healthy4u

New way to get kids interested in medicine: post confidential medical records on a homework site?

Was this a new way to get kids interested in medical careers? Or was it an accident due to the highest levels of negligence associated with lowest/cheapest standards in hiring for mission critical roles? <blockquote><a href="http://www.nytimes.com/2011/09/09/us/09breach.html?_r=1&hp">Patient Data Posted Online in Major Breach of Privacy </a> New York Times Sept. 8, 2011 Kevin Sack A medical privacy breach at <a href="http://topics.nytimes.com/top/reference/timestopics/organizations/s/stanford_university/index.html?inline=nyt-org" title="More articles about Stanford University" class="meta-org">Stanford University</a>’s hospital in Palo Alto, Calif., led to the public posting of medical records for 20,000 emergency room patients, including names and diagnosis codes, on a commercial Web site for nearly a year, the hospital has confirmed. Since discovering the breach last month, the hospital has been investigating how a detailed spreadsheet made its way from one of its vendors, a billing contractor identified as Multi-Specialty Collection Services, to a Web site called “Student of Fortune,” which allows students to solicit paid assistance with their school work. Gary Migdol, a spokesman for Stanford Hospital and Clinics, said the spreadsheet first appeared on the site on Sept. 9, 2010, as an attachment to a question about how to convert the data into a bar graph.<div id="articleBody"> </div></blockquote><div id="articleBody"> To teach the kids to be medical bean counters at an early age, perhaps? <blockquote>Even as government regulators strengthen oversight by requiring public reporting of breaches and imposing heavy fines, experts on medical security said the Stanford incident spotlights the persistent vulnerability posed by legions of outside contractors who gain access to private data. </blockquote> In the Oct. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/10/private-medical-records-offered-for.html">Private medical records offered for sale</a>" I wrote about how such data was for sale by onion-like layers contractors - cheap. <blockquote>The spreadsheet contained names, diagnosis codes, account numbers, admission and discharge dates, and billing charges for patients seen at Stanford Hospital’s emergency room during a six-month period in 2009, Mr. Migdol said. It did not include Social Security numbers, birthdates, credit-card accounts or other information used to perpetrate identity theft, he said, but the hospital is offering free identity protection services to affected patients. </blockquote> (Partial) luck prevailed - this time. <blockquote>The breach was discovered by a patient and reported to the hospital on Aug. 22, according to a letter written four days later to affected patients by Diane Meyer, Stanford Hospital’s chief privacy officer. The hospital took “aggressive steps,” [i.e., its CIO made a quick, panicky phone call - ed.] and the Web site removed the post the next day, Ms. Meyer wrote. It also notified state and federal agencies, Mr. Migdol said. </blockquote> Perhaps "aggressive steps" should have been taken before private medical data was published on a kid's homework site? <blockquote>“It is clearly disturbing when this information gets public,” he said. “It is our intent 100 percent of the time to keep this information confidential and private, and we work hard every day to ensure that.” </blockquote> Would "Master of the Obvious" (a favorite line of my early medical mentor, cardiothoracic surgeon/polymath <a href="http://www.facebook.com/pages/Dr-Victor-P-Satinsky/147849525268828">Dr. Victor P. Satinsky</a>, be too kind a response to this statement? <blockquote>Diane Dobson, of Santa Clara, Calif., said her “jaw dropped” on Saturday when she intercepted the letter from Ms. Meyer addressed to her 21-year-old son, who she said received emergency psychiatric treatment at Stanford in 2009. Ms. Dobson said it could have been disastrous if her son, who lives at home, had learned that his name was linked online to a diagnosis for psychosis. “My son, I can tell you, is fragile and confused enough that this would have sent him over the edge,” Ms. Dobson said. “Everyone with an electronic medical record is at risk, and that means everyone.” </blockquote> My sympathies go out to this mother and her son. Her concerns show that cavalier attitudes towards EMR's can lead to catastrophe beyond identity theft or career damage. <blockquote>The incident at Stanford, while egregious in its details, is far from rare. Records compiled by the Department of Health and Human Services reveal that personal medical data for more than 11 million people has been improperly exposed during the last two years alone ... The major breaches — a disconcerting log of stolen laptops, hacked networks, unencrypted records, misdirected mailings, missing files and wayward e-mails — took place in 44 states. </blockquote> I'm certain there is an increasing amount of critical medical data being withheld by patients as publicity about these breaches become more well-known. <blockquote>The breaches at Stanford reinforce that even the most prestigious medical centers are not immune to risk. <a title="Web site" href="http://www.massgeneral.org/"> Massachusetts General Hospital</a> in Boston, which trains Harvard medical students, agreed this year to pay a $1 million federal fine after an employee left paper medical records on a subway train while commuting to work. The pages contained the names of 192 patients, and diagnoses for about a third of them, including for H.I.V./AIDS. They were never recovered. </blockquote> I note these are both pioneers in electronic health records. Imagine what might be happening at Podunk Hollow General Hospital... <blockquote>Mr. Migdol said the hospital had concluded that “there is no employee from Stanford Hospital who has done anything impermissible.” He said he expected the federal Department of Health and Human Services to conduct its own investigation. Susan McAndrew, deputy director of <a href="http://topics.nytimes.com/top/reference/timestopics/subjects/h/health_information_privacy/index.html?inline=nyt-classifier" title="Recent and archival health news about health information privacy." class="meta-classifier">health information privacy</a> for the department’s Office of Civil Rights, said she could not discuss whether an investigation was in progress ... Bryan Cline, a vice president with the Health Information Trust Alliance, a nonprofit company that establishes privacy guidelines for health care providers, said that nearly 20 percent of breaches were perpetrated by outside contractors, accounting for more than half of all the records exposed. </blockquote> When you start to outsource mission critical data, you should probably be prepared to take responsibility for whomever you outsource it to. <blockquote>The vendor, identified by Mr. Migdol as Multi-Specialty Collection Services LLC, based in Los Angeles, could not be reached for comment. Mr. Migdol said the company created the spreadsheet as part of a billing-and-payment analysis for the hospital. He said the hospital immediately suspended its relationship with the contractor and received written certification that previous files would be destroyed or returned securely. </blockquote> Apparently someone there with access to the spreadsheet was less than careful about keeping it away from children. One wonders if they would have been more careful with pornography... <blockquote>“We’re still kind of caught in the pre-high-tech trust model instead of the insurance model,” Mr. Cline said. “Health care providers say, ‘I’m going to have some contract language and then just trust that you’ll protect my data because if you don’t I’m going to sue you.’ That just doesn’t work, as we can see. You have to do due diligence, something to assure yourself that the people you’re giving your data to can be trusted.”</blockquote> <div class="articleCorrection"> </div> </div> I'd say we're still in the stone age with respect to our irrational exuberance about health IT. See my series of articles on these issues at these query links: <a href="http://hcrenewal.blogspot.com/search/label/computer%20security">computer security</a>, <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">medical record privacy</a>, <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20confidentiality">medical record confidentiality</a>. A fundamental set of rules in today's hire-on-the-cheap, keep-staffing-minimal environment is this: <blockquote>1. If you want information to be kept secure, don't place it on a computer. 2. If you place the information on a computer, don't place the computer on a network. 3. If you place the computer on a network, the information is no longer secure. </blockquote>In our current culture I do not believe these issues to be easily remediable, but hiring the truly best and brightest (after satisfactory scores in a very hard test in critical thinking skills) into IT roles - including design, implementation, and management - might be a start. -- SS

New way to get kids interested in medicine: post confidential medical records on a homework site?

Was this a new way to get kids interested in medical careers? Or was it an accident due to the highest levels of negligence associated with ...

Đọc thêm »

Another Hospital Putting on the Ritz

The usual definition of a hospital is an institution which treats the sick and injured,.  That is a messy business, so some hospital executives seem to yearn to be doing something a little more - shall we say - upscale.  For example, the Chattanoogan <a href="http://www.chattanoogan.com/articles/article_207569.asp">reported</a>: <blockquote>Erlanger Health System will launch in October one of the most ambitious employee training initiatives in its 120-year history. All 4,500 employees will participate in a new service excellence program based on the legendary Ritz-Carlton service model. 'This is not a program. This is the beginning of long-term cultural transformation,' says Erlanger CEO James Brexler. 'Our board and leadership team believe this initiative is one of the most significant developments in the continued evolution of Erlanger.' The Erlanger Health System strategic plan, adopted by the board of trustees last year, identified service excellence as a priority. Funding for the initiative was approved in this year’s operating budget. The corporate university of Ritz-Carlton was selected to help take Erlanger’s patient experiences to the next level.</blockquote> A hospital, of course, provides services to patients. However, it seems glaringly obvious that the sort of services required by the sick and injured, especially the critically ill, are very different than those people who go to four-star hotels. Providing care to a patient on a ventilator (breathing machine), for example, hardly resembles providing spa services to a wealthy hotel guest. Furthermore, Erlanger Health System is a public, non-profit health system with a <a href="http://www.erlanger.org/body.cfm?id=38">mission</a> that involves service to the poor: <blockquote>To deliver excellence in medical care to improve the health status of our region, while providing vital services to those in need, and training to health professionals through affiliation with academic partners</blockquote> The Boston hotel in the Ritz-Carlton chain, its flagship property, <a href="http://www.ritzcarlton.com/en/Properties/BostonCommon/Rooms/Default.htm">boasts</a> that it: <blockquote>features hotel rooms and suites in Boston designed as sanctuaries of urban luxury. </blockquote> Where is the parallel to providing health care services to "those in need" who are acutely ill and injured? By the way, a few days after the Erlanger, Ritz-Carlton connection was announced, the Time Free Press <a href="http://timesfreepress.com/news/2011/aug/30/830-a1-erlanger-defends-ritz-bid-process">noted</a> questions about how the contract was awarded: <blockquote>Erlanger officials defended the no-bid procedure Monday, saying the hospital was correct in bypassing a competitive bid process and awarding a 'professional services' contract to Ritz-Carlton. 'Tennessee law says government entities do not have to bid professional services,' hospital spokeswoman Susan Sawyer said. Even early in the process, Whisman said, 'it was so clearly the Ritz going forward.' 'There was a lot of board support, executive-level support and steering committee support,' she said. 'Ritz had it all.'</blockquote> Furthermore, how well the money will be spent may be difficult to find out: <blockquote>In October, a Ritz-Carlton speaker is expected to lead several four-hour sessions, each of which will hold 400 employees, hospital officials said. The bill for those sessions is $288,000. On Thursday, Sawyer said Ritz-Carlton prohibited the media from attending the sessions because of proprietary information the hotel chain prefers to keep secret.</blockquote> It is not that the hospital system has money to burn, as the Chattanoogan just <a href="http://www.chattanoogan.com/articles/article_207569.asp">revealed</a>: <blockquote>Erlanger Health System officials reported a $1.3 million loss for July,...</blockquote> In addition, <blockquote>Admissions were under budget by 1.6 percent for the month and ahead of the previous year by 3.8 percent.</blockquote> So, in summary so far, a public hospital system that is currently experiencing budgetary challenges is spending hundreds of thousands of dollars for the Ritz-Carlton luxury hotel chain to train its employees in secret sessions about "service excellence," and the hospital system's management thinks this is a top priority. In my humble opinion, this illustrates a larger problem with the leadership of health care. Health care organizations are often lead by ultra <a href="http://hcrenewal.blogspot.com/search/label/generic%20managers">generic managers</a>, that is, managers trained in such fields as marketing, public relations, and finance, but without any experience or training in actually taking care of patients. (The supremacy of generic management is strange given that patient care itself has become so specialized.) The utter lack of gut feeling for what health care is really about seems to lead to managers thinking that hospitals are <a href="http://hcrenewal.blogspot.com/2005/09/reasoning-by-misanalogy-revisited-how.html">like automobile assembly plants</a>, or in this case, like luxury hotels. I cannot but help believe that such ultra generic managers, who do not appreciate the values of health care professionals, and do not understand the health care context, are going to make some very bad decisions, and are an important cause of health care dysfunction. I cannot help believe that the <a href="http://www.erlanger.org/body.cfm?id=191">Erlanger CEO</a>, Mr James Brexler, (whose most advanced degree was a "Masters of Public Affairs from North Carolina State University") was entirely off base when he was <a href="http://www.chattanoogan.com/articles/article_207720.asp">quoted</a>: <blockquote>'This is not a flavor-of-the-month thing,' continues CEO Brexler. 'This is a strategic priority and business imperative. We are committed to this. We are excited about it. Our staff is excited. Our physicians are excited. The results, we believe, will be evident to our patients and their families.'</blockquote> True health care reform would make sure health care leaders actually understand health care and uphold its values. PS - Long ago, we <a href="http://hcrenewal.blogspot.com/2006/03/putting-on-ritz.html">noted</a> the trustees of another hospital system who seemed to think that Ritz-Carlton experience was perfect background for hospital executives.

Another Hospital Putting on the Ritz

The usual definition of a hospital is an institution which treats the sick and injured,. That is a messy business, so some hospital executi...

Đọc thêm »

Yet more health IT articles based on functionalist and determinist assumptions of the general format “what is the impact of technology X on outcome Y"

The article "Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" by Greenhalgh, Potts, Wong, Bark and Swinglehurst at University College London appeared in the Dec. 2009 <a href="http://www.milbank.org/quarterly.html">Milbank Quarterly</a>. I wrote about it extensively and quoted it at <a href="http://hcrenewal.blogspot.com/2009/12/healthcare-it-as-cybernetic-miracle.html">this post</a>. A key statement: <blockquote>... This review has also identified some areas where more research does not appear to be needed ... [including] simplified experimental studies based on functionalist and determinist assumptions of the general format “what is the impact of technology X on outcome Y?” or variations thereof ... the circumstances in which they add value are more limited than is often assumed. We [also] believe that surveys of attitudes of patients or staff towards ‘the EPR’ or ‘computerization’ which are not adequately contextualized have almost no enduring value.</blockquote> So guess what was just published in the NEJM? An article based on functionalist and determinist assumptions of the general format “what is the impact of technology X on outcome Y." In a special article entitled "Electronic Health Records and Quality of Diabetes Care", NEJM August 31, 2011 (<a href="http://healthpolicyandreform.nejm.org/?p=15235&query=TOC">link</a>), a study was performed in which the researchers: <blockquote>... compared EHRs with paper-based records in a long-term regional collaborative that seeks to improve care and outcomes for patients with chronic conditions. </blockquote> They found that: <blockquote> ... EHR sites were associated with higher levels of achievement of and improvement in regionally vetted standards for diabetes care and outcomes. Our findings focus on composite standards, although the results were similar for virtually all component standards. </blockquote> This is not really news. I had the same results in a more limited EHR data-based study of diabetics ... in 1997. As I've often written, health IT can be of great benefit...but only if done well. (I have to frequently repeat that there is massive, perhaps <a href="http://en.wikipedia.org/wiki/Wicked_problem">wicked</a> complexity behind those simple two words "done well.") When not done well, disaster can strike. There are no statistics in in the NEJM article regarding complications, "close calls", patient injuries, or patient deaths due to the implementation of health IT. I sincerely doubt the incidence was zero. Their dismissal or lack of mention is common in the medical and health IT literature and seems to reflect an amoral, pervasive paternalism in medicine. The amoral paternalism in turn seems to be a repeat of the attitudes towards experimentation that led to the many human subjects protections that apply everywhere else in biomedicine (<a href="http://ohsr.od.nih.gov/guidelines/index.html">link</a>) - except computing - e.g.: <a href="http://ohsr.od.nih.gov/guidelines/45cfr46.html"></a><blockquote><a href="http://ohsr.od.nih.gov/guidelines/45cfr46.html">45 CFR 46</a> Protection Of Human Subjects <a href="http://ohsr.od.nih.gov/guidelines/GrayBooklet82404.pdf">Guidelines for Conduct of Research Involving Human Subjects at NIH (Gray Booklet) (pdf file)</a> <a href="http://ohsr.od.nih.gov/guidelines/belmont.html">The Belmont Report</a> Ethical Principles and Guidelines for the Protection of Human Subjects of Research <a href="http://ohsr.od.nih.gov/guidelines/nuremberg.html">Nuremberg Code</a> Directives for Human Experimentation <a href="http://ohsr.od.nih.gov/guidelines/helsinki.html">World Medical Association Declaration Of Helsinki</a> </blockquote> To their credit, the NEJM authors did issue several caveats: <blockquote>... we compared sites that had sophisticated EHR systems with paper-based organizations that, as safety-net practices, care for a vulnerable patient population and may have fewer quality-related resources than other paper-based practices ... Our results, showing accelerated improvement in care and outcomes, should encourage those concerned that the quality of ambulatory care may fail to improve with increased adoption of EHRs [per numerous past studies - ed.] ... our study did not determine changes in achievement after the conversion from paper to electronic records, which would provide more compelling evidence of the benefits of EHRs.</blockquote> One might wonder how the tens or hundreds of millions of dollars spent on EMR's might compare, with regard to disease management, with the results achieved by hundreds of dedicated people who could be hired for that purpose for far less money. In other words, the ROI issues of the health IT investment vs. alternatives are not addressed (they rarely are), and truly robust RCT's were not performed comparing the two alternatives. Greenhalgh et al. also wrote in the aforementioned Milbank article: <blockquote>... as a cross-cutting theme in all the above areas, the realpolitik of EPR projects within and between organizations and interest groups should be more explicitly explored ... Orlikowski and Yates have called for more research on the “messy, dynamic, contested, contingent, negotiated, improvised, heterogeneous, and multi-level character of ICTs [information & communications technologies - ed.] in organizations” (page 132) (Orlikowski and Yates 2006). We suggest that sponsors and publishers eschew sanitized accounts of successful projects and instead invite studies of the EPR in organizations that “tell it like it is” – perhaps using the critical fiction technique to ensure anonymity (Winter 1986).</blockquote> There's no trace of that in the new NEJM article. Where health IT is concerned, that's where the money is (no pun intended) in learning how to "do health IT well." -- SS

Yet more health IT articles based on functionalist and determinist assumptions of the general format “what is the impact of technology X on outcome Y"

The article " Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Met...

Đọc thêm »

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...

Đọc thêm »

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...

Đọc thêm »

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...

Đọc thêm »

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...

Đọc thêm »