%2BSupport/InterQual%2BDecision%2BSupport.html">InterQual</a>", Blue Cross would pay at an observation rate, an outpatient rate, even though Abington provided inpatient care. Read the article or the link above for more on that cookbook. Now about the denial and the second guessing of doctors: <blockquote>"Respectfully," [senior medical director at Independence Blue Cross Donald Liss] added, "I'd say, jeez, this is the perfect case for observation. Is she going to respond, get better in six, eight, 12 hours from now and perk up? That's the one where you would want to keep an eye on her, responding to therapy or not."[How does he know? He was not present. He did not perform an exam. He did not get a "sense" of the patient. - ed.] Liss wanted to emphasize that "I have a personal interest in the continued existence of Abington. My wife and I delivered our kids there. I live within a mile.</blockquote> That's very nice, but irrelevant. What is relevant is this: <blockquote>"We don't intend to tell the ER doc how to practice medicine," he added. "I appreciate the conundrum and challenge that creates at the point of care. "But unashamedly our job is to be a good steward of the dollars our customers entrust us [such as patients just like Randy Klein? - ed.] to spend on health care."</blockquote> This is bull. It is a lie. I find this statement offensive and insulting to my intelligence. I am indeed tired of the lying and the spin. Of course the insurance company representatives are telling the ER doctor how to practice medicine. Patient disposition decisions are part of an ER physician's practice of medicine. Insurance company interference in those decisions is precisely a matter of telling ER docs how to practice medicine. Their profits depend on it. Now for the EHR angle: <blockquote>... Joanne Mainart and Donna Tobin are nurses and case managers at Abington who review admissions. Mainart was hired for this job a year ago; Tobin joined her in March.They sit at their own computer in the ER [i.e., with their own access to the EHR - ed.], away from patients, and when they see a black ball beside a patient's name [signifying the insurer may deny an inpatient claim and pay at aforementioned "outpatient inpatient" rates - ed.], their job is to examine medical records and treatments and determine if the patient meets criteria for inpatient admission.Doctors still make the decision. These nurses only advise. But their mission is to make sure patients get put in the right category - inpatient admission or observation [so the hospital can be paid appropriately - ed.] Assigning Mainart and Tobin to the ER was Abington's response to the push toward observation.</blockquote>And this: <blockquote>... Blue Cross has its own team of utilization review nurses, all of whom, it says, have at least five years experience and have received special training in utilization review.One of the nurses, working at the Blue Cross offices in Plymouth Meeting, got access to Abington's computers through a secure logon [they can see the EHR too! - ed.] and reviewed the same records Tobin had the previous evening.[Note the centrality of the computers in this payment "poker game" process - ed.] The Blue Cross nurse did not feel Klein met InterQual. [Since nurses cannot unilaterally make these decisions, a physician later reviewed the case and concurred - ed.] </blockquote> So, there we have it. Physicians' work is interfered with by EHR's ostensibly put in place to "help them", but in reality a behind-the-scenes cybernetic game of financial chess is going on, worth billions to hospitals and the insurers. If that is not a compelling driver for EHR technology, I don't know what is. Unfortunately, it does not benefit patients or doctors clinically (my relative was nearly killed earlier this year by the unintended adverse consequences of an ED EHR system), and it looks like the upper hand financially now lies with the insurers. Hospitals like Abington estimate they "will lose $12 million a year because of [the denials]." Hospitals around the state and nation are feeling the same financial pressure. Per Abington Chief of Staff Jack Kelly, a former director of my Residency program there: <blockquote>John J. Kelly, [now] Abington's chief of staff and top doctor, said: "It actually costs us more money to do observation. You might say that doesn't make any sense."He said Abington has had to hire more staff and "compress everything" - in other words, try to provide the same care it gives an inpatient but squeeze that into 24 hours of observation.Kelly also said staff was required to do more documentation "because you're paid by the hour for observation. It's craziness.""What they're asking us to do sometimes is dangerous, I think," said Kelly, speaking for himself and not the hospital."The 'retrospectacope' is the most powerful instrument known to man," he added. [That sounds like vintage Jack - ed.] "Part of the reason we spend so much of our resources in training physicians is to develop that sense of judgment about who needs what. And we're being second-guessed by everybody strictly on the basis of costs."I understand the need to be sensitive to costs, yet they're going to cripple us, the insurers [and] the government."</blockquote> Note his statement: <blockquote style="font-style: italic;">"Part of the reason we spend so much of our resources in training physicians is to develop that sense of judgment about who needs what."</blockquote> I concur with his assessment, and from personal experience. I was one of the physicians he trained. A plague of our current culture is the permitting of second guessing by people who both lack the expertise of the experts, and/or lack the crucial benefit of direct, concurrent observation of the patient. In conclusion: First, it is increasingly apparent that clinical information technology has been hijacked from its inventors and pioneers. It has been morphed from a tool that was supposed to help clinicians in their private doctor-patient relationship, into a cybernetic control mechanism for bureaucrats. Second, until this culture takes away the power from ill informed bureaucrats, people need to bring a bodyguard (medical advocate) with them to any hospital encounter. "If you are second-guessed wrong, your patient's dead" seems an apropos motto for this era. -- SS

Inpatient or outpatient and the battle to control costs: The truth about the push for electronic medical records?

Electronic health records have been pushed like opiates on a run-down inner city street corner for some years now; yet the evidence does not...

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Study highlights 'lurking question' of measuring EHR effectiveness: The science in Medical Informatics is dead

<div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;">The science in Medical Informatics is dead. I'm not going to even use academic fabric softener in my assertion, e.g., "may be", "appears to be", or "is it?" (as a question) dead. It's dead. When HIT experts recommend changing the study goalposts when existing studies don't give results they'd like to see, rather than first and foremost critically and rigorously examining why we're seeing unexpected results, science is dead.<a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=213cd2a382634858bbe315d958ccc5a4&URL=http%3a%2f%2fwww.healthcareitnews.com%2fnews%2fstudy-highlights-lurking-question-measuring-ehr-effectiveness" target="_blank"> </a> </div> <blockquote style="margin-right: 0px;font-family:arial;" dir="ltr"> <div dir="ltr"> </div> <div dir="ltr"> </div> <div dir="ltr"> <a href="http://www.healthcareitnews.com/news/study-highlights-lurking-question-measuring-ehr-effectiveness"> </a><a href="http://www.healthcareitnews.com/news/study-highlights-lurking-question-measuring-ehr-effectiveness"></a><a target="_blank"></a><a href="http://www.healthcareitnews.com/news/study-highlights-lurking-question-measuring-ehr-effectiveness">Study highlights 'lurking question' of measuring EHR effectiveness</a> December 22, 2010 | Molly Merrill, Associate Editor WASHINGTON – Hospitals' use of electronic health records has had just a limited effect on improving the quality of medical care nationwide, according to a study by the nonprofit RAND Corporation. The study, published online by the American Journal of Managed Care, is part of a growing body of evidence suggesting that new methods should be developed to measure the impact of health information technology on the quality of hospital care. [In other words, we're not getting the results we thought and hoped we'd get with "Clinical IT 1.0", so let's alter the study methodologies and endpoints --- rather than using the results we have to identify the causes and improve the technology to see if we can do better with "Clinical IT 2.0." Further, it's not as if there's no other data on why health IT might not <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">work as hoped</a> - ed.] Most of the current knowledge about the relationship between health IT and quality comes from a few hospitals that may not be representative, such as large teaching hospitals or medical centers that were among the first to adopt electronic health records. [This implies "other" "representative" hospitals are either not doing it right, or the technology is ill suited for them and may never work. Which is it? We really need to know before we proceed with hundreds of billions more in this "Grand Experiment" - ed.] The RAND study is one of the first to look at a broad set of hospitals to examine the impact that adopting electronic health records has had on the quality of care. The research included 2,021 hospitals – about half the non-federal acute care hospitals nationally. Researchers determined whether each hospital had EHRs and then examined performance across 17 measures of quality for three common illnesses – heart failure, heart attack and pneumonia. The period studied spanned from 2003 to 2007. The number of hospitals using either a basic or advanced electronic health records rose sharply during the period, from 24 percent in 2003 to nearly 38 percent in 2006. [How many billions of dollars diverted from patient care needs does that represent? - ed.] Researchers found that the quality of care provided for the three illnesses generally improved among all types of hospitals studied from 2004 to 2007. The largest increase in quality was seen among patients treated for heart failure at hospitals that maintained basic electronic health records throughout the study period. However, quality scores improved no faster at hospitals that had newly adopted a basic electronic health record than in hospitals that did not adopt the technology. [In other words, the improvements or lack thereof had little to do with electronic vs. paper record keeping - ed.] In addition, at hospitals with newly adopted advanced electronic health records, quality scores for heart attack and heart failure improved significantly less than at hospitals that did not have electronic health records. [In other words, the clinical IT was probably impairing doctors compared to simpler paper methods and good HIM personnel - ed.] EHRs had no impact on the quality of care for patients treated for pneumonia. Researchers say the mixed results may be attributable to the complex nature of healthcare. [That is likely true, but maybe the mixed results are also -- and even more likely in major part -- due to poorly designed and/or poorly implemented IT - ed.] Focusing attention on adopting EHRs may divert staff from focusing on other quality improvement efforts. [That speaks to poor EHR overkill, poor usability, unfitness for purpose, and other issues that may or may not be remediable in short or even long term - ed.] In addition, performance on existing hospital quality measures may be reaching a ceiling where further improvements in quality are unlikely. [That speaks to a low ROI or even negative for the hundreds of billions of dollars being diverted to the IT sector - ed.] "The lurking question has been whether we are examining the right measures to truly test the effectiveness of health information technology," said Spencer S. Jones, the study's lead author and an information scientist at RAND. "Our existing tools are probably not the ones we need going forward to adequately track the nation's investment in health information technology." ["Probably" not the ones we need? How can the authors know this? This is not science, it is speculation. Further, I'd say the scientific imperative before we design "the right measures" to "truly" test the effectiveness of HIT is to understand why the measures we're using now are not showing the desired results, because perhaps they are perfectly adequate and are revealing crucial flaws, overestimations and false assumptions that need to be dealt with, now, not after another round of billions is spent - ed.] New performance measures that focus on areas where EHRs are expected to improve care should be developed and tested, according to researchers. [In pharma clinical trials, this is akin to what is known as "changing the study methodologies and endpoints" - a form of manipulating clinical research, usually with the true ultimate endpoint of money - ed.] For example, EHRs are expected to lower the risk of adverse drug interactions, but existing quality measures do not examine the issue. [I believe the studies that have been done of CPOE have not been consistently supportive, and in fact show CPOE might create new med errors - ed.] "With the federal government making such a large investment in this technology, we need to develop a new set of quality measures that can be used to establish the impact of electronic health records on quality," Jones said. [This is truly putting the cart before the horse <a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html">as I wrote here</a>. The studies showing the benefit should have long preceded the "large investments" that were decided upon - ed.] Support for the study was provided by RAND COMPARE (Comprehensive Assessment of Reform Efforts). RAND developed COMPARE to provide objective facts and analysis to inform the dialogue about health policy options. COMPARE is funded by a consortium of individuals, corporations, corporate foundations, private foundations and health system stakeholders. Other authors of the study are John L. Adams, Eric C. Schneider, Jeanne S. Ringel and Elizabeth A. McGlynn.</div></blockquote> <blockquote style="margin-right: 0px;font-family:arial;" dir="ltr"> <div dir="ltr"> </div> <div dir="ltr"> </div> <div dir="ltr"> </div> <div dir="ltr"> </div> <div dir="ltr"> </div> <div dir="ltr"> </div> <div dir="ltr"> </div> <div dir="ltr"> </div> <div dir="ltr"> </div> <div dir="ltr"> </div> <div dir="ltr"> </div> <div dir="ltr"> </div> <div dir="ltr"> </div> <div dir="ltr"> </div> </blockquote> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> The overarching assumption is that the metrics are wrong, not the quality and fitness for purpose of the technology, the 'wrongness' of which is painfully obvious from the aforementioned other literature, e.g., <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">link</a>, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">link</a>, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=other">link</a>, and the many posts at this blog referring to other literature. Are the authors unaware, one might ask? I know they are not. (Or - blinded? That is, could there be external pressures affecting the thought processes? The arguments might not unreasonably be construed to be skewed from that perspective.) Recognizing the atrocious user experience and mission hostile nature of the technology (<a href="http://www.tinyurl.com/hostileuserexper">link</a>), how disruptive it is (<a href="http://hcrenewal.blogspot.com/2005/03/upenn-not-what-doctor-ordered.html">link</a>, <a href="http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html">link</a>), how <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU">poorly implemented it is often by domain amateurs</a> to support <a href="http://hcrenewal.blogspot.com/2010/12/inpatient-or-outpatient-battle-to.html">financial battles of the payers</a>, not <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">cognitive processes of clinicians</a>, I am amazed there's any signs of improvement at all, not outright deterioration. (That there is not outright deterioration of care displays if anything the results of the hard mental labor and ingenuity of clinicians to work around the technology's deficits.) I note that the last time RAND looked at such matters there were problems with pro-health IT bias, among other issues (see my Feb. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/02/heartland-institute-research-commentary.html">Heartland Institute Research & Commentary: Health Information Technology</a>"). Carl Sagan wrote that science is a candle in the dark in a demon haunted world. It seems the demons are winning. -- SS </div>

Study highlights 'lurking question' of measuring EHR effectiveness: The science in Medical Informatics is dead

The science in Medical Informatics is dead. I'm not going to even use academic fabric softener in my assertion, e.g., "may...

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BLOGSCAN - Charles Ferguson, "Inside Job," and Parallels and Interlinks with the Health Care Crisis

BLOGSCAN - Charles Ferguson, "Inside Job," and Parallels and Interlinks with the Health Care Crisis

On the Naked Capitalism blog , there is a video clip of an interview with Charles Ferguson, who directed Inside Job (see this post ). It is...

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These Pharma-Paid "Key Opinion Leaders" Know Better

At "<a href="http://hcrenewal.blogspot.com/2010/12/lancet-emphasizes-threats-to-academic.html">The Lancet Emphasizes the Threats to the Academic Medical Mission</a>" Roy Poses summarized the major categories of ills affecting healthcare today. The list reads like a list of the <a href="http://en.wikipedia.org/wiki/Plagues_of_Egypt">Ten Plagues of Egypt</a> visited upon the Pharaohs (actually thirteen categories are listed, but plagues they are indeed to patients and conscientious medical practitioners). This list, with keyword-hyperlinked examples, can serve as an index to the threats to healthcare's core values covered at the Healthcare Renewal blog: <ul style="color: rgb(255, 0, 0);"><li>1. Abandonment of traditional prohibitions of the commercial practice of medicine</li><li>2. Making money takes precedence over education</li><li>3. The medical school re-imagined as a biotechnology company</li><li>4. Faculty become employees of industry</li><li>5. Academics become "key opinion leaders" paid to market drugs and devices </li><li>6. Control of clinical research given to commercial sponsors </li><li>7. Conflicts of interest allow manipulation and suppression of clinical research</li><li>8. Academics take credit for articles written by commercially paid ghost-writers</li><li>9. Whistle blowers are discouraged, or worse, and academic freedom is damaged</li><li>10. Leadership of academic medical centers by businesspeople</li><li>11. Leaders of teaching hospitals and universities become millionaires</li><li>12. Medical school leaders become stewards (as members of boards of directors) of for-profit health care corporations </li><li>13. Leaders of failed finance firms become stewards of academic medicine</li></ul> Today in my local newspaper, the Philadelphia Inquirer, an article that focused on plagues #4 and #5 was published entitled "Faculty still paid by drug firms." The article contains a personal reminder to me that the "faculty" know of the dubiousness of their deeds from long ago. More on that momentarily. <a href="http://www.philly.com/inquirer/front_page/20101224_Faculty_still_paid_by_drug_firms.html" style="font-weight: bold;"></a><blockquote><a href="http://www.philly.com/inquirer/front_page/20101224_Faculty_still_paid_by_drug_firms.html" style="font-weight: bold;"> </a>Posted on Fri, Dec. 24, 2010 <a href="http://www.philly.com/inquirer/front_page/20101224_Faculty_still_paid_by_drug_firms.html" style="font-weight: bold;">Faculty still paid by drug firms</a> Medical-school policies often fail to keep doctors from lecturing on Big Pharma's dime. By Tracy Weber and Charles Ornstein PROPUBLICA Officials at the University of Pennsylvania believed they had a strong tool to prevent pharmaceutical-company money from corrupting the medical faculty. In 2006, they acted to keep drug marketers out of their hospital and clinics, to ensure that treatment decisions were made for the right reasons. In one of the country's first policies of its kind, Penn also told its physicians that they "should not participate in industry marketing activities." Penn's chief medical officer, P.J. Brennan, said he thought the policy was clear: Company-paid lectures are forbidden. "It flies in the face of what a professional ought to be," he said. [Perhaps the policy would have been clearer to the esteemed academic faculty if written in Latin, as in "Vexillum pensus lectures es inconcessus", or perhaps Greek "εταιρεία πληρωμένος διάλεξη είναι απαγορευμένος"? - ed.] But an investigation by ProPublica found that 20 of Penn's doctors have delivered such lectures since 2009. Five, including one who left Penn last month, were paid more than $40,000. </blockquote>$40,000 can buy a lot of opinions, or skew the opinions of otherwise scientific personnel. Those who deny this are either deluded or overly enamored by the hot sports car they plan to have in their garage... <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiJQgwT_zDNItTEMvq77LvyWZ-fZoVyUpuZTaLm_NREtWNmX-0fFB55T0R1vwNFmcAPUCwUKFObJ0dWqkPOx07BQAfVmG4MeoTJScL2x7TSa3gtLFdLw0gmQDmdV9gk7RTwQuZZaf4Ts9cG/s1600/aston-martin-sports-car.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5554265450842923602" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiJQgwT_zDNItTEMvq77LvyWZ-fZoVyUpuZTaLm_NREtWNmX-0fFB55T0R1vwNFmcAPUCwUKFObJ0dWqkPOx07BQAfVmG4MeoTJScL2x7TSa3gtLFdLw0gmQDmdV9gk7RTwQuZZaf4Ts9cG/s320/aston-martin-sports-car.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 254px; height: 154px;" /></a>What's the big deal with giving pharma-sponsored and paid "educational talks", anyway, when you can then more easily afford one of these? </div> The article continues: <blockquote>[Penn] was not the only [school] caught off-guard. ProPublica checked on 12 medical schools and teaching hospitals and found that faculty at half also lectured for drug firms in the last two years, despite restrictions on such speeches. Among them, Stanford University, the University of Pittsburgh, and the University of Colorado Denver have initiated reviews. Conflict-of-interest policies have become more important as academic medical centers worry that promotional talks undermine the credibility not only of the physicians giving them, but also of the institutions they represent. [Asking a physician about conflicts of interest who is recommending some relatively new therapy or device, or novel use of an existing treatment, should now be considered standard patient operating procedure - ed.] Yet when it comes to enforcing the policies, schools have allowed permissive interpretations and relied on the honor system. [In other words, the academic old boy's club turns a blind eye to abuses - ed.] ProPublica's review shows that approach isn't working: Many doctors are in apparent violation, and ignorance or confusion about the rules is widespread. As a result, some faculty stay on the pharmaceutical lecture circuit, where they can net tens of thousands of dollars in extra income.</blockquote> I find this doubly troubling. When I was a pharma research lab middle manager, a careful analysis I'd conducted over several months with the key scientific stakeholders demonstrated a $4 million+ annual gap in funding for provision of drug scientists with the information assets and informatics tools they needed to optimally perform their work. Yet, I was only able to secure about a third of that (much of which was later rescinded after several late-state drugs in develpoment were withdrawn) while massive amounts of money was spent on marketing activities. (Even worse, the decisions were made by non-science-grounded computer personnel, further insulting my intelligence...and insulting the pocketbooks of investors and stockholders.) The article then notes something we've noted frequently at this blog: <blockquote>Critics of the practice say delivering talks for drug companies is incompatible with the job of teaching future generations of physicians. That's because drug firms typically pick the topic of the lecture, train the speakers, and require them to use company-provided presentation slides. "You're giving someone else's messages, someone else's talk, someone else's judgments," said Bernard Lo, a medical professor at the University of California, San Francisco, who chaired a national panel examining conflicts of interest in medicine. </blockquote> Lo then delivers the coup de grâce in a single sentence: <blockquote style="font-weight: bold;">"We don't allow our students to use someone else's work."</blockquote> Indeed, my students are now required by our university to attest to the originality of every assignment of submission, with penalties up to and including failure of a course and/or expulsion. In the face of the plagiarism made possible by new information and communications technologies (e.g., the Web), this policy will become more common. Yet, it seems that some esteemed academic faculty, due to desire for money, cannot "keep it in their pants" and practice the morals their organizations preach. (The oldest profession suffers a similar vice.) Then there's this startling finding: <div><blockquote>Reporters compared the names of faculty members at a dozen medical schools and teaching hospitals with ProPublica's Dollars for Docs database of payments to doctors publicly reported by seven drug companies. Lists of the physicians whose names matched were provided to the universities and hospitals for verification and comment. ... "For God's sake, if the media can look at these websites, why can't we?" said David Rothman, president of the Institute on Medicine as a Profession at Columbia University. "Why trust if you can verify?"</blockquote> </div> I would suggest the answer to that question has to do with will, as opposed to lacking a way. Now the personal angle: <blockquote> At Penn, the top paid speaker, according to Dollars for Docs, was Corey Langer, director of thoracic oncology at Penn's Abramson Cancer Center. He made nearly $70,000 speaking for Eli Lilly & Co. in 2009 and the first half of 2010. Langer also received unknown amounts from other firms, such as Genentech Inc., OSI Pharmaceuticals Inc., and Bristol-Myers Squibb Co., according to his disclosure for a medical education program this month. By e-mail, Langer said he was "now fully aware" of Penn's policy and was "taking measures to curtail speaking for pharmaceutical companies.</blockquote> I find this very sad. This is a former medical school classmate at Boston University School of Medicine, Class of '81; in fact for a year we stood at adjacent tables in Gross Anatomy dating back to 1977. I knew him to be a brilliant student, and in several interactions with him in the early 1990's when I worked at an adjacent hospital to his, felt he had become an excellent clinician. Interestingly, there was, in fact, a significant brouhaha in the class over gifting by pharmaceutical companies offering stethoscopes, black bags, and other accouterments of practice ca. 1978 or 9 as clinical rotations began. Several in the class were actually militant about the class setting a "no gifts from pharma" policy due to its potential effects on medical judgment and practice, and I recall the vigorous debates in the BU lecture halls vividly. This was in the late 1970's, I note, not 2010. That one of my former classmates claims to only now be "fully aware" of pharma-related anti-conflict of interest issues in 2010 (like many others as in the article appear to become - after they are caught red handed) is a sad reminder to me of the state of healthcare and the corrosive influence of money. The phenomenon is not just at a few organizations. The article continues: <div><blockquote>UC Denver's experience was mirrored at other schools where officials discovered their policies were not working as expected. The University of Pittsburgh's 2008 policy bans paid speaking in many cases, said Barbara Barnes, an associate vice chancellor in charge of industry relationships. Yet ProPublica found 22 Pitt doctors in its database. At Stanford University, ProPublica found that more than 12 of the school's doctors were paid speakers, in apparent violation of its 2009 policy. Two had earned six figures since last year. Philip Pizzo, the dean of Stanford's medical school, sent an e-mail to all medical school staff last week calling the conduct "unacceptable." Some doctors' excuses, he wrote, were "difficult if not impossible to reconcile with our policy."[I'll bet those "excuses" would have made superb case studies in logical fallacy as well - ed.]</blockquote> At least some are willing to own up to their behavior, although probably under duress: </div> <blockquote>Some Stanford doctors said they were in the wrong. Among them was Alan Yeung, vice chairman of Stanford's department of medicine and chief of cardiovascular medicine, who has been paid $53,000 by Lilly since 2009. In an e-mail, Yeung said he quit speaking for the company this fall. "I take full responsibility for this error," he said. "Even though I felt that these activities are worthwhile educational endeavors, the perceived monetary conflict may be too great."</blockquote> While this is stated with typical academic fabric softeners and odor removers ("perceived", "may be", etc.), it's a start. Finally, ethical simplicity itself: <blockquote>[Stanford Medical School dean] Pizzo compared some doctors' explanations to what a police officer might hear after catching a motorist running a late-night stop sign. "You can give 1,000 reasons: 'There was nobody around. It's safe,' " he said. "The reality is, it's still a stop sign." </blockquote> Perhaps universities need to develop a suitable "stop sign" for posting outside their faculty offices. May I suggest the following version: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjN2yfXjTe8WyKmH69xcb8BbcVq7d_4G0sKQW3iARckTWApkzIcTUEsq00xmo1swGdIHfFbYiD7q6FDfuNEpGf_E221ey3zF2honPXDwJhtCcohdEo7gYXSbLYW5B3gBwHPCQSnmFQKaM6_/s1600/stop.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5554276317987355890" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjN2yfXjTe8WyKmH69xcb8BbcVq7d_4G0sKQW3iARckTWApkzIcTUEsq00xmo1swGdIHfFbYiD7q6FDfuNEpGf_E221ey3zF2honPXDwJhtCcohdEo7gYXSbLYW5B3gBwHPCQSnmFQKaM6_/s320/stop.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 190px; height: 190px;" /></a>(click to enlarge) </div> -- SS

These Pharma-Paid "Key Opinion Leaders" Know Better

At " The Lancet Emphasizes the Threats to the Academic Medical Mission " Roy Poses summarized the major categories of ills affecti...

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Mylan Settles, Merck KGaA Pays the Fine

The<a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements"> parade of legal settlements</a> involving large health care organizations accused of wrong-doing just gets more and more crowded.  Here is the latest, <a href="http://www.pittsburghlive.com/x/pittsburghtrib/news/breaking/s_714910.html#">courtesy</a> the Pittsburgh Tribune-Review: <blockquote>Mylan Inc., a generic-drug manufacturer in Cecil, agreed to a $280 million settlement of allegations that its Dey Inc. specialty-drug subsidiary cheated the government out of millions of dollars by reporting falsely inflated payments for several drugs, the Justice Department said. 'The government paid millions of claims for far greater amounts than it would have if Dey had reported truthful prices,' the Justice Department said. Mylan acquired Dey when it purchased Merck KGaA's generic-drug business in October 2007 for $6.8 billion. The government's action began before Mylan acquired Dey. Dey said in a statement that Merck KGaA is responsible for paying the full amount of this settlement as well as all costs and other expenses associated with pending and future related Medicare and Medicaid reimbursement lawsuits involving Dey.</blockquote> It all gets so tiresome, doesn't it. However, before one starts yawning, remember how such settlements are markers of the prevalence of bad behavior by major health care organizations. The continuing <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">parade of settlements</a> thus is a big clue that there is something very rotten going on in health care, that the leadership of health care is increasingly amoral, greedy, and lawless. Here again is our generic statement on the phenomenon:  As in many previous cases, note that the monetary cost of the above settlement, while it seems large to normal humans, would be just slightly more than round-up error for a large multi-national company.  As I have said repeatedly,  penalties that only appear to be (relatively small) costs of doing business are unlikely to deter future bad behavior. Until the people who actually authorized, directed and implemented the bad behavior have to suffer some negative consequences, expect the bad behavior to continue.  As long as the bad behavior continues, expect health care costs to continue to rise, while access falls, and quality suffers.  True health care reform requires accountability, integrity, and transparency of health care organizational leadership.

Mylan Settles, Merck KGaA Pays the Fine

The parade of legal settlements involving large health care organizations accused of wrong-doing just gets more and more crowded. Here is...

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Exactech Settles, Its Regional Sales Director Pleads Guilty

The march of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> by health care organizations continues.  Here is a curious story in two parts.  The first part was <a href="http://www.gainesville.com/article/20101207/ARTICLES/101209597/1109/sports?Title=Exactech-must-pay-3-million-to-avoid-prosecution">reported</a> in the most detail by the Gainesville (FL) Sun: <blockquote>Gainesville-based Exactech must pay $3 million and submit to a year of federal monitoring under a settlement to avoid prosecution on charges that resulted from an investigation into whether orthopedic implant manufacturers were paying kickbacks to surgeons to use their products. The company announced the deferred prosecution agreement Tuesday after three years of an expanded federal probe. The U.S. Attorney's Office for the District of New Jersey agrees not to prosecute charges of conspiracy to violate federal anti-kickback laws if the company avoids any violations for a year. </blockquote> What did Exactech do to wind up in this pickle? It is not really clear. The article noted: <blockquote>What the U.S. Attorney calls kickbacks Exactech calls consulting fees to surgeons to help develop better products — a common practice in the medical product field.</blockquote> One can get a little better idea of what was going on by seeing what changes the company agreed to make: <blockquote>Exactech will continue using surgeons as consultants, but under a more rigorous process that verifies that the work is needed, tracks the surgeons' work and pays them fairly.</blockquote> The article went out of its way to say: <blockquote>In accepting the agreement, Exactech does not admit to any wrongdoing and the U.S. Attorney acknowledges that the company's conduct did not hurt patient health or patient care.</blockquote> Meanwhile, however, a short <a href="http://www.dailyrecord.com/article/20101208/UPDATES01/101208051/Chester-NJ-salesman-pleads-guilty-to-violations-of-US-kickback-laws">article</a> appeared in the Parsipanny (NJ) Daily Record: <blockquote>A salesman from Chester pleaded guilty to conspiring to violate a federal anti-kickback statute by entering into illegal financial deals to get surgeons to use his company's products, the US Attorney's Office said Tuesday. Douglass Donofrio, 45, director of sales for Exactech Inc.'s northeast region, entered his guilty plea Tuesday before District Judge Garrett E. Brown in Trenton. Exactech, a publicly traded, Gainesville, Fla.-based national manufacturer and distributor of orthopedic implant devices and supplies, simultaneously agreed to 12-month deal with the justice department to federal monitoring. 'This is a reasonable resolution, giving Exactech credit for positive steps it has taken while requiring continued reform and compliance to avoid more serious consequences,' acting U.S. Attorney Gilmore Childers said in a statement released by his office. 'The agreement does not erase the past, but supports a future corporate culture that will not tolerate kickbacks as business as usual. Unlawful consulting relationships compromise the integrity of our healthcare system, and we will continue to hold institutions and individuals accountable who are willing to put profits over patients.' Exactech is charged in a criminal court complaint with conspiring to violate the federal anti-kickback statute. The complaint alleges that from 2002 through late 2008, Exactech entered into consulting agreements with certain orthopedic surgeons — deals which were designed and implemented, in part, to induce the surgeons to use, and cause the purchase of, Exactech's hip and knee reconstruction and replacement products, according to Childers' office.</blockquote>Note that probably because this case was small in monetary terms, reporting about it was fragmented and brief, making it very difficult to get a sense of what really was going on.  So, while Exactech did not admit to any wrong-doing, one of its mid-level managers admitted to apparently just the sort of wrong-doing of which the company was accused. If that manager was only a lone loose cannon, why would the company have been pushed to change how it uses surgeon consultants, and why would it need "support" for "a corporate culture that will not tolerate kickbacks as business as usual?" Nonetheless, only that one mid-level manager admits he did anything wrong.  If anyone else did anything wrong, who they were, and what they did remains unclear, hidden within a swirl of legalese.  Maybe unethical practices occurred, and maybe the new deferred prosecution agreement will prevent further unethical practices, but who can tell?  If anything unethical did happen, there seems to no longer be any mechanism in health care to find out and  do something about it.  This case appears to be a good example of how language can be tortured by legalistic parsing that avoids the fundamental ethical problems that now plague health care. As Dr Bernard Carroll <a href="http://hcrenewal.blogspot.com/2010/12/impeachment-its-about-institution-not.html">posted</a> recently, "legalistic charges and defenses are not the right way to go in exposing and ejecting bad actors from our field," because this approach "favors the bad actors, who flaunt their constitutional protections with the taunt, prove it."  Instead, as Dr Carroll implied, the standard in health care should require more than just avoiding felony convictions. Even though the current case is small in monetary terms, it is a marker of unethical behavior.  The ongoing parade of legal settlements and <a href="http://hcrenewal.blogspot.com/search/label/crime">criminal </a>pleadings and convictions involving health care organizations, when viewed in its entirety, should convince professionals and policy-makers that health care is undergoing an ethical meltdown.  The fines imposed by the settlements have never been large enough to be more than costs of doing business, and hence are unlikely to change behavior.  The legalistic approach has not resulted in more than a few people who authorized, directed, or implemented the bad behavior that lead to the settlements paying any personal penalties.  If we want the bad behavior to stop, we clearly need some other way to deter it.  Until we come up with one, expect it to continue, and to continue driving up costs, driving down access, and making patients' outcomes worse.

Exactech Settles, Its Regional Sales Director Pleads Guilty

The march of legal settlements by health care organizations continues. Here is a curious story in two parts. The first part was reported ...

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