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Spine Surgeons Reticent About Disclosing Huge Medtronic Payments

Starting in 2007, we posted (<a href="http://hcrenewal.blogspot.com/2007/11/orthopedic-device-makers-reveal.html">here</a>, <a href="http://hcrenewal.blogspot.com/2007/11/few-answers-and-many-more-questions.html">here</a>, <a href="http://hcrenewal.blogspot.com/2007/11/one-more-payment-to-academic-health.html">here</a>, <a href="http://hcrenewal.blogspot.com/2008/03/stories-about-device-manufacturers.html">here</a> and <a href="http://hcrenewal.blogspot.com/2008/06/more-multi-million-dollar-orthopods.html">here</a>) about the payments, often huge, that five manufacturers of prosthetic joints (<a href="http://www.biomet.com/">Biomet</a>, DePuy Orthopaedics (a unit of <a href="http://www.jnj.com/">Johnson & Johnson</a>), Stryker Orthopedics,a unit of <a href="http://www.stryker.com/">Stryker Inc</a>, <a href="http://www.zimmer.com/">Zimmer Holdings</a>, and <a href="http://www.smith-nephew.com/">Smith & Nephew</a>) revealed they made to orthopedic surgeons and various academic and other organizations. We also <a href="http://hcrenewal.blogspot.com/2007/11/aaos-responds-to-disclosure-of-payments.html">noted</a> that some of the leadership of the major orthopedic societies have received substantial amounts from these companies, as <a href="http://hcrenewal.blogspot.com/2007/11/aaos-patient-discussion-guide-regarding.html">have the societies themselves</a>. In 2008, our <a href="http://hcrenewal.blogspot.com/2008/06/more-multi-million-dollar-orthopods.html">post </a>on this subject noted the minimal disclosure some of the surgeons receiving these huge payments made when writing scholarly articles on related topics.  In 2009, <a href="http://www.nejm.org/doi/full/10.1056/NEJMsa0807160">an article</a> in the New England Journal of Medicine showed that almost 30% of surgeons who got such payments in 2007 failed to disclose them when they presented at the 2008 American Academy of Orthopedic Surgeons meeting.(1) Medtronic's Payments to Spine Surgeons This month, the media reported that Medtronic also made payments, sometimes huge, to orthopedic and spine surgeons (see <a href="http://brodyhooked.blogspot.com/2010/12/highest-rolling-spine-surgeons-digging.html">this post</a> by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog, and our summary post <a href="http://hcrenewal.blogspot.com/2010/12/blogscan-medtronics-multi-million.html">here</a>.)  Now <a href="http://www.jsonline.com/watchdog/watchdogreports/112487909.html">further investigation</a> by John Fauber of the Milwaukee Journal-Sentinel suggests that surgeons receiving often huge payments from Medtronic may not have been good at disclosing them either. The article examined payments made to surgeons who authored two major studies about bone morphogenetic protein-2, a biologic drug manufactured by Medtronic used to promote bone growth at surgical sites: <blockquote>Over the last decade, a small group of prominent surgeons from around the country has been enlisted by medical device-maker Medtronic to do clinical research or write articles about the company's new spine surgery product. This year alone, many of those doctors received payments of hundreds of thousands to millions of dollars each in royalties for a variety of other Medtronic spinal devices, according to a Journal Sentinel analysis of newly released company payments. Medtronic began disclosing the payments this year, in advance of a federal requirement set to take effect in 2013. Since it won approval for narrow uses in 2002, the product - bone morphogenetic protein-2, known as BMP-2 - has been an increasingly dominant force in spinal fusion surgery, with sales of about $800 million a year, often for use in other procedures. Independent doctors say the product's success is due largely to positive findings made by the surgeons affiliated with the company. Doctors involved with two of the many research articles on BMP-2 published since it was approved - one in 2002, the other in 2004 - received a combined $6 million in royalties this year for other Medtronic spinal products, the newspaper found. The payments went directly to the doctors or business entities they are associated with.</blockquote> No Disclosure in a 2002 Article The Journal-Sentinel article referred to two scholarly articles written about BMP-2. Regarding the first, <blockquote>At the time BMP-2 was approved in 2002, little was known about the financial connections between Medtronic and doctors associated with the clinical trial. Likewise, little was known that year when the Journal of Spinal Disorders & Techniques published the article on the trial. The paper made no mention of doctors getting royalties or having any financial connection to the company.</blockquote>[Note: I am unable to find this article using standard search techniques, so I cannot give a citation for it.] Regarding the lack of disclosures made in the first article, <blockquote>The four co-authors of a 2002 paper about that trial received a total of $2.8 million this year from Medtronic in royalties for products not including BMP-2. The paper made no mention of any financial relationship between the authors and Medtronic. Burkus, who also was involved in the 2004 study, again declined to say if he was receiving royalties from Medtronic or if had some other financial connection with the company at the time the 2002 paper was published. He got $573,000 through September. Curtis Dickman, a Phoenix surgeon, did not respond to phone calls and e-mails. He and Vantage Investments LLC received $306,000 in royalties. Matthew Gornet, a St. Louis surgeon, and Gornet Enterprises got $591,000 in royalty payments. Gornet said he did not have a financial connection with the company at the time of the study, though he developed a relationship as a consultant right after the trial, an arrangement that ended after about a year. He said his patent rights with Medtronic did not begin until 2003 and none of his royalties involves BMP-2. The last author listed was Thomas Zdeblick, an orthopedic surgeon at the University of Wisconsin School of Medicine and Public Health. Through September, he and Taz Consulting received $1.4 million in royalties for a variety of products. Other records show Zdeblick has received more than $23 million in royalties from Medtronic since 2002. In an e-mail, Zdeblick said he had no financial interest in BMP-2. He does receive royalties for the invention of the LT-Cage, which was used in the BMP-2 clinical trial, but the two products are sold separately.</blockquote> Little Disclosure in the 2004 Article Regarding the second article,(2) <blockquote>Three of the four authors of a 2004 article on the study of the productare listed as receiving nearly $4 million this year in royalties from Medtronic for a variety of spinal products, not BMP-2. That paper was important because it involved a clinical trial that had to be stopped because the product was causing troubling bone formation in the spinal canal of patients. In the paper, that finding was downplayed, with the authors describing the results as 'encouraging.' [Professor Dan] Spengler, the Vanderbilt orthopedic surgeon and former medical journal editor, said he doubted the paper would have been written in such positive terms by authors without financial ties to Medtronic. He described the article as egregious, saying it 'just blew off the complications. It's a horrible article.' Orthopedic surgeon [University of California - Irvine Clinical Professor Charles] Rosen said the paper was biased, calling it 'more of a marketing paper than an objective scientific study.'</blockquote> Regarding the disclosures made in the second article, <blockquote>The article described three of the authors as consultants to Medtronic, though it did not disclose that any of them were receiving royalties at the time. Regis Haid, lead author of the article and an Atlanta neurosurgeon, told the Journal Sentinel he was getting royalties for other Medtronic products. Haid noted disclosure rules for medical journals have become more stringent in recent years. He said BMP-2 provides excellent benefit to patients, adding he had it implanted in his own neck in an off-label procedure. ;I have BMP in me, and I would put it in you . . . ,' he told a reporter. Through September, Haid and Spinal Engineering LLC received about $2 million in royalties this year from Medtronic. Meanwhile, co-author Ken Burkus, a Columbus, Ga., surgeon, and RBCK Research & Consulting, received $573,000. 'Very importantly, you cannot assume that such royalty payments were made prior to 2010,' he said in an e-mail, declining to say whether he got royalties at the time the paper was written. 'I follow the rules to my fullest ability as put forward by the specific journal.' He took issue with criticism that the paper put a positive spin on a troubling clinical trial. 'I believe the words used were appropriate . . . ,' he said. 'I believe the words used were neither 'positive nor negative' but rather were representative of the data presented.' He said if other doctors have problems with the paper, they should take it up with the editor of the journal: 'They can write a letter to the editor.' Co-author Charles Branch Jr., chairman of neurosurgery at Wake Forest University, and the university itself have received $1.2 million in royalties this year. A spokeswoman for the university said it owns the intellectual property rights to Branch's patents and that royalties generally are split with 35% to the individual and 65% to the university. None of those royalties involved BMP-2, university media relations manager Bonnie Davis said in an e-mail. She said Branch and Wake Forest were getting royalties at the time the paper was published, but not when the trial was going on. In a separate e-mail, Branch said use of the term 'encouraging' in the paper 'was not a strong endorsement,' but, rather, recognition that patients getting BMP-2 had superior results to those receiving a traditional bone graft.</blockquote>Summary So here we go again.  Once again we see an example of a single medical device company paying heroic amounts, hundreds of thousands to over a million dollars a year, to surgeons ostensibly as royalties for their intellectual property.  The company and the surgeons were all rather cagey about the nature of the intellectual property for which the money was paid, and about the justification for the size of the payments. While it is likely that the payments have been going on for a while, previous influential articles written by some of the surgeons receiving the payments contained at best minimal disclosure of their financial relationships with Medtronic, and gave no hint about the magnitude of these relationships.  These previous influential articles seemed more enthusiastic about a Medtronic product than was justified by their results.  Of course, maybe getting hundreds of thousands or millions of dollars a year from a commercial health care firm could lead to some excess enthusiasm about its products. It seems that every drug, biotechnology, and device company has its stable of highly paid physicians and surgeons who can be counted on for their enthusiasm about the companies' products, and their reticence about their financial relationships with the companies.  We have often discussed the pervasiveness of the web of conflicts of interest that seems to link most commercial health care firms with most influential medical academics and practitioners.  The web seems even more pervasive than we once imagined, and the conflicts seem even more intense.  Those who laud ties between academic medicine and industry may perseverate about how collaboration leads to innovation, while denying that mere money can influence professional judgement.  However, it is difficult to imagine how even the most well-intentioned professional would not be influenced by hundreds of thousands or millions of dollars a year.  When professionals hide the magnitude of such relationships, it only raises more suspicions that they know they have something to hide because they realize they have been bought. The ever increasing revelations about conflicts of interest pervading academic medicine should inspire extreme skepticism about clinical research or clinical teaching supported in any way by commercial interests.  At the very least, these revelations justify the need for detailed and complete disclosure of all financial relationships among commercial health care firms and academic and practicing physicians, and others who make or influence health care decisions.  I suspect that if such full disclosure took place, physicians, other health care professionals and the public, at least those who had not been paid themselves, would be so aghast that such relationships would not remain legal for long.  References 1.  Okike K, Kocher MS, Wei EX, Mehlman CT, Bhandari M.  Accuracy of conflict-of-interest disclosures reported by physicians. N Engl J Med 2009; 361:1466-1474. 2. Haid RW, Branch CL, Alexander JT, Burkus JK. Posterior lumbar interbody fusion using recombinant human bone morphogenetic protein type 2 with cylindrical interbody cates. The Spine Journal 2004; 4: 527-539.

Spine Surgeons Reticent About Disclosing Huge Medtronic Payments

Starting in 2007, we posted ( here , here , here , here and here ) about the payments, often huge, that five manufacturers of prosthetic jo...

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How Marketing Mixes Into Medical School Curricula - an Example from Canada

Misery loves company, so here is an interesting case reported by the Canadian Press, <a href="http://www.ctv.ca/CTVNews/Health/20101223/university-of-toronto-pain-course-revised-101223/">via CTV News</a>, about how students in a pain management course at the University of Toronto complained that marketing seemed to have been mixed into their curriculum: <blockquote>The complaint centered around students being provided a book on managing chronic pain that was funded and copyrighted by the maker of the prescription pain killer OxyContin. The book had been brought in by a non-faculty lecturer with financial ties to the drug company. </blockquote> It turned out that: <blockquote>From 2002 to 2006, the pain course was funded by donations, included $117,000 in unrestricted educational grants from four drug companies -- Merck-Frosst, Purdue Pharma, Pharmacia Canada and Pfizer -- although they had no input into course content. Since 2007, the program has been funded solely from faculty budgets. [Dean of Dentistry Dr David] Mock said Purdue's copyrighted book on pain management had been brought in by Dr. Roman Jovey, an unpaid guest lecturer and co-author of the book who left copies 'for anyone to take.' Jovey, medical director for a chain of clinics called the Centres for Pain Management, is a member of Purdue's speakers' bureau, paid by the company to conduct workshops and lectures. </blockquote> Dr Jovey defended handing out the free book produced by his part-time employer: <blockquote>Jovey confirmed he had left copies of the 371-page book, entitled 'Managing Pain: The Canadian Health Care Professionals Reference,' for students. 'It was a gift from Purdue. I'm not at all embarrassed or ashamed. I think it's a darn good book. "If we all want to be politically correct and have the appearance of being politically correct, then I guess I get it, that nothing that has any kind of pharma logo or name or ownership should be given out to medical students,' he said Wednesday. 'But the losers are the medical students because I think it's a high-quality book, it's very readable and they're deprived of it this year because of this controversy. And I guess they will be in the future.' </blockquote> However, it appeared that the "darn good" book's content was biased in favor of Purdue's product, Oxycontin: <blockquote>Dr. Irfan Dhalla said he has concerns about the content of the book, which a medical student taking the course brought to his attention. 'There are definitely things that are not consistent with the evidence,' said Dhalla, a staff physician at St. Michael's Hospital and a lecturer at the university. 'For example, oxycodone ... is listed as a moderate-potency opioid, when I think everybody agrees it's a very strong opioid, up to twice as strong as morphine.' While it's appropriate to prescribe oxycodone for severe acute pain or cancer pain, Dhalla said the book suggests that physicians can prescribe the drug for chronic non-cancer pain with relative safety for the patient. 'And I think people with experience know that that is just not the case. When you prescribe to people with chronic non-cancer pain, it's very difficult to do that safely,' he said, noting that the book pays little attention to issues of addiction and deaths from overdose. 'The book in several places makes reference to a claim that the rates of addiction if opioids are used for chronic non-cancer pain are very low. And they're not nearly as low as is claimed in the book.' In fact, a study by Dhalla and colleagues published last year showed prescription rates for opioids -- including OxyContin, a long-acting form of oxycodone -- soared in Ontario over the last two decades, as did the number of deaths linked to the narcotic. </blockquote> A subsequent inquiry has recommended revising the curriculum and dispensing with the drug company funded book. This is another example of how marketing has infiltrated medical education. It suggests that market influenced education likely includes not only opinions in favor of the specific product being marketed, but distortions of fact to support the product that are hardly evidence-based. Furthermore, it shows how conflicts of interest facilitate marketing influenced medical education. Note that the bringer of the biased textbooks in this case was being paid honoraria to speak on behalf of the pharmaceutical company, but presumably not to teach the particular course in question. However, his enthusiasm readily carried over to his work in that course. We have <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">discussed</a> how pharmaceutical marketers regard the "key opinion leaders" whom they pay to speak as salespeople. One would expect salespeople to be enthusiastic for their product even outside of their normal working hours. In my humble opinion, this is why no medical academic should be allowed to simultaneously be a commercially paid "key opinion leader." By the way, note that this case also suggests how the issues we discuss on Health Care Renewal are relevant globally, not just to the US. I tend to be wary of blogging about cases in other countries, since there may be subtle difference in context across countries that might make interpretation of cases more difficult when viewing them from abroad. However, I think that the facts and language here are straightforward enough for me to be fairly confident about what was going on. Nonetheless, if any Canadian think I have got this wrong, please let me know. Meanwhile, if anyone is blogging about similar issues from beyond the US shores, please let me know so I can add their work to our blog roll. Hat tip <a href="http://www.margaretsoltan.com/?p=28432">to Prof Margaret Soltan</a> on the University Diaries blog.

How Marketing Mixes Into Medical School Curricula - an Example from Canada

Misery loves company, so here is an interesting case reported by the Canadian Press, via CTV News , about how students in a pain management ...

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Hackensack University Medical Center CEO's $5 Million Golden Parachute: "the Public Will Perceive the Institution as a Kind of Insider's Group"

Last year was an embarassing one for Hackensack University Medical Center (HUMC), a large academic medical center affiliated with the University of Medicine and Dentistry of New Jersey.  In April, former state senator Joseph Coniglio was convicted of fraud (against the public) and extortion for a scheme that involved him being paid $5000 a month for undefined consulting work for HUMC while he promoted the hospital's interests in the state legislature (see post <a href="http://hcrenewal.blogspot.com/2009/04/new-jersey-legislator-found-guilty-of.html">here</a>).  A subsequent investigative report revealed widespread self-dealing on the part of the HUMC board (see post <a href="http://hcrenewal.blogspot.com/2009/04/hospital-board-members-with-juice-in.html">here</a>).  Soon after, the HUMC CEO, John Ferguson, announced his retirement, <a href="http://www.nj.com/news/index.ssf/2009/05/hackensack_university_medical.html">per the Newark Star-Ledger</a>. Scandal Leads to Apparent Reforms So when I read <a href="http://www.northjersey.com/news/112298739_Hospital_works_to_rebuild_reputation_hurt_by_trial.html">an article</a> from last week on NorthJersey.com entitled "Hackensack University Medical Center works to revamp reputation hurt by trial" I hoped that these travails lead to some real improvements in the leadership and governance of the institution.  Hope springs eternal, and the article did describe some apparent progress. The medical center's board of trustees was streamlined: <blockquote>the hospital's board of governors — once a 57-member behemoth run by a core group of powerful and politically connected members — was whittled to less than half its former size and is now overseen by what the hospital is calling a 'reinvigorated' parent company, Hillcrest Health Service System Inc.</blockquote> Conflicts of interest and self-dealing were apparently banned <blockquote>Members of the two boards may no longer do business directly with the hospital — a significant change because some of them own or work for companies that have been paid millions of dollars by Hackensack. In 2009 alone, these companies were paid $13.2 million by the hospital, according to its federal tax filings. They were paid $17.4 million in 2008.</blockquote>The Devil in the Details Although the board was reduced in size, it gained almost no new members, and the politically-connected members who previously were accused of self-dealing remained: <blockquote>Serving as chairman of the board of governors is Joseph M. Sanzari, a construction magnate, multimillion-dollar donor and longtime board member. His company, a joint venture with former board Chairman J. Fletcher Creamer Jr., has been one of the highest-paid independent contractors at the medical center.</blockquote> Also, <blockquote>There were no new board members until Tuesday, when two were appointed. Many who held influential positions on the board of governors — including Sanzari, Creamer and Joseph Simunovich — are still in key roles. </blockquote> Furthermore, there was a big loop-hole in the apparent ban on conflicts of interest and self-dealing: <blockquote>members of both the board of governors and Hillcrest can still do business with the hospital as long as they work as subcontractors or move to the foundation board or a newly created advisory panel that doesn't have voting or fiduciary powers.</blockquote> Also, <blockquote>Members of the board of governors and Hillcrest still can be hired as subcontractors. The ban on doing business with the hospital also doesn't cover members of the advisory panel or the board that oversees the foundation. About a dozen members of these two groups are affiliated with companies that have made money — millions, in some cases – in work with the hospital.</blockquote> As one outside expert noted, <blockquote>'They may have changed the structure, but if you don't change the people, you don't change the culture,' said Jamie Orlikoff, a governance expert who advises the National Hospital Association.</blockquote> Furthermore, <blockquote>'People who had influence and clout when they were members of a fiduciary board will still have influence and clout even if they are moved to an advisory board,' Orlikoff said.</blockquote> So, <blockquote>'The concern is that the public will perceive the institution as a kind of insider's group and things are being done to benefit them,' said Daniel Borochoff, president of the American Institute of Philanthropy.</blockquote>The CEO's Golden Parachute Hope spring eternal, but is too often crushed.  However, at least the former CEO is gone. But it turns out he got quite a going away present. As described in <a href="http://www.northjersey.com/news/112365189_Severance_raised_hospital_chief_s_pay_to__7_7M.html">a companion article</a>, <blockquote>John P. Ferguson received a severance package of more than $5 million when he was forced out as president of Hackensack University Medical Center last year, bringing his total compensation for 2009 to $7.7 million, according to recent federal tax filings.</blockquote> The other executives who presided over HUMC in 2009, the year that its former consultant was convicted, also did very well for themselves, <blockquote>His senior vice president for operations, Doreen Santora, received $2.6 million — including more than $1.5 million in severance — when she left in the executive reshuffling that followed, the documents show. In all, seven top executives at the non-profit hospital each received more than $1 million in total compensation in 2009, up from five the year before.</blockquote> This extremely generous compensation could not be related to the financial success of the hospital at the time: <blockquote>The compensation packages came in a year in which tax filings show the 775-bed medical center employed 317 fewer staff and Moody's Investors Service downgraded its credit rating to Baa1, leading to higher interest payments when new debt is issued.</blockquote> If this was pay for performance, by what measure these executives' performance was measured was not clear. Actually, who even decided to award them such sumptuous pay was unclear: <blockquote>only a handful of board members were aware of the millions of dollars in pay and perks that had been handed out to executives over the last few years. Several employees saw their overall compensation double or triple. Board members expressed 'sticker shock' when they first learned of the compensation numbers at a fall 2009 meeting, said J. Fletcher Creamer Jr., who completed his term as chairman of the board of governors in March. 'We went through every single executive' whose salaries must be disclosed on the IRS form for non-profit institutions, Creamer said in an interview earlier this year. 'It's the first time they actually saw it. … We always made the numbers available if they wanted to come see it, but not everyone looked.'</blockquote> Keep in mind that per the first NorthJersey.com article, Mr Creamer will still be in a "key role" at HUMC, his failure to think that top executives' compensation was something his fellow board members needed to consider notwithstanding. Summary Is this any way to run a hospital "which has a national reputation for quality care?" The hospital leadership did and still appears to be an "insider's group" which works to promote its own self-interest. As we have <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">said before</a>, far too often the leaders of not-for-profit health care institutions seem more interested in padding their own bottom lines than upholding the institutions' missions. They often seem entirely unaware of their duty to put those missions ahead of their own self-interest. Like the financial services sector in the era of "greed is good," health care too often seems run by <a href="http://hcrenewal.blogspot.com/2009/12/compensation-madness-insiders-hijacking.html">"insiders hijacking established institutions for their personal benefit."</a> True health care reform would encourage leadership of health care who understand health care and care about its mission, rather than those who see a quick way to make a small fortune.

Hackensack University Medical Center CEO's $5 Million Golden Parachute: "the Public Will Perceive the Institution as a Kind of Insider's Group"

Last year was an embarassing one for Hackensack University Medical Center (HUMC), a large academic medical center affiliated with the Univer...

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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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