healthy4u

Johnson and Johnson Pleads Guilty - a Reminder of the "Lost Decade" of Nesiritide

It was just a <a href="http://www.bloomberg.com/news/2011-07-09/j-j-s-scios-unit-charged-in-misbranding-of-natrecor-drug-1-.html">short article</a> in Bloomberg about yet another misstep by Johnson and Johnson.... <blockquote>Johnson & Johnson (JNJ)’s Scios unit agreed to pay an $85 million fine and plead guilty to misbranding the heart drug Natrecor, the U.S. said. Scios was charged in July with misbranding the medicine because its labeling lacked adequate directions for use. Under a plea agreement reached after months of negotiation with prosecutors, Scios will be placed under organizational probation for three years in addition to paying the fine....</blockquote> Although the case did involve a guilty plea, the fine actually seemed small compared to some others we have seen lately. The article made it sound like this was just a technical mis-step in labeling. A Darker History However, another brief paragraph hinted at a more complex background: <blockquote>Natrecor, given intravenously, was one of the first drugs for congestive heart failure when it was approved in 2001, and in 2004 it generated $230 million in revenue. Sales plummeted to less than $100 million in 2006 after reviews of its use in less than 1,000 patients tied the medicine to worsening kidney function and higher death rates. </blockquote> Of course, to a physician, the first sentence makes no sense. Digitalis was probably the first effective drug for heart failure, and its use was described in the 18th century. To the rest we should pay heed. A Lack of Evidence for Benefit Outweighing Harm In fact, in 2005, Dr Eric Topol wrote a commentary in the New England Journal that discussed Natrecor's (nesiritide's) troubled history.(1) Here are the main points: - Nesiritide was first tested on seriously ill, hospitalized patients with congestive heart failure. - The drug improved one measure of physiogic function, the pulmonary capillary web pressure. However, patients given nesiritide had a not statistically significant increase in mortality, and a later significant decrease in kidney function. - Nesiritide was thus only approved for short-term use in acutely ill heart failure patients (in 2001). - However, its manufacturer, Scios, a Johnson and Johnson subsidiary, vigorously promoted it for out-patient "tune ups," a use for which there was no evidence that its benefits outweighed its harms. - This use, however, was very lucrative for the company at a price of $500 per dose. So, <blockquote>outpatient nesiritide use has become widespread, fulfilling sales objectives for the manufacturer and bringing in revenue for physicians. The overall sales figure for nesiritide is projected to be $700 million for 2005, nearly double last year's tally; it represents payment for more than 1.4 million treatments. Given that nearly 10 times as much drug is used for serial administration in outpatients as for the one-time use in hospitalized patients, much of this growth clearly stems from the off-label 'tune-up' application.</blockquote> At that time, Dr Topol summarized the case thus: <blockquote>The nesiritide story reflects some recurring themes: in other recent cases, too, major safety problems have been uncovered after a drug has been approved. Nesiritide was approved on the basis of a single trial in which surrogate end points were assessed three hours after administration. In cardiovascular medicine, we learned long ago that therapies directed at surrogate end points — such as the suppression of premature ventricular contractions or, for inotropic agents, an improved ejection fraction — can be associated with excess deaths. With the low threshold set for regulatory approval, the FDA did not demand appropriate warnings on the label regarding an increased risk of death or worsened renal function and did not require the performance of trials that would have provided definitive verification of the safety and efficacy of nesiritide. We practice medicine in an era in which there is one pharmaceutical-company representative for every five physicians and in which companies will stretch the limits in their marketing of drugs. The boundary lines that previously separated industry from the FDA and academia have unfortunately become blurred. </blockquote>No Evidence of Benefit in 2011, the End of the "Lost Decade" Finally, in 2011, a larger study of the drug appeared.(2) It did not show that nesiritide increased mortality at 30 days, but neither did it decrease it. Essentially, it showed that the drug had no clinically important advantage over standard therapy. In an accompanying commentary, Dr Topol used the nesiritide case as an example of a "lost decade" due to "deficient clinical development of certain pharmaceutical agents."(3) <blockquote>The FDA, without a prospective plan or capability to force the sponsor to perform a fitting trial after approval, unwittingly created a monster. Physicians, who prescribed nesiritide without definitive knowledge of efficacy or safety, particularly for off-label use such as for tune-up clinics, were treating patients without an adequate evidence base. The manufacturer in this case was the chief culprit because it widely promoted nesiritide in the early years after its approval but was unwilling to appropriate the resources to design and execute a compelling trial. </blockquote> Summary The sorry nesiritide case now seems to be staggering towards its conclusion with little fanfare (although the Bloomberg article noted that the legal proceedings related to it are not over.  There is a pending civil False Claims suit brought by the US Department of Justice.) So, 10 years after the drug was widely marketed to patients for whom it would do no good, the "chief culprit" has had a pay a small financial price, relative to the revenue it received, for an offense tangential to the lost decade created for patients and physicians who thought that nesiritide might be worth using. As usual in such cases, no individual who authorized, directed or implemented the "monster" that was the dubious nesiritide marketing campaign has suffered any negative consequences. This was just the latest in a long series of legal misadventures by the once revered Johnson and Johnson. Its most recent guilty plea for a marketing offense was only a month ago (see post <a href="http://hcrenewal.blogspot.com/2011/08/why-cultivate-weldons-confidence-ceo.html">here</a>.) That blog post listed five other recent adverse legal results related to the company's marketing. Of course, as long as the company's leaders seem immune to any sort of negative consequences for its bad behavior, and as long as its board seems happy to pay millions to the executives who preside over these messes, why should the bad behavior stop? Do we expect multi-millionaire executives to actually worry about the ethics and morals of what they are doing? - not in an era when "greed is good," at least until the whole economy collapses from the aggregated greed of its leaders. For physicians, the nesiritide case should remind us not to deploy a test or treatment without good evidence that it actually does patients more good than harm, even if we really hope it does, and even if the company that markets it really hopes so too.  For all of us, the case should remind us that if there are short-term monetary rewards but no penalties for unethical behavior, unethical behavior will continue. References 1. Topol E. Nesiritide - not verified. N Engl J Med 2005; 353: 113-116. Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMp058139">here</a>. 2. O'Connor CM, Starling RC, Hernandez AF et al. Effects of nesiritide in patients with acute decompensated heart failure. N Engl J Med 2011; 365: 32-43. Link <a href="http://www.nejm.org/doi/full/10.1056/nejmoa1100171">here</a>. 3. Topol EJ.  The lost decade of nesiritide.  N Engl J Med 2011; 365: 81-82.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMe1103116">here</a>.

Johnson and Johnson Pleads Guilty - a Reminder of the "Lost Decade" of Nesiritide

It was just a short article in Bloomberg about yet another misstep by Johnson and Johnson.... Johnson & Johnson (JNJ)’s Scios unit agre...

Đọc thêm »

NPfIT Programme goes "PfffT"

More on the travails of the UK's moribund National Programme for IT in the NHS. It's officially gone "PffffT"... <blockquote> <a style="font-weight: bold;" href="http://www.guardian.co.uk/society/2011/sep/22/nhs-it-project-abandoned">NHS told to abandon delayed IT project</a> Denis Campbell, health correspondent The Guardian, Wednesday 21 September 2011 £12.7bn computer scheme to create patient record system is to be scrapped after years of delays The NHS has spent billions of pounds on a computerised patient record and booking system, which has never worked properly. An ambitious multibillion pound programme to create a computerised patient record system across the entire NHS is being scrapped, ministers have decided. The £12.7bn National Programme for IT is being ended after years of delays, technical difficulties, contractual disputes and rising costs.</blockquote> And failure to read and comprehend sites like "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/">Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties</a>" (extant since ca. 1999) and this very blog... <blockquote> Health secretary Andrew Lansley, Cabinet Office minister Francis Maude and NHS chief executive Sir David Nicholson have decided it is better to discontinue the programme rather than put even more money into it. The axe may be wielded , with ministers likely to criticise the last Labour government for initiating the project but doing too little to ensure it delivered its objectives. An announcement has been expected for months after the National Audit Office cast serious doubt on the wisdom of ploughing further money into the scheme and David Cameron told MPs in May that he was considering that advice. Whitehall sources confirmed the decision had been made because of coalition cost-cutting and the ongoing problems. "It was meant to be a very helpful thing for NHS staff and patients but instead has become this amazingly top-heavy, hideously expensive programme. The problem is, it didn't deliver", said a Department of Health source.</blockquote> We, of course, in the United States will learn from all this and our "National Program for IT in the HHS" will go splendidly... <blockquote>"It was too ambitious, the technology kept changing, and loads and loads of money has been put into it. It's wasted a lot of money that should have been spent on nurses and improving patient care, and not on big international IT companies."</blockquote> Perhaps they do read Healthcare Renewal after all, because I've written exactly that in numerous posts... <blockquote>The move comes after ministers received fresh advice from the Cabinet Office's major projects authority, which assesses the value for money of major public spending schemes. It concluded "there can be no confidence that the programme has delivered or can be delivered as originally conceived", recommending ministers "dismember the programme and reconstitute it under new management and organisation arrangements".</blockquote> How about with leaders with domain-specific expertise, too, as I wrote at my Aug. 2010 post "<a href="http://hcrenewal.blogspot.com/2010/08/are-computers-in-medicine-narcotic-why.html">Are computers in medicine narcotic? Why did the National Programme for IT fail?</a>" At that post I sadly observed that: <blockquote>... [NPfIT] also failed because of collective ignorance of these domains [e.g., healthcare informatics, social informatics, etc. - ed.] among its leaders, and among those who chose the leaders. For instance, as I wrote <a href="http://hcrenewal.blogspot.com/2009/12/uk-mp.html">here</a>: <blockquote>The Department of Health has announced the two long-awaited senior management appointments for the National Programme for IT ... The Department announced in February that it was recruiting the two positions as part of a revised governance structure for handling informatics in the Department of Health. Christine Connelly will be the first Chief Information Officer for Health and will focus on developing and delivering the Department's overall information strategy and integrating leadership across the NHS and associated bodies including NHS Connecting for Health and the NHS Information Centre for Health and Social Care.Christine Connelly was previously Chief Information Officer at Cadbury Schweppes with direct control of all IT operations and projects. She also spent over 20 years at BP where her roles included Chief of Staff for Gas, Power and Renewables, and Head of IT for both the upstream and downstream business. Martin Bellamy will be the Director of Programme and System Delivery. He will lead NHS Connecting for Health and focus on enhancing partnerships with and within the NHS. Martin Bellamy has worked for the Department for Work and Pensions since 2003. His main role has been as CIO of the Pension Service.</blockquote> Excuse me. Cadbury Schweppes (candy and drink?) The Pension Service? As national leaders for healthcare IT? Instead of sobriety, attitudes about health IT seem to universally be "sure, the experts think you shouldn’t ride a bicycle into the eye of a hurricane, but we have our own theories." (See <a href="http://hcrenewal.blogspot.com/2008/12/open-letter-to-president-barack-obama.html">here</a> and <a href="http://hcrenewal.blogspot.com/2008/05/htrea-parallel-world-of-hit.html">here</a>.) The domain of health IT needs a very stiff period of detox and rock-solid sobriety before it can achieve the (non-revolutionary) benefits of which it is capable. </blockquote> Riding bicycles into eyes of hurricanes, I'm sorry to say, really is not a good idea. Back to the current Guardian article: <blockquote>Its highly critical verdict said: "The project has not delivered in line with the original intent as targets on dates, functionality, usage and levels of benefit have been delayed and reduced. It is not possible to identify a documented business case for the whole of the programme. Unless the work is refocused, it is hard to see how the perception can ever be shifted from the faults of the past and allowed to progress effectively to support the delivery of effective healthcare."</blockquote> That is a stark assessment. I think we in the U.S. remain deluded as to the true complexity of a scheme for national health IT, using today's systems. <blockquote>Health minister Simon Burns, who is responsible for the NHS, said recently: "The nationally imposed system is neither necessary nor appropriate to deliver this. We will allow hospitals to use and develop the IT they already have and add to their environment either by integrating systems purchased through the existing national contracts or elsewhere." Providers of NHS care such as hospitals and GP surgeries will now be told to strike IT deals locally and regionally to get the best programmes they can afford. </blockquote> Common sense regarding the need for some degree of local control in healthcare, in a country with socialized medicine yet. <blockquote>It is still unclear how much money the government has agreed to pay contractors in recent negotiations over cancellation fees for scrapping the project. </blockquote> Let's just say, the amount will not be peanuts. <blockquote>Lansley told the the Daily Mail: "Labour's IT programme let down the NHS and wasted taxpayers' money by imposing a top-down IT system on the local NHS, which didn't fit their needs. "We will be moving to an innovative new system driven by local decision-making. This is the only way to make sure we get value for money from IT systems that better meet the needs of a modernised NHS." Serious doubts about the project's future were confirmed this year when the cross-party House of Commons public accounts committee said it was "unworkable" and that, despite huge investment, had failed to deliver.</blockquote> Sadly, I knew and predicted this years ago. And I'm not even British, although I have spoken to many <a href="http://en.wikipedia.org/wiki/Amateur_radio_call_signs_of_Great_Britain">G-prefixed ham radio operators</a> over the years. This is one prediction I am not happy to see come true. You can guess the next prediction of mine that I hope also doesn't occur. -- SS

NPfIT Programme goes "PfffT"

More on the travails of the UK's moribund National Programme for IT in the NHS. It's officially gone "PffffT"... NHS told ...

Đọc thêm »

Australia and Health IT: Will Government Officials Ever Learn?

Perhaps New Zealand professor Shaun Goldfinch's article "Pessimism, Computer Failure, and Information Systems Development in the Public Sector" should be required reading in their neighboring continent due northwest: <blockquote>Pessimism, Computer Failure, and Information Systems Development in the Public Sector. (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand). Cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Goldfinch_pessimism_PAR.pdf">link</a> to pdf</blockquote> Here's what's about to "go down" (no pun intended) Down Under, this time in the Australian state of <a href="http://en.wikipedia.org/wiki/Queensland">Queensland</a>: <blockquote> <a style="font-weight: bold;" href="http://www.couriermail.com.au/news/queensland/health-software-on-the-sick-list/story-e6freoof-1226142181877">Queensland Health eyes software system despite red flags </a> Koren Helbig From: The Courier-Mail September 21, 2011 12:00AM QUEENSLAND Health is poised to sign a multimillion-dollar contract for computer software similar to that labelled "defective" by an IT expert who audited its use in southern hospitals. University of Sydney's Professor Jon Patrick said electronic medical records systems built by Cerner Corporation for the NSW Government crashed frequently and risked patient safety. A similar Cerner system installed by the Victorian health department also has been plagued by glitches and is five years behind schedule.</blockquote> Dr. Jon Patrick's detailed forensic analysis of a Cerner ED system is <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=91&Itemid=146">at this link</a> and has been a subject of numerous posts on this blog. <blockquote>"I don't think there's any reason for optimism that they can be improved," Prof Patrick said. Leaked internal documents have surfaced detailing problems already looming within Queensland, as bureaucrats negotiate with US-based Cerner to build a $243 million electronic medical records system in Queensland hospitals. Technical information for the proposed Cerner system and existing IT platforms that it must work with was "often incomplete, not-comprehensive, inaccurate and out-of-date", a leaked position paper found. Another email addressed to chief information officer Ray Brown, released to the State Opposition under Right to Information laws, warned of the increasing need to document potential risks "even if we can't find the resources to remove them" in case of disaster and patient death.</blockquote> I guess dead patients can't complain about that, unless provided with underground megaphones. <blockquote>"The no-surprises rule may be applicable and would help in a Coroner's Court," the clinical adviser wrote. But, in a written statement, Mr Brown last night backed Cerner, which he said had successfully operated systems at the Royal Brisbane and Women's and Princess Alexandra hospitals for more than a decade.</blockquote> A few anecdotes of success, let's ignore those pesky anecdotes of problems, and - WHAM! - let's spend billions and roll this out statewide/nationwide. The problem with this (il)logic was well-explained by another physician Down Under who chooses to remain anonymous. See my August 2011 post "From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things" <a href="http://hcrenewal.blogspot.com/2011/08/from-senior-clinician-down-under.html">at this link</a>. Read it carefully.... <blockquote>Mr Brown said Queensland had learnt from interstate problems and would implement an "end-to-end solution", rather than trying to marry different systems across hospitals. Independent experts had verified the rollout and more than 4000 staff had been consulted, indicating their support for Cerner software, he said. The debate came after The Courier-Mail yesterday detailed Opposition claims that Queensland Health bureaucrats deliberately changed an independent report to favour Cerner when hunting for software suppliers in 2009, which QH vehemently denied. Prof Patrick, chair of Language Technology at the university's School of IT, said problems with Cerner's NSW and Victorian systems were well documented in 2009. He said Queensland bureaucrats likely knew of the faults, which should have served as "red flags". Cerner did not respond to a call for comment.</blockquote> May I suggest that "red flags" often get ignored when the color green is present, at least in the U.S. (I don't know the colors of Australian currency.) <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiHLTMH1usG4D_gk7S1KF2vxfi2nsRdQGPHK9P7YUhyphenhyphen8STBFJf-NZ-HN9pvkfeW9VgUFkbuXktE-bog-sEHeBK4-Eb-OhOa5B12sVmgfJU5mG_eyj_VqR8BM6yqsS6K3Di9nyyfyyParK99/s1600/100k.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5654573291010095522" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiHLTMH1usG4D_gk7S1KF2vxfi2nsRdQGPHK9P7YUhyphenhyphen8STBFJf-NZ-HN9pvkfeW9VgUFkbuXktE-bog-sEHeBK4-Eb-OhOa5B12sVmgfJU5mG_eyj_VqR8BM6yqsS6K3Di9nyyfyyParK99/s320/100k.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 381px; height: 161px;" /></a>Who cares about "Red flags" when you can have wads of these? </div> -- SS Addendum: Dr. Patrick notes this at his aforementioned university page: <blockquote>3.13 Statement on 22nd August 2011. I attended the HIC conference in Brisbane in the beginning of August and at a dinner hosted by IBM on the 2nd August I met Mr Greg Wells, the CIO of HSS, and the person responsible for the FirstNet roll out in NSW. He stated that Cerner had provided new software that would solve all of the User Interface problems and it was being rolled at the present time in the Northern Area Health Service region. He said all installations across the state would have this solution by Christmas this year. We shall watch with interest. </blockquote> I guess solving problems <a href="http://sydney.edu.au/engineering/it/%7Ehitru/index.php?option=com_content&task=view&id=120&Itemid=116">like these</a> simply takes a lot of pizzas and Coca-Cola. -- SS

Australia and Health IT: Will Government Officials Ever Learn?

Perhaps New Zealand professor Shaun Goldfinch's article " Pessimism, Computer Failure, and Information Systems Development in the P...

Đọc thêm »

What the Pfizer (IV)? - One Board to Rule Them All

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>).  We then discussed lack of transparency in Pfizer's communication about management performance <a href="http://hcrenewal.blogspot.com/2011/08/what-pfizer-ii-lack-of-transparency.html">here</a>, and how bad management was rewarded with outsize compensation <a href="http://hcrenewal.blogspot.com/2011/08/what-pfizer-iii-enormous-pay-for-poor.html">here</a>.  To continue what has become a lengthy series, let us now discuss the board of directors who were responsible for "stewardship" or governance of what turned out to be a very troubled company. Let us focus on the membership of the boards that appointed the two CEOs Fortune described as failed. Henry A "Hank" McKinnell - 2001 In 2001, the board appointed Henry A "Hank" McKinnell CEO.    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. In 2001, the board is as listed below.  (I include their current positions, any former positions as chairman, CEO, president or the equivalence, and current leadership positions in health care or finance.)  - - Michael S Brown - Distinguished Chair in Biomedical Sciences, Texas Southwestern Medical Center...  Director of Regeneron Pharmaceuticals - M Anthony Burns - Chair of the Board, former CEO of Ryder System Inc ...  Director of JP Morgan Chase and Co...  Trustee of the University of Miami - Robert N Burt - Chairman of the Board and CEO of FMC Corporation...  Director of the Rehabilitation Institute of Chicago and Evanston Hospital Corp - W Don Cornwell - Chairman of the Board and CEO of Granite Broadcasting Corporation...  Director of CVS Corporation - William H Gray III - President and CEO of the College Fund/UNCF...   Director of JP Morgan and Co...  Trustee of the University of Miami - Constance J Horner - Guest Scholar at the Brooking Institution...  Director of the Prudential Insurance Company of America - William R Howell - Chairman Emeritus and former CEO of JC Penney Company Inc...  - Stanley O Ikenberry - President of the American Council on Education...  Former President of the University of Illinois...  President of the Board of Overseers of Teachers' Insurance and Annuity Association - College Retirement Equities Fund (TIAA-CREF) - Harry P Kamen - Former Chairman of the Board and CEO of Metropolitan Life Insurance Company...  Director of Banco Santander Central Hispano SA, BDirect Capital ...  Metropolitan Life Insurance Company - George A Lorch - Chairman Emeritus and Former CEO of Armstrong Holdings Inc... - Alex J Mandl -  Chairman of the Board and CEO of Teligent - Henry A McKinnell - CEO of Pfizer...  Director of Moody's Corporation - Dana G Mead - Retired Chairman and CEO of Tenneco Inc...  Director of Zurich Financial Services - John F Niblack - President of Pfizer Global Research and Development - Franklin D Raines - Chairman and CEO of Fannie Mae...  - Ruth Simmons - President of Brown University... Director of Goldman Sachs Group Inc, Metropolitan Life Insurance - Michael I Sovern - Chairman of the Board of Sotheby's Holdings Inc...  President Emeritus of Columbia University  - Jean-Paul Valles - Chairman and Former CEO of Minerals Technology Inc - William C Steer Jr - Former CEO of Pfizer...  Director of Metropolitan Life Insurance Company...  Director of New York University Medical Center....  Member of the Board of Overseers of Sloan-Kettering Cancer Center The box score is...  Of 19 directors, 17 were current or former chairpeople or CEO/ Presidents of large organizations.  Eight  had leadership positions at teaching hospitals, academic medical centers, medical schools or their parent universities, or other influential non-profit health care organizations.  1 had a leadership position at a potentially competing pharmaceutical company.  1 had a leadership position at a pharmacy corporation. Furthermore, 10 had leadership positions in financial services corporations, including some that were implicated in the global financial collapse, and/or required massive federal bail-outs to avoid collapse. Jeffrey Kindler 2006 In 2006, the board appointed Jeffrey Kindler CEO.  Mr 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 board in 2006 appears below, with information formatted as above.  Note that all were members in 2001, although some members from 2001 were no longer there.  - Michael S Brown - Distinguished Chair in Biomedical Sciences at University of Texas Southwestern Medical Center at Dallas...  Director of Regeneron Pharmaceuticals. - M Anthony Burns - Chairman and CEO Emeritus of Ryder System Inc....  Life trustee of the University of Miami - Robert N Burt - Retired Chairman and CEO of FMC Corporation... - W Don Cornwell - Chairman of the Board and CEO of Granite Broadcasting Corporation....  Director of CVS Corporation. - William H Gray III - Chairman of the Amani Group...  Director of JP Morgan Chase and Co, Prudential Financial Inc - Constance J Horner - Former Guest Scholar at the Brookings Institute...  Director of Prudential Financial Inc - William R Howell - Chairman and CEO Emeritus of JC Penney Company Inc...  Director of Deutsche Bank Trust Corporation and Deutsch Bank Trust Company Americas. - Stanley O Ikenberry - President Emeritus University of Illinois...  President, Board of Overseers TIAA-CREF - George A Lorch - Chairman and CEO Emeritus of Armstrong Holdings Inc....  Director of HSBC Finance Co and HSBC North America Holding Company. - Henry A McKinnell - CEO of Pfizer...   Director of Moody's Corporation. - Dana G Mead - Chairman of Massachusetts Institute of Technology Corporation.  Former Chairman and CEO of Tenneco Inc...  Director of Zurich Financial Services. - Ruth J Simmons - President of Brown University...  Director of Goldman Sachs Group Inc. - William C Steere Jr - Chairman and CEO Emeritus of Pfizer...  Director of Metlife Inc and Health Management Associates...  Director of New York University Medical Center...  Member of the Board of Overseers of Memorial Sloan-Kettering Cancer Center. The new box score is similar to the old one, as expected, since none of the directors in 2006 was new since 2001.  Of 13 directors, 11 were current or former chairpeople or CEO/ Presidents of large organizations. Five had leadership positions at teaching hospitals, academic medical centers, medical schools or their parent universities, or other influential non-profit health care organizations. 1 had a leadership position at a potentially competing pharmaceutical company. 1 had a leadership position at a pharmacy corporation. 1 had a leadership position at a for-profit hospital operating company. Furthermore,  9 had leadership positions in financial services corporations, including some that were implicated in the global financial collapse, and/or required massive federal bail-outs to avoid collapse. Summary The board that acquiesced to huge compensation for very dysfunctional leadership arguably provided dubious "stewardship" of the company and the interests of its stockholders.  The composition of the board suggests some reason for this.  The board itself was mainly composed of current and former CEOs, and hence may have felt more in common with the executives whom it was supposed to supervise than the stockholders.  Many board members had conflicts of interests, also leading organizations that were supposed to be dealing at least at arms length with Pfizer.  Many of the board members were likely influenced by the corporate culture of the financial services industry, since they were in leadership roles there as well.  That culture, which let unaccountable, hugely remunerated executives gamble with other peoples' money, personally benefit when the gambles went well, and unload their losses on others, including tax-payers when their gambles failed, seems to have infected health care. We have often discussed how conflicted, overpaid, and/or unaccountable leadership can damage non-profit health care organizations, like hospitals and academic medical institutions.  I would suggest it can also damage for-profit health care corporations, sapping their ability to create new and useful products, and undercutting shareholders. I submit that all health care organizations would benefit from leadership and stewardship that cares more about patients' and the public's health, and the values of health care professionals than it does about the welfare of CEOs; that is accountable for and receives incentives proportionate to its effect on health and health care; and that is free from conflicts of interest and corruption.  True health care reform would reform health care leadership and governance.

What the Pfizer (IV)? - One Board to Rule Them All

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

Đọc thêm »

Blake Medical Center (Bradenton, Fla.) Ignores Health IT Warning Letter From 100 Staff Physicians

In an article in the Bradenton Herald, Bradenton, FL, I found the following passage I bolded below truly striking: <a href="http://www.bradenton.com/2011/09/04/3467295/digital-doctors-will-technology.html"></a><blockquote><a href="http://www.bradenton.com/2011/09/04/3467295/digital-doctors-will-technology.html">Digital doctors: Will technology help or harm?</a> Sept. 4, 2011 By DAVID GULLIVER BRADENTON -- At <a href="http://blakemedicalcenter.com/home/index.dot">Blake Medical Center</a>, the prognosis for pen and paper is poor: Doctors’ traditional tools for tracking cases and ordering medications and procedures are being phased out in favor of computers. ... Blake [Medical Center], which has been building its EHR system for years, launched a feature in April for doctors to enter their daily progress notes electronically. In June, it added a feature for ordering medications and procedures via computer. It’s part of a national push, called hCare, by Blake’s parent company HCA. But many doctors were reluctant to give up their pens. More than 100 staff physicians signed a letter asking for the computerization project to be put on hold, saying the system is cumbersome and likely to induce errors.</blockquote><div style="border: medium none; text-align: left; background-color: transparent; color: rgb(0, 0, 0); overflow: hidden; text-decoration: none;">Wow. Physicians with guts. If I were an executive at this hospital, I'd make sure I were fully insured and my assets were in my spouse's name, especially in lawsuit-happy Florida. If a patient injury or death occurs related to the EMR issues addressed in the letter from 100 staff physicians, which would/should seriously concern if not absolutely alarm any reasonable person, there could be charges of negligence, including criminal negligence, against the administration. <a href="http://legal-dictionary.thefreedictionary.com/Criminal+Negligence"></a><blockquote><a href="http://legal-dictionary.thefreedictionary.com/Criminal+Negligence">Criminal negligence</a>: The failure to use reasonable care to avoid consequences that threaten or harm the safety of the public and that are the foreseeable outcome of acting in a particular manner ... Criminal negligence is negligence that is <a href="http://definitions.uslegal.com/c/criminal-negligence/">aggravated, culpable or gross</a>. </blockquote>A jury will not be happy with the letter being ignored, either. <blockquote>... The project’s supporters acknowledge doctors and nurses have made mistakes as they learn the system, though they are unaware of any resulting in harm to patients. [Is that how you want your healthcare to proceed? - ed.] </blockquote>In other words, no patient exposed to this experiment and its risks (a key issue here) was known to "hit the jackpot" - yet: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiJxrkTkwmZ4rUVbNMcwUGcPnqsuk5muXrpiwzPFpGyAIZPQrsk4eKnupZETpkoJ4ErpTkqK7djgYv1Kclh7hhWHfWJZRAr2OlaFa6T52CNYS7icmgYYH2NK5VyMDlhIYReUqrKRjgnAz6j/s1600/winner.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5653834695663706834" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiJxrkTkwmZ4rUVbNMcwUGcPnqsuk5muXrpiwzPFpGyAIZPQrsk4eKnupZETpkoJ4ErpTkqK7djgYv1Kclh7hhWHfWJZRAr2OlaFa6T52CNYS7icmgYYH2NK5VyMDlhIYReUqrKRjgnAz6j/s320/winner.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 320px; height: 240px;" /></a>The EHR Slot Machine of Risk. Click to enlarge. (From my March 2011 post "<a href="http://hcrenewal.blogspot.com/2011/03/on-emr-forensic-evaluation-from-down.html">On an EMR Forensic Evaluation by Professor Jon Patrick from Down Under: More Thoughts</a>.") Congratulations! You've hit the EHR mis-processing jackpot! Perhaps today is a good day to die... </div> <blockquote>But they contend that, in the long run, an electronic system will be safer than using paper records -- something critics grudgingly admit. Still, even as a $27 billion federal program is encouraging hospitals and doctors to launch EHR systems, no regulatory agency tests or regulates them. So a crucial question remains unanswered: Does it truly improve care? [Nobody really knows - e.g., see recent post <a href="http://hcrenewal.blogspot.com/2011/09/does-highly-wired-correspond-to-best.html">here</a>, and literature list <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">here</a> - ed.] </blockquote> Critics readily admit health IT has the potential to improve healthcare, but that the technology is not yet nearly ready to do so, especially on a national basis, and is experimental. Far more work is needed. For example, according to the <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">National Research Council of the United States</a>: <blockquote>Current efforts aimed at the nationwide deployment of health care information technology (IT) will not be sufficient to achieve medical leaders' vision of health care in the 21st century and may even set back the cause, says a new report from the National Research Council. The report, based partially on site visits to eight U.S. medical centers considered leaders in the field of health care IT, concludes that greater emphasis should be placed on information technology that provides health care workers and patients with cognitive support, such as assistance in decision-making and problem-solving. ... In the long term, success will depend upon accelerating interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering.</blockquote> Critics also readily admit that organizations experimenting with this technology without patient informed consent, on the basis of some future good, need lessons on the ethics of human experimentation. Risk to patients seems to be of little concern to this industry. It also now seems that hospital executives have become so arrogant that they fail to recognize the risks to themselves in ignoring their own medical staffs on HIT issues. Perhaps they think they will be able to simply blame the physicians, using clinicians as scapegoats, but with official sites like <a href="http://www.ucguide.org/">this</a> now coming online ... I think that excuse will rapidly lose traction. </div>-- SS Sept. 19 addendum: A major motivator for ignoring the physicians' warnings at this <a href="http://hcahealthcare.com/home/index.dot">HCA</a> (Hospital Corp. of America) hospital may be financial. See my Aug. 2011 post "<a style="font-weight: bold;" href="http://hcrenewal.blogspot.com/2011/08/why-ehrs-are-mission-hostile.html">Why EHR's Are Mission Hostile</a>." -- SS

Blake Medical Center (Bradenton, Fla.) Ignores Health IT Warning Letter From 100 Staff Physicians

In an article in the Bradenton Herald, Bradenton, FL, I found the following passage I bolded below truly striking: Digital doctors: Will tec...

Đọc thêm »

Another Episode of "But Don't Worry, Your Records are Safe..."

Oops! <a href="http://www.independent.co.uk/life-style/health-and-families/health-news/nhs-trust-sends-data-cd-to-landfill-2355834.html"></a><blockquote><a href="http://www.independent.co.uk/life-style/health-and-families/health-news/nhs-trust-sends-data-cd-to-landfill-2355834.html">NHS trust sends data CD to landfill</a> By Wesley Johnson Friday, 16 September 2011The personal information of 1.6 million people has been put at risk after a CD was sent to a landfill site by an NHS trust by mistake, a watchdog said. The Eastern and Coastal Kent Primary Care Trust put the CD, which contained the name, address, date of birth, NHS number and GP of about 1.6 million people, in a filing cabinet during an office move. But no one told staff who sent the cabinet to the landfill site and it has not been recovered, the Information Commissioner's Office said. ... An undertaking signed by the trust's chief executive Ann Sutton read: "The Information Commissioner was provided with a report by the data controller informing that a filing cabinet containing personal data had been sent to landfill during a move of office premises. "The filing cabinet contained a CD holding the address, date of birth, NHS number and GP practice code of approximately 1.6 million individuals. </blockquote> Read the whole article. They promise to be more careful - next time. <blockquote> The trust said it would now take action to bring in clear policies and procedures for when moving office, improve staff training and boost security against unauthorised and unlawful processing, accidental loss, destruction and damage of personal records.</blockquote> That is reassuring - I guess. -- SS

Another Episode of "But Don't Worry, Your Records are Safe..."

Oops! NHS trust sends data CD to landfill By Wesley Johnson Friday, 16 September 2011 The personal information of 1.6 million people has b...

Đọc thêm »

Does "Highly wired" Correspond to "Diligence in Following Guidelines" for Care?

One might think the hospitals that have spent tens or hundreds of millions of dollars on healthcare IT would fare the best in performance measures, i.e., adherence to guidelines (irrespective of whether those measures reflect better outcomes, a topic for another time). Yet, once again that does not appear to be the case. This might seem paradoxical at first glance. However, as I tell my students, there are no paradoxes - only false assumptions: <blockquote style="font-family:arial;"> <a href="http://www.nytimes.com/2011/09/15/us/hospital-performance-improved-report-finds.html?_r=1">Report Finds Improved Performance by Hospitals</a> New York Times By KEVIN SACK Published: September 14, 2011 In the latest advance for health care accountability, the country’s leading hospital accreditation board, the Joint Commission, released a <a title="Link to Joint Commission list of top performers." href="http://www.jointcommission.org/assets/1/18/Top_Performers_2010_list_9_13_11.pdf">list</a> on Tuesday of 405 medical centers that have been the most diligent in following protocols to treat conditions like <a href="http://health.nytimes.com/health/guides/disease/heart-attack/overview.html?inline=nyt-classifier" title="In-depth reference and news articles about Heart attack." class="meta-classifier">heart attack</a> and <a href="http://health.nytimes.com/health/guides/disease/pneumonia/overview.html?inline=nyt-classifier" title="In-depth reference and news articles about Pneumonia." class="meta-classifier">pneumonia</a>. Almost without exception, most highly regarded hospitals in the United States, from Johns Hopkins in Baltimore to the Mayo Clinic in Rochester, Minn., did not make the list. </blockquote> The "most highly regarded" hospitals tend to also be "the most wired." One would think that all that hardware would improve "diligence in following protocols" compared to paper-based hospitals. But this is apparently not the case. <blockquote style="font-family:arial;">... “Reputation and performance on important measures of quality do not always correlate,” said Dr. Mark R. Chassin, the Joint Commission’s president. As an example, none of the 17 medical centers listed by U.S. News & World Report on its “<a title="Link to US News & World Report hospital honor roll." href="http://health.usnews.com/health-news/best-hospitals/articles/2011/07/18/best-hospitals-2011-12-the-honor-roll">Best Hospitals Honor Roll</a>” this year are on the Joint Commission’s list of 405 hospitals that received at least a 95 percent composite score for compliance with treatment standards. About one-third of a hospital’s score in the U.S. News methodology is based on its reputation as gauged by a survey of physicians. </blockquote>These results are not inconsistent with reports such as: <ul type="disc" style="font-family:arial;"><li class="MsoNormal" style="">The 2009 <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">National Research Council report on Health IT</a>, that found that IT even at some of the "best" computerized centers "did not support physicians' cognitive needs";</li></ul><ul><li><a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000387">The Impact of eHealth on the Quality and Safety of Health Care: A Systematic Overview</a>. Black AD, Car J, Pagliari C, Anandan C, Cresswell K, et al. PLoS Medicine 8(1): e1000387 (Jan. 18, 2011). doi:10.1371/journal.pmed.1000387, that found that "There is a large gap between the postulated and empirically demonstrated benefits of eHealth technologies. In addition, there is a lack of robust research on the risks of implementing these technologies and their cost-effectiveness has yet to be demonstrated, despite being frequently promoted by policymakers and “techno-enthusiasts” as if this was a given";</li></ul> <ul><li><a href="http://www.amjmed.com/article/S0002-9343%2809%2900816-X/abstract">Hospital Computing and the Costs and Quality of Care: A National Study</a>. Himmelstein. Wright, Woolhandler. The American Journal of Medicine, Volume 123, Issue 1 , Pages 40-46, January 2010, that found "Hospitals on the “Most Wired” list performed no better than others on quality, costs, or administrative costs";</li></ul>  <ul face="arial" type="disc"><li class="MsoNormal" style=""><a href="http://archinte.ama-assn.org/cgi/content/full/archinternmed.2010.527">Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality</a>. Max J. Romano, BA; Randall S. Stafford, MD, PhD, Arch Intern Med. Published online Jan. 24, 2011. doi:10.1001/archinternmed.2010.527, that found that there was "no consistent association between EHRs and CDS and better quality. These results raise concerns about the ability of health information technology to fundamentally alter outpatient care quality";</li></ul><ul face="arial" type="disc"><li class="MsoNormal" style=""><a href="http://archinte.ama-assn.org/cgi/content/short/167/13/1400" target="_parent">Electronic Health Record Use and the Quality of Ambulatory Care in the United States</a>. Linder, Ma, Bates et al. Arch Intern Med. 2007;167:1400-1405, that found that "as implemented, EHRs were not associated with better quality ambulatory care";</li></ul><ul face="arial" type="disc"><li class="MsoNormal" style="">Other articles compiled at my post "An updated reading list on heath IT" <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=readinglist">at this link</a>. </li></ul> In fact, it is my belief further investigation is needed to measure the distracting effects of information technology on the delivery of healthcare. <blockquote style="font-family:arial;">... The Joint Commission list, at <a target="_" href="http://www.jointcommission.org/">www.jointcommission.org</a>, omitted the Cleveland Clinic; Massachusetts General Hospital in Boston; Duke University Medical Center in Durham, N.C.; Ronald Reagan U.C.L.A. Medical Center; and the University of California San Francisco Medical Center, among others. It did not include a single hospital in New York City, or the most prominent centers in Chicago and Houston. “It’s pretty glaring that they’re not there,” said Dr. Peter J. Pronovost, the senior vice president for patient safety and quality for Johns Hopkins Medicine.Rather, the Joint Commission list of top performers included a disproportionate share of small and rural hospitals, as well as 20 Veterans Affairs medical centers. About 14 percent of roughly 3,000 eligible hospitals made the cut. </blockquote>Small and rural hospitals may have clinicians who are able to remain focused on the business of healthcare - patient care - rather than the business of bureaucracy - notably, performing the task of data entry clerks for payers, and being subject to the whims of the mission hostile user experience (<a href="http://www.tinyurl.com/hostileuserexper">link</a>) of commercial health IT that can cause injury (<a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">link</a>) and even kill (<a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">link</a>).In my own personal experience, the care provided to my mother in her final months of life by a small local hospital in my area - using paper - was superior in terms of ensuring basics of good care were followed, to that of the highly computerized behemoth that maimed my mother. The smaller hospital provided more individualized care and attention, because the clinicians were not distracted by balky technology and the "legible gibberish" output by these systems. Unfortunately, the small hospital was then acquired by the behemoth. I was there during the rollout of the EHR from the parent. It was not pretty, and I soon found the small hospital's nurses and physicians as distracted as those at the large center, for example in dealing with risky informational abominations such as grossly defective allergy lists (<a href="http://hcrenewal.blogspot.com/2011/03/ehr-legible-gibberish-another-example.html">link</a>).Perhaps the toxic effects of today's commercial health IT need to be taken into account in the Joint Commission's future studies. -- SS

Does "Highly wired" Correspond to "Diligence in Following Guidelines" for Care?

One might think the hospitals that have spent tens or hundreds of millions of dollars on healthcare IT would fare the best in performance ...

Đọc thêm »