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Forbes contributor Nicole Fisher, claimed proponent of healthcare human rights, writes long article on EHRs that neglects to mention patient harm

The field of health IT lives a charmed life. Even self-stated human rights advocates in healthcare won't seem to broach the topic of EHR-related harms and lack of informed consent processes regarding their use in a patient's care, even when authors openly state their concerns for patient and human rights. This is despite known harms at potentially alarming levels as indicated by organizations including the IOM, FDA, ECRI Institute, AHRQ, Harvard Med Mal insurer CRICO, The Joint Commission, NHS in the UK, and others. Forbes contributor Nicole Fisher (<a href="http://www.forbes.com/sites/nicolefisher/">http://www.forbes.com/sites/nicolefisher/</a>) published an article in Forbes dated 3/18/2014 and entitled "Electronic Health Records - Expensive, Disruptive And Here To Stay" (<a href="http://www.forbes.com/sites/nicolefisher/2014/03/18/electronic-health-records-expensive-disruptive-and-here-to-stay/">http://www.forbes.com/sites/nicolefisher/2014/03/18/electronic-health-records-expensive-disruptive-and-here-to-stay/</a>). You can read the article at the above link.  It focuses on physician distraction and dissatisfaction, poor usability and usefulness, expense, and related issues.  Of course, quotes from HHS figure prominently. Nowhere, however, is mention of EHR-related harms to patients, such as reported by the aforementioned organizations mentioned - as in this very small sample list of posts, which contain links to source: <blockquote class="tr_bq">Patient Safety & Quality Healthcare: "CRICO Malpractice Claims Analysis Confirms Risks in EHRs" <a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html">hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html</a> Peering Underneath the Iceberg's Water Level: ECRI "Deep Dive" Study of Health IT "Events" <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> Internal FDA memorandum on HIT risks <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> IOM Report - "Health IT and Patient Safety: Building Safer Systems for Better Care" <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html">http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html</a> EHRs and Deadly glitches <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a> (multiple posts) Not to forget issues of breach of privacy:  <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy</a> (multiple posts)</blockquote> Nor are mentioned the issues of the experimental, unregulated nature of this technology, and the lack of any informed consent process regarding patient's rights to decide whether or not to have these systems used in their care. The only mention of "unintended consequences" links to "<a href="http://www.emrandhipaa.com/guest/2014/03/11/unintended-icd-10-consequences-inadequate-clinical-documentation-can-negatively-impact-physician-profiles-icd-10-tuesdays/">Unintended ICD-10 Consequences: Inadequate Clinical Documentation Can Negatively Impact Physician Profiles</a>." This is in my view disappointing, and seems to be yet another extraordinary healthcare IT industry accommodation, remarkable for an author with the following bio (emphases mine): <blockquote class="tr_bq"><a href="http://www.forbes.com/sites/nicolefisher/">http://www.forbes.com/sites/nicolefisher/</a> Nicole Fisher is the Founder and Principal at HHR Strategies, a health care and human rights focused advising firm. Additionally, she is a Senior Policy Advisor and health policy expert on health economic analyses mainly focusing on Medicare, Medicaid and health reform, specifically as they impact women and children. Nicole runs a Health Innovation and Policy page at Forbes.com highlighting and advising companies, ideas and people that are changing the health care landscape. She is also currently pursuing her PhD at the University of North Carolina in the Health Policy and Management Department. Her writing has appeared in other publications such as Health Affairs, Wall Street Journal, Washington Post, Centers for Medicare & Medicaid Services Journal, Wright on Health, The Health Care Blog and Health Services Research. Before pursuing her PhD in health policy, Nicole earned her Master’s degree in Public Policy from the University of Chicago and her undergraduate degree from the University of Missouri. Her health care and policy work at those institutions had an emphasis on underserved populations, women's and children’s issues. She presides on several Boards for domestic and international health organizations and frequently speaks on health reform and human rights.</blockquote> One might conclude the computer has more rights than the patient and the clinician via this Forbes piece. Finally, although I am a domain specialist (<a href="http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx">http://www.kaiserhealthnews.org/stories/2013/february/18/scot-silverstein-health-information-technology.aspx</a>), I am getting rather tired of having to point out the obvious to major media outlets and writers, in essence doing their homework for them.  I'm sure other bloggers feel the same way.  The title of the Forbes piece should have been "Electronic Health Records - Expensive, Disruptive, Deadly." To the author of the Forbes piece and other HIT writers, here is the face (and gravestone) of someone injured by this "disruptive" technology.   <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> A few babies too:  <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html</a> A family man:  <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html">http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html</a> I know of others from my legal work supporting the EHR-related injured and deceased that I cannot mention.  And I am but one person. If health IT were causing rapes** and child abuse, rather then merely causing mundane severe injuries and equally mundane deaths, would the media would pay more attention? -- SS ** I sadly note that EHR's without proper security measures in force actually did enable rape-like behavior in 2011, as at "EHR as Molestation Candidate Selector: What was this Resident looking for in the EHR before 'examining' female patients?" at <a href="http://hcrenewal.blogspot.com/2011/02/what-was-this-medical-resident-looking.html">http://hcrenewal.blogspot.com/2011/02/what-was-this-medical-resident-looking.html</a>.

Forbes contributor Nicole Fisher, claimed proponent of healthcare human rights, writes long article on EHRs that neglects to mention patient harm

The field of health IT lives a charmed life. Even self-stated human rights advocates in healthcare won't seem to broach the topic of EHR...

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CA Supreme Court upholds "whistleblower" protection for Modesto physician - and on replacing the abuser-favoring connotations of "whistleblower" with "Corporate Integrity Advocate"

"Whistleblower" is a term commonly used to refer to insiders in an organization who do not "go along to get along" or look the other way with regard to corruption and malfeasance. The connotation, of course, is that these individuals are "snitches" and "non-team players", in other words, the "bad guys."  They are then punished for their good deeds. (More on the term "whistleblower" below.) Here's one "whistleblower" who punished back: <blockquote class="tr_bq">California Supreme Court upholds whistleblower protection for Modesto physician By Ken Carlson February 20, 2014 <a href="http://www.modbee.com/2014/02/20/3201156/california-supreme-court-upholds.html">http://www.modbee.com/2014/02/20/3201156/california-supreme-court-upholds.html</a> The California Supreme Court ruled Thursday that a Modesto physician who challenged the termination of his hospital privileges has whistleblower protections. Dr. Mark Fahlen, a kidney specialist, filed a March 2011 whistleblower lawsuit in Stanislaus County Superior Court after Sacramento-based Sutter Health canceled his privileges to care for patients at Memorial Medical Center. Fahlen’s lawsuit claims that Sutter Central Valley Hospitals and Steve Mitchell, then the chief operating officer of Memorial, persuaded the Sutter Gould medical group to fire him and terminated his hospital privileges because of his complaints about insubordination and substandard care by hospital nurses.</blockquote> At least they didn't threaten to plaster his complaints to his forehead as occurred in Ohio (<a href="http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html">http://hcrenewal.blogspot.com/2013/07/hows-this-for-patient-rights-affinity.html</a>). <blockquote class="tr_bq">His attorney said the court decision guarantees that physicians have the same protections as hospital employees if they report problems that threaten to harm patients.</blockquote> That "guarantees protections" and "report problems that threaten to harm patients" have to appear in the same sentence at all is symptomatic of the most severe form of patient-be-damned dysfunction in this industry. <blockquote class="tr_bq">It’s “the biggest victory for patient rights since California’s health care whistleblower law was adopted in 1999,” said attorney Stephen Schear of Oakland. “In a hospital environment dominated by corporate giants too often more focused on protecting their marketing and brand name than patient health, today’s ruling will finally unshackle doctors from fear of retribution so they can protect patients.”</blockquote> Ditto my prior comment. <blockquote class="tr_bq">In a case closely watched by the hospital industry, the American Medical Association supported Fahlen with a “friend of the court” brief. The California Hospital Association and groups such as Kaiser Foundation Hospitals, Scripps Health and Dignity Health filed briefs on behalf of the defendants.</blockquote> That is rather indicative of the mindsets of those who filed briefs on behalf of the defendants. <blockquote class="tr_bq">... After he was given staff privileges at Memorial in 2004, Fahlen complained to administrators that nurses refused or failed to follow his patient care instructions. According to facts in the case, Fahlen had six clashes with nurses about patient care from August 2007 to April 2008. He told supervisors and administrators that nurses were insubordinate and that their care was substandard. One complaint was regarding a nurse’s refusal to transfer a patient to intensive care, delaying for five hours the appropriate level of care for the patient, the doctor said.</blockquote> What if the patient had died, I ask? <blockquote class="tr_bq">Mitchell, the chief operating officer, blamed Fahlen for his conflicts with nursing staff and contacted Sutter Gould’s medical director about Fahlen’s conduct. Sutter Gould cut ties with Fahlen in May 2008, causing his malpractice insurance to be canceled. Fahlen decided to start his own practice and arranged a meeting with Mitchell to talk about his hospital privileges. Mitchell wrote in an email to Memorial’s chief executive officer that Fahlen “does not get it,” meaning that he was going to lose his privileges. The CEO replied that it “looks like we need to have the medical staff take some action on his MedQuals!!! (or medical qualifications). Soon!” According to the lawsuit, Mitchell told Fahlen at the meeting that he should resign and leave town, or the hospital would report him to the Medical Board of California. Fahlen charged that a subsequent in-house investigation, and an executive committee decision not to renew his privileges, occurred in retaliation for his complaints about patient care.</blockquote> In other words, the doctor was a "disruptive physician" - a bad schoolboy who needed to be spanked - which was, of course, more important to the executives than maimed or dead patients. <blockquote class="tr_bq">Fahlen asked for a hearing, resulting in an October 2009 to May 2010 review by a six-physician committee at Memorial. The panel concluded that the evidence did not show he was incompetent or that his behavior had endangered patients. [But] Memorial’s board of trustees overruled the panel in early 2011.  [It's not hard to imagine that few if any on that board were themselves medical professionals - ed.]</blockquote> It's more likely in my view that this physician was ultra-competent. <blockquote class="tr_bq"> Sutter attorneys argued that the doctor first needed to exhaust other legal remedies before bringing the whistleblower lawsuit. The Supreme Court dismissed a previous expectation that doctors exhaust other remedies before filing suit with claims of retaliation. Such conditions would “seriously undermine the Legislature’s purpose to afford a whistleblower on a hospital medical staff the right to sue,” the Supreme Court’s opinion said.</blockquote> Next, a typical circular argument: <blockquote class="tr_bq"> Attorney Lowell Brown, who handles physician disciplinary cases for hospitals, said Thursday’s ruling will “change the rules of the game,” though additional court decisions will be needed to clarify issues. He predicted doctors will be reluctant to serve on hospital panels that review the competency or behavior of physicians. “The doctor can claim the action is being taken because he or she is whistleblowing,” Brown said. “No one ever produces evidence that a sham peer review has taken place. What we will see is sham whistleblower complaints about peer reviews.”</blockquote> Since sham peer review (see more at <a href="http://hcrenewal.blogspot.com/2009/10/sham-peer-review-could-this-bad-faith.html">http://hcrenewal.blogspot.com/2009/10/sham-peer-review-could-this-bad-faith.html</a>) is done secretly and behind closed doors, with protections, it's pretty hard to produce "evidence" of the type required in court. <blockquote class="tr_bq">... Fahlen said the ruling means that “doctors no longer have to choose between speaking out for their patients or continuing with their careers.”</blockquote> Again, this is an absolutely perverse choice foisted upon clinicians by corporatized, financialized medicine and its leadership. ------------ More on the term "whistleblower" itself. My attitude about that term is clear - the people who use it are attempting an ad hominem attack in one word.  It is a bad term, with bad connotations, and does not actually describe what the individual is attempting to accomplish. AHIMA's  Kim Baldwin Stried-Reich has a similar view, and a suggestion for replacement of that term with a more descriptive and non-abusable term: <blockquote class="tr_bq">"Changing Perception of ‘Whistleblowers’"</blockquote><blockquote>From  <a href="http://journal.ahima.org/2014/03/01/hipaa-whistleblower-protections-promote-information-governance/">http://journal.ahima.org/2014/03/01/hipaa-whistleblower-protections-promote-information-governance/</a> ... According to Kim Baldwin Stried-Reich, the former Speaker of the AHIMA House of Delegates, the new amendment to the HITECH-HIPAA Omnibus rule demonstrates both the increasing importance and value HIM professionals have today in ensuring both integrity and compliance with rules, regulations, and laws governing access and disclosure of health information within their organizations. Baldwin Stried-Reich is a privacy and compliance officer with the Lake County Physicians Association, in Waukegan, IL. She notes that while the new provision provides specific protections against disclosures reported to an oversight agency by whistleblowers and workforce members who are victims of a crime, she’s not so sure this new rule will encourage individuals, such as HIM professionals to speak-up and speak-out when or if they see evidence of systematic and ongoing non-compliance with federal mandates. One reason for this is the widespread use of the word “whistleblower,” which often carries negative connotations. She prefers the term “corporate integrity advocate.”</blockquote> "Corporate Integrity Advocate" clearly and unequivocally describes what the individuals - including those who write for blogs such as this one - are trying to accomplish. It is also a term that is rather hard for malfeasance-doers to use as ad hominem.. <blockquote class="tr_bq">“Perhaps if Health and Human Services had utilized another term, such as ‘corporate integrity advocate’ more individuals would understand what the intent of this new law is and that it is meant as an avenue individuals can choose to pursue if their professional integrity and ethics are not in alignment with the corporation’s any longer,” Baldwin Stried-Reich says.</blockquote> "Not in alignment with the lack of the corporation's integrity and ethics" is a more direct, and likely more accurate, way to put it. <blockquote class="tr_bq">A relevant example of this is evident in the settlement that Shasta Regional Medical Center (SRMC) entered into with the Department of Health and Human Services (HHS) following an investigation concerning the breach of PHI after senior-level executives intentionally disclosed protected information to the media on at least three separate occasions. The Shasta case demonstrates how and why corporate integrity advocates or whistleblowers are needed to facilitate change within their organizations when it is warranted, Baldwin Stried-Reich explains.</blockquote> That example is but the tip of the iceberg.  There are many posts on this blog alone dealing with the issues of <s>whistleblowers</s> Corporate Integrity Advocates (see the query link <a href="http://hcrenewal.blogspot.com/search/label/whistle-blowers">http://hcrenewal.blogspot.com/search/label/whistle-blowers</a>). The term "whistleblower" needs to be retired ASAP. -- SS

CA Supreme Court upholds "whistleblower" protection for Modesto physician - and on replacing the abuser-favoring connotations of "whistleblower" with "Corporate Integrity Advocate"

"Whistleblower" is a term commonly used to refer to insiders in an organization who do not "go along to get along" or lo...

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Medical Malpractice Insurer CRICO Challenges "EMR Complacency" - Or Do They?

In my Feb. 28, 2014 post "Malpractice Claims Analysis Confirms Risks in EHRs" (<a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html">http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html</a>) I pointed out that the annual medical malpractice claims related to health IT received by the insurer for the Harvard medical community, one of the world's best users of health IT, might represent a significant percentage of the annual med mal claims in the state of Massachusetts.  Many involved serious injury. I also pointed out that the claims themselves represent only a small fraction of total incidents of med mal-related harms (including due to IT), due to the economic realities of med malpractice litigation. In the press release reproduced below, CRICO writes of poor integration and "design deficiencies" - bad health IT - and that "there has been no apparent leader in this field making a concerted effort to design the next generation of EMRs with the physician in mind", and that they hear "significant frustration from physicians related to their experience with EMRs."  However, CRICO does not write of the reasons why these issues are as prevalent as they are. Their claim appears to be, in essence, that these problems will be solved through dialog and "conversation" - in other words, appeals to corporate altruism. Why this industry receives special accommodation even from those who have to pay for their mistakes is beyond me: <blockquote class="tr_bq">CRICO Challenges EMR Complacency  <a href="http://www.rmf.harvard.edu/EMR">http://www.rmf.harvard.edu/EMR</a>  February 6, 2013 In a recently released video, CRICO offers a vision of how EMRs of the future might improve health care safety for both patient and physician.  Press Release:  Cambridge, MA — CRICO, the patient safety and medical professional liability company serving the Harvard medical community, has produced a video that puts forth a future vision of how Electronic Medical Records (EMRs) might be embedded into the physician workflow in a manner that would improve health care delivery. CRICO has based the dramatization on real malpractice cases. Through combined analysis of how harm can come to patients from flawed encounters with providers, and conversations with medical and technological visionaries across the country, the video integrates various scenarios into an idealized patient/physician encounter.  Hearing significant frustration from physicians related to their experience with EMRs, CRICO was inspired to envision a way in which they might be better integrated into  the clinical workflow. This would allow the EMR to offer some relief to physicians and nurses who face seemingly insurmountable challenges of time and data management. Luke Sato, MD, chief medical officer and senior vice president for CRICO said, “The impetus behind this video was to facilitate a dialogue among health care professionals—physicians, IT, hospital administrators—about why we aren’t making better progress in the development of EMRs.  Through analysis of medical malpractice claims, we have line of sight to design deficiencies in the EMR that contribute to claims. The best technological design is one that is integrated seamlessly into one’s workflow. The current EMR is passive—the physician has to actively look for data instead of the technology anticipating what the physician needs to act on.” Opinions within the health care industry are diverse about EMRs but there has been no apparent leader in this field making a concerted effort to design the next generation of EMRs with the physician in mind. In addition to a need for standards across systems, the manual data entry of today’s EMRs adds to the burden of already time-pressed physicians. The film was created as a collaborative effort between CRICO’s Luke Sato, MD and David Ting, MD, associate medical director for information systems at Massachusetts General Physicians Organization, who acted as an expert resource for script development and video production. Ting said, “The actual purpose of the video is to ask whether we might intelligently prioritize today’s choices to move our institutions toward improved patient care and improve provider and practice work-life experience.” While most of the technology that is used in this dramatization is available today, other elements are further out. CRICO’s future vision, as depicted in the video, is meant as a launching pad to begin the conversation about how new technologies can provide a way to enable EMRs to enhance, streamline, and make safer the patient-physician encounter. Dr. Ting has encouraged his colleagues at MGH to view the video and share their feedback. The physician reaction has elicited a variety of reactions and diverse feedback ranging from “cool, efficient, saves time, and improves outcomes” to “I don’t want voices interfering with my patient interactions.”  The video is available for viewing on the CRICO website, <a href="https://exchangeweb.drexel.edu/owa/redir.aspx?C=boV17iId5ky3j-AH7i-8UbFkSFsPF9EI1dNj1bsYgpqo6Y-wxui_17h2gLlU68Tga7gAZSNP4So.&URL=https%3a%2f%2fwww.rmf.harvard.edu%2fEMR" target="_blank">www.rmf.harvard.edu/EMR</a>.  ABOUT CRICO For more than 30 years, CRICO has been the patient safety and medical professional liability company owned by and serving the Harvard medical community. CRICO is an internationally renowned leader in evidence-based risk management, proudly serving more than 12,000 physicians (including residents and fellows), 22 hospitals, and nearly 209 other health care organizations.</blockquote> They see the problems but do not engage the human reasons for the problems, including generic leadership, conflicts of interest, incompetence, territoriality, profit motive, and the other ills that we write of till our faces turn blue at Healthcare Renewal. In other words, their "challenge to EHR complacency" is about as powerful as our challenges have been to Vladimir Putin regarding Crimea and Ukraine. Perhaps when the payouts become even more severe, insurers will think it a good idea to stop 'making nice' with an intrusive and unregulated industry that has invaded clinical affairs like a bull in a china shop. <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/AVvXsEgaWP3zIvzuW2hnbvndLEoTuKD54nAHbQjth4Rgxipxag7L7yracMBpy_ofQ_pUn719eiqRvGFanSAjZ8P2B8UrlbYmkLvElRI7-rSujvgY05Q_XCD7ms5qQqwg5w0kCPUB5_MEapO7uGJn/s1600/bull.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="243" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgaWP3zIvzuW2hnbvndLEoTuKD54nAHbQjth4Rgxipxag7L7yracMBpy_ofQ_pUn719eiqRvGFanSAjZ8P2B8UrlbYmkLvElRI7-rSujvgY05Q_XCD7ms5qQqwg5w0kCPUB5_MEapO7uGJn/s1600/bull.jpg" width="320" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">Can we please, pretty please dialog for a bit about your breaking the dishes?</td></tr></tbody></table> -- SS

Medical Malpractice Insurer CRICO Challenges "EMR Complacency" - Or Do They?

In my Feb. 28, 2014 post " Malpractice Claims Analysis Confirms Risks in EHRs " ( http://hcrenewal.blogspot.com/2014/02/patient-sa...

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Clinical Trial Prestidigitation - Making Old Data Look Worse So New Data Looks Better

Prestidigitation, also known as <a href="http://en.wikipedia.org/wiki/Sleight_of_hand">sleight of hand</a> or legerdemain, is a form of stage magic which uses dextrous manipulation and misdirection to distract the viewer from seeing it. The example, <a href="http://www.bloomberg.com/news/2014-02-25/boehringer-kept-pradaxa-analysis-from-fda-records-show.html">reported</a> by Bloomberg on 26 February, 2014, is discussed late because the nature of the trick meant it took me a while before I understood how it was done. Background Pradaxa, a new anticoagulant, was approved by the US Food and Drug Administration (FDA) in 2010 for use by patients with atrial fibrillation to prevent strokes.  We <a href="http://hcrenewal.blogspot.com/2014/02/cant-this-be-avoided-how-corporate.html">discussed</a> previously the release of documents during litigation that showed how marketers from its manufacturer, Boehringer - Ingelheim, attempted to manipulate the results of a clinical study of the drug.  The study results initially seemed to suggest that blood tests should be used to monitor therapy with it.  However, that would have contradicted a key marketing message, that Pradaxa was more convenient than warfarin because it did not require blood tests for monitoring. Litigation by patients alleging that Boehringer-Ingelheim concealed the severity of the bleeding risks caused by the drug continues.  The Bloomberg <a href="http://www.bloomberg.com/news/2014-02-25/boehringer-kept-pradaxa-analysis-from-fda-records-show.html">report</a> dealt with how the company responded to requests by the FDA for data about these risks.     The Question from the FDA As per Bloomberg, <blockquote class="tr_bq">In the Pradaxa case, the regulators asked Boehringer to compare fatal bleeding reports received by the FDA against the number of patients using the drug in order to establish a death rate. The request was made to allow the FDA to 'evaluate the need for modifications to the Pradaxa label or future study,' according to a letter made public as part of the court files. The company reported back that 6.1 of every 10,000 patients who used the drug after approval developed fatal bleeding, the court documents showed. The regulators also asked Boehringer to reanalyze results from an earlier study used to gain approval to see how that rate compared. </blockquote> So, in other words, the FDA wanted to assess the rate of bleeding reflected by reports received after the drug had gone on the market (that is, the FDA was evaluating data from post-marketing surveillance.)  To do so, it wanted to calculate the proportion of patients who took the drug who developed fatal bleeding.  Then it wanted to compare this rate to the rate of fatal bleeding found in the previous controlled trials of the drug done by the manufacturer to secure drug approval.  Note that these trials are also considered the major source of clinical research evidence about the benefits and harms of the drug. The major source of clinical evidence about Pradaxa (dabigatran) was the RE-LY trial (Randomized Evaluation of Long-Term Anticoagulation Therapy), sponsored by Boehringer-Ingelheim, published in the New England Journal of Medicine [Connolly SJ, Ezekowitz MD, Yusuf S et al.  Dabigatran versus warfarin in patients with atrial fibrillation.  N Engl J Med  2009; 361:1139-1151.  Link <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa0905561">here</a>.]   The trial reported that the rates of life-threatening bleeding were 1.8% per year for warfarin, 1.45% for high dose dabigatran, and the rates of major bleeding of 3.36% versus 2.21%.  However, the trial report did not include rates of fatal bleeding per se, nor the rates of patients with major bleeding who then died.   Presto Chango According to Bloomberg, here is how Boehringer-Ingelheim responded to the question from the FDA about the rate of fatal bleeding. <blockquote class="tr_bq">That effort produced two separate analyses by the company, according to the unsealed court documents. One, looking only at people whose primary cause of death was bleeding, found 5.8 of 10,000 patients died per year. The other, which included anyone who had a major bleeding event and died for any reason, found a rate of 19.5 fatal events per 10,000 patients per year, the documents show.  The report sent to the FDA, though, contained only the analysis indicating the death rate from the earlier research was much higher than the numbers seen after approval, according to the court filings. Potentially, such a finding could head off any after-market action by the FDA because the data showed the drug was safer after it was approved and widely used.   </blockquote> So, to recapitulate, Boehringer-Ingelheim used results from the RE-LY trial to persuade the FDA that its new drug was safe and effective.  However, the company did not include, at least in the results reported publicly, any measure of fatal bleeding in patients given the drug.  It now appears that the rate of major bleeding in patients who subsequently died was high, perhaps high enough to have raised questions about the safety of the drug prior to approval, had it been revealed. However, after the drug had been approved, when the question was about rates of severe bleeding after the drug had been marketed, the company furnished an analysis of data from the clinical trial that now showed a very high bleeding rate. That was the major misdirection, the sleight of hand.. It would make the rate of fatal bleeding in the post-marketing surveillance data appear low.  But apparently this data also kept the eyes of the FDA focused on the question of bleeding in the post-marketing period.  Did no one in the FDA notice that while this high rate of bad bleeding in the trial made the post-marketing surveillance look good, it also raised questions about whether the drug should have been thought to have been safe enough to be approved in the first place?   By the way, Bloomberg also reported that Boehringer-Ingelheim performed a trick for European regulators,  <blockquote class="tr_bq">Selective disclosure of Pradaxa information may have camouflaged a serious safety signal, according to an assessment report from <a href="http://www.ema.europa.eu/ema/" rel="external" title="Open Web Site">European Medicines Agency’</a>s Committee for Medicinal Products for Human Use in August 2012. That agency is the European Union’s drug regulator. Boehringer also didn’t give the EMA the figures showing that real-world bleeding rates were higher when the committee conducted a similar review and published a report in August 2012. The panel’s analysis, which concurred with Boehringer’s, concluded that Pradaxa’s bleeding risks among the general population were 'substantially less' than the rates seen in the study the drugmaker used as the basis for approval. It didn’t have the analysis showing the risk was higher using a different approach, according to the unsealed files. 'If the reporting rate in the post-marketing phase had been higher than in' Boehringer’s study, 'there would clearly have been a safety concern,' agency officials wrote. </blockquote> Summary We have discussed a variety of ways that companies that sell health care goods (like drugs or devices) and services may <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulate clinical research</a> to make their products look better than they may actually be.  It appears that these companies may hire very clever people who are very knowledgeable about the design of clinical research to game the system to aid marketing, but meanwhile obfuscate the clinical research data that clinicians and patients rely on to make clinical decisions in the best interests of patients, and that policy makers rely on to make decisions in the best interests of the public.  So far, the hands of the corporate marketers seem to be quicker than the eyes of the clinicians, patients, and policy makers. I wonder, though, how those very clever people sleep well at night knowing that their talents for legerdemain are being used to increase revenues and make corporate insiders rich, at the expense of patients, and of patients' health? As I have said before, and most recently in the context of <a href="http://hcrenewal.blogspot.com/2014/02/cant-this-be-avoided-how-corporate.html">discussing</a> the previous example of manipulation of clinical research to support Pradaxa marketing,  I strongly advocate that those who author authoritative systematic reviews, meta-analyses, and clinical practice guidelines base their work on extremely rigorous, skeptical reviews that assume the likelihood that all commercially sponsored published clinical research has been manipulated (and that research that even post manipulation could not be twisted to support marketing many have been <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed</a>)  Reviews, meta-analyses, and guidelines that were not so based on extremely critical review should also be viewed with a jaundiced eye.  Perhaps it is possible to devise legal and regulatory methods to at least make such manipulation more transparent.  Maybe this case, however, should again suggest that clinical research, that is, research on human beings, should be completely separated from those with vested interests in selling products or services which could be better hyped were the research turn out in their favor.  Hat tip to <a href="http://1boringoldman.com/index.php/2014/02/26/foot-in-mouth-disease/">1BoringOldMan</a>.

Clinical Trial Prestidigitation - Making Old Data Look Worse So New Data Looks Better

Prestidigitation, also known as sleight of hand or legerdemain, is a form of stage magic which uses dextrous manipulation and misdirection ...

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As the Door Turns - The Ongoing Interchange of Leaders Among Large Health Care Corporations, Those who Represent Them, and Government

The revolving door is the two-way conduit between leadership positions in government and industry that helps to enable health care, and maybe all of society, to be run by a group of insiders who can move easily between large or influential health care organizations and the government bodies that are supposed to regulate, oversee, and enforce laws relevant to them. It has been three months since our last <a href="http://hcrenewal.blogspot.com/2013/12/for-whom-door-revolves-from-for-profit.html">update</a> on the <a href="http://hcrenewal.blogspot.com/search/label/revolving%20doors">revolving door</a> as it applies to health care, so here is our latest effort, according to the chronological order of the initial media coverage.  Foundation Leader with Ties to Eli Lilly and to Former Synthes CEO to the White House As <a href="http://www.nytimes.com/2013/12/13/us/politics/new-obama-adviser-brings-corporate-ties.html">reported </a>by the New York Times in December, 2013, new White House senior adviser John D Podesta, who founded and ran the nominally non-profit organization Center for American Progress, had multiple ties to health care corporations and their leaders, e.g., to pharmaceutical maker Eli Lilly, <blockquote class="tr_bq">The pharmaceutical giant Eli Lilly was also a donor because of what it said was the Center for American Progress’s advocacy for patients’ rights — and just as the debate heated up in Washington over potential cuts to the Medicare program that covers Lilly’s most profitable drugs.</blockquote> Although, for the record, <blockquote class="tr_bq">Neera Tanden, the president of the Center for American Progress, said in an interview that the group frequently takes positions that conflict with the corporate agendas of its donors, including companies like Eli Lilly. </blockquote> Also an important but somewhat less obvious linkage was described thus by the Times,  <blockquote class="tr_bq"> In addition, he earned $90,000 as a consultant to the HJW Foundation of West Chester, Pa, according to an aide working with him on the disclosure report he is preparing. HJW is a nonprofit group run by Hansjörg Wyss, a billionaire businessman and major contributor to the Center for American Progress.</blockquote> What the Times did not say about Mr Wyss was that he is the former CEO of Synthes, a Swiss based medical device company, since merged into Johnson and Johnson   As we <a href="http://hcrenewal.blogspot.com/2011/12/it-was-best-of-times-it-was-worst-of.html">wrote</a> in 2011, <blockquote class="tr_bq"> Synthes USA, the American branch of a Swiss based device company, first settled charges that it had been paying surgeons with company stock to use its products in its clinical trials in 2009 (see <a href="http://hcrenewal.blogspot.com/2009/05/synthes-settles-agrees-to-stop-giving.html">this post</a>).  Then prosecutors alleged that these were not really rigorous trials. Instead, for marketing purposes, executives of Synthes subsidiary Norian persuaded surgeons to use its Norian XR product in a case series of spine surgery patients and then publish the results.  Three patients who received the product for this 'off-label' use died.  This scheme was alleged to have been directed by "person no. 7," whom journalists identified as the company CEO, Hansjorg Wyss (see post <a href="http://hcrenewal.blogspot.com/2009/06/synthes-indicted.html">here</a>.)   In an unusual move, the prosecutors indicted four company executives, who then pleaded guilty.  They did not take any further action against Wyss, who turns out to be one of the world's richest men (see post <a href="http://hcrenewal.blogspot.com/2009/12/person-no-7-also-known-as-83rd-richest.html">here</a>).</blockquote> However, at the time the former executives were sentenced, one of the executive's attorney's claimed, <blockquote class="tr_bq">Wyss was the undisputed leader of the company. 'He made some of the very critical decisions that put the trials on the ultimate pathway,' Gurney said. 'The culture of an organization is set at the top.'</blockquote> Former Deputy White House Press Secretary to Global Strategy Group, Whose Clients Include Pfizer, Purdue Pharma, and WellPoint As reported by the National Journal in December, 2013, <blockquote class="tr_bq">Bill Burton Old gig: Deputy White House press secretary New gig: Formed and ran Priorities USA Action, a super PAC that raked in more than $75 million during the 2012 campaign; recently joined the public affairs firm Global Strategy Group as a managing director. Clients <a href="http://globalstrategygroup.com/about/#our-clients">include</a> GE, Cisco, American Express, Comcast, and Pfizer.</blockquote> Other health care clients include health insurance company Empire BCBS, pharmaceutical company Purdue Pharma, and for-profit health insurance company WellPoint Former National Health Information Technology Coordinator to Get Real Health As <a href="http://www.govhealthit.com/news/former-national-coordinator-lends-credo-vision-patient-engagement-company">reported</a> by Government HealthIT in February, 2014, <blockquote class="tr_bq">Three months after leaving the federal government, [former National Coordinator for Health Information Technology] Farzad Mostashari, MD, is joining the board of directors at the patient engagement company Get Real Health. The big-thinking, bow-tied public health veteran is currently studying accountable care policies full-time at the Brookings Institution, and said he’s joining the Get Real Health board to help it '‘stay’ real as it innovates and serves patients and providers.' The Rockville, Maryland-based company was founded in 2000, starting out as a connected health consulting outfit and then, after working with Microsoft’s HealthVault in 2007, launching its own health technology in 2012, the InstantPHR patient engagement platform.</blockquote> From CareScience Inc to National Coordinator for Health Information Technology to Health Evolution Partners The <a href="http://www.govhealthit.com/news/former-national-coordinator-lends-credo-vision-patient-engagement-company">article</a> about Dr Mostashari also mentioned in passing a more complicated set of transitions involving an earlier national coordinator for health care information technology.    <blockquote class="tr_bq">Mostashari is not the only former national coordinators to step into the health IT private sector after federal service. David Brailer, MD, the first appointee to the role of the national coordinator for health IT, is now running the San Francisco private equity firm Health Evolution Partners.</blockquote> But in fact, according to his rather glowing Wikipedia <a href="http://en.wikipedia.org/wiki/David_Brailer">entry</a>, Dr Brailer also came from the commercial health care IT industry, <blockquote class="tr_bq"> In 1992, Brailer left academia and founded a company spun out of his Ph.D. thesis, inventing ways to measure health-care quality. This became CareScience Inc., a Philadelphia software firm that helped hospitals improve efficiency and prevent errors. Under Brailer, CareScience established the nation's first health care Application Service Provider (ASP). Brailer led the company through several financings, strategic partnerships, an initial public offering in 2000, and sale to global software firm Quovadx in 2003.</blockquote> <a href="http://en.wikipedia.org/wiki/David_Brailer#cite_note-11"></a> Then, in 2004, <blockquote class="tr_bq">Brailer was appointed as the first National Health Information Technology Coordinator, pursuant to an executive order by President George W. Bush on April 27, 2004, which called for widespread deployment of health information technology within 10 years.</blockquote> According to his Health Evolution Partners <a href="http://www.healthevolutionpartners.com/david-j-brailer-md-phd/">biography</a>, Dr Brailer is also now a member of the boards of directors of American Optical Services, CenseoHealth, Optimal Radiology, and Walgreen Co. From Aide to Congressman Young to a Lobbying Firm with Health Care Clients Then to Congress According to the <a href="http://www.tampabay.com/news/politics/elections/david-jolly-elected-to-represent-pinellas-county-in-congress/2169727">Tampa Bay Times</a>, yesterday Republican David Jolly won a special election to a congressional seat for Florida.  The article noted that Mr Jolly was "once an obscure aide to the late Republican U.S. Rep. C.W. Bill Young and then a Washington lobbyist,..." His past work was described in more detail in a <a href="http://www.republicreport.org/2014/jolly/">post</a> on the Republic Report blog, <blockquote class="tr_bq">David Jolly, the Republican congressional candidate vying for the special election in Florida next week, has not only made a career out of lobbying. Records reviewed by Republic Report show that Jolly’s clients won millions of dollars in taxpayer earmarks from his old boss, the late Rep. C.W. 'Bill' Young (R-FL), an appropriator known for his lavish use of the earmarking process. </blockquote> Futhermore, <blockquote class="tr_bq">Two of the firms that hired Jolly as a lobbyist - BayCare Health Systems and Alakai Defense Systmes - won lucrative earmarks from Young while paying Jolly to influence the committee where Young was a senior member. In 2009, BayCare Health Sytems retained Jolly and another former Young staffer named Douglas Gregory.  Later that year, Young secured a $1 million earmark for BayCare Health Systems for 'facilities and improvements.'</blockquote> Summary Note that the revolving door does not seem to discriminate according to political party or ideology.  The cases above involved both Republicans and Democrats. But the revolving door does discriminate against the not well connected, because it seems to provided preferred posts in the upper echelons of government for industry insiders, and preferred posts in the upper echelons of industry for government insiders.  As we have said many times before, the constant interchange of health care insiders among government, large health care corporations, and the lobbying and legal firms which represent them certainly suggests that health care, like many other sectors, seems to be run by an amorphous group of insiders who owe allegiance neither to government nor industry. However, those who work in government are supposed to be working for the people, and those who work on health care within government are supposed to be working for patients' and the public health.  If they are constantly looking over their shoulders at potential private employers who might offer big checks, who indeed are they working for? <div itemprop="articleBody"></div>Attempts to turn government toward private gain and away from being of the people, by the people, and for the people have no doubt been going on since the beginning of government (and since the Constitution was signed, in the case of the US).  However, true health care reform  would require curtailing the severe sorts of conflicts of interest created by the revolving door. Real heath care reform would require  multiyear cooling off periods before someone who worked in the commercial world can get a job in a government whose work has direct effect on his or her previous employer or industry sector, and before someone who worked in government whose work had direct effect on a particular economic sector can accept a job for a company in that sector.

As the Door Turns - The Ongoing Interchange of Leaders Among Large Health Care Corporations, Those who Represent Them, and Government

The revolving door is the two-way conduit between leadership positions in government and industry that helps to enable health care, and mayb...

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Regulation of HIT by federal independent agency vs. federal executive agency / Open criminal probe of GM recall

In the FY2014 HHS budget-in-brief document (PDF at <a href="http://www.hhs.gov/budget/fy2014/fy-2014-budget-in-brief.pdf">http://www.hhs.gov/budget/fy2014/fy-2014-budget-in-brief.pdf</a>) on page 115, there's this: <div class="gmail_extra"> <div style="margin-left: 40px;">Patient Safety and Health IT Usability Patient safety and usability continue to be a focus for ONC. Working with federal partners AHRQ and FDA, ONC will create the foundation for a patient safety program that will be launched in FY 2014called “The Patient Safety Plan”. The Plan seeks to ensure that health IT is safely designed and implemented, medical staff are properly informed and trained to use their health IT systems, and a surveillance system is established to monitor health IT related patient safety events and ensure that unsafe conditions are corrected.</div></div> I believe the health IT industry now realizes some form of regulation is inevitable after, for example, revelations from medical malpractice insurers that a significant number of lawsuits involve the effects of health IT (see for instance my post "Malpractice Claims Analysis Confirms Risks in EHRs" at <a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html">http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html</a>). I also believe that industry and its pundits have pushed for the most favorable regulation possible.  This involves pushing for regulation by agencies with the least agency independence as possible, as I bring out below.  HHS along with its member branches FDA, AHRQ and ONC are executive departments of the US government  The legislation that governs the way such departments and agencies may propose and establish regulations is the Administrative Procedure Act of 1946 (<a href="http://en.wikipedia.org/wiki/Administrative_Procedure_Act">http://en.wikipedia.org/wiki/Administrative_Procedure_Act</a>). First, it seems the executive branch is attempting to concentrate more power within itself over health IT through proposals like in the FY2014 HHS document. I also point out that that HHS (and its offices such as ONC, FDA etc.) are federal executive departments.  <a href="http://en.wikipedia.org/wiki/United_States_federal_executive_departments" target="_blank">http://en.wikipedia.org/wiki/United_States_federal_executive_departments</a>. These are not entirely independent of presidential control: <blockquote>"The heads of the federal executive departments, known as secretaries of their respective department, form the traditional Cabinet of the United States, an executive organ that serves at the disposal of the president and normally act as an advisory body to the presidency."</blockquote> In other words, the leaders serve at the pleasure of the President. This is as opposed to the executive department cousin, the federal independent agency, such as the NRC (Nuclear regulatory commission) and NTSB (national transportation safety board) that are independent agencies (<a href="http://en.wikipedia.org/wiki/Independent_agencies_of_the_United_States_government" target="_blank">http://en.wikipedia.org/wiki/Independent_agencies_of_the_United_States_government</a>): <blockquote>Independent agencies of the United States federal government are those agencies that exist outside of the federal executive departments (those headed by a Cabinet secretary). More specifically, the term may be used to describe agencies that, while constitutionally part of the executive branch, are independent of presidential control, usually because the president's power to dismiss the agency head or a member is limited.</blockquote> It is no secret the administration is determined to push as rapid as possible rollout of health IT, come hell or high water, via HITECH, its coming penalties and other measures.  Its predecessor administration was a bit more genteel and circumspect in this regard. It is clear to me that, in the current political environment, regulation by a federal executive agency is minimalist and will likely be politically ineffective, due to fear of its leadership of being dismissed if they upset the upper echelons.   I note that Jeffrey Shuren, a physician and attorney, director of FDA CDRH already stated in 2010 that "health IT is a political hot potato" as a reason that FDA "has largely refrained from enforcing our regulatory requirements."  See my April 2011 post "FDA Decides Regulating Implantable Defibrillator Medical Devices a 'Political Hot Potato'; Demurs" at <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html</a> for links to source. I believe it would be better to place the authority for health IT regulation under the aegis of a federal independent agency, whether an existing one or one created for that purpose, so that its leaders are more independent of executive branch control. ----- I predict that without meaningful regulation, this is where the health IT industry will find itself in a few years. <blockquote class="tr_bq"><a href="http://www.reuters.com/article/2014/03/11/us-autos-gm-recall-probe-idUSBREA2A1RZ20140311" target="_blank">http://www.reuters.com/article/2014/03/11/us-autos-gm-recall-probe-idUSBREA2A1RZ20140311</a> Reuters - Federal prosecutors are examining whether General Motors is criminally liable for failing to properly disclose problems with some of its vehicles that were linked to 13 deaths and led to a recall last month, according to a source familiar with the investigation. The New York-based probe is in its early stages, and the source did not elaborate on the legal theory behind the potential criminal liability. .. Federal investigators are reviewing information about how GM handled reports of problems with ignition switches that first came to light 10 years ago, according to the source. The federal probe by the U.S. attorney in Manhattan adds to a growing list of U.S. authorities examining the recall, which GM announced in February. The National Highway Traffic Safety Administration (NHTSA) previously opened an investigation into whether GM reacted swiftly enough in its recall. Earlier on Tuesday, Reuters reported that a U.S. Senate committee chairman is seeking a hearing on the issue. The U.S. House Energy and Commerce Committee also ordered GM and NHTSA to turn over information about GM's ignition switch problems. The problems in some instances allowed the engine and other components, including front airbags, to turn off while the vehicle was traveling at high speed. More than 1.6 million older vehicles are affected. The failure is believed to be caused when weight on the ignition key, road conditions or some other jarring event causes the ignition switch to move out of the "run" position, turning off the engine and most of the car's electrical components mid-drive, with sometimes catastrophic results. GM has recommended that owners use only the ignition key with nothing else on the key ring. .. The House committee examining the GM issue, led by Michigan Republican Fred Upton, gave the company and NHTSA until March 25 to turn over information about their responses to consumers' complaints about the problem. The committee has asked GM officials to provide a briefing no later than March 18 on how GM has responded to reports of incidents since 2003 and its interaction with NHTSA since then on problems related to the ignition defect. Upton led the 2000 investigation into Firestone tire failures on Ford Motor Co vehicles, resulting in the TREAD Act that requires automakers to report complaints of defects to the NHTSA. That law also makes it a crime to intentionally mislead the agency about defects that lead to serious accidents. ... The person familiar with the criminal probe declined to discuss whether prosecutors were considering liability under the TREAD Act.</blockquote>  In fact, there is no good reason the health IT sector has been excluded from such actions, through an unprecedented regulatory accommodation this single healthcare sector has enjoyed for decades - namely, that of no true regulation at all.   <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/AVvXsEjAREJP0qSqoHqaCCq9y3x81HIJTzS6-HLSU3as_BIzCDOfNAHgX2WAaVEFDLHSYhUMaJFX_l6DHv-RxT00pyP3RJcFQfgbCqBsXJG_-xohfHQYOYO1jqYyqUUObqd3ro9ymPy1cI1ivlXh/s1600/dilbert.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="150" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjAREJP0qSqoHqaCCq9y3x81HIJTzS6-HLSU3as_BIzCDOfNAHgX2WAaVEFDLHSYhUMaJFX_l6DHv-RxT00pyP3RJcFQfgbCqBsXJG_-xohfHQYOYO1jqYyqUUObqd3ro9ymPy1cI1ivlXh/s1600/dilbert.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"> <div class="MsoNormal">Sure, let's regulate a <s>potentially</s> proven dangerous healthcare technology, health IT (a glamor child of this administration) by a federal executive agency that serves "at the disposal" of the President ... instead of a federal independent agency, with ... uh ...better independence.  Great idea!</div></td></tr></tbody></table> -- SS 3/12/14 Addendum: Note this report of possible delays by the Department of Transportation on disclosure of GM ignition defects, by its National Highway Traffic Safety Administration branch, that caused fatalities and where disclosure could have (and finally now has) resulted in huge legal problems for GM.  GM is a company that was a centerpiece of the administration's economic interventions in recent years: <blockquote class="tr_bq">Did the Obama White House Protect GM? Liz Peek The Fiscal Times March 12, 2014</blockquote><blockquote><a href="http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM">http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM</a> Did the Obama administration purposefully hide problems with GM cars? Were they panicked that a massive recall of GM products would undermine one of President Obama’s most self-congratulatory campaign themes – that he “saved” Detroit’s auto industry? This is a tale of two car companies: GM, shining star in President Obama’s reelection galaxy, and Toyota, which became political fodder. The House Energy and Commerce Committee announced two days ago that it would undertake an investigation into why it took GM until quite recently to address a decade of complaints about stalling problems with several car models, and why the National Highway Traffic Safety Administration did not demand a recall of the troubled lines earlier on.  [Because they were afraid to? - ed.]  Reports of unexpected stalling in Chevy Cobalts began to trickle in as early as 2003 when 7 incidents were relayed to NHTSA, according to The New York Times ... </blockquote> Read the whole article. The Department of Transportation is ... you guessed it ... a <a href="http://en.wikipedia.org/wiki/United_States_federal_executive_departments">federal executive agency</a>, not a federal independent agency. -- SS <div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;"><div class="field field-name-field-author-ref field-type-entityreference field-label-hidden"><div class="field-items"><div class="field-item odd"><a href="http://www.thefiscaltimes.com/Authors/P/Liz-Peek" rel="author">Liz Peek</a></div></div></div>The Fiscal Times <div class="field field-name-field-release-date field-type-datetime field-label-hidden"><div class="field-items"><div class="field-item odd">March 12, 2014</div></div></div><div class="field field-name-body field-type-text-with-summary field-label-hidden"><div class="field-items"><div class="field-item odd">Did the Obama administration purposefully hide problems with GM cars? Were they panicked that a massive recall of GM products would undermine one of President Obama’s most self-congratulatory campaign themes – that he “saved” Detroit’s auto industry? This is a tale of two car companies: GM, shining star in President Obama’s reelection galaxy, and Toyota, which became political fodder. The House Energy and Commerce Committee announced two days ago that it would undertake an investigation into why it took GM until quite recently to address a decade of complaints about stalling problems with several car models, and why the National Highway Traffic Safety Administration did not demand a recall of the troubled lines earlier on.  Reports of unexpected stalling in Chevy Cobalts began to trickle in as early as 2003 when 7 incidents were relayed to NHTSA, <a href="http://www.nytimes.com/2014/03/09/business/auto-regulators-dismissed-defect-tied-to-13-deaths.html?_r=0">according to The New York Times</a>.</div></div></div>- See more at: http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM#sthash.Ed9FH0ZD.dpuf</div><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;">National Highway Traffic Safety Administrationsuspected of causing many deaths:  "Did the Obama White House Protect GM?", The Fiscal TimesMarch 12, 2014, <a href="http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM">http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM</a>.Note that the Department of Transportation is ... you guessed it ... a <a href="http://en.wikipedia.org/wiki/United_States_federal_executive_departments">federal executive department</a>.</div><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;">Did the Obama White House Protect GM?</div><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;">Did the Obama White House Protect GM?</div>

Regulation of HIT by federal independent agency vs. federal executive agency / Open criminal probe of GM recall

In the FY2014 HHS budget-in-brief document (PDF at http://www.hhs.gov/budget/fy2014/fy-2014-budget-in-brief.pdf ) on page 115, there's t...

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American Board of Internal Medicine Policy Condones Keeping Conflicts of Interest Secret

The latest complication of the CareFusion/ Dr Denham/ NQF/ Dr Cassel/ ABIM case was the revelation that the current president of the NQF, Dr Christine Cassel, after resigning her position on the board of directors of for-profit publicly held group purchasing organization Premier Inc, was found to have been on the board of for-profit privately held predecessor of Premier Inc since 2008 (see post<a href="http://hcrenewal.blogspot.com/2014/03/the-plot-of-carefusion-dr-denham-nqf.html"> here</a>).  Before Dr Cassel was CEO of NQF, she had been the president and CEO of the American Board of Internal Medicine for 10 years.  So apparently she was on the board of the predecessor of Premier Inc for about five years while she was leading the ABIM. This relationship appears to be as serious a conflict of interest for Dr Cassel in her previous role as leader of the ABIM as it was for her current role as leader of the NQF.  Since she had this conflict for so long as leader of the ABIM without public disclosure, it seems logical to ask whether she was a long-term violator of ABIM policy, and hence sort of a long-term rogue CEO? To answer that, one needs to review the ABIM <a href="https://www.abim.org/conflict-of-interest-policies.aspx">conflict of interest policy</a>. What Sort of Conflicts of Interest Does the ABIM Ban? The official wording is: <blockquote class="tr_bq">It is the policy of the Board that Directors, Subspecialty Board and Committee members, consultants and other individuals involved in developing ABIM products will not be employed (as staff or as a consultant) at greater than fifty percent by a commercial entity, except in such instances where explicit exceptions to the policy have been made by the Board. Unless a compelling reason is presented for granting an exception, such individuals will be asked to resign their position of service to the Board.</blockquote> Let us parse that a bit.  The policy applies to the leadership of the ABIM, Directors, Subspecialty Board and Committee members, consultants, and individuals involved in developing products, so it applies broadly. However, conflicts are only banned when they exceed a 50% time commitment.  But the time commitments required by many sorts of relationships among physicians and health care corporations are ill-defined.  For example, in the initial public offering <a href="http://investors.premierinc.com/common/download/download.cfm?companyid=AMDA-24J90L&fileid=694238&filekey=8152d7d0-9413-4cdb-920c-e10edc2d3c05&filename=Premier_IPO_Prospectus.pdf">prospectus</a> for Premier Inc, the public document that announced her membership on the new public company's board, there is no information about the time commitment required by this position. Also, physicians can earn large amounts of money for relatively small investments of time.  For example, not only can members of boards of directors make hundreds of thousands of dollars for ill defined time commitments unlikely to approach 10% full time equivalent, but also, <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">key opinion leaders</a> acting as primarily marketing consultants can also earn hundreds of thousands of dollars for undocumented time commitments, and physicians can earn hundreds of thousands or millions of dollars from royalty payments from patent holdings that require no current work (look<a href="http://hcrenewal.blogspot.com/2007/11/orthopedic-device-makers-reveal.html"> here</a> for example).  So a physician could easily earn hundreds of thousands or millions of dollars from health care corporations without approaching a nominal 50% time commitment.  I suspect that this ban would apply to almost no one other than a full-time corporate employee. Furthermore, the policy is not absolute.  Exceptions can be made for "compelling reasons," which are not further defined.  This is thus a very weak element of the policy  How are Conflicts of Interest that are Not Banned Managed? The policy states, <blockquote class="tr_bq">Given that prohibition of all financial interest in commercial entities would excessively restrict the pool of eligible candidates for Board membership, the Board's policy to regulate conflicts of interest consists of disclosure, self-monitored (and Chair-overseen) abstention from participation in decision-making that relates to the conflict, and adjudication of potential conflicts of interest situations by the Conflict of Interest Committee of the Board of Directors. Individuals (non-staff) involved in developing ABIM policy and products — ABIM Directors, Subspecialty Board Directors and Committee members, consultants, the President and relevant staff members will be requested at the time of their appointment and annually thereafter to execute a disclosure.</blockquote> I would note that the rationale is highly questionable.  One often hears from apologists for conflicts of interest that all competent doctors are conflicted because health care corporations identify all the most expert doctors and hire them as speakers, consultants, etc (look <a href="http://hcrenewal.blogspot.com/2009/09/latest-version-of-argument-that-we-are.html">here</a> for example).  We have shown examples on this blog of some less than stellar individuals with extensive financial involvements with health care corporations.  For example, we have posted (<a href="http://hcrenewal.blogspot.com/2007/06/which-physicians-pharmaceutical.html">here</a>, <a href="http://hcrenewal.blogspot.com/2010/10/not-best-and-brightest-drug-marketers.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2011/01/im-not-here-to-sell-drugs-then-why-use.html">here</a>) about physicians dubbed key opinion leaders by pharmaceutical companies who lacked board certification, had been subject to sanctions by state medical boards, had received warnings from the FDA, had lost hospital privileges, and had been convicted of crimes. On the other hand, there probably are quite a few smart, dedicated, expert physicians who eschew major financial involvement with health care corporations. The policy goes on to state that for some individuals, the management would be recusal from participation in relevant decisions, <blockquote class="tr_bq"> Test Committees and other policy committees will be expected to discuss the conflict of interest policy, and to share relevant disclosures, with the expectation that committee members will disclose any significant actual or perceived conflicts and abstain from discussion where such conflicts exist. In the event that a potential conflict of interest situation arises about which explicit policy does not exist, the Conflict of Interest Committee of the Board will hear and judge the appeal.</blockquote> Note that recusal may be inadequate management.  Committees tend to learn to get along with each other.  The views of committee members who have to recuse themselves may be well known, and may be supported by their fellow members even when their recused colleagues are not in the room. Worse, the policy says nothing about whether higher level ABIM leaders even need to recuse themselves.  The recusal policy apparently only applies to committee members.  There seems to be no policy about management of conflict affecting So the management of conflicts of interest proposed by the ABIM document seems to be rather minimalist. Who Makes Decisions about ABIM Conflicts of Interest? The policy states that disclosures will be made to, <ul><li><blockquote class="tr_bq">President and Chair of the Board;</blockquote></li></ul><blockquote></blockquote><ul><li><blockquote>The chairs of the relevant Subspecialty Boards, Test-Writing Committees, and other Committees of the Board, members who serve on the relevant Boards and Committees, and staff working with the respective committees;</blockquote></li></ul><blockquote></blockquote><ul><li><blockquote>The Conflict of Interest Committee members and Conflict of Interest Committee staff,</blockquote></li></ul>As noted above, <blockquote class="tr_bq">adjudication of potential conflicts of interest situations[would be] by the Conflict of Interest Committee of the Board of Directors.</blockquote> However, again it is not clear whether they can adjudicate conflicts affecting anyone other than test and policy committee members.  Furthermore, whether anyone oversees conflicts affecting members of the Board of Directors is not clear. Thus it is not clear who, if anyone, manages conflicts of interest affecting the top ABIM leaders, particularly the CEO and members of the board of trustees.  This aspect of the policy seems ambiguous. How are Conflicts of Interest Publicly Disclosed? The short answer is they are not.  The relevant wording is: <blockquote class="tr_bq">Information that is disclosed will be kept confidential except to the <ul><li>President and Chair of the Board;</li><li>The chairs of the relevant Subspecialty Boards, Test-Writing Committees, and other Committees of the Board, members who serve on the relevant Boards and Committees, and staff working with the respective committees;</li><li>The Conflict of Interest Committee members and Conflict of Interest Committee staff,</li></ul>except as required for the purposes of continuing medical education.</blockquote> Let me reiterate, conflicts of interest are NOT PUBLICLY DISCLOSED.  They are kept confidential, secret, hidden, opaque.  Only the insiders listed above may know about them. We have been discussing the prevalence and severity of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest </a>affecting health care professionals and policy-makers, and <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">institutional conflicts of interest </a>affecting health care organizations for years.  Based on the principle that sunlight is the best disinfectant, many now agree that disclosure of these conflicts of interest is a necessity, although there is considerable discussion about whether the current movement to make conflicts of interest public will reduce their effects.  However, in my humble opinion, concealing conflicts of interest is inherently dishonest.   Yet that is the policy of the American Board of Internal Medicine. Summary So, while it appears that the former president and CEO of the ABIM had a severe conflict of interest generated by her membership on the board of directors of a privately held for-profit group purchasing organization, her failure to disclose it publicly did not violate ABIM policy. The reason is that the ABIM policy on conflicts of interest appears to be extremely weak and ambiguous.  Worse, it condones keeping conflicts of interest secret, which to me appears inherently dishonest and unethical. This is very disturbing given that the ABIM has great influence on medical practice and health policy, previously was regarded as prestigious and trustworthy, and has been expanding the scope of its activities to make it even more influential, e.g., by now requiring physicians to participate in periodic ABIM sanctioned or sponsored activities and take repeated ABIM exams to "maintain" their board certification. In my humble opinion, if the ABIM wants to continue to be trusted as it has been in the past, it needs a wholesale revision of its conflict of interest policies, and meanwhile needs to completely make public in detail the conflicts of interest affecting individuals who lead it, make its policy, write its examinations, construct its educational and maintenance of certification activities, and produce its other "products."  The ABIM ought to consider suspending attempst to expand its influence, e.g., by intensifying its requirements for maintenance of certification, until it has disclosed all relevant conflicts and improved its conflict of interest policies. 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.  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.

American Board of Internal Medicine Policy Condones Keeping Conflicts of Interest Secret

The latest complication of the CareFusion/ Dr Denham/ NQF/ Dr Cassel/ ABIM case was the revelation that the current president of the NQF, Dr...

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