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"The 'Third Rail' that No One Wishes to Analyze" - Conflicts of Interest Affecting Health Care Foundations

On Health Care Renewal we discuss what we think are important issues affecting health care that seem to be rarely mentioned in the medical and health care literature and the "main-stream media."  In particular, we focus on problems in health care leadership and governance, how they threatened the core values of health care professionals, and how these threats contribute to rising costs, and declining access and quality.  One of our preoccupations has been why these problems remain so <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a>.  A new article in PLoS Medicine [Stuckler D, Basu S, McKee M. Global health philanthropy and institutional relationships: how should conflicts of interest be addressed? PLoS Med 8(4): e1001020. doi:10.1371/journal.pmed.1001020.  Link <a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001020#pmed.1001020-Robert1">here</a>. ] seems to have uncovered another missing link to the anechoic effect.  Private Foundations and Their Influence on Global Health The article noted the importance of the influence of private foundations on global health: <blockquote>While corporate involvement in and government aid for health has been extensively analyzed and critiqued in the public health literature, less attention has been paid to the impact of private donors on public health. Over the past decade, the bulk of new health aid designed to reach the Millennium Development Goals has come from individuals and corporations. The influence of this private philanthropy on global health is profound and transformative.</blockquote> So, <blockquote>Private foundations operate outside the typical boundaries of democracy; unlike government ministries, private foundations cannot be influenced in the same way by the communities affected by the foundations' actions. In the interests of public health, and particularly because poor communities affected by foundations do not automatically have a feedback mechanism to influence the decisions of private funders, we argue that it is appropriate to subject private foundations to the same scrutiny received by public institutions. In this paper, we examine the scope of potential conflicts of interests that exist among the private foundations that are major funders of global health.</blockquote> I would add that private foundations may have an outsize influence not only on global public health policy, but also on health care policy within particular countries, including the US.   This may arise because of the perception that they are more independent and nearer the cutting edge than are government and industry sources of funding. For example, here in the US, the Kellogg and Robert Wood Johnson Foundations have been widely perceived by health care, services and policy researchers as especially influential and respectable sources of funding, possibly partially because of the perception that they have less self-serving agendas than do government agencies and for-profit health care corporations. The Possibility of Conflicts of Interest The authors noted increasing concern about conflicts of interest affecting the activities of for-profit corporations involved in public health and health care: <blockquote>because tensions can arise between the profit motives of corporations and the promotion of public health. Whereas corporations make products that can improve health (such as pharmaceuticals and vaccines) and relationships between public health institutions and for-profit corporations can be seen as positive opportunities for corporations to improve public health, corporations also make products that damage health (such as tobacco or unhealthy foods). And because some corporations have a vested interest in the activities of public health bodies, there have been documented attempts to influence the public health agenda by establishing associations with health care institutions</blockquote> Thus the authors thought it also made sense to address conflicts of interest affecting private foundations operating in the global health space. They performed a case-study of the largest global health foundation, the Bill & Melinda Gates Foundation, while also briefly discussing four other large global health foundations, the Ford Foundation, W. K. Kellogg Foundation, Robert Wood Johnson Foundation, and Rockefeller Foundation. Stock Holdings The article noted that the Gates Foundation had substantial investments in food and pharmaceutical companies: <blockquote>The Bill & Melinda Gates Foundation's corporate stock endowment is heavily invested in food and pharmaceutical companies, directly and indirectly .... The Foundation holds significant shares in McDonald's (9.4 million shares representing about 5% of the Gates' portfolio), and Coca-Cola (>15 million shares, over 7% of the Foundation's portfolio, not counting Berkshire Hathaway holdings). In 2009 the Bill & Melinda Gates Foundation sold extensive pharmaceutical holdings in Johnson & Johnson (2.5 million shares), Schering-Plough Corporation (14.9 million shares), Eli Lilly and Company (about 1 million shares), Merck & Co. (8.1 million shares), and Wyeth (3.7 million shares).</blockquote> Also, the Foundation indirectly invests in food and pharmaceutical companies through its holdings of Berkshire Hathaway: <blockquote>Berkshire Hathaway's largest investment is in Coca-Cola. It owns an additional 8.7% of Coca-Cola (Warren Buffett's firm is the largest shareholder in Coca-Cola, having stock worth >$10 billion dollars) and 6.3% of Kraft (Buffett is also the largest shareholder of Kraft). Berkshire Hathaway also has significant ownership in <a href="http://hcrenewal.blogspot.com/search/label/GlaxoSmithKline">GlaxoSmithKline</a>, <a href="http://hcrenewal.blogspot.com/search/label/Sanofi-Aventis">Sanofi-Aventis</a>, <a href="http://hcrenewal.blogspot.com/search/label/Johnson%20and%20Johnson">Johnson & Johnson</a>, and <a href="http://hcrenewal.blogspot.com/search/label/Procter%20and%20Gamble">Procter & Gamble</a>, and is one of the main global investors in the latter two pharmaceutical companies. </blockquote> The article also noted that the Ford, Rockefeller, Kellogg and Robert Wood Johnson Foundation had significant holdings in Coca-Cola, Kellogg, PepsiCo, <a href="http://hcrenewal.blogspot.com/search/label/Pfizer">Pfizer</a>, GlaxoSmithKline, McDonalds, Nestle, NovoNordisk, YumBrands, Pizza Hut, KFC, Johnson & Johnson, and Sanofi-Aventis, and that the Ford Foundation held shares in a tobacco company, Lorillard, and the Kellogg and Rockefeller Foundations "were indirectly invested in tobacco corporations through conglomerate equity funds...." This admittedly case-based data suggested that the major private foundations active in global health may have financial holdings that could possibly influence their actions in favor of the vested interests of food, pharmaceutical, and even tobacco companies. Conflicts Affecting Foundation Leadership The article noted that: <blockquote>Several of the [Gates] Foundation's members of the management committee, leadership teams, affiliates, and major funders are currently or were previously members of the boards or executive branches of several major food and pharmaceutical companies ... including Coca-Cola, Merck, Novartis, General Mills, Kraft, and Unilever.... </blockquote> In addition, <blockquote>Further overlaps between Bill & Melinda Gates Foundation leadership, other private foundations, and circular flows of personnel with food and pharmaceutical companies were observed .... Such patterns of interlinked board directorships, common among corporations and nonprofit organizations, were similarly found in the other private foundations studied.</blockquote> Examples provided in an appendix were: <blockquote>Anne Fudge, the chairman of the Gates Foundation’s US Program Advisory Panel is also on the board of directors of Rockefeller Foundation (in addition to General Electric, <a href="http://hcrenewal.blogspot.com/search/label/Novartis">Novartis</a>, Unilever, and Harvard University, among others).</blockquote> Furthermore, <blockquote>Members of personnel also move between the Foundation and pharmaceutical companies. For example, in April 2010, a former <a href="http://hcrenewal.blogspot.com/search/label/Merck">Merck</a> senior vice president, Richard Henriques, became the chief financial officer of the Gates Foundation. At least two other members of the Gates Foundation leadership have transferred from the leadership of GlaxoSmithKline to sit on the Foundation’s board of directors, including Kate James, the chief communications officer, and Tachi Yamada, until February 2011, the head of the Foundation’s global health program. Similar patterns were observed with the other foundations studied. </blockquote> Again, this admittedly case-based data suggested that the major private foundations active in global health may have leaders who have financial relationships that could possibly influence their actions in favor of the vested interests of food and pharmaceutical companies. Program Initiatives Possibly Related to Conflicts The article asserted: <blockquote>The bulk of the Bill & Melinda Gates Foundation's financial transfers in global health have been to programs developing medical technologies....</blockquote> In particular, <blockquote>Overall, about 42% of all funding was spent on health care delivery or increasing access to drugs, vaccines, and medical commodities, while an additional one-third was allocated to technology development (mainly for vaccines and microbicides) or basic science research.</blockquote> Specific programs were related to companies in which the the Gates Foundation or its leaders had financial interests: <blockquote>The Foundation has established partnerships with the Coca-Cola Company, which, in the words of the Foundation, are intended to 'create new market opportunities for local farmers whose fruit will be used for Coca-Cola's locally-produced and sold fruit juices'.</blockquote> Also, <blockquote>many of the Foundation's pharmaceutical development grants may benefit leading pharmaceutical companies such as Merck and GlaxoSmithKline....</blockquote> and <blockquote>Johnson & Johnson has entered a clinical partnership to develop new HIV-prevention technology, noting 'the work between Johnson & Johnson and the Gates Foundation is a strong, strategic, comprehensive relationship'.</blockquote> While there are many needs in global health, and many approaches to addressing these needs, this limited case-based data suggested that a strong focus of the Gates Foundation was on approaches that revolve around drugs, devices and biotechnology, again which would tend to favor the vested interests of the pharmaceutical companies which the Foundation holds in its investment portfolio and with which some of its leaders have or had financial relationships. Discussion While the data from this case-study were limited, they do suggest that major private foundations that support global health, and by extension, health care, services, and policy research may have institutional conflicts of interest, and their leaders may have personal conflicts of interest. It is possible that these conflicts have steered global health policy to favor vested interests, particularly towards approaches that depend on drugs and devices, perhaps instead of more effective ones using less technology. Furthermore, it is possible that that these conflicts of interest have helped create the anechoic effect.  Conflicts of interest could have pushed the foundations in directions that favored specific vested interests, and away from others that may threaten such interests.  Many of the issues we discuss on Health Care Renewal may threaten such interests.  Private health foundations have been notably uninterested in addressing how problems in leadership and governance of health care organizations can threaten core values, They have been particularly uninterested in addressing specific tactics used when leadership is ill-informed, incompetent, self-interested, conflicted, or even corrupt, e.g., deceptive practices used to promote products and services, and promote policies favorable to vested interests, including, of course, deliberate creation of conflicts of interest (such as the cultivation of key opinion leaders). In fact, a particular version of the anechoic effect surrounds the private foundations themselves, as described by Stuckler et al: <blockquote>Although the philanthropic activities of wealthy individuals and corporations have attracted controversy in the past (Text S1), their charitable mission often means that they face less scrutiny than governments; critical analysis of foundations can be seen as 'biting the hand that feeds us.' As a result, within the global health community, private donors are sometimes viewed as the 'third rail' that no one wishes to analyze. </blockquote> We have often commented on the pervasiveness of conflicts of interest in health care. Now we see them affecting even the most respected private health care foundations which were previously regarded as independent. The web of conflicts of interest may benefit those personally involved, but to the detriment of patients' and the public's health. Unfortunately, as the web has gotten more complex, it stifles awareness of the problem by the unconflicted, much less their ability to respond. At a minimum, I urge that private health care foundations fully disclose their institutional conflicts of interest, and the conflicts of interest of their leaders. If they wish to maintain their previously sterling reputations, they ought to consider divesting themselves of financial holdings that generate institutional conflicts, and of leaders who have financial relationships that generate personal conflicts. Hat tip: to Ed Silverman <a href="http://www.pharmalot.com/2011/04/foundations-conflicts-of-interest-and-drugmakers/">on the PharmaLot blog</a>.

"The 'Third Rail' that No One Wishes to Analyze" - Conflicts of Interest Affecting Health Care Foundations

On Health Care Renewal we discuss what we think are important issues affecting health care that seem to be rarely mentioned in the medical a...

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Johnson and Johnson Runs Afoul of Foreign Corrupt Practices Act

Johnson and Johnson, the once highly reputed international pharmaceutical and device company, cannot catch a break.  International Bribery Charges As <a href="http://www.bloomberg.com/news/2011-04-08/johnson-johnson-will-pay-70-million-to-resolve-bribery-claims.html">reported </a>by Bloomberg, the latest story is about bribery claims across multiple countries and two continents: <blockquote>Johnson & Johnson (JNJ), the world’s second-biggest seller of medical products, will pay $70 million after admitting that the company bribed doctors in Europe and paid kickbacks in Iraq to win contracts and sell drugs and artificial joints. Subsidiaries of J&J paid bribes to doctors and hospital administrators in Greece, Poland and Romania, the Securities and Exchange Commission and Department of Justice said today in filings at U.S. District Court in Washington. The company also made illegal payments to Iraqi officials to win contracts under the U.N. oil-for-food program, the filings said. J&J, based in New Brunswick, New Jersey, used slush funds, sham contracts and off-shore companies in the Isle of Man to carry out the bribery, the SEC said. Public health system doctors and administrators who ordered J&J products such as surgical implants or prescribed the company’s drugs were rewarded in a variety of ways, including with cash and travel. </blockquote>Simultaneously, in the UK, <blockquote>J&J’s DePuy International Ltd. subsidiary was ordered to pay 4.8 million pounds ($7.9 million) to resolve U.K. claims related to the bribery in Greece, the Serious Fraud Office said in a statement today. </blockquote> <a href="http://online.wsj.com/article/SB10001424052748704415104576250912912672614.html">Per the Wall Street Journal</a>, the company also entered into a deferred prosecution agreement. Admissions of Guilt The company could not deny wrong-doing, as <a href="http://online.wsj.com/article/SB10001424052748704415104576250912912672614.html">reported</a> by the Wall Street Journal: <blockquote>As part of the settlement, J&J acknowledged responsibility for the actions of its units, employees and agents who made 'various improper payments to publicly employed health-care providers in Greece, Poland and Romania in order to induce the purchase of medical devices and pharmaceuticals manufactured by J&J subsidiaries,' according to the Justice Department.</blockquote> Also, <blockquote>J&J also acknowledged that kickbacks were paid on behalf of J&J units to the former government of Iraq under the United Nations Oil-for-Food program in order to secure contracts to provide humanitarian supplies.</blockquote>But No Apology, Nor Acknowledgement of Responsibility The Johnson and Johnson CEO issued the de rigeur non-apology apology: <blockquote>'More than four years ago, we went to the government to report improper payments and have taken full responsibility for these actions,' J&J Chief Executive William C. Weldon said in a press release. 'We are deeply disappointed by the unacceptable conduct that led to these violations.' </blockquote> Notice the clever phrasing that seems to deny that Weldon had any responsibility for these actions, which occurred in the remote past and which were addressed as soon as top management were made aware of them. Management was Aware In fact, however, as <a href="http://www.bnet.com/blog/drug-business/internal-emails-j-j-knew-of-bribery-8220black-hole-8221-for-years/7911">discussed</a> by Jim Edwards on his BNEt blog, it appears that management had been well aware of the bad behavior for a long time: <blockquote>But J&J’s internal emails, plus the U.K. Serious Fraud Office’s records, indicate that J&J management knew as early as 1999 that it was making improper payments to Greek sales agents, and that money was disappearing into what it called a 'black hole' in Europe. Yet J&J later acquired the company that operated that 'black hole' in order to maintain its illegal sales relationships in Greece, according to the SEC’s complaint. And although the SEC praised J&J’s cooperation in its probe, J&J took eight years to initially inform the SEC of its problems.</blockquote> For the gory details, see his blog post. Only the Latest Troubles This latest ethical black eye comes after numerous other troubles for the giant company. As Bloomberg put it: <blockquote>The settlement comes less than a month after J&J’s McNeil Consumer Healthcare unit signed a consent decree giving the Food and Drug Administration more oversight at three plants making children’s Tylenol, Motrin and other over-the-counter drugs recalled in the past year because of faulty ingredients or foul odors caused by chemical contamination of storage pallets. The March 10 agreement left the plants under enhanced scrutiny for five years, and J&J faces fines of as much as $10 million a year if the FDA doesn’t approve of changes at the facilities, the company said in a statement last month. J&J has recalled more than 50 products since the start of 2010, from the consumer medications to failing artificial hips, improperly rinsed contact lenses, insulin cartridges that may leak and cracked syringes loaded with prescription drugs. The company installed a new corporate quality-control director and announced companywide compliance standards in August. In February, J&J reorganized its consumer division and announced the head of its DePuy Orthopaedics unit had resigned. </blockquote> There is actually more. We <a href="http://hcrenewal.blogspot.com/2011/03/jury-finds-johnson-and-johnsons.html">noted</a> last month that Johnson and Johnson's Janssen's subsidiary's Risperdal marketing was found deceptive by a South Carolina jury. In addition,  In 2010, another jury found that the company had committed marketing fraud in its promotion of Risperdal (see post <a href="http://hcrenewal.blogspot.com/2010/10/last-weeks-scandals.html">here</a>), and its Ortho-McNeil-Janssen subsidiary also made a guilty plea to a misdemeanor for and civil settlement of charges of "misbranding" Topamax (see post <a href="http://hcrenewal.blogspot.com/2010/05/sunday-settlement-and-guilty-plea.html">here</a>). No Penalties for Individuals As in many such cases we have <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">discussed </a>before, despite the seriousness of the charges and the corporate, although not individual admissions of responsibility, no individual in the US apparently will suffer any negative consequences for the misbehavior.  (Per the WSJ, one UK executive went to prison for bribery by DePuy in Greece.)  Moreover, rather than suffering, the US company leadership has personally profited.  As we have mentioned more than once, most recently <a href="http://hcrenewal.blogspot.com/2011/03/despite-recalls-legal-settlements.html">here</a>, the increasing numbers of legal and regulatory sanctions and the increasing numbers of product recalls stand in stark contrast to the plutocratic remuneration given to top Johnson and Johnson executives.  CEO Weldon received about $29 million in 2010, while his top five lieutenants each got from over $5 million to just under $9 million.  The company board asserted that Weldon "met expectations," and exerted "strong leadership."  At best, it appears that the clubby and out-of touch governance of health care organizations, generally by fellow members of the CEO's guild, leavened with a few conflicted academic health care leaders, rewards insiders despite, or even because of  failed leadership.   So once more with feeling, ... health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research.  On the other hand, those who authorize, direct and implement bad behavior ought to suffer negative consequences sufficient to deter future bad behavior. If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses. Meanwhile, I can only ask Johnson and Johnson executives and board members, have you no shame? ADDENDUM (13 April, 2011) - See also posts <a href="http://gooznews.com/?p=2716">by Merrill Goozner</a> on the GoozNews blog, and <a href="http://www.healthbeatblog.com/2011/04/-bribing-doctors-.html">by Maggie Mahar</a> on the HealthBeat blog.

Johnson and Johnson Runs Afoul of Foreign Corrupt Practices Act

Johnson and Johnson, the once highly reputed international pharmaceutical and device company, cannot catch a break. International Bribery C...

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Toward Meaningful Usability: Five Keys to Creating Physician- Centric CPOE (Wait - The Terms "Safety", "Risk" and "Error" Are Missing)

In a 2011 "White Paper" from a company <a style="font-family: arial;" href="http://www.patientkeeper.com/">PatientKeeper</a> entitled "<a style="font-family: arial;" href="http://info.patientkeeper.com/rs/patientkeeper/images/WhitePaper_CPOE_2011.pdf">Toward Meaningful Usability: Five Keys to Creating Physician-Centric CPOE</a>" (PDF), an organization whose motto is "Enabling Physicians to Focus on Patients ... Not Technology", I again note a common phenomenon. Certain verboten terms are absent. What might those terms be? More on that in a moment... They speak of "the failure of CPOE": <blockquote style="font-family:arial;">The failure of CPOE to date can be attributed to many factors that ultimately lead to a lack of physician adoption. CPOE systems have historically been designed to support the workflow of the departments responsible for fulfilling the orders rather than the physician workflow around entering orders. As a result, entering orders electronically can take significantly longer than written or verbal orders and often requires the physician to change the way they currently practice medicine.</blockquote> That's a problem, considering the following observation (paraphrased from a "why-pharma-fails" post <a style="font-family: arial;" href="http://www.eyesopen.com/en/blog/what-is-really-killing-pharma">at this link</a>): <blockquote>"The machine was made for Clinicians, not Clinicians for the Machine."</blockquote> But still, words are missing from the White Paper. Again, more on that in a moment.<blockquote style="font-family:arial;">... Hospitals often purchase CPOE on the premise that standardization of care through evidence-based order sets is the optimal way to improve patient care delivery and reduce healthcare costs. In fact, most standardized care is not supported by evidence so spending months or even years to achieve order set consensus only serves to delay implementation and use while increasing the overall cost of the order entry system.</blockquote>Well, yes, but where are those missing words?<blockquote style="font-family:arial;">Most CPOE systems expose physicians to all clinical alerts regardless of severity. The preponderance of these alerts disrupts the ordering process, leads to alert fatigue, and results in frustration on the part of the physician. Finally, the number of available workstations, including those on the hospital floors and in patient rooms, is limited, and physicians may have to wait in queue to enter their orders. This may lead to an increase in verbal orders from the physician to the nurse, pharmacist, etc. as well as frustration with a process that requires more physician time than simple pen and paper.</blockquote> There must be a lot of frustrated doctors out there. Still, the shibboleth terms are missing.Cited are the usual KOL's:<blockquote style="font-family:arial;">1 D. W. Bates, J. M. Teich, J. Lee et al., “The Impact of Computerized Physician Order Entry on Medication Error Prevention,” Journal of the American Medical Informatics Association 6 (July/August 1999): 13–21. 2 D. W. Bates and A. A. Gawande, “Improving Safety with Information Technology,” New England Journal of Medicine 348 (June 19, 2003): 2526–34. 3 Jason Hess, KLAS Enterprises (Orem, Utah), “Are We There Yet? Getting to Meaningful CPOE Use”, July 13, 2010</blockquote> Still no mention of the missing critical terms. <blockquote>The next generation of CPOE solutions must ultimately save physicians time, rather than simply being time-neutral. Otherwise, they will suffer the fate of most previous attempts to implement this required functionality – at the cost of improved patient care, better outcomes, and lost ARRA stimulus dollars.</blockquote> In other words, the worst-case scenario is wasted promotional dollars and maintenance of the clinical status quo. Still, key terms are missing. What are those terms? Here they are, the unaccounted-for outcomes of CPOE and its toxicity in its present form: <ul style="font-weight: bold;font-family:arial;"><li>Safety (as in, "reduction of") </li><li>Risk (as in, "of injury, increased") </li><li>Danger (as of, "putting patients in") </li><li>Error (as in, "the outcome of toxic HIT") </li><li>Harm (as in, "injury and death") </li></ul> This was no mere White Paper. A more appropriate term might be a "Snow White" paper: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjiSevn6pb57z1SXyyfyWyiPFVqqkuawTWoi-ugZxPvDk5d_oJIBowDTY3Jw3m6Cn2wJVZ7fxTrwsFsw6mhYMk0rzJetVeM1uk98EFS1ULf2XjY1214rp3Jk-CmpQS0O5TVKsrbTWuyavl5/s1600/snowwhite.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5595065095026637714" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjiSevn6pb57z1SXyyfyWyiPFVqqkuawTWoi-ugZxPvDk5d_oJIBowDTY3Jw3m6Cn2wJVZ7fxTrwsFsw6mhYMk0rzJetVeM1uk98EFS1ULf2XjY1214rp3Jk-CmpQS0O5TVKsrbTWuyavl5/s320/snowwhite.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 110px; height: 153px;" /></a>CPOE, An Enchanted Technology. Find the Prince! </div>Health IT, including dysfunctional and toxic CPOE, causes frustration among doctors. CPOE failure is merely "physician nonacceptance." But the frustration among injured or dead patients and their families seems never to be mentioned or considered in this industry. I pointed out that similar terms were missing from the PCAST (President’s Council of Advisors on Science and Technology) report on health IT at my Feb. 2011 post "<a href="http://hcrenewal.blogspot.com/2011/02/presidents-council-of-advisors-on.html">Brief Comments on the PCAST Report on Health IT</a>." Shhhh! -- SS

Toward Meaningful Usability: Five Keys to Creating Physician- Centric CPOE (Wait - The Terms "Safety", "Risk" and "Error" Are Missing)

In a 2011 "White Paper" from a company PatientKeeper entitled " Toward Meaningful Usability: Five Keys to Creating Physician...

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Security and Privacy Considerations for Health IT Systems

I find the links at this piece from George Mason University, "<a href="http://securehealth.freshdefense.net/">Security and Privacy Considerations for Health IT Systems</a>", and the opinions expressed within it of interest. Emphases and [bracketed comments in red italics] mine: <div id="body"> <div id="hdr"> </div><blockquote><div id="hdr">First posted: 3 March 2010 Last updated: 26 March 2010 </div> <h3>Preface</h3> We seek to understand the nature and distribution of risks to security and privacy inherent in designing and deploying health information technology (HealthIT, eHealth; we use both terms interchangeably). We posit that achieving the appropriate balance of these risks and potential costs (to doctors, patients, hospitals, and the American taxpayer) requires careful, deliberate study to understand the nature of this new problem. [This is not occurring anywhere near the extent it needs to, and the absence of health IT industry regulation in the U.S. does not help; cf. 2009 National Research Council report on health IT summarized <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572">here</a> - ed.] Although health care reform in the United States is a highly-charged political issue, this Web page is not meant to be a political document or support a particular political point of view or legislative agenda. Instead, this page supplies a collection of information detailing the pitfalls and challenges involved in deploying a large-scale information infrastructure around the recording, tracking, and maintenance of patient and other medical information. We are interested in the technical security and privacy issues that emerge from what we believe is a fundamentally different data acquisition and storage problem than previous industry efforts at record keeping for other forms of data. [Clinical computing and business computing are indeed different - ed.] Our central hypothesis is that the government and private sector are rushing [you think? - ed.] into the deployment of eHealth technology without careful consideration of the design criteria necessary to ensure accurate and private data collection and without a realistic understanding of the costs of such a large software deployment. We certainly agree that improving the efficiency and efficacy of health care delivery while reducing the cost to the taxpayer and patients is an important and critical activity. Achieving this goal, however, demands a more careful approach than has heretofore been adopted. <h2>Introduction</h2> The application of information technology (especially back-office data storage applications) to various facets of medical care in the U.S.A. and other countries has often promised decreased cost, increased quality of health care, and no risk to privacy, among other benefits. Such belief in the reliability and integrity of information systems is an unwarranted leap of faith on behalf of legislators and the general public. [I have written similar words - ed.] Designing health IT systems for medical environments requires careful, thoughtful analysis. Yet, Health IT (particularly EMR systems) are de facto seen as a solution to the problem of costs, waste, fraud, and needlessly duplicated medical tests. The <a href="http://www.whitehouse.gov/issues/health-care/">White House web site comments</a> on ARRA funding for EMR work: "The Recovery Act also invests $19 billion in computerized medical records that will help to reduce costs and improve quality while ensuring patients’ privacy." The scientific community has largely been silent on this issue, although the political rhetoric can be quite intense. Yet, most every side of the health care debate currently raging in the US accepts without question the benefits of health IT while ignoring the potential pitfalls and downsides of such technology. [Again, this is a common theme here at Healthcare Renewal - ed.] We use the terms "eHealth" and "Health IT" interchangeably. In large part, we consider the application of computer technology in medical devices and procedures (such as remote operating rooms, advances in digital imaging, etc.) as a related but separate area from our criticism of the management of healthcare and patient information. Those systems pose different risks to patients; we comment on them only insofar as their use is driven by analysis of data held in IT systems. <h2>General Resources</h2> <ol><li><a href="http://patientprivacyrights.org/?posts=all">Patient Privacy Rights</a> website (added 26 March 2010, G. Weaver)</li><li>Scot Silverstein's <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/">Healthcare IT Failure and Difficulties Case Examples: Medical Informatics Perspectives on Clinical Information Technology</a> (added 24 March 2010) </li><li> <a href="http://bx.businessweek.com/health-information-technology/reference/">Health Information Technology Reference Guide</a> -BusinessWeek</li><li> The <a href="http://www.privacyrights.org/Medical-Privacy">Privacy Rights Website on Medical Privacy</a> </li><li> <a href="http://openmrs.org/wiki/OpenMRS">OpenMRS</a> an open-source medical records system</li><li> <a href="http://medical.sourceforge.net/">Another MRS</a> </li><li> <a href="http://spectrum.ieee.org/computing/software/learning-from-software-failure">Learning From Software Failures</a> (frontmatter prefacing the IEEE Spectrum analysis of the FBI's Virtual Case File system) [<a href="http://securehealth.freshdefense.net/content/spectrum-learnfrom.pdf">PDF</a><a>]</a></li><a> </a><li><a> </a><a href="http://en.wikipedia.org/wiki/Capability_Maturity_Model">Capability Maturity Model</a> </li><li>A workshop on <a href="http://www.usenix.org/events/healthsec10/cfp/">Health Security and Privacy</a>, sponsored by the USENIX Association </li></ol> <h2>Risks to the Public Trust in Computer Professionals</h2> Hastily undertaking the transformation of the information infrastructure behind health care systems with little forethought or oversight entails the risk of the public rejecting the expertise and credibility of the computing profession. Just because we could do something does not mean that we should. There is an imperative to study the new problems posed by large-scale EMR, particularly one of national scope or connectivity. [One reason is that the risks and benefits are unknown - ed.] No imperative exists, however, to aggressively adopt the current generation of solutions that are little more than back-office data management applications dressed up with new terminology. [This description of health IT and the lack of imperative is excellent. Adopting national HIT prior to reasonable understanding of the possible problems and risks to patients is what I have referred to as "putting the cart before the horse"- ed.] Furthermore, academics and scientific professionals have a conflict of interest in this area. Indeed, academics stand to benefit tremendously from money being spent on this area: schools (<a href="http://hit.gmu.edu/">GMU</a> included) are quick to set up research centers dealing with various aspects of medical IT and eHealth. While there is a need for careful research into the many security, privacy, and functionality aspects of large medical IT systems, academics can be in the uncomfortable position of being funded by government or corporate money and trying to formulate an unbiased opinion as to the quality and efficacy of the state of the art in eHealth systems and practices. [COI in biomedicine is another common topic addressed at HC Renewal - ed.] <ol><li> Dartmouth received $3 million under ARRA for an <a href="http://www.dartmouth.edu/%7Enews/releases/2009/08/05.html">NSF-funded</a> <a href="http://www.ists.dartmouth.edu/projects/tish.html">TISH program</a> </li><li> GMU's internally funded <a href="http://hit.gmu.edu/">Mason Center for Health Information Technology</a> </li><li> <a href="http://cm.bell-labs.com/who/ken/trust.html">Reflections on Trusting Trust</a> (reputation is important in designing infrastructure)</li></ol> <h2>Risks to Good Medicine</h2> Health IT systems are not a panacea. Data models, systems, and user interfaces designed by computer scientists and professional software developers without much substantive input from health care professionals can lead to inefficiency and bad medicine [the common scenario for HIT development today - ed.], and risks loss of life or permanent injury to patients. [I, unfortunately, have family experience in that regard now - ed.] <ol><li> <a href="http://www.syleum.com/2009/03/17/healthcare-data-model/">The Data Model That Nearly Killed me</a> [<a href="http://securehealth.freshdefense.net/content/data-model-killme.pdf">PDF</a>] [An excellent essay by a patient who is also a data modeling expert - ed.] </li><li> <a href="http://www.businessweek.com/magazine/content/09_18/b4129030606214.htm">The Dubious Promise of Digital Medicine</a> [<a href="http://securehealth.freshdefense.net/content/dubious.pdf">PDF</a>] </li><li> Slashdot: <a href="http://science.slashdot.org/article.pl?sid=09/04/28/1229225">Why Digital Medical Records Are No Panacea</a> 28 April 2009 [<a href="http://securehealth.freshdefense.net/panacea.pdf">PDF</a>]</li><li>http://community.livejournal.com/therightfangirl/1142946.html </li></ol> <h2>Data Leakage Models and Data Corruption Issues</h2> One risk of large-scale EMR is a misunderstanding of the data loss dynamics of large public data systems. In addition, large databases tend to have errors: errors that are insidious and easily replicated due to the amount of automation present in such systems. It is an open question whether these errors pose a lesser or greater risk than errors due to bad handwriting on transcribed paper records. [The last point is controversial, but likely accurate - ed.] <ol><li><a href="http://online.wsj.com/article/SB10001424052748703580904575132111888664060.html?mod=WSJ_hpp_sections_opinion">Your Medical Records Aren't Secure</a> [<a href="http://securehealth.freshdefense.net/content/wsj.medrecords.pdf">PDF</a>] (March 23, 2010)</li><li> <a href="http://www.enterprisestorageforum.com/technology/features/article.php/3843151">Why Cloud Storage Use Could Be Limited in Enterprises</a> [<a href="http://securehealth.freshdefense.net/content/cloud.pdf">PDF</a>]</li><li> Dan Geer on <a href="http://www.usenix.org/publications/login/2005-12/openpdfs/geer.pdf">Back-of-the-envelope style estimates</a> [link is to PDF]</li><li> <a href="http://www.wired.com/threatlevel/2009/10/ncic">Woman Loses Job Due to Error in FBI Criminal Database</a> [<a href="http://securehealth.freshdefense.net/content/lost-job-fbi.pdf">PDF</a>]</li><li> <a href="http://www.computerworld.com/s/article/9127066/P2P_networks_rife_with_sensitive_health_care_data_researcher_warns_?taxonomyId=16&intsrc=hm_topic">P2P Networks Rife With Sensitive Health Care Data, Researcher Warns</a></li><li> <a href="http://www.scmagazineus.com/medical-data-leakage-rampant-on-p2p-networks/article/127216/">Medical data leakage rampant on P2P networks</a> [<a href="http://securehealth.freshdefense.net/content/dataleak-p2p.pdf">PDF</a>] </li><li> The previous two links refer to <a href="http://mba.tuck.dartmouth.edu/digital/Research/ResearchProjects/JohnsonHemorrhagesFC09Proceedingd.pdf">this study</a> by <a href="http://mba.tuck.dartmouth.edu/digital/Research/ResearchProjects/ResearchInadvertent.html">researchers from the Tuck School of Business</a> at Dartmouth College</li><li> <a href="http://cacm.acm.org/magazines/2010/3/76292-a-framework-for-health-care-information-assurance-policy-and-compliance/fulltext">A Framework for Health Care Information Assurance Policy and Compliance</a> Communications of the ACM, 1 March 2010 </li></ol> <h2>Assessing the Cost of Large Software Projects and eHealth</h2> Managing the design, construction, and delivery of a large software project is a complicated, fluid process. Government and industry can often fail in expensive and spectacular ways. [Indeed - ed.] Government agencies (particularly state and local government without in-house expertise), may play the role of uninformed client being sold digital snake oil at the expense of the taxpayer. Examples include the FBI's Virtual Case File system, AT&T's wireless database failure, and the Ontario eHealth scandal, among others listed below. <ol><li> <a href="http://www.cnn.com/2005/US/02/03/fbi.computers/">Report: FBI wasted millions on 'Virtual Case File'</a> CNN.com [<a href="http://securehealth.freshdefense.net/content/CNN-FBI-VCF-waste.pdf">PDF</a>] </li><li> <a href="http://www.washingtonpost.com/wp-dyn/content/article/2006/08/17/AR2006081701485.html">The FBI's Upgrade That Wasn't: $170 Million Bought an Unusable Computer System</a> by Dan Eggen and Griff Witte, Washington Post, 18 August 2006 [<a href="http://securehealth.freshdefense.net/content/post-VCF.pdf">PDF</a>]</li><li> <a href="http://spectrum.ieee.org/computing/software/who-killed-the-virtual-case-file">Who Killed the Virtual Case File?</a> IEEE Spectrum [<a href="http://securehealth.freshdefense.net/content/spectrum-VCF.pdf">PDF</a>]</li><li> <a href="http://www.cio.com/article/32228/Project_Management_AT_T_Wireless_Self_Destructs">Project Management: AT&T Wireless Self-Destructs</a> [<a href="http://securehealth.freshdefense.net/content/cio-att.pdf">PDF</a>]</li><li> Slashdot: <a href="http://news.slashdot.org/story/09/12/01/0115246/Harvard-Says-Computers-Dont-Save-Hospitals-Money">Harvard Says Computers Don't Save Hospitals Money</a> [<a href="http://securehealth.freshdefense.net/content/slashdot-harvard.pdf">PDF</a>]</li><li> <a href="http://www.computerworld.com/s/article/print/9141428/Harvard_study_Computers_don_t_save_hospitals_money?taxonomyName=Hardware&taxonomyId=12">Harvard study: Computers don't save hospitals money</a> Computerworld, 30 November 2009 [<a href="http://securehealth.freshdefense.net/content/computerworld-no-save.pdf">PDF</a>]</li><li> The aforementioned <a href="http://www.amjmed.com/webfiles/images/journals/ajm/AJM10662S200.pdf">Harvard Study</a></li><li> <a href="http://www.cbc.ca/canada/toronto/story/2009/10/07/ehealth-auditor.html">EHealth scandal a $1B waste: auditor</a> -CBC News, 7 October 2009 [<a href="http://securehealth.freshdefense.net/content/eHealth-CBC-1B-waste.pdf">PDF</a>]</li><li> <a href="http://www.cbc.ca/canada/story/2009/06/07/ehealth-kramer.html">Head of eHealth Ontario is fired amid contracts scandal, gets big package</a> -CBC News, 7 June 2009 [<a href="http://securehealth.freshdefense.net/content/eHealth-CBC-head-fired.pdf">PDF</a>]</li></ol> <h2>The Role of Health IT in Health Care Public Policy</h2> <ol><li> <a href="http://www.whitehouse.gov/issues/health-care">Health Care: The President's Proposal for Health Reform</a> - whitehouse.gov [<a href="http://securehealth.freshdefense.net/content/whitehouse-health.pdf">PDF</a>]</li><li> <a href="http://money.cnn.com/2009/01/12/technology/stimulus_health_care/">Obama's big idea: Digital health records</a> -CNN.com, 12 January 2009 [<a href="http://securehealth.freshdefense.net/content/CNN-digital-health-records.pdf">PDF</a>]</li><li> <a href="http://www.ihealthbeat.org/perspectives/2009/wheres-the-hit-in-hcr-health-care-reform.aspx">Where's the HIT in HCR (Health Care Reform)?</a> -ihealthbeat, 8 July 2009 [<a href="http://securehealth.freshdefense.net/content/hit.pdf">PDF</a>]</li><li> <a href="http://www.healthleadersmedia.com/content/223238/topic/WS_HLM2_TEC/What-Obama-Means-for-Health-Information-Technology.html">What Obama Means for Health Information Technology</a> -HealthLeadersMedia, 11 November 2008 [<a href="http://securehealth.freshdefense.net/content/healthleaders-obama.pdf">PDF</a>]</li><li> <a href="http://thehill.com/blogs/hillicon-valley/technology/71399-the-healthcare-bills-take-on-technology">The Healthcare Bill's Take on Technology</a> -The Hill, 12 September 2009 [<a href="http://securehealth.freshdefense.net/content/thehill-tech.pdf">PDF</a>]</li></ol></blockquote> </div> I discovered this piece after someone clicked on the contained link to my Drexel University website. I find the thoughts here and the hyperlinks of great interest, forming yet another "primer" on the real world issues affecting health IT adoption. -- SS

Security and Privacy Considerations for Health IT Systems

I find the links at this piece from George Mason University , " Security and Privacy Considerations for Health IT Systems ", and ...

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...THEM OR YOUR LYING EYES?

…THEM OR YOUR LYING EYES? A few days ago I <a href="http://hcrenewal.blogspot.com/2011/04/who-you-gonna-believe.html">discussed</a> stonewalling by the American Psychiatric Association over charges that they were partners in a ghostwritten textbook. The issue resonated with many people, including <a href="http://carlatpsychiatry.blogspot.com/2011/04/like-bad-penny-nemeroffschatzberg.html">Daniel Carlat</a>, <a href="http://1boringoldman.com/index.php/2011/04/05/still-on-the-radar-screen/">John Nardo</a>, <a href="http://pogoblog.typepad.com/pogo/2011/04/ghostwriting-controversy-haunting-the-american-psychiatric-association.html">the POGO blog</a>, <a href="http://alison-bass.blogspot.com/2011/04/tale-of-censorship-and-secrecy-starring.html">Alison Bass</a>, <a href="http://www.pharmalot.com/2011/04/american-psychiatric-association-and-ghostwriting/">Ed Silverman</a>, and others. The APA has not seen its way clear to releasing key documents that might clear up the charges. By stonewalling, the APA just does more damage to its image and credibility. They come across as uninterested in transparency, and they appear to be fighting a rearguard action to defend the indefensible. What kind of key documents could the APA have released? In our <a href="http://pogoblog.typepad.com/pogo/letter-to-apa-20110128.html">letter</a> last January we suggested several, including the contract involving the American Psychiatric Press, the medical communications company (Scientific Therapeutics Information, Inc. or STI), the grant-giving drug company, the professional writers, and the nominal authors of the allegedly ghostwritten book. What might the contract have told us? Well, it probably looks a lot like <a href="http://www.healthyskepticism.org/files/docs/gsk/paroxetine/study329/19980403STIContract.pdf">this contract</a>, which involves the same medical communications company, the same drug company, and one of the same professional writers, Sally Laden. It was developed right around the same time as the textbook was planned, and it is for a ghostwritten journal article promoting the infamous Paxil Study 329. Look carefully at <a href="http://www.healthyskepticism.org/files/docs/gsk/paroxetine/study329/19980403STIContract.pdf">this contract </a>and you will be in no doubt about who did the essential work of writing and framing the article or about whether the corporation had control over the content. Now ask yourselves, if the contract for the textbook doesn’t look like this then why ever would the APA want to suppress it? That behavior just makes people conclude that the contract for the textbook does look like <a href="http://www.healthyskepticism.org/files/docs/gsk/paroxetine/study329/19980403STIContract.pdf">this contract </a>and that the APA knows it has plenty to hide. A first principle of cover-ups and stonewalling is that everyone needs to be on the same page with the cover story. When they are not, the façade collapses and the actors come across like the Three Stooges, all heading for the door at the same time. Today, thanks to the sleuthing of Phyllis Vine at Mental Illness Watch, we saw the stooges exposed in their clumsiness. Phyllis Vine discovered <a href="http://www.miwatch.org/2011/04/apas_ghostwriting_controversy_grows.html">material</a> on the corporate website of STI that has them featuring the textbook in the ‘portfolio’ that aims to attract new business to the company. Juxtapose that with the adjacent claim that STI’s skills are to "develop, write, edit, and submit a high-quality article to your target audience." Now is there any doubt about how this game is played? Now is there any doubt about whether the APA has come clean? Well, if there were any remaining doubt it has been removed by another development: All the materials describing the STI ‘portfolio’ have been removed from the company’s website. Fortunately, Phyllis Vine had captured it <a href="http://www.miwatch.org/2011/04/apas_ghostwriting_controversy_grows.html">here</a>, and so did <a href="http://carlatpsychiatry.blogspot.com/2011/04/new-smoking-gun-in-apa-textbook-fiasco.html">Daniel Carlat </a>through the <a href="http://replay.waybackmachine.org/20081121071704/http:/www.stimedinfo.com/results02_publications.htm">Wayback machine</a>. It was picked up some more by Mickey Nardo <a href="http://1boringoldman.com/index.php/2011/04/11/csi-miwatch/">today</a>. It looks like the APA is going to have more explaining to do. As the old Groucho Marx line goes, Who you gonna believe, them or your lying eyes? Bernard Carroll

...THEM OR YOUR LYING EYES?

…THEM OR YOUR LYING EYES? A few days ago I discussed stonewalling by the American Psychiatric Association over charges that they were partn...

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What's Killing Pharma, With Some Lessons For Hospital IT

<div>An excellent essay on the pathologies killing the pharmaceutical industry is at this link:<a href="http://www.eyesopen.com/en/blog/what-is-really-killing-pharma"> http://www.eyesopen.com/en/blog/what-is-really-killing-pharma</a> . The essay talks about mismanagement, marketing over R&D, management fads, ill-informed managers and many other issues we've discussed in one context or another here at Healthcare Renewal. This paragraph in particular struck my eye for several reasons: <blockquote>... Another good one [reason pharma is dying - ed.]: empowering IT departments to make scientists use the same infrastructure as the guy at the front desk. Rather than see that scientists often have different computing needs than other parts of the business, IT demands obeisance to the corporate norm. In doing so, they hinder the kind of innovation (e.g., Linux, GPU solutions) that used to regularly occur because scientists are quite computer literate, thank you. Instead, IT departments make it impossible for competent people to manage their own resources. They create obstacles instead of removing them. Machine was made for Man, not Man for the Machine.</blockquote> The paragraph struck me because: <ul><li>It fits with my experience and that of my colleagues in other pharmas. See my essay "<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=pharma">Sure path to R&D and industrial failure: Conflation of IT with information science in the pharmaceutical industry</a>."</li></ul><ul><li>Replace "scientists" with "doctors" and you have defined a major problem with health IT In the healthcare delivery sector.</li></ul><ul><li>Finally, this bon mot is extremely apropos to both environments: "Machine was made for Man, not Man for the Machine."</li></ul>Sixty years into the "computer revolution", pharma, healthcare, and the IT industry itself have not learned this simple lesson. I have to believe in 2011 this phenomenon is at least in part due to an abundance of powerful computers relative to the supply of humans in these industries with densely-interconnected gray matter. I think the author of the aforementioned piece agrees. He concludes: <blockquote>... The film industry long ago recognized that what is important is talent. No one can predict what will be a blockbuster (drug or movie), but Hollywood has at least recognized that movie-making is a talent-based industry. Perhaps today’s pharma chiefs need to see themselves as latter-day studio heads—I’m sure they’d love that!—and come to the same conclusions. Define the vision, get and keep the right people, stop making it harder for talented people to do their jobs, give them the time and resources to be creative. Then maybe, just maybe, they would start curing pharma.</blockquote> -- SS </div>

What's Killing Pharma, With Some Lessons For Hospital IT

An excellent essay on the pathologies killing the pharmaceutical industry is at this link: http://www.eyesopen.com/en/blog/what-is-really-...

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BLOGSCAN: Circling the Wagons Around the RUC

On the Care and Cost Blog, Brian Klepper <a href="http://careandcost.com/2011/04/08/the-ruc%E2%80%99s-defense/">suggested</a> that the defenders of the <a href="http://hcrenewal.blogspot.com/search/label/RUC">RUC</a> (RBRVS Update Committee) are getting worried.  He showed that a letter signed by medical specialty societies, but not the major societies that represent generalists, deployed logical fallacies in support of the secretive committee dominated by proceduralists that de facto sets payments to physicians by the US Medicare system, and which seems largely responsible for the gulf between payments for procedures and for primary and "cognitive" care.  His summation: <blockquote>The arguments mounted by the AMA and the specialty societies are really nothing more than a vested industry’s efforts to preserve the status quo at all costs. (Think Wall Street’s apologists in this year’s Oscar-winning documentary, <a href="http://www.rottentomatoes.com/m/inside_job_2010/">Inside Job</a>.) But this approach has brought health care and the US economy to the brink of economic catastrophe. Averting disaster will require an approach that dampens or bypasses the voices of the advisors who got us here, and strengthens the voice of primary care, which <a href="http://content.healthaffairs.org/content/29/5.toc">overwhelming data</a> show produce better care at lower costs.</blockquote>

BLOGSCAN: Circling the Wagons Around the RUC

On the Care and Cost Blog, Brian Klepper suggested that the defenders of the RUC (RBRVS Update Committee) are getting worried. He showed ...

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