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Millions for tribute, but not one cent for defense: If hospitals cannot afford to legally defend EMR mishaps, should they be investing in them?

<div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;">Imagine an airline going out and buying new multimillion-dollar jets with increased fuel efficiency and that produce less pollution. However, they knowingly buy them under conditions of not being able to afford to perform complete diagnostics/forensics for the FAA when something goes awry and a plane malfunctions or crashes. Absurd? Apparently not in the domain of healthcare IT. The hospital where my mother was injured (now of blessed memory as a result) has still refused to substantively answer EMR-related questions, after a motion by my mother's attorney to compel discovery. As part of their legally sworn-truthful response they write:</div> <div dir="ltr" style="font-family:arial;"> </div> <blockquote style="margin-right: 0px; font-weight: bold;font-family:arial;" dir="ltr"> <div dir="ltr"> "The burden and expense of more detailed responses would put a substantial drain on the hospital's limited resources."</div></blockquote> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> If this is true, perhaps hospitals (which generally do have limited resources) should not be spending tens or hundreds of millions of dollars on electronic medical records, a still-experimental technology (<a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html">link</a>). It also causes concern about the maintenance state of the current technology. The general point of which this is a specific example is this: If hospitals cannot afford to defend/produce forensics for the technology when mishaps inevitably occur (such as in the Feb. 2010 FDA internal memorandum on health IT related mishaps, <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">link</a>, which the director of CDRH states are likely the "tip of the iceberg, <a href="http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html">link</a>), then perhaps hospitals need to rethink the initial investment and ongoing maintenance/upgrading costs until the technology is more mature. Should the motto of hospitals be "Millions for IT tribute, but not one cent for defense?" Finally, in the same brief claiming poverty, I, now representing my deceased mother was referred to as a "self-described expert in computerized medical records" and "critic of use of computerized medical records in hospitals" (as opposed to the reality of my being a critic of misuse of computerized medical records, especially deficient ones, in hospitals). </div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;"> </div> <div dir="ltr" style="font-family:arial;">Just to further nail that point down as to my being a health IT amateur and Luddite, they also included as an attachment to their brief my entire CV and publications history -- 17 pages long - as retrieved from <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=about" target="_blank">http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=about</a>, picture included. (Perhaps I should send the hospital a thank-you note for introducing me to the judge, without my having to lift a finger.) Also issued were subpoenas for another fifteen or so doctors and practices that saw my mother, in addition to many others in past subpoenas. These records, mostly paper, will need to be reviewed. This will likely be a very profitable piece of work with many billable hours for the retained defense firm's lawyers. All this was more than one month after the state's Medicare Quality Improvement Organization found my mother's care "did not meet applicable professionally accepted standards of healthcare", and the deficiencies led to the catastrophic "subsequent medical complications" that she filed a complaint about while still lucid. Medicare also set up a monitoring program at the facility "for several quarters" as a result. (This was not mentioned in the defendant's brief to the court.) In effect, for probably $300+ per hour for legal services in the attempt to defend a case Medicare itself found not to have met applicable professionally accepted standards of healthcare, the hospital seems to have plenty of money. Again, the general point here is this: I believe this type of behavior is not atypical for hospitals today, and is likely another unfortunate manifestation of the medical leadership deficiencies and ethical gaps (e.g., at <a href="http://hcrenewal.blogspot.com/search/label/leadership">link</a>, <a href="http://hcrenewal.blogspot.com/search/label/Mismanagement">link</a>) commonly noted on this blog. -- SS </div>

Millions for tribute, but not one cent for defense: If hospitals cannot afford to legally defend EMR mishaps, should they be investing in them?

Imagine an airline going out and buying new multimillion-dollar jets with increased fuel efficiency and that produce less pollution. How...

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Smart ALEC's Strange Bedfellows

A number of articles in the Nation, plus posts by some of our blogging colleagues discussed the American Legislative Exchange Council (ALEC) and its role in policy, including health policy advocacy.  The <a href="http://www.thenation.com/article/161978/alec-exposed">lead article</a>, "ALEC Exposed," in the Nation, characterized ALEC as: <blockquote>a critical arm of the right-wing network of policy shops that, with infusions of corporate cash, has evolved to shape American politics. Inspired by Milton Friedman’s call for conservatives to 'develop alternatives to existing policies [and] keep them alive and available,' ALEC’s model legislation reflects long-term goals: downsizing government, removing regulations on corporations and making it harder to hold the economically and politically powerful to account. Corporate donors retain veto power over the language, which is developed by the secretive task forces. The task forces cover issues from education to health policy.</blockquote>ALEC and Health Care Reform Wendell Potter contributed an <a href="http://wendellpotter.com/2011/07/alec-exposed-sabotaging-healthcare/">article</a> about ALEC's position on health care reform. First, <blockquote>ALEC crafted the Freedom of Choice in Health Care Act, which, despite its Orwellian name, was written to deny the citizens of any state that passed it the freedom to set up such a system. By declaring that Congressional attempts to regulate health insurance at the federal level would be unconstitutional, it would effectively ban not only a federal single-payer proposal but also a federally created health insurance exchange and a federally operated public insurance option. </blockquote> ALEC <blockquote>adopted a strategy to shape rather than stop reform. Its top five goals became: § Keeping single-payer proposals off the table; § Ensuring that the final bill contain a clause requiring all Americans not eligible for an existing federal program to buy coverage from a private insurance company; [note that thus the "mandate" that pseudo-conservative groups like the Tea Party hate seems to have been pushed by big commercial insurance firms, and by some of the Tea Party's backers, not by the "big government" the Tea Party also loves to hate] § Preventing the new law from establishing a government-run plan (the 'public option') that would compete with private insurers; § Making sure that the reform law is implemented primarily at the state level, to keep the federal government from assuming any significant new oversight of private insurers’ business practices; and § Keeping any new regulations and consumer protections to a minimum. Insurers achieved their first four goals, with ALEC playing a key role in a well-coordinated effort to keep the most progressive proposals from being enacted at the state or federal level. </blockquote>Corporate Funders and Influencers The articles in the Nation suggest that ALEC's health policy advocacy is shaped only by commercial health care insurance. However, it appears that ALEC is supported by a much broader spectrum of health care corporations and other corporations whose products affect health care. It's <a href="http://www.alec.org/AM/Template.cfm?Section=Private_Enterprise_Board&Template=/CM/HTMLDisplay.cfm&ContentID=15992">"Private Enterprise Board"</a> includes Mrs Sandra Oliver, First Vice Chairman, Bayer Corp; Mr John Del Giorno, Second Vice Chairman, GlaxoSmithKline; Mr David Powers, Treasurer, Reynolds American; and Board Members Mr Don Bohn, Johnson and Johnson, Mr Jeffrey Bond, PhRMA, and Mr Michael Hubert, Pfizer. A PRWatch <a href="http://www.prwatch.org/news/2011/07/10887/cmd-special-report-alecs-funding-and-spending">special report</a> on its funding noted: <blockquote>98% of ALEC's funding comes from corporations like Exxon Mobil, corporate 'foundations' like the Charles G. Koch Charitable Foundation, or trade associations like the pharmaceutical industry's PhRMA and sources other than 'legislative dues.'</blockquote> In more detail, <blockquote>Other current ALEC corporate leaders have given an undisclosed sum to ALEC this year and before. These companies include: CenterPoint 360 (a firm that helps companies 'manage legislation'), Altria (formerly Phillip Morris tobacco), the American Bail Coalition (the trade group for for-profit bail bonds), AT&T, Bayer (aspirin), Coca-Cola, Diageo (Crown Royal and other liquor), Energy Future Holdings (Texas electricity), ExxonMobil, GlaxoSmithKline (Tums and other brands), Intuit (Quickbooks), Johnson & Johnson (lotion), Koch Industries (Georgia Pacific paper products and other brands), Kraft Food (Macaroni and Cheese dinners), Peabody Energy (the largest private coal company in the world), Pfizer (Viagra), PhRMA (the pharmaceutical trade group), Reed Elsevier (Lexis/Nexis legal research), Reynolds American (tobacco), Salt River Project (energy), State Farm Insurance, United Parcel Service, and Wal-Mart (world's largest retailer).</blockquote> So ALEC supporters include some very strange bed fellows. Commercial Insurance in Bed with Pharma ALEC has championed health care positions that seem designed to favor commercial health insurance.  However, it is supported by many corporations with which commercial health insurance ostensibly negotiates at arms length, and whose prices commercial health insurance ostensibly wants to lower.  These include pharmaceutical companies, Bayer, GlaxoSmithKline, and Pfizer, and pharmaceutical/ biotechnology/ device conglomerate Johnson and Johnson, all represented by PhRMA.  It is very curious, to say the least, that such companies are helping to fund a set of policy objectives all designed to further the interests of commercial insurance companies as listed above.  Perhaps the leaders of drug companies think that commercial insurers are likely to be easier negotiators than would be some future hypothetical "public option," (government run insurance company).  Perhaps the leaders of commercial insurance companies realize that they can more plausibly raise their administrative costs, and the amounts they pay to top executives, when overall health care costs, fueled by pharmaceutical and device prices, are rising. A UK Company in Bed with American State Legislators ALEC is supposed to be directed at American state legislatures, and be a membership organization for American state legislators.  It literally includes a graphic of a waving American flag on its <a href="http://www.alec.org/AM/Template.cfm?Section=Home">home page</a>.  However, it is supported by at least one foreign (UK) pharmaceutical company, GlaxoSmithKline.  It is very curious that a British company seems to be seeking to influence the US state legislative process. The appropriateness, and the legality of a British company seeking to influence American state legislatures I leave to be judged by others.  Pharmaceutical Companies (Including Those that Make Smoking Cessation Products) in Bed with Tobacco Companies ALEC is supported by pharmaceutical companies that all promise to improve health care.  These particularly include those that make or sell products that are designed to improve health by aiding smoking cessation, (GlaxoSmithKline, Johnson and Johnson, and Pfizer).  However,by their side stand two tobacco companies, Reynolds America and Altria, whose products the pharmaceutical companies' products are designed to counter.  It is very, very curious that smoking cessation product manufacturers would team up with tobacco companies.  Perhaps cynics among the leadership of the drug companies realize that the market for smoking cessation products increases with tobacco sales.  Perhaps cynics among the leadership of tobacco companies think that the knowledge that there are treatments, albeit not very effective ones, to aid in smoking cessation may encourage people to start or continue smoking (an interesting but rarely discussed example of the "moral hazard" that free market economists love to otherwise discuss).   Summary So in my humble opinion, the strange bedfellows among health care related corporations funding ALEC suggest 1) how little the health care system functions like anything resembling an ideal free market; and 2) how top organizational leaders may have feel they have more in common with each other than they do with their more lowly employees, customers, clients, and the public at large. True health care reform would require decreasing the size and power of large health care organizations, and ensuring that their leaders put their mission, and their patients' and the public's health ahead of their personal enrichment. Hat tip to Naomi Freundlich's <a href="http://www.healthbeatblog.com/2011/08/alec-the-industry-sponsored-group-behind-state-efforts-to-sabotage-health-reform.html">post</a> on the Health Beat blog.

Smart ALEC's Strange Bedfellows

A number of articles in the Nation, plus posts by some of our blogging colleagues discussed the American Legislative Exchange Council (ALEC...

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Say It Ain't So - Howard Dean Runs Through Revolving Door to Become Biotechnology Booster

The revolving door now accommodates the whole political spectrum.  A Salon <a href="http://www.salon.com/news/politics/war_room/2011/09/01/howard_dean_paid_advocate">article</a> documented the transit of one Howard Dean, former darling of the left-wing of the Democratic party: <blockquote>Howard Dean has long cultivated an image as the plainspoken doctor who speaks for the left wing of the Democratic Party, a role he still plays as a pugnacious pundit on TV. But since his term as chairman of the Democratic National Committee ended in January 2009, Dr. Dean has taken on a less-noticed role: paid advocate for interest groups that would find few fans among the progressive voters once energized by Dean's 2004 presidential bid. Dean may not be the worst of the 'buckrakers,' those prototypical capital characters who exploit their name and connections without regard for principle. But his recent political forays seem to have diverged from his trailblazing left-liberal past. As senior strategic advisor at McKenna Long & Aldridge, a heavyweight Washington lobbying firm, Dean played a prominent role representing the biotech industry during the healthcare bill debate, staking out a position on biopharmaceutical drugs that was decried by consumer groups. 'Gov. Dean was very helpful to us,' biotech CEO Jim Greenwood told a trade publication 'As a physician clearly focused on healthcare, a Democrat leader and clearly to left of center, his efforts were impactful.' Greenwood is the head of the Biotechnology Industry Organization (BIO), a trade group that lobbies for the industry in Washington.</blockquote> In particular, <blockquote>Dean arrived in the comfortable K Street offices of McKenna Long & Aldridge shortly after his term as DNC chair ended in January 2009. He had been passed over by President Obama for the secretary of health and human services Cabinet post, and he needed a paying job. In announcing his appointment, the firm said Dean would 'provide guidance to clients, particularly in the areas of healthcare and alternative energy resources.' Dean has been careful not to register as a lobbyist, a designation that would prompt legal disclosure requirements. Both McKenna and the governor's spokeswoman declined to reveal which clients he has worked for. Dean took on a very public role during the 2009 healthcare reform battle, specifically going to bat for the biotech industry -- whose trade association is a client of McKenna. At stake was how the government would regulate a growing class of drugs called biologics or biopharmaceuticals and their generic competitors. The industry argued for a longer period -- at least 12 years -- in which expensive brand-name biologics would face no competition from less costly generics. Consumer groups argued that, to keep costs down, the period of exclusivity should be just five years. Dean jumped into the fight on the side of the industry, writing an Op-Ed in the Hill in 2009 arguing that a 'commonsense and fair approach' would be to bar generics for 'at least 12 years.' 'If we discourage investment, we jeopardize the development of the next generation of breakthrough medicines and cures,' he wrote, echoing a key industry talking point.</blockquote> Dr Dean also apparently did some paid health policy advocacy on behalf of other clients: <blockquote>In January, he waded into another high-stakes healthcare fight, this one being waged in New York state between foreign medical schools and their American competitors. The issue was whether foreign-trained doctors would have access to hospitals in New York for their residencies. Dean wrote an Op-Ed in the Albany Times-Union, 'N.Y. needs its foreign-trained doctors,' that repeated talking points of foreign medical schools, which, Dean's bio blurb noted, are clients of McKenna Long & Aldridge. While the firm won't say whom Dean has worked for, his bio page on McKenna's website offers some clues.</blockquote> Dean also took on a few other jobs for corporate health care. For example, <blockquote>He currently serves on the board of advisors at Vatera Health Partners, a New York-based venture capital fund whose mission is 'to support and grow emerging biopharmaceutical companies.' It's not clear from the public record how long he has served in the position. But his presence on the Vatera board indicates that he has a personal financial stake in the biopharmaceutical industry.</blockquote> Also, he is now <blockquote>serving on the board of Extendicare, a Canadian long-term care company.</blockquote> Dr Dean's new job did not sit well with a former colleagues on the left side of the US political spectrum who had a distinctly different position on the issue of biologic exclusivity: <blockquote>'It was devastating to have him involved because of his reputation,' says James Love, director of Knowledge Ecology International, a public interest group that fought for a shorter period of exclusivity. 'He's considered to be independent of industry and on the left, so it was really shocking to us when we first saw this. But there it was.'</blockquote> The Salon article ended on this disillusioned note: <blockquote>Dean is indeed uniquely positioned: Between his former followers and his current clients, between his idealist liberal past and the cynical culture of K Street, between independence and cooptation.</blockquote> We have discussed how other government officials and political leaders transited the revolving door to work for corporate health care (e.g., starting <a href="http://hcrenewal.blogspot.com/2010/12/former-nih-director-spins-trhough.html">here</a>, and more lately <a href="http://hcrenewal.blogspot.com/search/label/revolving%20doors">here</a>). However, this most recent case seems to present the most vivid contrast between previous reputation and later employment.  Actually, while Dr Dean was clearly an advocate for changing health care, he was not a supporter of some ideas usually labeled left-wing," such as a single payer system (see <a href="http://www.ontheissues.org/2008/Howard_Dean_Health_Care.htm">here</a>).  However, the Washington Times <a href="http://www.washingtontimes.com/news/2004/jan/5/20040105-103754-1355r">reported</a> that when he was running for President in 2004, the Club for Growth Political Action committee ran an television advertisement calling him the proprietor of a: <blockquote>tax-hiking, government-expanding, latte-drinking, sushi-eating, Volvo-driving, New York Times-reading … Hollywood-loving, left-wing freak show </blockquote> The transformation of Dr Howard Dean from a target of the Club for Growth to a paid helper and talking points echoer of the Biotechnology Industry Organization illustrates that nowadays the revolving door accommodates all kinds of politicians. The door remains legal, but its continuing rapid spin raises more and more concern that even the ostensibly most left-wing politicians may act to avoid offending any future lucrative corporate employer. So the coziness between government and the medical-industrial complex is increasingly revealed, and the ability of current government officials and politicians to represent the people rather than corporate CEOs is increasingly in doubt. True health care reform would have to somehow reduce the resultant corporatism.

Say It Ain't So - Howard Dean Runs Through Revolving Door to Become Biotechnology Booster

The revolving door now accommodates the whole political spectrum. A Salon article documented the transit of one Howard Dean, former darlin...

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JAMA Article Begs Key Questions About Case of Contaminated Heparin

There was a recent reminder of the case of the tainted heparin, which begged more questions than it answered.  (A case summary is appended to the end of this post, and nearly all our posts are <a href="http://hcrenewal.blogspot.com/search/label/heparin">here</a>.)  The case is of fundamental importance because it involves the failure of pharmaceutical companies to fulfill their core mission, to supply pure, unadulterated drugs.   Three years later, how the heparin was adulterated, and who was responsible are still unknown. JAMA just published a major news article (Kuehn BM. As production goes global, drug supply faces greater risks to safety, quality.  JAMA 2011; 306: 811-813.  Link <a href="http://jama.ama-assn.org/content/306/8/811.full">here</a>.) This, in turn, was based on a five page case study of the heparin incident in a report by the Pew Health Group entitled "After Heparin: Protecting Consumers from the Risk of Substandard and Counterfeit Drugs" (link <a href="http://www.prescriptionproject.org/assets/pdfs/Pew_Heparin_Round4b_SinglePgs_b.pdf">here</a>).  Reading between the lines, the Kuehn article raised several questions which it did not seek to answer, but which we have raised previously. Why Didn't Baxter Look the Gift Horse in the Mouth? The JAMA article noted that in general, "pharmaceutical companies are shifting the production of drugs and drug ingredients to emerging economies - primarily India and China - to save money."  [italics added for emphasis]  Also, "Many emerging economies do not have robust regulatory systems, and regulators from the United States or other countries may face hurdles in trying to oversee production in these nations." Why were Baxter International executives not concerned about the quality of a drug offered cheaply from firms in countries with little regulatory oversight?  Note that we have been asking versions of this question since 2008, e.g., "How hard did Baxter scrutinize the production of the drug? How hard did SPL scrutinize its production? Did Baxter, SPL and/or the FDA realize the drug was being produced in an unlicensed Chinese chemical factory which had never been inspected by the Chinese or US government? If they did, why did they accept its product? If they didn't, why didn't they know?" - from <a href="http://hcrenewal.blogspot.com/2008/02/in-middle-of-all-those-pigs-in-china.html">this post</a> on February, 16, 2008. Who Is Responsible for the Complexity and Opacity of the Out-Sourced Supply Chain? The article stated, "In addition to becoming more global, the drug supply chain has also become more complex, .... Drug ingredients are now imported from 150 countries, and multiple suppliers, producers, and distributors may be involved in the production and import of a single drug."  In particular, the article noted that "Baxter relied on the assessment of another company when it began receiving heparin from the plant through which the adulterated drug came."  (The nameless other company was Scientific Protein Laboratories.)  Also, it noted that the supply chain began at "the primitive workshops that extract heparin crude by cooking and drying pig intestines" and proceeded to "the companies that consolidate materials from many such workshops and sell them to the factories that produce heparin."  The article did not discuss how this particular supply chain came into existence. Did not drug companies in developed countries, like Baxter International in this case, create these convoluted supply chains (mainly to save money, as noted above)?  If not, did they not at least enable the creation and operation of these chains by purchasing their products without asking too may questions?  In any case, the supply chain's complexity and opacity arose out of individual humans' decisions, not an act by a deity.  Why Have no Individuals Been Held Accountable?  The article noted that the Pew report suggested, "increasing the financial penalties and allowable prison terms for individuals and companies who violate the rules from their current maximums of $10 000 or 3 years in prison." The implication was that these penalties have proven insufficient.  However, the article failed to note that so far in the case of the tainted heparin, no such penalties have even been sought.  To my knowledge, neither Baxter International, Scientific Protein Laboratories, nor any individual who worked for them has ever been charged with any violation of "the rules" that could result in any penalty as much as "$10 000 or 3 years in prison."    I have asked repeatedly why so far there has been no obvious effort to hold any individual accountable for the contaminated heparin?  (see <a href="http://hcrenewal.blogspot.com/2010/07/prosecuting-doctors-for-importing-iuds.html">this post</a> from July 19, 2010, in which I noted legal actions against doctors who implanted IUDs imported from and approved in Canada and asked, "why are we so vigorously pursuing individual doctors for an apparently technical violation of laws that did patients no apparent harm, when we are not pursuing health care corporate executives for selling adulterated drugs that likely killed patients?  Why Are the Key Issues In This Case Still So Anechoic? Neither the JAMA article nor the heparin case study in the underlying Pew report directly addressed these questions.  The JAMA article also omitted such details as the name of the company from which Baxter directly purchased the heparin (Scientific Protein Laboratories) and the total number of deaths that may have been related to the heparin.  (It only mentioned 3 deaths related to heparin, while the Pew Report noted the FDA got reports of 68, six more of which it allowed were "possibly caused by the adulterant, 24 were unlikely, and 35 were unassessable.")  As mentioned above, the JAMA article seemed to imply that criminal penalties have been applied to corporate executives whose companies may have profited from cheap but defective out-sourced drugs (but none have been applied in the heparin case).   Ironically, while the JAMA article identified the "culprit" for the adverse events in the heparin case, it used the word to refer to the compound that adulterated the heparin, not those who added it, or who enabled its addition.  Summary Thus, the public discussion in the main-stream medical media of the case of the adulterated heparin is still remarkably squeamish even three plus years after it first became public.  While the heparin case has made it into major medical journals, it still simply is not done to even publicly discuss whether the leaders of health care organizations who become rich partly as a result of decisions such as the unsupervised, uninspected, apparently barely considered out-sourcing of heparin to be accountable when these decisions turn out to have adverse effects on patients. If we cannot even discuss the accountability of leaders of health care organizations, how can we hope to actually hold them accountable?   To repeatedly reiterate, as long as the leaders of health care organizations are not held accountable for the results of their decisions on health care quality, cost, and access (even in such extreme quality violations as those resulting in multiple patient deaths), we can expect continuing decisions that sacrifice quality, increase costs, and worsen access, but that are in the self-interest of the people making them. To really reform health care, we must hold health care organizations and their leaders accountable (and not blame all the problems on doctors, other health care professionals, patients, and society at large). Case Summary - We have posted several times, recently <a href="http://hcrenewal.blogspot.com/2011/06/first-contaminated-heparin-case-verdict.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 in 2007, hundreds of such reactions, and 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. (See posts <a href="http://hcrenewal.blogspot.com/2008/02/in-middle-of-all-those-pigs-in-china.html">here</a> and <a href="http://hcrenewal.blogspot.com/2008/03/heparin-in-era-of-hogwash.html">here</a>.) - 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>.)  Note that SPL was recently bought out and taken private, making its current leadership even less transparent (see post <a href="http://hcrenewal.blogspot.com/2010/10/more-contaminated-heparin-but-who-leads.html">here</a>).  A 2010 inspection of an SPL facility by the FDA revealed ongoing manufacturing problems (see post <a href="http://hcrenewal.blogspot.com/2011/02/fda-to-scientific-protein-laboratories.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>.)  Efforts to make documents to be used in these cases public so far have not succeeded (see post <a href="http://hcrenewal.blogspot.com/2010/08/proprietary-information-confidentiality.html">here</a>). - A government report which attracted little attention warned of the dangers of pharmaceutical ingredients made in China and subject to virtually no oversight. (See post <a href="http://hcrenewal.blogspot.com/2010/04/another-echo-of-case-of-deadly-heparin.html">here</a>.) -  Despite requests from the US, the Chinese government did not investigate the production of the heparin that lead to the deaths (see post <a href="http://hcrenewal.blogspot.com/2010/07/more-about-what-we-dont-know-about.html">here</a>.) -  In February, 2011, a congressional investigation of the case was announced, but results are so far unavailable (see post <a href="http://hcrenewal.blogspot.com/2011/02/three-years-later-congressional.html">here</a>.) -  In June, 2011, a jury returned the first verdict in a civil case about the contaminated heparin, awarding money from Baxter International and Scientific Protein Laboratories to the estate of a man who apparently died due to tainted heparin (see post <a href="http://hcrenewal.blogspot.com/2011/06/first-contaminated-heparin-case-verdict.html">here</a>).

JAMA Article Begs Key Questions About Case of Contaminated Heparin

There was a recent reminder of the case of the tainted heparin, which begged more questions than it answered. (A case summary is appended t...

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Will Hired Executives Let "Healing Prevail Over Profit?" - Questions from Public and Catholic Non-Profit Health Systems

Hospital - noun, 1.  a charitable institution for the needy, aged, infirm or young  2.  an institution where the sick or injured are given medical or surgical care, <a href="http://www.merriam-webster.com/dictionary/hospital">Merriam-Webster</a>              - noun.  1.  an institution providing medical and surgical treatment and nursing care for sick or injured people, <a href="http://oxforddictionaries.com/definition/hospital?region=us">Oxford Dictionary</a> Two recent NY Times articles raise concerns that changes in leadership may cause hospitals to stray from their original purpose.  Cook County Health and Hospitals System The first NY Times <a href="http://www.nytimes.com/2011/08/19/us/19cnchealth.html">article</a> discussed leadership of Cook County Health and Hospitals System (in the Chicago, IL area). This is a public health system whose mission was traditionally "to serve Cook County's neediest patients." The management of the system, however, is now increasingly in the hands of paid consultants. For example, until recently, its COO (chief operating officer) was: <blockquote>Mr. [Tony] Tedeschi, [who] like other of the system’s recent top managers, works for the Sibery Group, which has had contracts with the system to provide temporary executive talent.</blockquote> Furthermore, his successor was <blockquote>Ms. [Carol] Schneider, whose contract runs through December, works for the Washington Group Ltd., a consulting company that provides administrative help to the system. </blockquote> Furthermore, <blockquote>PricewaterhouseCoopers has a three-year, $50 million contract calling for it to save the system $300 million or bring in the equivalent in new revenue.</blockquote> Not to mention, <blockquote>consultants from the Sibery Group, which is based in Oak Brook, [were appointed] to top management posts within County Health. For example, a Sibery employee, Robert Hamilton, was until recently chief operating officer of Provident Hospital. Another, David Sibery, was until recently head of support services for the health system. </blockquote> Turning leadership over to executives hired by outside, commercial firms has lead to concern. <blockquote>The role consultants play at County Health is the object of strong criticism from doctors, nurses and other staff members who say they fear that consultants driven by the bottom line are at odds with the system’s obligation to serve Cook County’s neediest patients. Hundreds of front-line staff members have been laid off in the last two years. </blockquote>One particular concern was the lay-offs directed by yet another group of consultants. <blockquote>The county decided to close Oak Forest based in part on the advice of Navigant Consulting, which in a 2009 report found that Cook County’s hospitals were overstaffed compared to those of other health systems. Navigant’s assessment also formed the basis for the layoff of 1,350 people systemwide in the last two years. Doctors, nurses and union leaders argued that Navigant’s calculations were flawed. </blockquote> Most troubling are allegations that outsourced leadership by commercial consultants is stifling health care professionals' input into the system, including perhaps whistle-blowing about threats to its core mission: <blockquote>A doctor at a county clinic who would not let his name be used because he feared losing his job said consultants were 'coming at it like our county system is a system that could make money.' The purpose of the system 'is to take care of people regardless of their ability to pay,' the doctor said. 'If they want to get out of that commitment, that’s fine, but they’re going to leave people in the dust.' </blockquote> In addition, <blockquote>A nonunion supervisor, who would speak only on the condition that her name not be used for fear of retaliation, said the constant presence of consultants — and a lack of clear results — was undermining staff morale. 'I’ve never seen employee morale as low as it is now, at all levels,' the supervisor said. A survey of employees conducted by management in January found that fewer than a third of health system employees think senior managers are 'trustworthy' or have 'a sincere interest in the well-being of employees.' The survey also found that more than half of employees do not think they can voice their opinion without fear of retaliation. Dr. Richard David, co-director of neonatal intensive care at Stroger Hospital, said doctors were frustrated that Pricewaterhouse consultants had not sought their advice and seemingly ignored opinions offered by medical staff members. Dr. David said cuts most likely recommended by consultants were interfering with patient care in his unit. He cited calls from other doctors that go unanswered because staff reductions have left only one desk clerk, who also covers another unit. </blockquote>So it appears that through the miracle of out-sourcing, nominally public hospitals can now be lead by hired executives from commercial firms, whose corporate culture may be more about laissez faire capitalism than serving the poor.  SSM Health Care The <a href="http://www.nytimes.com/2011/08/21/us/21nuns.html">second</a> NY Times article was about the exit of nuns as leaders of Catholic hospitals and health systems.  In summary, <blockquote>In 1968, nuns or priests served as chief executives of 770 of the country’s 796 Catholic hospitals, according to the Catholic Health Association. Today, they preside over 8 of 636 hospitals. ... only 8 of 59 Catholic health care systems are directed by religious executives. </blockquote> The focus of the article was on the retirement of Sister Mary Jean Ryan as CEO of SSM Health Care, (SSM honors Sisters of St. Mary, a predecessor of the Franciscan Sisters of Mary, the Sister's order). Sister Mary Jean Ryan was not a typical hospital system CEO: <blockquote>her legacy ... extends to preaching about the dignity of patients, paying blue-collar workers above scale, making her hospitals smoke-free, banning the use of foam cups and plastic water bottles, and insisting on gender-neutral and nonviolent language. There are no 'bullet points' in SSM presentations, and photographs are 'enlarged,' never 'blown up.' Even Sister Mary Jean can struggle to define precisely what the nuns brought to their hospitals. 'There is this thing called presence, she said, explaining that she was trained to see Jesus in the face of every patient....</blockquote> Also, her leadership: <blockquote>meant turning away business arrangements with doctors who decline to accept Medicaid. It has meant discounting treatment for the poor and offering charity care to the uninsured, just as the order’s founders did. The St. Louis nuns’ earliest ledgers denoted patients unable to pay as 'Our dear Lord’s.' </blockquote> But Sister Mary Jean has left, and this, and the general loss of religious leadership of Catholic hospitals and health systems: <blockquote>has stirred angst in many Catholic hospitals about whether the values imparted by the nuns, concerning the treatment of both patients and employees, can withstand bottom-line forces without their day-to-day vigilance. Although their influence is often described as intangible, the nuns kept their hospitals focused on serving the needy and brought a spiritual reassurance that healing would prevail over profit, authorities on Catholic health care say. </blockquote> Money is likely to become much more important at SSM: <blockquote>Mr. William P Thompson, Sister Mary Jean’s handpicked successor, said he planned to hold fast to her commitment to patients, the environment and nonviolence. But he also acknowledged that he would be 'trying to drive more efficiencies in the system.' </blockquote> One cannot help but wonder if these "efficiencies" will resemble those deployed by the outsourced consultant leadership of Cook County.  On Private Equity and Catholic Hospitals Furthermore, there is reason to think that Catholic, non-profit hospitals and health care systems may become even more like commercial firms. An <a href="http://www.healthleadersmedia.com/page-1/FIN-269977/Private-Equity-Interest-In-Nonprofit-Hospitals-Growing">article</a> in HealthLeaders Media about the increasing interest by private equity firms in non-profit hospitals and health care systems noted, <blockquote>[A] well-publicized deal was the buyout of Massachusetts-based Caritas Christi Health Care, which was a nonprofit, by Cerberus Capital Management. [see our posts <a href="http://hcrenewal.blogspot.com/search/label/Caritas%20Christi">here</a> and <a href="http://hcrenewal.blogspot.com/search/label/Steward%20Health%20Care">here</a>] The 2010 sale not only gave Caritas a cash infusion, but altered its tax status to for-profit. These acquisitions moved to center stage the use of private equity capital as a strategic opportunity for healthcare leaders. For instance, this past February, the nation's largest Catholic health system, Ascension Health, partnered with the Stamford, CT–based private equity firm Oak Hill Capital Partners, embarking on a joint venture to buy Catholic hospitals. Leo P. Brideau, FACHE, president and CEO of the St. Louis–based Ascension Health Care Network, says the joint venture allows the organization to provide an alternative funding source for the acquisition of Catholic healthcare entities.</blockquote> Then, <blockquote>Brideau says seeing other Catholic hospitals financially flounder—only to be sold to non-Catholic entities—aligns with the organization's mission to grow its network of Catholic hospitals. The vision to strengthen Catholic healthcare was another driver for Ascension's partnership with Oak Hill Capital. </blockquote> However, the article raises further concerns about whether private equity's interest in non-profit, particularly Catholic hospitals will help these institutions' missions.  The thinking of one private equity expert was: <blockquote>The core goal of a nonprofit hospital or health system is to provide patients with high-quality, cost-effective care, while earning a healthy margin; private equity firms have a different end goal. The general aim of a private equity firm is to achieve a large return on investment in the form of capital gains. How the private equity firm achieves those ends is where hospitals need to do their homework, [managing partner of Linden Capital Partners Brian] Miller says. </blockquote> Despite what private equity gurus may think, non-profit hospitals' missions never used to make a goal "earning a healthy margin" co-equal with that of taking good care of patients. It does not appear that achieving "a large return on investment" will be compatible with the traditional culture of Catholic hospitals in which "healing would prevail over profit." Nor does it appear compatible with the recent words of Pope Benedict XVI (as reported by the AP, <a href="http://articles.boston.com/2011-08-18/news/29901339_1_young-people-pope-benedict-xvi-ethics">via</a> the Boston Globe): <blockquote>'The economy doesn’t function with market self-regulation but needs an ethical reason to work for mankind,' he told reporters traveling aboard the papal plane. 'Man must be at the center of the economy, and the economy cannot be measured only by maximization of profit but rather according to the common good.' He said the current crisis shows that a moral dimension isn’t 'exterior' to economic problems but 'interior and fundamental.'</blockquote> Summary As hospitals and health systems are increasingly lead by people from the world of business, at a time when business culture increasingly believes "greed is good," the fundamental values of hospitals and health care professionals are more often ignored, if not directly threatened.  To repeat, health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research. If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

Will Hired Executives Let "Healing Prevail Over Profit?" - Questions from Public and Catholic Non-Profit Health Systems

Hospital - noun, 1. a charitable institution for the needy, aged, infirm or young 2. an institution where the sick or injured are given m...

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Why Cultivate Weldon's Confidence? - CEO Goes to White House Days After His Company's Latest Guilty Plea Announced

Earlier this month, US President Barack Obama met "with eight business leaders to hunt for ideas to revive the economy," <a href="http://online.wsj.com/article/SB10001424053111904006104576504261025589134.html">according to</a> the Wall Street Journal.  At the session, the President asked "what he and his administration could do to improve their confidence...."  The reporters' White House informants emphasized that the point was "listening to the CEOs and not telling them what to do." Included amongst the eight CEOs was "Bill [William] Weldon of Johnson & Johnson."  Why would the US President want to improve Mr Weldon's confidence? Johnson and Johnson's Latest Guilty Plea After all, two days earlier, Bloomberg <a href="http://www.bloomberg.com/news/print/2011-08-09/j-j-reaches-tentative-agreement-with-u-s-on-risperdal-criminal-charge.html">noted</a> how Mr Weldon's company was ready to plead guilty, yet again. <blockquote>Johnson & Johnson (JNJ) said it reached an agreement to settle a misdemeanor criminal charge related to marketing of its antipsychotic drug Risperdal. The U.S. has been investigating its Risperdal sales practices since 2004, including allegations the company marketed the drug for unapproved uses, J&J said in its quarterly filing yesterday. The Justice Department and the U.S. attorney in Philadelphia 'are continuing to pursue both criminal and civil actions,' the company said. </blockquote> In particular, <blockquote>The agreement in principle on the criminal charge is 'pursuant to a single misdemeanor violation of the Food, Drug and Cosmetic Act,' the company said. </blockquote> Other Recent Johnson and Johnson Legal Misadventures This would be just the latest in a string of adverse legal results for Johnson and Johnson. As Bloomberg noted regarding Risperdal: <blockquote>Last year, jurors in Louisiana ordered the drugmaker to pay almost $258 million to state officials for making misleading claims about the antipsychotic’s safety. J&J has appealed. [see our post <a href="http://hcrenewal.blogspot.com/2010/10/last-weeks-scandals.html">here</a>] In June, a South Carolina judge ordered J&J officials to pay $327 million in penalties for deceptively marketing the medicine. J&J has asked the judge to throw that verdict out. [see our post <a href="http://hcrenewal.blogspot.com/2011/03/jury-finds-johnson-and-johnsons.html">here</a>] 'The attorneys general of approximately 40 other states have indicated a potential interest in pursuing similar litigation against' the Janssen unit, J&J said.</blockquote> Furthermore, the company has been in legal hot water regarding how it sold other products: <blockquote>In April, in a separate case, J&J agreed to pay $70 million to resolve criminal and civil charges after admitting it bribed doctors in Europe and paid kickbacks in Iraq to win contracts and sell drugs and artificial joints. As part of a deferred prosecution agreement, J&J subsidiary DePuy was charged with conspiracy and violations of the Foreign Corrupt Practices Act. [see our post <a href="http://hcrenewal.blogspot.com/2011/04/johnson-and-johnson-runs-afoul-of.html">here</a>] In May 2010, J&J’s Ortho-McNeil Pharmaceutical LLC pleaded guilty to a misdemeanor charge of selling a misbranded drug, admitting it illegally marketed its Topamax epilepsy drug. J&J paid $81 million to resolve criminal and civil cases. [see our post <a href="http://hcrenewal.blogspot.com/2010/05/sunday-settlement-and-guilty-plea.html">here</a>]</blockquote> Johnson and Johnson's 25 Recalls And just a few days after President Obama's meeting with Mr Weldon and his fellow CEOs, just the latest in the string of recalls of apparently defective products was announced by Johnson and Johnson. Tylenol, made by the McNeil Consumer Healthcare division of Johnson and Johnson, was the recalled product this time, <a href="http://blogs.wsj.com/health/2011/08/15/jj-recall-watch-tylenol-cold-gelcaps-pulled/">per</a> the Wall Street Journal Health Blog. Note that this post was part of the blog's now long-running J+J Recall Watch feature, and the post cataloged 25 separate recalls of Johnson and Johnson products since 2009, including previous recalls of various versions of Tylenol, and a June, 2011, recall of Risperdal. We have written several times about the inability of Johnson and Johnson management to fulfill a core component of any drug company's mission, to produce pure, unadulterated products (look <a href="http://hcrenewal.blogspot.com/2011/01/why-is-johnson-and-johnson-spinning-out.html">here</a>, <a href="http://hcrenewal.blogspot.com/2010/09/should-president-of-university-of.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/07/are-ill-informed-leaders-cause-of-drug.html">here</a>). We have also noted several times (e.g., <a href="http://hcrenewal.blogspot.com/2011/04/johnson-and-johnson-runs-afoul-of.html">here,</a> <a href="http://hcrenewal.blogspot.com/2011/03/jury-finds-johnson-and-johnsons.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2011/03/despite-recalls-legal-settlements.html">here</a>) how CEO William Weldon continues to get richer and richer despite his company's guilty pleas, product recalls, and other questionable behavior (for more details about the latter, look <a href="http://hcrenewal.blogspot.com/search/label/Johnson%20and%20Johnson">here</a>). Whose Confidence to Cultivate? So again I ask, why would the US President want to cultivate William Weldon's confidence?  At best, I can only hope that Mr Weldon was invited to the White House because its staff did not do their homework, and only noted the size of the company he leads, rather than the rate of its blunders and misdeeds.  There is already too much evidence that government is excessively cozy with the leaders of big health care (and other) corporations, and gets too much of advice from them rather than from less well-heeled citizens.  At least, if the President is going to get advice from corporate CEOs, he should try to find some whose companies appear to be better lead.     Maybe the difficulty he would have finding such CEOs in the health care field would provide a clue that true health care reform requires better leadership and governance of health care organizations.

Why Cultivate Weldon's Confidence? - CEO Goes to White House Days After His Company's Latest Guilty Plea Announced

Earlier this month, US President Barack Obama met "with eight business leaders to hunt for ideas to revive the economy," according...

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Quis Custodiet Ipsos Custodes? Redux

Revised HHS Rules for Conflict of Interest Fall Short This morning NIH Director Dr. Francis Collins announced <a href="http://freepdfhosting.com/3dde31520d.pdf">revisions</a> to the existing 1995 regulations on objectivity in research that is funded by the Public Health Service. The focus is on significant financial interests (SFI) and on financial conflicts of interest (FCOI). The regulations illustrate the 3-way dance involving academic institutions (the grantees), NIH (the grantor) and academic scientists (the investigators). Thanks to Senator Grassley (R-Iowa) and his investigator Paul Thacker, headlined revelations in recent years about unacceptable management of FCOI at places like Stanford (Alan Schatzberg), Emory (Charles Nemeroff) and Harvard (Joseph Biederman) forced these revisions of the NIH regulations. The general initial reaction to the new rules has been critical – <a href="http://www.pharmalot.com/2011/08/nih-issues-new-conflict-of-interest-rules/">here</a> and <a href="http://pogoblog.typepad.com/pogo/2011/08/the-national-institutes-of-health-new-ethics-rules-a-swing-and-a-miss.html">here</a>, for instance. Many stakeholders had urged the NIH to require that institutions make the disclosed FCOI of their investigators available on a public website. Dr. Collins had intimated that we could expect to see this change, so there is consternation that it somehow became derailed by institutional lobbying in recent months. The stated concern was that institutions would feel burdened by the need to maintain these data bases. Instead, if citizens wish to inquire about FCOI involving PHS-derived research funding, they will need to write to the institution, which is obliged to respond within 5 days. That’s not exactly user friendly. POGO today made the smart <a href="http://pogoblog.typepad.com/pogo/2011/08/the-national-institutes-of-health-new-ethics-rules-a-swing-and-a-miss.html">suggestion</a> that the data could easily be attached to information about awarded funds on the <a href="http://projectreporter.nih.gov/reporter.cfm">NIH RePORTER</a> website, that already exists. A second failing is that the revised regulations do not close the regulatory loophole through which Charles Nemeroff strolled when he moved from Emory to the University of Miami. We covered that incident <a href="http://hcrenewal.blogspot.com/#uds-search-results">several times</a> on this blog last year. Though Nemeroff was under a 2-year sanction and banned from participating in NIH-funded research at Emory, his friend Thomas Insel, Director of NIMH, assured the dean of the medical school at Miami that Nemeroff was in good standing to apply for NIH funding when he moved from Emory. To underline the point, Insel displayed the bad judgment of appointing Nemeroff to 2 new NIMH review committees. Do today’s revised regulations prevent a repeat of this administrative travesty? No, they don’t. There is some mention of ensuring oversight if a sanctioned investigator wishes to transfer a grant to a new institution, but nothing to prevent the Nemeroff-Insel dance from being repeated. Here is the relevant section of today’s <a href="http://freepdfhosting.com/3dde31520d.pdf">announcement</a> (page 89): We did, however, agree with one respondent that it would be helpful to clarify, in the grants context in particular, that institutional sanctions against an Investigator can travel with the Investigator upon his or her transfer to another Institution. Specifically, we have revised 42 CFR 50.606, paragraph (a), as follows: “If the failure of an Investigator to comply with an Institution’s financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the PHS-funded research, the Institution shall promptly notify the PHS Awarding Component of the corrective action taken or to be taken. The PHS Awarding Component will consider the situation and, as necessary, take appropriate action, or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the PHS-funded research project. The PHS may, for example, require Institutions employing such an Investigator to enforce any applicable corrective actions prior to a PHS award or when the transfer of a PHS grant(s) involves such an Investigator.” This revision is intended to reference the range of options for the PHS Awarding Component to consider, depending on the specific circumstances at issue. For example, PHS may decide to initiate government-wide suspension or debarment of the Investigator under 2 CFR Part 376; or to use enforcement measures under 45 CFR 74.62, e.g., perhaps to make the approval of a transfer contingent upon the former Institution’s disclosure of the corrective action- including the specific sanctions against the Investigator- to the new Institution; and/or to use special award conditions under 45 CFR 74.14, e.g., perhaps to make the new Institution agree to take the same or similar action against that Investigator or explain to the PHS Awarding Component in writing why such action was not taken and what alternative measures will be used to ensure compliance. What’s wrong here? Everything is optional; everything is discretionary; everything is contextual – that is a formula for NIH and the academic institutions to just look the other way. And if a Nemeroff decides just to relocate without transferring a grant then he is free to start reapplying again right away. Miami would not be required to continue applying the Emory sanction banning him for 2 years from involvement in federal grants. The PHS Awarding Component (NIMH in this case) may or may not get involved, or it may pass the buck to the new institution. So what has changed? If it is left up to compromised federal bureaucrats like Thomas Insel, and institutional administrators like Pascal Goldschmidt at Miami, then nothing has changed. It's business as usual, folks. Dr. Collins, you have not done what you set out to do. Too bad.

Quis Custodiet Ipsos Custodes? Redux

Revised HHS Rules for Conflict of Interest Fall Short This morning NIH Director Dr. Francis Collins announced revisions to the existing 199...

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