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RUCing About - Conflicts of Interest Affecting the Members of the RBRVS Update Committee

Since 2007, we have been <a href="http://hcrenewal.blogspot.com/search/label/RUC">writing</a> about the secretive RUC (RBRVS Update Committee), the private AMA committee that somehow has managed to get effective control over how Medicare pays physicians. The RUC has been accused of setting up incentives that strongly favor invasive, high technology procedures while disfavoring primary care and other "cognitive medicine." Despite the central role of (perverse) incentives in raising health care costs while limiting access and degrading quality, there was surprisingly little discussion about the pivotal role played by the RUC until the formation of the "<a href="http://replacetheruc.org/">Replace the RUC</a>" movement (see post <a href="http://hcrenewal.blogspot.com/2011/03/getting-out-of-our-ruc-open-letter-to.html">here</a>).  Recently, the leaders of Replace the RUC scored a journalistic coup by putting the current list of RUC members publicly on-line.  As we have <a href="http://hcrenewal.blogspot.com/2011/02/replace-ruc.html">discussed</a>, previously the membership of this committee was kept very obscure, although the committee argued it was not exactly secret.  Some Google searching suggests one possible reason that the RUC was in no hurry to disclose its own membership.  It appears that many of the RUC members have significant conflicts of interest with respect to their roles as de facto setters of the rates at which physicians are paid by the government. The RUC Members and Their Financial Relationships Below is the list of the current RUC membership (from<a href="http://careandcost.files.wordpress.com/2011/04/ruc-composition.xlsx"> this link</a>), and relevant conflicts of interest obtained by Google searching.  Note that for each member, I first give the name, affiliation relevant to the RUC, location, and first year of membership as provided by the link above.  Then I list relevant financial relationships that appear to present conflicts of interest. - Barbara Levy, MD Chair, RVS Update Committee Federal Way, WA 2000 Consultant/Advisory Boards: Conceptus; AMS; Covidien; Halt Medical; Gynesonics; Idoman Medical (hysteroscopic surgery and sterilization, endometrial ablation, electrosurgery, vaginal hysterectomy) per <a href="http://www.uptodate.com/contents/obstetrics-gynecology-and-womens-health/peer-reviewers?topicId=226">UptoDate</a> - Bibb Allen, Jr., MD American College of Radiology (ACR) Birmingham, AL 2006 - Michael D. Bishop, MD American College of Emergency Physicians (ACEP) Bloomington, IN 2003 - James Blankenship, MD American College of Cardiology (ACC) Danville, PA 2000 Lecture fees from Sanofi-Aventis per <a href="http://www.nejm.org/doi/full/10.1056/nejmoa0802944#t=article">New England Journal of Medicine</a> - Robert Dale Blasier, MD American Academy of Orthopaedic Surgeons (AAOS) Little Rock, AK 2008 - Joel Bradley, MD American Academy of Pediatrics (AAP) Brentwood, TN 2008 Medical Director, Americhoice by UnitedHealthcare, per <a href="http://www.acopeds.org/meetings/2009fop/2009FoP.pdf">AAP conference brochure</a> - Ronald Burd, MD American Psychiatric Association (APA) Fargo, ND 2006 - William F. Gee, MD American Urological Association (AUA) Lexington, KY 2010 Member, Physician Advisory Board, Aetna <a href="http://www.aetna.com/about-aetna-insurance/initiatives/physician-advisory-board/physician-advisory-current-board-members.html">per Aetna</a> - John O. Gage, MD American College of Surgeons (ACS) Pensacola, FL 1991 - David F. Hitzeman, DO American Osteopathic Association (AOA) Tulsa, OK 1996 - Peter A. Hollmann, MD CPT Editorial Panel (AMA/CPT) Providence, RI 2003 Medical Director, Blue Cross and Blue Shield of Rhode Island, per <a href="http://www.rimed.org/bio-hollmann.asp">RI Medical Society</a> - Charles F. Koopmann, Jr., MD American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) Ann Arbor, MI 1996 - Robert Kossmann, MD Renal Physicians Association (RPA) Santa Fe, NM 2009 Member of Advanced Renal Technologies Advisory Board, Network 15 Medical Advisory Board, Baxter Home Dialysis Advisory Board, Fresenius Medical Advisory Board per <a href="http://www.renalmd.org/page.aspx?id=1408">Renal Physicians Association</a> - Walter Larimore, MD American Academy of Family Physicians (AAFP) Colorado Springs, CO 2009 - Brenda Lewis, DO American Society of Anesthesiologists (ASA) Cleveland, OH 2009 - J. Leonard Lichtenfeld, MD American College of Physicians (ACP) Atlanta, GA 1994 Member, Physician Advisory Board, Aetna per <a href="http://www.aetna.com/about-aetna-insurance/initiatives/physician-advisory-board/physician-advisory-current-board-members.html">Aetna </a> - Scott Manaker, MD, PhD American College of Chest Physicians (ACCP) Philadelphia, PA 2010 Consultant to Pfizer and Johnson and Johnson. Owns stock in Neose Technologies, Pfizer, Johnson & Johnson, and Rohm and Haas per <a href="http://chestjournal.chestpubs.org/content/134/4/680.full.pdf">Chest</a> - Bill Moran, MD Practice Expense Review Committee Oklahoma City, OK 2000 - Guy Orangio, MD American Society of Colon & Rectal Surgeons (ASCRS) Atlanta, GA 2009 - Gregory Przybylski, MD American Association of Neurological Surgeons (AANS) Edison, NJ 2001 Stock Ownership: United Healthcare (300 shares);  ...  Scientific Advisory Board: United Health Group (B, Spine Advisory Board) per <a href="http://www.nassannualmeeting.org/Documents/AM11_Prelim.pdf">NASS meeting</a> - Marc Raphaelson, MD American Academy of Neurology (AAN) Leesburg, VA 2009 personal compensation for activities with Jazz Pharmaceuticals and Medtronics as a speakers bureau member or consultant per <a href="http://www.marathonmultimedia.com/store/products_pdfs/disclosures/aan10/1FC.001.pdf">AAN</a> - Sandra Reed, MD American College of Obstetricians and Gynecologists (ACOG) Thomasville, GA 2009 GlaxoSmithKline Consulting, $1750 in 2009, $1500 in 2010 per ProPublica Dollars for Docs search through <a href="http://projects.propublica.org/docdollars/">here</a> - Daniel Mark Siegel, MD American Academy of Dermatology (AAD) Brooklyn, NY 2003 Vivacare Dermatology Advisory Board, 2006 – present. Photomedex Scientific Advisory Board, 2006-present, Ad Hoc consultant to ClickDiagnostics, per<a href="http://www.encite.us/pdf/dansiegel_cv.pdf"> Encite CV</a> DermFirst-Shareholder, Logical Image – Consultant, Vivacare - Consultant per <a href="http://www.mohssurgery.org/files/conf/papers/2009%20ACS%20Physician%20Session/SIEGEL-EHR%202014%20is%20Closer%20Than%20You%20Think.pdf">MOHS Surgery</a> - Lloyd S. Smith, DPM Health Care Professionals Advisory Committee Bethesda, MD 2007 - Peter Smith, MD Society of Thoracic Surgeons (STS) Durham, NC 2006 Eli Lilly, Consulting, $1500 in 2009, $1990 in 2010 per Pro Publica Dollars for Docs search through <a href="http://projects.propublica.org/docdollars/">here</a> Advisor or consultant to Bayer per <a href="http://www.medscape.org/viewprogram/7877">Medscape</a> - Susan Spires, MD College of American Pathologists (CAP) Lexington, KY 2007 - Arthur Traugott, MD American Medical Association (AMA) Champaign, IL 2006 - James Waldorf, MD American Society of Plastic Surgeons (ASPS) Jacksonville, FL 2008 - George Williams, MD American Academy of Ophthalmology (AAO) Royal Oak, MI 2009 Advisory Team, <a href="http://www.retro-sense.com/advisors.html">RetroSense Therapeutics</a> Shareholder and consultant for ThromboGenics Ltd. and holds intellectual property on the use of plasmin per <a href="http://www.revophth.com/content/d/retinal_insider/c/26258/">Review of Opthamology</a> Alcon Laboratories, consultant, lecturer; Allergan, consultant, lecturer; Macusight, consultant, equity owner; Neurotech, consultant; Nu-Vue Technologies, equity owner, patent/ royalties; OMIC- Ophthalmic Mutual Insurance Company, employee; Optimedica, consultant, equity owner; Thrombogenics, consultant, equity owner per <a href="http://www.aao.org/meetings/annual_meeting/subspecialty/upload/09-Financial-Disclosures-Subspecialty-Day.pdf">AAO meeting</a> Pfizer, “Professional Advising,” $5534 in 2009 per Pro Publica Dollars for Docs search through <a href="http://projects.propublica.org/docdollars/">here</a> Summary There you have it.  A substantial proportion, almost half, 14 of 29 members of the RUC have financial relationships with pharmaceutical companies, biotechnology companies, device companies, companies that directly provide health care, and health care insurance companies.  As we have noted in our <a href="http://hcrenewal.blogspot.com/search/label/RUC">previous discussions</a> of the RUC, that committee has been accused of being the de facto controller of how the US government pays physicians.  In that role, it has been accused of favoring procedural care rather than cognitive or primary care by increasing the relative financial incentives for the former over the latter.  This may be one of the most important reasons for the expensive, high-technology, procedural-heavy style of care in the US, which has likely been a major driver for increasing costs, declining access and stagnant quality. It seemed obvious that a committee dominated by a majority of physicians who perform procedures would tend to favor bigger financial incentives for procedures.  But now it appears the committee also includes a substantial number of people who work part-time or have ownership interests in companies that also stand to benefit from increasing use of procedures.  Procedures drive increased consumption of drugs, supplies and devices, and lead to larger revenue for hospitals and clinics.  Thus these financial relationships could reasonably be suspected of even further distorting the committee's decision-making in favor of procedures. I was surprised how many RUC members have financial ties to health care insurance companies.  Such companies are not usually thought of as beneficiaries of high-technology, procedural care.  However, if one conceives of their revenue as a percentage of health care costs, perhaps they are.  Furthermore, one can only wonder if the links between the RUC and health care insurance companies have anything to do with how such companies have apparently unquestioningly adapted the RBRVS system controlled by the RUC? The prevalence of conflicts of interest among RUC members highlight the need for a more accountable, transparent and honest system to manage how the government pays physicians, and a need for more transparency and accountability in the relationship among the government, health care insurance, and physicians.  As we have previously <a href="http://hcrenewal.blogspot.com/2011/02/replace-ruc.html">noted</a>,  there are still many unanswered questions about the RUC: - How did the government come to fix the payments physicians receive? Government price-fixing has not been popular in the US, yet this has caused no outcry. - Why is the process by which they are fixed allowed to be so opaque and unaccountable? Why are there no public hearings on the updates, and why is there no input from practicing physicians or organizations other than those related to the RUC? - How did the RUC become de facto in charge of this process? - Why does the AMA [keep the membership of the RUC so opaque, and] give no input into the RUC process to its general membership? - Why is the RUC membership so dominated by procedural specialists? Why were primary care physicians, who made up at least a sizable minority of physicians when the update process was started, not represented according to their numbers? - Why has there been so little discussion of the RUC and its responsibility for an extremely expensive health care system dominated by high-technology, expensive, risky and invasive procedures? Stay tuned, maybe these will be answered in our life-times....

RUCing About - Conflicts of Interest Affecting the Members of the RBRVS Update Committee

Since 2007, we have been writing about the secretive RUC (RBRVS Update Committee), the private AMA committee that somehow has managed to ge...

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Will a Pharmaceutical CEO Finally Be Held Accountable for Misbehavior on His Watch?

It appears there may be a move afoot to have the leader of a large health organization suffer some negative consequences for the misbehavior of his organization.  As <a href="http://www.stltoday.com/business/local/article_7625e006-112f-57e2-a4ca-d8ee57474b2a.html">reported</a> by the St Louis Post-Dispatch, <blockquote>For the past 34 years, Howard Solomon has presided over Forest Laboratories Inc., a midsize pharmaceutical company that runs its national sales operations from Earth City. Solomon, 83, took home $8.3 million last year as the company's chairman, president and chief executive officer. But his company's marketing arm also fell into trouble, pleading guilty to federal charges that its sales force illegally marketed the antidepressants Celexa and Lexapro to children and adolescents, even though these drugs had not been approved for minors. Now, the federal Department of Health and Human Services is attempting to oust Solomon from his job. According to the company, the agency's Office of Inspector General advised Solomon, a Yale Law School alum, last week that it planned to exclude him from doing any business with federal Medicare and Medicaid programs. The move — similar to the government's exclusion of KV Pharmaceutical's former chairman, Marc Hermelin — is part of a new effort by regulators to use this enforcement tactic to root out 'untrustworthy individuals' who knew or should have known that health care fraud was being committed on their watch.</blockquote> This appears to be big news. As we have discussed ad infinitum, there has been a parade of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> by large health care organizations of charges of various kinds of wrong-doing. Some of these settlements have involved apparently large monetary penalties. However, the settlements have almost never been accompanied by any negative consequences for the people who authorized, directed or implemented the bad behavior. The concern all along has been that monetary settlements may just be regarded as a cost of doing business, and as long as misbehavior is lucrative, such settlements have no deterrent effect. In fact, the current practice seemed to grant impunity to corporate leaders. Actually barring a corporate executive from Medicare, which could result in the collapse of his company were he or she not to resign, would be a significant step towards accountability. Note that the St Louis Post-Dispatch article documented the rarity of imposing any negative consequences on corporate health care executives: <blockquote>Prosecutors have long been criticized for seldom filing charges against individuals associated with drug companies that are convicted of criminal conduct. Huge fines in recent years against Pfizer Inc. and Eli Lilly & Co., for example, did not stop their chief executives from continuing in their jobs.</blockquote> Also, <blockquote>Solomon, who joined the company in 1977, would become the second drug company executive barred from doing business with federal health care programs under a specific provision of the law that authorizes the exclusion of individuals who have not been convicted of a crime. In October, the agency's Office of Inspector General posted 'guidance' saying that, when there is evidence that an owner/operator or company officer "knew or should have known" of his organization's criminal conduct, the agency 'will operate with a presumption in favor of exclusion.' Hermelin, an owner/operator of KV Pharmaceutical, was excluded in November from federal health care programs for 20 years — and stepped down from the company's board of directors. He pleaded guilty last month to two criminal misdemeanors connected with his firm's shipment of oversized morphine tablets, and was sentenced to 30 days in the County Jail. In addition, three executives of the Connecticut-based pharmaceutical company Pardue Frederick were excluded for 15 years from federal health programs under a different provision of the law, after their guilty pleas in 2007 in connection with the misbranding of the painkiller OxyContin.</blockquote>Meanwhile, it seems that health care corporate CEOs can find academics who will defend their actions no matter what.  It was instructive to see one such defense of Solomon described in the Post-Dispatch article: <blockquote>Jackson Nickerson, a professor of organization and strategy at Washington University's Olin Business School, said the agency's 'underlying model' for exclusion appeared to be an example of over-regulation. 'It's predicated on the assumption that if a company has done something wrong, it must mean the senior executives have done something wrong,' he said. 'You are branded as being unethical if a subordinate makes a decision that turns out to be a bad one.' Nickerson said that to encourage innovation, company executives needed to delegate certain responsibilities to employees lower down in the organization. 'The dilemma is, how do you engage in global competition and decentralize, while at the same time be held accountable as an individual leader?'</blockquote> It does seem that it would be hard for top corporate executives to keep their eyes on the actions of all subordinates. On the other hand, it also seems that top corporate executives have justified their out-sized compensation by taking personal credit for everything good that happens to their organizations. If they want such credit, why should they escape responsibility when some actions go wrong? Note that Prof Nickerson played the "innovation" card. A common justification for many corporate health care practices is that they enable innovation. This argument is thrown around so often I begin to suspect it comes from corporate public relations' talking points. (See <a href="http://hcrenewal.blogspot.com/2011/02/health-care-corporate-disinformation.html">this post</a> about the development of such talking points.) Of course, the more a corporation is truly decentralized to support innovation, the less it can argue that the top executives deserve huge salaries because of their close involvement in everything that goes on at that corporation. Furthermore, while Forest Laboratories' previous marketing practices might have been innovative, that did not make them ethical. As we noted in an <a href="http://hcrenewal.blogspot.com/2010/09/forest-pharmaceuticals-pleads-guilty-to.html">earlier post</a>, the company was accused of marketing anti-depressants to children when they had only previously been approved for adults. Their marketing tactics allegedly included suppressing negative studies, and paying physicians to prescribe the drugs. The company pleaded guilty to obstruction of justice for lying to the FDA during a plant inspection, and to misdemeanor charges of misbranding and distributing an unapproved drug contrary to an FDA directive. In addition, an <a href="http://hcrenewal.blogspot.com/2009/09/lexapro-marketing-plan-was-meant-to.html">earlier post </a>summarized memos made public by a congressional investigation about Forest Laboratories' marketing of Lexapro. These included coopting medical education, "key opinion leaders," and medical associations for marketing purposes: - The marketing plan from the marketing department paid for medical education as a "promotional objective," that is, to market, not to educate. - Thought leaders and consultants were again paid by marketing to market, and sometimes to provide opinions about "promotional strategies" and "commercial development." - Medical associations are funded by marketing "for commercial and policy activities." So the facts in the Forest Laboratories case make protests that holding corporate leaders accountable for misbehavior on their watches will stifle innovation seem disingenuous. Furthermore, it makes no sense to pay top corporate leaders outrageous amounts for everything good that happens on their watch without similarly holding them accountable for everything bad that happens then. If the US government is really going to hold one corporate leader responsible for misbehavior by his subordinates on his watch, that would be a step forward.  As we have said again and again, we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

Will a Pharmaceutical CEO Finally Be Held Accountable for Misbehavior on His Watch?

It appears there may be a move afoot to have the leader of a large health organization suffer some negative consequences for the misbehavior...

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Henry Ford Health System Decides Meaningful Use Not That Meaningful

The CMIO for inpatient services for Henry Ford Health System discusses the Michigan system's decision to hold off on applying for meaningful use funding in 2011, and what that means for its long-term vision of connecting clinical goals with IT support. April 15, 2011. Podcast running time: 3:58 (<a href="http://www.hhnmag.com/hhnmag/HHNDaily/HHNDailyDisplay.dhtml?id=4620008509">link to podcast</a>).Excerpts: <blockquote>“The clinician experience of delivering care has never been more complicated. Implementation and adoption of these Electronic Health Records seems to be to many people an end in itself—and that’s unfortunate. The implementation and adoption of EHR is a means to an end and one of those ends is better patient care and another one is clinician efficiency or better and more effective care. And that part feels to me that it gets lower priority and gets overlooked for the sake of adoption and implementation especially now with the federal requirements coming on. Now we must adopt, adopt, adopt. And the clinician experience is left behind. The complexity of being a physician is almost overwhelming both in the hospital and clinic setting and that’s one of my great concerns.”</blockquote> - John Frownfelter, MD CMIO, Henry Ford Health System Health IT in its present <a href="http://www.tinyurl.com/hostileuserexper">poorly usable form</a> only makes being a clinician more overwhelming. As I wrote at "<a href="http://hcrenewal.blogspot.com/2010/07/meaningful-use-final-rule-have.html">Meaningful Use Final Rule</a>", meaningful use initiatives before "meaningful usability" has been achieved have put the cart before the horse. Henry Ford, inventor of the assembly line, would probably have approved. An assembly line is appropriate for building identical widgets, but inappropriate for the implementation of health IT in the <a href="http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf">extremely </a><a href="http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf"> complex, poorly bounded, conflicted, highly variable, uncertain, high-tempo work domain</a> of hospitals, especially if the implementation is just for implementation's sake. -- SS

Henry Ford Health System Decides Meaningful Use Not That Meaningful

The CMIO for inpatient services for Henry Ford Health System discusses the Michigan system's decision to hold off on applying for meani...

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Abbott Laboratories Settles, Again

In 2007, we <a href="http://hcrenewal.blogspot.com/2007/01/suits-win-again-how-big-bad-greedy.html">discussed</a> a scheme that Abbott Laboratories seemed to be using to boost the price of Kaletra, a combination of two protease inhibitors it markets to treat HIV and AIDS. Kaletra is a combination of rinoavir (Norvir, sold by Abbott as a single drug), and leponavir. Kaletra was apparently losing sales to the combination of Norvir with Reyataz (atazanavir), made by Bristol-Myers-Squibb. So Abbott increased the price of Norvir by 400%. As <a href="http://www.businessweek.com/news/2011-04-15/abbott-agrees-to-pay-52-million-to-resolve-aids-drug-case.html">reported</a> so far only by Bloomberg, Abbott just settled a class-action lawsuit alleging that its price hike for Norvir was anti-competitive. <blockquote>Abbott Laboratories agreed to pay $52 million to resolve claims by direct drug buyers that it tried to harm competition when it quadrupled the price of its HIV medicine Norvir in 2003. The settlement, which is subject to court approval, would resolve a class-action lawsuit filed on behalf of Abbott customers that purchased Norvir, a boosting agent for other HIV drugs, and a second medicine Kaletra, which includes Norvir, according to an April 8 filing in federal court in Oakland, California. Abbott denied wrongdoing, according to the accord. Abbott increased the wholesale price of a Norvir capsule containing 100 milligrams to $8.57 from $1.71, the Abbott Park, Illinois-based company said in court documents. GlaxoSmithKline Plc and drug retailers and distributors sued, claiming other drugmakers that used Norvir in their medicines couldn’t compete on price with Kaletra, and the price increase penalized drug customers that wanted to buy medicines that competed with Kaletra.</blockquote> Note that, as we discussed <a href="http://hcrenewal.blogspot.com/2010/12/abbott-laboratories-and-pig-roasts.html">here</a>, this is the third significant settlement by Abbott in the last six months. In December, 2010, the company settled claims that it defrauded Medicare and Medicaid for $421 million, and claims that a subsidiary paid kickbacks to doctors to sell its products for $41 million. For other discussion of Abbott's recent misbehavior, look <a href="http://hcrenewal.blogspot.com/search/label/Abbott">here</a>. So while we were discussing other issues, the parade of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> continued. It is beginning to seem like every major pharmaceutical/ device/ and biotechnology company has settled or pleaded guilty to multiple allegations of significantly bad behavior in the last few years. This suggests how bad the leadership of most of these companies has become. Nonetheless, in the current case, like nearly all others, the penalties were paid by the companies themselves, not the people who authorized, directed or implemented the bad behavior. We and others have commented repeatedly that the resulting relative impunity of leaders of health care organizations will hardly deter future bad behavior. (Note that this impunity seems similar to that employed by leaders of finance after the global financial collapse/ Great Recession.) Not only do the leaders not pay penalties, but they continue to become hugely rich at the expense of their companies. For example, Abbott CEO Miles D White enjoyed total compensation of $25,564,283 in 2010, down only slightly from the 26,213,996 he received in 2009, according to the 2011 Abbott proxy statement (available <a href="http://www.abbottinvestor.com/phoenix.zhtml?c=94004&p=irol-sec">here</a>). Threats by government officials to start to employ the "Responsible Corporate Officer Doctrine," (available since 1943) to hold individuals accountable for health care organizations' misdeeds so far appear to be empty (see <a href="http://hcrenewal.blogspot.com/2010/06/attempt-to-hold-health-care-leaders.html">this post</a>). So to repeat Cassandra-like,  we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

Abbott Laboratories Settles, Again

In 2007, we discussed a scheme that Abbott Laboratories seemed to be using to boost the price of Kaletra, a combination of two protease inh...

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Khadafy's Academic Mercenaries' Health Care Connections

We just <a href="http://hcrenewal.blogspot.com/2011/04/henry-kissinger-icelands-promoter.html">discussed</a> Henry Kissinger as an early example of the intellectual mercenary, and recent striking examples of academic mercenaries,particularly the Harvard University-derived Monitor Group's academically disguised public relations work for Libyan tyrant Moammar Khadafy. We concluded that academic mercenaries help foster the corporate culture in which health care is now immersed.  However, it also appears they may have direct influence on health care.  Monitor Group Leadership Consider for example the main figure in the Monitor Group - Khadafy scandal.  According to a Boston Globe <a href="http://articles.boston.com/2011-03-04/news/29342456_1_moammar-khadafy-libyan-government-consulting">article</a>, Michael Porter developed the Monitor-Khadafy connection: <blockquote>Monitor’s work in Libya began when Michael Porter, a Harvard Business School professor who is among the country’s top theorists on management strategies, received a call from Saif Khadafy around 2001, according to Porter. Saif, a Western-leaning doctoral student who US officials hoped would become the next leader of Libya, asked for his expertise to help change Libya’s battered, Soviet-style economy.</blockquote>(Saif, of course, later sided with his father in brutally putting down anti-government protesters.) According to <a href="http://drfd.hbs.edu/fit/public/facultyInfo.do?facInfo=bio&facEmId=mporter">his official Harvard biography</a>, Michael Porter also has a big interest in health care: <blockquote>Since 2001, Professor Porter has devoted considerable attention to competition in the health care system, with a focus on improving health care delivery. His work with Professor Elizabeth Teisberg, including the book Redefining Health Care: Creating Value-Based Competition on Results (Harvard Business School Press, 2006), is influencing thinking and practice not only in the United States but numerous other countries.</blockquote>In fact, the New England Journal of Medicine published his four-page commentary on "value-based" health care reform in 2009 [Porter ME. A strategy for health care reform - toward a value-based system. N Engl J Med 2009; 361: 109-112. Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMp0904131">here</a>.] The journal required that he disclose financial relationships with other health care organizations, including <blockquote>receiving lecture fees from the American Surgical Association, the American Medical Group Association, the World Health Care Congress, Hoag Hospital, and the Children's Hospital of Philadelphia, receiving director's fees from Thermo Fisher Scientific, and having an equity interest in Thermo Fisher Scientific, Genzyme, Zoll Medical, Merck, and Pfizer.</blockquote>The Boston Globe <a href="http://articles.boston.com/2011-03-04/news/29342456_1_moammar-khadafy-libyan-government-consulting">article</a> identified two more Monitor leaders who helped develop the Libyan connection: <blockquote>Porter brought in Monitor, a firm he had helped found, along with other associates including former Harvard professors Mark Fuller, who is now the firm’s chairman, and Joseph Fuller, who works at Monitor and also collaborates on research with some Harvard professors. </blockquote> Mark Fuller, the current CEO of the Monitor Group, who wrote to the Libyan government proposing to counter its "deficit of positive public relations" as <a href="http://motherjones.com/politics/2011/03/libya-qaddafi-monitor-group">described</a> by Mother Jones, per the New Profit Inc <a href="http://newprofit.com/cgi-bin/iowa/about/summary/41.html">web-site</a> is: <blockquote>a Member of Harvard University's Major Gifts Steering Committee, a Member of the [Harvard] Board of Overseers' Committee on University Resources,...</blockquote>Joseph Fuller was an unsuccesful candidate for the Harvard Board of Overseers in 2010. His <a href="http://www.harvard.edu/alumni/candidates_overseers.php">biography</a> for that candidacy also stated: <blockquote>He and his wife, Ruthanne Schwartz Fuller, MBA ’83, served on the HBS Board of Dean’s Advisors and Joe on the Harvard College Fund and the FAS Undergraduate Education Planning Committee.</blockquote> So of the three Monitor Group leaders who developed the stealth public relations campaign for Khadafy, the leader who set up the relationship with Libya has a professed interest in health care, published on health policy in a prominent journal, and has financial ties to multiple health care organizations. The two others have leadership roles within their own university which are likely to affect its medical and health care spheres Monitor's Hired Academics Furthermore, of the seven outside academics the Monitor Group paid to help promote the Khadafy regime per the Mother Jones <a href="http://motherjones.com/politics/2011/03/libya-qaddafi-monitor-group">article</a>, three had health care connections.  Richard Perle is on the <a href="http://www.newhealthsciences.com/Board.aspx">board of directors </a>of New Health Sciences Inc, a biotechnology company. In 2008, Francis Fukuyama was <a href="http://www.rand.org/news/press/2008/04/07.html">elected</a> a member of the Board of Trustees of the Rand Corporation, which does substantial health care research. Benjamin Barber's <a href="http://www.benjaminbarber.com/bio4.html">own biography </a>claims he has been on the National Advisory Board of American Health Decision Inc since 1992. Summary As we noted before, severe problems with the leadership and governance of health care seem not to be only due to specific deficiencies within health care, but may also be influenced by larger societal problems.  The leadership of many organizations seems to have been given over to self-serving opportunists with no fixed values or loyalties. David Halberstam described Henry Kissinger as a prototype of these "wildly ambitious agents of opportunity," also as: <blockquote>the free agent—the professional political player who brilliantly manipulated the press, played both sides of issues, and put his own agenda ahead of all others. </blockquote> We <a href="http://hcrenewal.blogspot.com/2011/04/henry-kissinger-icelands-promoter.html">discussed</a> examples of such free agents who cloaked themselves in the mantles of two formerly prestigious academic institutions, Columbia and Harvard Universities. Both universities have medical schools, teaching hospitals, and considerable influence within medicine and health care. So it seems likely that the free agency of faculty outside of medicine and health care could influence how things are done within medicine and health care. Furthermore, we have demonstrated that many free agents whose focus may not primarily be on health care and medicine may have wide-ranging activities including some that directly affect medicine and health care. The pervasive nature of free agents, or agents of opportunity within academia, government, and the rest of society shows why it has been so hard to challenge the threats to core values created by conflicts of interest in medicine and health care. The conflicted already hold much of the power within the larger society in which medicine and health care operate. They are unlikely to favor restrictions on their brother and sister free agents within the medical and health care sector. So our effort to address concentration and abuse of power in health care, and promote accountability, integrity, honesty, and ethics in health care leadership and governance must necessarily take into account these issues in society at large. The bad news is that the problems are much bigger than we first imagined. The good news is that we have potential allies facing similar problems throughout the world. But it is now really clear that to truly reform health care, we must improve the accountability, integrity, honesty and ethics of not only health care leadership and governance, but of all organizational leadership and governance. That should keep us busy for a while.

Khadafy's Academic Mercenaries' Health Care Connections

We just discussed Henry Kissinger as an early example of the intellectual mercenary, and recent striking examples of academic mercenaries,p...

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Henry Kissinger, Iceland's Promoter, Khadafy's Apologists, and the Rise of the Academic Mercenary

In which we discuss how medical academic mercenaries (like the key opinion leaders paid to promote drugs and devices cloaked in their academic and professional credentials) now appear to be just part of a larger problem. Henry Kissinger Almost 17 years ago, an article by David Halberstam in Vanity Fair(1) should have warned us of the rise of the academic and intellectual mercenary.  However, back in those go-go years of the new gilded age, most of us were not listening.  Halberstam focused on Henry Kissinger, once a protege of New York Governor and then US Vice President Nelson Rockefeller, who became the infamous President Nixon's National Security Advisor, then Secretary of State: <blockquote>Kissinger’s capacity to be all things to all campaigns—an overt Rockefeller man, a semi-overt Humphrey man, and a covert Nixon man—reflects the emergence of the rootless operator in the modern superstate. Kissinger was the first—though there were others to follow—of the wildly ambitious agents of opportunity set loose in the wilds of Washington and other capitals. They are interchangeable men, singular in their ambitions, unhampered by traditional loyalties or affiliations. They are men so cool and detached in their geopolitical views that they sometimes seem to be part of a new international elite, readily transferable to the governments of allies and adversaries alike.</blockquote> Two recent dramatic stories show how prevalent academic mercenaries, another breed of "rootless operators," or "wildly ambitious agents of opportunity," have become. Promoting Iceland: Columbia Professors' "Inside Job" The Academy Award winning documentary film, <a href="http://www.sonyclassics.com/insidejob/">"Inside Job," </a>suggested that one cause of the Great Recession was the wrong-headed deregulation of the financial industry deceptively promoted by academics who failed to disclose they were being paid by those who stood to benefit from deregulation.  (See our post <a href="http://hcrenewal.blogspot.com/2010/10/what-conflicted-web-we-weave-academic.html">here</a>.) Reconsideration of the roles of two of the academics cited in the film who are faculty at Columbia University shed more light on how public policy was influenced by academics hired to do public relations. The Columbia Spectator just published a three- part series on the local controversy with global implications. At least a few Columbia faculty realized that it did not look good for their colleagues to do public relations while pretending they were delivering disinterested academic opinions: <blockquote>[Columbia Economics Department Chair Michael] Riordan added that it is important that Columbia protect its reputation and the public’s trust in its professors’ expert opinions. 'What does the university stand for but if not for the quality of the ideas that come out of that university?' he asked. (2)</blockquote> Also, <blockquote>Teachers College professor Kathleen O’Connell ... called the film 'appalling' and said that 'the Columbia professors were even more appalling.' She said she was especially surprised considering Hubbard and Mishkin have both had high-ranking government jobs—Hubbard was at one time a top economic adviser to former President George W. Bush, and Mishkin was a governor of the Federal Reserve. 'I was shocked at the lack of ethics that they displayed. They are in really powerful positions—they have been in powerful positions in the Federal Reserve and the President’s economic advisors,' O’Connell said.(3)</blockquote> However, there was much resistance to change. Just as we have seen in arguments about <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> affecting medical faculty, there were those who denied that being paid to consult could affect any faculty member's thinking about the source of the payment: <blockquote>But some, including Business School professor and University Senator Frank Lichtenberg, oppose the disclosure of consulting to the University. Lichtenberg said that many factors besides money can influence professors’ academic opinions. 'There are lots of other sources of bias and non-neutrality in academia anyway,' Lichtenberg said. 'People often have predispositions for or against different hypotheses, and unfortunately, those sometimes prevail.' Some professors question whether paid consulting positions influence researchers at all. Business School professor Bruce Greenwald said that the economists featured in 'Inside Job' have 'long espoused and long promoted' pro-market ideas and would have made the same arguments regardless of financial ties.(4)</blockquote> So we have economists denying the effect of economic incentives? Beyond that, there were arguments that public disclosure of conflicts of interest would violate faculty members' privacy. <blockquote>But full public disclosure is not likely to gain much traction in the debate over a University-wide policy. Steele said that it is not necessary to publicly release disclosures made privately to University officials. 'I don’t think that the public needs to have access to forms that people fill out and all the materials that go into that,' [Provost Paul] Steele said. 'That would be onerous at least, and there might be other objections … that you are invading people’s sense of privacy and freedom.'(2)</blockquote>I suppose that would have made some sense if the faculty member had not made any public pronouncements that could have been influenced by the undisclosed conflicts. However, the contention in "Inside Job" was that conflicted academic economists publicly advocated on behalf of their undisclosed clients. For example, <blockquote>In 2006, the Iceland Chamber of Commerce paid Columbia Business School professor Frederic Mishkin $134,858 to co-author a report on Iceland’s economy and banking systems. In the report, titled 'Financial Stability in Iceland,' Mishkin painted a bright picture of the country’s economic future, but he did not disclose who was paying him to write it. 'Although Iceland’s economy does have imbalances that will eventually be reversed, financial fragility is not high and the likelihood of a financial meltdown is very low,' Mishkin wrote. Two years later, Iceland’s economy collapsed. Its major banks failed, its currency lost much of its value, and thousands of its citizens lost their jobs. The New York Times wrote at the time that, to Icelanders, 'the collapse came so fast it seemed unreal, impossible.'(2) </blockquote> Harvard Professors' Paid Apologia for Moammar Khadafy Praising Iceland's economy was one thing. Praising brutal Libyan leader Moammar Khadafy as democratic was another. In March, 2011, Mother Jones disclosed(5) how a consulting group run by Harvard professors was hired in part to burnish the image of Moammar Khadafy, who since has ordered brutal attacks on protesters within his country. <blockquote>In February 2007 Harvard professor Joseph Nye Jr., who developed the concept of "soft power,' visited Libya and sipped tea for three hours with Muammar Qad'afi. Months later, he penned an elegant description of the chat for The New Republic, reporting that Qaddafi had been interested in discussing 'direct democracy.' Nye noted that 'there is no doubt that' the Libyan autocrat 'acts differently on the world stage today than he did in decades past. And the fact that he took so much time to discuss ideas—including soft power—with a visiting professor suggests that he is actively seeking a new strategy.' The article struck a hopeful tone: that there was a new Qaddafi. It also noted that Nye had gone to Libya 'at the invitation of the Monitor Group, a consulting company that is helping Libya open itself to the global economy.' Nye did not disclose all. He had actually traveled to Tripoli as a paid consultant of the Monitor Group (a relationship he disclosed in an email to Mother Jones), and the firm was working under a $3 million-per-year contract with Libya. Monitor, a Boston-based consulting firm with ties to the Harvard Business School, had been retained, according to internal documents obtained by a Libyan dissident group, not to promote economic development, but 'to enhance the profile of Libya and Muammar Qadhafi.' So The New Republic published an article sympathetic to Qaddafi that had been written by a prominent American intellectual paid by a firm that was being compensated by Libya to burnish the dictator's image.</blockquote> Monitor also sponsored trips to Libya for scholars from other universities who also later wrote positively about Khadafy's and his reign over Libya, presumably after they had received their large consulting fees. The Boston Globe reported(6) in more detail about a proposal by Monitor to write a laudatory book about Khadafy: <blockquote>It reads like Libyan government propaganda, extolling the importance of Moammar Khadafy, his theories on democracy, and his 'core ideas on individual freedom.' But the 22-page proposal for a book on Khadafy was written by Monitor Group, a Cambridge-based consultant firm founded by Harvard professors. The management consulting firm received $250,000 a month from the Libyan government from 2006 to 2008 for a wide range of services, including writing the book proposal, bringing prominent academics to Libya to meet Khadafy 'to enhance international appreciation of Libya' and trying to generate positive news coverage of the country.</blockquote> As further documented in the Globe article, it was very clear that Monitor was paid not just to provide consultation, but to do public relations work on behalf of the Khadafy regime. Yet an article in the Nation(7) made it clear that the prominent academics it hired did not disclose who paid them, or the purposes of those payments: <blockquote>Joseph Nye of Harvard’s Kennedy School wrote in The New Republic in 2007 that Muammar Qaddafi was interested in discussing 'direct democracy.' Anthony Giddens of the London School of Economics wrote in the Guardian the same year that Libya under Qaddafi could become 'the Norway of North Africa.' Benjamin Barber of Rutgers University wrote in the Washington Post, also in 2007, that Libya under Qaddafi could become 'the first Arab state to transition peacefully and without overt Western intervention to a stable, non-autocratic government. Great minds think alike? Actually, no: all were being paid by Libyan money, under a $3 million per year contract with a consulting group which promised to 'enhance the profile of Libya and Muammar Quadhafi' in Britain and the US. One more thing: none of them said in The New Republic, the Guardian, or the Washington Post that they were being paid by Libyan money.</blockquote> So here again we have the elements of what Wendell Potter (see <a href="http://hcrenewal.blogspot.com/2011/02/wendell-potters-deadly-spin.html">this post</a>) called the "third party strategy." A public relations company hires outside "experts" with veneers of academic or professional credibility to promote the interests of its clients, without disclosing that the "experts" have become paid flacks. Again, this is bad enough when it is done on behalf of health policies favorable to commercial insurance companies. It is worse when it is done on behalf of brutal dictators. More recently, the Globe discovered(8) that the Monitor Group negotiated with the head of the Libyan intelligence service who had been implicated in various violent acts, <blockquote>He is Moammar Khadafy’s brother-in-law and his most trusted aide, convicted in absentia for the 1989 bombing of a French airliner and implicated in the 1996 massacre of 1,200 Libyan political prisoners. But in 2006, Abdullah Al Sanusi was also the man who arranged the services of a noted Cambridge consulting firm in a very different project: revamping Libya’s reputation on the world stage. Sanusi, a longtime head of Libya’s intelligence services, oversaw initial negotiations with the Monitor Group, which was vying for a contract with Libya to bring prominent Americans to speak to Khadafy as part of an effort to improve ties and nudge the pariah country toward reforms. 'We believe that your commitment to creating a program of mutual education and relationship building with the Unit ed States remains of critical importance at this turning point in Libyan history. We remain privileged to be trusted with this work,' Monitor’s chief executive, Mark Fuller, and project director, Rajeev Singh-Molares, wrote to Sanusi in 2006. </blockquote> However, so far, Harvard leadership has if anything been more defensive about its faculty members' stealth public relations work for a brutal dictator than was Columbia's leadership about its faculty member's stealth public relations work for Iceland. As reported(9) again by the Boston Globe, <blockquote>A prominent Harvard professor and former university administrator urged Harvard President Drew Faust during a faculty meeting yesterday to express 'shame'’ on behalf of the university at the disclosure of financial ties between a senior academic and Libyan dictator Moammar Khadafy. Saying nothing would send the wrong message to students, giving them the impression that personal financial gain could come at the expense of ethical conduct, said Harry Lewis, a computer science professor who formerly served as undergraduate dean. 'Shouldn’t Harvard acknowledge its embarrassment, and might you remind us that when we parlay our status as Harvard professors for personal profit, we can hurt both the university and all of its members?' Lewis asked Faust at the monthly gathering of the arts and sciences faculty. Faculty meetings are closed to outside media, but Lewis provided the Globe a written transcript of his statement, which he sent to Faust several days ago. Faust — who, according to Lewis, told him she did not want to be 'scold in chief' — said she supports the wide discretion of faculty members to pursue the directions of academic inquiry and outside engagements they choose.</blockquote> How low once proud institutions have fallen was demonstrated by a Harvard President who could not bring herself to "scold" faculty who were paid to provide public relations for a brutal dictator while hiding behind their Harvard titles.  Her action was not just "a weak standard for an institution of global leadership,"(10) but failed to erase "a distinctive odor, one that emanates from the corruption of academic reputation."(11) Summary Since before we first started this blog, we wondered somewhat despairingly how medicine, and particularly academic medicine, had become so badly lead.  Since the global economic collapse/ Great Recession it belatedly became clear that health care has just been swept along by the waves that drove larger social, economic and political institutions.  In particular, when we wondered how conflicts of interest had become so pervasive in medicine, we did not realize how pervasive conflicts of interest and corruption had become throughout the world.  The fact that leaders of previously revered educational institutions like Columbia and Harvard still cannot bring themselves even to admit the need to disclose conflicts, much less "scold" people for selling out to brutal tyrants indicates how deep the rot has gone. Fixing the great problems of health care will require fixing the greater problems of society at large.  We must learn to discredit, not honor the "wildly ambitious agents of opportunity" that have been sent out to dominate the new gilded age.    References 1.  Halberstam D. The new establishment: the decline and fall of the Eastern Empire. Vanity Fair, October, 1994. Link <a href="http://www.vanityfair.com/business/features/1994/10/old-establishment-decline-199410">here</a>. 2. Poliak S. 'Inside Job' prompts new look at conflict of interest policy. Columbia Spectator, April 13, 2011. Link <a href="http://www.columbiaspectator.com/2011/04/13/inside-job-prompts-new-look-conflict-interest-policy">here</a>. 3. Poliak S. After documentary, B-school rethinking ethics. Columbia Spectator, April 15, 2011. Link <a href="http://www.columbiaspectator.com/2011/04/15/after-documentary-b-school-rethinking-ethics">here</a>. 4. Poliak S, Roth S. 'Inside Job' sparks three separate reviews of disclosure policy. Columbia Spectator, April 14, 2011. Link <a href="http://www.columbiaspectator.com/2011/04/14/inside-job-sparks-three-separate-reviews-disclosure-policy">here</a>. 5. Corn D, Mahanta S. From Libya with love. Mother Jones, March 3, 2011. Link <a href="http://motherjones.com/politics/2011/03/libya-qaddafi-monitor-group">here</a>. 6. Stockman F. Local consultants aided Khadafy. Boston Globe, March 4, 2011. Link <a href="http://articles.boston.com/2011-03-04/news/29342456_1_moammar-khadafy-libyan-government-consulting">here</a>. 7. Wiener J. Professors paid by Qaddafi: providing 'positive public relations.' The Nation, March 5, 2011. Link <a href="http://www.thenation.com/blog/159046/professors-paid-qaddafi-providing-positive-public-relations">here</a>. 8. Stockman F. Top Khadafy aide helped craft deal with local firm. Boston Globe, March 30, 2011. Link <a href="http://www.boston.com/news/local/massachusetts/articles/2011/03/30/cambridge_firm_worked_in_partnership_with_top_khadafy_aide">here</a>. 9. Jan T. Harvard leader confronted on professor's ties to Libya. Boston Globe, April 6, 2011. Link <a href="http://articles.boston.com/2011-04-06/news/29389347_1_arts-and-sciences-faculty-professor-harvard-officials">here</a>. 10. Anonymous. Yes, Harvard chief should scold profs who worked for Khadafys.  Boston Globe, April 11, 2011.  Link <a href="http://articles.boston.com/2011-04-11/bostonglobe/29407081_1_harvard-governance-academics">here</a>. 11.  Barrett PM. The professors and Qaddafi's extreme makeover.  Bloomberg BusinessWeek, April 6, 2011.  Link <a href="http://www.businessweek.com/magazine/content/11_16/b4224004951872.htm">here</a>.

Henry Kissinger, Iceland's Promoter, Khadafy's Apologists, and the Rise of the Academic Mercenary

In which we discuss how medical academic mercenaries (like the key opinion leaders paid to promote drugs and devices cloaked in their academ...

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FDA Decides Regulating Implantable Defibrillator Medical Devices a "Political Hot Potato"; Demurs

<div style="font-family: inherit;">Well, not exactly, but they have decided regulation of another medical device is a political hot potato, and demurred on enforcing regulation: </div><div style="font-family: inherit;"> </div><div style="font-family: inherit;">Health IT. </div><div style="font-family: inherit;"> </div><div style="font-family: inherit;">Health IT are medical devices.</div><div style="font-family: inherit;"> </div><div style="font-family: inherit;">FDA's Chair of the Center for Device and Radiological Health, Jeffrey Shuren, MD JD, stated this explicitly on Feb. 25, 2010 (see testimony to the HHS Health Information Technology HIT Policy Committee at <a href="http://web.archive.org/web/20120320111030/http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_11673_910717_0_0_18/3Shuren_Testimony022510.pdf" target="_blank">this PDF</a>) that:</div><div style="font-family: inherit;"> </div><div dir="ltr" style="font-family: inherit;"> </div><blockquote dir="ltr" style="font-family: inherit; margin-right: 0px;"><div dir="ltr">... Under the <a href="http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.htm">Federal, Food, Drug, and Cosmetic Act</a>, [that regulates all drug, medical devices, etc. in the United States - ed.] HIT software is a medical device. Currently, the FDA mandates that manufacturers of other types of software devices comply with the laws and regulations that apply to more traditional medical device firms. These products include devices that contain one or more software components, parts, or accessories (such as electrocardiographic (ECG) systems used to monitor patient activity), as well as devices that are composed solely of software (such as laboratory information management systems).</div></blockquote> <div dir="ltr" style="font-family: inherit;">That leaves no doubt that these are medical devices. However, he also stated: </div><div dir="ltr" style="font-family: inherit;"> </div><blockquote dir="ltr" style="font-family: inherit; margin-right: 0px;"><div dir="ltr">To date, FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices.</div></blockquote><div dir="ltr" style="font-family: inherit;"> </div><div dir="ltr" style="font-family: inherit;"> In other words, this medical device receives special accommodation over all others,such as heart stents, defibrillators, spine and knee implants, etc., all of which have been in the news in recent years for major defects and malfunctions, up to and including causing patient deaths. The extent would have likely been far, far worse had these gadgets been unregulated. One should ask: why the special accommodation for health IT medical devices? What are the underlying politics, and who is behind them? Especially when FDA is <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">aware of potential risks</a> that may only be the "<a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">tip of the iceberg</a>?" The selective reluctance to enforce the FD&C Act persists to this day. See for example this link regarding his statements just a few days ago here in Philadelphia: <a href="http://healthcare-informatics.com/ME2/dirmod.asp?sid=&nm=&type=Publishing&mod=Publications%3A%3AArticle&mid=8F3A7027421841978F18BE895F87F791&tier=4&id=611B2533503749379725490812695CE6">Will FDA Regulate EHR's?</a> : </div><div dir="ltr" style="font-family: inherit;"> </div><blockquote dir="ltr" style="font-family: inherit; margin-right: 0px;"><div dir="ltr">Speaking at the first annual PharmEHR Summit in Philadelphia on April 7, Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health at the FDA, said his agency could change its traditional hands-off approach to EHRs, but he acknowledged that the potential of FDA regulation raises serious clinical issues [the only clinical issues I can think of are in holding vendors accountable for patient injury - ed.] and is a “political hot potato.” “As of right now we’re not regulating EHRs, and it may turn out that we won’t,” he said.</div></blockquote><div dir="ltr" style="font-family: inherit;"> A "political hot potato" as the reason for an FDA hands-off policy?  Remarkable.  <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiI2QShfTWCl06lqXyCcaehfFzoJSLu3_OtMxVB-bnVuGhQWn_7i4yvFeTnCeLsNjh8whx23eZ0byDmduGxPfJKX249d8tVtAX2-yVjFcjfwEeY52suLsiHJJo6whxMI7_AWbFQUqh5pGvg/s1600/hot_potato.gif" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="277" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiI2QShfTWCl06lqXyCcaehfFzoJSLu3_OtMxVB-bnVuGhQWn_7i4yvFeTnCeLsNjh8whx23eZ0byDmduGxPfJKX249d8tVtAX2-yVjFcjfwEeY52suLsiHJJo6whxMI7_AWbFQUqh5pGvg/s320/hot_potato.gif" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Tossing away political hot potatoes and ... patients.</td></tr></tbody></table> Likely translation: FDA regulation of health IT will never happen. One implication is that health IT quality, safety, efficacy, privacy, security, and other issues about these systems will remain subject to HHS and industry caprice. While we're at it, let's deregulate <a href="http://www.aboutlawsuits.com/zimmer-nexgen-knee-lawsuit-filed-17178/">knee implants</a> too... -- SS Addendum April 19, 2011: Roy Poses observes that: <blockquote> Here is a great example of regulatory capture. The health care IT industry has amassed such political clout that it now has impunity to regulation. Once again, combined economic and political power trumps patients' and the public's health and safety. We will not be able to really reform health care until we can provide for honest, independent health care regulation to uphold patients' and the public's health.</blockquote> -- SS</div>

FDA Decides Regulating Implantable Defibrillator Medical Devices a "Political Hot Potato"; Demurs

Well, not exactly, but they have decided regulation of another medical device is a political hot potato, and demurred on enforcing regulati...

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