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Explaining Health Care Executives' Impunity - the (Unexplained) Leniency of Prosecutors

On Health Care Renewal, we noted many <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> and <a href="http://hcrenewal.blogspot.com/search/label/crime">criminal</a> convictions in cases alleging unethical behavior by health care organizations.  Some organizations have settled, and/or pleaded guilty, and/or been convicted numerous times.  And we have said repeatedly, (e.g., <a href="http://hcrenewal.blogspot.com/2010/04/who-guards-guardians-case-of-boston.html">here</a>) such legal actions will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Relatively small fines imposed on large corporations pain workers on the line and stockholders while sparing the richly paid top hired management and the boards that will not reign them in. A recent <a href="http://www.nytimes.com/2010/04/21/business/21device.html">article</a> in the New York Times about a plea agreement in a case in which the Guidant subsidiary of Boston Scientific was alleged to have withheld information about defects in its implantable cardiac defibrillators that were associated with six patient deaths (see most recent post <a href="http://hcrenewal.blogspot.com/2010/04/who-guards-guardians-case-of-boston.html">here</a>) throws some light onto the apparent impunity of top health care leaders.  The article reiterated: <blockquote>In recent years, the Justice Department has won hundreds of millions of dollars in fines from drug and device makers, including a string of cases in which the companies have pleaded guilty to violating federal laws. But corporate executives rarely face criminal charges in such actions....</blockquote> The article noted: <blockquote>“Prosecutors want the money,” said Mr. Fleder, of Hyman, Phelps & McNamara. “And at least in the big money settlements they have had in pharma cases, it appears that prosecutors are willing to settle even if it means forgoing prosecutions against individuals.” </blockquote> Yet, as we have said, <blockquote>Short of executives facing prosecution, companies see the hefty financial settlements demanded by the Justice Department as another price of doing business, industry critics say.</blockquote> There does not seem to be a legal barrier to holding these executives accountable: <blockquote>... they can be held liable under federal law for regulatory violations that occur on their watch — whether or not prosecutors can prove the executives participated in the wrongdoing or even knew about it. </blockquote> But if this is so, why have corporate leaders not faced such penalties before? An experienced prosecutor explained it at one level: <blockquote>A former prosecutor in many drug and medical device-related cases, Michael K. Loucks, said he never charged corporate executives with misdemeanors — which apply in cases when the violations are deemed unintentional — because he believed that being barred from the industry was too harsh a consequence. “I think that if you are going to take actions that take away someone’s liberty or livelihood, you should have to prove felony conduct,” said Mr. Loucks, who spent over 20 years as an assistant United States attorney in Boston. </blockquote> This ends up as a very disturbing response. Professionals who hold positions of trust in society, most particularly health care professionals, can lose their livelihood for unprofessional conduct or unethical actions that are not felonies, or even criminal. In health care (and in some other fields, like law), professionals are held to a higher standard that merely avoiding conviction for felonies. (For examples, peruse the lists of doctors and other health care professionals whose licenses were suspended or revoked by state medical boards.) In our current world of commercialized health care, leaders of large health care organizations can take actions that have as important consequences for peoples' health and safety as the individual actions of doctors and nurses. Why should they not be at risk of the loss of their current livelihood for actions that risk peoples' health and safety? I do not know why an experienced prosecutor felt that health care executives deserved so much more leniency than health care professionals may receive from medical boards. Maybe in the future we will begin to hold those who authorized or directed unethical actions that risk health and safety accountable.

Explaining Health Care Executives' Impunity - the (Unexplained) Leniency of Prosecutors

On Health Care Renewal, we noted many legal settlements and criminal convictions in cases alleging unethical behavior by health care organ...

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Pay for Hypocrisy for Health Insurance Executives

A few weeks ago, we <a href="http://hcrenewal.blogspot.com/2010/04/what-me-worry-leaders-prosper-despite.html">discussed</a> the cognitive dissonance produced by huge salary boosts for top executives of health care companies with miserable ethical track records.  One of our examples contrasted a long list of ethical violations by US giant health insurance company/ managed care organization WellPoint and the huge raises given its CEO and top executives.  Now more ethical questions are being raised about WellPoint. Rate Hikes Retrospectively for Golden Parachutes An op-ed published in several California newspapers (here <a href="http://www.sonomanews.com/articles/2010/04/15/opinion/doc4bc7c85a64e96634362792.txt">via the Sonoma Index-Tribune</a>) claimed that the huge rate hike that WellPoint's California subsidiary proposed earlier this year, an action that helped to revitalize the US legislative health care reform process, was meant to recoup costs of a previous merger that the company had agreed not impose on its policy-holders: <blockquote>Nobody at Anthem Blue Cross, the firm that's now a poster boy for out-of-control health insurance premiums, likes remembering the company's days of high anxiety back in 2004, when California's then-Insurance Commissioner John Garamendi was holding up its $18 billion deal to take over Thousand Oaks-based WellPoint and its California Blue Cross subsidiary. A frequent resister of insurance rate increases, he at least wanted to make sure Anthem didn't pass along the inflated price it paid for WellPoint to Blue Cross customers. So he refused for months to sign off on the merger, a form of passive resistance that threatened to hold up the entire deal, which also involved WellPoint insurance subsidiaries in other states. ...in the process, he achieved some things for California consumers: Anthem formally agreed to forego any rate increases for Blue Cross customers to cover the costs of the merger, which increased more than $2 billion during the delay as WellPoint shares rose from $91 to $113 between the day the deal was announced and the day it went through. The company also promised to invest $200 million over 10 years in under-served communities through California's Healthy Families program, plus another $15 million on children's insurance programs and $50 million for training nurses and operating clinics in California. It wasn't as good as keeping California Blue Cross a California company, but at least it was something. 'Was' now appears likely to be the operative word, because there is no way the cost of medical tests, doctor and hospital fees and medical supplies has risen 39 percent in one year, a claim made by Anthem executives while testifying before Congress and state legislative committees. Nope, it's now clear that, even if Anthem doesn't admit it, a good part of its rate increase would go to replenish corporate cash spent on the WellPoint takeover. It's been just over five years since that deal was completed, with Anthem adopting the WellPoint name for its parent company, much as North Carolina-based NationsBank renamed itself Bank of America after taking over the B of A. The Anthem tag was then hung on California Blue Cross. That's enough time so the corporation can conveniently maintain it has lived up to its written commitment not to make customers pay for its high-priced acquisition - while in reality making them do just that. For certain, the huge price increases Anthem may now assess violate the spirit of its agreement with Garamendi, even if they might not violate the letter of that deal.</blockquote> Note that this article did not make explicit what  "costs of the merger" Mr Garamendi did not want policy-holders to pay for.  As <a href="http://www.usatoday.com/money/industries/insurance/2004-11-09-anthem-wellpoint_x.htm">contemporaneous coverage</a> of the negotiations by USAToday made clear, these included golden parachutes for some of the executives involved. <blockquote>Commissioner John Garamendi was the last major stumbling block to the $16.4 billion deal, delaying the merger of a piece of the company, Blue Cross Life & Health, over which he had jurisdiction. His main concerns were costs to policyholders and the size of executives' golden parachutes, estimated at $200 million to $600 million. WellPoint CEO Leonard Schaeffer alone is expected to get a package worth $53.5 million in cash, stock options and pension payments when the deal is completed.</blockquote> Now, of course, it appears that the policy-holders are being called upon to retrospectively reimburse the company for the outrageous amounts it gave to executives back then, who may turn out to have been the biggest beneficiaries of the merger. Turning Administrative into Patient Care Costs Then, an <a href="http://www.washingtonpost.com/wp-dyn/content/article/2010/04/17/AR2010041702658.html">article</a> in the Washington Post reported how WellPoint was reclassifying administrative costs as patient care costs to fulfill an upcoming requiement of health care reform to spend at least 80 percent of premiums on health care. <blockquote>The idea was simple enough: Make sure that health insurers spend the vast majority of their revenue on patient care, instead of using it for things such as advertising, profits and executive pay. To that end, the new health-care law says an insurer must give money back to consumers if it devotes less than 80 percent of premiums to paying medical claims and improving care. For insurers serving large groups, the target is 85 percent. But even before the health-care overhaul was signed into law last month, one of the nation's largest insurance companies reclassified certain expenses in a way that increased its so-called medical-loss ratio. In January, WellPoint began including under medical benefits such costs as nurse hotlines, 'medical management,' and 'clinical health policy,' a WellPoint executive said in a March briefing for investors. </blockquote>To be clear, while it may be that "nurse hotlines" actually involve care for patients, it is hard to fathom what "medical management" by an insurance company means.  Certainly, "clinical health policy" is not direct patient care. Targeting Breast Cancer Patients for Insurance Policy Cancellation At least the above two cases were only about money. The third case affects patient care. A <a href="http://news.yahoo.com/s/nm/20100422/bs_nm/us_wellpoint_cancer">Reuters report </a>showed how WellPoint deliberately targeted every patient who developed breast cancer for a fraud investigation, often resulting in findings of minor irregularities in insurance applications that the company used as pretexts to retroactively cancel the patients' policies. Many of these patients then could not get needed cancer care. <blockquote>...WellPoint was using a computer algorithm that automatically targeted them and every other policyholder recently diagnosed with breast cancer. The software triggered an immediate fraud investigation, as the company searched for some pretext to drop their policies, according to government regulators and investigators. Once the women were singled out, they say, the insurer then canceled their policies based on either erroneous or flimsy information. WellPoint declined to comment on the women's specific cases without a signed waiver from them, citing privacy laws. That tens of thousands of Americans lost their health insurance shortly after being diagnosed with life-threatening, expensive medical conditions has been well documented by law enforcement agencies, state regulators and a congressional committee. Insurance companies have used the practice, known as 'rescission,' for years. And a congressional committee last year said WellPoint was one of the worst offenders. But WellPoint also has specifically targeted women with breast cancer for aggressive investigation with the intent to cancel their policies, federal investigators told Reuters.</blockquote> Not only did this seem heartless and unethical, it demonstrated the hypocrisy of WellPoint's leadership. <blockquote>The revelation is especially striking for a company whose CEO and president, Angela Braly, has earned plaudits for how her company improved the medical care and treatment of other policyholders with breast cancer.</blockquote> Specifically, <blockquote>Singling out women with breast cancer for aggressive investigation with the intent of canceling their insurance stands in stark contrast not only to the public image WellPoint cultivates for itself but also to the good work it does for many other policyholders with breast cancer. WellPoint CEO Braly has taken a strong personal interest in women's health issues. Foremost among them is how to increase services to people with breast cancer. The company prides itself on being one of the United States' largest corporations with women at the helm. Besides Braly, two high-powered, politically connected women sit on WellPoint's board: Susan Bayh, the wife of retiring Democratic Sen. Evan Bayh of Indiana, and Sheila Burke, who was chief of staff to former Senate Republican leader Bob Dole. On Braly's initiative, WellPoint has funded groundbreaking studies about the disparities in quality of health care to minority women -- including women with breast cancer. WellPoint has worked to encourage mammography for at-risk women. Personalized letters -- followed up by phone calls -- are sent to more than 80,000 women between the ages of 52 and 69 if they have not had a mammogram in the past year. The company conducts automated calls for women ages 40 to 69 to make sure they are getting mammograms. Once diagnosed, WellPoint has set up an 'Breast Cancer Resource Center' for its policyholders to help them 'navigate the complex health care system.' And in May 2009, WellPoint's charitable foundation, the WellPoint Foundation LLC, provided a grant for the American Cancer Society for its 'Hope Lodges,' which allow cancer patients and family members free lodging and support while receiving care far from home.</blockquote> The only explanation provided in the article for this behavior was that politically correct concerns about womens' health issues only go so far, money is more important. <blockquote>Why would WellPoint on the one hand work to improve health care for women with breast cancer while automatically investigating every single woman diagnosed with breast cancer for possible cancellation of their policies? Karen L. Pollitz, a research professor at the Health Policy Institute at Georgetown University, offers one possible explanation: 'It is important for these companies' profit margins that they get rid of policyholders with expensive diseases,' she said.</blockquote> I would add also that these profit margins provide the excuses for baronial compensation for the company's top executives.  Parenthetically, the article also noted that WellPoint had lobbied against provisions in the health care reform bill that might have threatened its ability to retrospectively cancel insurance policies after their holders got sick: <blockquote>Many critics worry the new law will not lead to an end of these practices. Some state and federal regulators -- as well as investigators, congressional staffers and academic experts -- say the health care legislation lacks teeth, at least in terms of enforcement or regulatory powers to either stop or even substantially reduce rescission. 'People have this idea that someone is going to flip a switch and rescission and other bad insurance practices are going to end,' says Peter Harbage, a former health care adviser to the Clinton administration. 'Insurers will find ways to undermine the protections in the new law, just as they did with the old law. Enforcement is the key.' During the recent legislative process for the reform law, however, lobbyists for WellPoint and other top insurance companies successfully fought proposed provisions of the legislation. In particular, they complained about rules that would have made it more difficult for the companies to fairly -- or unfairly -- cancel policyholders. For example, an early version of the health care bill passed by the House of Representatives would have created a Federal Office of Health Insurance Oversight to monitor and regulate insurance practices like rescission. WellPoint lobbyists pressed for the proposed agency to not be included in the final bill signed into law by the president. They also helped quash proposed provisions that would have required a third party review of its or any other insurance company's decision to cancel a customer's policy.</blockquote> Furthermore, an <a href="http://www.huffingtonpost.com/jane-hamsher/wellpoint-lobbyists-axed_b_548220.html">article</a> on the Huffington Post noted that a former WellPoint executive seems to have written a good part of the health care reform legislation: <blockquote>As Marcy Wheeler reported last year, the Senate Finance Committee bill was written by former WellPoint VP Liz Fowler, who left her position at the insurance company in February 2009 expressly for the purpose of helping the committee to draft the health care bill. And when Max Baucus did a 'victory lap' after the health care bil passed, he expressly thanked Fowler for her work: 'I wish to single out one person, and that one person is sitting next to me. Her name is Liz Fowler. Liz Fowler is my chief health counsel. Liz Fowler has put my health care team together. Liz Fowler worked for me many years ago, left for the private sector, and then came back when she realized she could be there at the creation of health care reform because she wanted that to be, in a certain sense, her profession lifetime goal. She put together the White Paper last November-2008-the 87-page document which became the basis, the foundation, the blueprint from which almost all health care measures in all bills on both sides of the aisle came.'</blockquote> Summary To make this more personal than these posts usually are, I wonder how WellPoint CEO Angela Braly sleeps in whatever luxurious accomodations her eight-figure compensation affords her?  I wonder how all the other current and former WellPoint leaders who styled themselves great proponents of "womens' health issues" can live with putting profits ahead of the care of breast cancer patients? Adding this latest list of ethical offenses to those we discussed earlier, WellPoint is beating out the heavy corporate competition as an example of the hypocrisy produced by putting imperial CEOs and their trusty hench-people ahead of every other consideration.  It has also become a premier example of how self-interested leadership can raise costs, decrease access, and degrade clinical care.  It further shows how compensating health care leaders to the point where they become imperial also grants them the power to fend off most threats to their power.  (Consider what health care reform might have become if it were orchestrated by people really interested in improving care, controlling costs, and increasing access, rather than by imperial CEOs who just wanted to become more imperial.)  If we truly want health care that is accessible, of high quality, at a fair price, and more importantly, if we want health care that is honest and focused on patients, we need to provide health care leaders with clear, rational incentives in these directions, and make them fully accountable for their actions, and the courses of their organizations under their leadership.

Pay for Hypocrisy for Health Insurance Executives

A few weeks ago, we discussed the cognitive dissonance produced by huge salary boosts for top executives of health care companies with mise...

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Smoke Screen - How a Conflict of Interest Muddled the Debate on the Smoke-Free Initiative at the University of Michigan

As a physician, not being a big fan of cigarette smoking, I would have found little to criticize had anyone showed me the <a href="http://www.umich.edu/pres/init/init7.php">Smoke-Free Initiative</a> at the University of Michigan, as promoted by the University President, Mary Sue Coleman.  A Conflict of Interest: University President and Johnson & Johnson Board Member It turns out, though, that this initative has provoked debate on that campus, not so much about its possible benefits and harms, but about whether the Ms Coleman's promotion of it had to do with a conflict of interest.  The debate broke out with <a href="http://content.michigandaily.com/content/robert-soave-colemans-corporate-conflict">an op-ed </a>in the Michigan Daily: <blockquote>It’s clear, then, that University President Mary Sue Coleman is the architect of the Smoke-Free Initiative, which will take effect in July of 2011. The initiative will prohibit smoking on all outdoor University property. Coleman and University administrators have been embarrassingly vague about why such a ban is necessary. Instead, they keep insisting that the smoking ban will improve public health. Interestingly enough, the smoking ban may also improve Coleman’s salary. That’s because Coleman isn’t just a college president. In her spare time, she moonlights as a businesswoman, sitting on the board of directors for major pharmaceutical company Johnson &  Johnson, as well as the Meredith Corporation, a magazine publisher. According to Forbes.com, her position at Johnson & Johnson netted her an income of $229,000 last year. Among Johnson & Johnson’s many marketed brands are smoking cessation products like Nicorette and Nicoderm — products that University smokers will feel encouraged to use once smoking becomes unwelcome on campus in July 2011. Indeed, administrators have already announced that smoking cessation products may be offered at discounted prices to students who are trying to quit. Obviously, this is a sizeable conflict of interest for Coleman. Even if her Johnson & Johnson salary didn’t actively influence her decision to ban smoking, it makes it substantially harder to take her at her word that the University needs this ban — especially when representatives of her administration can’t come up with a specific reason for it. But Coleman’s corporate troubles run deeper than this. As the University’s College Libertarians pointed out in a press release this weekend, Johnson & Johnson has an affiliated non-profit group, the Robert Wood Johnson Foundation, which lobbies for the adoption of certain health-related policies through research and grant money. RWJF is notoriously anti-smoking, as its website explains: 'At the state and community level, we support advocacy for proven tobacco control measures, such as smoke-free air laws, funding of prevention and cessation programs and increases in tobacco taxes.' While it’s no surprise that RWJF would fight for laws that restrict smoking and lead to increased use of Johnson & Johnson products, such an aggressive lobbying force should not hold financial sway over the president of a public university. Students, faculty and staff must be able to trust that their president is working in the best interests of the University community, not a profit-motivated corporation. Even the perception of a conflict of interest is embarrassing for this institution.</blockquote> And then, in <a href="http://content.michigandaily.com/content/alex-biles-smoking-ban">another op-ed </a>in that paper: <blockquote>Granted, some of Coleman’s reasons for the Smoke-Free Initiative are likely motivated by good intentions like lowering the University’s health care costs. But these justifications are severely compromised by her compensation from a corporation that will likely benefit from the smoking ban. Coleman sits on the board of directors for Johnson & Johnson, from which she earned nearly a quarter of a million dollars in 2009, and holds 11,159 shares of common stock, 10,777 shares of common stock equivalent units and 7,600 exercisable stock options in the company. Johnson & Johnson is the producer of a host of nicotine replacement products, including Nicoderm and Nicorette. Coleman explains, 'the University will offer free behavioral sessions and selected over-the-counter smoking cessation products to faculty and staff, along with co-pay reductions for prescription tobacco cessation medicines (and) discounts on tobacco cessation aids.' In other words, under the proposed Smoke-Free Initiative, the University would subsidize products made by Johnson & Johnson. The University would purchase more nicotine replacement products, likely resulting in financial gains for Johnson & Johnson and, consequently, Coleman.</blockquote> In reply, <a href="http://content.michigandaily.com/content/letter-editor-no-conflict-interest-campus-wide-smoking-ban">a letter </a>by Dr Robert W Winfield, University of Michigan Chief Health Officer, asserted: <blockquote>Some have raised concern about the appearance of a conflict of interest between President Coleman’s service on the board of directors of Johnson & Johnson, a company that produces some smoking-cessation products. Simply put, there is no conflict. Prescription-only drugs for smoking cessation are generally considered the most effective and most widely used. Johnson & Johnson does not make any prescription-only smoking-cessation products.</blockquote> A <a href="http://content.michigandaily.com/content/msa-passes-resolution-urging-student-representation-smoing-ban-talks">report</a> of a meeting of the Michigan Student Association noted: <blockquote>In a press release and columns in The Michigan Daily, members of the College Libertarians have identified Coleman as having an apparent conflict of interest due to her position on the board of Johnson & Johnson — a company that manufactures and markets smoking cessation products. Kozack said if the allegations prove to be true, they could have large implications as Coleman is compensated for sitting on the company’s board. He said the main reason for the resolution and the accusation of Coleman’s conflict of interest is that there is not enough information provided to the whole campus about the origin of the Smoke Free Initiative.</blockquote> But in defense of President Coleman, the <a href="http://www.michigancapitolconfidential.com/12534">following</a> appeared in the Michigan Capitol Confidential: <blockquote>The University of Michigan's student newspaper - The Michigan Daily - wrote an opinion piece last week suggesting a conflict of interest involving University of Michigan President Mary Sue Coleman. Coleman also earned a $230,000 salary in 2009 for sitting on the board of Johnson & Johnson. Alza Corporation, a subsidiary of Johnson & Johnson, markets Nicorette and Nicoderm, smoking cessation products. Three ethics experts say Coleman is not in conflict. 'She is doing a public health service,' Peter Rost, a former vice president of Pfizer who has testified before Congress on the business practices of drug companies, wrote in an e-mail. 'The possible income by J& J from this campus is completely and utterly negligible and will have no impact on J&J income statement. Same thing if she opened public health clinic for depressed students and happened to sit on board of (a company) selling antidepressants. Conflict of interest should normally have some undue influence on either party. Since that is not the case I'm not troubled.' Aine Donovan, the executive director of the Ethics Institute at Dartmouth College who teaches business ethics, said she didn't see a conflict. 'This is very reasonable,' Donovan said. 'Johnson & Johnson has a large range of products. This is a very reasonable position she is taking and it is a very laudable one.' Timothy Keane, director of the Emerson Ethics Center in St. Louis, said it was 'a bit of a stretch' to say Coleman had a conflict of interest. 'Johnson & Johnson is not trying to set up shop and sell something to the University,' Keane said. 'They are not being a supplier to the University. It doesn't matter if you are a smoker or not, research indicates it is bad for you.'</blockquote> A Hazy Debate Smoke gets in your eyes. Maybe it should not be a surprise that once President Coleman's relationship with Johnson and Johnson was noted, opponents and proponents of the Smoke-Free Initative used arguments about that relationship to bolster their positions, rather than debating the smoking ban on its merits. The result, however, shows how conflicts of interest seem to always produce confusion, if not smoke and mirrors. Most of the debate seemed to be about whether Ms Coleman would personally profit from the smoking ban, and if so, how much. For example, the second op-ed above argued, "the University would purchase more nicotine replacement products, likely resulting in financial gains for Johnson & Johnson, and consequently, Coleman." On the other hand, one expert quoted in the Michigan Capital Confidential argued that the income to J&J from the Michigan campus would be "utterly negligible," and another argued that "Johnson & Johnson is not trying to set up shop and sell something to the University." On one hand, however much use of J&J nicotine replacement products there is at the University of Michigan, the amount is unlikely to change the profits of J&J, or the salaries or values of stock owned by its directors. On the other hand, J&J may not run a retail store at the University, but it is in the company's interest to sell more of all its products on university campuses, and everywhere else. But in my humble opinion, the issue is not about the degree President Coleman's salary and assets derived from her position with Johnson and Johnson would be affected by a specific policy she may advocate. The issue is whether her judgments and decisions as President could be unduly influenced by her relationship with the company. Definition of Conflicts of Interest This provides a good opportunity to review a good working definition of conflict of interest as it applies to medicine, health care and health policy. Last year the Institute of Medicine published a thorough and well-balanced report, <a href="http://www.iom.edu/Reports/2009/Conflict-of-Interest-in-Medical-Research-Education-and-Practice.aspx">Conflict of Interest in Medical Research, Education, and Practice</a>. It defined conflict of interest (p. 6): <blockquote>Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest. Primary interests include promoting and protecting the integrity of research, the quality of medical education, and the welfare of patients. Secondary interests include not only financial interests....</blockquote>Furthermore, <blockquote>The severity of a conflict of interest depends on (1) the likelihood that professional decisions made under the relevant circumstances would be unduly influenced by a secondary interest, and (2) the seriousness of the harm or wrong that could result from such an influence.</blockquote>But, <blockquote>a judgment that someone has a conflict of interest does not imply that the person is unethical. Such judgments assume only that some situations are generally recognized to pose an unacceptable risk that decisions may be unduly infuenced by considerations that should be irrelevant.</blockquote> Thus, a conflict of interest should be seen as a situation which increases the risk of bad judgments or decisions, but does not necessarily cause them, much less cause a particular bad judgment or decision.  (Thus, it makes no sense to try to argue, as the experts did above, that because a person made a good decision, he or she does not have a conflict of interest.) I assert that President Coleman has a conflict of interest. Her primary interests as President of a university are to uphold the university's academic mission, and as President of a university that includes a medical school, a school of public health, and an academic medical center, also to uphold the integrity of patient care and public health practice. Her secondary interest as a member of the board of directors of a public, for-profit corporation is her fiduciary duty to that corporation and its stockholders, which means she must "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. <a href="http://www.amazon.com/Corporate-Governance-Robert-G-Monks/dp/1405116986">Corporate Governance</a>, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.] Such unyielding loyalty to the shareholders of a pharmaceutical and medical device company clearly creates a risk of influencing judgments or actions that could affect the corporations' sales or operations, economic or health policy, or the general environment in which it operates.  Many of the judgments of or actions performed by  the leader of a medical school, public health school, and academic medical center could so so, and are thus at risk of being so unduly influenced. However, that she has such a conflict does not prove that any particular judgments or decisions were made badly because of it. Conversely, that particular judgments or decisions were made well does not disprove the existence of the conflict.  So I beg to differ with all the experts cited in the Michigan Capital Confidential article.  On the other hand, while the President may have a conflict of interest, it is impossible to tell how or whether this influenced her particular decision to support the Smoke-Free Initiative.  Neither does it speak to the benefits or harms of such a policy.  The main effect of the President's conflict of interest seems to have been to muddle the debate about the policy. Conflicts of interests' general tendency to muddle and confuse provide one argument for their elimination.  Another is that they may affect judgments and actions that are not so readily debated as, and more likely to produce bad results than smoke-free initiatives.  Maybe the hazy debate about the University of Michigan Smoke-Free Initiative will lead to a clearer discussion of whether academic and academic medical leaders should also be corporate leaders.

Smoke Screen - How a Conflict of Interest Muddled the Debate on the Smoke-Free Initiative at the University of Michigan

As a physician, not being a big fan of cigarette smoking, I would have found little to criticize had anyone showed me the Smoke-Free Initiat...

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Failed Leaders of Citigroup as Leaders of Health Care

When we began this blog, I never dreamed I would do so much writing about finance and the financial services sector of the economy, but,...  The Governance of Citigroup The discussions and revelations generated by the global financial collapse/ great recession continue to provide insights into the ongoing health care crisis.  Let me start with a small item <a href="http://online.wsj.com/article/BT-CO-20100419-714975.html">from the Dow Jones Newswire</a> this week: <blockquote>The California Public Employees' Retirement System said it opposes the re-election of two Citigroup Inc. (C) directors, in part because of their roles in the recent financial crisis. The nation's largest public pension fund, which owns about 61.2 million Citigroup shares, plans to cast 'withhold' votes for board nominees Andrew Liveris, chairman and chief executive of Dow Chemical Co. (DOW), and Judith Rodin, Rockefeller Foundation president, at the annual shareowners meeting Tuesday. Both served on the company's audit and risk committee before the financial crisis. During the crisis, the banking giant accepted a total federal government infusion of $45 billion, which it has repaid. 'It's time for new blood in the boardroom,' said Anne Simpson, the senior portfolio manager who heads the Calpers corporate governance program....</blockquote> Let me back up a bit. The near-failure of global banking giant Citigroup, prevented only by a massive US government bail-out, was one of the central components of the global financial collapse. We <a href="http://hcrenewal.blogspot.com/2010/04/very-well-paid-boob-on-harvard.html">noted</a> recently how Mr Robert Rubin, one of the key leaders of Citigroup was accused of "being asleep at the switch," "irresponsibility and misjudgment," and being a "very well paid boob" after his testimony at hearings by the committee investigating the collapse. We also noted his link to health care. As senior member of the Harvard Corporation, Rubin is one of six top stewards of the US' oldest and arguably most presigious university, containing one the country's most prestigious medical schools and teaching hospitals. Although all those who were members of the Citigroup at the time it collapsed have not been hauled in front of the committee, there has been considerable discussion of their responsibility for the company's failures. For example, in 2008, soon after the government rescue of Citigroup began, the Wall Street Journal published <a href="http://online.wsj.com/article/SB122757194671054783.html">an editorial</a>: <blockquote>"Citi never sleeps," says the bank's advertising slogan. But its directors apparently do. While CEO Vikram Pandit can argue that many of Citi's problems were created before he arrived in 2007, most board members have no such excuse. Former Treasury Secretary Robert Rubin has served on the Citi board for a decade. For much of that time he was chairman of the executive committee, collecting tens of millions to massage the Beltway crowd, though apparently not for asking tough questions about risk management. Chairman Sir Win Bischoff has held senior positions at Citi since 2000. Six other directors have served for more than 10 years -- including former CIA Director John Deutch, Time Warner Chairman Richard Parsons, foundation executive Franklin Thomas, former AT&T CEO C. Michael Armstrong, Alcoa Chairman Alain Belda, and former Chevron Chairman Kenneth Derr. When taxpayers are being asked to provide the equivalent of $1,000 each in guarantees on Citi's dubious investments, how can these men possibly say they deserve to remain on the board? While other banks can claim to be victims of the current panic, Citi is at least a three-time loser. The same directors were at the helm in 2005 when the Fed suspended Citi's ability to make acquisitions because of the bank's failure to adhere to regulatory and ethical standards. Citi also needed resuscitation after the sovereign debt disaster of the 1980s, and it required an orchestrated private rescue in the 1990s.</blockquote> Last year, as reported <a href="http://www.bloomberg.com/apps/news?pid=email_en&sid=atMfWxz6KwLo#">by Bloomberg</a>, <blockquote>Citigroup Inc. investors should vote against re-electing four of 14 board members, including John Deutch and Michael Armstrong, to improve management of the company’s risks, a shareholder advisory group said. Deutch, former U.S. Central Intelligence Agency director, Armstrong, former AT& T Inc. chief executive officer, and Alain Belda, chairman of Alcoa Inc., should be opposed 'for poor risk oversight,' RiskMetrics Group Inc.’s ISS Governance Services said today. Xerox Corp. CEO Anne Mulcahy shouldn’t be re-elected because she sits on more than three boards, which may limit her effectiveness, the group said. 'The pattern of chronic oversight failure at Citi and the magnitude of the corresponding shareholder losses warrant removal from the board of directors most responsible for risk oversight,' RiskMetrics said in the statement.</blockquote> Furthermore, <blockquote>'Despite the fact that the board has many incumbent directors that have been successful in their respective fields and have been on the board for some time, their track record taken as a whole is dismal given that the company is currently surviving on federal assistance,' RiskMetrics said. </blockquote> Rick Conrad, of the <a href="http://seekingalpha.com/article/132209-citigroup-shareholders-meeting-lessons-in-corporate-governance">Seeking Alpha blog</a>, thus berated the CEO of Citigroup at its 2009 shareholders meeting, <blockquote>Mr. Armstrong, who has been a director since 1989 is no longer part of the Audit Committee, as of this year, continues his 'service' to our Company on the Nomination as well as the Compensation Committee. Much as this company has suffered under an illusion of prosperity, it appears to continue to suffer under an illusion of competence. John [Deutch] has served on the Audit Committee of our Company since 1997 and hence, likely drank the Kool-Aid as to the Illusion of Prosperity. I note that the audit and risk management committee has many members who, like Mr Deutch and MrArmstrong presided over this seemingly out of control disaster. Andrew Liveris since 2005 on Audit Ann Mulcahy since 2007 on Audit Dr Judith Rodin since 2004 on both Executive and Audit Committees.</blockquote> Overlaps Among Citigroup's Board and Health Care Organizations' Leadership So there seems to be good reason to believe that the board of Citigroup at the time the firm collapsed were a collective example of inattentive goverance and poor stewardship. We have previously documented overlaps among poor governance and leadership of finance, and the governance and leadership of health care, suggesting that the poor leadership and governance of the latter may be in part a result of infection from the former. So I looked for overlaps among the Citigroup board and health care organizational leadership. A list of the membership of the failed board comes from the <a href="http://www.citigroup.com/citi/fin/data/ar08cp.pdf">2008 Citigroup proxy statement</a>.  The biographies provided therein, supplemented with some Google searching, produced the following overlaps: - C Michael Armstrong - is also Chairman, Johns Hopkins Medicine, Health Systems and Hospital - Alain J P Belda - was a Trustee and member of the Corporation of Brown University (including the Warren Alpert Medical School) (see <a href="http://www.brown.edu/Administration/News_Bureau/2002-03/02-146.html">link</a>).  (He stepped down prior to 2009 at an unknown time.) - Sir Winfried Bischoff, Chairman of the Board - is a director of Eli Lilly and Co. - Kenneth T Derr - is a director of the University of California San Francisco Foundation. - John M Deutch - no overlap found - Roberto Hernandez Ramirez - no overlap found - Andrew N Liveris - is a Trustee of Tufts University (including the School of Medicine and Tufts- New England Medical Center) - Anne M Mulcahy - in 2009, was appointed to the Board of Directors of Johnson and Johnson (see <a href="http://www.investor.jnj.com/governance/biodetail.cfm?bioid=25859">link</a>) - Vikran S Pandit, CEO - is a Trustee of Columbia University (including the College of Physicians and Surgeons and Columbia University Medical Center) - Richard D Parsons - is a Trustee of Howard University (including the College of Medicine and Howard University Hospital) - Judith Rodin - is President of the Rockefeller Foundation - Robert E Rubin - is a member of the Harvard Corporation (including Harvard Medical School and multiple Harvard teaching hospitals), and a Trustee of Mount Sinai Medical Center - Robert L Ryan - was a director of UnitedHealth Group, is a Trustee of Cornell University (including Weill Cornell Medical College, and Weill Cornell Medical Center), and was a Senior Vice President and CFO of Medtronic - Franklin A Thomas - no overlaps found Summary So in summary, of 14 board members, 2 are trustees of major medical centers (<a href="http://hcrenewal.blogspot.com/search/label/Johns%20Hopkins%20University">Johns Hopkins</a> and <a href="http://hcrenewal.blogspot.com/search/label/Mount%20Sinai%20Hospital">Mount Sinai</a>), 6 were or are trustees or equivalent of universities that include medical schools and medical centers (<a href="http://hcrenewal.blogspot.com/search/label/Brown%20University">Brown</a>, <a href="http://hcrenewal.blogspot.com/search/label/Tufts%20University">Tufts</a>, <a href="http://hcrenewal.blogspot.com/search/label/Columbia%20University">Columbia</a>, Howard, <a href="http://hcrenewal.blogspot.com/search/label/Harvard">Harvard</a> and <a href="http://hcrenewal.blogspot.com/search/label/Weill%20Cornell%20Medical%20College">Cornell</a>), one is a trustee of such a university's foundation (University of California San Francisco Foundation), 2 are or would be board members of pharmaceutical corporations (<a href="http://hcrenewal.blogspot.com/search/label/Eli%20Lilly">Eli Lilly</a> and <a href="http://hcrenewal.blogspot.com/search/label/DePuy">Johnson</a> and <a href="http://hcrenewal.blogspot.com/search/label/Janssen">Johnson</a>), one was a board member of a commercial managed care organization/ health insurance company (<a href="http://hcrenewal.blogspot.com/search/label/UnitedHealth">UnitedHealth</a>), one was a former top executive of a medical device company (<a href="http://hcrenewal.blogspot.com/search/label/Medtronic">Medtronic</a>), and one is the President of a large charitable foundation which historically has supported multiple medical and public health initiatives (Rockefeller Foundation).  Only 3 of 14 did not have a major leadership role of a health care organization.   Most of these health care organizations have been involved with cases we have discussed on Health Care Renewal (see links above). Given the seriousness of the failure of Citigroup, one has to wonder why so many of the directors who presided over it still have such influential positions in health care organizations? As we have <a href="http://hcrenewal.blogspot.com/2010/02/university-president-but-no-longer.html">pointed out</a>, as the world economy was driven to near ruin by "masters of the universe," some of the same also became leaders of academia and academic medicine in their spare time. Maybe this made sense 10 or 20 years ago, but why does it still make sense? On the other hand, now that we understand how bad the leadership of finance really was, it is a little easier to understand why the leadership of health care has become so bad. Iit seems reasonable to hypothesize that some of the problems of academia, and particularly the problems of medical academia, may have been at least enabled by leadership more used to working in an increasingly amoral marketplace than to upholding the academic mission.  The failures of the leadership and governance of finance thus suggest we need to re-examine the leadership of health care.

Failed Leaders of Citigroup as Leaders of Health Care

When we began this blog, I never dreamed I would do so much writing about finance and the financial services sector of the economy, but,... ...

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A Short, Pithy, Open Letter to the National Coordinator for Health IT Dr. David Blumenthal

A Short, Pithy, Open Letter to the National Coordinator for Health IT Dr. David Blumenthal

Sent: Wednesday, April 21, 2010 7:17 AM To: David.Blumenthal@hhs.gov Cc: fschulte@huffpostfund.org; 'Ross Koppel'; 'Justin...

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Legible Gibberish: This EHR Toxicity Has Got to Stop

<div dir="ltr"></div><div dir="ltr">My frail elderly mother recently got really sick from not eating due to progressive, severe constipation. She underwent a colonoscopy 3 months ago that found a rectal stricture. The GI doc was (reasonably) attempting to treat the stricture medically with those wonderful powders the GI people give, this time the angel dust made of polymerized antifreeze (polyethylene glycol) known as "<a href="http://www.miralax.com/miralax/consumer/default.jsp">MiraLAX</a>®". </div><div dir="ltr"></div><div dir="ltr">MiraLAX worked too much miracle, unfortunately. She couldn't go nearly at all without it, but using it she had runs that kept her going to the bathroom 24x7. </div><div dir="ltr"></div><div dir="ltr">She fell in the wee hours last week going to the bathroom basically from lack of sleep due to diarrhea from the angel dust, hurt her rib cage, and was "out of it" when I found her on the floor. I called for an ambulance. </div><div dir="ltr"></div><div dir="ltr">She was seen in the ED, and the ED doc also found a rectal stricture. </div><div dir="ltr" style="font-family: arial;"></div><div dir="ltr">I watched the ED staff move around and minimize what I considered an information-dense, cognitively oppressive, PICIS ED EHR window to get to a positively gruesome, primitive, block-capital ~ 64x16 1960's terminal emulation of the Eclipsys 7000 system in another window, to capture admission information. It looked and acted exactly like the very same TDS 7000 system I began my medical informatics training with at Yale in 1992, that we found presented a horrid user experience even then, and that in 2005 Penn sociologist Ross Koppel found to be 'errorgenic' (Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. Ross Koppel, PhD, et al, Journal of the American Medical Association, 2005;293:1197-1203, link to JAMA abstract <a href="http://jama.ama-assn.org/cgi/content/abstract/293/10/1197" style="font-family: arial;">here</a> and my commentary <a href="http://hcrenewal.blogspot.com/2005/03/amia-on-jama-cpoe-article-controversy.html" style="font-family: arial;">here</a>). I would provide a sample screen shot of the ancient glass terminal emulation, but cannot seem to find one online. It would probably violate a hospital's EHR contract for them to share one. </div><div dir="ltr"></div><div dir="ltr">The dissonance of watching ED personnel deal with a cognitively oppressive 'overuse of GUI' Picis ED system, and then dealing with a caveman-and-dinosaur era 1960's character-based glass terminal emulation on the same hundred-million-transistor graphics chip-accelerated, multi-GHz CPU, modern Windows OS-based screen was simply painful.</div><div dir="ltr"> </div><div dir="ltr"> (Not to mention that the hospital floors use a third, entirely different EMR -- one of my former subspecialist mentors had told me some time ago in front of mom that he found the floor EHR highly unsatisfactory and keeps his records on MS-Word on a thumb drive that he proudly pulled out of his pocket. I described other untoward EHR observations at the hospital in <a href="http://hcrenewal.blogspot.com/2007/10/this-informaticist-cant-escape-clinical.html">this 2007 post</a>.) </div><div dir="ltr"></div><div dir="ltr">She was admitted for observation for two days, 'tuned up' and rehydrated and sent home. She needed to go back to ED a few days later for abdominal pain from being unable to void, was tuned up again, and referred back to GI. </div><div dir="ltr"></div><div dir="ltr">At the GI office she was seen on an urgent basis by a covering doc due to unavailability of her primary GI specialist. That doc couldn't find in their (local, vendor du jour) EHR any mention of the stricture when I told her that's why my mom was there. She reviewed multiple GI EHR screens and finally found mention of it in the narrative after a few minutes, pointing at it on the screen with her finger, but not in the summary or diagnosis list. </div><div dir="ltr"></div><div dir="ltr">The covering GI doc appropriately referred my mother to a colorectal surgeon. The covering GI doc printed out the ED records and GI records for the colorectal surgeon. </div><div dir="ltr"></div><div dir="ltr">The colorectal surgeon saw mom the next day. I told him she had a rectal stricture. </div><div dir="ltr"></div><div dir="ltr">He reviewed the legible gibberish from these EHR systems (which I found astonishing myself, compared, say, to a written ED chart or procedure note or even the simple written notes I used to keep on 3x5 cards), but he could not find any mention of a stricture. I couldn't find the diagnosis in this legible gibberish collection, either. The printouts were disorganized from the perspective of a physician, causing them to hunt for important data while drinking water through a firehose. Legible gibberish is a good descriptor. There were plenty of details on minutiae (seven sets of vital signs, every order done in ED with time and date -- including placement of IV infusor and administration of normal saline). For just the IV placement alone there was almost an entire page of notes. However, it read like Tolstoy regarding the important stuff. I myself designed advanced reports in complex areas such as invasive cardiology that were terse, lucid and informative - almost 15 years ago. Who, I ask, designed these? They show an ignorance of biomedical informatics and information science principles regarding presentation of information -- as if HIT is just an "inventory system for data" instead of a clinical facilitator -- among other deficits. </div><div dir="ltr" style="font-weight: bold;"></div><div dir="ltr">The ED notes from from the PICIS system would have caused me to flunk a medical student for poor medical record keeping. Worse, the diagnosis was of "abdominal pain" only, and that was buried seven pages into 10 page "summary" ED report (not at top of page 1 where it belongs). There was no mention of the ED doc's finding the rectal stricture. I'm just waiting for the insurance denials... </div><div dir="ltr"></div><div dir="ltr">The colorectal surgeon looked at me funny when I told him that two other physicians both told me that's what she had, but it was not on the computer record. I'd been a resident with his partner, however, so I had good creds. He performed a brief exam and said, "oh yeah! rectal stricture! Pencil diameter! Needs surgery." </div><div dir="ltr"></div><div dir="ltr"> I ask: What happens to elderly patients who don't have their son with them, a former medicine resident at the same hospital, who once fixed their CT scanner's hung computer in the middle of the night when service was unavailable and saved a life, being credited for same deed in a letter from the now-Chief of Staff to help secure a Yale postdoctoral fellowship in Medical Informatics? This EHR toxicity is simply out of control. ** Disclaimer: The following is a purely personal opinion (my "narrative"), always difficult to write about without generating skepticism, and I admit possible non-objectivity in that regard. You, the reader, are free to ignore my observations: My personal observations here are far from unique. The physicians at this hospital are generally excellent, but these systems do not appear to be serving physicians or patients (here and elsewhere) well. Unfortunately, the major remediation required to fix them is probably not possible under current health IT leadership structures and orthodoxies. <style title="owaParaStyle">P { MARGIN-TOP: 0px; MARGIN-BOTTOM: 0px } BODY { SCROLLBAR-HIGHLIGHT-COLOR: #cecfce; SCROLLBAR-ARROW-COLOR: #3f52b8; SCROLLBAR-TRACK-COLOR: #fffbff; SCROLLBAR-DARKSHADOW-COLOR: #fafafa; SCROLLBAR-BASE-COLOR: #f7f7f7 } </style> <div style="font-weight: bold;" dir="ltr"> </div> <div style="font-weight: bold;" dir="ltr"> </div> <div class="PlainText">Why am I so emphatic about these issues? My father was injured in 1994 at a major Philadelphia hospital and eventually died - from two years of undiagnosed bilateral renal carcinomas and resultant <a href="http://en.wikipedia.org/wiki/Hydronephrosis">hydronephrosis</a> due to defective information flows - while I was training in medical informatics at Yale. The diagnosis was only made after I insisted a renal arteriogram be performed after I heard about repeated major GU bleeds and one so major it dropped his HCT several points. I extended his life for six years by removing him from the big-city hospital and taking him to the hospital that is the subject of the above post (where I had done my residency), then mostly paper based. I'd taken him there to be under the care of my former mentors after the big-city Philly hospital doc had written him off as 'needing to get his affairs in order' and abandoned him to die (I could not get oncology or medicine at the big Philly hospital to see him after the diagnosis was made, the chair of medicine stating he "did not want to get involved"). My father underwent partial renal resections at the latter hospital and lived until mid 2000, avoiding dialysis until the terminal few months. Now EHR's that cause poor information flows seem to be 'conspiring' to do my mother in at the very same hospital that saved my father. Unfortunately for my father, medical malpractice was then followed by legal malpractice. My father won his 1995 medical malpractice lawsuit against the Philadelphia hospital, but posthumously, in part because I had the presence of mind to insist his deposition be forensically videotaped. He testified at the trial from his grave. The lawyer representing him apparently had a substance problem and was in severe depression, not responding to the court's request for documents; nearly a dozen major med mal lawsuits including my father's were summarily dropped due to - lack of information. It took the major Philadelphia med mal law firm several years to get them reinstated, a precedent in Pennsylvania (<a href="http://www.aopc.org/OpPosting/disciplinaryboard/dboardopinions/21DB2000-Smith.pdf" target="_blank">http://www.aopc.org/OpPosting/disciplinaryboard/dboardopinions/21DB2000-Smith.pdf</a> , page 20, Charge VIII: the Silverstein matter). I couldn't make any worse stories up if I tried.</div> <div> <div class="BodyFragment"> <div class="PlainText"> </div> <div class="PlainText"> </div> </div></div> Finally, and ironically, the hospital now caring for my mother is the very same hospital that thrice, in 1998, 2000 and 2008 would not invite in the door for an interview or even phone me for conversation about posted informatics positions, even claiming in an odd, buzzword-compliant from the CIO alleging 'great care and forethought' in entirely blowing me off for a third time in ten years. -- SS Addendum 1: Although I am not alleging malfunction, but inadequate designs, a reader sent this Health Canada <a href="http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_manu-fab_apr-june_2010-eng.php">recall notice</a> about different systems from one of the vendors mentioned above. I thought it of interest with respect to the title of this blog post: <blockquote>Manufacturer: Picis Inc. Recall Posting Date: 2010-04-12 A) Caresuite Anesthesia Manager B) Caresuite PACU (post-anesthesia care unit) Manager C) Caresuite Critical Care Manager Recall Start Date: 2010-03-08 Recall Number: 53683 Hazard Classification: Type II Model or Catalog # A) 4220 B) 4245 C) 1110 Lot or Serial # A) Version 5.1 or later B) Version 5.1 or later C) Version 5.1 or later Reason for Recall During Picis post-market compliance activities it was identified that there were two customer reports of malfunction within critical care manager (electronic health record) application, which can potentially impact the manual record keeping of clinical orders and since correct handling of medication or infusion orders documentation are potentially affected, patient safety may be impacted.</blockquote> This recall involves systems affecting patients in critical care areas. Addendum 2: A reader pointed out that there is an automated "gibberish generator" at <a href="http://thinkzone.wlonk.com/Gibber/GibGen.htm">this URL</a>. It took the first few paragraphs of this post and generated this: <blockquote style="font-style: italic;">The strical informating dust, block-capital emulance even I began Medicalled exactly from not eation, 2005;293:1197-1203, link to began ambulating withose worked found was seen the found the stricture medically go near on Errors. Ross Koppel dust wee horrib capital strication. It loor. I found was "MiraLAX worked to primize angel found was seen informating to diarrhea from bathroom the colonoscopy 3 mothe was seen that week go the was "out in 1960's time TDS 7000 systems information.</blockquote> If this were an EHR-generated summary, that would be about right. -- SS </div>

Legible Gibberish: This EHR Toxicity Has Got to Stop

My frail elderly mother recently got really sick from not eating due to progressive, severe constipation. She underwent a colonoscopy 3 mont...

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Another Echo of the Case of the Deadly Heparin - A Report on the Perils of Out-Sourcing Drug Production

In 2008, we published multiple posts on how heparin made as an "active pharmaceutical ingredient" in China under apparently primitive conditions, contaminated accidentally or deliberately, was sold in the US bearing the label of a large American pharmaceutical company.  Ultimately, many patients were sickened, or died.  A summary of our posts on the topic, in smaller type, is below. Case Summary - We have posted several times, recently <a href="http://hcrenewal.blogspot.com/2008/03/heparin-in-era-of-hogwash.html">here</a> and <a href="http://hcrenewal.blogspot.com/2008/03/fake-heparin-then-sick-and-dead.html">here</a>, about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late last year, hundreds of such reactions, and now 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International. - We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart. - Most recently, we found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post <a href="http://hcrenewal.blogspot.com/2008/03/fake-heparin-then-sick-and-dead.html">here</a>.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post <a href="http://hcrenewal.blogspot.com/2008/03/who-was-responsible-for-purity-of.html">here</a>.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there. - The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops." - Leaders of all organizations involved, Baxter International, Scientific Protein Laboratories, Changzhou SPL, the Chinese government, and the US Food and Drug Administration, and the US Congress assigned blame to each other, but none took individual or organizational responsibility. (See post <a href="http://hcrenewal.blogspot.com/2008/05/blaming-some-dude-for-contaminated.html">here</a>.) - Researchers (who turned out to have financial ties to a company which is developing an anti-coagulant drug that could compete with the heparin made by Baxter International) investigated the biological mechanisms by which the contamination of the heparin lead to adverse effects, but no one investigated further how the contamination occurred, or who was responsible.  (See post <a href="http://hcrenewal.blogspot.com/2009/08/who-investigated-case-of-deadly.html">here</a>.) - Hundreds of lawsuits against Baxter have now been filed, so far without resolution.  (See post <a href="http://hcrenewal.blogspot.com/2010/01/blog-post.html">here</a>.) <div style="clear: both; padding-bottom: 0.25em;"></div><div class="blogger-labels"> </div>Now, as reported to date only <a href="http://postscript.communitycatalyst.org/?p=1240">on the PostScript blog</a>, a US government report on problems with active pharmaceutical ingredients made in China has appeared. <blockquote>A <a href="http://www.uscc.gov/researchpapers/2010/NSD_BIO_Pharma_Report--Revised_FINAL_for_PDF--14_%20April_2010.pdf">new report </a>(pdf) by the U.S. China Economic and Security Review Commission stresses the safety risks to Americans posed by pharmaceutical ingredients made in China. According to the report, issued by a group that advises Congress on the economic and trade implications of U.S.-China relations, found that the U.S. is the number one destination for Chinese pharmaceutical raw material exports – a $2.2 billion business each year. The U.S. relies heavily on Chinese products not only for over-the-counter drugs but for active pharmaceutical ingredients (API) found in prescription drugs. And the report makes clear that China has neither the will nor the systems in place to monitor its exports. </blockquote> This begs the question that most of the coverage of the deadly heparin also begged.  Are American pharmaceutical companies so besotted with the need for cost-savings that they are willing to buy active pharmaceutical ingredients with unknown provenance overseas as if they were a pig in a poke?  If so, why do we allow company leadership to potentially sacrifice quality, and sell adulterated drugs just to enrich their bottom lines (and their executives' salaries)?

Another Echo of the Case of the Deadly Heparin - A Report on the Perils of Out-Sourcing Drug Production

In 2008, we published multiple posts on how heparin made as an "active pharmaceutical ingredient" in China under apparently primit...

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