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Polly Want a Million (Plus)

We have frequently posted about attempts to justify financial relationships among physicians and medical academics on one hand, and pharmaceutical, biotechnology, device and other health care corporations, on the other. Some defenders of such relationships now have gone so far as to start their own society, whose meeting was covered and commented on by fellow "pharmascolds," including <a href="http://carlatpsychiatry.blogspot.com/2009/07/acre-meeting-welcome-to-anger-village.html">Dr Daniel Carlat </a>and <a href="http://brodyhooked.blogspot.com/2009/07/carlats-take-on-acre-some-ruminations.html">Dr Howard Brody</a>. The usual justification of these relationships is that they are necessary for "innovation" and the onward progress of medical science, education, and care. I have yet to see any logic or evidence to back up these assertions, nor have I seen anyone defend these relationships who does not also have personal financial relationships of their own with health care corporations. (See examples <a href="http://hcrenewal.blogspot.com/2008/01/logical-fallacies-and-discussion-of.html">here</a>, <a href="http://hcrenewal.blogspot.com/2007/04/can-people-with-conflicts-of-interest.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2009/07/again-logical-fallacies-in-defense-of.html">here</a>.) Meanwhile, cases of individual physicians and academics whose lucrative relationships with industry seem to generate huge conflicts of interest continue to surface. The latest example ferreted out by investigators working for US Senator Charles Grassley (R - Iowa) is that of Dr David Polly. (Recall that Dr Polly was one of the strongest defenders of Dr Thomas Kuklo, who was accused of falsifying clinical research results in a way that seemed to favor the product of his own corporate benefactor [see post <a href="http://hcrenewal.blogspot.com/2009/05/breach-of-trust.html">here</a>].) The main points were <a href="http://online.wsj.com/article/SB124882216054688233.html">reported</a> by David Armstrong and Thomas M Burton in the Wall Street Journal, <blockquote>In May 2006, University of Minnesota spine surgeon David Polly urged a Senate committee to fund research into the severe arm, leg and spine injuries suffered by soldiers in Iraq and elsewhere. Dr. Polly told the committee he was testifying on behalf of the American Academy of Orthopaedic Surgeons and referenced his prior work caring for soldiers as a surgeon at the Walter Reed Army Medical Center. What Dr. Polly didn't disclose during his testimony was that his trip to Washington was paid for by Medtronic Inc., the big medical-device maker whose bone growth product, called Infuse, has been used to treat soldiers, according to company records. Dr. Polly and colleagues in Minnesota subsequently received a $466,644 Department of Defense grant for a two-year study beginning in February 2007 to evaluate Infuse in cases where an injury is also infected, according to the university. Dr. Polly was paid $1.14 million by Medtronic for consulting services from 2004 to 2007. Details of Dr. Polly's consultant billing were provided by Medtronic to Sen. Charles Grassley, an Iowa Republican who has been scrutinizing the relationship between academics and industry. </blockquote> Although there have now been many reported cases of medical academics who collected large payments from health care corporations, the services they provided in exchange for the money have not always been very clear. Defenders of financial relationships among physicians and medical academics and industry have argued that most payments were for valuable research, education, or health care activities. However, Senator Grassley's office provided the details of Dr Polly's invoices, and several of the news articles so far described what he did for the money. Per the Wall Street Journal article, <blockquote>In total, Dr. Polly billed Medtronic for more than $50,000 in lobbying-related costs. He made trips to Washington in 2005 and 2006 and called on several members of Congress, according to the records. According to billing records, Dr. Polly's billing rate was $4,750 for an eight-hour day in 2007, and he billed as many as 13,000 minutes a quarter -- or 216 hours over three months. In some months, he conducted at least some Medtronic business on nearly every day. His consulting log indicates that on one occasion he spent one minute to wake up a Medtronic executive, although he listed 'no charge' for that service. He did bill Medtronic for the 30 minutes he spent in the car with that executive after waking him up. </blockquote> An accompanying post on the Wall Street Journal Health Blog provided <a href="http://blogs.wsj.com/health/2009/07/29/what-a-doctor-did-that-was-worth-1-million-to-medtronic/">more information</a>: <blockquote>Did you ever wonder what doctors do to earn big consulting contracts from medical device companies and pharmaceutical concerns? Records released by Medtronic to Sen. Charles Grassley, a longtime critic of the ties between academics and and health-care companies, provide a rare and detailed glimpse into the daily billings of a consultant — in this case, spine surgeon David Polly of the University of Minnesota. Polly collected more than $1 million in four years of work for Medtronic, according to the records, which you can take a look at <a href="http://s.wsj.net/public/resources/documents/UMinnLetter.pdf" target="blank">here</a>. The services he provided were many, but among them, Polly was paid to write articles for medical journals; write a chapter in a book and a book outline; recruit patients for publicity efforts; attend Medtronic national sales meetings; travel to conferences in Japan, Paris and elsewhere; lead training and educational sessions for physicians; and lobby Congress. Polly also billed for at least two phone calls with Medtronic CEO William Hawkins as well as charging the company $2,000 when Mr. Hawkins visited an operating room. In October, 2003, he billed the company $12,000 for attending a medical meeting of the North American Spine Society, at $4,000 a day. There are also scores of entries for work billed in five-minute increments, usually to send email or return phone calls. The bill for each five-minute charge? $49.48 a pop. </blockquote> So did the $1.2 million Medtronic spent on Dr Polly's services inspire any "innovation?" Did it lead to any scientific progress or improved health care? I am not sure. It is clear, however, that a good chunk of this money went to support marketing, advocacy, and lobbying. The items in bold italics above were clearly in support of marketing, advocacy and lobbying, not science, medical education, or patient care. (To give Dr Polly the benefit of a doubt, some other items listed above could have been related to research, education, or patient care, although this is not indisputable.) So the case of Dr Polly corroborates my deep skepticism of the financial relationships among physicians and medical academics on one hand, and corporations that sell health care goods and services on the other. We "pharmascolds," - a preferable term might be health care skeptics - suspect that many of these relationships are really about stealth marketing and advocacy. The companies often pay to market their products and services, or advocate positions to the companies' advantage, but prefer that their salespeople and advocates are cloaked in academic guises, and wreathed in the rarefied aura of respected academic institutions. (Note that some of us are just as skeptical about relationships among academic institutions and other health care not-for-profit organizations on one hand, and such corporations on the other, for analogous reasons.) While the leadership of our formerly distinguished medical academic institutions remains infiltrated, if not dominated by people earning many thousands of dollars from health care corporations, I must remain skeptical about how much of these institutions supposedly academic output is actually stealth marketing and stealth health policy advocacy. At the very least, medical academics, medical academic institutions, and other health care not-for-profits or NGOs should reveal in detail what payments they get from companies selling health care products or services, and how these payments could relate to the companies' marketing or lobbying efforts. In the US, some such disclosure would be mandated by the proposed "Sunshine" legislation now being considered by the US Congress. (By the way, note that this problem is hardly confined to the US, and needs global, not just American attention.) However, physicians (at least physicians in full-time private practice, academic positions, and employed by mission-oriented not for profit organizations) should go further, and consider whether receiving industry money is worth the ongoing damage it does to our professionalism and our professional reputations. Medical schools, universities, health care foundations, disease advocacy groups, and other health care not-for-profits and NGOs should also go further, and consider whether receiving industry money is worth the ongoing damage it does to their missions, and their institutional reputations. See also comments by Prof Margaret Soltan <a href="http://www.margaretsoltan.com/?p=15588">on the University Diaries blog</a>.

Polly Want a Million (Plus)

We have frequently posted about attempts to justify financial relationships among physicians and medical academics on one hand, and pharmace...

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Wyeth: Ghostwritten Papers Fake, But Accurate

It looks like Wyeth has lost its battle to keep secret its practices regarding <a href="http://hcrenewal.blogspot.com/2005/04/ghosts-busted.html">ghostwriting</a> of scientific papers. The issue in question is whether ghostwriting contributed to excessive prescription of post-menopausal hormones and increased the incidence of breast cancer: <blockquote>Posted on Sun, Jul. 26, 2009 Philadelphia Inquirer <a href="http://www.philly.com/inquirer/world_us/51709602.html">Wyeth told to release documents on ghostwriting</a> Associated Press LITTLE ROCK, Ark. - A federal judge has ordered the unsealing of thousands of pages of documents pertaining to the ghostwriting practices of Wyeth Pharmaceuticals, which is being sued over hormone-replacement drugs. U.S. District Judge Bill Wilson ordered the papers unsealed Friday at the request of a medical journal and the New York Times. Plaintiffs' attorneys presented the papers earlier at trial to show that Wyeth routinely hired medical-writing firms to ghostwrite articles that appeared in seemingly objective medical journals but included only the name of a scientific researcher as the author. </blockquote>Of course, in addition to the violation of accepted practices of authorship, such as specified by <a href="http://www.docstoc.com/docs/922992/Guidelines-for-the-Conduct-of-Research-at-NIH">NIH</a> and the <a href="http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1416675">International Committee of Medical Journal Editors</a>, among others, such lucky authors get to "count" such papers in their academic portfolios, presumably also in violation of their own institutional policies and guidelines for fair attribution and intellectual honesty, e.g., <a href="http://www.hms.harvard.edu/fa/attribution.html">here</a>. Ghostwriting may also skew the tenure process, providing advantages to the unscrupulous academic over the ethical scientist or scholar. (One wonders about the true percentage of the massive number of papers claimed by some medical academics actually written by the putative first author.) <blockquote>The ruling came in a case that involves about 8,000 lawsuits that have been combined before Wilson. The lawsuits focus on whether Wyeth hormone-therapy drugs Prempro and Premarin, used to treat symptoms of menopause, have caused breast cancer in some women. The New Jersey drugmaker, which has major operations in the Philadelphia area, had already turned over the documents, which it says concern about 40 articles in medical journals and other publications, to Sen. Charles Grassley (R., Iowa).</blockquote> How is evidence based medicine possible if just one drug company has sponsored ghostwritten articles in 40 medical journals and other publications? What is the "total mass" of questionable articles now infecting the literature? <blockquote>Grassley sought them last year without a subpoena as part of a congressional investigation into drug-industry influence on doctors. The documents were shown to jurors at trial but have otherwise been unavailable publicly. Plaintiffs say ghostwriting is when a drug company conjures up the concept for an article that will counteract criticism of a drug or embellish its benefits, hires a professional writing company to draft a manuscript conveying the company's message, retains a physician to sign off as the author, and finds a publisher to unwittingly publish the work. </blockquote> There are several layers of dishonesty in this activity, including foreknowledge of scientific deception through fraudulent misrepresentation of authorship by the pharma, dishonesty of the physician who "signs off" as first author, and misrepresentation by the pharma, the writing company and the physician about provenance of the article to scientific publishers. <blockquote>Drug firms disseminate their ghostwritten articles to their sales representatives, who present the articles to physicians as independent proof that the companies' drugs are safe and effective. Wyeth attorney Stephen Urbanczyk acknowledged that the articles were part of a marketing effort. But he said that they were also fair, balanced, and scientific.</blockquote> What business does a lawyer have lecturing the public that the articles were a dishonest marketing effort masquerading as legitimate science, but were "fair and scientific?" How does he know? In addition, the "fake but accurate" excuse is getting quite shopworn. Hopefully, Sen. Grassley will approach ending this ghostwriting practice with vigor. In fact, this raises another issue. I have written that management of pharma by those lacking biomedical bona fides is, by definition, mismanagement. This is a case in point. Wyeth's President, Board Chair and CEO <a href="http://www.nj.com/business/index.ssf/2008/06/wyeth_ceo_poussot_takes_chairm.html">Bernard Poussot</a> lacks <a href="http://phx.corporate-ir.net/phoenix.zhtml?c=78193&p=irol-govBio&ID=161712">biomedical credentials</a>. Harry Truman said "the buck stops here", but a in the case of scientific ghostwriting, CEO's such as Poussot cannot vouch firsthand for the accuracy and fairness of their company's science. He lacks the expertise. The buck does not stop at his desk; he is dependent on scientific underlings in such matters. This affair is another instantiation of my belief that pharma is best led by those with relevant scientific expertise such as Merck under clinician-scientist <a href="http://en.wikipedia.org/wiki/P._Roy_Vagelos">Dr. Roy Vagelos</a>. (It is perhaps not coincidental that Merck became a shadow of its former self under non-scientist Raymond Gilmartin.) <blockquote>Wyeth, the world's No. 12 pharmaceutical company by sales, is being bought this fall by No. 1 drugmaker Pfizer. </blockquote> How appropriate, as Pfizer is led by the former top lawyer for McDonald's and Boston Chicken, <a href="http://www.nytimes.com/2006/07/29/business/29pfizer.html?_r=1&adxnnl=1&ref=business&adxnnlx=1154188929-t+A9XFX2vNTip4coSmtyLA&oref=slogin" title="external link">bringing to life my "If you've run McDonald's, you can run anything" metaphor.</a> If a wise investor were to take a bearish position on a stock, this merged company would be an excellent candidate. Finally, another ghostwriter of sorts recently died, Sandford Dody (1918-2009). Dody anonymously penned best selling autobiographies of actresses Bette Davis and Helen Hayes, among many other notables. Such ghostwriting is essentially victimless, as opposed to its counterpart in the scientific domain. However, Mr. Dody had an astute observation about the practice, even when there was no trail of diseased or dead bodies. Per the WSJ article "<a href="http://online.wsj.com/article/SB124881878743688051.html">A Ghostwriter Who Struggled to Accept Life in the Shadows</a>": <blockquote> ... Mr. Dody, who died July 4 at the age of 90, found the work spiritually destructive. "After all," he wrote, "how does one become a ghost without dying a little?"</blockquote> In the case of biomedical ghostwriting, the conspirators all "die a little" in purveying their intellectual dishonesty on a trusting public. It's too bad some of that same public also dies, and not just a little, as wages of professorial ghostwriting sins. <div>The acknowledgements are where minor contributions and reviews get placed in an ethically-attributed scientific paper. Anyone who does not understand this, or rationalizes "honorary authorship" or similar workarounds to meaningful attribution does not belong in science.</div><div> Finally, scientific ghostwriting must stop. I also believe its conspirators should be excluded from receiving public money for research and excluded from the biomedical literature for a good, long period of time.<div> -- SS<div> </div><div> <a href="http://www.nytimes.com/2006/07/29/business/29pfizer.html?_r=1&adxnnl=1&ref=business&adxnnlx=1154188929-t+A9XFX2vNTip4coSmtyLA&oref=slogin" title="external link"> </a></div></div></div>

Wyeth: Ghostwritten Papers Fake, But Accurate

It looks like Wyeth has lost its battle to keep secret its practices regarding ghostwriting of scientific papers. The issue in question i...

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Are the Health Plans of the Very Rich Different from Yours and Mine?

Yesterday, the New York Times published an intriguing <a href="http://www.nytimes.com/2009/07/27/health/policy/27insure.html">story</a> about "Cadillac" (that is, expensive) health insurance plans, <blockquote> Goldman Sachs is one of the nation’s richest banks, and hundreds of top Goldman employees have a health care package to match — one of the 'gold-plated Cadillac' plans cited by those involved in the health care debate in Washington. Goldman’s 400 or so managing directors and its top executive officers participate in the bank’s executive medical and dental program as part of their benefits, according to documents filed with the Securities and Exchange Commission. The program generally costs the bank $40,543 in premiums annually for each participant’s family. Those taking part in the plan include the company’s chief executive, Lloyd C. Blankfein, and four other top officers, as well as managing directors, whose base salary is $600,000. Goldman’s medical coverage entered the health care discussion on Sunday when David Axelrod, senior adviser to President Obama, cited the Goldman program as an example of the expensive benefits the administration might consider taxing to help pay for its health care program. 'The president actually was asked this the other day by Jim Lehrer, and what he said was that this was an intriguing idea to put an excise tax on high-end health care policies like the ones that the executives at Goldman Sachs have, the $40,000 policies,' Mr. Axelrod said. A proposal by Senator John F. Kerry, Democrat of Massachusetts, would impose an excise tax on the insurers that issue policies like Goldman’s, with the expectation that the insurers would pass along most, if not all, of the cost to employers who buy the plans. Leaders of the Senate Finance Committee, which is working on bipartisan version of the health care legislation in Congress, had long expressed interest in taxing some employer-provided benefits — a move many budget experts say would help slow the steep rise in health costs. Negotiators have not yet determined the value of the plans that would set off a tax on the insurance companies; the numbers under discussion range from $20,000 to $40,000 annually, a senior administration official said. The lower end of that range would increase the amount of money the tax would raise but would also hit some middle-class workers, whose unions in some cases negotiated robust health benefits in lieu of pay increases. Typical employer-provided plans cost $13,000 to $20,000 per family, depending on the location and the age of the plan participants. A health care package costing $40,000 or more a year would generally have no co-payments or deductibles, according to Paul Fronstin, an analyst at the Employee Benefit Research Institute, a Washington nonprofit that studies benefits. It would also have no limits on doctors or procedures, no restrictions on pre-existing conditions and no requirements for referrals. Few people have such policies, Mr. Fronstin said. 'It would only be top executives who run big businesses, mainly people in the C suite,' said Mr. Fronstin, referring to companies’ chief officers. </blockquote> It was not clear from this article how many top corporate executives have such plans, and whether leaders of other kinds of organizations, like large not-for-profits, also have them. My main concern about such plans is not how much they contribute to top corporate leaders' compensation packages. Such packages are generally already so outrageously huge that providing $40,000 rather than $13,000 worth of health insurance is a trivial increase. My concern is not that plan recipients' demands for health care will collectively increase health care costs, because they include only a tiny portion of the population. My main concern, instead, is how much these plans further insulate already cocooned top executives from the vicissitudes of daily life, particularly related to coping with our current dysfunctional health care system. What benefits executive health care plans provide is not clear, but presumably they insulate executives from having to deal with the managed care/ health insurance bureaucracy which frustrates patients seeking particular services, but not necessarily the most expensive, or least beneficial services. Such executives might thus not have gut level appreciation of how dysfunctional the health care system has become for even insured patients. Since top executives often are disproportionately influential members of the "<a href="http://hcrenewal.blogspot.com/search/label/superclass">superclass</a>," their disconnection from the realities of dysfunctional health care is likely to translate into little real support by the powers that be for meaningful health care reform. There support may be further retarded by the influence of their fellow superclass members whose personal fortunes depend on the status quo in health care. Real improvement of health care may depend on finding leaders who have better understanding of the plight of real people.

Are the Health Plans of the Very Rich Different from Yours and Mine?

Yesterday, the New York Times published an intriguing story about "Cadillac" (that is, expensive) health insurance plans, Goldman...

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Announcing the 10 Days in Google Books game

Which infamous book thief got caught stealing from the Chicago Public Library and was later acquitted on grounds of insanity? How many European cities are mentioned in Karen Fowler's "The Jane Austen Book Club?" And can you figure out what curious objects Dorothy is picking from a tree in this illustration from Frank Baum's "Ozma of Oz?" <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhlYJENkQ3uyj2sjkEScqiSK0eDXcxnf4QD_6NMFB-41ALPnJEK9g958EAZ9nXtWP7JLKK3ULvu-UV8s_lFUqgh7Ksx1Q-YJkgPSgpDf-rxUnl1X4_QV3-Xj3TcuMwaYYd5U7HilIHBw4kK/s1600-h/books1.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5363180930433724594" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhlYJENkQ3uyj2sjkEScqiSK0eDXcxnf4QD_6NMFB-41ALPnJEK9g958EAZ9nXtWP7JLKK3ULvu-UV8s_lFUqgh7Ksx1Q-YJkgPSgpDf-rxUnl1X4_QV3-Xj3TcuMwaYYd5U7HilIHBw4kK/s400/books1.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 289px; height: 400px;" /></a> Stumped? Find the answers to these and other fun questions in the <a href="http://books.google.com/game">10 Days in Google Books game</a>. Each day, we'll ask you five trivia questions on a different theme. Search <a href="http://books.google.com/">Google Books</a> to find the answers with hints to help you along the way. After you answer each day's questions, you can enter a contest to win a Sony Reader. If you enjoy the game, come back the next day for another set of questions — and another chance to win. <a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhobbpw4g8MWdZHFuEvdqL_YpiUA0hiE4Lm75MQAxk4a7RPQX5zsLW4r4vVT6s8df2cNbdYf_w8fjibKC0hfqUlBRxboapvCrTzfVrQbZ905bovvRGB8Gliie8yuch57DxVcnc5CMnsEw5b/s1600-h/Books2.jpg" onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5363181083101871602" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhobbpw4g8MWdZHFuEvdqL_YpiUA0hiE4Lm75MQAxk4a7RPQX5zsLW4r4vVT6s8df2cNbdYf_w8fjibKC0hfqUlBRxboapvCrTzfVrQbZ905bovvRGB8Gliie8yuch57DxVcnc5CMnsEw5b/s400/Books2.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 400px; height: 259px;" /></a> For official rules, including prize descriptions, visit <a href="http://books.google.com/game">http://books.google.com/game</a>. (Please note: Some books may not be available in full view to those outside the United States.) The first 20,000 people to play the game will also receive commemorative Google Books laptop stickers. So all you bookworms out there, <a href="http://books.google.com/googlebooks/game">start playing</a> now! Posted by Hicham Alaoui, Associate Product Marketing Manager, Google Books

Announcing the 10 Days in Google Books game

Which infamous book thief got caught stealing from the Chicago Public Library and was later acquitted on grounds of insanity? How many Europ...

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BLOGSCAN - Reports from the ACRE Meeting

The proceedings at the first meeting of the benignly titled Association of Clinical Researchers and Educators (ACRE) was chronicled on the Carlat Psychiatry Blog <a href="http://carlatpsychiatry.blogspot.com/2009/07/acre-meeting-welcome-to-anger-village.html">here</a>, and on Postscript, the Prescription Project blog <a href="http://blog.prescriptionproject.org/?p=733">here</a>. ACRE, <a href="http://hcrenewal.blogspot.com/2009/07/stossel-and-acre-wheres-beef.html">founded by Dr Thomas Stossel </a>(see relevant post <a href="http://hcrenewal.blogspot.com/2007/04/can-people-with-conflicts-of-interest.html">here</a> on the sorts of arguments Dr Stossel has made), was founded to defend academics who are paid on the side by drug, biotechnology, and device companies from the complaints of the "pharmascolds." What I found most troubling was that the conference was officially opened by Dr Jeffrey Flier, the Dean of the Harvard medical school, implying a medical school endorsement of this group, and featured presentations by the presidents of the American Association of Clinical Endocrinologists, and the American Society of Hypertension, implying endorsement by these medical societies. But also see<a href="http://brodyhooked.blogspot.com/2009/07/carlats-take-on-acre-some-ruminations.html"> the comments </a>by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog that there may be a silver lining to this cloud.

BLOGSCAN - Reports from the ACRE Meeting

The proceedings at the first meeting of the benignly titled Association of Clinical Researchers and Educators (ACRE) was chronicled on the C...

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How "Independent" a Source of Health Care Reform Data?

This week, a Washington Post <a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/07/22/AR2009072203696.html">article</a> discussed who provides the data being cited in the ongoing US debate about health care reform. <blockquote> The political battle over health-care reform is waged largely with numbers, and few number-crunchers have shaped the debate as much as the Lewin Group, a consulting firm whose research has been widely cited by opponents of a public insurance option. To Rep. Eric Cantor (Va.), the House Republican whip, it is 'the nonpartisan Lewin Group.' To Republicans on the House Ways and Means Committee, it is an 'independent research firm.' To Sen. Orrin G. Hatch (Utah), the second-ranking Republican on the pivotal Finance Committee, it is 'well known as one of the most nonpartisan groups in the country.' </blockquote> But how independent is the Lewin group? <blockquote> Generally left unsaid amid all the citations is that the Lewin Group is wholly owned by UnitedHealth Group, one of the nation's largest insurers. More specifically, the Lewin Group is part of Ingenix, a UnitedHealth subsidiary that was accused by the New York attorney general and the American Medical Association of helping insurers shift medical expenses to consumers by distributing skewed data. Ingenix supplied UnitedHealth and other insurers with data that allegedly understated the 'reasonable and customary' doctor fees that insurers use to determine how much they will reimburse consumers for out-of-network care. In January, UnitedHealth agreed to a $50 million settlement with the New York attorney general and a $350 million settlement with the AMA, covering conduct going back as far as 1994. Ingenix's chief executive, Andrew Slavitt, said the company's data was never biased, but Ingenix nonetheless agreed to exit that particular line of business. 'The data didn't have the appearance of independence that's necessary for it to be useful,' Slavitt said. Lewin Group Vice President John Sheils said his firm had nothing to do with the Ingenix reimbursement data. Lewin has gone through 'a terribly difficult adjustment' since it was bought by UnitedHealth in 2007, he said, because the corporate ownership 'does create the appearance of a conflict of interest.' 'It hasn't affected . . . the work we do, and I think people who know me know that I am not a good liar,' Sheils said. </blockquote> Is it only an appearance of conflict, and how objective is the Lewin Group's work? <blockquote> Lewin's clients include the government and groups with a variety of perspectives, including the Commonwealth Fund and the Heritage Foundation. A February report by the firm contained information that could be used to argue for a national system known as single-payer, the approach most threatening to insurers, Sheils noted. But not all of Lewin's reports see the light of day. 'Let's just say, sometimes studies come out that don't show exactly what the client wants to see. And in those instances, they have [the] option to bury the study,' Sheils said. </blockquote> So, in summary, a group providing ostensibly "independent" data and opinions about an important health care policy debate is actually a subsidiary of a commercial managed care organization/ health care insurance company which clearly has vested interests in certain policy options. While the consulting group apparently struggles to be objective, its top leader reported that is fashions its reports at the behest of its clients, and that clients can "bury" reports that offend them, possibly because they do not serve their vested interests. It is not surprising that participants in the current, noisy debate about health care reform, like many other health policy debates, have vested interests, and that their positions are likely to promote these interests. However, what should at least be disturbing is how often those with vested interests try to appear to be disinterested and independent. Should we trust "independent" voices that actually are conflicted, or those who cite "independent" views that actually come from interested parties? By the way, we first posted about the Lewin Group's actual status as an Ingenix, and hence UnitedHealth subsidiary <a href="http://hcrenewal.blogspot.com/2009/01/who-is-warning-us-about-shortage-of.html">here</a> in January, 2009, and first posted about how its contribution to the current health care reform debate was being touted as independent <a href="http://hcrenewal.blogspot.com/2009/04/who-is-warning-us-about-perils-of.html">here</a> in April, 2009. That a news organization with the status of the Washington Post is now picking up this story suggests a little optimism that the <a href="http://hcrenewal.blogspot.com/2007/08/bling-bling-poltical-correctness-and.html">anechoic effect </a>might be weakening.

How "Independent" a Source of Health Care Reform Data?

This week, a Washington Post article discussed who provides the data being cited in the ongoing US debate about health care reform. The pol...

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Physicians Down Under Get Direct About Danger of Bad HIT

Too often, physicians acquiese to demands by hospital executives that they adjust to and use health IT, even if that health IT is flawed. This is despite the fact that liability for patient care resides with the physicians, not the HIT vendor or executives. Several physicians Down Under have had enough: <blockquote><a href="http://www.dailyexaminer.com.au/story/2009/07/23/doctors-issue-a-deadly-warning/">Doctors issue deadly warning</a> Daily Examiner, Grafton, Australia David Bancroft | 23rd July 2009 It seems incredible that a patient record system that aims to improve treatment could kill people [not so incredible to the informed - e.g., see "<a href="http://iig.umit.at/efmi/badinformatics.htm">Bad Informatics Can Kill</a>" - ed.], but that is a claim being made about a new system that is almost certainly going to be introduced into the Grafton Base Hospital next week. Earlier this month, leading health officials from the Lismore Base Hospital wrote to the North Coast Area Health Service (NCAHS) claiming a new Surginet electronic medical record system that had been operating in the hospital for several months would 'inevitably' lead to the death of patients. But the health service said changes had been made to the Surginet electronic medical record (EMR) system since the concerns were raised by the four senior clinicians on July 2, and the system had been operating 'satisfactorily' in Sydney without patient concerns being raised. ["Without concerns raised" does not mean they do not exist - ed.] In their letter to NCAHS chief executive officer Chris Crawford, which was copied to the Minister for Health John Della Bosca, the four medical specialists said there had been recurring problems over several months and 'these have not improved'. “This has resulted in unnecessary compromise of patient safety,” they wrote. “There have been repeated well demonstrated cases of near miss disasters due to these problems. [Will patients be as lucky the next time? - ed.] “We believe that negative patient outcomes, including death, will inevitably result from the continuing use of this system. “Surginet is fundamentally flawed. “New technology should: improve the quality of our work; help us to be more efficient, and; make routine tasks easier. “EMR Surginet does none of these; in fact it has had the opposite effect. “We believe that the Surginet EMR system is unsafe and will result in patient morbidity and mortality.” Surginet was to be implemented at the Grafton Base Hospital yesterday, but after concerns were raised with the area health service, implementation was delayed until next Wednesday. A health service spokesman said the implementation had been delayed so the software producers, Cerner [an American company behind the HIT products that caused difficulty in the UK - see the UK House of Commons report <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm" style="font-weight: bold;">here</a>, esp. points 5 and 6 - ed.], could speak with Grafton surgeons and anaesthetists prior to the implementation about any concerns they may have. “NCAHS takes any concerns raised about patient safety seriously and is addressing these,” the spokesman said. “It should be emphasised that Surginet is operating satisfactorily in Sydney hospitals without patient safety concerns being raised. [Again, that does not mean they do not exist; clinicians may be afraid to speak out and working furiously to establish workarounds to problems - ed.] “It is a system used worldwide that can be adapted to accommodate local work practices in NSW hospitals. ["Can be adapted" - anything "can be adapted". But has this application actually been adapted to the culture in NSW hospitals? - ed.] “Arrangements are being made for discussions to be held with the department heads by representatives of the EMR project team and Cerner.” The spokesman said Surginet had recently been introduced at the Maclean Hospital and there had been no complaints and the NCAHS had actually received a letter of thanks from the hospital. [A letter of thanks from whom at the hospital, exactly, and based on what substantive claims? - ed.] </blockquote> Such discrepancies between one hospital and the next regarding HIT require critical evaluation - erring on the side of patient safety, not IT vendor convenience. Considering the aforementioned UK House of Commons report and the "near miss disasters" mentioned by the Australian physicians, such due diligence is mandatory in my opinion. Further, American physicians can probably learn from these Australian counterparts in being vocal about HIT problems. -- SS

Physicians Down Under Get Direct About Danger of Bad HIT

Too often, physicians acquiese to demands by hospital executives that they adjust to and use health IT, even if that health IT is flawed. T...

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