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When Clinical Trials are Meant for Marketing, not Science

The development of the randomized controlled clinical trial (RCT) was one of the major scientific advances in clinical medicine.  RCTs provide a major part of the evidence underlying evidence based medicine.  RCTs provide a major source of data used by the US Food and Drug Administration, and similar agencies in other countries, to decide whether to approve drugs or devices to manage particular clinical problems.  Unfortunately, with the rise of the RCT came a rise in attempts to <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppress</a> and <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulate</a> clinical trials by those with vested interests, often in selling the products and services the trials can evaluate. Many of the examples we have discussed were of attempts at manipulation or suppression of clinical trials originally done to provide evidence for product approval, or even ostensibly to advance clinical science.  Yet a relatively new article covering evidence revealed from litigation about the drug gabapentin (Neurontin) originally made by Parke-Davis, first a part of Warner Lambert, now part of Pfizer suggests that many clinical trials may not be done to advance science, or even just to provide data to regulators, but only to market products. The article is Vedula SS, Goldman PS, Rona IJ, Greene TM, and Dickersin K. Implementation of a publication strategy in the context of reporting biases: a case study based on new documents from the Neurontin litigation.  Trials 2012; 13: 136.  Link<a href="http://www.trialsjournal.com/content/13/1/136"> here</a>. Methods Summary The article described a case study based on documents revealed in 2008 litigation.  The purpose of the study was: <blockquote class="tr_bq">to describe the implementation of a publication strategy for off-label marketing of gabapentin, within the context of reporting biases and spin of Pfizer and Parke-Davis’s clinical trial findings, for four off-label uses: migraine prophylaxis, treatment of bipolar disorders, neuropathic pain, and nociceptive pain. </blockquote> The study examined documents revealed through the 2008 litigation.  It concentrated on documents relating to the marketing of Neurontin for four off-label indications, that is, for four potential reasons to use the drug which had not yet been approved by the US FDA.  It focused on documents discussing strategies for marketing for these indications, and then documents about particular company sponsored RCTs done for these indications. Strategies to Sell Drugs The documents examined by the investigators showed that Parke-Davis prepared "marketing assessments" for four possible indications for Neurontin.  The assessments discussed two possible strategies.  The "indication strategy" would be to conduct trials for the purposes of providing data to the FDA in the hope that the FDA would then approve the new indication for the drug.  The "marketing strategy" would be, in the words of an internal company memo quoted in the study, to conduct clinical trials and <blockquote class="tr_bq">to disseminate the information as widely as possible through the world’s medical literature</blockquote> In other words, the publication strategy involved using RCTs first for marketing, rather than scientific or regulatory purposes. How the Trials were Controlled by Marketers  The publication strategy involved not simply doing trials and publicizing their results, but controlling the messages conveyed by the trials to make sure they primarily supported marketing.  This was done by having the company's marketing department control the content of the trial reports. <blockquote class="tr_bq"> A Neurontin Publications Subcommittee (NTN PSC) was formed within Pfizer and Parke-Davis to implement a publication plan. Minutes from meetings between the NTN PSC and Medical Action Communications (MAC), a medical writing company, indicate that a list of key messages, guiding the content of published reports related to the trials of gabapentin for off-label indications, was developed based on a branding guide </blockquote>Thus it appeared to be that marketers, not physicians or scientists were in control of supposedly scholarly research publications appearing in medical journals. The marketers controlled content by controlling those who wrote it. <blockquote class="tr_bq"> A standard operating procedure related to publication of affiliate-driven manuscripts was identified in internal company documents dated October 16, 2002, and it sheds further light on the publication planning process (see Figure 3<a href="http://www.trialsjournal.com/content/13/1/136/figure/F3"></a>). (The term affiliate in this context refers to Pfizer’s foreign affiliates, that is, corporations related to Pfizer by either shareholdings or other means of control, including subsidiary, parent, or sibling corporations). According to the internal company documents, 'affiliate-driven manuscripts' were written for Pfizer and Parke-Davis by MAC and sent to the authors for approval. Each article was coordinated by a manuscript team, consisting of representatives from the medical and marketing divisions of the company. The documents also indicate that all affiliate-driven manuscripts should be forwarded to the NTN PSC for review. One of the objectives of manuscripts being reviewed by the NTN PSC was to ‘ensure that they are in-line with current product messages and areas of interest’</blockquote>Manipulating the Dissemination (and Analysis) of Research Results Note that the control of publication by marketers describe above involved ghost-writing of articles by medical education and communications companies (MECCs).  Later the article explained that these ghost writers were "not appropriately acknowledged" in the resulting published articles. The Vedula et al study article provided examples of "spin" in the writing of again supposedly scholarly research publications used in fact to support marketing, and controlled if not composed by marketers. <blockquote class="tr_bq"> We identified spin in publications related to 8/12 trials included in our analysis.... We classified the following as spin: emphasis in the published report on outcomes that were not specified in the study protocol (Study 879–201) ...; conclusions that did not match study findings described in the internal company research report (Study 945–220) <a href="http://www.blogger.com/blogger.g?blogID=9551150" name="d7865e503"></a>...; extensive rationale to explain away statistically non-significant (unfavorable to the sponsor) findings (Study 945–209; 945–291; No study number - Gorson) <a href="http://www.blogger.com/blogger.g?blogID=9551150" name="d7865e508"></a><a href="http://www.blogger.com/blogger.g?blogID=9551150" name="d7865e510"></a><a href="http://www.blogger.com/blogger.g?blogID=9551150" name="d7865e512"></a>...; conclusion of treatment effectiveness from an uncontrolled study (Study 945–250) ...; emphasis on statistically significant secondary outcomes despite negative findings for the primary outcome (Study 945–271) ...; and an explicit description of an attempt to spin study findings (as described in internal company emails) (Study 945–306).</blockquote> Note that while most of these examples of spin involved manipulation of the dissemination of study results, that is, doubtful, biased or fallacious arguments based on apparently unbiased data, they also involved manipulation of the analyses (in italics).  The article also described manipulation of dissemination involving the timing of publication, including delaying publication of an article despite the wishes of the study's investigators because the results were not statistically significant, and hence not favorable for marketing.  Summary Documents revealed by litigation about Neurontin in 2004 provided insights about how pharmaceutical and presumably other kinds of health care corporations may conduct systematic, deceptive stealth marketing campaigns to promote their products and services (look<a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html"> here</a>).  We noted that initial media coverage of documents revealed in the 2008 litigation also suggested the existence of a systematic "publication strategy" to control dissemination of results of particular trials, while suppressing trials whose results could not easily be spun to provide support of marketing objectives (look <a href="http://hcrenewal.blogspot.com/2008/10/did-pfizer-marketers-suppress-and.html">here</a>). Now the new paper by Verdula et al fill out our knowledge of this case.  The paper suggests that randomized controlled clinical trials may be done not to advance science, or even convince regulators, but primarily to market their sponsors' products.  Thus some significant proportion of the clinical research literature, the literature that physicians and other health professionals have relied upon to make evidence-based decisions for their patients, may exist mainly for marketing purposes.  Even the most rigorous methods used by clinical epidemiologists to review research are meant to discover problems that arose from human error or the inevitable trade-offs made when research is done in the real world, but not deliberately introduced biases and defects meant to promote vested interests.  Thus it is not clear that even the most "evidence-based" medical decisions are based on real scientific evidence rather than the spinning of marketers. Thus health care professionals, policy makers, researchers, and the interested public need to be even more skeptical about arguments made to promote innovative treatments and other clinical interventions.  However, it is not clear that even rigorous skepticism can defend the integrity of evidence based medicine from marketing disguised as clinical research. Going forward, we must consider erecting an impregnable barrier between clinical research and those whose primary interest is to make money by selling health care goods and services.  If we do not do that, we will forever need to worry that we really have no idea what "works in medicine," and whether any particular test, treatment, or program provides benefits that outweigh its harms.

When Clinical Trials are Meant for Marketing, not Science

The development of the randomized controlled clinical trial (RCT) was one of the major scientific advances in clinical medicine. RCTs provi...

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HITECH and Experimental Airplanes

HITECH and Experimental Airplanes

This from a commenter, who has been deeply involved in major governmental health IT initiatives in another land, who wishes to remain anonym...

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Computer Viruses Are "Rampant" on Medical Devices in Hospitals

As if there weren't enough problems with hospitals as computing backwaters, now there's this: <blockquote class="tr_bq"><a href="http://www.technologyreview.com/news/429616/computer-viruses-are-rampant-on-medical-devices/" target="_blank">Computer Viruses Are "Rampant" on Medical Devices in Hospitals</a> A meeting of government officials reveals that medical equipment is becoming riddled with malware. Technology Review Published by MIT David Talbot Wednesday, October 17, 2012 Computerized hospital equipment is increasingly vulnerable to malware infections, according to participants in a recent government panel. These infections can clog patient-monitoring equipment and other software systems, at times rendering the devices temporarily inoperable. While no injuries have been reported, the malware problem at hospitals is clearly rising nationwide, says Kevin Fu, a leading expert on medical-device security and a computer scientist at the University of Michigan and the University of Massachusetts, Amherst, who took part in the panel discussion.</blockquote> I note the seemingly universal refrain "no injuries have been reported" once more (see <a href="http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised" target="_blank">this query link</a> to similar statements regarding IT malfunctions), which is irrelevant since reporting mechanisms for medical errors are <a href="http://www.seattlepi.com/local/article/Despite-law-medical-errors-likely-go-unreported-889076.php" target="_blank">noted to be deficient</a>. <blockquote class="tr_bq">Software-controlled medical equipment has become increasingly interconnected in recent years, and many systems run on variants of Windows, a common target for hackers elsewhere. The devices are usually connected to an internal network that is itself connected to the Internet, and they are also vulnerable to infections from laptops or other device brought into hospitals.  [I note that it should be impermissible to connect "alien" machines to a hospital's network without authorization, and that attaining that level of security protection is not difficult - ed.]  The problem is exacerbated by the fact that manufacturers often will not allow their equipment to be modified, even to add security features. In a typical example, at Beth Israel Deaconess Medical Center in Boston, 664 pieces of medical equipment are running on older Windows operating systems that manufactures will not modify or allow the hospital to change—even to add antivirus software—because of disagreements over whether modifications could run afoul of U.S. Food and Drug Administration regulatory reviews, Fu says.</blockquote> In other words, let's run at high risk if it avoids the time and expense of FDA reviews that would ensure the equipment is safe and operates as expected with the software updates. <blockquote class="tr_bq">As a result, these computers are frequently infected with malware, and one or two have to be taken offline each week for cleaning, says Mark Olson, chief information security officer at Beth Israel.</blockquote> It is unclear how the servers running the hospital information system, electronic health records systems, physician order entry systems etc. are immune to spread of the malware. <blockquote class="tr_bq"> "I find this mind-boggling," Fu says. "Conventional malware is rampant in hospitals because of medical devices using unpatched operating systems. There's little recourse for hospitals when a manufacturer refuses to allow OS updates or security patches." The worries over possible consequences for patients were described last Thursday at a meeting of a medical-device panel at the National Institute of Standards and Technology Information Security and Privacy Advisory Board, of which Fu is a member, in Washington, D.C. At the meeting, Olson described how malware at one point slowed down fetal monitors used on women with high-risk pregnancies being treated in intensive-care wards.</blockquote> In its face, that is potentially catastrophic depending on the degree of "slowdown" and whether data is lost. <blockquote class="tr_bq">"It's not unusual for those devices, for reasons we don't fully understand, to become compromised to the point where they can't record and track the data," Olson said during the meeting, referring to high-risk pregnancy monitors. "Fortunately, we have a fallback model because they are high-risk [patients]. They are in an IC unit—there's someone physically there to watch. But if they are stepping away to another patient, there is a window of time for things to go in the wrong direction."</blockquote> The reasons seem obvious to anyone who's had a serious malware infection on their PC.  I've only had one - a computer I bought at a fleamarket for $7 was so severely infected it was unusable for even basic tasks, and was resistant to virus removal.  I solved that problem by installing a fresh copy of the OS, immediately followed by all patches and the latest anti-malware software. <blockquote class="tr_bq">The computer systems at fault in the monitors were replaced several months ago by the manufacturer, Philips; the new systems, based on Windows XP, have better protections and the problem has been solved, Olson said in a subsequent interview.</blockquote> This implies the older systems were running on Win 98 or earlier or an old version of Win NT.  Amazing. <blockquote class="tr_bq">At the meeting, Olson also said similar problems threatened a wide variety of devices, ranging from compounders, which prepare intravenous drugs and intravenous nutrition, to picture-archiving systems associated with diagnostic equipment, including massive $500,000 magnetic resonance imaging devices. Olson told the panel that infections have stricken many kinds of equipment, raising fears that someday a patient could be harmed. "We also worry about situations where blood gas analyzers, compounders, radiology equipment, nuclear-medical delivery systems, could become compromised to where they can't be used, or they become compromised to the point where their values are adjusted without the software knowing," he said. He explained that when a machine becomes clogged with malware, it could in theory "miss a couple of readings off of a sensor [and] erroneously report a value, which now can cause harm."</blockquote> I opine that harm could already have occurred; it just may not been recognized as such nor reported.  Disappearing data and other EHR failure modes known to have caused harm and/or deaths could be related to malware, for example. <blockquote class="tr_bq">... Malware problems on hospital devices are rarely reported to state or federal regulators, both Olson and Fu said. This is partly because hospitals believe they have little recourse. Despite FDA guidance issued in 2009 to hospitals and manufacturers—encouraging them to work together and stressing that eliminating security risks does not always require regulatory review—many manufacturers interpret the fine print in other ways and don't offer updates, Fu says. And such reporting is not required unless a patient is harmed. "Maybe that's a failing on our part, that we aren't trying to raise the visibility of the threat," Olson said. "But I think we all feel the threat gets higher and higher."</blockquote> I note that health IT related problems are also rarely reported, with only one vendor being the exception (see my post on the FDA MAUDE voluntary reporting database <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html" target="_blank">here</a>).  The reasons likely are not because "hospitals believe they have little recourse" - the real reasons may be fear, complacency and/or incompetence. <blockquote class="tr_bq"> Speaking at the meeting, Brian Fitzgerald, an FDA deputy director, said that in visiting hospitals around the nation, he has found Beth Israel's problems to be widely shared. "This is a very common profile," he said. The FDA is now reviewing its regulatory stance on software, Fitzgerald told the panel. "This will have to be a gradual process, because it involves changing the culture, changing the technology, bringing in new staff, and making a systematic approach to this," he said.</blockquote> Changing the culture would be nice, considering we are now entering a national rollout of complex enterprise clinical resource and workflow control systems anachronistically known as "electronic medical records." <blockquote class="tr_bq">In an interview Monday, Tam Woodrum, a software executive at the device maker GE Healthcare, said manufacturers are in a tough spot, and the problems are amplified as hospitals expect more and more interconnectedness. He added that despite the FDA's 2009 guidance, regulations make system changes difficult to accomplish: "In order to go back and update the OS, with updated software to run on the next version, it's an onerous regulatory process."</blockquote> My comment is, if you can't take the heat of work in the real-world medical setting, if you cannot be part of the medical team, then get out of the clinic.  You're likely to do more harm than good. <blockquote class="tr_bq">John Halamka, Beth Israel's CIO and a Harvard Medical School professor, said he began asking manufacturers for help in isolating their devices from the networks after trouble arose in 2009: the Conficker worm caused problems with a Philips obstetrical care workstation, a GE radiology workstation, and nuclear medical applications that "could not be patched due to [regulatory] restrictions." He said, "No one was harmed, but we had to shut down the systems, clean them, and then isolate them from the Internet/local network." He added: "Many CTOs [chief technology officers - ed.] are not aware of how to protect their own products with restrictive firewalls. All said they are working to improve security but have not yet produced the necessary enhancements."</blockquote> Then why are they CTO's?  Is this the phenomenon of generic or underqualified managers rearing its head? <blockquote class="tr_bq"> Fu says that medical devices need to stop using insecure, unsupported operating systems. "More hospitals and manufacturers need to speak up about the importance of medical-device security," he said after the meeting. "Executives at a few leading manufacturers are beginning to commit engineering resources to get security right, but there are thousands of software-based medical devices out there."</blockquote> One can only wonder if others have done a Ford Pinto cost-benefit analysis and decided the costs of settlement from injured and dead patients is less than the cost of remediation. -- SS

Computer Viruses Are "Rampant" on Medical Devices in Hospitals

As if there weren't enough problems with hospitals as computing backwaters, now there's this: Computer Viruses Are "Rampant&quo...

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More Reasons to Doubt How CEOs are Chosen and Paid

Health Care Renewal is about problems with the leadership and governance of health care organizations.  Since the global financial collapse/ great recession began in 2008, it became evident that the problems we saw affecting health care leadership were similar to problems affecting other large organizations, notably financial firms.  Recently, I spotted a series of articles that raise more questions about how business leaders, and by extension, leaders of health care organizations are chosen and paid. Doubts about Generic Managers We have often questioned the wisdom of having health care organizations lead by people with little if any direct health care experience, little knowledge of health care on the ground, and little commitment to health care's core values.  We have called such leaders <a href="http://hcrenewal.blogspot.com/search/label/generic%20managers">generic managers</a>. A New York Times <a href="http://www.nytimes.com/2012/09/23/business/ceos-and-the-pay-em-or-lose-em-myth-fair-game.html">article</a> by Gretchen Morgenson from September, 2012, cited new academic work that questioned the abilities of generic managers.  The <a href="http://irrcinstitute.org/pdf/Executive-Superstars-Peer-Benchmarking-Study.pdf">source article </a>was Elson CM, Ferrere CK.  Executive superstars, peer groups, and overcompensation - cause, effect and solution.  Ms Morgenson summarized, <blockquote class="tr_bq">Mr. Elson and Mr. Ferrere conclude, contrary to the prevailing line, that chief executives can’t readily transfer their skills from one company to another.</blockquote> Furthermore, Ms Morgenson interviewed Mr Elson, who said, <blockquote class="tr_bq">But we found that C.E.O. skills are very firm-specific. C.E.O.’s don’t move very often, but when they do, they’re flops.</blockquote>Also, <blockquote class="tr_bq"><div itemprop="articleBody">But there is little evidence, according to Mr. Elson and Mr. Ferrere, that a hot market exists for interchangeable chief executives. First, they note numerous academic studies indicating that C.E.O.’s selected from within a company perform better than outsiders, especially in the creation of long-term shareholder value. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">'There is no conclusive empirical evidence that outside succession leads to more favorable corporate performance, or even that good performance at one company can accurately predict success at another,' the authors conclude. 'In short, executive skills cannot pass the most basic test of generality: transferability.' </div><div itemprop="articleBody"> </div><div itemprop="articleBody">To be sure, this flies in the face of the widely held view that skilled managers have become generalists and are therefore far more interchangeable than in previous years. Proponents of this thesis argue that top managers today can accumulate a broad knowledge of economics, finance and management science, giving them the ability to manage any type of company effectively. Technological advancements also give chief executives access to untold amounts of data about a particular company that in previous times would have taken years to amass and synthesize, this view holds. </div><div itemprop="articleBody"> </div><div itemprop="articleBody">But the data on actual C.E.O. moves raises questions about just how portable C.E.O. skills really are. The Delaware paper cites several studies indicating that relatively few chief executives land new top jobs elsewhere. One study, a 2011 analysis of roughly 1,800 C.E.O. successions from 1993 to 2005, found that less than 2 percent had been public-company chief executives before their new jobs. </div></blockquote>This data and these observations seem to broadly apply to business executives, but there is no reason to think they do not apply to executives of health care corporations.  Furthermore, given that on its face, health care is less like making automobiles than, say, the restaurant business is, there is no reason to think doubts this raises about the abilities of generic managers should not be even bigger in health care, and should apply not just to for-profit, but to not for profit corporations.  Yet the trend in health care seems to increasingly favor generic managers of not just for-profit health care corporations, but also hospitals and hospital systems, non-profit health insurers and managed care organizations, health care charities, disease advocacy groups, and even medical associations, medical schools, and their parent universities.   Doubts about Executive Compensation Peer-Group Benchmarking We have often posted about<a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation"> amazingly generous compensation</a> given to top leaders of health care organizations.  Health care corporate CEOs can make tens of millions of dollars, occasionally even more.  While CEOs of not for profit health care organizations make less, they still now can makes millions of dollars.  Ms Morgenson called the usual justification for these huge amounts of compensation the "pay-'em-or-lose-'em" myth. <blockquote class="tr_bq">Corporations are forever defending big executive paydays. If we don’t pay up, the argument goes, our sharpest minds will jump to our rivals. </blockquote>This notion, or myth, depends on the argument that generic managers are the best managers, which appears to be largely unsubstantiated, as we noted above. <blockquote class="tr_bq"> In other words, the argument that C.E.O.’s will leave if they aren’t compensated well, perhaps even lavishly, is bogus. Using the peer-group benchmark only pushes pay up and up. </blockquote> Furthermore, <blockquote class="tr_bq">Importantly, the study disputes the notion that executive pay today is a result of an efficient bidding process for finding and retaining a scarce and valuable commodity: managerial talent. 'In essence, this process creates a model of a competitive market for executives where it otherwise does not exist,' the authors wrote. 'Through the operation of a market, it is argued, wages are bid up to an executive’s outside opportunities.' </blockquote> Instead, as noted above, since the skills needed to run one sort of company or organization may not readily transfer to other companies and organizations, even seemingly similar ones, such a market does not exist.     Incentives Based on Short-Term Financial Results We have also previously discussed (look <a href="http://hcrenewal.blogspot.com/2012/04/health-care-dysfunction-explained-by.html">here</a>) how contemporary economic dogma suggest that the only measure of success of a for-profit corporation is "shareholder value," which has come to mean the stock price over the short term.  There is reason to think that this focus on short-term economic performance has also become the major measure of success of health care organizations.  Another word for this phenomenon is <a href="http://hcrenewal.blogspot.com/search/label/financialization">"financialization."  </a> An <a href="http://www.independent.co.uk/news/business/comment/anthony-hilton-how-bonuses-make-bosses-reluctant-to-invest-in-the-future-8163804.html">op-ed</a> in the UK Independent questions this focus because of its economic effects.  Anthony Hilton wrote about the views of Andrew Smithers, <blockquote class="tr_bq">His starting point was that the economy was floundering because of inadequate demand. Personal spending is flat for obvious reasons but the real culprit is the companies who are hoarding cash and refusing to invest. Others have noticed the cash hoarding but explain it away by saying we live in uncertain times and companies will start investing again once they become more confident about the economic outlook. Smithers disagrees fundamentally with this. He says companies are not investing because executives are bonused to deliver short-term profits. Costly spending on investment projects is therefore anathema to them. Investment may deliver long-term prosperity but by that time they will have left the company. It also depresses short-term profits while they are still there. We have in the last two decades, under the mantra of shareholder value and aligning the interests of management with shareholders, created a new breed of management incentivised to believe that what is good for them is good for the business. They dislike investment because it reduces their bonuses . They don't invest surplus cash. They hoard it or they use it to buy back their own company's shares. When the majority of the managements in publicly quoted companies start behaving this way, as they now do, we have a serious problem. They are sitting on cash which is the equivalent of six per cent of GDP. This deadweight of unused resources prevents lift-off and threatens to leave the economy forever trapped in the mire. Smithers says this behaviour by management is a structural change — meaning it is something which won't go away. It makes this down- turn different from all that have gone before.</blockquote>There is no reason to think that health care corporations are not hoarding money in the sense described above.  If so, they may be failing to invest in drugs or devices that would have helped patients in the future. Because of the limited reporting required of large health care non-profit organizations in the US, it may be very hard to tell if they are similarly hoarding money, but if they are, the effects again might be to fail to provide patients long-term benefits they might otherwise have enjoyed. The Ultimately Self-Destructive Outcome Meanwhile, <a href="http://www.nytimes.com/2012/10/14/opinion/sunday/the-self-destruction-of-the-1-percent.html">writing in</a> the New York Times, Chrystia Freeland, the author of Plutocrats: the Rise of the New Global Super-Rich and the Fall of Everyone Else, explained why picking the wrong leaders  and paying them too much may be bad for everyone.  We have noted that an increasing fraction of the wealthiest one percent of the US are current and former corporate executives.  Ms Freeland wrote how domination by an increasingly wealthy and powerful elite usually dooms the countries they dominate. <blockquote class="tr_bq">what separates successful states from failed ones is whether their governing institutions are inclusive or extractive. Extractive states are controlled by ruling elites whose objective is to extract as much wealth as they can from the rest of society.</blockquote>So <blockquote class="tr_bq">it is the danger America faces today, as the 1 percent pulls away from everyone else and pursues an economic, political and social agenda that will increase that gap even further — ultimately destroying the open system that made America rich and allowed its 1 percent to thrive in the first place.  </blockquote> Furthermore, <blockquote class="tr_bq">It is no accident that in America today the gap between the very rich and everyone else is wider than at any time since the Gilded Age. Now, as then, the titans are seeking an even greater political voice to match their economic power. Now, as then, the inevitable danger is that they will confuse their own self-interest with the common good. The irony of the political rise of the plutocrats is that, like Venice’s oligarchs, they threaten the system that created them.</blockquote>So it is not merely that overcompensating generic executives has likely been one of the major reasons our health care is so expensive, inaccessible, and mediocre.  The larger problem of overpaying under skilled executives threatens to destroy our whole society.  How cheerful Summary The way forward seems clear.  It is just blocked by the interests of the rich and powerful elite which our current foolish policies have created. In a health care context, leaders of organizations should only be those with clear knowledge of, experience in, and commitment to the values of health care.  Their compensation should be reasonable, and based on their ability to uphold these values first, with financial goals clearly second, and short-term financial goals probably not at all.  Pay should not be bench-marked to compensation of leaders of other organizations, especially not of vastly different kinds of organizations. Whether there is any chance of such changes happening while corporate boards of directors, and non-profit boards of trustees are dominated by executives of other organizations is doubtful.  Thus we also need to change the governance of for-profit health care corporations to clearly reflect the long-term interests of the stockholders, who will only prosper if in the long run their companies provide products and services that help patients at a fair price and with minimal risks.   Thus we further need to need to change the governance of health care non-profits to reflect the needs of patients, their communities and other key constituencies.  That should keep us all busy for a while.

More Reasons to Doubt How CEOs are Chosen and Paid

Health Care Renewal is about problems with the leadership and governance of health care organizations. Since the global financial collapse/...

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Back to the Future - Another Medical Device Company Accused of Hiding ICD Defects

Suppression of data about defects in and failures of implantable cardiac defibrillators (ICDs) was one of the big issues we featured in the early days of <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> (2005-06).  At that time, Guidant, later acquired by Boston Scientific, was accused of hiding data that certain of its defibrillator models failed, possibly leading to preventable patient deaths (see <a href="http://hcrenewal.blogspot.com/2006/03/call-for-transparency-and-physician.html">this post</a> and follow links backward).  Boston Scientific, which acquired Guidant, settled a civil lawsuit and was put on probation in 2011 after it pleaded guilty to misdemeanor charges of failing to file required reports with the US Food and Drug Administration (see post <a href="http://hcrenewal.blogspot.com/2011/01/guidant-boston-scientific-gets.html">here</a>).   Similarly, in 2010, Medtronic settled multiple patients' lawsuits charging that it knowingly marketed a faulty ICD (see post <a href="http://hcrenewal.blogspot.com/2010/10/last-weeks-scandals.html">here</a>). St Jude and the Obscure Riata Data Now in 2012, A Wall Street Journal <a href="http://online.wsj.com/article/SB10000872396390444223104578036752346768278.html">article </a>suggested that St Jude Medical Inc hid problems with its Riata implanted cardiac defibrillator (ICD) for years.    <blockquote class="tr_bq">In December, 2010, St Jude Medical Inc issued a warning letter to doctors: Wires inside Riata defibrillator leads—cables that connect the heart to implantable defibrillators—were sometimes breaking through their insulation from the inside out. The problem, which ultimately led to a recall last year, could cause defibrillators to send unnecessary jolts to the heart or fail to deliver lifesaving shocks to return chaotic heart rhythms back to normal. The company said it had identified dozens of cases with visible signs of the problem, and pulled Riata from the market. For many doctors, this was the first notice of a problem with Riata. But before that 2010 warning, physicians including Alan Cheng, director of Johns Hopkins Medicine's arrhythmia service; Samir Saba, chief of electrophysiology at the University of Pittsburgh Medical Center; and Ernest Lau at the Royal Victoria Hospital in Belfast, Ireland, say they had encountered this so-called "inside-out abrasion" in their own practices between 2006 and 2009. When these doctors brought the incidents to the attention of St. Jude they say they were told by company officials and field representatives that the incidents were isolated. The malfunctions described by the doctors didn't result in deaths. St. Jude had been tracking the problem for several years, according to company documents collected by the Food and Drug Administration and reviewed by The Wall Street Journal. Cases involving the so-called inside-out abrasion date to at least October 2005, the documents show. Inside-out abrasion became a focus of an internal St. Jude audit, which examined multiple cases of the failure before April 2008.</blockquote>The Journal article noted that more transparency about device failures might allow physicians to spot problems earlier and prevent harm to patients. <blockquote class="tr_bq">more than a dozen physicians and device-safety experts say that if St. Jude had acknowledged the inside-out failure earlier, physicians might have identified the scope of the problem sooner. In some cases, doctors concede that they, too, believed the failures were isolated and therefore didn't act quickly to report problems to St. Jude or the FDA, which may have made it harder to spot the growing trend of failures. The leads were implanted in more than 13,000 patients since July 2008. 'Every time you have a failed lead, you assume it's an isolated event, but, you start to string together isolated events, and then you have a recall,' said Dr. Saba. </blockquote>Summary So, for Health Care Renewal, this is a straightforward case, at least so far.  Yet another health care organization, this time, a medical device company, failed to reveal data that might have reflected unfavorably on one of its products, and hence lead to decreases in short-term revenue.  However, by suppressing the information, the company may have allowed doctors to keep implanting a potentially faulty device, and exposed patients to risk, possibly of fatality.  We have discussed many at least somewhat parallel cases of suppression of research (<a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">here</a>), and many cases of other kinds of deception by health care organizations (<a href="http://hcrenewal.blogspot.com/search/label/deception">here</a>).  Yet these cases continue to occur, physicians and other health care professionals continue to be fooled by secrecy and data suppression, and patients continue to be harmed by drugs, devices, or other interventions made by people who knew, or ought to have known that they were more dangerous than they appeared to be.  One problem may be that the people with the most influence on medical practice and health policy continue to cheer lead for the veracity of information about drugs, devices, and other health care interventions supplied by the people who most stand to gain from selling same.  A few weeks ago, the editor of the august New England Journal of Medicine, Dr Jeffrey M Drazen MD, scoffed at physicians' skepticism of pharmaceutical industry funded clinical research, claiming that there were only "a few examples of industry misuse of publications...." [Drazen JM. Believe the data. N Engl J Med 2012;  367:1152-1153.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMe1207121">here</a>.]  In doing so, Dr Drazen seemed to ignore all the stories about suppression of medical research (some of which we have discussed <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">here</a>), manipulation of medical research (some discussed <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">here</a>), and deception (some discussed <a href="http://hcrenewal.blogspot.com/search/label/deception">here</a>) and secrecy (some discussed <a href="http://hcrenewal.blogspot.com/search/label/secrecy">here</a>) practiced by large health care organizations, including but not limited to drug, device, biotechnology, and health care information technology companies. Instead, the possibility that St Jude kept hidden data about the failings of one of its ICD models reminds us how skeptical we ought to be about the information provided, or not provided by those with vested interests in selling health care goods or services.  Physicians, health care professionals, those interested in health policy, and the public at large need to collectively exert pressure on the leaders of health care organizations to promote greater transparency, especially about data reflecting on benefits and harms of health care goods and services.  .

Back to the Future - Another Medical Device Company Accused of Hiding ICD Defects

Suppression of data about defects in and failures of implantable cardiac defibrillators (ICDs) was one of the big issues we featured in the ...

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A Response to the NY Times Article "Ups and Downs of EMRs" So Full Of The Usual Refrains, I Am Using It To Throw A Spotlight On Those Endlessly-Repeated Memes

My Google search alert turned up a response to the Oct. 8, 2012 NY Times article <a href="http://www.nytimes.com/2012/10/09/health/the-ups-and-downs-of-electronic-medical-records-the-digital-doctor.html" target="_blank">The Ups and Downs of Electronic Medical Records</a> by Milt Freudenheim. It was posted on the blog of a company Medical-Billing.com and is filled with the usual rhetoric and perverse excuse-making. It is, in fact, so laden with typical industry refrains and excuse-making that I am using it to throw a spotlight on the misconceptions and canards proffered by that industry in defense of its uncontrolled practices: <blockquote class="tr_bq"><a href="http://www.medical-billing.com/blog/medicalbilling/news/pid-598/a-response-to-the-ny-times-on-electronic-medical-records/" target="_blank">A Response to the NY Times on Electronic Medical Records</a> Posted on October 10, 2012 by Kathy McCoy A recent article by the New York Times entitled “The Ups and Downs of Electronic Medical Records” has generated a lot of discussion among the HIT community and among healthcare professionals. It’s an excellent article, looking at concerns that a number of healthcare professionals have about the efficiency, accuracy and reliability of EMRs. One source quoted, Mark V. Pauly, professor of health care management at the Wharton School, said the health I.T. industry was moving in the right direction but that it had a long way to go before it would save real money. “Like so many other things in health care,” Dr. Pauly said, “the amount of accomplishment is well short of the amount of cheerleading.” Seriously? I can’t believe we’re still having this conversation.  [Emphasis in the original - ed.] </blockquote> I can believe it -- and quite seriously -- as it's a "conversation" long suppressed by the health IT industry and its pundits. Seriously, I can't believe the comment about "it's an excellent article"; that comment appears to merely be a distraction for the interjection of attacks upon the substance of selfsame "excellent" article. <blockquote class="tr_bq"> In a world where I can go to Lowe’s and they can tell me what color paint I bought a year ago, or I can call Papa John’s and they know what my usual pizza order is, how can we expect less from our healthcare systems?</blockquote> Because healthcare is not at all like buying paint and ordering a pizza, being several orders of magnitude more demanding and complex and on many different planes (e.g, educational, organizational, social and ethical to name a few).  Only the most avid IT hyper-enthusiast (or those prone to <a href="http://www.merriam-webster.com/dictionary/ignoratio%20elenchi" target="_blank">ignoratio elenchi</a>) would make such a risible comparison. <blockquote class="tr_bq">I recently joined a new healthcare system, and I have been impressed and pleased by their use of EMR and technology. I no longer have to worry about whether I told the new specialist everything he or she needed to know about my health history; it’s in my record. I no longer have to remember when I had my last tetanus shot; it’s in my record. My care is coordinated between doctors, labs, etc., better than it ever has been before. In the past, I felt as though my healthcare was a giant patchwork quilt—and some of the stitches were coming loose, frankly. This new system with a widely used EMR, to me, is a huge improvement.</blockquote> The problem with this argument is that n=1, and the going's not yet gotten tough, such as it had for people injured or killed as a result of the experimental state of current health IT. <blockquote class="tr_bq">Granted, the problems cited in the article are real and need to be addressed. </blockquote> Another dubious statement to be followed with excuses ... here it is: <blockquote class="tr_bq">However, the article itself mentions some redundancies that are in place to insure that a system going down doesn’t throw the entire Mayo Clinic into freefall. And certainly, additional redundancies may be needed to insure that prescriptions aren’t incorrectly sent to a pharmacy for the wrong patient, etc.</blockquote> Those "redundancies" are not complete, do not cover for all aspects of enterprise health IT when it is down, and <a href="http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised" target="_blank">necessarily compromise patient care</a> when they have to be called upon.   I, for one, a physician, would not enjoy being a patient nor taking care of patients when the "IT lights" go out. <blockquote class="tr_bq">Do doctors and medical staff need to learn how to code correctly so that they aren’t accused of cloning? Yes—but that’s a relatively easy problem to fix. The problem has already been identified, and training has already begun to address the issue.</blockquote> Cloning of notes and "coding correctly" are two entirely different issues.  Easy to fix?  The health IT industry has been saying all its problems are easy to fix, i.e., in version 2.0 ... for the past several decades, when few if any problems have been. <blockquote class="tr_bq">I have been through this type of problem before, as have many of you, with new systems. It’s called a learning curve, and it’s relatively easy to work through with patience and determination. I have encountered situations before where the team I was working with threw up their hands when they ran into problems learning a new database system and said “It doesn’t work.” Yet in time, they learned to love the system—and some of the biggest doubters became the experts on it.</blockquote> I surmise that since they were forced into using it, the Stockholm Syndrome was likely at work.  However, speculation aside, the seemingly banal statement that "it’s called a learning curve" is an ethical abomination.  The subjects of these systems are human beings, not lab rats. Further, health IT is not a "<a href="http://hcrenewal.blogspot.com/2010/01/does-ceo-of-google-use-google.html" target="_blank">database system</a>."  It is an enterprise clinical resource and clinician workflow control and regulation device.  This statement illustrates the dangers of having personnel of a technical focus in any kind of authority role in health IT.  Their education and worldview is far too narrow. <blockquote class="tr_bq">Healthcare professionals overcome more difficult challenges than this every day; they bring people back from the dead, for Pete’s sake! I have no doubt that they will adapt and learn to utilize EMRs so that they improve healthcare and take patient care to levels currently unimaginable.</blockquote> Wrong solution, completely ignoring (or perhaps I should say willfully ignorant of) the fact that there's good health IT and bad health IT (GHIT/BHIT).  The IT industry needs to adapt to healthcare professionals, not the other way around, by producing GHIT and banishing BHIT.  This point needs to be frequently repeated, I surmise, due to tremendous disrespect for healthcare professionals by the industry. <blockquote class="tr_bq">And to say, as was quoted in the article: “The technology is being pushed, with no good scientific basis”? Ridiculous, with all due deference to Dr. Scot M. Silverstein, a health I.T. expert at Drexel University who reports on medical records problems on the blog Health Care Renewal and made the statement.</blockquote> The only thing "ridiculous" is that Ms. McCoy was clearly too lazy to check the very blog she cites, as conspicuously cited in the NY Times article itself.  (That assumes she has the education and depth to understand its arguments and copious citations.) Lack of RCT's, supportive studies weak at best with <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html" target="_blank">literature conflicting</a> on value, National Research Council indicating current health IT <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572" target="_blank">does not support clinician cognitive processes</a>, <a href="http://hcrenewal.blogspot.com/2012/10/honesty-and-good-sense-on-electronic.html" target="_blank">known harms but IOM/FDA both admitting the magnitude of EHR-related harms is unknown</a>, <a href="http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html" target="_blank">usability poor</a> and in need of significant remediation, cost savings <a href="http://hcrenewal.blogspot.com/2012/09/wsj-koppel-and-soumerai-major-glitch.html" target="_blank">in doubt</a> - these are just a few examples of where the science (as medicine knows it) does not in 2012 support hundreds of billions of dollars for a national rollout of experimental health IT. I wish it were not so, but alas, that is the current reality. <blockquote class="tr_bq">Database management of information has been proven to be an improvement on paper records in just about every industry there is; healthcare will not be an exception.</blockquote> Ignoring the repeated "database" descriptor, I agree, eventually, that electronic information systems will improve upon paper.  That's why I began a postdoctoral fellowship in Medical Informatics two decades ago.  However, the technology in its present form interferes with care and is an impediment to the collection and accuracy of that data, and the well being of its subjects, e.g.:   <ul><li><a href="http://jamia.bmj.com/content/early/2012/09/06/amiajnl-2012-001145.abstract" target="_blank">Next-generation phenotyping of electronic health records</a>, George Hripcsak,David J Albers, J Am Med Inform Assoc, doi:10.1136/amiajnl-2012-001145 .  The national adoption of electronic health records (EHR) promises to make an unprecedented amount of data available for clinical research, but the data are complex, inaccurate, and frequently missing, and the record reflects complex processes [economic, social, political etc. that bias the data - ed.] aside from the patient's physiological state. </li></ul> As I've written before, a good or even average paper system is better for patients than bad health IT, and the latter prevails over good health IT in 2012. These issues seem chronically to be of little interest to the hyper-enthusiasts as I've written <a href="http://hcrenewal.blogspot.com/2012/02/health-it-ddulites-and-disregard-for.html" target="_blank">here</a> and <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">here</a> (perhaps the author of the Medical Billing blog post could use her wrist and eyes and navigate there and read). <blockquote class="tr_bq">Is it hard? Yes, it’s hard. To quote the movie A League of Their Own, “If it were easy, everyone would do it.”</blockquote> It's even harder to do when apologists make excuses shielding a very dysfunctional industry. <blockquote class="tr_bq">Everyone can’t do it. But I have no doubt that healthcare professionals will do it. Remember that part about bringing people back from the dead? This is a lesser miracle.</blockquote> If qualified healthcare professionals were in charge of the computerization efforts, there would be a smoother path. However, that is sadly not the case.  It will not happen until enough pressure is brought to bear on the IT industry and its apologists, which I believe will most likely only happen though coercion, not debate. Finally, the endless stream of excuses and rhetoric that confuse non-healthcare professionals, such as typical patients who are the subjects of today's premature grand health IT experiment and our decision-makers in Washington, needs to be relentlessly challenged.  The stakes are the well being of anyone needing medical care. -- SS Note:  my formal reply to the Medical Billing blog post above awaits moderation.  I am reproducing it here: <ol class="commentlist"><li class="alt" id="comment-60380"> <div class="commentmetadata"><a class="url" href="http://hcrenewal.blogspot.com/" rel="external nofollow">Scot Silverstein, MD</a> on 12 Oct 2012 at 3:59 pm # </div>Your comment is awaiting moderation. <div class="comment_text"> Dear Ms. McCoy, Will all due deference, your own experience with EHR’s is obviously limited. Your comments demonstrate an apparent lay level of understanding of medicine and healthcare informatics. “Ridiculous?” “Learning curve?” I.e., experimentation on non-consenting human subjects putting them at risk with an unregulated, unvetted medical technology? That is, as kindly as I can put it, a perverse statement. Perhaps I am too harsh. You clearly didn’t check the link to the Healthcare Renewal blog conspicuously placed in the NYT article by Milt Freudenheim. I suggest you should educate yourself on the science and ethics of medicine and healthcare informatics. I am posting the gist of your comments, and my reply, at that blog. I do not think most truly informed patients would agree to being guinea pigs as your comments suggest is simply part of the “leaning curve.” Scot Silverstein, M.D. </div></li></ol>I'll bet the author of the Medical-Billing.com post never heard critique like this coming from today's typical abused-into-submission, <a href="http://hcrenewal.blogspot.com/2007/10/physicians-learned-helplessness.html" target="_blank">learned helplessness-afflicted</a> physicians. A bit harsh?  Lives are at stake. -- SS

A Response to the NY Times Article "Ups and Downs of EMRs" So Full Of The Usual Refrains, I Am Using It To Throw A Spotlight On Those Endlessly-Repeated Memes

My Google search alert turned up a response to the Oct. 8, 2012 NY Times article The Ups and Downs of Electronic Medical Records by Milt Fr...

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Health IT Ten Commandments (1970) v. Health IT Truisms (2012)

In 1970, health IT pioneer Dr. Octo Barnett at Harvard/MGH wrote his "Health IT Ten Commandments" (from Collen's "<a href="http://www.amazon.com/History-Medical-Informatics-United-States/dp/0964774305">A history of Medical Informatics in the United States, 1950-1990</a>"):  <blockquote class="tr_bq">1. Thou shall know what you want to do 2. Thou shall construct modular systems - given chaotic nature of hospitals 3. Thou shall build a computer system that can evolve in a graceful fashion 4. Thou shall build a system that allows easy and rapid programming development and modification 5. Thou shall build a system that has consistently rapid response time and is easy for the non-computernik to use 6. Thou shall have duplicate hardware systems 7. Thou shall build and implement your system in a joint effort with real users in a real situation with real problems 8. Thou shall be concerned with realities of the cost and projected benefit of the computer system 9. Innovation in computer technology is not enough; there must be a commitment to the potentials of radical change in other aspects of healthcare delivery, particularly those having to do with organization and manpower utilization 10. Be optimistic about the future, supportive of good work that is being done, passionate in your commitment, but always guided by a fundamental skepticism.</blockquote> Four decades later, I write the following 2012 "Health IT Truisms" (perhaps more to follow).  Many of the points summarized here can be found in the past 8 years of my writing on this blog: <blockquote class="tr_bq">1.  Health IT in 2012 remains experimental, not proven effective or safe, with actual results conflicting. 2.  Health IT is costly, not money-saving, diverting scarce healthcare resources away from actual healthcare provision to the IT industry. 3.  "EHR" is an anachronistic term (that disarms the uninformed, who "see" an innocuous file system)  for what is now an enterprise medical resource and workflow control system. 4.  The proper framework in which to view "resistance" to health IT is not Luddite clinicians vs. IT modernists.  It's pragmatist clinicians (with ethical and legal obligations and responsibilities), vs. IT hyper-enthusiasts who ignore or are blinded to the ethical considerations and downsides, and whose actions are based not on science, but on faith in technology and self interest. 5.  HIT can be partitioned into good health IT (GHIT) and bad HIT (BHIT) - see definitions at the introduction to  <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases">http://www.ischool.drexel.edu/faculty/ssilverstein/cases</a>. 6.  BHIT prevails due to its being far cheaper to produce than GHIT and due to lack of meaningful industry regulation of quality, usability and safety. 7.  The lack of HIT regulation, post-market surveillance, formal validation and accountability is a special accommodation that is unprecedented in modern medicine. 8.  Underlying HITECH and "Meaningful use" is the assumption that all HIT is good HIT. 9.  A good or even average paper system is better for patients than a bad health IT system. 10.  The incentives and coercive aspects of HITECH would not be needed if GHIT prevailed. 11.  The coercive force of government should have been directed not at users, but at sellers, to produce GHIT and to abolish BHIT. 12.  The term "meaningful use" is political rhetoric whose criteria were decided by committee and industry influence; nobody knows if meeting the criteria will prove truly "meaningful" or not.  (That medical informaticists placidly accepted the term is a disgrace to a field that strives for terminological precision; "good faith use" would have been precise). 13.  Human research protections are given the blind eye with respect to commercial health IT. 14.  Health IT being used safely is currently by happenstance and via compensation for flaws by clinicians who improvise (which itself introduces risk and is stressful), not by design. 15.  Business IT a/k/a MIS personnel have far too narrow an education and experience to make pronouncements about health IT "transforming" medicine. 16.  IT personnel should be part of the medical team, including liability for IT-related failure. 17.  The commercial health IT sector is not an evidence-based domain. 18.  A cybernetic "Libby Zion" catastrophe is unavoidable, and probably the only way to "transform" the health IT industry into an evidence-based industry - essential before that industry can even begin to "transform" (i.e., facilitate improvement of) medicine.</blockquote> Had Dr. Barnett's Ten Commandments not been disobeyed in favor of cybernetic idolatry, the Health IT Truisms in 2012 would appear far different. -- SS

Health IT Ten Commandments (1970) v. Health IT Truisms (2012)

In 1970, health IT pioneer Dr. Octo Barnett at Harvard/MGH wrote his " Health IT Ten Commandments " (from Collen's " A h...

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