Abort, Retry, Fail? - Lancet Avoided Much Recent Unpleasantness in Reporting on New Gates Foundation CEO (Including Her Defense of $55,000 a Year for Bevacizumab)
The April 26, 2014 issue of the prestigious journal Lancet used two full pages and two separate articles by the same author to discuss the ascension of the Gates Foundation new CEO, Dr Susan Desmond-Hellmann.(1-2)Two Somewhat Redundant Lancet Articles Dr Desmond-Hellmann trained as an oncologist, spent time working on AIDS and Kaposi's Sarcoma in Uganda, but then spent much of her career as a pharmaceutical/ biotechnology executive, as described in the first article,(1)After returning from Uganda, Desmond-Hellmann joined the nascent Taxol development programme at Bristol-Myers Squibb, before being poached by Arthur Levinso...
Source: Health Care Renewal - May 5, 2014 Category: Health Management Tags: anechoic effect boards of directors conflicts of interest Gates Foundation Genentech health care foundations health care prices Lancet medical journals Procter and Gamble UCSF Source Type: blogs

The Pervasiveness of Health Care Corruption as Shown by Another Roundup of Legal Settlements
Legal settlements are one way to document unethical and even corrupt behavior by large health care organizations, even if they may not deter bad behavior in the future.  It is time for another roundup of settlements by large pharmaceutical and device companies, presented in alphabetical orderAbbott LaboratoriesThis one goes back to late December, 2013.  As described in the Chattanoogan (from Tennessee):Abbott Laboratories, a global healthcare company, has agreed to pay $5.475 million to settle alleged violations of the False Claims Act, and other federal laws and regulations in connection with the operation of it...
Source: Health Care Renewal - April 30, 2014 Category: Health Management Tags: Abbott antitrust Baxter Endo Health Solutions fraud Hospira kickbacks legal settlements Neurontin Pfizer restraint of competition RICO Source Type: blogs

From a physician and former USAF air traffic controller/pilot on the state of healthcare IT
From a colleague, a physician and blogger and fellow AMIA member with an eclectic background, on the state of healthcare information technology.  Reposted with his permission.Emphases in bold are mine:To restate the old joke, the nice things about medical informatics standards, are their are so many of them too chose from… don’t think we necessarily need to invest even more time and energy on ever more sophisticated data models or ever more exhaustive standards (which are then largely ignored).  The fact of the matter is that the EMR remains in the United States a tool for maximization of reimburseme...
Source: Health Care Renewal - April 27, 2014 Category: Health Management Tags: AMIA F16 Frank Meissner healthcare IT difficulties human computer interaction Source Type: blogs

In ECRI Institute's new 2014 "Top 10 Patient Safety Concerns for Healthcare Organizations", Healthcare IT is #1. (FDA: E-cigarettes are REALLY dangerous.)
The ECRI Institute in Pennsylvania (https://www.ecri.org/About/Pages/default.aspx) has had health IT as among the "Top Ten Healthcare Technology Risks" for several years running.  Search this blog on "ECRI" for mention of those reports.Just off the press, though, is ECRI's "Top Ten patient safety concerns for 2014".  The PDF report is available at https://www.ecri.org/EmailResources/PSRQ/Top10/Top10PSRQ.pdf.Health IT is number one, perhaps as a result of the ECRI Deep Dive study of Health IT risk with its hair-raising numbers of 171 "IT incidents", 8 resultant injuries, and...
Source: Health Care Renewal - April 27, 2014 Category: Health Management Tags: #ecigarettes #ecigs #EHR #EMR #HITsm E-cigarettes ecri institute Top Ten patient safety concerns for 2014 Source Type: blogs

Followup to "CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives"
At my April 16, 2014 post "CMS does not have any information that supports or refutes claims that a broader adoption of EHRs can save lives" (http://hcrenewal.blogspot.com/2014/04/cms-does-not-have-any-information-that.html) I noted that the American Association of Physicians and Surgeons (AAPS) had received a reply from CMS to a FOIA request that:"We [CMS] do not have any information that supports or refutes claims that a broader adoption of EHRs can save lives." Put another way, the country is embarking on a $1 trillion healthcare experiment, and blindly.I mentioned I'd post the letter when received f...
Source: Health Care Renewal - April 26, 2014 Category: Health Management Tags: arra Centers for Medicare and Medicaid Services CMS foia Freedom of Information Act healthcare IT benefits healthcare IT risk #EHR #EMR #HCIT #HITsm Source Type: blogs

Hypocrisy at the FDA: Let's regulate E-cigarettes ... E-medical records, E-medical ordering and related Bad Health IT? They get a gentleman's pass.
Bad health IT is defined at my Medical Informatics academic site (http://cci.drexel.edu/faculty/ssilverstein/cases/) as follows:Bad Health IT ("BHIT") is health 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 p...
Source: Health Care Renewal - April 26, 2014 Category: Health Management Tags: #ecigarettes #ecigs bad health IT E-cigarettes FDA healthcare IT regulation Source Type: blogs

EHR recall: Use of this affected product may cause serious adverse health consequences, including death
Here is another example of a grossly defective health IT product, this from last year but only posted by FDA publicly on 3/14/2014 at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm389356.htm: "There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it included data from another case. Use of this affected product may cause serious adverse health consequences, including death."One wonders why problems like this are found in the field when real patients are involved, not in ...
Source: Health Care Renewal - March 24, 2014 Category: Health Medicine and Bioethics Commentators Tags: FDA recall healthcare IT defects healthcare IT risk McKesson McKesson Anesthesia Care Source Type: blogs

Better Late than Never - JAMA Article Advocates Banning Academic Medical Leaders from Serving on Many Health Care Corporate Boards
Conclusion So 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 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.As we have said again and again, the web of conflicts of inter...
Source: Health Care Renewal - March 20, 2014 Category: Health Medicine and Bioethics Commentators Tags: academic medical centers boards of directors boards of trustees conflicts of interest leadership medical schools You heard it here first Source Type: blogs

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 (http://www.forbes.com/sites/nicolefisher/) published an article in Forbes dat...
Source: Health Care Renewal - March 20, 2014 Category: Health Medicine and Bioethics Commentators Tags: CRICO ECRI Deep Dive Study FDA forbes healthcare IT risk IOM Committee on Patient Safety and Health Information Technology Nicole Fisher Source Type: blogs

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:California Supreme Court upholds whistleblower protection for Modesto physicianBy Ken CarlsonFebruary 20, 2014 http://ww...
Source: Health Care Renewal - March 19, 2014 Category: Health Medicine and Bioethics Commentators Tags: ad hominem fallacy AHIMA Corporate Integrity Advocate financialization Kim Baldwin Stried-Reich Mark Fahlen MD sham peer review Steve Mitchell Sutter Health whistle-blowers Source Type: blogs

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-safety-quality-healthcare.html) 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, represented 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 t...
Source: Health Care Renewal - March 19, 2014 Category: Health Medicine and Bioethics Commentators Tags: bad health IT CRICO David Ting MD Harvard healthcare IT risk Luke Sato MD Source Type: blogs

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 to distract the viewer from seeing it. The example, reported 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.BackgroundPradaxa, 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 discussed previously the release of documents during litigation that showed how marketers from its manuf...
Source: Health Care Renewal - March 18, 2014 Category: Health Medicine and Bioethics Commentators Tags: Boehringer Ingelheim deception FDA manipulating clinical research Pradaxa Source Type: blogs

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 update on the revolving door 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 Synthe...
Source: Health Care Renewal - March 13, 2014 Category: Health Medicine and Bioethics Commentators Tags: David Brailer Eli Lilly ONC Pfizer Purdue Pharma revolving doors Synthes WellPoint White House Source Type: blogs

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 this:Patient Safety and Health IT UsabilityPatient safety and usability continue to be a focus forONC. Working with federal partners AHRQ and FDA,ONC will create the foundation for a patientsafety program that will be launched in FY 2014called “The Patient Safety Plan”. The Plan seeksto ensure that health IT is safely designed andimplemented, medical staff are properlyinformed and trained to use their health ITsystems, and a surveillance system is establishedto monitor health IT ...
Source: Health Care Renewal - March 12, 2014 Category: Health Medicine and Bioethics Commentators Tags: Administrative Procedure Act of 1946 AHRQ FDA federal executive department federal independent agency healthcare IT regulation HHS ONC Source Type: blogs

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 here).  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 year...
Source: Health Care Renewal - March 6, 2014 Category: Health Medicine and Bioethics Commentators Tags: ABIM boards of directors conflicts of interest deception Dr Christine Cassel Premier Inc transparency Source Type: blogs

The Plot of the CareFusion/ Dr Denham/ NQF/ ABIM/ Dr Cassel Case Thickens Even More - Current NQF and Previous ABIM CEO Found to be Long-Term Premier Inc Board Member, Resigns from that Board
The plot of the CareFusion/ Dr Denham/ NQF/ Leapfrog Group case (as we previously entitled it)  just will not stop thickening.Background To summarize the events up to our last post on the subject:   -  The case became public with an apparently routine legal settlement between CareFusion and the US Department of Justice -  The CareFusion settlement for $40.1 million was made in response to allegations that kickbacks were made to promote ChloraPrep, a solution meant for preoperative and other health care skin cleaning-  The Department of Justice news release also alleged that payments were ...
Source: Health Care Renewal - March 3, 2014 Category: Health Medicine and Bioethics Commentators Tags: ABIM conflicts of interest Dr Christine Cassel group purchasing organizations National Quality Forum Premier Inc Source Type: blogs

Some inconvenient observations regarding our "National Program for IT in the HHS"
(To astute readers, "National Program for IT in the HHS" is a not-very-thinly-veiled reference to the NPfIT, the National Programme for IT in the NHS, a £12.7bn project that went "pffft.")I have been very concerned  over the years about EHR and other clinical IT risk, and with patient's rights (e.g., to a safe care environment, a legal obligation of healthcare facilities to maintain in the U.S).Looking at the medical malpractice data at my Feb. 28, 2014 post "Malpractice Claims Analysis Confirms Risks in EHRs" (http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare....
Source: Health Care Renewal - March 3, 2014 Category: Health Medicine and Bioethics Commentators Tags: CRICO Healthcare IT failure healthcare IT risk HIT regulation medical malpractice Source Type: blogs

Patient Safety & Quality Healthcare: "Malpractice Claims Analysis Confirms Risks in EHRs"
Two "EHRs are not as pure as driven snow"-related stories in one day.  It's hard to keep up:After my earlier post today "EHRs: The Real Story" - Sobering assessment from Medical Economics, now there's this.From the journal "Patient Safety & Quality Healthcare" (PSQH):Malpractice Claims Analysis Confirms Risks in EHRsJan/Feb 2014 Article available at this link.[Short header on several EHR-related care foul ups]... Distressing situations like those described above are happening around the country as healthcare organizations adopt electronic health records (EHRs) in growing numbers. Alth...
Source: Health Care Renewal - February 28, 2014 Category: Health Medicine and Bioethics Commentators Tags: CRICO Ddulite health IT failure health IT risk healthcare IT dangers healthcare IT safety lawsuit medical malpractice Source Type: blogs

"EHRs: The Real Story" - Sobering assessment from Medical Economics
From Medical Economics -"EHRs: The Real Story",  pg. 18-27, Feb. 10, 2014, available here (PDF).Full issue at http://medicaleconomics.modernmedicine.com/sites/default/files/images/MedicalEconomics/DigitalEdition/Medical-Economics-February-10-2014.pdf - it is large, 12 MB:... "Despite the government’s bribe of nearly $27 billion to digitize patient records, nearly 70% of physicians say electronic health record (EHR) systems have not been worth it. It’s a sobering statistic backed by newly released data from marketing and research f rm MPI Group and Medical Economics that suggest nearly two-th...
Source: Health Care Renewal - February 28, 2014 Category: Health Medicine and Bioethics Commentators Tags: AMIA healthcare IT dissatisfaction Healthcare IT failure HIMSS Medical Economics surveys Source Type: blogs

On the destruction of medicine as a profession: "Try bending a lawyer over a barrel"
From a physician colleague, a dedicated professional, reposted with redaction of locale with permission.This speaks for itself.  I believe there are a great number of medical professionals who would speak out this way, if they did not fear retaliation (as does my colleague, hence anonymity) or if they were not suffering from the syndrome of clinician learned helplessness (http://hcrenewal.blogspot.com/2007/10/physicians-learned-helplessness.html):Scot,Yesterday I spent some time in a family docs office in [redacted] who has been experiencing an EHR failure in his office. Naturally its messed up his work flow not to me...
Source: Health Care Renewal - February 27, 2014 Category: Health Medicine and Bioethics Commentators Tags: bureaucracy demoralization learned helplessness Source Type: blogs

Incoming President of IOM Outed as Member of Boards of Alnylam Pharmaceuticals, Medtronic and Pepsico
We just discussed how the new CEO of the National Quality Forum was revealed to be a member of the board of directors of Premier Inc, and discussed the implications of this apparently intense conflict of interest.  Now another new leader of an influential non-profit organization dedicated to improving health and health care has also been shown to have major conflicts of interest.All Hail the New President of the Institute of MedicineIn 2010, we posted about a student protest of the salaries of some top administrators at Duke University, including then Chancellor of Health Affairs Dr Victor Dzau, at a time when the uni...
Source: Health Care Renewal - February 24, 2014 Category: Health Medicine and Bioethics Commentators Tags: Alnylam Pharmaceuticals boards of directors conflicts of interest Genzyme Institute of Medicine Medtronic Pepsico Source Type: blogs

We're Sorry ... Our New EMR May Screw Up Your Care, But Don't Worry ... Patient Safety Has Not Been Compromised
A sign seen at a hospital system recently (name redacted):We're Sorry for any "Delays" as we start using our new EMR system ... But as a patient, you'll notice many benefits.   As to risks, nothing to see here ... move along.   (Click to enlarge)FirstNet is an EMR system for Emergency Departments. What's missing here is this:While "glitches" that can harm you can happen anytime with these systems, at startup time disruptions and malfunctions that could cause injury or death (as reported by FDA, U.S. Institute of Medicine, ECRI Institute per their Deep Dive study of health IT risk and...
Source: Health Care Renewal - February 23, 2014 Category: Health Medicine and Bioethics Commentators Tags: healthcare IT risk informed consent Patient care has not been compromised Source Type: blogs

The CareFusion/ Dr Denham/ NQF /Leapfrog Goup Case that Would Not Go Away - NQF CEO Outed as Member of Premier Inc Board
The story of the CareFusion/ Dr Denham/ NQF/ Leapfrog Group case refuses to go away, even if it still has not created any echoes in the mainstream media or the medical and health care literature.  Now it appears that the NQF has an even bigger conflict of interest problem than previously reported.  BackgroundAs of our last post on 5 February, 2014, the background was--  The case became public with an apparently routine legal settlement between CareFusion and the US Department of Justice -  The CareFusion settlement for $40.1 million was made in response to allegations that kickbacks were made to pr...
Source: Health Care Renewal - February 21, 2014 Category: Health Medicine and Bioethics Commentators Tags: boards of directors conflicts of interest group purchasing organizations National Quality Forum Source Type: blogs

Computer woes hit Banner hospital system: Another large EHR outage ... but patient safety was not compromised
Here is yet another story in the genre of "EHRs go out, but patient care has not been compromised." (See query link at http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised; there are more than 20 posts there now):Computer woes hit Banner hospital systemKen Alltucker, The Arizona Republic 12:30 a.m. EST February 20, 2014http://www.usatoday.com/story/news/nation/2014/02/19/computer-woes-slam-banner-hospital-system/5630829/The Phoenix-based health system used backup paper records to help provide patient care.PHOENIX -- Banner Health grappled with a widespread computer outage Wed...
Source: Health Care Renewal - February 20, 2014 Category: Health Medicine and Bioethics Commentators Tags: Banner Health System health IT risk healthcare IT crash Patient care has not been compromised Source Type: blogs

To Die in Texas - Dr Mahmood's Apparently Fatal Stealth Hospital System Collapses Nearly Anechoically
I would bet that most people in the US still think our health care system is highly regulated.  Some may thus conclude that the system is basically safe, because, for example, drugs have to be proven safe and effective to be approved by the government, and hospitals must be licensed and run by competent people who are thoroughly vetted.  Of course, some people still think that the US has, or had until recently, the best health care system in the world (look here).Furthermore, the view that less regulation is always better is no quite popular in the US and elsewhere.  For example, after the chemical spill thr...
Source: Health Care Renewal - February 18, 2014 Category: Health Medicine and Bioethics Commentators Tags: adverse effects anechoic effect deception generic management generic managers hospital systems mission-hostile management mortality patient safety quality Source Type: blogs

InformaticsMD on NPR Affiliate KNPR regarding electronic medical record privacy: St. Rose hospital group used patient information to solicit patient lobbying?
Radio station News 88.9 KNPR, the NPR affiliate in Las Vegas did a segment today on the following news story.  The station's Senior Producer had invited me to participate via phone regarding patient privacy issues.Emphases mine:  http://www.reviewjournal.com/news/federal-complaint-alleges-st-rose-hospitals-violated-patient-privacyFebruary 10, 2014 - Updated  February 11, 2014 Federal complaint alleges St. Rose Hospitals violated patient privacyBy STEVEN SLIVKALAS VEGAS REVIEW-JOURNALDignity Health, the owner of St. Rose Dominican Hospitals, is facing a federal complaint alleging it violated patient privacy b...
Source: Health Care Renewal - February 13, 2014 Category: Health Medicine and Bioethics Commentators Tags: Dave Becker Dignity Health Health Services Coalition healthcare IT risk KNPR medical record confidentiality medical record privacy St. Rose hospital group Source Type: blogs

"Can't This be Avoided?" - How Corporate Marketers Manipulated a Clinical Research Report to Avoid "Undermining" Marketing Messages
ConclusionsThis case study, only made possible by the public release of internal corporate documents in the course of litigation, suggests that in retrospect the dissemination of the results of one particular clinical trial were manipulated in a somewhat subtle way so that the data would not contradict a marketing message that now appears rather fictional.In the absence of litigation, and of a judge willing to make public documents that one party to the litigation doubtless wanted to hide, the manipulation of this particular study might never have been apparent.  Most clinical research is now sponsored by health care ...
Source: Health Care Renewal - February 13, 2014 Category: Health Medicine and Bioethics Commentators Tags: Boehringer Ingelheim deception manipulating clinical research Pradaxa secrecy Source Type: blogs

H.R.2957 and its proposal to limit eDiscovery of potentially admissible and material evidence in EHR-related medical disasters
Do computers have more rights than patients?It often appears that way to me. Health IT and its industry sector seem to garner extraordinary regulatory accommodations compared to other healthcare and life-critical sectors - such as freedom from meaningful safety regulation, freedom from need for human research subjects protections and informed consent on EHR risks ... and in this proposal, freedom from full legal Discovery:US Congress has a bill, H.R.2957 - Behavioral Health Information Technology Act of 2013, 113th Congress (2013-2014), at http://beta.congress.gov/bill/113th/house-bill/2957) with a section (SEC. 4. PROVIDI...
Source: Health Care Renewal - February 11, 2014 Category: Health Medicine and Bioethics Commentators Tags: eDiscovery H.R.2957 healthcare IT special accommodation PROTECTIONS FOR USERS OF CERTIFIED EHR TECHNOLOGY Rules Enabling Act Source Type: blogs

A Day In The Life Of A (Reluctant But Coerced) EHR-Using Physician - And Her Patients
A reader, a physician who wishes to be unnamed due to fear of retaliation, writes the following:Dear Dr. Silverstein,As you write, there is not a transaction of medical care that does not go through EHR systems.However, these poorly usable EHR systems stifle creative and artistic thought required to link risk, benefit, and probability of diagnosis with risks and benefits of testing and therapeutics.Assuring safety and efficacy with pre- and  aftermarket surveillance will maximize the possibility of achieving the potential of the technologies.Additionally, when I use these electronic ordering systems and  librarie...
Source: Health Care Renewal - February 9, 2014 Category: Health Medicine and Bioethics Commentators Tags: healthcare IT dangers healthcare IT distraction healthcare IT safety healthcare IT toxicity Source Type: blogs

Who Knew? ... Judge Finds that Hospital Takeover of Medical Practices Raised Prices
A story that caused only a few ripples in the media in late January, 2014, corroborates concerns about the increasing concentration of power in health care, and suggests new skepticism about the continuing transition of physicians from independent professionals to corporate employees.The Judge Quashes a Hospital System's Acquisition of Physicians' PracticesThe original story was carried, albeit briefly, in some national business news sources, e.g., the Wall Street Journal and Bloomberg news.   In summary, according to the WSJ, A federal judge ruled Friday that an Idaho hospital system must unwind its acquisition ...
Source: Health Care Renewal - February 7, 2014 Category: Health Medicine and Bioethics Commentators Tags: anechoic effect antitrust concentration of power corporate physician restraint of competition St Luke ' s Health System Source Type: blogs

The Implications of the CareFusion/ Dr Denham/ NQF/ Leapfrog Group Case Continue to Grow, but Remain Anechoic
The story about CareFusion, Dr Charles Denham, and the National Quality Forum certainly has legs, but continues to tread very softly. BackgroundAt the time of our last post, on January 28, 2014, the basics were:-  The case became public with an apparently routine legal settlement between CareFusion and the US Department of Justice -  The CareFusion settlement for $40.1 million was made in response to allegations that kickbacks were made to promote ChloraPrep, a solution meant for preoperative and other health care skin cleaning-  The Department of Justice news release also alleged that payments wer...
Source: Health Care Renewal - February 5, 2014 Category: Health Medicine and Bioethics Commentators Tags: anechoic effect CareFusion conflicts of interest deception kickbacks Leapfrog Group manipulating clinical research National Quality Forum Source Type: blogs

The Greedy Leading the Greedy - Multimillionaire Former Johnson and Johnson CEO Approved Huge Compensation for JP Morgan Chase CEO After Company Paid $20 Billion in Legal Settlements
JP Morgan Chase CEO Got Huge Raise Despite Company's Recent Huge Legal Settlements The current compensation set by the board of directors of JP Morgan Chase for CEO Jamie Dimon, $20 million a year, has attracted some attention (e.g., see this commentary by Matt Taibbi), especially given the contrast between his raise and the $20 billion or so the company had to pay out last year in settlements of allegations of unethical practices.  A New York Times opinion piece rushed to Mr Dimon's defensein the world of executive compensation, especially when viewed from the rarefied perspective of other chief executives, and more ...
Source: Health Care Renewal - January 31, 2014 Category: Health Medicine and Bioethics Commentators Tags: boards of directors executive compensation finance impunity Johnson and Johnson JPMorgan Chase legal settlements William Weldon Source Type: blogs

Putting Finance Executives in Charge of Health Care? - What Could Possibly Go Wrong?
A US News and World Report article affirms what we have previously written, that those charged with the stewardship of US hospitals are even more inclined now to hire top managers with little or no health care experience or credentials. Putting Finance Managers in Charge They particularly seem to favor executives drawn from the world of finance.Just to make it really clear, the exposition started with the article title, Wanted: Hospital CEOs Without Health Care Experience The article drew on some of the figures about executive hiring which we discussed in December, 2013,It’s expected that two-thirds of hosp...
Source: Health Care Renewal - January 30, 2014 Category: Health Medicine and Bioethics Commentators Tags: finance financialization generic management generic managers hospitals ' coup d etat Source Type: blogs

The CareFusion/ Denham/ NQF Case - the Plot Thickens
Discussion turned to recommendations for preventing infections caused by central lines, the thin tubes inserted into a vein to deliver fluids or medications. Dr. Gregg Meyer of Massachusetts General Hospital in Boston, the co-chair of the committee with Denham, brought up the forthcoming study. 'Chuck (Denham) made me aware of it,' Meyer said. He then asked Pronovost, a leading expert on preventing central-line infections, what he thoughtThe final report did delete the specific reference to ChloraPrep as the preferred method for preparing surgical sites,.After the meeting, when the committee’s draft report was publi...
Source: Health Care Renewal - January 28, 2014 Category: Health Medicine and Bioethics Commentators Tags: CareFusion conflicts of interest deception institutional conflicts of interest manipulating clinical research National Quality Forum Source Type: blogs

Martin Health System, Florida: Our EHRs were out for two days, but patient care has not been compromised, sayeth Pinocchio
This is yet another post in my ever-growing "our EHRs went out due to IT incompetence, and chaos ensued, but patient care has not been compromised" series (see query link: http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised):Martin Health System looking into network outage that slowed hospital operationsPosted: 01/24/2014By: Meghan McRobertshttp://www.wptv.com/dpp/news/region_martin_county/martin-health-system-looking-into-network-outage-that-slowed-hospital-operationsMARTIN COUNTY, Fla.-- Martin Health System is looking into what caused some computer hardware to fail Wednes...
Source: Health Care Renewal - January 25, 2014 Category: Health Medicine and Bioethics Commentators Tags: Martin Health System Martin Hospital South Martin Medical Center Meghan McRoberts Patient care has not been compromised Scott Samples Tradition Medical Center Source Type: blogs

Windy city blues
WINDY CITY BLUESThere is an academic ethics mess brewing in the windy city… at The University of Chicago. It involves a start-up Chicago corporation, a star statistician in the medical school, seed money in the form of NIH research grants, the American Psychiatric Association, and the chairman of the APA’s DSM-5 Task Force. It involves the appearance of self-interested bias in the DSM-5 process. It involves a recidivist pattern of failure to disclose material conflict of interest. And it involves academic journal editors (JAMA and JAMA Psychiatry) who did not do the right thing when the perps were outed.I brok...
Source: Health Care Renewal - January 25, 2014 Category: Health Medicine and Bioethics Commentators Tags: American Psychiatric Assn Bernard Carroll David Kupfer David Weiss DSM-5 Ellen Frank Howard Bauchner JAMA Network Joseph Coyle Paul Pilkonis Robert Gibbons University of Chicago Source Type: blogs

Physician whose mother had heart surgery reflects on sane EHR use
The following from a physician I know, an ED physician, on the care their mother received at a major academic medical center's teaching hospital using EHR.Emphases mine:Mom just had aortic valve at hospital [name redacted] associated with [redacted] Medical School.  EHR used was [major EHR vendor name redacted] but it clearly had been pushed into the background......1) Every ICU patient also had a printed chart in a notebook (paper) medical record book kept at the nursing station.  Just like the old days. It was the most commonly used source of info to the residents and staff.2) Not once did I see an EHR physical...
Source: Health Care Renewal - January 24, 2014 Category: Health Medicine and Bioethics Commentators Tags: EHR-associated clerical work healthcare IT risks Source Type: blogs

Putting in the Ski Lifts - National Quality Forum Leaders Improve Conflict of Interest Policies in Response to CareFusion Case
The complex case that came to light with reports of a legal settlement by CareFusion of allegations that it paid kickbacks to promote its ChloraPrep product just got even more complex, but now also a bit more hopeful, and hence much more hopeful than most of the cases we discuss..Background As we noted yesterday, the CareFusion settlement seemed routine when it was first briefly reported in the media.  Then Modern Healthcare published a series of articles about its ramifications, the latest appearing today. In summary prior to the latest article,-  the CareFusion settlement for $40.1 million was made in response ...
Source: Health Care Renewal - January 23, 2014 Category: Health Medicine and Bioethics Commentators Tags: conflicts of interest guidelines institutional conflicts of interest National Quality Forum transparency Source Type: blogs

Our Man in the NQF? - CareFusion Settles Kickback Allegations for $40.1 Million and Government Alleges They Meant to Manipulate National Quality Forum Standards
What appeared to be yet another entry in the march of legal settlements turns out to be more interesting than it first appeared.The Basic Story: Off-Label Marketing  The story was initially briefly reported in the media.  A report in the Seattle Post-Intelligencer on 9 January, 2014, was perhaps the most complete, CareFusion, a manufacturer of medical and surgical supplies and medical devices, has agreed to settle charges of illegal marketing practices and kickback payments for promoting sales of the company’s surgical preparation solution, Chloraprep.Under the terms of the settlement with Washington, other...
Source: Health Care Renewal - January 22, 2014 Category: Health Medicine and Bioethics Commentators Tags: CareFusion conflicts of interest guidelines institutional conflicts of interest kickbacks legal settlements National Quality Forum pay for performance Source Type: blogs

Five Years Into Compelled National Adoption of Electronic Medical Records, Which Were Advertised As Capable Of Only Good, ONC Issues Safety "Suggestions"
Ten years after creation of the ONC office, and almost five years into compelled national adoption of health IT under HITECH (financial penalties soon start to accrue for non-users or non-adopters of "certified" systems and in at least one state, denial of medical licensure), the HHS's Office of the National Coordinator for health IT released the cutely-named "SAFER" guides ("Safety Assurance Factors for EHR Resilience").That's progress.  (A previous ONC leader, for instance, had opined that the FDA’s injury findings related to health IT that appeared in the Internal FDA memorandum ...
Source: Health Care Renewal - January 21, 2014 Category: Health Medicine and Bioethics Commentators Tags: ECRI Deep Dive Study healthcare IT risk ONC SAFER Safety Assurance Factors for EHR Resilience Source Type: blogs

Computers + a few docs can manage "an entire city", and other cybernetic miracles
The computing aboard the Apollo spacecraft, that provided computation and electronic interfaces for guidance, navigation, and control of the spacecraft that went to the moon, was primitive by today's standards.   From Wikipedia (http://en.wikipedia.org/wiki/Apollo_Guidance_Computer):The Apollo flight computer was the first to use integrated circuits (ICs). While the Block I version used 4,100 ICs, each containing a single 3-input NOR gate, the later Block II version (used in the crewed flights) used 2,800 ICs, each with dual 3-input NOR gates.  [Today's CPUs alone have millions of logic gates and can have bi...
Source: Health Care Renewal - January 20, 2014 Category: Health Medicine and Bioethics Commentators Tags: cybernetic miracle Source Type: blogs

More Pharmaceutical Misadventures - Actelion Damages Upheld, Genzyme (Sanofi Subsidiary) Settled, Merck Fined
The march of legal settlements by large health care organizations goes on, albeit with ever more quiet footsteps as the number of journalists available to amplify their sounds declines.  Last week we noted the shutdown of PharmaLot, a journalistic blog edited by Ed Silverman that was one of the few that reported fearlessly on the pharmaceutical industry, warts and all.So we dedicate this round up of legal settlements by pharmaceutical companies announced last month, December, 2013, to Ed Silverman, who reported on two of the cases below, and whose reports have been silenced by the shutdown of the PharmaLot web-site by...
Source: Health Care Renewal - January 18, 2014 Category: Health Medicine and Bioethics Commentators Tags: Actelion adverse effects deception Genzyme legal settlements Merck restraint of competition Sanofi-Aventis Source Type: blogs

Out Goes 2013. Some Year-End Observations on Healthcare IT: The Data Granularity Theater of the Absurd, Be Careful What You Ask For, And a Little Totalitarianism from HIStalk Blog
As 2013 comes to a close, here are some year-end observations on Healthcare IT:From the Dec. 30, 2013 New York Times article "Roughed Up by an Orca? There’s a Code for That" (http://www.nytimes.com/2013/12/30/technology/medical-billing-nears-a-new-era-of-ultra-specific-codes.html):1) ICD-10: the Data Granularity Theater of the Absurd... ICD-9 [used in the United States for medical statistics since 1979 and for billing since 2002] ... has about 14,000 codes to specify diagnoses and 3,000 to specify inpatient procedures. ICD-10, with codes containing up to seven digits or letters, will have about 68,000 for d...
Source: Health Care Renewal - December 31, 2013 Category: Health Medicine and Bioethics Commentators Tags: Dr. Jayne HIStalk ICD-10 John Halamka National Practitioner Data Bank totalitarianism Source Type: blogs

No Needle, but the Damage was Done - A New Example of Suppression of Research about Adverse Effects of Prescription Narcotic Analgesics
This story feels personal, since as a physician who trained starting in the 1970s, figuring out how to manage patients who desperately wanted narcotics, whether to relieve pain, relieve addiction, or relieve financial distress has been a constant challenge.Background  - Treating Pain while Avoiding "the Needle and the Damage Done"Almost as soon as I started clinical training in medical school I came up against the problem of narcotics.  In the 1970s, narcotic addiction was a pressing problem that threw a dismal shadow over society..  In the hospital and emergency room we daily saw overdoses and the...
Source: Health Care Renewal - December 26, 2013 Category: Health Medicine and Bioethics Commentators Tags: conflicts of interest deception Janssen Johnson and Johnson key opinion leaders narcotics suppression of medical research Source Type: blogs

Another Reason to Put Everyone's Confidental Medical Information Into Today's Massively Secure (Surely They Are, No?) EHR systems
Office of Inspector GeneralDepartment of the Treasury Oct. 17, 2013Audit report INFORMATION TECHNOLOGY: OCC's (Office of the Comptroller of the Currency) Network and Systems Security Controls Were DeficientPDF available at: http://www.treasury.gov/about/organizational-structure/ig/Audit%20Reports%20and%20Testimonies/OIG-14-001.pdf Highlights:... To accomplish our objective, we performed a series of internal and external vulnerability assessments and penetration tests on OCC’s workstations, servers, network-attached peripherals (such as cameras and printers), infrastructure devices, and Internet websites.... We determ...
Source: Health Care Renewal - December 21, 2013 Category: Health Medicine and Bioethics Commentators Tags: computer security medical record confidentiality medical record privacy Office of the Comptroller of the Currency Source Type: blogs

Health Care Experience? - Hospital CEOs Don't Need No Stinkin' Health Care Experience
Discussion In 1988, Alain Enthoven advocated in Theory and Practice of Managed Competition in Health Care Finance, a book published in the Netherlands, that to decrease health care costs it would be necessary to break up the "physicians' guild" and replace leadership by clinicians with leadership by managers (see 2006 post here). Thus from 1983 to 2000, the number of managers working in the US health care system grew 726%, while the number of physicians grew 39%, so the manager/physician ratio went from roughly one to six to one to one (see 2005 post here). As we noted here, the growth continued, s...
Source: Health Care Renewal - December 20, 2013 Category: Health Medicine and Bioethics Commentators Tags: financialization generic management generic managers hospitals ' coup d etat Source Type: blogs

EHR cut-and-paste problem is only one of the several mechanisms to clone documentation - and facilitate fraud
In my Dec. 10, 2013 post "44% of hospitals reported to HHS that they can delete the contents of their EHR audit logs whenever they'd like" (http://hcrenewal.blogspot.com/2013/12/44-of-hospitals-reported-to-oig-that.html) I observed that the "money quote" of the Modern Healthcare article that prompted the post, "Feds eye crackdown on cut-and-paste EHR fraud" by Joe Carlson was not the issue of EHR cut-and-paste features and billing fraud, but EHRs and audit trail alteration.Dr. Stephen R. Levinson, an E/M compliance and healthcare quality expert among other areas of expertise (see http://www.li...
Source: Health Care Renewal - December 19, 2013 Category: Health Medicine and Bioethics Commentators Tags: EHR cut and paste fraud healthcare IT note cloning healthcare IT note copying ONC Stephen R. Levinson MD upcoding Source Type: blogs

An Idiotically-Designed EHR Medication Discontinuation "Feature"
Over at The Healthcare Blog, Michael Chen, MD, a family physician and EHR designer in Portland, Oregon wrote a piece entitled "Why EHR Design Matters" (http://thehealthcareblog.com/blog/2013/12/18/why-ehr-design-matters/).  I am cited.Dr. Chen reports on a major commercial EHR with the following "feature":... In this well known EHR, you are presented a medication list for a patient. As a physician, you assume that this list is a current medication list and is up to date.  However, the reality is that this EHR system automatically removes a medication from the list when it is determined to be e...
Source: Health Care Renewal - December 19, 2013 Category: Health Medicine and Bioethics Commentators Tags: healthcare IT dangers healthcare IT defects Michael Chen MD The Healthcare Blog Source Type: blogs

The Camel's Aching Back - Johnson and Johnson and Novartis Fined 16 Million Euro for "Anticompetitive" Scheme to Delay Generic Fentanyl
Legal and regulatory actions unfavorable for giant pharmaceutical, biotechnology and device company Johnson and Johnson just keep coming.  We last discussed such a story only two weeks ago here. The Latest Case This latest story got only desultory US coverage from the wire services.  The most complete version is in the European Commission press release.  The basics were:The European Commission has imposed fines of € 10 798 000 on the US pharmaceutical company Johnson & Johnson (J&J) and € 5 493 000 on Novartis of Switzerland. In July 2005, their respective Dutch subsidiaries concluded ...
Source: Health Care Renewal - December 17, 2013 Category: Health Medicine and Bioethics Commentators Tags: antitrust Fentanyl Johnson and Johnson mission-hostile management narcotics Netherlands Novartis restraint of competition Source Type: blogs

A Second Order Cover Up? - Judge Finds Boehringer Ingelheim Allowed Destruction of Records Bearing on Allegations of Cover Up of Drug Adverse Effects
This case generated little coverage, a story in Bloomberg, and a post on PharmaLot, but perhaps should have received more attention.Background - the Pradaxa Case The background, per Bloomberg, is thatBoehringer [Ingelheim BmbH] is preparing to face the first federal court trial of claims that it hid Pradaxa’s bleeding risks. Pradaxa is dabigatran, a new anti-coagulant drug that can be used without frequent monitoring of blood tests, as is required when using the older drug warfarin.  However, unlike warfarin, the effects of dabigatran cannot be quickly reversed should a patient on the drug start to bleed. T...
Source: Health Care Renewal - December 16, 2013 Category: Health Medicine and Bioethics Commentators Tags: Boehringer Ingelheim deception Pradaxa warfarin Source Type: blogs