Efficacy, We Don't Need No Stinking Proof of Efficacy - Says Apparent Trump Candidate to Lead FDA
DiscussionWe could do our usualrant about the revolving door here.   Obviously, the revolving door pheonomenon is a serious conflict of interest, if not form of corruption, that should have no place in our government, particularly in its agencies that are concerned with health care.  But there is a bigger issue here.So add anyone who might have to receive any medical treatment to the long list of people who should be worried about a future Trump administration.  Maybe we would all be better off if Mr Tump finds something else to do for the next four years.  Maybe he should stick tobeing executive p...
Source: Health Care Renewal - December 9, 2016 Category: Health Management Tags: adverse effects Donald Trump evidence-based medicine FDA revolving doors Source Type: blogs

The Combating Corruption in Health Care and Pharmaceuticals Symposium
ConclusionsAs I have said before, and nowonce more with feeling... if we really want to reform health care, in the very little time we may have before our health care bubble bursts (which appears imminent in the US), we will need to take strong action against health care corruption.  Such action will really disturb the insiders within large health care organizations who have gotten rich from their organizations'misbehavior, and thus taking such action will require some courage.  Yet such action cannot begin until we acknowledge and freely discuss the problem.  The first step against health care corruption is...
Source: Health Care Renewal - December 1, 2016 Category: Health Management Tags: accountability health care corruption transparency WHO Good Governance for Medicines Programme Source Type: blogs

Round Up No Suspects: the Bio Telemetry Settlement Demonstrates the Continuing Impunity of Health Care Organizational (and Other) Leaders
Themarch of legal settlements by important health care organizations continues, although now producing barely an additional ripple on top of the white-capped covered ocean of news and commentary roiled by the recent US election.  However, even the latest small settlement is a reminder of all the problems that continue under the surface.  (And I have now beaten this metaphor to death, sorry.)The SettlementAs reported very brieflyin NJ.com:A company that monitors cardiac devices worn by heart patients has agreed topay $1.3 million in civil fines to resolve allegations it paid kickbacks to doctors to persuade them t...
Source: Health Care Renewal - November 22, 2016 Category: Health Management Tags: bribery health care corruption impunity kickbacks legal settlements medical devices Source Type: blogs

Trumping En Masse Through the Revolving Door - the Trump Advisory and Transition Teams
We have frequently posted on therevolving door as a type of severe conflict of interest, if not corruption, affecting health care.  Our posts have covered various cases of people going from influential positions in or related to health care and some anti-health corporations, and government positions that make health care policy or regulate health care. Donald J Trump, the president elect, has pledged to " drain the swamp, " that is, to generally reduce crony capitalism, conflicts of interest, the revolving door, and government corruption (e.g., lookhere.)  However, it appears that his campaign advi...
Source: Health Care Renewal - November 18, 2016 Category: Health Management Tags: Altria Celgene Cerberus conflicts of interest Donald Trump Pfizer PhRMA Purdue Pharma revolving doors Source Type: blogs

Latest Example of the Rigged Health Care System: BTG Pleaded Guilty to " Misbranding " for Marketing a Device Never Proven to Do Any Good
Just before the US Presidential election, yet another story of how the health care system is rigged slipped just barely into public view.   The only media report with any detail about itcame from the Corporate Crime Reporter on November 7, 2016.The Selling of an Unproven Invasive DeviceThe basics were:Pennsylvania-based medical device manufacturer Biocompatibles Inc., a subsidiary of BTG plc, pled guilty to misbranding its embolic device LC Bead and will pay more than $36 million to resolve criminal and civil liability arising out of its illegal conduct.So,Biocompatiblespled guilty to a misdemeanor charge in conn...
Source: Health Care Renewal - November 9, 2016 Category: Health Management Tags: crime deception impunity legal settlements medical devices Source Type: blogs

Trumping the Evidence - The Donald Denies Asbestos Related Disease, Post-Traumatic Stress Disorder, Chronic Traumatic Encephalopathy but Asserted Vaccines Cause Autism
One of the main causes of health care dysfunction identified by demoralized health care professionals in our 2003 qualitative study was threats to evidence-based medicine, and by extension, evidence-based public health and health policy.(1) Since then, we have frequently discussed threats such asmanipulation andsuppression of clinical research to further vested interests, and distortion of research dissemination, such asghost written articles, often enabled byindividual andinstitutional conflicts of interest.These and other causes of health care dysfunction which we discuss, however, have hardly been the stuff of political...
Source: Health Care Renewal - November 2, 2016 Category: Health Management Tags: asbestos Donald Trump evidence-based medicine health policy public health Source Type: blogs

Legal Settlements to Remind Us How Our Health Care System Became Rigged: by GSK, Novartis, CVS
Amidst the sound and fury of the US election season, almost under the radar sneaklegal settlements demonstrating continuing bad behavior by big health care organizations, and the continuing lack of accountablity of these organizations'leaders.We note three cases involving unethical practices leading to overuse of pharmaceuticals that appeared in the last two months, in chronological and alphabetical order.GlaxoSmithKline Settles Charges of Bribing Chinese DoctorsA summary fromStat by Ed Silverman on September 30, 2016,GlaxoSmithKline on Friday agreed topay $20 million to settle charges of violating the Foreign Corrupt Prac...
Source: Health Care Renewal - October 19, 2016 Category: Health Management Tags: Abbott bribery CVS deception GlaxoSmithKline impunity kickbacks legal settlements Novartis Omnicare Source Type: blogs

Petitions for Research Integrity and Against Corruption Available for Signature
Recently, two petitions relevant to the goals ofHealth Care Renewal have become available. US Petition to " Stop False Reporting of Drug Benefits& Harms by Making FDA& NIH Work Together "Health Care Renewal blogger Dr Bernard Carroll, along with Dr Mickey Nardo, who blogs on1BoringOldMan, and Emeritus Professor John H Noble Jr have authored a petition to improve the reporting of clinical research in the US, and hence combat themanipulation of clinical research, a topic we often discuss.Its essence is:We now petition Congress to require the FDA and NIH to coordinate their monitoring and sharing of key...
Source: Health Care Renewal - October 17, 2016 Category: Health Management Tags: health care corruption manipulating clinical research RightCare Transparency International Source Type: blogs

ONC to Boost Oversight over EHR Usability, Patient Safety Woes
ONC (The Office of the National Coordinator for Health Information Technology at HHS,https://www.healthit.gov/newsroom/about-onc) is reportedly getting more authority to oversee HIT quality.Some initial observations:(1) More government control of yet another healthcare domain may be a double-edged sword, BUT:(2) Something had to be done about HIT, and this initiative could have a good outcome if not overwhelmed too much by corporate and inter-party politics (in our current environment, that is far from assured), and(3) It validates what we have been writing about on this blog since 2004, and elsewhere on my part since abou...
Source: Health Care Renewal - October 16, 2016 Category: Health Management Tags: healthcare IT certification healthcare IT safety ONC Source Type: blogs

Transparency International Once Again Takes on Health Care Corruption
This report was actually one of the first efforts from a new Transparency International initaitive to address health care corruption, entitled theTransparency International Pharmaceuticals& Healthcare Programme.  Itsmission statement begins [italics added by me]:Every day, all around the world,people suffer and die due to corruption in the pharmaceutical and healthcare sector. Our vision is a world where less corruption leads to improved global health and healthcare outcomes, leaving no one behind.Building on twenty years of experience in this and other sectors, Transparency International ’s Pharmaceuticals&...
Source: Health Care Renewal - October 11, 2016 Category: Health Management Tags: anechoic effect health care corruption Transparency International Source Type: blogs

Ransomware and incompetence in backups leads to medical data loss...but the thieves were honest thieves!
" An honest thief! " said Caledon Hockley of Jack Dawson, after planting the Heart of the Ocean diamond necklace in Jack's pocket. https://www.youtube.com/watch?v=G5UEwCHUHjgThe headline of this posting may sound absolutely insane, but it is factual.But don't worry, your precious medical data is far safer than it ever was on that 5,000-year-old invention, papyrus.Marin patients ’ medical data lost after cyber attackBy Richard Halstead, Marin Independent Journal   September 30, 2016http://www.mercurynews.com/2016/09/30/marin-patients-medical-data-lost-after-cyber-attack/The Marin Healthca...
Source: Health Care Renewal - October 10, 2016 Category: Health Management Tags: computer security glitch Lee Domanico Marin Healthcare District Marin Independent Journal medical record confidentiality Prima Medical Foundation ransomware Richard Halstead Source Type: blogs

From my totally nonprofessional viewpoint, it looks like at least the first two of these hospital deaths were directly related to bad health IT
The Connecticut " Health I-Team " site (http://c-hit.org/data-mine/data-mine-hospital-inspection-reports/) provides access to a database sourced from the Connecticut Department of Public Health that includes reports of violations at Connecticut hospitals found during inspections, as well as corrective actions taken to prevent similar future violations.Their Mission Statement is as follows at http://c-hit.org/about/:Mission StatementThe non-profit Connecticut Health Investigative Team [C-HIT] is dedicated to producing original, responsible, in-depth journalism on issues of health and safety, in Connectic...
Source: Health Care Renewal - October 6, 2016 Category: Health Management Tags: Connecticut Health I-Team EPIC Yale Medicine Yale-New Haven Hospital Source Type: blogs

Not So Wondrous Drugs? - New Warnings about Severe Adverse Effects of New, Heavily Marketed Drugs for Hepatits C,
In conclusion, evidence-based medicine rigorously applied suggests that individual health care and health policy decisions should be driven by the best available evidence, mostly from clinical research, about the benefits and harms of tests, treatments, programs, and so on, in the context of what outcomes matter to patients. The skepticism EBM should engender could lead to health care that is more about patients and their outcomes, and less about ideology, hype, and hucksterism. If only such skepticism were easier to find........APPENDIX - Clinical Research about Hepatitis C TreatmentsStarting in March, 2014, we havep...
Source: Health Care Renewal - October 6, 2016 Category: Health Management Tags: adverse effects clinical trials deception evidence-based medicine Gilead hepatitis C marketing Sovaldi Source Type: blogs

Our ED wait times wil be longer than usual this weekend (and beyond) so we can attend to the computer.
A hospital system, Pinnacle Health, not all that far from me in the Harrisburg, PA area is rolling out EPIC this weekend.The following banner is at the top of their homepage at http://www.pinnaclehealth.org/locations-and-providers/:ALERT: Due to our transitioning of a new computer system this weekend, ER wait times may be longer than normal. Click to enlarge.! ALERT: Due to our transitioning of a new computer system this weekend, ER wait times may be longer than normal. If you have a minor illness that doesn ’t require a trip to the ER, you can visit one of our Express or FastCare clinics or if un...
Source: Health Care Renewal - October 1, 2016 Category: Health Management Tags: EPIC healthcare IT difficulties healthcare IT risk PinnacleHealth Source Type: blogs

Whose Hospitals Are They, Anyway? - Steward to Sell Off, but Continue Operating All Its Hospitals
This looks like the latest trend in thefinancialization of and diffusion of accountability for health care organizations.  The case involves good ol 'Steward Health Care, which was the subject of quite a fewHealth Care Renewal posts back in the day.Background - Caritas Christi Bought by Cerberus Capital Management, Became Steward Health Care[Cerberus, the three headed dog,per William Blake]Steward is what used to beCaritas Christi Health Care System, formerly a Catholic, non-profit health care system in Massachusetts.  In 2010, Caritas Christi was purchased by Cerberus Capital Management, aprivate equity, aka lev...
Source: Health Care Renewal - September 29, 2016 Category: Health Management Tags: Cerberus financialization hospital systems private equity Steward Health Care Source Type: blogs

You Cannot Worry About Health Care Reform When You Must Bow Down to a Tyrant
We started Health Care Renewal to highlight major health care problems whose discussion had previously been nearlytaboo, with the hopes that this discussion would lead to true health care reform.  These problems includedconcentration of power within health care organizations; leadership of such organizations that was oftengeneric, and hence ill-informed, unsympathetic orhostile to the values of health care professionals,self-interested,conflicted, or outrightcriminal orcorrupt; and threats to the scientific basis of health care, includingmanipulation andsuppression of clinical research.We have come a long way in our u...
Source: Health Care Renewal - September 26, 2016 Category: Health Management Source Type: blogs

Someone wasn't listening to me at my 2012 Keynote to the Health Informatics Society of Australia
In late July 2012 I gave an invited keynote presentation to the Health Informatics Society of Australia (HISA) at the annual Health Informatics Conference (HIC 2012), that year in Sydney.I wrote up my presentation at http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html and my slide deck is online at http://cci.drexel.edu/faculty/ssilverstein/HISA2012_Final.ppt.My message included the following:Critical thinking is essential at all times in healthcare ... or your patient's dead.Critical thinking is not mindless criticism; on the contrary, it is reflective, inquisitive, logical thinking ...
Source: Health Care Renewal - September 24, 2016 Category: Health Management Tags: Australia Cairns and Hinterland Hospital cerner healthcare IT dangers healthcare IT difficulties HIC2012 Source Type: blogs

Cancer is just a software platform problem: Microsoft will'solve' cancer within 10 years by'reprogramming' diseased cells
A short post.Hand a computer scientist a computer and some genetic data, and the world then becomes a deterministic, binary place:Microsoft will'solve'cancer within 10 years by'reprogramming'diseased cellsSept. 20, 2016Sarah Knapton, Telegraph science editorhttp://www.telegraph.co.uk/science/2016/09/20/microsoft-will-solve-cancer-within-10-years-by-reprogramming-dis/Microsoft has vowed to “solve the problem of cancer” within a decade by using ground-breaking computer science to crack the code of diseased cells so they can be reprogrammed back to a healthy state.Chris Bishop, laboratory director a...
Source: Health Care Renewal - September 20, 2016 Category: Health Management Tags: determinism Microsoft scientism Source Type: blogs

Pharmaceutical Company Leaders Pretend to Advocate for the Public Interest - But Maybe it's All " For the Love of Money "
In this political season, the US public is confronted with a blizzard of protestations from candidates who claim to want to serve their interests.  We ought to be used to this, because leaders of big health care organizations have been protesting for years about how they are always in it for the public and the patients'health.  Yet as we have repeatedly discuss, such leaders oftenmanage in ways that subvert their own mission.Recently, there were two striking examples of pharmaceutical leadership saying they were all about the public interest, despite evidence to the contrary.It's All About the Children Says Insys...
Source: Health Care Renewal - September 14, 2016 Category: Health Management Tags: deception Insys Therapeutics mission-hostile management Pfizer public relations Source Type: blogs

Oh So Quietly, Evidence of Bad Health Care Corporate Leadership Accumulates - Three AstraZeneca Settlements
While the news media is distracted by seemingly more spectacular issues, we hear the steady drip, drip, drip oflegal cases suggesting just how systemically bad the leadership of big health care organizations is.  From February 2015 to now, for example, there have been three cases involving multinational pharmaceutical giant AstraZeneca.Settlement of Allegations of Kickbacks to Give AZ Drugs Preferred Status in FormulariesFirst, in February 2015, reported in most detail by Ed Silvermanin the Wall Street Journal,AstraZeneca has agreed to pay the federal government $7.9 million to settle allegations the drug maker paid k...
Source: Health Care Renewal - September 8, 2016 Category: Health Management Tags: AstraZeneca bribery deception impunity kickbacks legal settlements Source Type: blogs

Health Care Renewal Bloggers to Teach Short Course on Why Physicians Do Not Make Rational, Evidence-Based Decisions
Health Care Renewal bloggers Dr Roy Poses and Dr Wally Smith will be teaching a short course on Sunday, October 23, 2016, at theannual North American meeting of the Society for Medical Decision Making, in Vancouver, British Columbia, Canada. The course title will be "Why Do Physicians Not Make Rational, Evidence-Based Decisions, and What Might Help?"We will emphasize many topics relevant toHealth Care Renewal.  These will include:- physician level factors that affect decision making, emphasizing the influence of extraneous values (values that should not be taken into account by physicians when making decisio...
Source: Health Care Renewal - August 31, 2016 Category: Health Management Tags: evidence-based medicine Source Type: blogs

Haunted by US Healthcare Inc - $27.9 Million/Year Aetna CEO Threatened Obamacare Pullback in Apparent Retaliation for Government Anti-Trust Litigation
ConclusionSo the story of US Healthcare Inc, and its merger with Aetna showed a repeating pattern: unfulfilled promises of wonders to come, angry health professionals complaining of bad health care, while the corporate insiders become rich.  So do we really think that the proposed Aetna Humana merger would " Drive Consumer-Focused, High-Value Health Care? "  If so, could I sell you a bridge from Brooklyn to Manhattan?This case shows how we have turned health insurance over to large for-profit corporations, in an era of laissez faire capitalism and light touch regulation, and in an era in whichmanagerial...
Source: Health Care Renewal - August 25, 2016 Category: Health Management Tags: Aetna concentration of power deception executive compensation health insurance managed care organizations mergers Source Type: blogs

The Haunting of CVS - by the Ghosts of Its, Caremark's, MedPartners' and HealthSouth's Past
DiscussionSo CVS Health is another example of a huge modern health care company, formed out of mergers, acquisitions, and other examples of financial engineering, that should truly be regarded as haunted by the ghosts of its past sins.  Yet this history remains ghostly, and its clammy touch on present events is barely perceived.  None of the earlier settlements seemed to influence how the later settlements were made.  No judge refused a given settlement because of the company's history of past alleged misbehavior.  No company manager ever suffered any negative consequences of these settlements.  Th...
Source: Health Care Renewal - August 18, 2016 Category: Health Management Tags: bribery Caremark crime CVS deception fraud HealthSouth legal settlements Source Type: blogs

Yes, the OS and filesystems on our EHR servers were hacked and our data encrypted for ransom, but " no medical information was looked at or compromised "
On this blog I have an entire series of posts regarding EHR crashes that point out an absurd-on-its-face and, in fact, insulting boilerplate executive response to the EHR unavailability:"BUT patient care has not been compromised. " The posts can be accessed via the query linkhttp://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised.It seems I may need another, related indexing term when EHRs get hacked and ransomware is inserted:" BUT no information was looked at or compromised. "I've seen this in various incarnations several times now. For instance, see my Feb...
Source: Health Care Renewal - August 16, 2016 Category: Health Management Tags: computer security Marin Medical Practice Concepts medical record confidentiality medical record privacy no information was looked at or compromised Patient care has not been compromised ransomware Source Type: blogs

Stanford authors: Evolutionary Pressures on the Electronic Health Record - " Deimplementing the EHR could actively enhance care in many clinical scenarios "
A brief post.  In this new JAMA article by Stanford authors:Evolutionary Pressures on the Electronic Health Recordhttp://jama.jamanetwork.com/article.aspx?articleid=2545405 Donna M. Zulman, MD, MS1,2; Nigam H. Shah, MBBS, PhD3; Abraham Verghese, MD4I note the passage:...Deimplementing the EHR could actively enhance care in many clinical scenarios.Simply listening to the history and carefully examining the patient who presents with a focused concern is an important means of avoiding diagnostic error.7 Many phenotypic observations (the outline of a cigarette packet in a shirt pocket, o...
Source: Health Care Renewal - August 15, 2016 Category: Health Management Tags: Abraham Verghese Donna M. Zulman healthcare IT deimplementation JAMA Stanford University Source Type: blogs

Politicians get a very bitter taste of the very same medicine they've forced onto clinicians and the public
This is a case of education - I hope - by fire on electronic information security, and why " going electronic " can be a risky business.  This is a lesson deeply needed by our government leadership who have been pushing an unfettered national rollout of electronic medical records systems, despite known and exploited security concerns of EHRs, among other concerns discussed at this blog.I've written dozens of posts, just based on casual searches of news, illustrating breaches of healthcare information technology security and privacy of information, as have others focusing primarily on these issues such as Pat...
Source: Health Care Renewal - August 15, 2016 Category: Health Management Tags: CNN computer security DCCC DNC Guccifer hacking medical record confidentiality medical record privacy Source Type: blogs

Ioannidis et al.: What Happens When Underperforming Big Ideas in Research [such as Healthcare IT Exceptionalism] Become Entrenched?
Some years ago, John P. A. Ioannidis, MD wrote this piece:"Why Most Published Research Findings Are False" , John P. A. Ioannidis, PLoS medicine,2005 August;2(8): e124He wrote:There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller;...
Source: Health Care Renewal - August 15, 2016 Category: Health Management Tags: healthcare IT exceptionalism JAMA John P. A. Ioannidis Michael J. Joyner Nigel Paneth Source Type: blogs

Transparency International Asks Health Care Professionals About Health Care Corruption
Transparency International, the global NGO that studies and fights corruption, seeks information from health care professionals abouthealth care corruption.  The details are in the official announcement below.  If you are a health care professional, please consider responding to this survey. Invitation to participate in a corruption in healthcare surveyTransparency International ’s health programme has commenced a new research project to identify the major types of corruption in the health sector. We feel that this research piece will contribute to understanding the corruption vulnerabilities in the he...
Source: Health Care Renewal - August 12, 2016 Category: Health Management Tags: health care corruption surveys Transparency International Source Type: blogs

How the System is Rigged - Johnson and Johnson Board Member Pretends to be Independent Brookings Institution Scholar
DiscussionIt is hardly news that US health care is broadly dysfunctional, that it suffers from ever rising costs, and questionable quality, while access has only somewhat improved after the 2009 Affordable Care Act.  The big question is why these problems seem so intractable.Our latest case illustrates that the problem may be that health policy making is dominated by people withconflicts of interest.  In the current case, one of the more influential voices on health care policy turns out not to have just a garden variety conflict of interest.  He actually has a duty to uphold the corporate interests of one o...
Source: Health Care Renewal - August 10, 2016 Category: Health Management Tags: boards of directors Brookings Institution hepatitis C Johnson and Johnson revolving doors You heard it here first Source Type: blogs

More on uncoupling clinicians from EHR clerical oppression
At my August 6, 2016 post (link) I wrote of my belief that " best practices " for EHR evolution call for:... a return to paper (specialized forms depending on the setting) for clinical data capture by busy doctors and nurses, and data entry into a computer via clerical personnel.I presented a late 1990's real-world experiment in creating such a system for invasive cardiology in the Delaware hospital system, Christiana Care Health System, where I was CMIO at that time.As at the links http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story and https://web.archive.org/w...
Source: Health Care Renewal - August 9, 2016 Category: Health Management Tags: Christiana Care Health System healthcare IT difficulties ICCD invasive cardiology paperless Source Type: blogs

Weird emails from Independence Blue Cross via its IT outsourcing partners: showing yet more health IT industry trust-destroying incompetence
In the past week I've received two emails that made me highly suspicious of medical/insurance identity theft.The emails came from Independence Blue Cross, ibx.com, into the email account I receive normal mailings from them, and seemed to indicate someone had created an unauthorized user account (I redacted my email address below):Aug. 5, 2016:From: noreply@ibx.comDate: Fri, Aug 5, 2016 at 7:19 PMSubject: User CreatedTo:[my email address redacted]User Created With UserId - userId20392, Password - password20392July 27, 2016: From: noreply@ibx.comDate: Wed, Jul 27, 2016 at 1:59 PMSubject: User CreatedTo: [my email addres...
Source: Health Care Renewal - August 8, 2016 Category: Health Management Tags: Connecture healthcare IT difficulties healthcare IT incompetence IBX.com Independence Blue Cross Inflow medical record confidentiality Source Type: blogs

NIST workshop " The Role of Standards in Preventing & Mitigating Health IT Patient Safety Risks " perhaps should be titled " The Role of Common Sense in Preventing & Mitigating Health IT Patient Safety Risks Before Rolling Out Bad Health IT Nationally "
Ready, fire, aim.As I wrote in 2010-12 at "Cart before the horse" posts at http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html and http://hcrenewal.blogspot.com/2012/06/cart-before-horse-part-3-ahrqs-health.html, rolling out health IT nationally before having a firm grasp of its risks was an abrogation of medical ethics and long standing treatises on medical experimentation, including the need for informed consent, dating back to the post-WW2 period.Ready, fire, aim: let's roll out health IT nationally, then figure out how to make it safe...Now we have this " worksh...
Source: Health Care Renewal - August 6, 2016 Category: Health Management Tags: healthcare IT safety NIST Siemens Healthcare Source Type: blogs

A Tenet of Impunity - Tenet Settles Kickback Allegations for $514 Million, No Individual Suffers Any Negative Consequences
ConclusionsNearly every big US health care corporation now seems to now have a long history of bad behavior, sometimes criminal behavior, that has not stopped the revenues from flowing, and the top managers from becoming millionaires, or billionaires.  Is it any wonder that a few years ago, nearly a majority of US respondents to a Transparency International poll declared our health care system to tbecorrupt (lookhere)?Their dark musings may be partially due to their awareness thathealth care corruption is a taboo topic.  As we wrote about it in 2016 (lookhere)... Essentially, there is so much money to be mad...
Source: Health Care Renewal - August 4, 2016 Category: Health Management Tags: anechoic effect corporate integrity agreement crime fraud health care corruption impunity kickbacks legal settlements Tenet Source Type: blogs

The Wages of Sin - a Small Illustration of How Executives Can Personally Profit from Bad Corporate Behavior in Health Care
Conclusions So this case appears to be a step forward, in that not all the people who apparently authorized, directed, or implemented the bad behavior could escape any negative consequences.   Keep in mind, however, that no one above the two convicted executives, no one at Johnson and Johnson who decided to acquire Acclarent, and let it continue its previous activities, seemed to suffer any negative consequences.   How much money those executives might have received in response to the revenues that the new subsidiary brought in is unknown. In conclusion, this case shows the perverse incentives at work ...
Source: Health Care Renewal - July 27, 2016 Category: Health Management Tags: adulterated devices crime Ethicon impunity Johnson and Johnson legal settlements medical devices perverse incentives Source Type: blogs

Law and Order? - Bristol-Myers-Squibb Settles Case Alleging Fraud and Kickbacks, No Admissions of Guilt, No Individuals Charged
Introduction   Donald Trump, Republican candidate for the US presidency last week announced he is the " law and order " candidate, accompanied by then vice presidential contender and New Jersey Governor Chris Christie. I wonder if all this interest in law and order will lead to increasing the effectiveness of enforcing laws when large US health care corporations are accused? For years, we have been watching a parade of legal settlements made by big US health care organizations.   These have included the biggest drug companies, biotechnology companies, device companies, insurance companies,...
Source: Health Care Renewal - July 21, 2016 Category: Health Management Tags: Abilify Bristol-Myers-Squibb crime impunity kickbacks legal settlements logical fallacies Source Type: blogs

UnitedHealth's Optum Division Settles Case Alleging it Enrolled Non-Terminally Ill Patients in Hospice, Thus Risking Their Deaths Due to Treatable Illnesses
Discussion The problem of fraudulant enrollment of non-terminal patients in hospice continues, despite our efforts over five years to make the problem more public.   The latest case involved a very big, very wealthy for-profit health care corporation which has had its share of troubles in the past .   Yet the latest case is as anechoic as earlier ones, including smaller cases this year. These enrollments may be motivated by the desire for more money, but they put patients at risk.   Nonetheless, such abuses by hospices get little press coverage, seemingly are ignored by health care regulators...
Source: Health Care Renewal - July 19, 2016 Category: Health Management Tags: fraud hospices legal settlements UnitedHealth Source Type: blogs

UnitedHealth's Optum Division Settles Case Alleging it Enrolled Non-Terminally Ill Patients in Hospice, Thus Risking Their Deaths Due to Treatable Illnesses
Discussion The problem of fraudulant enrollment of non-terminal patients in hospice continues, despite our efforts over five years to make the problem more public.  The latest case involved a very big, very wealthy for-profit health care corporation which has had its share of troubles in the past.  Yet the latest case is as anechoic as earlier ones, including smaller cases this year.These enrollments may be motivated by the desire for more money, but they put patients at risk.  Nonetheless, such abuses by hospices get little press coverage, seemingly are ignored by health care regulators and law enforcement,...
Source: Health Care Renewal - July 19, 2016 Category: Health Management Tags: fraud hospices legal settlements UnitedHealth Source Type: blogs

Abort, Retry, Fail - Billionaire Bill Gates Opines, Sans Evidence, on ... the Efficacy of Hepatitis C Treatment?
Conclusions So maybe Bill Gates' seemingly ill-informed apologia for the extremely high drug prices charged in the US, and his lack of understanding of the evidence about the efficacy, or lack thereof, of some of these high priced drugs is a small humorous story that indicates just the tip of the iceberg.  It appears that in our current market fundamentalist, neoliberal world, foundations may be more about promoting the commercial interests of their board members and officers than about improving the lot of humanity.  Yet for the most part they may succeed in obfuscating what they are doing through the haze of ma...
Source: Health Care Renewal - July 14, 2016 Category: Health Management Tags: conflicts of interest Gates Foundation Genentech Gilead global health health care foundations hepatitis C Sovaldi Source Type: blogs

Two recent stories of EHR un-exceptionalism, and a connection to prior HC Renewal posts including my own experiences
Conclusions During the initial phase of implementation of an EHR, inaccuracies were more common in progress notes in the EHR compared to the paper charts. Residents had a lower rate of inaccuracies and omissions compared to attending physicians. Further research is needed to identify training methods and incentives that can reduce inaccuracies in EHRs during initial implementation.Apparently not covered in the article was the issue of patient harms that might have occurred (and could still occur) due to the "significantly higher rate of inaccurate documentation" in the EHR.   "Beaumont Hospital&quo...
Source: Health Care Renewal - July 13, 2016 Category: Health Management Tags: Beaumont Hospital cerner healthcare IT difficulties healthcare IT litigation Mismanagement PinnacleHealth Siemens Siemens Healthcare Soarian Source Type: blogs

Physicians go flatline on EHR enthusiasm
In a new study, physicians' enthusiasm levels for EHR's seem to resemble this EKG:Do physicians really experience a satisfaction 'J-curve' with EHRs? Max Green July 6, 2016 http://www.beckershospitalreview.com/healthcare-information-technology/do-physicians-really-experience-a-satisfaction-j-curve-with-ehrs.html There's a school of thought about EHR adoption that suggests physicians experience an initial decrease in their positive perceptions of the technology, but over time those levels creep back up and ultimately surpass their pre-implementation perceptions. But does that J-curve actually exists for EHR...
Source: Health Care Renewal - July 8, 2016 Category: Health Management Tags: Becker ' s Hospital Review EPIC healthcare IT dissatisfaction JAMIA Max Green Source Type: blogs

Bad Apple or Bad Orchard? - A Narrative of Alleged Individual Research Misconduct that Sidestepped the Pharmaceutical Corporate Context
Conclusion So it seems that in this case a study which may not have been conducted according to research standards was likely a pharmaceutical sponsored, designed, and controlled Phase II trial done as part of an effort to seek approval for a new drug.  Hence this case was not only about allegations of individual research misconduct, but about yet more problems with the implementation of commercially controlled human experiments designed to ultimately further marketing as well as science.  Yet none of the public discussion so far of this case was about whether Pfizer had any responsibilities to assure the quality...
Source: Health Care Renewal - July 7, 2016 Category: Health Management Tags: anechoic effect clinical research integrity clinical trials New York University Pfizer pharmaceuticals Source Type: blogs

Still No Questions Asked - Journalists Fail to Challenge Talking Points Used to Justify Million Dollar Plus Executive Compensation at New York Non-Profit Hospitals
ConclusionSadly, the ever rising compensation of top health care managers seems to inspiring less, rather than more skepticism in the media.  No more is it true that  nearly all articles that try to delve into executive compensation at all at least quote some experts who are skeptical of current practices.The Journal News series included no such attempts at balance.  In my humble opinion, while it reported on useful facts, the opinions it contained leaned towards propaganda for managers' current privileged position in health care.  Despite all the blather about how top hospital executives deserve millio...
Source: Health Care Renewal - June 29, 2016 Category: Health Management Tags: boards of trustees conflicts of interest executive compensation hospital systems hospitals perverse incentives Source Type: blogs

New AMA President Andy Gurman, MD on EHRs: " I don't have one, and no one can make me use one. "
The love-fest with EHRs continues, to the great chagrin of the believers in fairies, unicorns and cybernetic utopia. Andy Gurman, MD, Takes Reins as AMA President Jun 17, 2016 Gale Scott, HCPLive http://www.hcplive.com/medical-news/andy-gurman-md-takes-reins-as-ama-president The American Medical Association ’s new president, Andrew W. Gurman, MD, known for his affability and quick wit, is not one to seek out controversy. In an interview before being sworn in this week as the AMA ’s annual meeting in Chicago, IL, Gurman said he has no agenda for his tenure at the top of the organization. Considering the ...
Source: Health Care Renewal - June 23, 2016 Category: Health Management Tags: AMA American Medical Association Andy Gurman healthcare IT dissatisfaction Source Type: blogs

New AMA President Andy Gurman, MD on EHRs: " I don't have one, and no one can make me use one."
The love-fest with EHRs continues, to the great chagrin of the believers in fairies, unicorns and cybernetic utopia.Andy Gurman, MD, Takes Reins as AMA PresidentJun 17, 2016Gale Scott, HCPLivehttp://www.hcplive.com/medical-news/andy-gurman-md-takes-reins-as-ama-presidentThe American Medical Association’s new president, Andrew W. Gurman, MD, known for his affability and quick wit, is not one to seek out controversy.In an interview before being sworn in this week as the AMA’s annual meeting in Chicago, IL, Gurman said he has no agenda for his tenure at the top of the organization.Considering the mass hatred of EH...
Source: Health Care Renewal - June 23, 2016 Category: Health Management Tags: AMA American Medical Association Andy Gurman healthcare IT dissatisfaction Source Type: blogs

Reckless indifference to nurse's concerns about bad health IT results in showing her the door?
At numerous past posts I referred to hospital executives' reckless indifference to the concern of seasoned clinicians about bad health IT, such as at   http://hcrenewal.blogspot.com/ 2013/07/rns-say-sutters-new- electronic-system.html and   http://hcrenewal.blogspot.com/ 2013/11/another-survey-on- ehrs-affinity-medical.html and other posts. I now see a stunning story of the results of EHR iconoclasty and patient advocacy: CNO claims hospital forced her out after she raised concerns about EMR Becker's Hospital Review Written by Akanksha Jayanthi   June 14, 2016   http://www...
Source: Health Care Renewal - June 22, 2016 Category: Health Management Tags: Autumn AndRa RN Dan Smith Harmoni EHR healthcare IT dangers healthcare IT risk Patient care has not been compromised Raymond Hino Sonoma West Medical Center Source Type: blogs

Reckless indifference to nurse's concerns about bad health IT results in showing her the door?
At numerous past posts I referred to hospital executives' reckless indifference to the concern of seasoned clinicians about bad health IT, such as at  http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html and  http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html and other posts.I now see a stunning story of the results of EHR iconoclasty and patient advocacy:CNO claims hospital forced her out after she raised concerns about EMRBecker's Hospital Review Written by Akanksha Jayanthi  June 14, 2016 http://www.beckershospitalreview.com/legal-regulator...
Source: Health Care Renewal - June 22, 2016 Category: Health Management Tags: Autumn AndRa RN Dan Smith Harmoni EHR healthcare IT dangers healthcare IT risk Patient care has not been compromised Raymond Hino Sonoma West Medical Center Source Type: blogs

Corruption of clinical trials reports: a proposal
CORRUPTION OF CLINICAL TRIALS REPORTS:A PROPOSALThere is a disconnection between the FDA’s drug approval process and the reports we see in medical journals. Pharmaceutical corporations exploit this gap through adulterated, self-serving analyses, and the FDA sits on its hands. I suggest we need a new mechanism to fix the problem – by independent analyses of clinical trials data.When they analyze and publish their clinical trials in medical journals, pharmaceutical corporations have free rein to shape the analyses. The FDA conducts independent analyses of the data submitted by the corporations, and it may deny or...
Source: Health Care Renewal - June 22, 2016 Category: Health Management Tags: Bernard Carroll citalopram clinical trials Eric Topol escitalopram FDA Forest Pharmaceuticals Jay Amsterdam Jon Jureidini Leemon McHenry Lisa Cosgrove Lundbeck Underwriters Laboratory vortioxetine Source Type: blogs

A Plea from a Traveling Blogger
A thousand apologies - since the Society for Medical Decision Making meeting in London, we have been traveling in the UK, and I have been unable to find the time to post on the blog.  But in exchange we have caught up with good old friends, met lovely people, and seen fabulous sights and beautiful country.  I plan to return very soon, and then after much catching up, will then resume normal activity.But a reminder - a comment on our latest post suggested that Health Care Renewal does good work, but requires more effort. Yet, all our blog posts are written by volunteers who have day jobs or are retired. ...
Source: Health Care Renewal - June 20, 2016 Category: Health Management Tags: blogs Source Type: blogs

Transparency International Reports on Massive Corruption in the Pharmaceutical Sector - Media Hardly Notices
Health Care Corruption as a Taboo Topic Transparency International (TI) defines corruption asAbuse of entrusted power for private gainIn 2006, TI published a report on health care corruption, which asserted that corruption is widespread throughout the world, serious, and causes severe harm to patients and society.the scale of corruption is vast in both rich and poor countries.Also, Corruption might mean the difference between life and death for those in need of urgent care. It is invariably the poor in society who are affected most by corruption because they often cannot afford bribes or private health care. But corruption...
Source: Health Care Renewal - June 8, 2016 Category: Health Management Tags: anechoic effect deception health care corruption manipulating clinical research marketing pharmaceuticals suppression of medical research Transparency International Source Type: blogs

Tranparency International Reports on Massive Corruption in the Pharmaceutical Sector - Media Hardly Notices
Health Care Corruption as a Taboo Topic Transparency International (TI) defines corruption asAbuse of entrusted power for private gainIn 2006, TI published a report on health care corruption, which asserted that corruption is widespread throughout the world, serious, and causes severe harm to patients and society.the scale of corruption is vast in both rich and poor countries.Also, Corruption might mean the difference between life and death for those in need of urgent care. It is invariably the poor in society who are affected most by corruption because they often cannot afford bribes or private health care. But corruption...
Source: Health Care Renewal - June 8, 2016 Category: Health Management Tags: anechoic effect deception health care corruption manipulating clinical research marketing pharmaceuticals suppression of medical research Transparency International Source Type: blogs