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From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things

<div style="font-family: arial;">A poster who wishes to remain anonymous, a Senior Clinician in the state of Victoria, Australia, added this comment to my March 2011 post on 'anecdotes.' (That post was entitled "<a href="http://hcrenewal.blogspot.com/2011/03/australian-ed-ehr-study-putting-lie-to.html">Australian ED EHR Study: An End to the Line "Your Evidence Is Anecdotal, Thus Worthless?</a>".)</div><div style="font-family: arial;">He makes a critical point I think has gotten lost in the HIT domain (emphases mine): </div><blockquote dir="ltr" style="font-family: arial; margin-right: 0px;"><div dir="ltr"> </div><div dir="ltr"> </div><div dir="ltr"> Anonymous <a href="http://hcrenewal.blogspot.com/2011/03/australian-ed-ehr-study-putting-lie-to.html?showComment=1313458003470#c4442262074669998129">August 15, 2011 9:26:00 PM EDT</a> said... Anecdote and Medicine. We are actually talking about two different things here. 1. Anecdotal reporting of a new and potentially exciting finding in Medicine is NEVER a reason to widely implement a new treatment or procedure. It represents the lowest category of evidence in any systematic review In any orthodox system of medicine in the developed world a new intervention would not be ratified or re-imbursed without EXTENSIVE study in Randomised trials - ie the mandatory three phase trial arrangement for new drugs. 2. Anecdotal reporting of side effects/failure for an implemented treatment is a crucial part of any risk management strategy within a healthcare setting. Individual incident reporting of harmful events AND near misses is crucial to help organisations (and regulatory agencies) understand where risks to patients and staff are to be found. A root cause analysis can then be undertaken and corrective measures introduced and their subsequent impact assessed. The process of 'closing the audit loop' is required or no reduction in risk can be verified. This is separate from the regular audit cycle which each Department should apply to aspects of its work, usually reviewing a particular intervention in rotation. In the above debate the pro e-Health lobby find themselves mis-interpreting both definitions. They support the positive anecdotes for the adoption of Electronic Health Records WITHOUT proper randomised evidence being available and they decry the anecdotes of negative experiences of implemented systems that in reality represent episodes of incident reporting. It appears the over-exuberant proponents of e-Health in general and for everything, need to attend revision courses in research methodology and risk management... [a fascinating observation - ed.] nb Irony of irony; Victoria now has State-wide implementation of risk management software which for all healthcare staff is the obligatory reporting mechanism for all incidents and near-misses. The system is so user unfriendly and time demanding virtually none of the busy hospital doctors I have spoken to access the system, even though 'training' has been undertaken. The system has been widely condemned at our Medical Staff Committee. Victoria has recently congratulated itself for a fall in annual number of critical incidents occurring in public hospitals! I will leave it to you to work out how such a positive risk management statistic could be generated in a healthcare system working near capacity with increasing year on year demand for its services...</div></blockquote> Per these observations: A critical distinction that seems to have become lost, even among the Medical Informatics academic elite (see, for instance, my Sept. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/09/dangers-of-critical-thinking-in.html" style="font-family: arial;">The Dangers of Critical Thinking in A Politicized, Irrational Culture</a>"), is the distinction between research observations on the one hand, and risk management-relevant incident reports on the other. It seems a form of erroneous thinking or logical fallacy. The lost distinction between research methods and risk management methods, that require very essential, very different consideration of "anecdotes", and the conflation of the two types of "anecdotes", are brilliant observations. Finally, the loss of consideration of the distinctions between the two different types of "anecdotal reporting" is part of what I have termed the lack of the rigor of medicine itself in HIT. -- SS

From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things

A poster who wishes to remain anonymous, a Senior Clinician in the state of Victoria , Australia, added this comment to my March 2011 post ...

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Why bankers need to stick to banking, and keep their profound lack of knowledge of biomedicine and Medical Informatics to themselves

<div style="text-align: center;">[Note: this post is very rich with hyperlinks. To fully understand the post, at least open the hyperlinks in a separate window and browse their material - ed.] </div> In April 2011 I referenced a 2007 comment about health IT ROI, by then-Congressional Budget Office (CBO) head Peter Orszag, in a post entitled "<a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2011/04/medicaremedicad-cuts-spend-money-on.html">Medicare/Medicaid Cuts? Spend Money on Patients - Not Computer Experiments</a>": <blockquote>... More on purported cost savings - Peter Orszag, former head of the Congressional Budget Office, said the use of electronic health records, without a major change in health care delivery, "would not significantly reduce overall health care costs" <a href="http://www.ihealthbeat.org/articles/2007/11/14/budget-office-downplays-ehrs-effect-on-reducing-health-costs.aspx?topic=ehrs%20and%20phrs">in the agency's 2007 report</a> on long-term health care spending. He also said that according to data from the report, the return on investment for EHR's "is not going to be as substantial as people think." The CBO concluded that predictions of cost savings from EHR's relied on "overly optimistic" assumptions and said much is unknown about the potential impact of health information technology. [That is, it is an experimental technology - ed.] Mass savings from health IT is an assertion that is both unproven and highly unlikely in my view.</blockquote> Mr. Orszag is now Vice Chairman of Global Banking at Citigroup. He seems to have changed his tune somewhat. In an Aug. 16, 2011 piece in Bloomberg entitled "<a style="font-weight: bold;" href="http://www.bloomberg.com/news/2011-08-17/health-care-prognosis-better-with-digital-law-commentary-by-peter-orszag.html">Health Care Prognosis Better With Digital Law: Peter Orszag</a>" he opines: <blockquote> Even with the all-too- depressing illustrations of political paralysis we’ve seen recently, government can still act to improve our lives. A good case in point: The U.S. health sector is rapidly digitizing, and federal legislation from early 2009 , passed well before the health-care reform act, is an important reason why. </blockquote> He refers to the Health Information Technology for Economic and Clinical Health a.k.a. HITECH Act embedded in the 'economic stimulus' ARRA bill. <blockquote>... Partners HealthCare has used its health IT to be more selective about which patients should have diagnostic imaging tests, such as MRIs and CT scans. The cost to Medicare for imaging tests nationwide roughly doubled from 2001 to 2009. And such tests are not only expensive but potentially dangerous. Frequently imaged patients face an increased risk of cancer because of exposure to excessive radiation. [That risk is not very large; on the other hand, insufficiently imaged patients are playing the "slot machine of life", which when they are unlucky leads to missed diagnoses, injury and death - ed.] Doctors at Partners now order imaging scans through the computer system and are automatically queried about the patients’ characteristics. For each case, the software then provides an “appropriateness” score, reflecting evidence- based protocols [i.e., likely based on averages, not the individual patient's nuances - ed.] for the image requested. And in some cases, the program suggests an alternative to imaging. </blockquote> I presume doctors' use of imaging is monitored based on the cybernetic "score." Orszag states: <blockquote>Comparing doctors: the system is also used to compare doctors to one another, so they know if they use imaging tests more or less than their peers do. </blockquote> I have yet to see robust (e.g., RCT-based) outcomes of this "regulator of care" function of health IT, wherein the physician is no longer the learned intermediary between patient and computer, but the computer instead is the cybernetic regulator of care between doctor and patient. I do know of a case, however, where cybernetic "regulation" of imaging seems to have helped kill an infant at another hospital (<a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">link</a>). <blockquote>From 2006 to 2009, imaging rates at Partners flattened, and in some specialties even started to decline, sometimes significantly. The number of outpatient images per patient, for example, fell 25 percent in that period, even after adjusting for patient characteristics such as age, ethnicity, gender, medical history and medications. ... The IT interventions appear to have been effective at reducing imaging rates across the board, including among the doctors who ordered the tests most. By 2009, that doctor at the 90th percentile ordered 20 images per 100 patients, a decline of almost 10. This one doctor’s net decrease in scans was larger than the total number of scans ordered by the doctor at the 10th percentile even in 2006. And the low-use doctor reduced his rate, too, by about two images per 100 patients. </blockquote> I'm still not seeing comparisons of how patients fared under the cybernetic imaging-control regime. <blockquote>More broadly, health IT is a necessary but not by itself sufficient step toward improving value in health care. A review of the health IT studies by the Congressional Budget Office, published in 2008, while I was the director of that agency, concluded that it “has the potential to significantly increase the efficiency of the health sector by helping providers manage information.” The CBO also found, however, that health IT couldn’t realize this potential without a supportive health-care delivery system that uses it aggressively. The most auspicious examples of IT use were in relatively integrated systems, such as Veterans Affairs, Partners HealthCare, Kaiser Permanente and Group Health Cooperative in Seattle. </blockquote> Here's where Orszag goes off the irrational-exuberance rails. He states the "potential" of HIT to "help providers manage information" is not reached because HIT is not widespread enough. He omits the potential of the technology to cause providers to mismanage information. Such mismanagement turned a close relative of mine into <a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html">roadkill</a>, which apparently is OK on the road to HIT utopia. He cites the VA, where highly specialized non-commercial HIT took decades to develop under relatively ideal conditions far removed from the traditional management information systems morass in the private sector (<a style="font-weight: bold;" href="http://www.amazon.com/Medical-Informatics-Electronic-Collaboration-Innovation/dp/0763739251">link</a>), and Kaiser (with <a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2006/11/kaiser-healthcare-it-meltdown.html">this history</a>) and Group Health, who are not exactly prolific publishers about their mishaps and travails with HIT. He omits the fact the FDA admits they know of HIT-related injury and deaths (link to <a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">FDA internal memo of Feb. 2010</a>), do not know the true levels of it but that their data probably represents the "tip of the iceberg" (<a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">link</a>), and that HIT is a medical device that should fall under the FD&C Act, but that is left unregulated (<a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">link</a>) because it's a "political hot potato." (Thus, in effect, its subjects, patients, are experimental test subjects without having given informed consent.) He omits the mission hostile nature of much commercial HIT (e.g., as demonstrated in the nine-part series <a style="font-weight: bold;" href="http://www.tinyurl.com/hostileuserexper">here</a>). He omits a growing body of literature suggesting health IT's outcomes are neutral or negative, despite billions of dollars of expense (link to <a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">Reading List</a>). He omits acknowledged national HIT failures in the UK (<a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2011/08/you-saw-it-here-first-uk-nhs-pulls-plug.html">link</a>, <a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2011/08/national-programme-for-it-in-nhs-aug.html">link</a>), and Australia and elsewhere (<a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2011/03/why-current-nature-of-healthcare-it.html">link</a>), in healthcare systems far smaller, more government-controlled and less complex than ours, efforts largely led by and utilizing American companies and products. He omits the apparently low quality and fundamental unreliability and unsuitability of today's commercial software (see examples at <a style="font-weight: bold;" href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=120&Itemid=116">link</a>, <a style="font-weight: bold;" href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">link</a>). He omits independent, renowned medical device testing organizations listing health IT as one of the top health risks of 2011 (<a style="font-weight: bold;" href="https://www.ecri.org/Press/Pages/Top-10-Health-Technology-Hazards-List-2011.aspx">link</a>). He omits the general futility of large-scale government IT initiatives, as in an article hidden in the Public Administration Review that contains near 150 references (<a style="font-weight: bold;" href="http://www.ischool.drexel.edu/faculty/ssilverstein/Goldfinch_pessimism_PAR.pdf">link</a>, PDF). In effect, commercial health IT is nowhere near fit for national rollout in 2011. I have two suggestions: 1. Bankers need to stick to banking, and keep their embarrassing lack of knowledge of biomedicine and Medical Informatics to themselves. 2. Mr. Orszag needs to spend some time reading the IT literature, without wearing blinders. Finally, on a personal note, I will not be taking investment advice from Mr. Orszag. I would not trust it, often finding that those deficient in publicly-available knowledge in one domain are often lacking knowledge in others. That's simply my personal preference. -- SS

Why bankers need to stick to banking, and keep their profound lack of knowledge of biomedicine and Medical Informatics to themselves

[Note: this post is very rich with hyperlinks. To fully understand the post, at least open the hyperlinks in a separate window and browse ...

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What the Pfizer (III)? - Enormous Pay for Poor Performance

The recent in-depth <a href="http://features.blogs.fortune.cnn.com/2011/07/28/pfizer-jeff-kindler-shakeup/">investigation</a> by Fortune reporters of 10 years of dysfunctional leadership at <a href="http://www.pfizer.com/">Pfizer</a>, the "world's largest research-based pharmaceutical company," raises many issues about leadership and governance in health care (see our post <a href="http://hcrenewal.blogspot.com/2011/08/10-years-of-pfizer-leadership-saga-of.html">here</a>).  To continue what is likely to become a lengthy series, let us now discuss the discrepancy between the markedly dysfunctional leadership performance documented in the Fortune article and the pay given to the leaders involved. "Hank" McKinnell et al - 2003-2006 Mr McKinell was forced to retire in 2006. The Fortune article described Mr McKinnell as a "desperate CEO" by 2002 because he could find no way to replenish the company's fading drug pipeline; who then became an absent CEO who "left a power vacuum" and then triggered internal political warfare by setting up a "bitter contest" over succession planning. The <a href="http://services.corporate-ir.net/SEC/Document.Service?id=P3VybD1odHRwOi8vaXIuaW50Lndlc3RsYXdidXNpbmVzcy5jb20vZG9jdW1lbnQvdjEvMDAwMDkzMDQxMy0wNi0wMDIwOTEvZG9jLzAwMDA5MzA0MTMwNjAwMjA5MS5wZGYmdHlwZT0yJmZuPTAwMDA5MzA0MTMwNjAwMjA5MS5wZGY=">2006 Pfizer proxy statement</a> reported the total compensation received by Mr McKinnell from 2003-2005. 2003 - $10,706,002 2004 - $11,355,317 2005 - $12,767,270 Each line reflects the combination of salary, bonus, other annual compensation, restricted stock awards, securities underly  options, LTIP payouts, and all other compensation.    The four other best paid executives were Karen Katen, Vice Chairman and President, Prizer Human Health,  David Shedlarz, Vice Chairman, Jeffrey B Kindler, Vice Chairman and General Counsel, and John LaMattina PhD, Senior Vice President, President, Pfizer Global Research and Development.  Their total compensation for these years were Ms Katen 2003 -  $4,747,478 2004 -  $8,541,220 2005 - $6,663,283 Mr Shedlarz 2003 - $3,722,508 2004 - $6,743,591 2005 - $3,897,293 Mr Kindler 2003 - $3,113,308 2004 - $4,181,817 2005 - $3,338,728 Mr LaMattina 2003 - $2,228,804 2004 - $4,410,130 2005 - $3,558,415 Despite MrMcKinnell's poor performance, he never received less than $10 million a year in the three years before he was forced out.  Other top managers, despite never effectively compensating for Mr McKinnell's bad performance earned at least $ 3 million a year in these three years, with one exception, one manager who only made a bit over $2 million in one of the three years. Jeffrey Kindler et al 2007 - 2010  Kindler was forced to resign in 2010. The Fortune article also described Mr Kindler as "suddenly desperate" after two failures of drugs in development; someone who "just couldn't make up his mind," about acquisitions and spin-offs; "anguished" about research, leading to a "messy" overhaul; and putting "destructive" trust in a subordinate with previously described problems with "character, integrity and divisiveness" leading to loss of the loyalty of the executive team. The <a href="http://services.corporate-ir.net/SEC/Document.Service?id=P3VybD1odHRwOi8vaXIuaW50Lndlc3RsYXdidXNpbmVzcy5jb20vZG9jdW1lbnQvdjEvMDAwMTE5MzEyNS0xMC0wNTc5NDkvZG9jLzAwMDExOTMxMjUxMDA1Nzk0OS5wZGYmdHlwZT0yJmZuPTAwMDExOTMxMjUxMDA1Nzk0OS5wZGY=">2010 Pfizer proxy statement</a> revealed the total compensation received by Mr Kindler from 2007-2009. 2007 - $13,075,099 2008 - $15,547,600 2009 - $14,898,038 In this proxy statement, each line included salary, bonus, stock awards, option awards, non-equity incentive plan compensation, change in pension value and non-qualified deferred compensation earnings, and all other compensation.  The four other best paid executives were F D'Amelio, Chief Financial Officer, I Read, Group President, Worldwide Biopharmaceutical Business, M Mackay, President, Pharmatherapeutics Research & Development, and Dr F Lewis-Hall, Chief Medical Officer.  Their total compensation for these years was: Mr F'Amelio 2007 - $12,338,821 2008 - $6,979,111 2009 - $7,858,969 Mr Read 2007 - $4,560,869 2008 - $7,629,185 2009 - $9,447,036 Mr Mackay 2007 - $3,590,158 2008 - $6,718,580 2009 - $5,878,806 Dr Lewis-Hall 2009 - $5,087,263 (hired in 2009) Despite Mr Kindler's poor performance, he never received less than $13 million a year in the three years before he was forced out.  Other top managers, despite never effectively compensating for Mr McKinnell's bad performance earned at least $ 4.5 million a year in these three years, with one exception, one manager who only made a bit over $3.5 million in one of the three years. Summary   The business oriented leaders of health care, and some of their sympathizers in health care and policy research are given to preach that "pay for performance," (P4P) applied to health care professionals is a solution to the problem of ever rising health care costs, and ever declining health care access and quality.    Pay for performance applied to the top hired leaders of health care organizations has become a cruel joke.     The Pfizer example shows a company with chronically bad leadership paid hundreds of times what average workers receive.  Despite a parched drug pipeline and languishing stock price, top managers made millions a year, and CEOs who would eventually be forced out for poor performance made tens of millions a year.  One cannot help but conclude that the main goal of Pfizer was to enrich its top managers.  Managers whose main goal is to enrich themselves, of course, are unlikely to manage well, and unlikely to promote development and manufacturing of drugs whose benefits exceed their harms, and which decrease symptoms, improve function, prevent morbidity, extend life, and generally benefit health.      Now that the scope of the failings of Pfizer's hired leaders has been made clearer, the company has become one of the best, or worst examples of self-interested leadership and its perils for health care.    As I have repeated endlessly,... health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior.   If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

What the Pfizer (III)? - Enormous Pay for Poor Performance

The recent in-depth investigation by Fortune reporters of 10 years of dysfunctional leadership at Pfizer , the "world's largest re...

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The National Programme for IT in the NHS: an Aug. 2011 Public Accounts Committee update on the delivery of detailed care records systems

At "<a style="font-weight: bold;" href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=2009">2009 a Pivotal Year in Healthcare IT</a>" I linked to summary points of a Jan. 2009 report about the UK's National Program for IT in the NHS (NPfIT) entitled "The National Programme for IT in the NHS: Progress since 2006." The report was prepared by the Public Accounts Committee of the UK Parliament's House of Commons. That report summary (<a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">link here</a>) was not pretty. An August 2011 update has been issued by the same body entitled "The National Programme for IT in the NHS: an update on the delivery of detailed care records systems." The 2011 summary is even less pretty than the 2009 version (<a href="http://www.publications.parliament.uk/pa/cm201012/cmselect/cmpubacc/1070/107004.htm">link here</a>). I reproduce it below with almost no added comments, as it speaks for itself relative to the many years of posts on health IT difficulties, failures and mismanagement I've authored at this blog and elsewhere. (Also see my May 2011 post "<a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2011/05/national-programme-of-failed-it-in-uk.html">NPfIT: National Programme of Failed IT in the NHS</a>" that summarizes a number of press accounts of the project.) The 2011 report begins: <blockquote>The National Programme for IT in the NHS (the Programme) was an ambitious £11.4 billion programme of investment designed to reform how the NHS in England uses information to improve services and patient care. The Programme was launched in 2002, and the Department of Health (the Department) has spent some £6.4 billion on the Programme so far.</blockquote> Here is the updated "progress" summary: <blockquote>The National Programme for IT in the NHS: an update on the delivery of detailed care records systems - Public Accounts Committee Conclusions and recommendations 1. The Department has been unable to deliver its original aim of a fully integrated care records system across the NHS. Poor progress since 2002 has meant the Department has had to reconsider what the expenditure can deliver. Many NHS organisations will now not receive a system through the Programme which will not provide for the transmission of individual case records across the whole NHS. The Department should review urgently whether it is worth continuing with all elements of the care records system, to determine whether the remaining £4.3 billion could be used to better effect to buy systems that work, are good value and deliver demonstrable benefits for the NHS. 2. There has been a substantial reduction in how many NHS bodies will receive new systems but the Department failed to secure a comparable reduction in costs. This casts the Department's negotiating capability in a very poor light. In London, the Department's negotiations with BT resulted in far fewer systems to be delivered for only a marginal reduction in fee. We are worried that the Department will fare no better in its current negotiations with CSC [a U.S.-based computer consulting company - ed.], which has delivered only 10 of 166 of its 'Lorenzo' systems in the North, Midlands and East. The Department has been in negotiations with CSC for over a year, and told us that it may be more expensive to terminate the contract than to complete it, although we also note that CSC has informed the United States Securities and Exchange Commission that it may receive materially less than the net asset value of its contract if the NHS exercises its right to terminate the contract for convenience. Given the Department's failure to secure a good deal in its contract renegotiation with BT, and its weak position with CSC, we consider it essential that the Major Projects Authority now exercises very close scrutiny over the Department's continuing negotiations with CSC, and that Government gives serious consideration to whether CSC has proved itself fit to tender for other Government work. It is important that CSC, particularly given its proposed purchase of iSoft, does not acquire an effective monopoly in the provision of care records systems in the North, Eastern and Midland clusters. This could result in the Lorenzo system effectively being dropped as the system of choice and many Trusts being left with little choice but to continue with out-dated interim systems that could be very expensive to maintain and to upgrade, or to accept a system of CSC's choice. CSC should not be given minimum quantity guarantees or a licence to sell a product other than that procured and selected by the Programme within the LSP contract. 3. The Department is unable to show what has been achieved for the £2.7 billion spent to date on care records systems. The Department failed to meet its commitment to report to the Committee by summer 2010 on the benefits delivered by the Programme. A statement of benefits to March 2010 was not provided to the NAO until May 2011 - more than a year out of date. The Department should, by September 2011, provide us with an updated statement of benefits to March 2011, which we will ask the National Audit Office to audit. 4. We are very concerned at the lack of evidence of risk management of security issues which may arise as a result of medical records being held electronically. The Department must address possible compromises in data security. 5. Weak management and oversight of the Programme have resulted in poor accountability for project performance. Sir David Nicholson has not been able to fulfil his duties as the Senior Responsible Owner for the Programme effectively, given his significant other responsibilities, weakening accountability for the Programme's extensive delays and increasingly poor value for money. It is essential that there is proper accountability for the Programme, especially since the current health reforms, according to Sir David, make it "quite difficult to shift a system like that into that environment"[<a name="n2"></a><a href="http://www.publications.parliament.uk/pa/cm201012/cmselect/cmpubacc/1070/107004.htm#note2">2</a>]. [Of course, planned U.S. healthcare reforms are also highly complex, making "shifting systems into that environment" a predictable nightmare - ed.] Sir David should now expect much closer scrutiny and oversight of his actions by the Major Projects Authority, but he must remain Senior Responsible Owner for the Programme so there is a clear line of accountability and responsibility for performance as well as continuity in managing the substantial risks that remain. 6. NHS trusts will take over responsibility for care records systems from 2015-16, but they do not currently have the information they need about potential future costs. After the implementation of forthcoming health reforms, the organisations currently managing the Programme will no longer exist and the risks will transfer to NHS trusts. However, at present these trusts have no direct contractual relationship with existing suppliers and no information about the likely cost of using care records systems beyond 2015. The Department should write to every NHS Trust making clear the detailed implications of their future responsibilities for care record systems, and in particular the financial liability to which each trust will be exposed. This information should include information about exit costs from the LSP contracts and future maintenance and running costs for those Trusts that continue with the Programme, and this information must be provided within two months. It should also specify the support that the centre will provide to Trusts procuring outside the Programme, particularly where such systems can be shown to represent value for money to the NHS or greater functionality. 7. It is unacceptable that the Department has neglected its duty to provide timely and reliable information to make possible Parliament's scrutiny of this project. Basic information provided by the Department to the NAO was late, inconsistent and contradictory. We are surprised that in its memorandum to us of 7 June 2011, two weeks after our hearing, the Department did not mention that it made an advance payment to CSC of £ 200 million in April 2011. The Department must provide timely and reliable information in future to support effective accountability to Parliament. [One wonders if the U.S. ONC office (Office of the National Coordinator for health IT) in HHS will perform any better - ed.] 8. According to Sir David Nicholson, the Department may have to think about an interim step - a transitional body of some description- creating the impression of major uncertainty about how this work should be managed in the future. We will return to this issue in the future. </blockquote> The full 2011 report is <a href="http://www.publications.parliament.uk/pa/cm201012/cmselect/cmpubacc/1070/1070.pdf">at this link</a> (PDF). This report makes the success of a similar multibillion dollar national health IT initiative in the U.S., a far larger, more complex, and chaotic healthcare system, seem even more unlikely. -- SS

The National Programme for IT in the NHS: an Aug. 2011 Public Accounts Committee update on the delivery of detailed care records systems

At " 2009 a Pivotal Year in Healthcare IT " I linked to summary points of a Jan. 2009 report about the UK's National Program f...

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Congresswoman Renee Ellmers on Health IT Concerns

A letter on Health IT from Congresswoman <a href="http://ellmers.house.gov/index.cfm?sectionid=94&sectiontree=2,94">Renee Ellmers</a>, (R) NC, Chairwoman of the U.S. House of Representative's Committee on Small Business, Subcommittee on Healthcare and Technology was just sent to Secretary of the Dept. of Health and Human Services Kathleen Sebelius. The themes in the letter will be familiar to readers of Healthcare Renewal. A PDF copy of the letter can be downloaded by clicking below, and the text follows. <div style="text-align: center;"><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh_2qirVMyivJO381vV0HLJ5llEXSAZTVTTq38vhgR-RkUBW0XIKs_CJQR43Sxm1tjdVyB8YkT_9FcRqSwIU02xHFgfYVe4TnyG4852AOTTRfq0U1PbZEmb8qgX06yZPn2b4IDfipISDnDD/s1600/ellmers.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5639969911782066050" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh_2qirVMyivJO381vV0HLJ5llEXSAZTVTTq38vhgR-RkUBW0XIKs_CJQR43Sxm1tjdVyB8YkT_9FcRqSwIU02xHFgfYVe4TnyG4852AOTTRfq0U1PbZEmb8qgX06yZPn2b4IDfipISDnDD/s320/ellmers.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 246px; height: 320px;" /></a>(<a style="font-weight: bold;" href="http://smbiz.house.gov/UploadedFiles/Health_IT_Concerns_Sebelius_8.11.11.pdf">click here</a> to download PDF) </div> Here is the text, along with several comments: <blockquote> August 11, 2011 The Honorable Kathleen Sebelius Secretary U.S. Department of Health and Human Services 200 lndependence Avenue, S.W. Washington, DC 20201 Via Facsimile: 202. 690.7380 Dear Secretary Sebelius: The House Small Business Committee, on which I serve, is required by the Rules of the House to study and investigate the problems of all types of small businesses. This jurisdiction extends to matters concerning small businesses and health care. I chair the Committee’s Subcommittee on Healthcare and Technology. On June 2, 2011, the Subcommittee held a hearing on the barriers to health information technology that are encountered by physicians and other providers in small practices. At the hearing, physicians testified that the cost to purchase and maintain a health IT system, is addition to staff training and downtime during the transition to health IT, are significant burdens for small practices. These barriers mere mentioned even by physicians who believe health IT would ultimately benefit their practices. Providers at the hearing also stated their concern about the Medicare reimbursement penalties that will be assessed against providers who do not demonstrate “meaningful use” of health IT by 2015. One of the frequently mentioned benefits of health IT has been a reduction in medical errors. However, recent news reports have noted incidents of health IT errors. An article in Sunday’s Pittsburgh Post-Gazette [a series, actually, <a style="font-weight: bold; font-style: italic;" href="http://hcrenewal.blogspot.com/2011/05/healthcare-renewal-cited-in-pittsburgh.html">here</a> and <a style="font-weight: bold; font-style: italic;" href="http://www.post-gazette.com/pg/11219/1165767-114-0.stm?cmpid=nationworld.xml">here</a>- ed.] cited a baby who was killed while computerized IV equipment prepared a lethal dose of an intravenous sodium chloride solution. The machine did not catch the pharmacy technician’s error. The article also noted that when a hepatitis C-positive kidney was accidentally transplanted from a live donor into a recipient, the physician team missed the electronic records alert, and the physicians complained that their electronic records system is cumbersome and difficult to adjust to any one physician’s needs. [You can be sure that my writings on health IT mission hostility, poor quality, lack of regulation, etc. as well as the cases of health IT-related injury and death I know of, including that of my own relative, will find their way to Rep. Ellmer's office - ed.] The Journal of the American Medical Association recently published a study of almost 4,000 computer-generated prescriptions that were received by a pharmacy chain. The report found that 12 percent of the prescriptions contained errors, which, the report said, is consistent with error rates with handwritten prescriptions. [I wrote about that <a style="font-weight: bold; font-style: italic;" href="http://hcrenewal.blogspot.com/2011/06/electronic-medication-prescribing-magic.html">here</a> - ed.] A modern, well-equipped office is critical to the practice of medicine, and health IT offers promise to all medical professionals. [But only when done well - and there is massive complexity behind those simple two words "done well" that is poorly recognized and/or ignored - ed.] Health IT has the potential to improve health care delivery, decrease medical errors, increase clinical and administration efficiency, and reduce paperwork. We most do all we can to ensure a commitment to our health care system and patient care. As technology rapidly evolves, I ask that you consider a study of health IT’s adoption, benefits and cost effectiveness. [Cart before the horse when being done AFTER a national multi-billion dollar rollout is put into law, <a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html">as I wrote here</a>, but better late than never - ed.] As part of the study, I hope you will also consider medical error rates — both human and technological --so that all errors can he better assessed and prevented. [I have been calling for this for years now - ed.] Sincerely, Renee Ellmers Chairwoman Subcommittee on Healthcare and Technology House Committee on Small Business </blockquote> I find this letter from a leading member of the House of Representatives remarkable. Importantly, Chairwoman Ellmers has a medical background (HHS Secretary Sebelius, to my knowledge, does not). Here is part of Chairwoman Ellmer's <a href="http://en.wikipedia.org/wiki/Renee_Ellmers">background</a> from Wikipedia: <blockquote>In 1990, she graduated with a Bachelor of Science degree in Nursing. Ellmers worked as a nurse in Beaumont Hospital's surgical intensive care unit. In North Carolina, she was clinical director of the Trinity Wound Care Center in Dunn.</blockquote> The only other letters like it asking questions like this that I know of came from a Republican Senator to the HIT vendors, Sen. Grassley of Iowa (see <a href="http://hcrenewal.blogspot.com/2009/10/washington-post-emrs-no-cure-all-sen.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/01/grassley-asks-hospitals-about.html">here</a>). Sen. Grassley also wrote directly on HIT problems to HHS Secretry Sebelius on Feb. 24, 2010; see the letter <a href="http://www.scribd.com/doc/27483558/Grassley-Feb-24-Letters">here</a>. -- SS

Congresswoman Renee Ellmers on Health IT Concerns

A letter on Health IT from Congresswoman Renee Ellmers , (R) NC, Chairwoman of the U.S. House of Representative's Committee on Small Bus...

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Now a Mainstream Notion: "Profit-seeking Players in Finance and Health Care Have Captured Congress"

We have been writing - some might say wailing Cassandra-like - about health care dysfunction since I published about it in the European Journal of Internal Medicine in 2003.(1) However, while our dismal warnings were inspired by fears of  health care professionals who saw bad things happening in their local health care environments, the notion that things were really bad in health care really did not get a lot of traction. After all, we were in the second decade of a prolonged economic "great moderation," the good times were rolling, so who was really worried by a few whiners and complainers in health care? However, after the fall of Lehman Brothers ushered in the global financial collapse, or great recession, this complacency was disturbed, and it began to appear that our problems in health care were not unique, but were linked to much bigger problems in the general political economy. However, the stock market rebounded, the bankers went back to making money, and economists declared the great recession over, reassuring those on the right, although the middle class continued to whine and complain about unemployment, stagnant wages, and mortgage foreclosures. Furthermore, a Democratic administration legislated both financial and health care reform, reassuring those on the left. We on <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> went on and on that things were not better, and health care reform no more than barely scratched the surface. Now with stock markets falling around the world, it appears that the great recession/ global financial collapse may not really be over.  In this increasingly dismal era, the notion that health care dysfunction has not really improved, and may in fact be an important component of the larger political economic problems may be getting more mainstream. To wit, last week, David Wessel <a href="http://online.wsj.com/article/SB10001424053111903885604576486001046286690.html">wrote</a> in the Wall Street Journal: <blockquote>Two big sectors of the U.S. economy have been on steroids: finance and health care. If anything is crowding out more productive activities, it's them, as ... [New York University economist Paul] Romer argued in a recent National Academy of Sciences lecture. The bloated financial sector—all those brains lured by big bucks who might otherwise have been employed in science, software, engineering or other fields—has harmed the U.S. economy more than any of our post-World War II communist adversaries did. The American health system costs more per person than any other, but isn't delivering the world's healthiest people. The U.S. isn't getting its money's worth from either sector. </blockquote> Furthermore, his diagnosis of the problem sounds like something we might have written on Health Care Renewal, if we wrote as well as he does: <blockquote>Profit-seeking players in finance and health care have captured Congress, resisted regulation that would curb their excesses and exploited antiquated rules and policy for private gain. [Paul Romer said,] 'The legislative process may just be too vulnerable to manipulation by very well-financed entities with an enormous amount of wealth and income at stake,' he said. 'Congress is for sale at bargain-basement prices.'</blockquote>My only quibble is that while those who have personally profited from health care and finance have exploited antiquated rules, they also cannily managed to dispose of many time-proven rules that stood in their way. In any case, we have written repeatedly about the linkages between finance and health care,(2) and how the current corrupt culture of finance has affected health care; that true health care reform will be very difficult because it will be resisted by those who have been made wealthy by the current system;(3) that they were made wealthy by the increasing commercialization of health care accompanied by the abandonment of previous regulations and safeguards;(4) and about their use of <a href="http://hcrenewal.blogspot.com/search/label/regulatory%20capture">regulatory capture</a> and <a href="http://hcrenewal.blogspot.com/search/label/embedded%20networks%20of%20influence">embedded networks of influence</a>(5) to further their aims. You heard it here first. Wessel's solution is: <blockquote>Congress should tie its own hands more often, retaining power to investigate and vote proposals up or down but avoiding the detailed crafting of legislative provisions that influence the flow of money. In other words, he wants more bodies such as the Base Closure and Realignment Commission (to decide which military bases to close), the Independent Payment Advisory Board (to identify ways Medicare can save money) and, perhaps, the new Joint Select Committee on Deficit Reduction (to find $1.5 trillion in deficit-reduction cuts). Maybe that's an answer. But it's clear that future prosperity depends on the U.S.—its government, business, people and universities—coalescing behind a strategy for growth and creating incentives so talent and capital flow to promising sectors where the U.S. still has an edge in an increasingly competitive global economy.</blockquote> My general suggestions maybe are complementary. True health care reform would help physicians and other health care professionals uphold their traditional values, including, as the AMA once stated, "the practice of medicine should not be commercialized, nor treated as a commodity in trade." True health care reform would put health care "delivery" back in the hands of mission-focused, not-for-profit organizations, which put patients' health, safety and welfare first. Health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses. Notes: 1. Poses RM. A cautionary tale: the dysfunction of American health care.  Eur J Int Med 2003; 14: 123-130.  Link <a href="http://www.ejinme.com/article/S0953-6205%2803%2900029-3/abstract">here</a>. 2.  Medical school leaders become stewards (as members of boards of directors) of for-profit health care corporations - An example is <a href="http://hcrenewal.blogspot.com/2010/12/duke-divinity-students-protest-pay-of.html">here</a>, and a summary of how we discovered this phenomenon in 2006 is <a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html">here</a>. The conflict of interest is severe because directors of for-profit corporations are supposed to have unyielding loyalty to the interests of the corporation and its stockholders, although they are frequently accused of acting mainly as cronies of the top hired executives (see <a href="http://hcrenewal.blogspot.com/2010/07/new-york-times-reports-university.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/01/one-small-step-towards-reducing.html">here</a>). Leaders of failed finance firms become stewards of academic medicine - We have found numerous examples, e.g., <a href="http://hcrenewal.blogspot.com/2010/04/failed-leaders-of-citigroup-as-leaders.html">here</a>, <a href="http://hcrenewal.blogspot.com/2010/04/wamu-worry-more-overlaps-between.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2010/03/members-of-board-of-now-bankrupt-lehman.html">here</a>, of top executives and/or board members of the finance firms who helped bring on the global financial collapse also being trustees of medical schools, academic medical centers, or their parent universities. Such "stewards" may bring to the academic environment the "greed is good" culture now pervasive in finance. 3.  For example, see <a href="http://hcrenewal.blogspot.com/2011/07/health-care-for-very-rich-is-different.html">this post</a> and its links   4. In the US, a Supreme Court decision was interpreted to mean that medical societies could no longer regulate the ethics of their members.  Until 1980, the US American Medical Association had  ruled that the practice of medicine should not be "commercialized, nor treated as a commodity in trade."  After then, it ceased trying to maintain this prohibition.  The result was increasing, now rampant commercialization.  See posts <a href="http://hcrenewal.blogspot.com/2007/12/relman-in-jama-on-threats-to-physicians.html">here</a> and <a href="http://hcrenewal.blogspot.com/2009/06/why-did-us-physicians-give-up-their.html">here</a>.   Furthermore, the notion that information asymmetry, uncertainty and ambiguity, and inability of patients to make coldly rational decisions about disease and its management made it impossible for health care to be an ideal free market, necessitating mechanisms to compensate for market failure became passe.  Such mechanisms were then abandoned, with disastrous results.  For further discussion, see <a href="http://hcrenewal.blogspot.com/2010/08/how-fallacy-of-perfect-health-care.html">this post</a>   5.  For example, see <a href="http://hcrenewal.blogspot.com/2011/06/embedded-networks-of-influence-in.html">this post</a>

Now a Mainstream Notion: "Profit-seeking Players in Finance and Health Care Have Captured Congress"

We have been writing - some might say wailing Cassandra-like - about health care dysfunction since I published about it in the European Jour...

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Retreat Back to Regulatory Capture: US FDA, NIH, Department of Health and Human Services All Back Off

After some brave words about transparency, integrity and all that, US government officials seem to be running back to the arms of the health care corporate CEOs. Weakening FDA Conflict of Interest Rules As <a href="http://www.reuters.com/article/2011/08/01/us-fda-bias-idUSTRE7703R320110801">reported</a> by Reuters, <blockquote>U.S. lawmakers likely will change the criteria for advisers reviewing new medicines next year because of complaints that the rules meant to prevent conflicts of interest make it harder to find real experts. Congressional lawmakers may require the Food and Drug Administration to relax the rules that bar advisers from reviewing a drug if they have even indirect financial ties to related manufacturers, as part of an FDA funding bill.</blockquote> This was not purely an initiative of legislators, but was egged on by a top FDA administrator <blockquote>The agency often must delay panel meetings while it searches for experts without conflicts, lawmakers and FDA officials say. Top doctors are usually the ones drugmakers hire as speakers or consultants. 'We have had difficulty in recruiting highly qualified people. And we've had delays in having panels because of this,' Dr. Janet Woodcock, head of the FDA's drugs center, told a House of Representatives hearing earlier this month. The result is that 23 percent of FDA advisory panels have vacancies, more than double the agency's stated goal, according to the FDA's quarterly report at the end of May.</blockquote> The rationale was that those paid by drug and device companies are the most expert: <blockquote>The FDA tightened guidelines in 2007 to minimize industry ties that could sway a panelist's view, partly inspired by the scandal with Merck's pain reliever Vioxx. Ten of the 32 panelists advising the FDA on the drug consulted for drugmakers. Nine of the 10 recommended putting the drug back on the market after it was pulled in 2004 over concerns about heart risk. The restrictions go too far, say lawmakers who want the FDA to approve more new medicines, in part because they promote American jobs. 'No longer can we deny experts simply because they have ties to industry,' said Georgia Representative Phil Gingrey during a House of Representative hearing on FDA funding last month. The committee's chairman, Fred Upton from Michigan, called the conflict of interest rules 'rigid and unrealistic.' Industry executives, who want the FDA to speed drug approvals, also support relaxing the rules. Biogen Idec CEO George Scangos said the guidelines 'exclude a lot of people who would be the best qualified.'</blockquote> Of course, the drug and device companies have been touting their paid "key opinion leaders" as the best and the brightest for a long time. There is plenty of evidence, however, that they are mainly those whom those companies find the most compliant, and in many cases, those who are willing to be stealth marketers on those companies' payrolls. (See this <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">post</a> about those who recruit KOLs regarding them as salesmen, and more <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">here</a>.)  "Key opinion leaders" supported by commercial grant funding may seem like experts to academic medical institutions' leadership who now value outside funding more than teaching and research excellence (see this <a href="http://hcrenewal.blogspot.com/2010/12/american-medical-schools-are-only-in-it.html">post</a>). Furthermore, as <a href="http://www.politico.com/news/stories/0811/60522.html">reported</a> by Politco, the Project on Government Oversight, a watchdog group, chastised FDA leadership for exaggerating the difficulty of finding unconflicted experts, concluding in their letter to the FDA Commissioner, "to gain the public trust, we must ensure that the FDA relies on the best available information for its policies, rather than personal opinions and biases." So far, government officials seem to be more worried about the opinions of corporate leaders than the public trust. Weakening NIH Conflict of Interest As <a href="http://http//www.nature.com/news/2011/110801/full/476017a.html">discussed</a> in Nature, <blockquote>Francis Collins hailed it as a 'new era of clarity and transparency in the management of financial conflicts of interest' (S. J. Rockey and F. S. Collins J. Am. Med. Assoc. 303, 2400–2402; 2010). But the director of the US National Institutes of Health (NIH) may have spoken too soon when he described a new rule, proposed last year, that would require universities and medical schools to publicly disclose online any financial arrangements that they believe could unduly influence the work of their NIH-funded researchers. Nature has learned that a cornerstone of that transparency drive — a series of publicly accessible websites detailing such financial conflicts — has now been dropped.</blockquote> In more detail, <blockquote>The NIH's parent agency, the Department of Health and Human Services (DHHS), proposed the new rule in May 2010, after congressional and media investigations revealed that prominent NIH grant recipients had failed to tell their universities or medical schools about lucrative payments from companies that may have influenced their government-funded research. The DHHS called the proposed websites 'an important and significant new requirement to … underscore our commitment to fostering transparency, accountability, and public trust'. Under the proposal, institutions with NIH-funded researchers would determine, grant by grant, if any financial conflicts existed for senior scientists on the grant. For example, these would include receiving consultancy fees, or holding shares in a company, 'that could directly and significantly affect the design, conduct, or reporting' of the research. The institutions would post the details online, where they would stay for at least five years. </blockquote> But of course the medical schools decided that it would just be too much trouble to do all this: <blockquote>'The websites don't appear out of nowhere,' says Heather Pierce, senior director of science policy at the Association of American Medical Colleges (AAMC) in Washington DC. They would 'require employees to not only create the website but to pull the information, review it, and make sure it is up to date and accurate'. That is not the only objection from the powerful academic lobbies. During the public comment period last summer, the Association of American Universities and the AAMC submitted a joint statement saying: 'There are serious and reasonable concerns among our members that the Web posting will be of little practical value to the public and, without context for the information, could lead to confusion rather than clarity regarding financial conflicts of interest and how they are managed.'</blockquote> Given how academic medical institutions have expanded their administrations and bureaucracy, the enormous amounts they spend on management, and the huge <a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation">compensation</a> they give their executives, and further given how much of their revenues come from government sources (Medicare, Medicaid money for patient care, Veterans Administration money supporting many faculty members, Medicare money funding graduate medical education, and NIH and other government research grants), the notion that getting a few staffers to process disclosures would be administratively or financially burdensome is just laughable. At least Iowa's Republican Senator Charles Grassley, seemingly one of the last politicians in Washington who cares about the integrity of government programs and spending, is upset. As <a href="http://blogs.nature.com/news/2011/08/senator_urges_white_house_not.html">reported</a> again by Nature, <blockquote>The US Senate's leading advocate for government transparency wrote today to the White House's budget office, demanding that it protect a proposed rule that would obligate universities to post their publicly-funded biomedical researchers' financial conflicts on a publicly accessible website. 'The public's business should be public... I urge OMB to follow through and approve a rule that includes a publicly available website,' Senator Charles Grassley, Republican of Iowa ..., wrote in in <a href="http://blogs.nature.com/news/Grassley.omb.pdf">this letter </a>to Jacob Lew, the director of the White House's Office of Management and Budget (OMB).</blockquote> Furthermore, he wrote: <blockquote>I am troubled that taxpayers cannot learn about the outside income of the researchers whom the taxpayers are funding, and this flies in the face of President Obama's call for more transparency in the government.</blockquote> We will see if his protest does any good, but again it appears that government officials are more worried about the revenues of big health care organizations than the needs of the public. Retreating from Threats to Disbar Forest Laboratories CEO We previously <a href="http://hcrenewal.blogspot.com/2011/05/logical-fallacies-to-defend-ceos-from.html">posted</a> about how the US Department of Health and Human Services threatened to disbar the CEO of Forrest Laboratories from dealings with the government after his company pleaded guilty to obstruction of justice and misbranding, and paid a $313 million fine. Now, <a href="http://online.wsj.com/article/SB10001424053111903885604576490631294926432.html">per</a> Alicia Mundy writing for the Wall Street Journal, things have changed: <blockquote>The U.S. government dropped efforts to force the resignation of a prominent pharmaceutical-company chief executive, reversing course after protests from the company and major business groups. The about-face on Forest Laboratories's longtime leader, Howard Solomon, represents a significant retreat by the Department of Health and Human Services, which has said it wants to step up punishments against drug-company executives when wrongdoing happens on their watch. Forest agreed last year to plead guilty to misdemeanors involving marketing of its drugs including the antidepressant Celexa, and it paid $313 million to resolve the matter. Mr. Solomon wasn't personally accused of any wrongdoing. Nonetheless, the government notified him in April that it was considering excluding him from jobs at health-care companies that sell to the U.S. government. It invoked a little-used clause in the Social Security Act that allows such an action against corporate leaders of companies found guilty of criminal misconduct, even if the leaders had no knowledge of the misconduct. The exclusion move would have effectively forced Forest to remove Mr. Solomon from office, because Forest and other drug companies rely on business from U.S. government agencies such as Medicare and the Veterans Administration. In a letter to Mr. Solomon on Friday, the office of the inspector general of the Department of Health and Human Services said, 'Based on a review of information in our file, and consideration of the information your attorneys provided to us both in writing and in an in-person meeting, we have decided to close this case.'</blockquote> We have <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">discussed</a> - some might say endlessly - how despite numerous publicly reported cases of wrongdoing by health care organizations, hardly any individual who authorized, directed or implemented the bad behavior has ever faced any negative consequences. There have been recent fulminations by some government officials that this is going to change. The case of the Forest Laboratories CEO appeared to be an example of such change, but no more. The Wall Street Journal went on to discuss why the government may have changed course: <blockquote>The government's retreat came after a barrage of complaints from Forest and business groups including the U.S. Chamber of Commerce and the Pharmaceutical Research and Manufacturers of America, the drug industry's leading trade group. In July, Forest spent $80,000 to hire former Louisiana Sen. John Breaux to lobby the government regarding exclusion, according to Senate records. Mr. Breaux didn't return a call requesting comment. Forest said earlier that it was just trying to make its case that this was a highly unusual action by the U.S. government.</blockquote> Of course it was unusual. That is the whole problem. In any case, it looked like the government was much more concerned about the coddling of corporate CEOs and their lobbyists' and cronies' opinions than about deterring bad behavior by large health care organizations. Summary After a bit of blustering by the current US administration about transparency and integrity it appears to be back to business as usual in the US capital. Over the last 20 years, government has increasingly answered to corporate CEOs instead of "we, the people." Protecting patients' and the public's health has given way to protecting the financial health of large health care organizations, and the compensation of rich CEOs. Federalism is giving way to corporatism. As long as this continues, expect our health care system to continue its slow collapse. Eventually, expect the CEOs to get in their private jets and escape while the rest of us picks up the pieces. Until we dispel the fog of corporatism that has spread over the government that was once supposed to be of the people, by the people, and for the people, expect no real health care reform, and expect continuing rising costs, declining access, and worsening patient care. Obviously, true health care reform would start with the government and its officials putting patients' and the public's health first, way ahead of the financial comfort of corporate CEOs. See also <a href="http://alison-bass.blogspot.com/2011/07/tougher-nih-rules-about-financial.html">comments</a> by Alison Bass.

Retreat Back to Regulatory Capture: US FDA, NIH, Department of Health and Human Services All Back Off

After some brave words about transparency, integrity and all that, US government officials seem to be running back to the arms of the health...

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