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The National Program for Healthcare IT in the United States, 2015

Here is what I predict the the National Program for Healthcare IT in the United States will likely resemble in 2015 - namely, the National Programme for IT in the NHS in 2010: <a href="http://www.guardian.co.uk/business/2010/mar/21/nhs-software-system-close-to-imploding"></a><blockquote><a href="http://www.guardian.co.uk/business/2010/mar/21/nhs-software-system-close-to-imploding">Delays with £12.7bn NHS software program bring it close to collapse</a> Sunday 21 March 2010 18.47 GMT Simon Bowers guardian.co.uk The government's ailing £12.7bn IT programme to overhaul paper-based <a href="http://www.guardian.co.uk/society/nhs" title="More from guardian.co.uk on NHS">NHS</a> patient records in England is close to imploding, potentially triggering a deluge of legal claims against the taxpayer running into billions of pounds, which could start to emerge weeks before a general election. The Guardian has discovered that mounting chaos and delays in installing core care records systems across the country is reaching a tipping point, with intense political pressure from Whitehall now falling on Morecambe Bay NHS Trust and a software "go-live" deadline set for the end of this month. Morecambe Bay is intended to be the first acute trust to take a new patient administration software package called Lorenzo, which has been delayed for four years. After a string of missed deadlines, the Department of Health set a deadline of March 2010 for Lorenzo last April. "If we don't see significant progress... then we will move to a new plan for delivering infomatics in healthcare," Christine Connelly, the Department of Health's director general of IT, said at the time. </blockquote>Problem #1:A problem of leadership. As I mentioned <a href="http://hcrenewal.blogspot.com/2009/12/uk-mp.html">here</a>, Christine Connelly knows as much about "informatics" as I know about candy making. She 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.Candy experience? More than <a href="http://en.wikipedia.org/wiki/Willy_Wonka">Willy Wonka</a>. Experience producing gas? Plentiful. Medical informatics expertise? Not so much. Predecessors also lacked genuine medical informatics expertise. This lack of appropriate expertise is all too common in healthcare leadership, and no exception is made for healthcare IT. <blockquote>Preparatory testing at Morecambe Bay is believed to have failed some weeks ago, though <a href="http://www.guardian.co.uk/business/isoft" title="More from guardian.co.uk on iSoft">iSoft</a>, the firm behind Lorenzo, last week insisted testing was "on track" and dismissed as "media speculation" suggestions that the deadline was in jeopardy. </blockquote>Problem #2:Claiming everything is going just fine. This initiative has been a debacle from the start, partly due to it being rushed for purposes of governmental grandstanding. Don't take my word for it. Take the word of these people: <ul><li>The UK Public Accounts Committee report on problems in the £12.7 billion national EMR program is <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">here</a>. </li></ul><ul><li> Gateway reviews of the UK National Programme for IT from the Office of Government Commerce (OGC) are <a href="http://www.connectingforhealth.nhs.uk/about/foi">here</a> (released under the UK’s Freedom of Information Act), and a summary of 16 key points is <a href="http://www.computerweekly.com/blogs/tony_collins/2009/06/16-key-points-in-gateway-revie.html">here</a>. </li></ul><ul><li>ComputerWeekly.com - <a href="http://www.computerweekly.com/Articles/2008/02/18/229447/secret-downing-street-papers-reveal-tony-blair-rushed-nhs.htm">Blair Rushed NHS IT</a></li></ul><ul><li>Telegraph.co.UK - more on rushing - <a href="http://www.telegraph.co.uk/health/healthnews/7408379/Patients-medical-records-go-online-without-consent.html">Patients' medical records go online without consent</a></li></ul> Back to the article:<blockquote>The BMA (British Medical Association) echoed calls for greater public scrutiny of contracts. "Changes to NHS IT should be driven not by financial or political expedience, but by a commitment to improving clinical care. If any new system is rushed through too quickly, there can be a negative impact on patient care."</blockquote> Problem #3: The obvious as stated by clinicians is ignored by project leaders and politicians. <blockquote>Failure at Morecambe Bay could see the largest regional contractor on the 10-year programme, US outsourcing firm Computer Sciences Corporation (CSC), come under renewed pressure to book heavy provisions against the value of three £1bn NHS contracts – a move likely to send the group's share price tumbling.It would also be bad news for iSoft, the Australian firm formerly called IBA Health, which in 2007 acquired crisis-stricken iSoft plc, the British firm behind Lorenzo, and took its name. It has told investors: "iSoft expects the milestone at Morecambe Bay to be met according to the timetable agreed between its partner CSC and the NHS, and expects this achievement to trigger a cash payment to the company."A Morecambe Bay delay could also push mounting tensions between the Department of Health and CSC into the hands of lawyers, as a squabble breaks out over who should foot the bill for seven years of underperformance since the National Programme contracts were signed in 2003. The government is already facing a reported £700m legal dispute with CSC's fellow regional contractor Fujitsu after the Japanese consultancy firm walked away from a £1bn contract to supply and install IT systems at NHS trusts across the South of England and the West Country three years ago. If CSC, an $11bn (£7.3bn) Virginia-based group listed on the New York stock exchange, were to enter into a parallel legal battle, it would leave 80% of care records IT contracts – the heart of the National Programme – in the hands of lawyers. After the departure of Fujitsu, and Accenture a year earlier, the only remaining regional contractor aside from CSC is BT, responsible for the London area. It was forced last year to wipe between half and 70% from the value of its £1bn contract with NHS London because of delays and software failings. </blockquote> Problem #4 (if you can follow all that nonproductive but expensive mayhem that does little beyond consuming precious healthcare resources better spent elsewhere): Too much outsourcing to a musical-chairs confederacy of management consultant firms rather than use of local expertise. <blockquote>... Disappointing results from the National Programme – once a flagship NHS modernising push for then prime minister Tony Blair – have become an embarrassment for Labour, and the project has lost the confidence of many NHS staff. Up to now, however, ministers have sought to stress that the taxpayer has not lost out. Earlier this month, health minister Mike O'Brien told BBC Radio 4's File on 4: "Yes, there have been delays. These delays have not cost the tax payer. They have cost the companies – they have taken the risk... Some of these companies have been more ambitious than they should have been." [In other words, they promised far more than they could deliver with the talent on hand - ed.] </blockquote> Problem #5: Incompetence, talent mismangement and not knowing what they do not know about healthcare IT. Read the rest of the article at the link above.Also note the UK's healthcare system is far smaller, far more monolithic, and far more easily controlled by government than that in the U.S. My belief is that the US program for health IT will likely resemble the UK's in just a few years' time, for the very same reasons. Unless, that is, major changes in the approaches to design and implementation occur, and soon, and the purpose of HIT reigned in to clinician support, not support of massive bureaucracies. I consider the necessary changes unlikely due to the intransigence of the IT culture and of the leadership behind the effort. Again, don't take it from me, take it from the <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">U.S. National Research Council</a> and other writers at <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=2009">this link</a>. -- SS

The National Program for Healthcare IT in the United States, 2015

Here is what I predict the the National Program for Healthcare IT in the United States will likely resemble in 2015 - namely, the National P...

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Effort to Make Health Insurance Reimbursement Fairer Lead by Director of Insurance Company Accused of Unfair Practices

We previously <a href="http://hcrenewal.blogspot.com/2009/01/unitedhealth-and-ingenix-settles.html">discussed</a> a legal settlement of charges that UnitedHealth's Ingenix subsidiary manipulated its database of payments to physicians so as to reduce its and other insurers' payments to "out-of-network" physicians.  One aspect of the settlement was a new initiative to better determine such payments.  Now that effort has been caught up in the web of conflicts of interests that has ensnared health care.  As <a href="http://www.syracuse.com/news/index.ssf/2010/03/su_professor_hired_to_rid_heal.html">reported</a> by the Syracuse (NY) Post-Standard, <blockquote>[New York state Attorney General Andrew] Cuomo obtained $100 million in settlements from 13 insurers, including Excellus, that used the defective reimbursement data supplied by Ingenix, a subsidiary of United Health, the nation’s second biggest insurer. Cuomo’s investigation showed insurers such as Excellus used that data to shortchange New York consumers by as much as 28 percent.</blockquote> Also, the settlement included <blockquote>money ... to create FAIR Health Inc., a New York City-based nonprofit that is supposed to come up with a new, fair reimbursement system that will be used by insurers nationwide. FAIR Health has contracted with SU [Syracuse University] to help create that database.</blockquote> The effort was lead by SU Professor Deborah Freund, "a distinguished professor of public administration and economics. She also is an adjunct professor of orthopedics and pediatrics at Upstate Medical University." However, <blockquote>Freund also happens to be listed on the health insurance company’s payroll. Excellus paid Freund $61,378 last year for serving on its board of directors, according to a financial report Excellus filed with the state last week. After The Post-Standard spent several days investigating her ties to the insurance company, Freund quit the Excellus board Friday afternoon.</blockquote> The Post-Standard noted, <blockquote>But some consumer advocates said it was odd that a paid director of Excellus, one of the companies targeted in Cuomo’s investigation, was playing such an important role. [Art] Levin, of the Center for Medical Consumers, said it was ironic that one of the people helping to fix a payment system riddled with industry conflicts of interest may have had a conflict of her own. 'This makes no sense whatsoever given that Excellus is part of the settlement,' Levin said. Chuck Bell, programs director of Consumers Union, publisher of Consumer Reports and an outspoken supporter of the payment reform project, was unaware of Freund’s ties to Excellus. 'I think it’s a concern because consumers do want this to be an entity that is independent of the insurance industry,' Bell said.</blockquote> Among Freund's defenders was <blockquote>Dr. Nancy Nielsen, immediate past president of the American Medical Association and a board member of FAIR Health, [who] said the AMA looked closely at Freund’s qualifications and her Excellus affiliation. She said the doctors’ group concluded her expertise is important to the project and was comfortable that there were enough safeguards in place to avoid any conflicts. Nielsen said FAIR Health would have independent experts not tied to the insurance industry review any recommendations from Freund’s research team.</blockquote> But to add another level of irony, and perhaps conflict of interest, the Minneapolis - St Paul Business Journal just <a href="http://twincities.bizjournals.com/twincities/stories/2010/03/01/daily1.html?surround=lfn">announced</a> <blockquote>The American Medical Association will use an electronic health records system from Ingenix, the company said Monday. The Eden Prairie health care information technology said its Web-based CareTracker software will run on an AMA platform currently in beta testing with the Michigan State Medical Society and will launch nationwide later this year. The platform is touted as a way to improve patient care, clinical efficiency and make administration simpler. CareTracker is the first such system that the AMA will provide to physicians online. 'Ingenix and the AMA will help doctors adopt health IT systems that reduce time spent on administrative tasks and enable them to devote more of their time to patient care,' said Bill Miller, Ingenix executive vice president of health care delivery systems, in a news release. 'Ingenix CareTracker integrates patient medical records and e-prescribing tools into the physician’s workflow. By selecting CareTracker for its platform, the AMA is helping physicians make smarter, more practical decisions about technologies to support their practice.'</blockquote> Although we often discuss conflicts of interests involving physicians or health care academics who moonlight for drug and device companies, and the effects of these relationships on clinical research and medical education, it seems like the pervasive web of conflicts of interest in health care has entangled just about every kind of health care organization, health care decision-maker, and health care opinion leader. Thus, we need to be extremely skeptical of just about everyone and every organization claiming to provide health care related goods and services, or whose goal is to improve any aspect of health care. The danger is that such skepticism will lead to cynicism and distrust. At the least, comprehensive, detailed disclosure of all even indirectly relevant financial and other relationships by all health care decision-makers and opinion leaders at any level, whether they be individuals or organizations, would make it somewhat easier to assess their decisions and opinions.

Effort to Make Health Insurance Reimbursement Fairer Lead by Director of Insurance Company Accused of Unfair Practices

We previously discussed a legal settlement of charges that UnitedHealth's Ingenix subsidiary manipulated its database of payments to ph...

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Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT

A paper I recently wrote on a critical issue in healthcare IT was rejected on first pass by the Medical Informatics academic community. The paper concerns the profound lack of publicly available data on unintended adverse consequences of healthcare IT and proposed steps that could be taken by ethical clinicians and others to remediate this gap. I have decided not to make "revisions", feeling the "problems" with the paper were likely more about its topic than its substance or format, making the topic unpublishable in the medical informatics literature. I am therefore making the paper available publicly. It is entitled "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT." The full paper is available via Scribd at this link: <a href="http://www.scribd.com/doc/28747771/" style="font-weight: bold;">http://www.scribd.com/doc/28747771/</a> (MS Word .doc format). Only this month has the FDA even <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=FDA_iceberg">acknowledged patient injury and deaths</a> due to health IT problems, and admits their numbers are likely the "tip of the iceberg" (in a future essay I will explain my reasoning as to why I believe their numbers may be three orders of magnitude or more off the mark and perhaps four orders of magnitude off when HIT goes national). About the paper: <blockquote>Abstract: Case reports, systematic statistical data and other information on unintended consequences (UC’s) of healthcare information technology (HIT) is relatively scarce despite ample literature on potential HIT benefits. This impedes optimal efforts at computerization of healthcare, and can and should be remediated. Objectives: To illustrate the relative scarcity of information on HIT UC’s, suggest contributing factors, and recommend tactical measures for improvement such as better user reporting of HIT UC’s and better diffusion of existing literature on the phenomenon. Methods: A number of recent indicators for scarcity of UC information were compiled and possible reasons described. Examples of suboptimal adverse results disclosures in related domains (e.g., the pharmaceutical industry) that may hold lessons for HIT were included. Results: UC information on HIT is relatively scarce likely due to a variety of influences and complex interactions among and between medicine, informatics, government and industry that, left unaddressed, may lead to delays or other harm to good faith efforts to computerize informational aspects of healthcare delivery and research. Conclusions: The relative scarcity of definitive information on the extent of HIT UC’s should be addressed in a responsible and ethical manner by clinicians, regulators and other stakeholders if this technology is to be successfully rolled out nationally. </blockquote> While some reviewers commented on paper organization and formatting issues, which is fair, the most striking review comments received were these: <blockquote> This paper addresses a potentially important issue but adds little that is new or that goes beyond what a reader might find in a major city newspaper. </blockquote>and <blockquote>Proposing a classification of sources of UC [unintended consequences - ed.] and analysis of reasons for undereporting of each type in the resulting classification could be a useful addition to the field.</blockquote> I do not recall reading many, if any, articles about the covering up of healthcare IT dangers in major city newspapers. Further, it's hard to "classify UC's" when there is scant data available about them in the first place. I feel it's more important, as I did in the paper, to propose reasons for underreporting of unintended consequences in a global fashion and propose remediation steps, not perform a useless exercise of classifying that which is tightly suppressed. I have the experience of being one of a very few medical informatics professionals to publicly challenge the HIT hysteria beginning over a decade ago at a website <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/medinfo.htm">at this link</a> and observing the reactions of the informatics community to that site. In addition to that experience, here are a few more points on why I think the paper unpublishable by the informatics community due to its controversial, HIT business-unfriendly topic: One reviewer opined they'd recognized the writing style and: <blockquote>... may have seen the paper prepublished on a blog somewhere.</blockquote> Coming from supposed information experts who must be aware of search engines and their indexing of blogs (this blog's stories uniformly coming up very high in Google searches, for instance), this comment was remarkable. It would seem the smart thing to have done would have been to prove their hypothesis false in a five-minute effort rather than slandering me to the editor. Further, if they'd recognized my writing, they'd surely have known I once ran a scientific library and was well aware of such publication issues, and write for this blog as well on the ethical issues concerning scientific publication. I propose the reason behind that comment was hostility. Finally, a reviewer offered this gem: <blockquote>Out of curiosity, I also wonder why all the web sites cited were accessed on the same date [the date of paper submission - ed.], if the date was noted at all.</blockquote> Coming from a community of supposed computing and information experts regarding the stated dates when cited websites were "last accessed", I could only shake my head. Peer review being somewhat of an echo chamber regarding controversial social issues in healthcare informatics (i.e., against the flow of the HIT business) , I turn the paper over to the court of public opinion. Fortunately, the paper will likely get far more exposure where it matters - i.e., outside the academic informatics orthodoxy - via web based dissemination than via publication in rarified informatics journals. -- SS

Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT

A paper I recently wrote on a critical issue in healthcare IT was rejected on first pass by the Medical Informatics academic community. The ...

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Who was at fault here? UK Woman left to die after computer decision support blunder

Who was at fault here? Those who modified the fall height parameters, those who designed the decision support system such that it could override life threatening problems based on a single parameter, endusers, their managers, or all? Or was the problem the syndrome of inappropriate confidence in computers (SICC syndrome)? I opine all of the above, in this cautionary tale: <a href="http://www.telegraph.co.uk/health/healthnews/7489669/Woman-left-to-die-after-999-ambulance-blunder.html"></a><blockquote><a href="http://www.telegraph.co.uk/health/healthnews/7489669/Woman-left-to-die-after-999-ambulance-blunder.html">Woman left to die after 999 ambulance blunder</a> By Laura Donnelly, Health Correspondent Telegraph.co.uk Published: 9:00AM GMT 21 Mar 2010 An investigation into a woman’s death has exposed a catastrophic decision by ambulance chiefs which may have cost hundreds of lives. The blunder arose when call centre staff were not warned of flaws with a computer system that prioritises emergencies before dispatching ambulances. Bonnie Mason, 58, fell down the stairs and died from a head injury after 999 controllers in Suffolk failed to identify her situation as “life-threatening”. An investigation by The Sunday Telegraph has uncovered a critical danger placed in the software used by most ambulance services. For years, 999 calls in life-threatening situations like Mrs Masons’s were accidentally “downgraded”, with call handlers told not to send the most urgent response. While some services spotted the risk, ordering operatives to override the computer’s orders manually, five of England’s 12 ambulance trusts did not allow call handlers to upgrade such calls [A belief that "the computer is omniscient" seems to be the only basis for such an exclusion of human judgment - ed.] They include the East of England ambulance service, which covers Suffolk and which only identified the risk after Mrs Mason’s death. The danger in the system was created by the country’s most senior ambulance officials as they altered the program used by most control centres in an attempt to manage demand for 999 services. Most ambulance services use an international computerised system designed in America. In the US version, a fall of more than 6ft receives the maximum priority response. However, the government committee which governs its use in this country decided that such cases should be deemed less urgent [what were they thinking? - ed], and excluded from an eight minute category A target response time. In doing so, they created a potentially lethal flaw in the system. It meant that if a call involved a fall of more than 6ft it was designated a lower priority – a category B response – despite the presence of life-threatening conditions which were supposed to receive the most urgent category A response. [NOTE: If the other life threatening conditions were ignored by the computer system after its "first-pass" look at the height of the fall, then who actually created the most severe flaw is unclear to me, those who altered the parameter or those who designed the overall decision support logic - ed.] As a result, Mrs Mason lay unconscious for more than 38 minutes. The first ambulance sent to her home in the village of Eye, Suffolk, was diverted to attend to a drunk woman who had fallen on a pavement 22 miles away in Thetford, Norfolk. Because the inebriated woman had fallen at ground level, her situation was prioritised over that of Mrs Mason [perhaps because their was no entry of a "height of fall" - ed.], who was close to death by the time paramedics arrived. The East of England ambulance service, which also covers Bedfordshire, Cambridgeshire, Essex, Hertfordshire and Norfolk, said its operatives were instructed never to “override” the advice of the automated system.</blockquote> Ambulance dispatchers instructed to "never override the advice of the automated system?" Simply stunning if true. Read the whole story at the link above. On another note: government committees have rarely worked well in domains where critical thinking is essential. (I can't wait for the comparative effectiveness committees using flawed data from flawed EMR's to start their work. I'd written about that issue <a href="http://www.thefreelibrary.com/The+syndrome+of+inappropriate+overconfidence+in+computing:+an...-a0201551413">here</a>.) Finally, "Our policy is to always trust the computer" is not a way to run life-critical healthcare services. Ever. -- SS

Who was at fault here? UK Woman left to die after computer decision support blunder

Who was at fault here? Those who modified the fall height parameters, those who designed the decision support system such that it could ove...

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King Pharmaceuticals Settles and One Columnist Writes that Such Settlements are Not the Answer

Here we go again.  The latest settlement in the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">parade</a> was made by the Alpharma subsidiary of King Pharmaceuticals, as <a href="http://www.reuters.com/article/idUSN1611445520100316">reported by Reuters</a>: <blockquote>Alpharma Inc, a unit of King Pharmaceuticals (KG.N), has agreed to pay $42.5 million to resolve allegations that it gave kickbacks to doctors to prescribe the pain drug Kadian and misrepresented its safety and effectiveness, the Justice Department said on Tuesday. Kadian, which is based on morphine [that is, a long-acting preparation of morphine], is used to treat chronic moderate to severe pain.</blockquote> We have ranted frequently about how settlements like this, which simply impose costs on large organizations that can easily be regarded as costs of doing business, but impose no penalties on the people who authorized, directed, or implemented bad behavior, do nothing to deter future bad behavior. Now at least we have company (see recent example of rant <a href="http://hcrenewal.blogspot.com/2010/03/sacks-medical-kv-pharmaceutical-plead.html">here</a>). Last week, a commentary by An Woolner <a href="http://www.businessweek.com/news/2010-03-16/jail-time-for-executives-might-stop-drug-crimes-ann-woolner.html">on Bloomberg</a>, included: <blockquote>Examples abound that these companies keep breaking rules and violating laws to make and market their products, no matter how many times they are caught, fined and forced to promise to go straight.</blockquote>Yet, <blockquote>The biggest fine ever imposed in U.S. history, $2.3 billion against recidivist Pfizer, represented a mere 14 percent of the revenue stream from selling the drugs at issue over seven years. [see our post <a href="http://hcrenewal.blogspot.com/2009/09/pfour-legal-settlements-for-pfizer-why.html">here.]</a> So immune to criminal sanctions was the New York-based company that it launched its off-label Bextra campaign at the same time the company was pleading guilty to doing precisely the same thing with other drugs. The anti-inflammatory medication was later yanked from the market because of increased risk of heart attacks and stroke.</blockquote> So, <blockquote>What’s to be done? The government can essentially kill a company by pushing for the parent firm to be barred from government work, which would include Medicaid and Medicare. Teaching a Lesson That would teach the company a lesson. But it would also hurt the millions of people who depend, in Pfizer’s case, on products from Accupril to treat congestive heart failure to Zyvox when you have certain pneumonias or infections. And then there are those thousands of company employees who do good, honest work and who would suddenly find themselves in already massive unemployment lines.</blockquote> Instead, <blockquote>The challenge is to find a way to make it not worthwhile to break the rules. Executives Behind Bars Throwing a few company executives in jail might do the trick. On occasion, sales managers and physicians have been prosecuted. As for top managers at pharmaceuticals, six have been convicted or pleaded guilty, mostly for misbranding or promoting off-label uses, according to the Justice Department. Winning felony convictions is tough to pull off because you have to prove they had specific intent to commit fraud. As with any white-collar crime, that is tricky. But there is a way around that obstacle, and the FDA announced this month that it would go that route to focus on pharmaceutical executives, the Wall Street Journal reported. The Food and Drug Act allows misdemeanor convictions without proof of intent to do wrong. That is an awesome power and it can be easily abused. The timing of the FDA announcement suggests that it’s a response to critics in Congress and a brutal Government Accountability Office report that the division operates without scrutiny or, well, accountability. And yet, used for the right cases, the misdemeanor prosecution of an executive or two who set up incentives for the sales force to push drugs illegally and withhold information about devices from regulators just might do the trick. Nothing else has yet.</blockquote> To which I say, amen.

King Pharmaceuticals Settles and One Columnist Writes that Such Settlements are Not the Answer

Here we go again. The latest settlement in the parade was made by the Alpharma subsidiary of King Pharmaceuticals, as reported by Reuters ...

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Study: Researchers with Glaxo ties favored Avandia

As mentioned in my previous post on the MIT controversy surrounding an economist's testifying to Congress on healthcare policy without revealing possible economic conflicts of interest that could affect his views, frequently expressed on this blog are concerns about undisclosed conflicts of interest and their corrosive effects upon healthcare (<a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">query link</a>). One major question that arises is the degree to which conflicts of interest can affect the integrity of the scientific literature. Answering this question is more a matter of social science research rather than biomedical inquiry. One internal medicine resident at the Mayo Clinic took on this challenge and published such a study, a systematic review, in the British Medical Journal. It is entitled "<a href="http://www.bmj.com/cgi/content/full/340/mar18_1/c1344" style="font-weight: bold;">Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review</a>" (BMJ 2010;340:c1344). Mayo Clinical researchers led by the resident, Amy Wang, examined more than 200 articles that appeared after an analysis in the NEJM linked Avandia to a 43 percent increased risk of heart attacks, and a subsequent clinical trial found no greater danger of heart disease. The results are fascinating. From a summary in the <a href="http://www.philly.com/inquirer/business/homepage/20100320_Study__Researchers_with_Glaxo_ties_favored_Avandia.html">Philadelphia Inquirer</a>:<blockquote> "We aimed to determine whether financial conflicts of interest with pharmaceutical manufacturers could be fueling this fire," wrote the researchers, led by Amy Wang, a resident in internal medicine at the Mayo Clinic in Rochester, Minn. "From our findings, it appears that the answer is yes.</blockquote> From the BMJ article itself, free full text available as of this writing at link above: <blockquote>For each article, we sought information about the authors’ financial conflicts of interest in the report itself and elsewhere (that is, in all publications within two years of the original publication and online). Two reviewers blinded to the authors’ financial relationships independently classified each article as presenting a favourable (that is, rosiglitazone does not increase the risk of myocardial infarction), neutral, or unfavourable view on the risk of myocardial infarction with rosiglitazone and on recommendations on the use of the drug.</blockquote> The "and elsewhere" can be a valuable addition to the capabilities of today's researchers, often enabled via the internet (e.g., non-literature based resources such as conference brochures, personal web pages, corporate and other financial disclosures. etc.) when articles themselves prove unrevealing. Overall, this is a straightforward methodology, and while potentially subject to bias and expertise issues, nonetheless seems an excellent new contribution to the needed social research on undisclosed COI's. As to results (see the full article for statistical details I am omitting here): <blockquote> Of the 202 included articles, 108 (53%) had a conflict of interest statement. Ninety authors (45%) had financial conflicts of interest. Authors who had a favourable view of the risk of myocardial infarction with rosiglitazone were more likely to have financial conflicts of interest with manufacturers of antihyperglycaemic agents in general, and with rosiglitazone manufacturers in particular, than authors who had an unfavourable view. There was likewise a strong association between favourable recommendations on the use of rosiglitazone and financial conflicts of interest. These links persisted when articles rather than authors were used as the unit of analysis, when the analysis was restricted to opinion articles or to articles in which the rosiglitazone controversy was the main focus, and both in articles published before and after the Food and Drug Administration issued a safety warning for rosiglitazone.</blockquote> While causality is not proven, these results are still stunning. Per the Inquirer's summary: <blockquote>... Almost 90 percent of scientists who wrote positive articles, reviews, or commentaries about Avandia had financial ties to London-based Glaxo, the study published in the British Medical Journal found. Almost three of every four authors who expressed negative views of the drug had no financial ties to manufacturers of diabetes medicines, while just 6 percent of those with positive opinions of the drug received no funding or fees from industry.</blockquote> The authors cite prior literature also demonstrating an associations of COI with pro-industry views (references 2-6; #2 is regarding the mid 1990's calcium channel blocker controversy). The authors observe that: <blockquote>In the past decade, research and policy has focused on this association [between COI and pro-industry views - ed.], leading to important progress in policies to manage and encourage disclosure of such financial conflicts of interest. </blockquote> Their findings about the effects of this "progress" was particularly disappointing, that only about half of the articles carried conflict-of-interest statements: <blockquote> Of the 202 eligible studies (10 reported original research, 91 were letters, editorials, or commentaries, and 101 were reviews, meta-analyses, or guidelines), 108 articles (53%) included a conflict of interest statement. [The other 47% did not - ed.] </blockquote>One wonders about the publishers of the articles themselves omitting COI statements, either acknowledging possible COI's or confirming that no COI's exist. <blockquote>... A total of 90 (45%) of the 202 articles were authored by individuals who had financial conflicts of interest. Of the 90 studies with conflicts of interest, 69 (77%) had a statement disclosing the conflict of interest in the article itself. The other 21 studies with financial conflicts of interest (23%) did not disclose these relationships, which were discovered through searching other publications by the same author or the internet. Three (14%) of these 21 studies published a statement declaring no conflicts of interest. [Oops - ed.]</blockquote> So, almost one quarter of articles with author COI did not disclose that fact, and several misrepresented the issue. Finally, the pharmaceutical company's view, also published in the Inquirer article cited above: <blockquote>A Glaxo spokeswoman said the company posted information and results from all its clinical trials on its Web site. "It's vital that people have trust in the way we do research and the way it's made public," Jo Revill, Glaxo spokeswoman, said yesterday. "Part of that is sharing data. What we have done is develop policies that will have disclosure and encourage disclosure." </blockquote> "Encouraging" disclosure of COI's is far too weak a stand for a pharmaceutical company to take on such a critical issue, in my view. The Mayo researchers wisely conclude: <blockquote> Disclosure rates for financial conflicts of interest were unexpectedly low, and there was a clear and strong link between the orientation of authors’ expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies. Although these findings do not necessarily indicate a causal link between the position taken on the cardiac risk of rosiglitazone in patients with diabetes and the authors’ financial conflicts of interest, they underscore the need for further changes in disclosure procedures in order for the scientific record to be trusted.</blockquote> Finally, I add that these findings are not too surprising. It's human nature not to bite the hand that feeds you. Money is also a powerful stimulant to the brain's rationalization (as opposed to rational) centers. We as a culture do truly need to understand the potential corrosive effects on the scientific literature of dysfunctions such as ghostwriting, financial and other conflicts of interest, publish-or-perish pressures of academia, and other such social issues. These practices also simply need to be abolished, for as I have written before on these pages ("<a href="http://hcrenewal.blogspot.com/2009/08/has-ghostwriting-infected-experts-with.html" style="font-weight: bold;">Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?</a>"), once a "critical mass" of faux knowledge is put into circulation via the scientific literature, even the ostensibly impartial experts' views can become tainted, dependent as they are on that very same scientific literature. Even worse, we don't know what that critical mass is - or whether we've reached it already. -- SS

Study: Researchers with Glaxo ties favored Avandia

As mentioned in my previous post on the MIT controversy surrounding an economist's testifying to Congress on healthcare policy without r...

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Gruber at MIT to Senators: "I Promise To Be Good ... Next Time"

Frequently expressed on this blog are concerns about conflicts of interest and their corrosive effects upon healthcare (<a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">query link</a>). We also have expressed concern about the mental gymnastics used by the privileged or those in positions of power to rationalize these COI's and/or justify keeping these COI's from the public's eye. In a stunning display of academic arrogance, MIT economics professor <a href="http://econ-www.mit.edu/faculty/gruberj/shortbio">Jonathan Gruber</a>, who promoted and defended the administration's health care policies before the U.S. Senate Committee on Finance as well as the Health, Education, Labor & Pensions Committee, while collecting $400,000 from HHS for his services, literally blew off a letter of inquiry from Senators Grassley and Enzi regarding possible conflicts of interest. (See <a href="http://www.google.com/search?client=firefox-a&rls=org.mozilla%3Aen-US%3Aofficial&channel=s&hl=en&source=hp&q=jonathan+gruber+conflict+of+interest+HHS&btnG=Google+Search">this Google search</a> on the terms "jonathan gruber conflict of interest HHS".) The professor has been a source of support for what many consider improbable arguments of the impact of current health care reform efforts, while being on the HHS dole. Sen. Grassley and Sen. Enzi have thus written Dr. Susan Hockfield, President of MIT, to "encourage" the professor to be a little more forthcoming in his replies. The letter to Hockfield and a copy of the original letter to Prof. Gruber can be <a href="http://finance.senate.gov/press/Gpress/2010/prg031710a.pdf">downloaded </a><a href="http://finance.senate.gov/press/Gpress/2010/prg031710a.pdf">here</a> (PDF). On Jan. 26, 2010 Gruber was asked some very specific questions by letter (summary below, see full letter at link above for details). He was asked by the Senators: <ul><li>To identify each contract, grant or cooperative agreement he has executed with the federal government, including the White House and HHS and its operating divisions, during the past five years. For each contract, he was asked to respond to a series of detailed questions on: specifics of work performed, federal official serving as contact, start/end dates, amount of compensation, plus a request for copies of the contracts, grants, cooperative agreements, and a copy of the deliverables;</li><li>To identify which of the contracts are "sole source", and provide the reasons the contracts were sole source, what official made that determination, and who is the federal official with whom he negotiated the sole sourcing;</li><li>To answer similar questions about contracts with state and local governments and private entities and individuals he had executed in the past five years;</li><li>To identify all interviews or statements made to the media on healthcare reform since the federally funded work began, and if asked during the interview or if he did so voluntarily, to state if he revealed the HHS relationship; and </li><li>To answer similar questions on all speaking engagements. </li></ul> To these detailed inquiries, the response was this (emphases mine): <blockquote>February 23, 2010 Dear Senators Grassley and Enzi: This letter responds to your letter to me dated January 26, 2010. I appreciate your commitment to the principle of transparency in government and can assure you that I never intentionally withheld my two HHS contracts from Congress. Indeed, my contracts were publicly disclosed on the federal government website, <a href="http://www.usaspending.gov/">www.usaspending.gov</a>. [Prof. Gruber seems to confuse the passive "publicly disclosed" with active "public disclosure," and apparently misses the point that a possible conflict of interest is an obligation of the principal(s) to disclose when they publish or speak, not an obligation of the audience to discover ex post facto via governmental or other websites - ed.] As you know, my professional research focuses on public finance and health economics and throughout my career I have worked with Democrats and Republicans alike on the critical issue of health care reform. I served as a consultant to then-Governor Mitt Romney in connection with health care reform efforts in Massachusetts and have also testified before the Congress on these issues. [That worked out <a href="http://www.washingtonexaminer.com/opinion/columns/What-Obamacare-has-already-done-for-Massachusetts-88191372.html" style="font-weight: bold; font-style: italic;">rather poorly</a>, according to Massachusetts Treasurer Tim Cahill - ed.] I was invited to testify jointly by the Majority and Minority Members of the Senate Finance Committee in the Summer of 2008 on the interaction of health insurance and the tax code and have testified more recently as well. In addition, over the past year in connection with my economic analysis work for HHS, I have worked closely with the staffs of both the Senate Finance and the Senate HELP Committees in evaluating various health care reform proposals and assessing how such proposals might be scored by the Congressional Budget Office. To the best of my recollection, during the course of my health care reform work with Congress, no Member or staffer ever asked me whether I held any government contracts. Given that the staff saw the time that I was devoting to this effort, in retrospect, I suppose I assumed they understood I was being paid for that work. [Assumed you were being paid ... to the tune of nearly half a million dollars? - ed.] Both my congressional testimony and the health care opinion pieces that I have authored reflect my longstanding policy views -- and were in no way influenced by my contracts with HHS, which related to technical economic modeling designed to determine the costs of various health care reform policy options. [Which raises another question: was that 'modeling' influenced by the HHS money? - ed.] It certainly did not occur to me that anyone would view my HHS contracts as relevant to my independent, long-held opinions regarding the economics of health care reform. [Really? - ed.] I regard the contract work I performed for HHS and my public speaking and writing as being independent and unrelated. But I do recognize the public interest in these disclosure issues and will certainly consider them in the context of future appearances on the Hill or in the media. [I note that "I will consider them" (i.e., disclosure 'issues') is an ambiguous statement, as opposed to "I will disclose my possible conflicts" - ed.] Thank you for your work on these issues. Sincerely, Jonathan Gruber </blockquote> In other words, I guess the public does have a right to know about my possible conflicts of interest when a major portion of the US economy's about to be up-ended, and I'll be a good boy and team player - next time. By the way, regarding your detailed questions, you do good work, but get lost. Academic contempt for disclosure of conflicts of interest seems to know few bounds. I doubt the letter to the MIT President will accomplish very much. Let's hope the responses from the <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/grassley_erecords102409.pdf">healthcare IT vendors</a> to Sen. Grassley's inquiries are more forthcoming than this academic one. Finally, it occurs to me that profligate spending of almost a half million dollars for the sole-source consultation of a single (already salaried) professor raises a concern about cherry-picking for theories supporting a certain point of view, and shows questionable governmental fiscal responsibility. That is the size of a research grant that could support, say, a significant fraction of the time of a half dozen academic collaborators with a diverse set of theories and views. -- SS Disclosure: I have not received a penny from HHS, government, academia, industry, or even Tinkerbell or the Tooth Fairy for these views.

Gruber at MIT to Senators: "I Promise To Be Good ... Next Time"

Frequently expressed on this blog are concerns about conflicts of interest and their corrosive effects upon healthcare ( query link ). We a...

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