CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives?

If this is true, the EHR hyper-enthusiasm problem is even worse than I believed.<br /><br />From the April 2014 newsletter of the American Association for Physicians and Surgeons (<a href="http://www.aapsonline.org/index.php/about_us/">http://www.aapsonline.org/index.php/about_us/</a>), an organization that is dedicated "to preserving the sanctity of the patient-physician relationship and the practice of private medicine":<br /><br /><blockquote class="tr_bq"><b>CMS Claims to Have No Information on EHRs</b><br /><br />On Mar. 14, 2014, the Office of Strategic Operations and Regulatory Affairs of the Centers for Medicare and Medicaid Services replied to a Freedom of Information Act (FOIA) request sent Apr. 4, 2012:  The American Recovery and Reinvestment Act of 2009 (ARRA) created the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs.  While our Office of E-Health Standards and Services works to implement the provisions of the ARRA, <b>we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."</b></blockquote><br />However, that doesn't stop our government from spending billions of taxpayer dollars on them, when, in fact, we <i>do know</i> of harms they cause.  One can reasonably assume their primary interest is in bookkeeping.<br /><br />With FDA, it's even worse.  Rather than stopping at admitting they simply don't know due to admitted impediments to knowing, they simply leap to a conclusion that the technology is of 'sufficiently low risk' not to warrant their regulatory attention, even if such systems meet the statutory requirements to be a medical device and thus fall under the Food, Drug & Cosmetic Act.<br /><br />See my Apr. 9, 2014 post <b>"FDA on health IT risk: We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it"</b> and its ten-point (and non-comprehensive) summary of risks: <a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>.  Another FOIA request is surely needed...<br /><br />More generally, I know from personal development and implementation experience that when "done well",<span style="font-size: small;"> that is, when</span> <b>good health IT </b>and good implementation practices are offered and with patient safety as a priority, health IT can save lives and improve care.  It's just that the commercial for-profit health IT sector does not meet those expectations, due largely to its leadership model from the merchant-computing culture.  Instead, bad health IT is the norm.  From my academic site at <a href="http://cci.drexel.edu/faculty/ssilverstein/cases/">http://cci.drexel.edu/faculty/ssilverstein/cases/</a>:<br /><br /><blockquote class="tr_bq"><span style="font-size: small;"><b>Good Health IT</b> is IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, can be easily, substantively and cost-effectively customized to the needs of medical specialists and subspecialists, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes. <br /><br /><b>Bad Health IT </b>is IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. </span></blockquote><br /> I am seeking source material from the AAPS and will post it.<br /><br />-- SS<br /><br /><b>April 26, 2014 Addendum:</b><br /><br />Below is the letter to AAPS from CMS.  Click to enlarge.<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiSrd8gxZN0QHQd4cLK_aeA3uDI-a9I__6VVZfa32Gz6iCAm8Y-r2APJEzYw_Mav9oJSOWtFXXJYCz3iIELuUPqiJtPt_xtwa1k4hzcXTmEwYOhHSHKmfx6bGUSrXInxG2ax_nK15KLDeDV/s1600/CMS_Letter.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiSrd8gxZN0QHQd4cLK_aeA3uDI-a9I__6VVZfa32Gz6iCAm8Y-r2APJEzYw_Mav9oJSOWtFXXJYCz3iIELuUPqiJtPt_xtwa1k4hzcXTmEwYOhHSHKmfx6bGUSrXInxG2ax_nK15KLDeDV/s1600/CMS_Letter.jpg" width="308" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">CMS:  "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But let's spend hundreds of billions of dollars anyway.]  Click to enlarge.<b><br /></b></td></tr></tbody></table><br /><b><u>An additional thought</u>:</b><br /><br />While CMS may "not have any information that supports or refutes claims that a broader adoption of EHRs can save lives", they <b>do have</b> (or should have made it their business to have) information <b><u>that EHRs cause harm and take lives</u></b> (e.g., via FDA at <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html">http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html</a> , ECRI at <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a> and others).<br /><br />-- SS<br /><br />

CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives?

If this is true, the EHR hyper-enthusiasm problem is even worse than I believed. From the April 2014 newsletter of the American Association ...

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Planned Obsolescence Disguised as Innovation, Oligopoly Disguised as a Free Market, and the Enrichment of Oligarchs

The New York Times published another<a href="http://www.nytimes.com/2014/04/06/health/even-small-medical-advances-can-mean-big-jumps-in-bills.html"> article</a> in its series on the high cost of US health care.  This one, focused on the care of type 1 diabetes mellitus and other chronic diseases, shines some light on the business management practices that now determine how our health care system functions, or not, and implies who benefits the most from them.<br /><br /><b>Planned Obsolescence Disguised as Innovation</b><br /><br />The article first discussed the brave new world of type 1 diabetes treatment.  The introductory theme was:<br /><br /><blockquote class="tr_bq">Today, the routine care costs of many chronic illnesses eclipse that of acute care because <i>new treatments that keep patients well have become a multibillion-dollar business opportunity</i> for device and drug makers and medical providers.</blockquote><br />Much of modern diabetes treatment seems to depend on medical devices and disposable medical supplies:<br /><br /><blockquote class="tr_bq">That captive audience of Type 1 diabetics has spawned lines of high-priced gadgets and disposable accouterments,<i> borrowing business models from technology companies like Apple: Each pump and monitor requires the separate purchase of an array of items that are often brand and model specific</i>.<br /><br />A steady stream of<i> new models and updates often offer dubious improvement</i>: colored pumps; talking, bilingual meters; sensors reporting minute-by-minute sugar readouts. [Diabetes patient] Ms. Hayley’s new pump will cost $7,350 (she will pay $2,500 under the terms of her insurance). But she will also need to pay her part for supplies, including $100 monitor probes that must be replaced every week, disposable tubing that she must change every three days and 10 or so test strips every day.</blockquote><br />Of course, the device and supply manufacturers claim that the high prices reflect the value of the wondrous new innovations:<br /><br /><blockquote class="tr_bq">Companies that produce the treatments say the higher costs reflect medical advances and the need to recoup money spent on research.</blockquote><br />Yet now the Times reporter was able to find physicians who claim the "innovations" are really just the latest version of planned obsolescence:<br /><br /><blockquote class="tr_bq">Diabetes experts say<b><i> a good part of what companies label as innovation amounts to planned obsolescence</i></b>. Just as Apple customers can no longer buy an iPhone 3 even if they were content with it, diabetics are nudged to keep up with the latest model.</blockquote>For example,<br /><br /><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="410" data-total-count="4006" id="story-continues-3" itemprop="articleBody">Those companies spend millions of dollars recruiting patients at health fairs, through physicians’ offices and with aggressive advertising — often urging them to get devices and treatments that are not necessary, doctors say. 'They may be better in some abstract sense, but the clinical relevance is minor,' said Dr. Joel Zonszein, director of the Clinical Diabetes Center at Montefiore Medical Center.</div><div class="story-body-text story-content" data-para-count="410" data-total-count="4006" id="story-continues-3" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="109" data-total-count="4115" itemprop="articleBody">'<i>People don’t need a meter that talks to them</i>,' he added. 'There’s an incredible waste of money.'</div></blockquote><br /><br />Pharmaceutical companies have also discovered this model.<br /><br /><blockquote class="tr_bq">insulin ... has been produced with genetic engineering and protected by patents, so that a medicine that cost a few dollars when Ms. Hayley was a child now often sells for more than $200 a vial, meaning some patients must pay more than $4,000 a year.</blockquote><br />In particular,<br /><br /><blockquote class="tr_bq">Synthetic human insulin is safer for patients, who sometimes developed reactions to animal insulin. But it is <i>made by only three companies: Eli Lilly, Sanofi and Novo Nordisk</i>. Manufactured in microbes, each one’s product has minor dissimilarities that reflect the type of cell in which it was made. Since the companies owned the cell lines, it is nearly impossible for other companies to make exact copies or even similar versions that would be cheaper, even once the patents expire. And the pharmaceutical companies defend the patents ferociously.<br /><br /><div class="story-body-text story-content" data-para-count="270" data-total-count="12681" itemprop="articleBody">What’s more, the three companies continued to refine their product, adding chemical groups that made the insulin absorb somewhat more quickly or evenly, for example. They are called insulin analogues, and their benefits are promoted tirelessly to doctors and patients.</div></blockquote><br /><br />Of course, the pharmaceutical companies also claim that it's all about innnovation,<br /><br /><blockquote class="tr_bq">Dr. Todd Hobbs, chief medical officer of Novo Nordisk, defended the rising prices of insulin, linking them to medical benefits. 'The cost to develop these new insulin products has been enormous, and the cost of the insulin to the consumer in developed countries has risen to enable these and future advancements to occur,' he wrote in an email.</blockquote> Not everyone is convinced,<br /><br /><blockquote class="tr_bq">'The insulins are tweaked for minor benefits that may help a small number of patients with difficult-to-control diabetes, and result in major price increases for all,' [Kings College, London, UK Professor] Dr. Pickup said. Because of analogues, he added, Britain’s National Health Service has had to spend 130 percent more on insulin in the past five years. <br /><br />In the United States, said Dr. Zonszein at Montefiore, the price of Humalog, Lilly’s analogue insulin, was typically two to four times that of its older human insulin line, called Humulin. 'There is not a lot of difference between Humulin and analogues,' he said, but he noted that Humulin was getting 'hard to find.' Sanofi Aventis has stopped selling its older product in the United States, and Mr. Kliff, the financial analyst, said other companies were likely to follow suit, effectively forcing patients to use the costlier versions.</blockquote><br /><br />The arguments about valuable innovation also do not explain why the prognosis of diabetes in the US does not seem to reflect all the money we spend on the disease,<br /><br /><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="306" data-total-count="4993" itemprop="articleBody">Complication rates from diabetes in the United States are generally higher than in other developed countries. That is true even though the United States <a href="http://www.cdc.gov/diabetes/statistics/complications_national.htm">spends more</a> per patient and per capita treating diabetes than elsewhere, said Ping Zhang, an economist at the Centers for Disease Control and Prevention.</div><div class="story-body-text story-content" data-para-count="306" data-total-count="4993" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="280" data-total-count="5273" itemprop="articleBody">The high costs are taking their toll on public coffers, since 62 percent of that treatment money comes from government insurers. The cumulative outlays for treating Type 1 and Type 2 diabetes <a href="http://www.diabetes.org/advocacy/news-events/cost-of-diabetes.html">reached nearly $200 billion</a> in 2012, or about 7 percent of America’s health care bill.</div></blockquote><br />So to summarize, there is considerable evidence that companies that make drugs and devices to manage type 1 diabetes constantly provide "innovations," yet most are minor changes that encourage obsolescence of previous products, but do not provide important increases in benefits or reductions in harm for patients.  <br /><br /><br /><b>Oligopoly Disguised as a Free Market</b><br /><br />Many in the US sing the praises of our supposed free-market health care system.  As noted above however, the insulin market is an oligopoly, dominated by three companies.  The diabetes device market is also dominated by a few companies, and in particular, the insulin pump market is dominated by a single company,<br /><br /><blockquote class="tr_bq"><a href="http://www.medtronic.com/">Medtronic</a> is the dominant insulin pump manufacturer,<i> serving 65 percent of American patients and the majority of those worldwide.</i> <i>Though smaller companies sell cheaper pumps, it is hard to make inroads</i>: Once familiar with the Medtronic system and its extensive support network for troubleshooting problems, patients are reluctant to switch. Doctors are leery of prescribing equipment from a new company that may be out of business in a year; their office computer may not sync with the new software anyway.</blockquote><br />Of course, Medtronic public relations will justify it all again based on innovation,<br /><br /><blockquote class="tr_bq">Medtronic declined to talk about specific prices, but said a core tenet was to make only 'a fair profit.' Amanda Sheldon, a spokeswoman, added: 'We are committed to reinvesting in research and development of new technologies to improve the lives of people with diabetes, and our current pricing structure ensures that we can bring new products to market.' </blockquote><br />The article also discussed the prices of treating chronic diseases other than diabetes.  For example, see how a nominally non-profit hospital priced treatments for chronic diseases,<br /><br /><blockquote class="tr_bq">Dr. Kivi was on high doses of steroids for debilitating joint pain that left him unable to walk at times.<br /><br />But when his last<i> three-hour infusion at NYU Langone Medical Center’s outpatient clinic generated a bill of $133,000</i> — and his insurer paid $99,593 — Dr. Kivi was so outraged that he decided to risk switching to another drug that he could inject by himself at home. </blockquote><br />However,  this pricing appears to have been facilitated by the hospital's increasing market domination generated by its purchase of physician practices, <br /><br /><blockquote class="tr_bq">He had moved his care to NYU Langone to follow his longtime doctor, who had <i>moved her practice from a nearby hospital where the same infusion had been billed at $19,000. The average price that hospitals paid for Dr. Kivi’s dose of Remicade late last year was about $1,200,</i> according to Medicare data.</blockquote><br />So in summary, a few companies now dominate the production of drugs and devices for the management of diabetes, and a few large hospitals may increasingly dominate the treatment of particular chronic diseases.  Such oligopolists are able to increase prices without improving treatment to or outcomes of patients.<br /><br /><b>Enrichment of the Oligarchs</b><br /><br />This example shows how the current US health care system is dominated by huge organizations, mostly for-profit corporations but including some nominally non-profit corporations that act similarly.  They loudly proclaim innovation, but much of that innovation seems to provide few benefits to patients, and actually appears to be planned obsolescence.  The result is high and ever-rising prices. So if patients do not benefit from this, who does?<br /><br />It does not appear to be the health care professionals,<br /><br /><blockquote class="tr_bq">Meanwhile, as the price of supplies rises,<i> endocrinologists remain among the lowest-paid specialists in American medicine,</i> meaning severe physician shortages in many areas and long waits to see a doctor.</blockquote><br />We  have seen other examples of how leaders of the big health care organizations have become as<a href="http://hcrenewal.blogspot.com/search/label/executive%20compensation"> rich as royalty</a>.  Therefore, let us consider the pay of the leaders of the organizations mentioned above.  I will focus on the two US based corporations, Eli Lilly and Medtronic, and the New York hospital, NYU Langone Medical Center.<br /><br /><u>Eli Lilly</u><br /><br />According to the company's <a href="http://investor.lilly.com/secfiling.cfm?filingID=59478-14-90&CIK=59478">2014 proxy statement</a>, the 2013 total compensation of its five highest paid hired executives was<br /><br />- John C Lechleiter PhD, CEO                                     <b><i> $11,217,000</i></b><br /><br />- Derica W Rice, CFO                                                   <b><i>$5,176,822</i></b><br /><br />- Jan M Lundberg, PhD, EVP, Science and Technology   <b><i>$4,774,535</i></b><br /><br />- Michael J Harrington, General Counsel                         <b><i> $3,174,222</i></b><br /><br />- Erico A Conterno, President Lilly Diabetes                    <b><i>$3,009,041</i></b><br /><br />Note that all of these executives save Mr Harrington have also amassed more than 100,000 shares of company stock, and Dr Lechleiter has amassed more than 1,000,000.<br /><br />It should be no surprise, given our recent discussion (e.g., <a href="http://hcrenewal.blogspot.com/2014/04/finally-article-in-large-circulation.html">here</a>) of the currently symbiotic relationship among top health care corporations and academic medicine, that several of the members of the Lilly board of directors that has exercised stewardship over the company, and is thus responsible for these gargantuan compensation packages and the business practices discussed above are top academic leaders.  These include,<br /><br />- Alfred G Gilman, MD, PhD, Regental Professor Emeritus, recent (until 2009) executive vice presdient, provost, and dean of medicine, University of Texas Southwestern  <br /><br />- William G Kaelin Jr, MD, Professor of Medicine, Associate Director of Basic Science, Dana-Farber Cancer Center, Harvard University<br /><br />- Marschall S Runge MD, Executive Dean and Chair of the Department of Medicine, University of North Carolina Medical School<br /><br />- Katherine Baicker PhD, Professor of Health Economics, Harvard University School of Public Health  (I must note that Prof Baicker is also - amazingly - on the Medicare Payment Advisory Committee, MEDPAC).<br /><br />- Ellen R Marram, Trustee, New York-Presbyterian Hospital<br /><br />- Ralph Alvarez, President's Council, University of Miami<br /><br />- R David Hooper, Trustee, Children's Hospital of Colorado<br /><br />- Franklyn G Pendergast MD PhD, Professor, Mayo Medical School<br /><br />All but the newest directors were paid at least $250,000 a year by the company (and thus by the executives the directors are supposed to supervise), and all but the newest directors had accumulated tens of thousands of shares of stock or the equivalent as pay for their services.<br /><br /><br /><u>Medtronic</u><br /><br />Similarly, according to the company's<a href="http://phx.corporate-ir.net/phoenix.zhtml?c=76126&p=irol-SECText&TEXT=aHR0cDovL2FwaS50ZW5rd2l6YXJkLmNvbS9maWxpbmcueG1sP2lwYWdlPTkwMjY0MzAmRFNFUT0wJlNFUT0wJlNRREVTQz1TRUNUSU9OX0VOVElSRSZzdWJzaWQ9NTc%3d"> 2013 proxy</a> (the latest now available), CEO Omar Ishrak made <b><i>$8,975,866</i></b> in 2013, and the next four highest paid executives all made over $2,500,000 each.   Mr Ishrak owned or could acquire the equivalent of more than 500,000 shares of stock, and the other top paid executives owned of could acquire from over 100,000 to over 1,000,000 shares of stock.<br /><br />Again, the executives were nominally supervised by a board of directors that included an academic and non-profit leader, Dr Victor J Dzau, MD former chancellor for health affairs at Duke University, and president-elect of the Institute of Medicine (note that we discussed Dr Dzau's conflicts of interest most recently <a href="http://hcrenewal.blogspot.com/2014/02/incoming-president-of-iom-outed-as.html">here</a>).  It also included a former government leader, Michael O Leavitt, former US Secretary of Health and Human Services; and a hospital leader, Preetha Reddy, Managing Director of Apollo Hospitals Enterprise Limited (India).  <br /><br /><u>NYU Langone Medical Center</u><br /><br />The Medical Center's<a href="http://www.guidestar.org/FinDocuments/2012/133/971/2012-133971298-09798bbc-9.pdf"> 2011 US form 990</a> is old, but the latest available, and is remarkably obscure, omitting, for example, mentioning the titles of any of the people listed as highest paid officers and employees.  The current CEO, was listed as receiving total compensation of just over $2.000,000.  Four individuals then received over $1,000,000.  The 990 form also mentioned that the Medical Center provided some individuals with first class travel, tax gross-up payments, housing allowances, and reimbursement for personal services.  Neither the 990, nor the center's <a href="http://www.med.nyu.edu/about-us/who-we-are/medical-center-leadership/trustees">web-site</a> makes all the possible conflicts of interest of its trustees obvious.    <br /><br />So in summary, the large organizations, for-profit and non-profit, that are able to greatly increase their prices through planned obsolescence disguised as innovation, and oligopoly disguised as free markets, are able to make their top executives very rich, and also enrich those who are supposed to exercise stewardship over them.  <br /><br /><br /><b>Summary</b><br /><br />An extensive journalistic investigation revealed how certain aspects of chronic care in the US health care system are dominated by a few large organizations.  These organizations are able to charge very high prices, mainly through market domination, and with the aid of marketing and public relations that tout planned obsolescence as valuable innovation.  The leaders of these organizations have become wealthy, often fabulously so.  This state of affairs has not been challenged by those who are supposed to provide stewardship, including many prominent academics. <br /><br />The US health care system is the most expensive, on a per capita basis, in the world, and far more expensive than that in any other developed country.  Yet there is no evidence that its results are superior to those of other countries.  What evidence there is suggests in fact that our results are mediocre at best.<br /><br />The current example suggests how the US system differs from those of other countries.  It has an ostensible free market focus.  Yet the system appears more to be an oligopoly, with most of its market components dominated by a few large organizations, run as an oligarchy, by a small, overlapping in-group of managers, executives and their cronies, with elements of corporatism, that is with the cooperation of, rather than regulation by government entities and leaders <br /><br />A real free market health care system would include a level playing field.  This could only be achieved by the government acting as a fair umpire, not a crony.  Anti-competitive practices would have to end.  Oligopolies would have to be broken.  Deceptive marketing and public relations would have to be exposed.  Leaders would have to be made accountable, especially for putting patients' and the public's health ahead of their own enrichment.  All this would be horribly difficult, as the oligarchs have amassed much money and control, and would oppose, possibly violently, any effort to challenge them.  If we do not challenge them in the US, however, not only will our health care continue to become ever more expensive, less accessible, and less beneficial to patients, but we will all cease to be citizens of one of the first real democracies, and end up serfs instead. 

Planned Obsolescence Disguised as Innovation, Oligopoly Disguised as a Free Market, and the Enrichment of Oligarchs

The New York Times published another article in its series on the high cost of US health care.  This one, focused on the care of type 1 di...

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Healthcare IT Amateur Kathleen Sebelius Resigns - Good Riddance

The Secretary of the U.S. Department of Health and Human Services (HHS) is resigning.<br /><br />Press reports say she is resigning in large part due to the Exchange Website debacle.<b>   </b>This from the New York Times:<b><br /></b><br /><blockquote class="tr_bq"><b>Health Secretary Resigns After Woes of HealthCare.gov</b><br /><a href="http://www.nytimes.com/2014/04/11/us/politics/sebelius-resigning-as-health-secretary.html?_r=0" target="_blank">http://www.nytimes.com/2014/<wbr></wbr>04/11/us/politics/sebelius-<wbr></wbr>resigning-as-health-secretary.<wbr></wbr>html?_r=0</a><br /><br />... Officials said Ms. Sebelius, 65, made the decision to resign and was not forced out <span style="color: red;"><b><i>[Yeah, right - SS]</i></b></span>. But the frustration at the White House over her performance had become increasingly clear, as administration aides worried that the crippling problems at HealthCare.gov, the website set up to enroll Americans in insurance exchanges, <b>would result in lasting damage to the president’s legacy.</b></blockquote><br />It's not as if there's no literature out there on how to create good health IT.  Doing so is not a state secret.  Simple (and free, unlike the hundreds of millions spent on incompetent <a href="http://en.wikipedia.org/wiki/Beltway_bandits">beltway-bandit</a> 'consultants') Google searches on the term <a href="https://www.google.com/search?q=%22healthcare+IT+failure%22">"healthcare IT failure"</a> or similar return ample resources that could have prevented the "lasting damage to the president's legacy."<br /><br />Way to go, Ms. Ex-Secretary.  Another health IT amateur bites the dust, as my early computer mentor, Philadelphia's George Washington High School math instructor Fred Holzwarth (<a href="http://www.historicbuckscounty.org/nths/HISTORIA/PDF/Historia_Nov2005.pdf">http://www.historicbuckscounty.org/nths/HISTORIA/PDF/Historia_Nov2005.pdf</a>) would have said.<br /><br />However, even worse ... far worse ...<br /><br />Under this Secretary of the Department of Health and Human Services, the principal watchdog agency over medicine and medical device safety under her aegis, the FDA, found that:<br /><br /><blockquote class="tr_bq">... products with health management heath IT functions, <b>includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software.</b><br /><br />Products with health management health IT functions are of<b> sufficiently low risk</b> and thus, if they <b>meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them.</b> </blockquote><br /><div style="margin-bottom: 0in;">Thus, patients are condemned to injury and death, probably at ECRI Deep Dive study levels [1], for the foreseeable future (see my post on that FDA decision at my April 9, 2014 post <a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html"> <style type="text/css">P { margin-bottom: 0.08in; }</style></a><b>"FDA on health IT risk: reckless, or another GM-like political coverup?"</b> at <a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>).</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">This is especially outrageous at the time massive investigations are ongoing about the 13 deaths caused by apparent coverups of a faulty General Motors <i>ignition switch.</i></div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">It was your FDA agency, Ms. Ex-Secretary.  You own that decision.</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">Good Riddance, indeed.  </div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">The person at this link: <a href="http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html">http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html</a> would certainly agree, if she were alive; she is not thanks to the very devices your FDA just perversely found to be of "sufficiently low risk."</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">-- SS</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;">Note:</div><div style="margin-bottom: 0in;"><br /></div><div style="margin-bottom: 0in;"><span style="font-size: x-small;">[1]  In 9 weeks in 36 PSO-member hospitals, 171 IT mishaps sufficient to cause harm were voluntarily reported; 8 injuries occurred, some severe, and 3 deaths may have been the result.  See <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>.</span></div>

Healthcare IT Amateur Kathleen Sebelius Resigns - Good Riddance

The Secretary of the U.S. Department of Health and Human Services (HHS) is resigning. Press reports say she is resigning in large part due t...

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FDA on health IT risk: reckless, or another GM-like political coverup? "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it."

In my Sept. 16, 2013 post <b>"An Open Letter to David Bates, MD, Chair, ONC FDASIA Health IT Policy Committee on Recommendations Against Premarket Testing and Validation of Health IT" </b>(<a href="http://hcrenewal.blogspot.com/2013/09/an-open-letter-to-david-bates-md-chair.html">http://hcrenewal.blogspot.com/2013/09/an-open-letter-to-david-bates-md-chair.html</a>) I wrote: <br /><br /><blockquote class="tr_bq">David Bates, Chair, ONC FDASIA Health IT Policy Committee<br />via email<br />    <br />Dear David, I am disappointed (and in fact appalled) at the ONC FDASIA Health IT Policy Committee's recommendations that health IT including typical commercial EHR/CPOE systems not be subjected to a premarket testing and validation process.  I believe this recommendation is, quite frankly, negligent. </blockquote><br />The resultant April 2014 report is out: "<b>FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework</b>."  It is available at <a href="http://www.healthit.gov/sites/default/files/fdasiahealthitreport_final.pdf">http://www.healthit.gov/sites/default/files/fdasiahealthitreport_final.pdf</a>.<br /><br />The report is an academic idealist's and industry's dream.  It is a patient's nightmare.<br /><br />Instead of regulation, the report recommends the creation of a nebulous <b>"Health IT Safety Center"</b> (pgs. 16 and 25) as a "public-private entity with broad stakeholder engagement, that includes a governance structure for the creation of a sustainable, integrated health IT learning system that avoids regulatory duplication and leverages and complements existing and ongoing efforts.<b><i>"  </i>In other words, a toothless organization without true regulatory authority.</b> <br /><br />The recommendations of the Health IT Policy Committee have apparently been taken seriously by FDA.  <br /><br />This FDA announcement recently appeared (FDA is part of HHS):<br /><br /><blockquote class="tr_bq"><a href="http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm390988.htm">http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm390988.htm</a><br /><br /><b><b>HHS News Release</b></b><br /><b><b>For Immediate Release:</b> April 3, 2014</b><br /><br /><b>Proposed health IT strategy aims to promote innovation, protect patients, and avoid regulatory duplication</b><br /><br /><b>HHS today released a draft report that includes a proposed strategy and recommendations for a health information technology (health IT) framework</b>, which promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally mandated report was developed in consultation with health IT experts and consumer representatives and proposes to clarify oversight of health IT products based on a product’s function and the potential risk to patients who use it.<br /><br />... As proposed in the draft report, posted on the ONC, FDA and FCC websites, there would be three health IT categories, based on function and level of risk, that focus on what the product does, not on the platform on which it operates (mobile medical device, PC, or cloud-based, for example).<br /><br />The first category, products with administrative health IT functions, poses little or no risk to patient safety and as such requires no additional oversight. They include software for billing and claims processing, scheduling, and practice and inventory management.<br /><br />The second category, products with health management heath IT functions, <b>includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software.</b><br /><br />Products with health management health IT functions are of<b> sufficiently low risk</b> and thus, if they <b>meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them.</b> Instead, the draft report proposes relying primarily on ONC-coordinated activities and private sector capabilities that highlight quality management principles, industry standards and best practices.</blockquote><br />The characterization of these admitted medical devices as <b>"sufficiently low risk"</b> is in my opinion grossly negligent (if not criminal).<br /><br />For instance, GM concealed an ignition flaw that resulted in 13 deaths.<b><i>  Look what's happening now in that sector.  Revelations of corporate wrongdoing and Congressional investigations:</i></b><br /><br /><blockquote class="tr_bq"><a href="http://www.nytimes.com/2014/03/31/business/us-regulators-declined-full-inquiry-into-gm-ignition-flaws-memo-shows.html">http://www.nytimes.com/2014/03/31/business/us-regulators-declined-full-inquiry-into-gm-ignition-flaws-memo-shows.html</a><br /><br />U.S. Agency Knew About G.M. Flaw but Did Not Act<br />By MATTHEW L. WALD<br />MARCH 30, 2014<br /><br />Federal regulators decided not to open an inquiry on the ignitions of Chevrolet Cobalts and other cars even after their own investigators reported in 2007 that they knew of four fatal crashes, 29 complaints and 14 other reports that showed the problem disabled air bags, according to a memo released by a House subcommittee on Sunday.<br /><br />Then in 2010, the safety agency came to the same decision after receiving more reports that air bags were not deploying.<br /><br />The memo also revealed that General Motors approved the faulty design of the switch in 2002 even though the company that made the part, Delphi, warned the automaker that the switch did not meet specifications. This followed a warning the year before — when the Saturn Ion was being developed — but G.M. said that “a design change had solved the problem,” according to the memo.<br />Continue reading the main story<br />Related Coverage<br /><br />The striking new details in the memo bolster the contention that both G.M. and the National Highway Traffic Safety Administration, more than previously acknowledged, <b>ignored or dismissed warnings for more than a decade about a faulty ignition switch that, if bumped, could turn off, shutting the engine and disabling the air bags. General Motors has recalled nearly 2.6 million cars and has linked 13 deaths to the defec</b>t.<b><i> </i></b></blockquote><br />13 deaths, and we get this: <br /><br /><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="362" data-total-count="2158" itemprop="articleBody">A House subcommittee, which gathered more than 200,000 pages of documents from G.M. and 6,000 pages from the agency, will hold a hearing on Tuesday. Mary T. Barra, <b>General Motors’ chief executive, and David Friedman, the acting administrator of the safety agency, are scheduled to testify. Both are also scheduled to testify before a Senate panel on Wednesday.</b></div><div class="story-body-text story-content" data-para-count="362" data-total-count="2158" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="241" data-total-count="2399" itemprop="articleBody"><b>“The problems persisted over a decade, the red flags were many, and yet those responsible failed to connect the dots</b>,” Fred Upton, a Republican of Michigan and the chairman of the House Energy and Commerce Committee, said in a statement.</div><div class="story-body-text story-content" data-para-count="241" data-total-count="2399" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="104" data-total-count="2503" itemprop="articleBody">The most damaging finding in the memo concerned the <b>four fatal crashes that went unheeded by regulators.</b></div><div class="story-body-text story-content" data-para-count="104" data-total-count="2503" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="224" data-total-count="2727" id="story-continues-5" itemprop="articleBody">In a presentation dated Nov. 17, 2007, the safety agency’s investigators reported to its Office of Defects Investigation on the fatal crashes, as well as broad range of complaints and other reports about cars shutting off.</div><div class="story-body-text story-content" data-para-count="224" data-total-count="2727" id="story-continues-5" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="355" data-total-count="3082" itemprop="articleBody">“The panel did not identify any discernible trend and decided not to pursue a more formal investigation,” the House memo said. The findings <a href="http://www.nytimes.com/2014/03/09/business/auto-regulators-dismissed-defect-tied-to-13-deaths.html" title="The report. ">reinforce an analysis</a> by<b> The New York Times published March 8 that found the agency had received more than 260 complaints about Cobalts, Ions and other cars in the recall, citing potentially dangerous shutdowns<i>.</i></b></div></blockquote><br />While GM is being grilled and raked over the coals, the health IT industry is likely going to get the healthcare industry's most generous and unprecedented special regulatory accommodation<b> </b>by FDA<b> due to its products being deemed of "sufficiently low risk"</b> (?) not to merit attention.<br /><br />--------------------------------------------<br /><div><br /></div><b>The FDA statement is particularly reckless, perhaps criminally so, given the following ten points.</b><br /><br />I add that the following are just highlights off the top of my head, and non-inclusive of all known facts on health IT risk:<br /><br />(1)  FDA's own 2010 "Internal Memo on HIT Risk", "not intended for public use" but exposed by Center for Public Integrity investigative reporter Fred Schulte (<a href="http://www.publicintegrity.org/authors/fred-schulte">http://www.publicintegrity.org/authors/fred-schulte</a>) when he was with the Huffington Post Investigative Fund (as described at <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2010/08/smoking-gun-internal-<wbr></wbr>fda-memorandum-<span style="font-family: inherit;">of.html</span></a><span style="font-family: inherit;">), stated:</span><br /><span style="font-family: inherit;">  </span><br /><span style="font-family: inherit;"> </span><br /><div style="margin-left: 40px;"><span style="font-family: inherit;"><span style="font-size: 100%;">...In summary, the <b>results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology</b>. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. <b>The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs [device reports] and impedes a more comprehensive understanding of the actual problems and implications. </b></span></span> </div><div dir="ltr"><span style="font-family: Arial; font-size: 100%;"></span></div><br />They then go on to categorize the known risk factors and the impediments to knowing about their occurrence:<span style="font-size: x-small;"><span style="font-family: inherit;"><b> </b></span></span><br /><br /><blockquote class="tr_bq"><span style="font-size: x-small;"><span style="font-family: inherit;"><b>Limitations of the MAUDE search and final subset of MDRs include the following:</b> </span></span><br /><br /><span style="font-size: x-small;"><span style="font-family: inherit;">1. Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including</span></span><br /><span style="font-size: x-small;"><span style="font-family: inherit;">...(a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues;</span></span><br /><span style="font-size: x-small;"><span style="font-family: inherit;">...(b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue;</span></span><br /><span style="font-size: x-small;"><span style="font-family: inherit;">...(c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports.<br />2. Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events.<br />3. Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device.<br />4 Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports.<br />5 The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting.</span></span></blockquote><br />In other words, FDA does not know the level of risk due to systematic impediments to information diffusion.<br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiRf0xG1UixoduxWOjXHN0BAMipTO7-63_YQZ4NKtaFyhMvkpdfo7MwpGBU8O0c6XKxBEM4owWvWl0RBV1amw0nVtJlMCMEwEy-o2fovaDZWLYJRc2uY6hS34Kl-lWLwwl9m-iZySg9o4b5/s1600/memo.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="320" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiRf0xG1UixoduxWOjXHN0BAMipTO7-63_YQZ4NKtaFyhMvkpdfo7MwpGBU8O0c6XKxBEM4owWvWl0RBV1amw0nVtJlMCMEwEy-o2fovaDZWLYJRc2uY6hS34Kl-lWLwwl9m-iZySg9o4b5/s1600/memo.jpg" width="243" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"><span style="font-size: x-small;">Internal FDA Memo ("not intended for public use") on potential dangers of health IT.  <b>Download the full PDF by clicking <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Internal-FDA-Report-on-Adverse-Events-Involving-Health-Information-IT.pdf">here</a></b>.</span></td></tr></tbody></table><br />I think it axiomatic to state that it is, at best, seriously misleading to now state a technology is of "low risk" while internally having admitted that the risk level is not known due to impediments to that knowledge.  That situation has not changed since this memo's internal FDA dissemination, and its disclosure by Schulte.<br /><br /><i><b>This is inexplicable on its face on scientific grounds.</b></i><br /><br />Further, another HHS agency, the Agency for Healthcare Research and Quality (AHRQ, <a href="http://www.ahrq.gov/">http://www.ahrq.gov/</a>) has also taxonomized in detail a rich tapestry of "how health IT can cause harm."  See "<b>AHRQ Health IT Hazards Manager Report</b>" at <a href="http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf">http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf</a> and its contained list of harms on pg. 29, reproduced below.<br /><br />AHRQ has no regulatory authority.  These failure modes are expensive to deal with, thus many will likely only be dealt with by the industry (if at all) <i>after</i> patient harms or near-misses.  Patients, however, are not experimental subjects for the debugging and "improvement" of experimental IT systems. <br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjGfJvUqIoCXmUuiiiqJvolkT3Ncg9DoM4VResY7HhOBmbfdZj29hKbwxLRTUbMi7gbaSCfQNdqcKqI6SKWi0JKIyOrHFgBfL3D0-rzEHwfVx6Lm37KilOi8LjiEUBdIzyH9oH47wXprM7H/s1600/ahrq.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="257" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjGfJvUqIoCXmUuiiiqJvolkT3Ncg9DoM4VResY7HhOBmbfdZj29hKbwxLRTUbMi7gbaSCfQNdqcKqI6SKWi0JKIyOrHFgBfL3D0-rzEHwfVx6Lm37KilOi8LjiEUBdIzyH9oH47wXprM7H/s1600/ahrq.jpg" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">AHRQ Health IT Hazard Manager Report - Hazard Modes of Health IT <b>(click to enlarge)</b></td></tr></tbody></table><br />Surely FDASIA is aware of this.<br /><br /><br /><div>(2)  FDA CDRH Director Jeff Shuren MD, JD's own statement that the known risks are "the tip of an iceberg" <span style="font-size: 100%;">at the<span style="font-weight: bold;"> HIT Policy Committee</span>, <span style="font-weight: bold;">Adoption/Certification Workgroup</span> on February 25, 2010, where the topic was "HIT safety" (The text is available <a href="http://web.archive.org/web/20120320111030/http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_11673_910717_0_0_18/3Shuren_Testimony022510.pdf" target="_blank">at this link</a>):</span><br /><br /><div style="margin-left: 40px;">...... In the past two years, we [FDA] have received <span style="font-weight: bold;">260 reports</span> of HIT-related malfunctions with the potential for patient harm – including <span style="font-weight: bold;">44 reported injuries and 6 reported deaths</span>. Because these reports are purely voluntary, they may represent only the<span style="font-weight: bold;"> tip of the iceberg</span> in terms of the HIT-related problems that exist<span style="font-style: italic;"><span style="font-weight: bold;">.</span></span></div></div><div></div><div></div><div></div><div></div><div></div><div><br />Considering the admitted impediments to information diffusion, it's likely even at this point that FDA knew the number of injuries and deaths was far larger than GM's mere 13 ignition defect-related deaths. </div><div><br /></div><div><div>(3)   FDA's <b>MAUDE (Manufacturer and User Facility Device Experience) databas</b>e is a voluntary medical device defects reporting system, but is not specifically purposed for health IT and is almost unknown to typical health IT users as a resource for reporting flaws.  <br /><br />MAUDE reports show health IT devices are <b>literally festooned with an incredible number of flaws</b>, as if they come from dirt-floor-covered software sweatshops with little oversight.<br /><br />These are defects that have made it into live hospital and caregiver devices, and have led to reported harms and death (see <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2011/01/maude-and-hit-risk-<wbr></wbr>mother-mary-what-in.html</a>).<br /><br />The voluntary nature of this MAUDE reporting by just a few HIT sellers, and lack of knowledge of it by health IT users as a resource, cannot fail to lead to the conclusion that the problems are far worse than this limited dataset indicates.<br /><br />(4)  The prestigious U.S. Institute of Medicine of the National Academies (<a href="http://www.iom.edu/">http://www.iom.edu/</a>), perhaps the top scientific authority in this country, also admitted the<b> risk levels of health IT were unknown due to systematic impediments to knowing.</b>  IOM noted this in their <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">late 2011 study on EHR safety</a>:</div></div><div><br /><blockquote>... While some studies suggest improvements in patient safety can be made, others have found no effect. Instances of health IT–associated harm have been reported. However, <b><u>little published evidence could be found </u></b><span style="font-weight: bold;"><u>quantifying the magnitude of the risk</u>. </span><br /><br />Several reasons health IT–related safety data are lacking include the <span style="font-weight: bold;">absence of measures and a central repository</span> (or<span style="font-weight: bold;"> linkages</span> among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is <span style="font-weight: bold;">contractual barriers (e.g., nondisclosure, confidentiality clauses)</span> that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “<span style="font-weight: bold;">hold harmless clauses</span>”). The committee believes these types of contractual restrictions <span style="font-weight: bold;">limit transparency, <u>which significantly contributes to the gaps in knowledge of health IT–related patient safety risks</u>. </span></blockquote><br />The IOM did note, contrary to FDA's current finding that these systems are of "<b>sufficiently low risk</b>", that: <br /><br /><blockquote><span style="font-weight: bold;">These barriers to generating evidence pose unacceptable risks to safety.</span><span style="font-style: italic;">[IOM (Institute of Medicine). 2012. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/Patient%20Safety%20and%20Health%20IT%20prepub.pdf">Health IT and Patient Safety: Building Safer Systems for Better Care</a> (PDF). Washington, DC: The National Academies Press, pg. S-2.]</span><span style="font-weight: bold;"><br /></span></blockquote><br />Also in the IOM report:<br /><br /><blockquote class="tr_bq">… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the<span style="font-weight: bold;"> ability to generalize the results across the health care system may be limited</span>. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect.<br /><br /><b>More worrisome, some case reports suggest that poorly designed health IT can create new hazards</b> in the already complex delivery of care. <u><b>Although the magnitude of the risk associated with health IT is not known</b></u>, some examples illustrate the concerns. Dosing errors, failure to detect life-threatening illnesses, and delaying treatment due to poor human–computer interactions or loss of data have led to serious injury and death.”</blockquote></div><div></div><div><br />IOM could not have stated the reality more explicitly than via their statement "<u><b>the magnitude of the risk associated with health IT is not known."</b></u> </div><div><br />(5)   Surely FDA (and the FDASIA committees responsible for the new Report) are aware of  the ECRI Institute's Deep Dive study results from a study they carried out within their PSO-member hospitals (<a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2013/02/peering-underneath-<wbr></wbr>icebergs-water-level.html</a>).  I would call 171 voluntarily-reported health IT-related mishaps in 36 hospitals over 9 weeks, with 8 injuries and 3 possible deaths, an alarming study.<br /><br />In fact, in 2014 based on their PSO data, the ECRI Institute identified health IT as #1 of the "Top Ten Technology Risks in Healthcare" (<a href="http://hcrenewal.blogspot.com/2014/04/in-ecri-institutes-new-2014-top-10.html">http://hcrenewal.blogspot.com/2014/04/in-ecri-institutes-new-2014-top-10.html</a>):<br /><br /><blockquote class="tr_bq"><span style="font-family: inherit;"><span style="font-size: small;">CONCERN #1: <b>Data integrity failures with health information technology systems</b></span></span><span style="font-family: inherit;"><span style="font-size: small;"> </span></span><br /><br /><span style="font-family: inherit;"><span style="font-size: small;">With the federal government offering financial incentives for hospitals and physician practices to adopt EHR systems, use of these systems more than tripled from 2009 through 2012. “Health IT systems are very complex,” says James P. Keller, M.S., vice president, technology evaluation and safety, ECRI Institute. <b>“They are managing a lot of</b><b> information, and it’s easy to get something wrong” if the systems are not designed and </b><b>implemented well.</b> While appropriately designed and implemented systems can provide complete, current, and accurate patient care information so that the clinician can make appropriate treatment decisions,<b> the presence of incorrect data can lead to incorrect</b> treatment, potentially leading to patient harm.</span></span></blockquote><span style="font-family: inherit;"><span style="font-size: x-small;"></span></span></div><div></div><div><br />I certainly would NOT aver that this technology's risk level is of "<b>sufficiently low risk</b>" to not warrant formal regulation by a body skilled in software regulation, as is FDA., e.g., for medical devices and for IT used in pharmaceutical clinical trials data management and drug manufacturing.<br /><br />See for example <b>"General Principles of Software Validation; Final Guidance for Industry and FDA Staff" </b>at <a href="http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm">http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm</a>.<br /><br />(I would <i><b>really</b></i> not enjoy being in a position to have to make such an averment about "<b>sufficiently low risk</b>" under GM ignition investigation-like conditions... )</div><div><br /></div>(6)  Surely FDA (and the FDASIA committees responsible for the new Report) are aware of the data reported by the medical malpractice insurer CRICO, that insures the Harvard medical community (see <a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2014/02/patient-safety-<wbr></wbr>quality-healthcare.html</a>):<br /><br /><blockquote class="tr_bq">... CRICO recently analyzed a year’s worth of medical malpractice claims in its comparative database [from numerous sources] and found <b>147 cases in which EHRs were a contributing factor</b>. Computer systems that don’t “talk” to each other, test results that aren’t routed properly, and mistakes caused by faulty data entry or copying and pasting <b>were among the EHR-related problems found in the claims, which represented $61 million in direct payments and legal expenses.</b>  ... <b>Half of the 147 cases resulted in severe injury.</b> <span style="color: red;"><b><i> [Death numbers are unstated - ed.] </i></b></span></blockquote><br />Note that these numbers were an examination of lawsuits filed; most medical malpractice never gets to the point of an actual filed lawsuit due to the unfavorable economics of the medical malpractice industry.  Perhaps 5% of actual events ever get filed, thus CRICO's data is also a "tip of an iceberg."<br /><br />(7)  Surely FDA (and the FDASIA committees responsible for the new Report) are aware of mass risk introduced by faulty systems such as in the incident in Rhode Island, at Lifespan Healthcare (<a href="http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html">http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html</a>), where thousands of prescriptions were altered by faulty HIT without physician knowledge.  Suffixes for the long acting version of a drug (e.g., "XL" or "XR") were dropped:<br /><br /><blockquote class="tr_bq">PROVIDENCE, R.I. (WPRI) - Rhode Island State Senator Jamie Doyle says he is <span style="font-weight: bold;">shocked to hear a <a href="http://www.lifespan.org/">Lifespan</a> computer glitch caused thousands of patients to receive the wrong types of medication. </span><span style="font-weight: bold;"><span style="color: red;">[Appx. 2,000 across five Lifespan hospitals according to the Providence Journal, see below, and </span></span><span style="font-weight: bold;"><span style="color: red;">the</span> <a href="http://www.washingtonpost.com/business/ri-senator-wants-investigation-after-up-to-2000-hospital-patients-got-wrong-form-of-medicine/2011/11/03/gIQAufcviM_story.html">WaPo</a></span><span style="font-weight: bold;"><span style="color: red;"> - ed.]</span></span><br /><br />Doyle is now calling for an independent review of all the hospitals Lifespan runs, and a review of the Rhode Island Department of Health.<br /><br />The DOH is investigating after learning patients who were supposed to receive medications taken once a day <b>instead received medications meant to be taken more than once per day.  <span style="color: red;">[In other words, they were taking short acting drugs on a long-acting once a day schedule, thus being massively under-dosed - ed.]</span></b></blockquote><br />(8)  The FDA (and the FDASIA committees responsible for the new Report) surely cannot be unaware of all of the "glitches" reported on in-situ health IT systems, as cataloged at this blog under the tag "glitch" and as of this writing numbering 25 posts, some including patient deaths.  See the results of the query link: <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a>.<br /><br />(9) Surely FDA (and the FDASIA committees responsible for the new Report) cannot be unaware that FDA itself had to recall health IT with flaws "serious enough to cause patient death":<br /><br /><blockquote class="tr_bq"><b>FDA recall.  McKesson Anesthesia Care – Patient Case Data May Not Match Patient Data</b>:  <b>Use of this affected product may cause serious adverse health consequences, including death. </b><br /><a href="http://hcrenewal.blogspot.com/2014/03/ehr-recall-use-of-this-affected-product.html">http://hcrenewal.blogspot.com/2014/03/ehr-recall-use-of-this-affected-product.html</a><br /><br /><b>FDA Recalls Draeger Health IT Device Because "This Product May Cause Serious Adverse Health Consequences, Including Death"</b> <br /><a href="http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html">http://hcrenewal.blogspot.com/2011/12/fda-recalls-health-it-software-because.html</a><br /><br /><b>FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems </b><br /><a href="http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html">http://hcrenewal.blogspot.com/2012/07/health-it-fda-recall-philips-xcelera.html</a><br /><br /><b>FDA recall:  An ED EHR "Glitch" That Mangles Prescriptions </b><br /><a href="http://hcrenewal.blogspot.com/2013/08/a-good-way-to-cynernetically-harm-or.html" target="_blank">http://hcrenewal.blogspot.com/<wbr></wbr>2013/08/a-good-way-to-<wbr></wbr>cynernetically-harm-or.html</a> </blockquote><br />(10)  FDA (and the FDASIA committees responsible for the new Report) are surely not unaware of my own report to its MAUDE database (because the hospital denied my request to issue the report itself) of a fundamental defect in a widely used health IT system, Eclipsys Sunrise, that nearly caused the death of my mother... AFTER she was seriously injured due to a flaw in an ED's EHR that did lead a year later to her death:<br /><br /><blockquote class="tr_bq"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=172955">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=172955</a>2 <br /><br />ECLIPSYS SUNRISE CLINICAL MANAGER       <br />Event Date 06/12/2010<br />Event Type  Injury   Patient Outcome  Hospitalization,Other,Life Threatening,Required Intervention<br />Event Description<br /><br />The eclipsys sunrise clinical manager emr/cpoe is in use at (b) (6) hospital. This system appears to have a serious deficiency: <b>an apparent lack of date constraint validity checking when users are seeking information on prior medication orders and administration. </b>(b) (6), (b) (6) was admitted (b) (6) 2010, for cerebrovascular problems. Famotidine iv was started prophylactically to prevent gastric problems, but was discontinued and changed to protonix a few days later due to suspicion of causing severe agitation and confusion, causing her to pull her lines. Around (b) (6) 2010, patient was transferred to physical therapy floor in the hospital. Hospital considers such a transfer to be a "discharge" and "readmission. " however, patient did poorly, had to be sent back to med-surg floor several days later. Due to having pulled a percutaneous endoscopic gastrostomy tube -peg tube-, she was started on TPN on (b) (6) 2010. In the first bag of tpn solution was 40 mg. Famotidine. Patient's mental status began deteriorating and she began to get very, very agitated and confused once again. Eclipsys sunrise problem/bug was noted when son, a physician informaticist -and author of this report- noted the 40 mg famotidine in the tpn bag, and reported to the floor rn that this was contraindicated. The rn pulled up the medication order and administration records on the eclipsys sunrise clinical manager system to confirm famotidine had been administered previously. Famotidine was shown only as being ordered for tpn on (b) (6), but not prior. The rn selected a date constraint entry box, at which time a calendar widget popped up. The rn set the date constraint back to (b) (6), then (b) (6), then (b) (6) 2010, but the use of the famotidine at that time did not appear. Son of patient demanded the famotidine be stopped anyway, which it was, and that an allergy entry be entered. However, it was fortunate son was a physician and remembered the name of the medicine. In tracing this error today, it was found that the data from admission on (b) (6) to "discharge" to physical therapy floor (b) (6) 2010, was unavailable since it was considered a "prior admission" although the patient had never left the hospital physically. The sunrise system, however, failed to flag the (b) (6) 2010 date constraint entries as 'out of bounds' for the current admission. <b>The validity of the date constraints was not checked, preventing the rn user from realizing he should have called up the prior admissions records. If son of patient had not been a physician, famotidine might have been continued and patient might have suffered more severe consequences than she did after the 40 mg was given in the first tpn bag</b>. As it was, she spent the next three days in a severe delirium and is only slowly recovering. That the eclipsys sunrise ehr did not alert its user that the date constraints they set for seeking medication ordering and administration data were out of bounds -beyond the range of the current "admission" <b>-is a significant and severe oversight and/or bg, and a danger to patients not fortunate enough to have a physician informaticist son closely monitoring their care. </b></blockquote><br />Addendum May 4, 2014:<br /><br />(11)   CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  (But let's spend hundreds of billions of dollars anyway.) <br /><br /><br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgKNTHRZ65twX8W-4VKJyyfOxz-EKIMmIfoipBwryewkc-IKs_JkusXtcujYkfmjqkzRE_1FyX0m7GAS3X-MTb0rq0yeup3rRxjRKLk2xmnWlO6BLlwHE0rJOqULoHziPGyOKQnO3Jkb2La/s1600/CMS_Letter.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="400" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgKNTHRZ65twX8W-4VKJyyfOxz-EKIMmIfoipBwryewkc-IKs_JkusXtcujYkfmjqkzRE_1FyX0m7GAS3X-MTb0rq0yeup3rRxjRKLk2xmnWlO6BLlwHE0rJOqULoHziPGyOKQnO3Jkb2La/s1600/CMS_Letter.jpg" width="308" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">CMS: "we do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives."  [But let's spend hundreds of billions of dollars anyway.]  <b>Click to enlarge.</b></td></tr></tbody></table><br />--------------------------------------------<br /><br />Note that these ten points themselves, all I had time to write about this morning, themselves represent a "tip of the iceberg" regarding health IT risks.<br /><br />In my opinion it's immensely reckless for FDA to make a statement that "products with health management heath IT functions, includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software<b> ...</b> are of <b>sufficiently low ri</b>sk" so as to not warrant formal regulation that is already in place for other healthcare software sectors.<br /><br />Fortunately, the public gets to comment via this announcement:<br /><br />Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology Report; Notice to Public of Availability of the Report and Web Site Location; Request for Comments<br /><a href="http://www.regulations.gov/#!documentDetail;D=FDA_FRDOC_0001-4678">http://www.regulations.gov/#!documentDetail;D=FDA_FRDOC_0001-4678</a><br /><br />I feel, however, that the decision is a given, and that the health IT industry has such regulatory capture that public comments will be ignored.  (Not that I won't try.)<br /><br />Finally:<br /><br />I ponder what ever happened to the inquiry responses about health IT defects and harm sought by the Senate Finance Committee, as reported in the Washington Post:<br /><br /><blockquote class="tr_bq"><b>Electronic medical records draw frequent criticisms</b><br />By Alexi Mostrous<br />Washington Post Staff Writer<br />Sunday, October 25, 2009 <br /><br /><a href="http://www.washingtonpost.com/wp-dyn/content/article/2009/10/24/AR2009102400967.html?hpid%3Dtopnews&sub=AR">http://www.washingtonpost.com/wp-dyn/content/article/2009/10/24/AR2009102400967.html?hpid%3Dtopnews&sub=AR</a><br /><br />... the Senate Finance Committee has amassed a thick file of testimony alleging serious computer flaws from doctors, patients and engineers unhappy with current systems.<br /><br /><b>On Oct. 16, the panel wrote to 10 major sellers of electronic record systems, demanding to know, for example, what steps they had taken to safeguard patients.</b> "Every accountability measure ought to be used to track the stimulus money invested in health information technology," said <a href="http://projects.washingtonpost.com/congress/members/g000386/" target="">Sen. Charles E. Grassley</a> (Iowa), the panel's ranking Republican. </blockquote><br />The results of that request seem to have gone to the recycle bin.<br /><br />-- SS<br /><br />

FDA on health IT risk: reckless, or another GM-like political coverup? "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it."

In my Sept. 16, 2013 post "An Open Letter to David Bates, MD, Chair, ONC FDASIA Health IT Policy Committee on Recommendations Against...

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Finally, An Article in a Large Circulation Medical Journal with Systematic Data about Leaders of Academic Medicine Conflicted by their Service on Health Care Corporate Boards

<b>Background - a New Species of Conflict of Interest </b><br /><br />Since <a href="http://hcrenewal.blogspot.com/2006/03/new-species-of-conflict-of-interest-in.html">2006</a>, we have posted repeatedly about  what was then a new species of severe <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a>.  This occurs when leaders of academic medical institutions or other health care non-profit organizations or non-governmental organizations (NGOs) also serve as members of <a href="http://hcrenewal.blogspot.com/search/label/boards%20of%20directors">boards of directors</a> of for-profit corporations  whose products and actions have major effects on health care.<br /><br />Most recently, we <a href="http://hcrenewal.blogspot.com/2014/03/american-board-of-internal-medicine.html">discussed </a>the cases of the current CEO of the National Quality Forum and past CEO of the American Board of Internal Medicine who was found to be on the board of for-profit hospital group purchasing organization Premier Inc, and had been on the board of its privately held but for-profit predecessors.  We then <a href="http://hcrenewal.blogspot.com/2014/02/incoming-president-of-iom-outed-as.html">discussed</a> the case of the incoming president of the US Institute of Medicine and former Chancellor of Health Affairs at Duke University who was on the boards of Alnylam Pharmaceuticals, Medtronic and Pepsico.  We next <a href="http://hcrenewal.blogspot.com/2014/03/turnabout-is-fair-play-why-university.html">discussed</a> the case of the current Dean of medicine at the University of Illinois who is on the board of Novartis.  <br /><br />We also recently <a href="http://hcrenewal.blogspot.com/2014/03/better-late-than-never-jama-article.html">posted</a> about the first time these sorts of severe conflicts of interest issue have been addressed in a large circulation medical journal.  A commentary in JAMA called for many such conflicts to be banned.<br /><br /><b>A Small Study of the Prevalence of a New Species of Conflict of Interest </b><br /><br />Now JAMA has just published a research letter which examined the prevalence of board members of large, for-profit, publicly held pharmaceutical companies who also were among the leadership of academic medical centers. [Anderson TS, Dave S, Good CB et al. Academic medical center leadership on pharmaceutical company boards of directors.  JAMA 2014; 311: 1353-5.  Link <a href="http://jama.jamanetwork.com/article.aspx?articleid=1853147">here</a>.]<br /><br />The authors looked at public data about 2012 board membership of the 47 biggest publicly held companies based on global prescription drug sales. They tabulated those who were also leaders at (apparently only US) academic medical centers.  <br /><br />The most important findings were:<br />- 19/47 companies (40%) had at least one board member who was a leader of an academic medical center (AMC)<br />- 16/17 US based companies had at least one board member who was also a leader of a US AMC<br />-  pharmaceutical company board members included 2 university presidents, 6 deans of medicine, 6 hospital or health system executives, 7 clinical department chairs or center directors<br />-  28 board members were also members of boards of trustees or directors of US hospitals, medical schools, or their parent universities.<br /><br /><b>Comments </b><br /><br />We have been trying to raise awareness of this issue since 2006.  Now we have some idea of the size of the problem.<br /><br />Keep in mind that this study did not attempt to determine the prevalence of academic medical center leaders on boards of smaller pharmaceutical companies, privately held companies, biotechnology or device companies, or other health care and health care related companies (e.g., for-profit hospital systems, health insurance companies, for-profit contract research organizations, for-profit medical education and communication companies, large companies with major health care components, etc, etc, etc)  It also did not attempt to determine the prevalence of leaders of other important health care non-profit organizations (e.g., hospitals and hospital systems, insurance companies, professional societies, patient advocacy groups, accrediting boards, etc, etc, etc) on health care or related corporate boards.  It also did not address leaders of health care organizations outside of the US.  So this study likely greatly underestimates the overall prevalence of and the number of people involved in what we first called a "new species of conflict of interest." <br /><br />But it is a start.  And publishing it in JAMA will begin to make more health care professionals, policy makers, and researchers, and more of the public at large aware of the problem.<br /><br />As I said before, it is very nice to see that the issue of what we once called a new species of conflict of interest finally has made the big time.  Whether it now gets any more traction remains to be seen.  Unfortunately, since conflicts of interest can be so profitable for the directly affected parties, I fully expect they will continue to oppose any restrictions.  The money they have made will likely be used to deploy marketing and public relations personnel and legal counsel to counter any attempts to try to make this aspect of health care more honest.<br /><br />As we have said again and again, the web of conflicts of interest that is pervasive in medicine and health care is now threatening to strangle medicine and health care.  Furthermore, this web is now strong enough to have effectively transformed US health care into an oligarchy or plutocracy.  Health care is effectively run by a relatively small group of people, mainly professional managers plus a few (lapsed?) health care professionals, who simultaneously run or influence multiple corporations and organizations.<br /><br />For patients and the public to trust health care professionals and health care organizations, they need to know that these individuals and organizations are putting patients' and the public's health ahead of private gain. Health care professionals who care for patients, those who teach about medicine and health care, clinical researchers, and those who make medical and health care policy should do so free from conflicts of interest that might inhibit their abilities to put patients and the public's health first.<br /><br />Health care professionals ought to make it their highest priority to ensure that the organizations for which they work, or with which they interact also put patients' and the public's health ahead of private gain, especially the private gain of the organizations' leaders and their cronies.<br /><br />ADDENDUM (3 April, 2014) - see also comments by Paul Levy <a href="http://runningahospital.blogspot.com/2014/04/how-not-to-set-example.html">on the Not Running a Hospital blog</a>, <a href="http://1boringoldman.com/index.php/2014/04/01/at-first-glance/">on the 1BoringOldMan blog</a>, and by Ed Silverman (welcome back!) on <a href="http://blogs.wsj.com/corporate-intelligence/2014/04/01/why-people-who-influence-reseach-are-popular-in-pharma-boardrooms/">the WSJ Corporate Intelligence blog</a>. 

Finally, An Article in a Large Circulation Medical Journal with Systematic Data about Leaders of Academic Medicine Conflicted by their Service on Health Care Corporate Boards

Background - a New Species of Conflict of Interest Since 2006 , we have posted repeatedly about  what was then a new species of severe conf...

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No Fooling - When a Retired Conservative Politician Warns About Oligarchy...

then things must be getting really bad.<br /><br />Of course, we have been warning about <a href="http://hcrenewal.blogspot.com/search/label/oligarchy">oligarchy</a>, and related issues such as <a href="http://hcrenewal.blogspot.com/search/label/concentration%20of%20power">concentration of power</a>, <a href="http://hcrenewal.blogspot.com/search/label/oligopoly">oligopoly</a>  in health care for a long time.  Basically, we have been warning that health care is increasingly run by a small group of insiders, mostly professional managers/ executives, and their cronies, who often have multiple overlapping leadership positions (e.g., as we <a href="http://hcrenewal.blogspot.com/2014/03/better-late-than-never-jama-article.html">discussed</a> recently, leadership of one health care organization while being member of the board of another), or may interchange positions through the <a href="http://hcrenewal.blogspot.com/search/label/revolving%20doors">revolving door</a>.  It appears that this pattern is merely part of a larger one involving US and even global society.<br /><br />While warnings about the growing threat of oligarchy or plutocracy have mainly come from people (including your loyal Health Care Renewal bloggers) who might be regarded as out of the mainstream, that is changing.<br /><br />We have a striking local example. <br /><br />David Carlin is a former Majority Leader of the Rhode Island Senate.  While he is a Democrat, he could hardly be called a flaming leftist.  He just published an <a href="http://www.providencejournal.com/opinion/commentary/20140401-david-carlin-is-it-oligarchy-in-democracy-out.ece">op-ed</a> in the Providence Journal which opened,<br /><br /><blockquote class="tr_bq">I am not a leftist. Far from it. Not only have I become a conservative in my old age, but I find myself growing more conservative every month.</blockquote><br />He then went on,<br /><br /><blockquote class="tr_bq"> Nonetheless, I think those on the left are correct about one thing, at least. They are right when they warn us that the United States, where the top 1 percent of people own about 40 percent of the nation’s wealth, has a <b><i>dangerous imbalance of wealth</i></b>.<br /><br />Please don’t misunderstand. I am far from agreeing with the leftist notion that the ideal society would be one in which wealth is equally distributed. This is absurd. Nonetheless, <i>this great inequality of wealth is dangerous for America. For it is making the United States <b>less and less a democracy</b> (a form of government in which the people rule) and <b>more and more an oligarchy</b> (a form of government in which a small number of very rich people rule).</i></blockquote><br />He did propose a specific remedy for the problem.  However, he did warn of the consequences in dire terms.<br /><br /><blockquote class="tr_bq">in the United States we have a special problem. For we are and always have been philosophically democratic. We believe that government is legitimate to the degree — and only to the degree — that it is chosen by the people. <i>When we conclude that in reality our government is controlled by the rich and super-rich, not the people, we will experience a <b>great legitimacy crisis</b>; our government will no longer feel legitimate to us, and thus it will not receive the deference that legitimate authority is entitled to. <b>Lawlessness and disorder will follow.</b></i></blockquote><br />That is pretty strong, and when people like Mr Carlin start making such strong warnings, things must be really bad.<br /><br />In my humble opinion, there are already plenty of reasons to have doubts about whether the ostensible authorities in health care are legitimate.  Just to mention some recent examples: we have discussed how the leaders of two major prestigious non-profit health care organizations (look <a href="http://hcrenewal.blogspot.com/2014/02/incoming-president-of-iom-outed-as.html">here</a> and <a href="http://hcrenewal.blogspot.com/2014/03/american-board-of-internal-medicine.html">here</a>) and one major medical school (look <a href="http://hcrenewal.blogspot.com/2014/03/turnabout-is-fair-play-why-university.html">here</a>) were revealed to simultaneously be responsible for the governance of for-profit health care organizations, some of which had clear track records of ethical misadventures which cast doubt on the abilities of these leaders to uphold their organizations' missions.  Two of the three leaders subsequently dropped their outside board memberships, but not their leadership positions, and their previous actions in those positions have not been revisited. <br /><br />In health care, if we do not re-establish leadership which is accountable for putting the health of patients and the public ahead of self-interest, the deluge will not be far behind.  

No Fooling - When a Retired Conservative Politician Warns About Oligarchy...

then things must be getting really bad. Of course, we have been warning about oligarchy , and related issues such as concentration of power ...

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Too Good to be True - Sovaldi Kerfuffle Focuses on Price, While Ignoring Limits of Evidence about Effectiveness and Safety

There seems to be rising skepticism about the prices we pay for the latest drugs, devices, and health care programs, especially in the US.  However, our faith in the near miraculous properties of the newest technology appears to go on unabated.  Skepticism, driven by the rigorous thinking that ought to be engendered by the dutiful application of the principles of <a href="http://hcrenewal.blogspot.com/search/label/evidence-based%20medicine">evidence-based medicine</a>, is rarely in evidence. <br /><br />The latest example is of how concern about the sky high price of one new medication seems to have eclipsed any skepticism about how much good that medicine may do for patients.<br /><br /><b>The Sovaldi Pricing Kefuffle</b><br /><br />Starting in early March, 2014, a media discussion began about the extremely high price set for a new drug for the treatment of hepatitis C.  As first<a href="http://www.washingtonpost.com/national/health-science/costly-hepatitis-drug-sovaldi-rattles-industry/2014/03/01/86cab0b4-a091-11e3-9ba6-800d1192d08b_story.html"> reported</a> by the Washington Post,<br /><br /><blockquote class="tr_bq">When the Food and Drug Administration approved a medication called Sovaldi [sofosbuvir, Gilead] in December,<i> it was hailed as a breakthrough in the fight against hepatitis C</i>, a blood-borne disease that affects 3.2 million Americans and <i>kills more people in the U.S. annually than AIDS</i>.<br /><br />Then California-based Gilead Sciences, the manufacturer, announced the price:<i> <b>$84,000</b> for a 12-week course</i>, more than what many cancer treatments cost in a year. </blockquote><br />The coverage focused on whether the price could possible be justified, while it generally conceding that the drug was a huge advance that was genuinely valuable. For example, the Post article noted, <br /><br /><blockquote class="tr_bq">The drug has also prompted a new round of hand-wringing over a larger issue: the escalating cost of specialty drugs, which are designed to treat chronic illnesses such as rheumatoid arthritis and multiple sclerosis and sometimes require special handling.<br /><br />While these <i>therapies are delivering body blows to some of the world’s most pernicious diseases</i>, they also are<i> testing the limits of what society is willing to pay for sought-after treatments or cures. </i></blockquote><br />The articles justified the drug's value with several assertions: <br /><br /><u>Sofosbuvir cures nearly everyone of hepatitis C</u><br /><br />For example, the Post article stated, <br /><br /><blockquote class="tr_bq">Sovaldi promises to cure nearly all sufferers... </blockquote><br />Similarly, a report by the authoritative <a href="http://www.kaiserhealthnews.org/stories/2014/march/03/insurers-debate-who-should-get-costly-hepatitis-c-drug.aspx">Kaiser Health News</a> stated that the drug has,<br /><br /><blockquote class="tr_bq">a success rate of better than 90 percent.</blockquote><br />A Bloomberg<a href="http://www.bloomberg.com/news/2014-03-03/gilead-ceo-becomes-billionaire-on-84-000-hepatitis-drug.html"> article</a> quoted Dr Leonard Berkowitz, chief of infectious disease as Brooklyn Hospital Center as saying the drug is<br /><br /><blockquote class="tr_bq">producing 'spectacular improvements' in cure rates....</blockquote><br />Going even farther, a Denver Post <a href="http://www.denverpost.com/news/ci_25275400/hepatitis-c-breakthrough-drug-sovaldi-promises-high-cure">article</a> quoted Dr Greg Everson, a hepatologist at the University of Colorado,<br /><br /><blockquote class="tr_bq">The word is cure.  To me, the cure of hep C is one of the most significant medical developments of the last 50 years.</blockquote><br /><u>Sofosbuvir is extremely safe and has few side effects </u><br /><br />For example, the Post article stated Sovaldi is <br /><br /><blockquote class="tr_bq">a once-daily pill that has far fewer side effects [than other treatments] </blockquote><br />The Bloomberg article again quoted Dr Berkowitz as saying the drug has<br /><br /><blockquote class="tr_bq">minimal toxicity</blockquote><br />The Denver Post quoted Dr Everson,<br /><br /><blockquote class="tr_bq">the side effects are almost nonexistent - mild headache and fatigue.</blockquote><br /><u>Without treatment, hepatitis C leads to very bad outcomes </u><br /><br />For example, the Post article stated, <br /><br /><blockquote class="tr_bq">The disease can go undetected for years and can eventually lead to cancer or cirrhosis of the liver. </blockquote><br />Kaiser Health News added,<br /><br /><blockquote class="tr_bq">If left untreated, hepatitis C can cause liver damage over the course of decades. </blockquote><br />An<a href="http://articles.latimes.com/2014/mar/09/business/la-fi-hepatitis-c-drug-costs-20140310"> article</a> in the Los Angeles Times noted,<br /><br /><blockquote class="tr_bq">Left unchecked, some hepatitis C infections result in liver damage, liver cancer or death.</blockquote><br />The Denver Post again quoted Dr Everson,<br /><br /><blockquote class="tr_bq">It's a devastating disease. [Also,] It can smolder for years without symptoms, then it destroys the liver - cirrhosis, cancer.</blockquote><br /><u>Sofosbuvir prevents nearly all these bad outcomes.</u><br /><br />This was more implied by the media than directly stated, although the Los Angeles Times did quote an executive vice president of Gilead, the manufacturer of Sovaldi,<br /><br /><blockquote class="tr_bq">Sovaldi ... results in very high cure rates that can avoid future costs related to disease progression or treatment failure....</blockquote><br />Only the New York Times provided just a hint of skunk odor at the garden party.  Its later <a href="http://www.nytimes.com/2014/03/22/business/lawmakers-attack-cost-of-new-hepatitis-drug.html">article</a> on some US congress members' attempt to investigate the pricing of Sovaldi contributed,<br /><br />But most people with hepatitis C never experience serious liver problems.  So many people would be fine without treatment.<br /><br />That little bit of odor notwithstanding, one could ask what is not to like about this drug.  But the coverage really focused on how many people felt the cost was still just too high.  Unstated, but again implied was the notion that these complaints were just sour grapes.  How could anyone begrudge a mere $84,000 for a safe, extremely effective curative drug that would prevent severe morbidity and premature death, yet cause almost no significant side effects?<br /><br />The problem is that the evidence that actually supports the "value proposition" for Sovaldi is actually not clear at all.  The bigger problem is that so far, discussion of this evidence in the media seems to be absent.<br /><br /><b>The Evidence about Treatment of Hepatitis C</b><br /><br />Let us consider the assertions above, and what evidence there may be to support them,  in slightly different order.<br /><br /><u>Without treatment, hepatitis C leads to very bad outcomes</u><br /><br />The earliest research on hepatitis C focused on patients who already had severe complications of the disease.  Thus, as Seeff et al wrote in 2000(1),<br /><br /><blockquote class="tr_bq">retrospective studies of person who have chronic, clinically obvious HCV infection may overemphasize more serious outcomes because they risk omitting persons with subclinical infection as well as those in whom infection spontaneously resolves.</blockquote><br />Yet popular conceptions of hepatitis C, especially those reflected by the current Sovaldi pricing kerfuffle, seem to reflect only the experience of the most unfortunate hepatitis C patients.  In contrast, studies that have followed cohorts of patients who have evidence of early hepatitis C infection show very different results.<br /><br />In 1999, Kenny-Walsh and colleagues reported a cohort of 390 women who had tested positive for hepatitis C after receiving infected immune globulin.(2)  They were able to follow them for 17 years.  In that time period, 43% of the women had no or minimal inflammation of the liver; 49% had no evidence of liver fibrosis; and only 2% had developed fibrosis.<br /><br />In 2000, Seeff and colleagues reported 45 years of follow up of young military men who were found to have evidence of hepatitis C infection from analysis of long stored frozen serum.  Only one (less than 3%) of their admittedly small cohort of 34 positive men had been found to have any sort of liver problem in that time period.(1)<br /><br />In 2001, Seeff and colleagues reported 20-year follow up of several cohorts including 222 patients who developed hepatitis characterized by abnormal liver enzymes after blood transfusion and for whom retrospective tests on stored blood revealed hepatitis C at that time.(3)  The total mortality over 20 years of the hepatitis C patients was not greater than a group of control patients who had been transfused but did not develop clinical hepatitis.  51% of the hepatitis C infected patients had no evidence of chronic hepatitis.  23% had no evidence of continuing hepatitis C infection. <br /><br />These admittedly old studies show that a significant minority of patients with hepatitis C infection spontaneously resolve their infections, and that a majority of patients have no evidence of significant liver disease over decades of observation.  Cirrhosis is actually a relatively rare outcome of hepatitis C infection, and there is no clear evidence that hepatitis C infection increases total mortality.<br /><br />Of course, once a patient with hepatitis C has been unfortunate enough to develop clear liver disease, that patient's prognosis is not so good. <br /><br />Thus, there is <i>no</i> clear evidence that the majority of patients with hepatitis C infection could benefit from anti-viral treatment given prior to development of any significant complications of the infection, because the majority of such patients may never develop any adverse effects of the infection.  Thus it is not at all obvious that any current hepatitis C treatment could be widely life-saving.<br /><br /><u>Treatment Prevents Nearly All Bad Outcomes</u><br /><br />There have been no long-term randomized controlled trials of any anti-viral treatment for hepatitis C that evaluated clinical outcomes like cirrhosis, liver failure, liver cancer, need for transplantation or death.  All trials of all agents have been relatively short term, and focused on reduction or elimination of detectable virus from the blood as an outcome.  As detailed in the latest evidence report from the US Preventive Services Task Force,(4) there have been observational studies that compared patients who were treated and had sustained virological responses (elimination of detectable virus from the blood) and those who did not in terms of long-term outcomes.  Such observational studies are liable, however, to confounding.  Patients who are willing to take treatment, fully comply with treatment, and respond better to therapy may be systematically different from those who refuse treatment, do not adhere to treatment, or whose treatment is not initially successful.  Most of these studies were considered to be of poor methodological quality, although the best, still only considered of fair quality, did show an association between virological responses and clinical outcomes.  There have been no studies of the comparative effectiveness of different anti-viral treatments.<br /><br />Thus, the evidence that anti-viral treatment for hepatitis C prevents any bad clinical outcomes, like cirrhosis, liver failure, liver cancer, or premature death is unclear. <br /><br />Now to consider the best evidence available about sofosbuvir.<br /><br /><u>Sofosbuvir cures nearly everyone of hepatitis C</u><br /><br />So far, the best study reported about sofosbuvir seems to be one in the New England Journal of Medicine in 2013.(5)  This report included an open-label (not blinded) controlled trial called FISSION of sofosbuvir plus ribivirin versus peginterferon alfa-21 plus ribivirin.  Its primary outcome measure was viral response 12 weeks after therapy (which lasted 12 weeks in the first group, 24 in the second).  The proportion of patients with responses 12 weeks after therapy were 67% in both groups.  Patients who received sofosbivir had lower rates of the common, uncomfortable complications attributed to interferon therapy than those who received peginterferon (e.g., fatigue, 36% versus 55%; nausea, 18% versus 29%).  However, while small, the proportion of patients with serious adverse events, not further defined in the article, were higher in the sofosbivir group, 3% versus 1%. <br /><br />Note that the above report also included what was euphemistically called a "single-group, open-label study."  This seems to be a fancy name for what is usually called a case series, that is, a series of patients given a particular treatment, without a control group.  The consensus in the evidence-based medicine community has long been that barring miraculous results, case series are nearly useless as evidence about treatments, primarily because it is not possible to separate the effects of the patient selection process from the treatment on the apparent outcomes.  Why this case series was included in the report is a secret known only to New England Journal editors. <br /><br />So setting aside that distraction, it is not obvious that sofosbivir increases even short-term virological response (at 12 weeks after treatment) compared to the best previously available treatment.  There is no evidence that sofosbivir can cure nearly everyone.  (Much of the enthusiasm seems to come from blood tests on treatment, disregarding the results shortly after treatment.)  These are not "spectacular" results."<br /><br /><u>Sofosbuvir is extremely safe and has few side effects</u><br /><br />From the above trial results, it is not obvious that the drug is extremely safe.  In fact, there is a suggestion that it may lead to an increase in serious adverse effects.<br /><br />While the drug does seem to produce fewer bothersome adverse effects, even the rates of these symptoms in those treated are not negligible.<br /><br /><b>Summary</b><br /><br />While there is concern about the gargantuan price asked for Sovaldi, the new treatment for hepatitis C, there seems to be little skepticism about the near miraculous claims made for the value of the new drug.  In fact, it almost appears that the debate about the price is reinforcing current dogma which promises nearly universal cures without major risks.  Yet the evidence is that many, perhaps most patients with hepatitis C will not benefit from treatment, and that the new drug is not much more, or any more likely to cure patients than older drugs.  Meanwhile, the evidence that the new drug is safer and causes fewer adverse effects is weak at best.<br /><br />The US health care system, and to some extent the health care systems in most developed countries are experiencing ever higher prices.  Much of these prices' effects seem to drive up remuneration of health care executives and managers, but whether they buy better care or outcomes for most people is not so clear.  The ever rising prices seem to be buoyed by endless enthusiasm for new tests, treatments, programs, and unbridled faith in the benefits of all new technology.  It is not clear how much of that is due to evidence, how much is based on ideology and unquestioning faith in technological progress, and how much is driven by marketing and public relations, which not always may be entirely honest and free from deception.<br /><br />Evidence-based medicine rigorously applied suggests that individual health care and health policy decisions should be driven by the best available evidence, mostly from clinical research, about the benefits and harms of tests, treatments, programs, and so on, in the context of what outcomes matter to patients.  The skepticism EBM should engender lead to health care that is more about patients and their outcomes, and less about ideology, hype, and hucksterism. <br /><br /><b>References</b><br />1.  Seeff LB, Miller RN, Rabkin CS et al.  45-year follow-up of hepatitis C virus infection in healthy young adults.  Ann Intern Med 2000; 132: 105-111.  Link <a href="http://annals.org/article.aspx?articleid=713226">here</a>.<br />2.  Kenny-Walsh E, for the Irish Hepatology Research Group.  Clinical outcomes after hepatitis C infection from contaminated anti-D immune globulin.  N Engl J Med 1999; 340: 1228- 1233.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJM199904223401602">here</a>.<br />3. Seeff LB, Hollilnger B, Alter HJ et al.  Long-term mortality and morbidity of transfusion- associated non-A, non-B, and type C hepatitis: a National Heart Lung and Blood Institute Collaborative Study.  Hepatology 2001; 33: 455-463.  Link <a href="http://www.ncbi.nlm.nih.gov/pubmed/11172349">here</a>.<br />4. Chou R, Hartung D, Rahman B et al.  Comparative effectiveness of antiviral treatment for hepatitis C virus infection in adults: a systematic review.  Ann Intern Med 2013; 158: 114.-123.  Link <a href="http://annals.org/article.aspx?articleid=1402433">here</a>.<br />5.  Lawitz E, Mangia A, Wyles D et al.  Sofosbuvir for previously untreated chronic hepatitis C infection.  N Engl J Med 2013; 368: 1878-1887.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1214853">here</a>.<br /><br />

Too Good to be True - Sovaldi Kerfuffle Focuses on Price, While Ignoring Limits of Evidence about Effectiveness and Safety

There seems to be rising skepticism about the prices we pay for the latest drugs, devices, and health care programs, especially in the US.  ...

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