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tag:blogger.com,1999:blog-95511502016-06-29T02:44:41.948-04:00Health Care RenewalAddressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.Roy M. Poses MDhttp://email@example.com:blogger.com,1999:blog-9551150.post-1205054483068168892016-06-23T14:46:00.003-04:002016-06-23T15:03:05.813-04:00New 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 mass hatred of EHRs by physicians (and nurses), the issue of EHR-related harms, compromised patient data security, physician scorecards, and other noxious issues, maybe he should have an agenda. E.g., see my Jan. 28, 2015 post "Meaningful use not so meaningful: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing" at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html.

... Though physicians' anger over the frustration of using existing electronic health records was a major topic of conversation at the [annual AMA] meeting, Gurman said he had little to add other than no one could make him use one.

 "I don't have an EHR," he said. Due to the fact that he runs his own practice he found it easier and cheaper just to forgo the enhanced payments he would get under the federal "meaningful use" regulations for converting to electronic records. "I just take the penalties," he said.

Not every physician can afford the time sink most EHRs represent, and the increasing penalties for non-users, unfortunately.

Perhaps on the AMA agenda should be a return to sense regarding physician and nurse documentation, with significant reduction in their clerical burden for starters.

-- SSInformaticsMDhttp://firstname.lastname@example.com:blogger.com,1999:blog-9551150.post-25709338876225754122016-06-22T15:02:00.000-04:002016-06-23T11:38:27.375-04:00Reckless 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/<wbr></wbr>2013/07/rns-say-sutters-new-<wbr></wbr>electronic-system.html and http://hcrenewal.blogspot.com/<wbr></wbr>2013/11/another-survey-on-<wbr></wbr>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.beckershospitalreview.com/legal-regulatory-issues/cno-claims-hospital-forced-her-out-after-she-raised-concerns-about-emr.html

 A former nursing executive at Sonoma West Medical Center in Sebastopol, Calif., has filed a lawsuit against the hospital, alleging she was fired after raising concerns the EMR was a threat to patient safety, reports The Press Democrat.

Autumn AndRa, RN, was serving as CNO of the hospital when she approached CEO Ray Hino and said the EMR, called Harmoni, was unsafe, according to the report.

Ms. AndRa was reportedly terminated from her CNO position April 14 and was offered a position in the intensive care unit, which her attorney Daniel Bartley told The Press Democrat would have been a demotion. Ms. AndRa left the hospital due to alleged harassment, according to Mr. Bartley.

If these allegations are true, a clinician, the Chief Nursing Officer, was shown the door in an act of recklessness for her complaining about bad health IT.

Some definitions:

Bad health IT:

Bad Health IT 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, lacks evidentiary soundness, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.

Reckless indifference:

Deliberate indifference is the conscious or reckless disregard of the consequences of one's acts or omissions. It entails something more than negligence, but is satisfied by something less than acts or omissions for the very purpose of causing harm or with knowledge that harm will result.

A wrongful termination lawsuit was apparently filed:

... The lawsuit alleges the EMR system mixes patients' records, so information in one patient's chart moves to another patient's chart. It also alleges the EMR has issues tracking and updating patient medications and does not display patient code status information, which informs providers of patients' desired medical interventions, according to the report.

These types of gross defects, if true, represent an on its face menace to patient safety.

Further, these issues (and the harm that may result) are well known. In fact ONC's contractor RIT just released a comprehensive review article on health IT problems (see "Report of the Evidence on Health IT Safety and Interventions", May 2016, at https://www.healthit.gov/sites/default/files/task_8_1_final_508.pdf).

CEO Ray Hino had the usual refrain seen in so many postings here (under the blog query "Patient care has not been compromised" - http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised):

Mr. Hino told The Press Democrat the EMR did not pose any danger to patients, and no patients have been harmed because of software defects.

Like most others uttering that line, as I've documented, Mr. Hino apparently lacks expertise (e.g., in clinical, IT or Medical Informatics domains) to render such a judgment about patient danger if the EHR did or does exhibit such problems. His bio is at https://www.linkedin.com/in/raymondhino.

As to whether patients were harmed, that is irrelevant if the EHR has such defects. Sooner or later, they will be. The issue is risk, not body counts (yet).

There's also this. The EHR in question is not the product of the major EHR vendors but the work of apparent insider. See http://about.harmonimd.com/usa/ referencing just two implementations, one at Somona West Medical Center, California, the subject of this post, and one at the Kilimanjaro Christian Medical Centre, Tanzania, Africa:

... The lawsuit also names Dan Smith, the developer of the EMR software in question, as a defendant. According to the lawsuit, Mr. Smith "has engaged in retaliation against [Ms. AndRa] and other employees who have voiced concerns that Mr. Smith's electronic medical records system, his self-dealing, and his management of medical and financial decisions are not in the best interests of SWMC and pose life-threatening risks to patient care," reports The Press Democrat.

Not only did Mr. Smith develop the software in question, but he is a significant financial backer and influencer at SWMC. According to a 2015 report from The Press Democrat, Mr. Smith and his wife have contributed nearly $9 million to the hospital in donations and forgivable loans, and he plays a role in "ever major decision" regarding the hospital. Mr. Smith is on SWMC's board of directors.

I really don't think injured or dead patients (or juries) will find those relationships an excuse for bad health IT, what seems like a clinical trial of new IT by a private company and owner without informed consent (including divulging to patients and users a possible COI), and the discharge of someone complaining about it.

Mr. Smith and hospital officials declined to comment on the lawsuit, citing pending litigation, according to the report.

My expertise is available should the parties so desire.

-- SS

6/21/2016 Addendum:

https://en.wikipedia.org/wiki/Human_subject_research

Human subjects

The United States Department of Health and Human Services (HHS) defines a human research subject as a living individual about whom a research investigator (whether a professional or a student) obtains data through 1) intervention or interaction with the individual, or 2) identifiable private information (32 C.F.R. 219.102(f)). (Lim, 1990)[2]

 As defined by HHS regulations:

 "Intervention"- physical procedures by which data is gathered and the manipulation of the subject and/or their environment for research purposes [45 C.F.R. 46.102(f)][2]

 "Interaction"- communication or interpersonal contact between investigator and subject [45 C.F.R. 46.102(f)])[2]

 "Private Information"- information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public [45 C.F.R. 46.102(f)] )][2]

 "Identifiable information"- specific information that can be used to identify an individual[2]

Human subject rights

In 2010, the National Institute of Justice in the United States published recommended rights of human subjects:

Voluntary, informed consent

Respect for persons: treated as autonomous agents

The right to end participation in research at any time[3]

Right to safeguard integrity[3]

Benefits should outweigh cost

Protection from physical, mental and emotional harm

Access to information regarding research[3]

Protection of privacy and well-being[4]

-- SSInformaticsMDhttp://firstname.lastname@example.com:blogger.com,1999:blog-9551150.post-76326109549521943022016-06-22T02:38:00.001-04:002016-06-23T11:57:02.034-04:00CORRUPTION OF CLINICAL TRIALS REPORTS: A PROPOSAL
CORRUPTION OF CLINICAL TRIALS REPORTS:<o:p></o:p>

A PROPOSAL<o:p></o:p>

There 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.<o:p></o:p>

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 delay approval. But the FDA does not challenge the reports that flood our medical journals, both before and after FDA approval. It is no secret that these publications are routinely biased for marketing effect, but the FDA averts its gaze. That failure of the FDA – a posture known as enforcement discretion – has been well documented. The question is why? At the same time, exposing the biases has been difficult for outsiders because the data are considered proprietary secrets.<o:p></o:p>

A Case Study

Now, a detailed example of deliberate corporate bias has finally been documented, through materials released in litigation. This exposé was reported by Drs. Jon Jureidini, Jay Amsterdam, and Leemon McHenry. Their findings were recently published, and their article is freely available on-line. This example concerned a clinical trial of an antidepressant drug in children and adolescents. The drug, citalopram, was already approved for use in adults, and its off-label use in children would spread if there was published supportive evidence. An Investigational New Drug (IND) protocol and plan of analysis were filed by Forest Laboratories with the FDA in 1999. The trial was completed in 2002, and the results were publishedin American Journal of Psychiatry in 2004 – but the FDA did not accept the results as sufficient to approve this drug for use in children or adolescent patients. By that time the patent on citalopram had expired and Forest Laboratories introduced a virtual twin drug, escitalopram (single active enantiomer). That more expensive version of citalopram was heavily promoted, and it was approved in 2009 for use in children, but even then the FDA specifically noted that safety and efficacy were not established in children under age 12. Since then, new analyses suggest that most antidepressant drugs have little evidence of efficacy even in older children.<o:p></o:p>

Tricks of the Trade<o:p></o:p>

In service of a positive report, the statistical analyses performed by Forest Laboratories deviated from the IND plan of analysis, and negative results were edited out. The biases now documented by Dr. Jureidini and his colleagues for that 2004 sponsored reportin American Journal of Psychiatry included: <o:p></o:p>

·  Inflating the main measure of the drug's effect by reporting an incorrect and clearly exaggerated effect size. On being challenged, the authors later explained their misinformed computation without actually acknowledging the error.<o:p></o:p>

· Failure to report secondary measures of response because they were negative. Those measures had been stipulated in the IND protocol to serve as cross-checks on the main result. These negative findings were airbrushed out of the publication by corporate marketing.<o:p></o:p>

· Unplanned, new secondary measures of response were inserted ex post facto because they were positive (that is a real no-no).<o:p></o:p>

· Violations of the IND protocol were not reported and were then fudged (patients who had properly been excluded per protocol were put back in for analysis, which made a nonsignificant primary outcome analysis turn positive).<o:p></o:p>

· Adverse events were analyzed and summarized in a misleading way.<o:p></o:p>

· The finding that the drug had no effect on depression in children under age 12 was not reported, even though an age-effect interaction analysis had been specifically projected in the IND protocol. This strategic omission left the impression that off label use of citalopram in younger children could be clinically reasonable.<o:p></o:p>

· The corporation knew that another, unpublished, trial in children, conducted by their European partner Lundbeck was negative, and that it raised concerns about suicide risk, but that information was withheld. The authors later were challengedin the journal about this concealment. Their responsewas utterly disingenuous.<o:p></o:p>

· The published article failed to acknowledge that it was authored by a non-medical ghostwriter, who took direction from marketing executives – the 2004 publication was a marketing product purporting to be an objective scientific report.<o:p></o:p>

· Academic authors were recruited only after the manuscript was written, reviewed, and approved in-house – these nominal academic authors were signed on to front for the corporate narrative. <o:p></o:p>

· The perfunctory role of the academic (ahem) authors is clear from the fact that they failed to recognize the wildly inflated effect size claimed for the drug – something that was instantly obvious to several groups of competent readers.<o:p></o:p>

The Payoff<o:p></o:p>

These changes created the appearance of a positive result, and the publication drew wide attention. According to Thomson Reuters Web of Science, it has been cited over 160 times, placing it in the top 5% of cited articles in clinical medicine from 2004. This early publication gave plausible justification for off-label use of citalopram/escitalopram in children, even with FDA approval having been denied, and even though the trial was actually negative. The FDA has reported that between 2005 and 2010 well over 750,000 patients up to age 17 received escitalopram, including almost 160,000 under age 12. Thus, the sleight of hand about failure to show even fudged efficacy in younger children is especially deplorable. Internal memoranda reproduced in the exposé by Dr. Jureidini and his colleagues give a clear picture of the corporate manipulation of the scientific publication process. Now we know – in black and white – just how bad the bias can be. This kind of data manipulation, with ad hoc cherry picking and moving of goalposts, is unacceptable, but it is entrenched. Indeed, it is business as usual – and the FDA looks away.<o:p></o:p>

A Specific Proposal<o:p></o:p>

Our primary defense against such perversions of scientific reporting is fidelity to the registered IND protocol and plan of statistical analysis. The solution is not hard to see: We need independent analyses of clinical trials because we cannot trust the corporate analyses. In effect, we need something like the Underwriters Laboratory to verify the statistical analyses of clinical trials. Nobody takes the manufacturing corporation's word for it concerning the safety and performance of X-ray machines or cardiac defibrillators. Why treat the statistical analysis of drug trials any differently? It's highly technical work. <o:p></o:p>

Who should assume that responsibility? Why not the FDA? After all, they alone see all the data. My specific proposal is for Congress to mandate that the FDA analyze all clinical trials data strictly according to the registered protocols and analysis plans. That requirement should apply to new drugs or to approved drugs being tested for new indications. It should apply also to publications reporting new trials of approved drugs. Corporations and investigators should be prohibited from publishing their own in-house statistical analyses unless verified by FDA oversight. <o:p></o:p>

Why Bother?<o:p></o:p>

There are three good reasons for prohibiting in-house corporate analyses of clinical trials data. First, as the present example illustrates, the inherent conflict of interest is simply too great to be ignored. Second, when corporate statisticians who answer to marketing executives get "creative" in the ways exposed here, then the conditions for valid statistical analyses no longer apply – the statisticians are then on a fishing expedition and they are no longer testing the defined study question with fidelity to the methods specified in the IND protocol. In that case, any nominally significant statistical findings are just exploratory, not actionable – not good enough to justify off-label use of the drug, especially when properly evaluated alternatives are available.<o:p></o:p>

Third, there can be no justification for treating the production of influential publications in medical journals any differently than we treat the production of potent drugs. Our FDA continuously inspects production facilities for evidence of physical adulteration, even as far away as China. They now need to monitor the adulteration of clinical trials reports in medical journals. The harms of adulterated analyses can be just as serious as the harms of adulterated products.<o:p></o:p>

Push Back from Pharma?<o:p></o:p>

We can expect the pharmaceutical industry to mount a First Amendment challenge to this proposal. It will fail, because the public health is too important. Just as there is no First Amendment right to shout fire in a crowded theater, so also corporations have no First Amendment right to say a drug is safe and effective when they know it isn't. That is a betrayal of patients. <o:p></o:p>

The corporations will also claim piously that their publications undergo peer review. Sadly, that is no barrier to this pervasive corporate bias because the peer reviewers for medical journals don't see all the real data – they see only the data the corporation wants them to see. Only the FDA sees all the data. We can no longer cling to the myth of informed and unbiased peer review of clinical trials reports. The corporations rely on that myth as a fig leaf to support their First Amendment claims and to defend their practice of in-house statistical analyses. Moreover, medical journals also are subject to bias and conflict of interest. We could note that the Associate Editor of American Journal of Psychiatry in 2004 was also a major U.S. key opinion leader for Forest Laboratories. According to one of the released depositions, he was instrumental in securing acceptance of the report by the journal.<o:p></o:p>

Business as Usual?<o:p></o:p>

The present example is not an isolated case. Dr. Jureidini and his co-authors described several similar, recent examples. One of those was the reanalysis by Jureidini and others of an infamous trial of paroxetine for pediatric depression. And still, fresh exposés keep appearing. The latest is from Lisa Cosgrove at the University of Massachusetts in Boston and her colleagues, involving "ghost management of the information delivery process" for another new antidepressant drug, vortioxetine – available on-line here. (What is it with the antidepressants, anyway?) On this Health Care Renewal blog, Roy Poses has called attention to these issues. As recently as June 8, 2016 he discussedthe Transparency International report on corruption in the pharmaceutical sector.<o:p></o:p>

Eric Topol, who helped to expose the Vioxx scandal, made similar points recently in a BMJ commentary: "The bad science in clinical trials has been well documented and includes selective publication of positive results, data dredging, P hacking, HARKing, and changing the outcomes that were prespecified at the beginning of the study…. Furthermore, the disparity between what appears in peer reviewed journals and what has been filed with regulatory agencies is long standing and unacceptable."<o:p></o:p>

It's No Time for Old Solutions

As the eye-popping numbers of children treated with escitalopram show, even off-label use of an undistinguished drug in a niche population can be highly profitable. That is why I am proposing that the statistical analysis of clinical trials data can no longer be entrusted to pharmaceutical corporations, on account of their massive inherent conflict of interest. Open access to patient level data, as well as pre-registration of protocols and of data analysis plans, have been actively promoted for some years now to clean up the corporate bias in clinical trials. These are positive developments, but they will not close the disconnection highlighted just above by Dr. Topol. The once idealistic world of clinical trials has changed irreversibly in the past 30 years. As one observer has noted, "… in the course of time the coordinated actions of industry, government, and the biomedical research community have degraded the basic rules of empirical science…" We would do well to acknowledge this fact, and to recognize with Abramson and Starfield that "The first step is to give up the illusion that the primary purpose of modern medical research is to improve Americans' health most effectively and efficiently. In our opinion, the primary purpose of commercially funded clinical research is to maximize financial return on investment, not health." <o:p></o:p>

When corporations are involved, there is no point in prolonging the myth of noble and dispassionate clinical scientists searching for truth in clinical trials. It's over. We would do better to stop pretending that corporate articles in medical journals are anything but marketing messages disguised with the fig leafs of coöpted academic authors and of so-called peer review. The case study reported out by Drs. John Jureidini, Jay Amsterdam, and Leemon McHenry shows us the real face of business as usual in commercial clinical trials. That being the case, it makes no sense to expect corporations and academic key opinion leaders suddenly to reform their biased and conflicted behavior. Only a structural change from the outside like I propose here has any chance of succeeding. The statistical analysis of clinical trials is too important to be entrusted to the sponsoring corporations. <o:p></o:p>

It is time for Congress to grasp this nettle. The time for enforcement discretion is past, and we need Congress either to direct the FDA to act or to create a new mechanism of oversight. To do nothing would be unthinkable.<o:p></o:p>

Bernard J. Carroll<o:p></o:p>

Professor and Chairman Emeritus, <o:p></o:p>

Department of Psychiatry,

Duke University Medical Center.<o:p></o:p>

E-mail: email@example.com

The writer is a former chairman of the Psychopharmacologic Drugs Advisory Committee, Food and Drug Administration, U.S Public Health Service.<o:p></o:p>

Acknowledgment: Several colleagues commented and made suggestions on drafts of this post – in particular John M. Nardo, MD, Donald F. Klein, M.D., and Patrick Skerrett from STAT News.<o:p></o:p>

Update 06-23-2016:  This post was cross-posted on Naked Capitalism, where some interesting comments can be found.<o:p></o:p>

Bernard Carrollhttp://email@example.com:blogger.com,1999:blog-9551150.post-73107717470229706022016-06-20T04:06:00.000-04:002016-06-20T04:12:48.621-04:00A Plea from a Traveling BloggerA 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. At the moment, we have no real budget, no paid staff, no investigators, no researchers, no paid legal counsel, much less communications and public relations specialists. If more effort is required, it may have to come from YOU, dear readers. If you think that casting light on the issues we discuss is important, and taking action to improve health care dysfunction is more important, YOU also need to do something.

Of course, we would greatly appreciate contributions to FIRM - the Foundation for Integrity and Responsibility in Medicine, the tiny non-profit organization which we formed to provide support to the blog and similar dissemination, education and advocacy efforts to address health care dysfunction. FIRM is a US 501(c)3 non-profit and so contributions are deductible in the US to the extent provided by law. You can send contributions to FIRM at 16 Cutler St, Suite 104, Warren, RI, 02885, USA. Or email me (info at firmfound dot org) with questions.

If FIRM had real money, maybe we could develop a staff and do a lot more to shine light on the dark side. However, what is really required is effort by more than one organization and a few volunteer bloggers. Consider doing something yourself. Write a guest blog post for us, start your own blog, write a letter to the editor, an op-ed, or a journal article. Write your legislator. Meet with your legislator's staff. Organize a group of like minded people and do something organized. If you are a health professional, try to do your work in a way that will address health care dysfunction.

Howwever, do not expect it to be easy. There are many people personally enriching themselves through the current system. They will do all they can to preserve the status quo. They may command vast marketing, public relations, lobbying, and legal resources (all ultimately paid using other peoples' - often your - money) to maintain the status quo.

Saying something to combat the anechoic effect is hard. Doing something is harder. But if we don't do something, it will all get worse.Roy M. Poses MDhttp://email@example.com:blogger.com,1999:blog-9551150.post-60224126555173141262016-06-08T10:28:00.000-04:002016-06-09T15:38:58.390-04:00Transparency International Reports on Massive Corruption in the Pharmaceutical Sector - Media Hardly NoticesHealth Care Corruption as a Taboo Topic

Transparency International (TI) defines corruption as

Abuse of entrusted power for private gain

In 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 in the richest parts of the world also has its costs.

The report did not get much attention. Since then, health care corruption has been nearly a taboo topic in the US. When health care corruption is discussed in English speaking developed countries, it is almost always in terms of a problem that affects benighted less developed countries. On Health Care Renewal, we have repeatedly asserted that health care corruption is a big problem in all countries, including the US, but the topic remains anechoic.

Yet somehow, a substantial minority of US citizens, 43%, seemed to believe that corruption is an important problem in US health care, according to a TI survey published in 2013 (look here). But that survey was largely ignored in the media and health care and medical scholarly literature in the developed world, and when it was discussed, it was again in terms of results in less developed countries. Health Care Renewal was practically the only source of coverage in the US of the survey's results.

Transparency International's New Report on Corruption in the Pharmaceutical Sector

Now Transparency International (TI) has tried, and Health Care Reenewal will try again. In June, 2016 Transparency International published a new report entittled

Corruption in the Pharmaceutical Sector

The report's executive summary states:

Within the health sector, pharmaceuticals stands out as sub-sector that is particularly prone to corruption. There are abundant examples globally that display how corruption in the pharmaceutical sector endangers positive health outcomes.

In my humble opinion, the report is particularly significant in that it classifies as corrupt various kinds of activities that occur within the pharmaceutical sector (and also in other parts of health care) which are often discussed publicly as anything from standard operating procedure through unfortunate errors to unethical behavior. These include many activities which we have frequently discussed on Health Care Renewal. For example,

Manipulation of Clinical Research

We have frequently discussed how pharmaceutical companies, and biotechnology, medical device, and other health care companies and organizations, may manipulate clinical research to enhance the likelihood that is results will favor their products and marketing goals, even if the results are biased, inaccurate, could mislead physicians and patients, and ultimately harm patients. The TI report included:

As pharmaceutical companies rely on gaining market entry in order to recoup R&D costs, when there is a lack of oversight in clinical trial data publication a conflict of interest exists in which a pharmaceutical company may have an incentive to manipulate clinical trial data. When clinical trial data is manipulated medical literature can become biased with positive findings fabricated, positive findings exaggerated or negative results hidden. This can result in inadequate prescribing patterns because HCPs rely on clinical trial data to make decisions on which medicines to use to treat patients.

Suppression of Clinical Research

We have frequently discussed how health care organizations (as above) may outright suppress clinical research when the results fail to support their interests. The TI report included:

Transparency and access to information through mandatory clinical trial registration, sanctions for not registering results or providing clinical trial information, and the publication of both positive and negative results are commonly discussed as helpful tools to curb corruption. With the European Medicines Agency (EMA) as a notable positive exception, public agencies and authorities do not require R&D-based pharmaceutical companies to make their raw data publicly available, making it impossible to verify whether the reported results are accurate. Based on laws and regulations clinical trial data is considered to be proprietary information, which allows pharmaceutical companies to conceal important data from the public domain.

Manipulation of the Dissemination of Clinical Research

We have frequently discussed how health care organizations may manipulate the dissemination of clinical research, through various forms of publications, presentations, courses, media summaries, etc, to favor their products and marketing goals, even if the results are misleading and could harm patients. For example, a while back we discussed the problem of "ghost-written" articles appearing in scholarly journals. The TI report included:

The practice of ghostwriting is also a risk with clinical trials. Ghostwriting involves the writing of clinical trial publications by industry and then having a highly esteemed researcher pass these findings off as their own without disclosing their actual involvement with the authorship of the article. It is a common practice, particularly in industry led trials. Ghostwriting is done to increase the prestige and reputation of the findings, while simultaneously researchers are able to improve their reputation, which can lead to promotions. Clearly this practice can result in inaccurate results being published.

Deceptive Marketing

We have frequently discussed how marketing of pharmaceuticals (and nearly everything else in health care) may be deceptive, favoring companies' products and services, but again misleading health care professionals and patients, and ultimately risking patient harm. In the extreme, pharmaceutical companies (and other health care organizations) may resort to bribes or kickbacks. The TI report included:

There are several methods for a corrupt pharmaceutical company to unethically market its medicines. At its most simple a pharmaceutical company can bribe a HCP directly with payments so its medicines are more likely to be prescribed. More abstrusely individuals may include a pharmaceutical company's medicine on the national list that is reimbursed by public funds, in return for an indirect bribe by being sent to inappropriate holiday destinations for lavish conferences.

Corrupt marketing practices also include pharmaceutical companies providing misleading information regarding the safety and efficacy of a medicine to influence doctors' prescribing habits and encouraging off-label, unlicensed use to increase sales.

Other Topics

Finally, the report mentions such issues as the revolving door, regulatory capture, etc, etc, etc

A Striking, and Strikingly Anechoic Report

Again, while the report summarizes information that is likely familiar to most Health Care Renewal readers, what is striking is that it describes manipulation of clinical research, suppression of clinical research, manipulation of dissemination of clinical research, and deceptive marketing as corruption. That is a sentiment rarely heard in the US, and one that appears nearly taboo.

Demonstrating the strength of the taboo, this striking report has gotten almost no attention in the media or scholarly medical and health care literature in the developed English-speaking countries. Let me note the important exceptions, however.

I learned of the report from a brief news item from the BMJ, the prestigious UK journal that seems most at the forefront of championing the integrity of medical and health care research.(1) The only substantial news article I could find on the report was also from the UK, in the Independent. Its sub-title is worth repeating:

Transparency International says corruption is making a few rich and wrecking the health of some of the world's poorest people

Also, there were brief articles in Reuters, and in (web-only) FiercePharma. That is about it so far.

The report itself suggests why it has been so anechoic, just like nearly every other attempt to expose health care corruption to public discussion. Essentially, there is so much money to be made through pharmaceutical (and by implication, other health care corruption) that the corrupt have the money, power, and resources to protect their wealth accumulation by keeping it obscure. In the TI Report itself,

However, strong control over key processes combined with huge resources and big profits to be made make the pharmaceutical industry particularly vulnerable to corruption. Pharmaceutical companies have the opportunity to use their influence and resources to exploit weak governance structures and divert policy and institutions away from public health objectives and towards their own profit maximising interests.

Keep in mind that the money made from corruption does not just go to innocent peoples' retirement funds that are invested in pharmaceutical stocks. It predominantly goes to top corporate executives and managers, and their cronies who preside over the corrupt practices.

I might as well repeat myself once again. As I wrote in 2015,

If we are not willing to even talk about health care corruption, how will we ever challenge it?

So to repeat an ending to one of my previous posts on health care corruption.... if we really want to reform health care, in the little time we may have before our health care bubble bursts, 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 to be able to say or write the words, health care corruption.

Reference

1. Torjesen I. Group calls for more to be done to tackle corruption in the pharmaceutical industry. BMJ 2016;353:i3099. Link here.Roy M. Poses MDhttp://firstname.lastname@example.com:blogger.com,1999:blog-9551150.post-54954976410235154622016-06-07T10:40:00.000-04:002016-06-07T11:00:51.538-04:00NY Times/Steve Lohr asks "Why the Economic Payoff From Technology Is So Elusive." The answer in medicine is obvious.In a June 5, 2016 article, New York Times reporter Steve Lohr (http://topics.nytimes.com/top/reference/timestopics/people/l/steve_lohr/index.html), who reports on technology, business and economics, asked the following question:

Why the Economic Payoff From Technology Is So Elusive
New York Times, Business Day
By STEVE LOHR
JUNE 5, 2016
http://www.nytimes.com/2016/06/06/business/why-the-economic-payoff-from-technology-is-so-elusive.html

Your smartphone allows you to get almost instantaneous answers to the most obscure questions. It also allows you to waste hours scrolling through Facebook or looking for the latest deals on Amazon. More powerful computing systems can predict the weather better than any meteorologist or beat human champions in complex board games like chess.

But for several years, economists have asked why all that technical wizardry seems to be having so little impact on the economy. The issue surfaced again recently, when the government reported disappointingly slow growth and continuing stagnation in productivity. The rate of productivity growth from 2011 to 2015 was the slowest since the five-year period ending in 1982.

Healthcare becomes the gravamen of the article:

One place to look at this disconnect is in the doctor's office. Dr. Peter Sutherland, a family physician in Tennessee, made the shift to computerized patient records from paper in the last few years. There are benefits to using electronic health records, Dr. Sutherland says, but grappling with the software and new reporting requirements has slowed him down. He sees fewer patients, and his income has slipped.

Unfortunately, the advisors who helped him with the article may have provided incomplete information:

... "The government funding has made a huge difference," said Dr. Ashish Jha, a professor at the Harvard School of Public Health. "But we're seeing little evidence so far that all this technology has had much effect on quality and costs."

In the face of, among many others, a stunning letter from 40 medical societies to HHS in 2015 that the technology is unfit for purpose (http://mb.cision.com/Public/373/9710840/9053557230dbb768.pdf), known and hair-raising defects (http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html), and many other complaints from physicians and nurses (e.g., http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html, http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html, query link http://hcrenewal.blogspot.com/search/label/glitch as just a few examples), such a statement is anserine.

Why would anyone expect (good) effects on "quality and costs" of healthcare when the technology is so unfit for purpose in design and implementation that it has alienated most of its users?

I've written previously about Jha's views in a May 27, 2009 post "Harvard's EMR Justification: We Just Have To Do Something" (http://hcrenewal.blogspot.com/2009/05/harvards-emr-justification-we-just-have_27.html):

 ... "I'm not suggesting EHR is going to be a panacea, but the one thing that is absolutely true is there is nothing else out there now that has any more political appeal," Jha says. "Everybody agrees, whether you are a conservative, moderate, or liberal, that we have to do something about healthcare. So the one place where we can all come to agreement is we have to do something about electronic records."

I do not think "political appeal" is a good justification for a multi-billion dollar cybernetic experiment in medicine, where the risks of the technology are considerable and where basic healthcare needs are not being well met among the poor and underprivileged.

Former ONC Chair David Brailer is quoted:

"People confuse information automation with creating the kind of work environment where productivity and creativity can flourish," said Dr. David J. Brailer, who was the national health technology coordinator in the George W. Bush administration. "And so little has gone into changing work so far."

Brailer was little better than Jha, and moves the goalposts with a type of circular logic. He appears to be saying that technology that will revolutionize medicine can't work until we change how things are done in medicine so the technology can revolutionize medicine.

The article then quotes one Tennessee physician, a Dr. Sutherland, who is "happy" to accept bad health IT, a resultant pay cut, and increased work:

... Today, Dr. Sutherland's personal income and the medical group's revenue are about 8 percent below where they were four years ago. But in 2015, both his earnings and the revenue of Healthstar, which employs 350 people in 10 clinics, increased slightly, by nearly 3 percent from 2014.

... Dr. Sutherland bemoans the countless data fields he must fill in to comply with government-mandated reporting rules, and he concedes that some of his colleagues hate using digital records. Yet Dr. Sutherland is no hater. Despite the extra work the new technology has created and even though it has not yet had the expected financial payoff, he thinks it has helped him provide better information to patients.

He values being able to tap the screen to look up potentially harmful drug interactions and to teach patients during visits. He can, for example, quickly create charts to show diabetes patients how they are progressing with treatment plans, managing blood glucose levels and weight loss.

He is working harder, Dr. Sutherland says, but he believes he is a better doctor. Blunt measures of productivity, he added, aren't everything. "My patients are better served," he said. "And I'm happier."

While being able to provide fancy charts and check drug-drug interactions (for which a massive and expensive EHR is certainly not needed; a PDA will suffice) is fine.

However, anyone who gladly accepts a pay cut, and inconvenience, and harder work due to bad health IT, and is a happy camper with that state of affairs, either suffers from the Stockholm syndrome or has a lot of discretionary income and free time to spare that many clinicians do not.

The article fails to mention the hundreds of thousands of other US docs and others in other lands (e.g., http://hcrenewal.blogspot.com/2016/05/hit-mayhem-canadian-style-nanaimo.html) who aren't happy at all with health IT as it is today.

---------------------------------------

I sent this email to Mr. Lohr.

From: S Silverstein
To:Steve Lohr
Date: Tue, Jun 7, 2016 at 10:02 AM
Subject: Re: Why the Economic Payoff From Technology Is So Elusive

Dear Mr. Lohr,

In medicine, the answer to this question is straightforward. I don't know if Ashish Jha brought this to your attention, or if he himself is aware of it.

This letter from nearly 40 different medical societies to HHS about bad health IT is specific about how bad the current health IT is:

http://mb.cision.com/Public/<wbr></wbr>373/9710840/9053557230dbb768.<wbr></wbr>pdf

You should be aware of the letter's contents. I've also attached it to this email.

In academic Medical Informatics, such matters are often ignored, as they run contrary to the narrative that IT will "revolutionize medicine"; I know, as I was Yale faculty in Medical Informatics myself.

The assumption in academic circles and in the Administration (unfortunately) is that "all health IT is good health IT."

Unfortunately, it is not. From my own site "Contemporary Issues in Medical Informatics: Good Health IT, Bad Health IT, and Common Examples of Healthcare IT Difficulties" at http://cci.drexel.edu/faculty/<wbr></wbr>ssilverstein/cases/ :

Definitions authored by myself and Australian informatics expert Dr. Jon Patrick:

Good Health IT ("GHIT") is defined as IT that provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician's hands, can be easily, substantively and cost-effectively customized to the needs of medical specialists and subspecialists, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes.

Bad Health IT ("BHIT") is defined as 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, is lacking in evidentiary soundness, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.

It comes as no surprise not to find productivity gains, but instead hundreds of thousands of angry physicians (and nurses), when health IT is mostly bad IT.

The health IT industry itself needs serious remediation before its products will be a boon to medicine.

Sincerely,

Scot Silverstein, MD

Drexel University, Philadelphia

http://drexel.edu/now/experts/<wbr></wbr>Overview/silverstein-scot/

p.s. I have not even broached the matter of health IT patient harms.

Patients are being harmed and dying of bad health IT. See for instance the CRICO insurance report at http://www.cci.drexel.edu/<wbr></wbr>faculty/ssilverstein/PSQH_<wbr></wbr>MalpractClaimsAnalyConfirRisks<wbr></wbr>EHR.pdf

---------------------------------------

I will add an addendum if I receive a reply.

-- SS
InformaticsMDhttp://firstname.lastname@example.com:blogger.com,1999:blog-9551150.post-16369581939706248152016-06-03T12:53:00.000-04:002016-06-03T15:24:28.300-04:00Clinical Practice Guidelines: Still Conflicted After All These YearsBackground: Untrustworthy Clinical Practice Guidelines

Since the 1990s, clinicians have been exhorted to follow clinical practice guidelines (CPGs) to improve their decision-making and patients' outcomes. When Dr Wally Smith and I started teaching a short course (often at the Society for Medical Decision Making meetings) about changing physician behavior, we naively set out to improve decisions by increasing adherence to such guidelines. We first thought that physicians' apparent shortcomings in guideline adherence were due to their lack of knowledge of the guidelines and the underlying evidence, and to their human cognitive limitations.

That approach, however, failed to yield ways to improve adherence. After a while, it occurred to us that there might be other reasons physicians did not follow guidelines, including their lack of trust of the guidelines or the evidence supposedly incorporated within them. We learned that integrity of the clinical evidence base has been severely degraded due to the manipulation of clinical studies by those with vested interests, and the outright suppression of trials for which manipulation does not produce the desired results.

Furthermore, as we became less naive, we learned that the integrity of the guideline development process was also suspect, again due to the influence of those with vested interest. No wonder physicians were suspicious of guidelines, and resisted adhering to them.

In 2011, the prestigious Institute of Medicine released a report on the development of better standards to produce more trustworthy guidelines (Clinical Practice Guidelines We Can Trust. Link here.) We posted about that report here, but noted that it was receiving little other attention, an example of the anechoic effect. The IOM report cited conflicts of interest (COIs) affecting the guideline development process as a major reason such guidelines might be untrustworthy, and suggested a variety of ways to reduce COIs affecting guidelines.

These included in particular:
- Guideline committee members should disclose their conflicts of interest in detail, and these should appear in the guidelines (Standard 2.1, 2.2)
- The number of conflicted committee members should be minimized, and in no case should be a majority of the committee (2.3, 2.4)
- Funders should have no role in guideline development (2.4)

This week, an original article(1) and editorial(2) in PLoS Medicine discussed how guidelines published since the report was produced addressed conflicts of interest.

Article Summary

Below I summarized the article, but presented results somewhat differently than did the authors.

Design

Campsall et al did a cross-sectional study of clinical practice guidelines that appeared in the US Agency for Healthcare Research and Quality (AHRQ) National Guideline Clearinghouse in 2012 from national or international organizations, excluding guidelines produced by organizations restricted to allied health professionals, guidelines produced by corporations, or guidelines that had no specific recommendations. They obtained information from the guidelines, the organizations' websites, and surveys sent to the organizations.

Study Population

The study population was 290 guidelines produced by 95 organizations. The response rate for the surveys was 68%. The organizations were primarily professional societies (67%) or disease advocacy groups (21%).

My comment is that therefore this study assessed guidelines mainly produced by non-profit organizations which ostensibly uphold health care professionals' values and/or primarily support patients' interests.

Industry Funding

63% of organizations reported receiving funds from biomedical companies. (It was not clear whether the remainder denied receiving such funding, or provided no information about funding.)

My comment is that the majority of such ostensibly "do-gooder" organizations are nonetheless at least somewhat supported by commercial firms that market health care products, presumably mainly drugs or devices.

Conflict of Interest Policies

Please note that the authors provided results to emphasize the positive, for example, they provided the proportion of organizations which provided specific types of information about COIs or had particular policies to reduce COIs. In most cases, I simply did subtractions to emphasize the negative. Furthermore, the authors further emphasized the positive by choice of denominator, as noted below.

20% of organizations did not provide any information about conflict of interest policies, and 7% asserted the existence of such policies, but did not disclose them. A majority, 55%, did not have disclosed policies that specifically dealt with with conflicts of interest affecting guidelines.

My comment is thus that a majority of these do-gooder organizations did not apparently even begin to address, at least in terms of clear, transparent written policy, the recommendations of the IOM report on trustworthy guidelines.

Measures to Improve Guidelines Trustworthiness by Decreasing Influence of Conflicts of Interest

The authors provided the number of organizations with disclosed policies that addressed particular issues of concern to the IOM in their report on trustworthy guidelines, but made the proportions of such organizations seem larger by using as a denominator the number of organizations that disclosed their entire policies, rather than the total number of organizations which produced the guidelines.

Therefore, they found that of the 60 (out of 95 total) organizations that fully disclosed their conflict of interest policies:
98% required committee members to disclose conflicts of interest;
90% required review of conflicts of interest before guideline publication;
68% required that a majority of guideline committee members be free of conflicts of interest;
92% reported publishing committee members' conflicts of interest within guidelines;
78% did not allow direct industry funding of guideline development
82% did not allow industry participation in selection of committee members
67% did not allow industry to review guidelines prior to publication.

That all sound good, but consider what happens when one uses the total sample of organizations in the denominators.

Therefore, the article also found that of all 95 organizations that produced the guidelines of interest:

38% did not require CPG committee members to disclose conflicts of interest
43% did not require review of committee members' conflicts of interest prior to guidelines development
57% did not require that a majority of guideline committee members be free of conflicts
44% did not report publishing committee members' conflicts of interest within guidelines
48% did not report preventing direct industry funding of guidelines
51% did not report preventing industry participation in selection of committee members
61% did not report preventing industry review of guidelines prior to publication.

My comment is that thus the results suggested that substantial numbers of organizations that produced CPGs did not demonstrate that they were committed to measures that would improve guidelines trustworthiness by reducing the influence of conflicts of interest.

Disclosure of Conflicts of Interest Within Guidelines

Again, it was necessary to recalculate some proportions using the full population of guidelines reviewed as the denominator.

Of the 290 guidelines reviewed:
65% "included disclosure statements regarding direct funding and support"
37% specifically disclosed the absence or presence of direct funding from biomedical companies
However,
49% did not disclose committee members' financial relationships
99% did not disclose relevant financial relationships of the organization (that is, institutional conflicts of interest) that produced the guidelines as a whole

My comment is that substantial numbers of published guidelines were not clearly produced so as to increase their trustworthiness by reducing the influence of conflicts of interest on them.

Did the Guidelines Follow the Organizations' Stated Policies?

The authors commendably provided information about whether the guidelines produced by organizations that disclosed conflict of interest policies followed those polices. They found:

16% of organizations "that reported that committee member conflicts of interested were published in guidelines" produced guidelines that did not include committee members' COI disclosure

61% of organizations that "reported the majority of committee members must be free of conflicts of interest" produced guidelines by committees with majorities of conflicted members

6% of organizations that "reported that industry partners were not permitted to directly fund clinical practice guideline development" produced guidelines which disclosed such funding.

My comment is that thus even of the organizations that stated they had policies in place to improve the trustworthiness of the guidelines they produced by reducing the influence of conflicts of interest, they allowed guidelines to be produced that did not follow those policies.

Authors' Conclusion

Financial relationships between organizations that produce clinical practice guidelines and the biomedical industry appear to be common. These relationships are important because they may influence, through guideline usage, the practice of large numbers of healthcare providers. We believe that to effectively manage conflicts of interest, organizations that produce clinical practice guidelines need to develop robust conflict of interest policies that include procedures for managing violations of the policy, make the policies publicly available, and disclose all financial relationships with biomedical companies.

Editorialists' Conclusion

The editorial by Bastian(2) was sharper in tone. It included an observation that reinforced my confession of naivete above:

With hindsight, I think those of us encouraging better methodology for guideline development in the 1990s took the issue of disclosure of financial interests too much for granted. It seemed so self-evident, it got barely a mention even in national policy on guideline development

She also noted that the Campsall study did not address all the ways conflicts of interest can influence guideline development:

Stelfox and colleagues focus particularly on the organizational conflicts of interest of guideline producers and their policies. They examine the financial interests of the organizations, but not of the individuals employed within those organizations. This same blind spot is evident when it comes to policies about committee members; the financial interests of the organizations that individuals represent tend to be disregarded. Yet these can be substantial, including for patients' organizations.
She noted that the failure of guidelines to report their developers' conflicts of interest is a continuing problem. The rate of failure to report found by Campsall et al was

about the same rate that Taylor and Giles found in 2004 and Norris and colleagues found in 2010.

Finally, she emphasized that we are still a long way from having guidelines that health care professionals and patients can trust:

Guideline processes without adequate financial conflict management have to become unacceptable to a far wider circle. They need to become unacceptable to influential committee members, to the medical journals that lend so many guidelines additional standing and reach, and to the membership of the professional societies that produce them. Until that happens, for guidelines as for clinical research, it's a case of caveat lector: let the reader beware.

My Summary

So should physicians trust clinical practice guidelines? At least this article suggests they ought to be very very skeptical of them. The IOM report meant to improve the trustworthiness of practice guidelines seems to be honored mainly in the breach. The likelihood that any given guideline was produced so as to reduce the influence of conflicts of interest on it is low. Even organizations that ostensibly put professional values and patients first in their efforts to develop guidelines seem to often be financially beholden to companies that want to sell drugs and devices. Physicians and patients ought to be concerned that most new clinical practice guidelines may be as much about marketing commercial products as improving medical practice or patients' outcomes.

The current US presidential race has made it evident that we have a lot of disgruntled citizens, many of whom believe our system is rigged to favor the "establishment." I suggest that the more we know about clinical practice guidelines, the more it appears that the health care system is rigged to favor certain parts of the "establishment," the big corporations that market drugs and devices, and their paid part-time hands within medical societies and patient advocacy groups who have turned these ostensibly idealistic, do gooder organizations into part-time marketing machines.

The huge and complex web of individual and institutional conflicts of interest that binds much of the health care system, the government, and industry may be good for the insiders, but is stifling improvement in our dysfunctional health care system. True health care reform would first expose these conflicts, then reduce or better yet, eliminate them, and make health care more about helping patients and less about making money by marketing commercial products.

Musical Interlude

To dispel the darkness a bit, Paul Simon, "Still Crazy After All These Years," 1992 acoustic version:

References

1. Campsall P et al. Financial relationships between organizations that produce clinical practice guidelines and the biomedical industry: a cross-sectional study. PLoS Medicine 2016; DOI;10.1371/journal.pmed.1002029 Link here.

2. Bastien H. Nondisclosure of financial interest in clinical practice guideline development: an intractable problem? PLoS Medicine 2016; DOI;10.1371/journal.pmed.1002030 Link here. Roy M. Poses MDhttp://email@example.com:blogger.com,1999:blog-9551150.post-22724561037809949672016-05-31T09:39:00.000-04:002016-05-31T13:24:06.468-04:00UK health IT 'glitch': Hundreds of thousands of patients have potentially been given an incorrect cardiovascular risk estimation after a major IT system errorThis in the UK.

What is euphemistically referred to as an "IT system error" is, in reality, the mass delivery of a grossly defective medical device adversely affecting hundreds of thousands of patients. I'm surprised not to see that other kindly euphemism, "glitch" (http://hcrenewal.blogspot.com/search/label/glitch):

http://www.pulsetoday.co.uk/your-practice/practice-topics/it/gps-told-to-review-patients-at-risk-as-it-error-miscalculates-cv-score-in-thousands/20031807.article

11 May 2016

By Alex Matthews-King

Hundreds of thousands of patients have potentially been given an incorrect cardiovascular risk estimation after a major IT system error, Pulse can reveal.

The MHRA has told GPs they will have to contact patients who have been affected by a bug in the SystmOne clinical IT software since 2009.

Of course, this refrain appeared, a corollary of "Patient care has not been compromised" (http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised) when health IT crashes and outages occur:

The regulator says that means that 'a limited number' of patients may be affected, and the risk to patients is 'low'.

At best, it's good that only a "limited number" of patients were "affected." I guess they feel they can justify a "limited number" of patient harms for the glory of a medical Cybernetic Utopia.

At worst, how do "the regulators" know exactly who was affected? Answer: they don't and this is boilerplate BS meant to CYA.

But Pulse has learnt that the 2,500 practices using SystmOne are having lists sent to them of around 20 patients per partner who may need to be taken off statins, or be put on them, after their risk is recalculated.

Statins are not an innocuous medication. From WebMD at http://www.webmd.com/cholesterol-management/side-effects-of-statin-drugs?page=2#1:

The most common statin side effects include:

 Headache

Difficulty sleeping

Flushing of the skin

Muscle aches, tenderness, or weakness (myalgia)

Drowsiness

 Dizziness

 Nausea or vomiting

Abdominal cramping or pain

 Bloating or gas

 Diarrhea

 Constipation

 Rash

Statins also carry warnings that memory loss, mental confusion, high blood sugar, and type 2 diabetes are possible side effects. It's important to remember that statins may also interact with other medications you take.

Not to mention the risks of not being on a statin if you truly need one.

And this number could increase if a practice provides NHS Health Checks routinely. In addition, the lists being sent to practices only go back to October 2015, but practices will be sent further lists potentially dating back to 2009 over the next few weeks.

Wait! The "regulators" said that 'a limited number' of patients may be affected. They are clairvoyant, I would imagine. Maybe one of them is Harry Potter?

The "regulators", who have the same powers as the man-wizard above, know through clairvoyance that only a limited number of people were affected, and risk to them low.

A statement from MHRA to Pulse said: 'An investigation has been launched into a digital calculator used by some GPs to assess the potential risk of cardiovascular disease (CVD) in patients.

'We are working closely with the company responsible for the software to establish the problem and address any issues identified.

The problem is incompetence and negligence. One wonders what testing was performed before this was unleashed on the public in the UK.

TPP told Pulse they were working to address the 'Clinical Safety Incident' and that the QRISK calculator was provided as an advisory tool to support decision making. They added they were working to ensure the issues were addressed and GPs are informed of affected patients 'as soon as possible'.

'Clinical Safety Incident' - what a wonderful euphemism for "healthcare IT debacle."

Deputy chair of the GPC's IT subcommittee Dr Grant Ingrams told Pulse it would be 'loads of work' to sort out.

He said: 'It affects everyone who has had a QRISK, and SystmOne are sending out messages to say "look at these patients". But then you have to see if the change is significant, and whether you would have made a different decision at the time, or put them on a different treatment'

It will probably be more work than if such a system had never been constructed.

Dr Ingrams said: 'There's potential harm both ways…What happens when a patient who had been of a high risk and this hadn't been identified and they've now had a stroke or heart attack? 'Similarly if someone had a low risk and they've been put on a statin and had a side-effect who's responsible? That's the clinical risk.'

Answer: the company that produced this grossly defective software, and those "regulators" who allowed it on the market without independent and thorough testing, are responsible.

Dr William Beeby deputy chair of the GPC's clinical and prescribing subcommittee, said the bug 'certainly had the potential to impact on patient confidence' and this could create even more work ... 'It's the tool we've been told to use. So if the tool is inaccurate, then you start to lose confidence and the doctors will then lose confidence as well.'

Patient confidence (let alone physician confidence) in cybernetics already took a big hit in the UK several years back, as at my Sept. 2011 post "NPfIT Programme goes PfffT" at http://hcrenewal.blogspot.com/2011/09/npfit-programme-going-pffft.html.

However, it seems, hyper-enthusiast overconfidence in health IT, including that of the "regulators", would not be injured even if bad health IT caused more casualties than the bombings and V2 attacks suffered by the UK in WW2.

After the health IT debacles involving billions of wasted pounds in the UK, perhaps the UK's "regulators" need to look upon health IT as fondly as this piece of technological wizardry.

A TPP spokesperson told Pulse: 'TPP is dealing with the Clinical Safety Incident involving the QRISK2 Calculator in SystmOne. The tool is intended to support GPs in assessing patients at risk of developing cardiovascular disease and in developing treatment plans. The QRISK2 Calculator is presented within SystmOne as an advisory tool.

"Advisory tool"? That the doctors can safely ignore? Hogwash.

'We are actively working to ensure the issues identified are addressed and to ensure that clinicians are informed of any patients that may have been affected as soon as possible.'

Until the next health IT "bug" arises, that is.

-- SS

InformaticsMDhttp://email@example.com:blogger.com,1999:blog-9551150.post-91672111328111640632016-05-31T07:37:00.000-04:002016-05-31T12:01:24.797-04:00HIT Mayhem, Canadian Style: Nanaimo doctors say electronic health record system unsafe, should be shut down, non-medical PR hacks say it's perfectly safeSome candid honesty:

To hell with doctors and nurses and their concerns about horrible health IT.

That seems the international standard in 2016 regarding their concerns. There's just too much money to be made in this business to worry about such piddling annoyances as maimed and dead patients.

Doctors, after all, don't know anything about computers, and cybernetic medical experiments on unconsenting human subjects are just good fun.

This new example from Canada:

http://www.theprovince.com/health/local-health/nanaimo+doctors+electronic+health+record+system/11947563/story.html

Nanaimo doctors say electronic health record system unsafe, should be shut down

By Cindy E. Harnett
Victoria Times Colonist
May 27, 2016

Implementation of a $174-million Vancouver Island-wide electronic health record system in Nanaimo Regional General Hospital — set to expand to Victoria by late 2017 — is a huge failure, say senior physicians.

Who cares what they say? They're just doctors, so sayeth the imperial hospital executives..

After a year of testing, the new paperless iHealth system rolled out in Nanaimo on March 19. Island Health heralds the system as the first in the province to connect all acute-care and diagnostic services through one electronic patient medical record, the first fully integrated electronic chart in the province.

EHR pioneer Dr. Donald Lindberg, retired head of the U.S. National Library of Medicine, called such total command-and-control systems "grotesque", and that was in 1969 (See http://hcrenewal.blogspot.com/2014/06/masters-of-obvious-aat-athens-regional.html). He observed back then:

But he's a doctor too, so what does he know, sayeth the hospital executives.

But nine weeks after startup, physicians in the Nanaimo hospital's intensive-care and emergency departments reverted to pen and paper this week "out of concern for patient safety."

Who cares what they say? apparently not the executives, per Toni O'Keeffe, Vice President and Chief, Communications and Public Relations, http://www.viha.ca/about_viha/executive_team/toni_okeeffe.htm, as below. The system's perfectly safe!

Doctors said the system is flawed — generating wrong dosages for the most dangerous of drugs, diminishing time for patient consultation, and losing critical information and orders.

"The whole thing is a mess," said a senior physician. "What you type into the computer is not what comes out the other end.

"It's unusable and it's unsafe. I'm surprised they haven't pulled it. I've never seen errors of the kind we are now seeing."

Doctors are so concerned, they want Island Health to suspend the implementation.

"Take it away and fix it and test it before you bring it back — stop testing it on our people," said one doctor. "Why wasn't this introduced in Victoria first? If they went live in Victoria first, they would have a riot."

(Is there anything unclear there, I ask?)

SHUT UP DOCTORS. IT''S PERFECTLY SAFE, sayeth the administration.

The doctors, who fear reprisals, spoke to the Times Colonist on condition of anonymity.

If doctors did not fear reprisals I'd have a full time job writing on EHR debacles. I could almost have one now.

The $174-million system started with a 10-year, $50-million deal for software and professional services signed in 2013 with Cerner Corporation, a health information technology company headquartered in Kansas City. Thus far, the company has been paid close to $12 million. The remaining $124 million is to be spent by Island Health for hardware, training and operating the system.

I wonder just how much graft there may be, driving what seems an international phenomenon of bad health IT with doctors and nurses complaining (e.g., examples of mayhem at http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html), patients being harmed and dying (e.g., ECRI Deep Dive study at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html), yet hospital execs and government officials gleefully moving full steam ahead.

The system is being used in Nanaimo's hospital, Dufferin Place residential care centre (also in Nanaimo), and Oceanside Health Centre in Parksville.

Since March 19, mobile touch-screen computer console carts have been rolling around hospital hallways. Voice-recognition dictation software immediately transcribes a doctor's verbal notes into a patient's electronic record, and scanners track each bar-coded patient bracelet around the hospital. But doctors complain the new technology is slow, overly complicated and inefficient.

Today's clinical IT is needlessly and blindingly complex. But hospital executives are, in my increasing view, too ignorant to recognize the necessity of simplicity in critical functions such as clinical medicine. Their jobs are child's play in comparison. (I should know; I once was a health IT executive after having practiced medicine for a number of years.)

"The iHealth computer interface for ordering medications and tests is so poorly designed that not only does it take doctors more than twice as long to enter orders, even with that extra effort, serious errors are occurring on multiple patients every single day," wrote one physician at the Nanaimo hospital.

In view of current warnings and that which is known, and has been known for many years from the literature about bad health IT, each and every adverse outcome of injury that occurs represents hospital executive gross negligence:

Gross negligence is a conscious and voluntary disregard of the need to use reasonable care, which is likely to cause foreseeable grave injury or harm to persons, property, or both. It is conduct that is extreme when compared with ordinary Negligence, which is a mere failure to exercise reasonable care. http://legal-dictionary.thefreedictionary.com/gross+negligence

I leave it to the reader to classify patient deaths.

"Tests are being delayed. Medications are being missed or accidentally discontinued."

My mother and other patients in whose litigation I have provided informatics expertise were injured and/or died from precisely that type of mistake.

Doctors can't easily find information entered by nurses, the physician wrote.

There are also complaints about the pharmacy module of Cerner's integrated system — the only joint build between Island Health and Cerner.

iHealth implementation staff brought in to input orders for physicians this week entered eight drug mistakes on one day and 10 on another, while there were no mistakes in the paper orders, doctors said. "If the experts can't enter it correctly, what is the average Joe going to do?" one doctor said.

Suffer, and take on all the liability, of course.

Another problem, they said, is patients' drug orders disappearing from the system.

Australian informatics expert Jon Patrick wrote of such issues in 2011 as at this link: http://hcrenewal.blogspot.com/2011/03/on-emr-forensic-evaluation-from-down.html. His technical paper was ignored, and pushback for having written it draconian.

Here's the administration's view:

... But Island Health spokeswoman Antoniette O'Keeffe said the system is safe and doing what it's intended to do.

To hell with the doctors concerns and with the patients.

"We are not going back to paper," she said. "We can't go back to paper. We don't have the mechanics to go back to paper."

I'll be generous about the stupidity represented by that statement. What she means is, we've jsut blown tens of millions of dollars on computers. We'd get out asses kicked by the Board if we admitted we blew it and went back to paper.

Island Health acknowledges that documentation for staff doing emergency-department patient intake was a challenge, noting Nanaimo is the busiest emergency department on the Island.

A mere "challenge." How about "was not possible in a 24 hour day?"

Nanaimo has some of the top physicians in the country and "we respect the feedback they are giving us, and so we are listening to them and we are tweaking and modifying the system," O'Keeffe said.

We respect their feedback. They say it should be shut down, but "the system is safe and doing what it's intended to do."

Challenges include getting medication orders into the system, getting clinical staff trained, work flow and documentation, O'Keeffe said.

More staff have been added to speed up admissions and others are working around the clock in the intensive-care and emergency departments to input handwritten physician orders into the system, O'Keeffe said.

Cerner is working with Island Health staff, "and they'll be here until we get this fully implemented," O'Keeffe said.

Ms. O'Keefe. bad health IT is never "fully implemented." (e.g., http://hcrenewal.blogspot.com/2013/11/weve-resolved-6036-issues-and-have-3517.html) Instead, clinicians learn to work around bad health IT, except when the risk of doing so slips through and patients get maimed or killed.

Island Health credits the system's electronic warnings for catching about 400 human-caused medication errors and conflicts at three sites, saying it's a sign that the system is working. It will produce a warning, for example, if the dosage is too high for a patient's weight, if the drug is not appropriate for a particular disease or if there's a drug conflict.

Across the country, thousands of medication mistakes are made daily due to human error, "and this system is designed to catch them," O'Keeffe said.

Doctors respond that so many irrelevant flags pop up, it creates confusion, while the computer loses or duplicates drug orders.

Ms. O'Keefe and her administration are obviously blissfully unaware of how health IT can cause medication errors en masse impossible with paper, e.g., "Lifespan (Rhode Island): Yet another health IT 'glitch' affecting thousands", http://hcrenewal.blogspot.com/2011/11/lifespan-rhode-island-yet-another.html. Of course, many hospital executives are ill-informed, lacking the curiosity of the average scientist or physician.

The system was a decade in the making for Island Health. Twenty-three clinical teams were involved in developing various components and there was user-group testing, modifications and feedback, O'Keeffe said. Training has gone on for the last year, she said. "You can only bring a system so far and then you have to put it in a real environment to test it."

At best - test it - yes, on unsuspecting human subjects known as patients, doctors and nurses. The ones who are harmed and the ones who die are worthy human sacrifice for the glory of computing, eh, Ms. O'Keefe?

At worst - what is wrong with this industry that each and every installation of this technology is an experiment?

Is it that the technology has exceeded the intellectual horsepower of available personnel? In my experience that has seemed to be the case.

By the end of the implementation, it's expected family doctors will also be able to access patient files started in acute-care settings. Island Health is working on that component now, O'Keeffe said. Once the system is working smoothly in Nanaimo, it will be installed in the north Island and then Victoria hospitals in 12 to 18 months, O'Keeffe said.

Runaway trains cannot be stopped.

Canadian lawyers, take note.

-- SS

Addendum: An Op-Ed on this matter is here:

http://www.timescolonist.com/opinion/op-ed/comment-new-computer-system-a-detriment-to-health-care-1.2264274

It is grim, written by a doctor under a pseudonym (Dr. Winston Smith is the pseudonym for a doctor in Nanaimo - that says much about fear of retaliation):

One health record. Making care delivery easier for health-care providers. Safer health care. These are the claims Island Health has made publicly for its new electronic health-record system iHealth, introduced initially at Nanaimo Regional General Hospital in March and intended to roll out across Vancouver Island in the coming months.
These are goals physicians share — many of whom enthusiastically use electronic records in their clinics. Despite "bumps in the road," Island Health claims the implementation of the system is going well.
But these claims are untrue. iHealth does not provide a single health record: It offers no less disjointed and poorly accessible a collection of patient information in differing programs and sites than the previous system.
The system is cumbersome, inefficient, not intuitive — and not simply because it is a new system, but because of its very nature. It's like trying to make a DOS-based computer work like an Apple or Windows-based system: You can perform many of the same functions, but it is slow, takes multiple steps and is inefficient.
Even the youngest generation, who have grown up with computers, and those with computing science degrees can't make it work effectively.
The system's ordering function is faulty and requires multiple separate steps and choices to order a simple medication: A processing issue safety experts know is highly likely to cause error.
And the system sometimes makes default changes in medication orders without the knowledge of the ordering physician. Single orders for medications disappear from the record, so that duplicate orders are initiated by unknowing doctors.
The consequence of these problems is that hospital-based care delivery is slower, more inefficient, more prone to error. Health-care providers are found interacting with their mobile computer monitors in already overcrowded hallways rather than providing direct patient care.
Nurses and doctors have less of a holistic appreciation of their patients and their illnesses because of the disjointed complexity of the electronic record rather than the simple navigability of the previous paper record and charting.
And communication with the computer system has supplanted direct discussion between health-care team members: Like trying to manage complex illnesses through text messages.
Health-care delivery is slower, so surgical operations are cancelled or delayed and patients leave the emergency department without being assessed; patients are not seen in a timely fashion or at all by specialists; medication errors are regular, so patients are medicated inappropriately or even overdosed; and some of our most experienced and valued health-care providers opt for early retirement or leave rather than continue the frustration and moral distress that this system has generated.
And the effect of iHealth is not restricted to the hospital, as some specialists have reduced their outpatient service because of the increased workload iHealth has caused.
In short, health care is not easier or better. The quality of care is worse and access is reduced. Improvements can be made and have been, but the system is fundamentally flawed. The impact on work efficiency and quality will never return to previous levels — a fact even the Island Health iHealth "champions" acknowledge.
Worse, iHealth is unsafe and dangerous. Medicine strives to be evidence-based, but there's no evidence electronic record systems improve quality of care, and plenty of evidence they do the opposite — particularly this one.
Doctors have expressed their concerns to Island Health. Rather than suspending the system, the health authority's response has been simply to delay its rollout beyond Nanaimo. It's OK to let our community suffer while they tinker.
Dr. Brendan Carr, the CEO of Island Health, tells us he'll "do whatever it takes to make this work," even while continuing to risk worsening quality of care and expending more of our taxpayer dollars — $200 million so far, a fraction of which applied to delivery of health-care services could provide inordinately better health-care outcomes than any electronic record can do.
The medical community has finally taken matters into our own hands in the interests of patient safety, quality of care and access. A number of departments are refusing to continue using the system and instead returning to the previous one.
Why does Island Health not withdraw this system? In sum, they've spent a lot of taxpayers' dollars on iHealth, a product of Cerner, which has been sued by hospital systems in the United States.
And as with many such systems, the objective has not been better patient care, but has been more Orwellian: Improved administrative data and control — no wonder Island Health is loath to give it up.
Well, Dr. Carr, the patient should be paramount. I and my family and my community are not expendable. No electronic record system should be introduced that will not explicitly improve health care, patient safety and access.
Any deterioration in health care is not an acceptable outcome. Suspend the iHealth experiment. Stop wasting taxpayer dollars. Sue for our money back for having been sold a lemon (as other jurisdictions have done).
Spend our tax dollars on services, infrastructure and equipment that will improve health care, not make it worse.
Dr. Winston Smith is the pseudonym for a doctor in Nanaimo.
- See more at: http://www.timescolonist.com/opinion/op-ed/comment-new-computer-system-a-detriment-to-health-care-1.2264274#sthash.rWwQcJZA.dpuf

... The system is cumbersome, inefficient, not intuitive — and not simply because it is a new system, but because of its very nature. It's like trying to make a DOS-based computer work like an Apple or Windows-based system: You can perform many of the same functions, but it is slow, takes multiple steps and is inefficient.

Even the youngest generation, who have grown up with computers, and those with computing science degrees can't make it work effectively.

The system's ordering function is faulty and requires multiple separate steps and choices to order a simple medication: A processing issue safety experts know is highly likely to cause error.

And the system sometimes makes default changes in medication orders without the knowledge of the ordering physician. Single orders for medications disappear from the record, so that duplicate orders are initiated by unknowing doctors.

Deadly.

The consequence of these problems is that hospital-based care delivery is slower, more inefficient, more prone to error. Health-care providers are found interacting with their mobile computer monitors in already overcrowded hallways rather than providing direct patient care.

This was not what the pioneers intended.

Nurses and doctors have less of a holistic appreciation of their patients and their illnesses because of the disjointed complexity of the electronic record rather than the simple navigability of the previous paper record and charting.

That sums up a major problem with today's health IT well.

The medical community has finally taken matters into our own hands in the interests of patient safety, quality of care and access. A number of departments are refusing to continue using the system and instead returning to the previous one.

This type of revolt, showing who really owns the hospital, needs to become commonplace.

Why does Island Health not withdraw this system? In sum, they've spent a lot of taxpayers' dollars on iHealth, a product of Cerner, which has been sued by hospital systems in the United States.

And as with many such systems, the objective has not been better patient care, but has been more Orwellian: Improved administrative data and control — no wonder Island Health is loath to give it up.

Indeed.

The CEO is himself a physician:

Well, Dr. Carr, the patient should be paramount. I and my family and my community are not expendable. No electronic record system should be introduced that will not explicitly improve health care, patient safety and access.

This anonymous doctor needs to speak to my mother, who I visited yesterday along with my father, on U.S. Memorial Day - at the cemetery after her encounter with bad health IT.

Read the whole Op Ed at the link above.

-- SS

New computer system a detriment to health care

New computer system a detriment to health care

InformaticsMDhttp://email@example.com:blogger.com,1999:blog-9551150.post-73695446168936031792016-05-26T16:43:00.001-04:002016-05-29T15:22:55.902-04:00Are You Ready for Some (Political) Football? - the NFL, Concussion Research, the NIH, and the Revolving DoorProbably because it involved the favorite American sport, the controversy about the risk of concussions to professional National Football League (NFL) players, and how the NFL has handled the issue is very well known. A recent article in Stat, however, suggested that one less well known aspect of the story overlaps some issues to concern to Health Care Renewal.

Allegations that a Prominent Physician and NFL Official Tried to Influence the NIH Grant Review Process

The article began,

Dr. Elizabeth Nabel, president of Boston's Brigham and Women's Hospital [BWH] and one of the nation's most prominent medical executives, was part of a National Football League effort to 'steer funding' for a landmark concussion study away from a group of respected brain researchers, according to a congressional committee report that was sharply critical of the league.

The report found that the NFL 'inappropriately attempted to influence' the National Institutes of Health's [NIH] grant selection process.

Dr Nabel, in fact, not only runs the BWH, a renowned teaching hospital and major component of Partners Healthcare, but also serves as the "chief health and medical advisor" to the NFL. Anyone who has followed even a bit of the media coverage about the NFL and concussions affecting football players knows that the NFL could be negatively affected by any more research that associates playing professional football, concussions, and the adverse effects of concussions.

The Stat article chronicled the intricate communications between Dr Nabel and the NIH as documented by a report from the Democratic staff of the House Committee on Energy and Commerce.

 It cited a series of communications between NFL representatives, including Nabel, and officials of the NIH, and a foundation that accepts gifts from private donors to support NIH research. The discussions began after the NIH decided last year to award a $16 million grant to a research team led by Dr. Robert Stern of Boston University — but before the award was publicly announced.

The money for the grant was to come from a donation pledged by the NFL to the Foundation for the National Institutes of Health, and league officials say they were concerned about aspects of Stern's group and the proposed study.

Research by Stern's team and BU colleagues has helped establish a link between football and chronic traumatic encephalopathy, long-term brain damage that's been observed in a growing number of athletes, including former NFL players, who suffered repeated head injuries.

The implication seems to be that this research group might be counted on to fearlessly pursue research even if the outcomes suggested that playing football might lead to adverse medical effects, which might not be so good for the NFL's interests. So,

Nabel, who knows the NIH well from her 10 years working as a high-level manager in the agency, sent two emails to Dr. Walter Koroshetz, director of the National Institute of Neurological Disorders and Stroke [NINDS], according to the report. That's the NIH branch that was awarding the grant.

In one email on June 23, 2015, she wrote, 'I am taking a neutral stance here,' while noting a concern about a potential conflict of interest: members of the NIH grant review panel had coauthored papers with two researchers that she had heard might be receiving the grant — Dr. Ann McKee and Dr. Robert Cantu of BU.

Later that day, she wrote Koroshetz that 'a Dr. Stern, who may also be with this group, has filed independent testimony in the NFL/Players Association settlement.'

Indeed, Stern was critical of how the settlement would be administered, pointing out flaws with the neuropsychological tests that the league proposed using to determine how to compensate injured players.

 Notwithstanding that Dr Nabel had an obvious conflict of interest herself: she worked for the NFL. In any case,

'I hope this group is able to approach their research in an unbiased manner,' Nabel's email continued, the report says.

Nabel sent Stern's testimony to Koroshetz, according to the report.

'My sole objective,' Nabel said in her statement, was to ask her former NIH colleagues to 'ensure there were no conflicts of interest among grant applicants.'

The NIH found no conflicts involving the grant review panel and stuck with its decision to award the grant to the Stern group. It ended up using internal funds, not the NFL money, to pay for the grant.

The NIH told STAT it agrees with the 'characterization of events in the report.'
An Affront to the Sanctity of the Grant Review Process?

Although Dr Nabel and the NFL asserted that they acted appropriately at all times, neither the committee staff nor one very prominent ethicist agreed,

The committee report said that Koroshetz disagreed ..., and said he was aware of no other instance where a donor raised objections to a grantee prior to the issuance of a notice of grant award.'

'The NFL's characterization of the appropriateness of its actions suggests a lack of understanding of the importance of the NIH's independent peer review process,' the committee report states.

Nabel's spokeswoman said Koroshetz never told Nabel her actions were inappropriate. 'In fact, all of their interactions were very collegial and cordial,' she said.

I will interject that the question was not whether Dr Nabel was hostile or bullying, but was whether she tried to inappropriately influence the grant review process. So also,

Arthur Caplan, a professor of bioethics at New York University, said Nabel's actions, as described in the report, risk harming Nabel's reputation and that of the Brigham. 'When she did anything to try to shape the selection of investigators or challenge the objectivity' of the grant selection process, he said, 'she had to know that that was 100 percent inappropriate, 100 percent unacceptable.'

Having served on numerous NIH and Agency for Healthcare Research and Quality (AHRQ) review committees (known as "study sections"), let me add some context at this point. Study section members must meet rigorous standards for freedom from conflicts of interest. They also fiercely guard their independence. The grant reviews they construct are supposed to be entirely about the scientific, clinical and public health merit of the proposals, and the scores they give proposals are the most important determinants of whether it gets funding. Funding decisions are actually made by agency staff and advisory boards, but are supposed to depend only on the reviews and the general priority of the proposals' topics. Nobody - I repeat, nobody - outside of this process is supposed to influence the funding decisions.

So the notion that big wigs from big outside organizations with vested interests in how a particular research project might turn out were communicating with top NIH officials about grant proposals, and that the officials allowed them to continue to communicate, and allowed even the chance they would be influenced by their communication strikes this old reviewer, to quote Dr Caplan, as "100 inappropriate, 100 percent unacceptable."

Did the Revolving Door Enable the Attempt to Influence NIH Grant Review?

Not directly discussed in the Stat article, however, was why Dr Koroshetz, director of NINDS, was willing to accept, if not agree with Dr Nabel's communications. The article did note that Dr Nabel was a former "high-level manager" at the NIH. In fact, according to her official Brigham and Womens' Hospital biography, Dr Nabel was director of the US National Heart, Lung and Blood Institute from 2005-2009. She became CEO of the BWH in 2010. Thus, she was a former top NIH leader who once held a rank commensurate with that held by Dr Koroshetz.

But wait, there is more. Also according to her official BWH biography, Dr Nabel's husband is one Gary Nabel, now the chief scientific officer at Sanofi. Dr Gary Nabel, in turn, was Director of the Vaccine Research Center at the National Institute for Allergy and Infectious Diseases (NIAID), another NIH institute, through 2012, but then according to Science, became chief scientific officer at Sanofi. So Dr Nabel's husband was also a high-ranking NIH leader, although apparently not as high-ranking as his spouse and the NINDS director with whom she communicated.

Thus it appears that maybe Dr Nabel had outsized influence at the NIH and on the NINDS director because she was a former NHLBI director, and the spouse of a former high-ranking NIAID leader. Her attempts to influence the NIH grant application process therefore appear to be a possible manifestation, albeit delayed, and partially at one spousal remove, of the revolving door pheonomenon.

We have noted that the revolving door is a species of conflict of interest. Worse, some experts have suggested that the revolving door is in fact corruption. As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.
 This case suggests how the revolving door may enable certain of those with private vested interests to have excess influence, way beyond that of ordinary citizens, on how the government works.

Worse, this case also suggests how it seems that the country is increasingly run by a cozy group of insiders with ties to both government and industry. In fact, just a little more digging reveals that a key player in this case has even more ties to big private health care organizations. According to ProPublica, in the last three months of 2014, Dr Elizabeth Nabel received $26,070 from Medtronic, mainly for food, travel and lodging, but which included $8572 for "promotional speaking/ other." In 2015, she was appointed to the board of directors of Medtronic, despite not having previously owned any Medtronic stock, according to the company's 2015 proxy statement. Also in 2015, she was appointed to the board of directors of Moderna Therapeutics. Her husband, as noted above, now works as chief scientific officer for Sanofi.

So, as we have said before.... The continuing egregiousness of the revolving door in health care shows how health care leadership can play mutually beneficial games, regardless of the their effects on patients' and the public's health. Once again, true health care reform would cut the ties between government and corporate leaders and their cronies that have lead to government of, for and by corporate executives rather than the people at large.

Video addendum: the beginning of "League of Denial" from PBS Frontline

ADDENDUM (29 May, 2016) - This post was republished on the Naked Capitalism blog. Roy M. Poses MDhttp://firstname.lastname@example.com:blogger.com,1999:blog-9551150.post-9902128266880175962016-05-20T12:07:00.002-04:002016-05-20T12:11:43.675-04:00No Questions Asked - Journalist Parrots the Talking Points in Support of Hospital Executive Compensation The problem of ever rising, amazingly generous pay for top health care managers is a frequent topic for Health Care Renewal. We have suggested that the ability of top managers to command ever increasing pay uncorrelated with their organizations' contributions to patients' or the public's health, and often despite major organizational shortcomings indicates fundamental structural problems with US health, and provides perverse incentives for these managers to defend the current system, no matter how bad its dysfunction.

In particular, we have written a series of posts about the lack of logical justification for huge executive compensation by non-profit hospitals and hospital systems. When journalists inquire why the pay of a particular leader is so high, the leader, his or her public relations spokespeople, or hospital trustees can be relied on to cite the same now hackneyed talking points.

As I wrote last year, and last week,

It seems nearly every attempt made to defend the outsize compensation given hospital and health system executives involves the same arguments, thus suggesting they are talking points, possibly crafted as a public relations ploy. We first listed the talking points here, and then provided additional examples of their use. here, here here, here, here, and here, here and here.

They are:
- We have to pay competitive rates
- We have to pay enough to retain at least competent executives, given how hard it is to be an executive
- Our executives are not merely competitive, but brilliant (and have to be to do such a difficult job).

Yet as we discussed recently, these talking points are easily debunked. Additionally, rarely do those who mouth the talking points in support of a particular leader provide any evidence to support their applicability to that leader.

Bit at least most journalists who inquire into hospital executive compensation make an attempt to be "fair and balanced" by also quoting experts who question the talking points.

Hospital Executive Compensation in Central Pennsylvania

However, we just found an ostensibly journalistic survey of local hospital executive compensation in the Reading (PA) Eagle which seemed designed to encourage the public to welcome their ever more highly paid corporate health overlords. This started with its title:

Nonprofit health care organizations pay for the best executives

And its opening paragraph

At first blush, the leaders of area hospitals are handsomely compensated. But a Reading Eagle analysis finds that their compensation is in line with hospital administrators in other areas.

The author was not shy about documenting the munificent pay of local hospital executives, seven of whom received more than $1 million as documented by their organizations' most recent financial reports.

 Harold Paz, CEO of Hershey Medical Center (Penn State University) topped the list in 2014, at $1.57 million.
+++
Second was Thomas E. Beeman, former president and CEO of Lancaster General Health, at $1.5 million.
+++
Third was Clint Matthews, president and CEO of Reading Health System, at $1.44 million in 2014, the most recent year information was available.

Then,

Fourth place in total compensation went to Ronald W. Swinfard, trustee and CEO of the Lehigh Valley Health Network, at $1.32 million in 2014.

Fifth place in total compensation was Kevin Mosser, director and CEO, WellSpan Health at Ephrata Community Hospital, at $1.29 million.

Sixth place was Rod Erickson, former president, Hershey Medical Center, Penn State, $1.28 million.

Seventh place was Richard Seim, president, WellSpan Specialty Services, WellSpan Health, $1.01 million.

In eighth place was Michael F. O'Connor, CFO. WellSpan, Ephrata Community Hospital, $993.618.

Ninth was Charles Chodroff, president, South Central Preferred, WellSpan Health, $906,582.

Tenth was Rodney Kirsch, senior VP, development, Hershey Medical Center Penn State, $860,445.

Eleventh was John Morahan, chair, president and CEO, Bornemann Health Corp. and St. Joseph Regional Health, at $841, 246. Bornemann is an affiliate of St. Joseph Regional Health, and compensation came from Catholic Health Initiatives.

Parroting the Talking Points

But the public should fear not, because, as the talking points say....

We have to pay competitive rates

This was invoked early in the article.

The Reading Eagle review also found that leaders of hospitals in Berks County are compensated in line with their counterparts at other medical centers in Pennsylvania.

Also,

Overall, the compensation of medical nonprofit leaders in Berks County is on par with leaders of similar locations elsewhere, said Chester Mosteller, founder and president of Mosteller and Associates, a human resource professional services firm in Reading.

We have to pay enough to retain at least competitive executives

To support both the first and this talking point, the article cited a local expert,

 Nonetheless, people are sometimes surprised at high compensation levels at nonprofit hospitals, said Tish Mogan, standards for excellence director at the Pennsylvania Association of Nonprofit Organizations in Harrisburg. But, Mogan noted, if the leaders of nonprofit hospitals were not well compensated, they could be poached by for-profit medical centers.

'They have to be competitive,...

Doubling down, the article also cited "Anna Valuch, director of marketing for Reading Health System," whose CEO, her boss, pulled down $1.44 million. She said

the system's board of directors takes seriously its responsibilities in terms of creating an executive compensation plan that is fair, competitive and consistent with the system's mission to provide the highest quality health care.

Later, the reporter quoted Ms "Cindy Bergvall, co-owner of accounting firm Bee Bergvall and Co in Bucks County and its affiliate, the Catalyst Center for Nonprofit Management," as saying

nonprofit health care organizations are competing with for-profit organizations for talent, so they must offer competitive wages.

Our executives are brilliant

Ms Morgan immediately segued into a claim that executives

have to make sure that somebody's in charge that has the capability to make sure that, if I'm on that procedure table, things are in place to take care of me,

Mr Mosteller had a different version of the brilliance argument.

'It's been extremely challenging with the Affordable Care Act and Medicare, and that all results in some very big challenges within the health care arena,' he said. 'It is by no means an easy nonprofit to run and manage. It's become increasingly complex to operate and fulfill your mission in those environments.'

Similarly, "J Andrew Weidman, chairman of the board of directors for Penn State Health St. Joseph," put all three talking points into one sentence,

'To be in the best position to recruit and retain vital and talented employees, we must pay competitive wages,' Weidman said.

So did "Brian Downs, director of media relations for Lehigh Valley Health Network," who worked for CEO Ronald W Swinfard, who pulled down $1.32 million,

'To attract and retain the highest caliber health care professionals needed to sustain the quality of care LVHN provides to our community, and to oversee the operation of a nearly $2 billion organization, we must offer compensation that is competitive with organizations we compete with for talent in the job market,' Downs said.
Note that several of these experts/ commenators worked directly for the very well compensated hospital system CEOs of interest, and the others apparently worked for firms that got financial support from these CEOs' hospital systems.

No Questions Asked

While the Eagle quoted multiple proponents of high executive pay repeating all the talking points, the reporter apparently did not challenge any of them to justify any of the talking points in the context of interest. In particular, no one provided any evidence that any of the particular executives are so brilliant, or as the article implies, why ALL local executives are brilliant. How can there not be a single average one in the bunch?

In fact, a quick Google search reveals reasons to questions the brilliance of at least some of them. For example, Hershey Medical Center, whose CEO was the highest paid of the group, has proposed a controversial merger which is the subject of strong opposition by the US Federal Trade Commission (FTC). (See articles in Modern Healthcare and PennLive. Per Modern Healthcare, the FTC is claiming that the merger would lead to "higher prices and diminished quality [of care]." Especially given that the FTC seemingly has a high threshold to challenge a hospital system merger, its opposition certainly suggests questions about current hospital management. Also, Lancaster General Health, whose CEO was the second best paid of the group, had to pause a big expansion project because of cost overruns (see this article in Lancaster Online), and suffered a major outage of its electronic health record (EHR) system (see this article in Lancaster Online).

Yet the Reading Eagle reporter did not raise these incidents, nor question anyone about the supposed brilliance of the leaders at the institutions that suffered them.

Furthermore, many of the points made on behalf of high executive pay raised obvious questions that were not asked. For example, Ms Morgan was not asked whether any executives actually have been recently "poached." Ms Bergvall was not asked to name the for-profit organizations with which the hospital systems was competing for talent. Strikingly, Ms Bergvall also was not asked to justify the assertion that it is the responsibility of hospital managers, not physicians, to make sure that "when I am on the procedure table, things are in place to take care of me."

Even more strikingly, Ms Bergvall was apparently not questioned further after she suggested that CEOs may command more pay simply because they may feel entitled to a big dollop of all the money flowing throught he health care system

when nonprofit organizations bill for services, like hospitals do, they usually have the financial resources to compensate people well.

'In the health care industry, you have an income stream that allows you to pay better,' Bergvall said.

Of course, many of the media reports on high executive compensation in health care do not report any cross-examination of its supporters. Perhaps these advocates refused to respond to such questions, or the reporters felt too intimidated to challenge them.

But nearly all articles that try to delve into executive compensation at all at least quote some experts who are skeptical of current practices. And there are real reasons to be skeptical. As we discussed here, there is a strong argument that huge executive compensation is more a function of executives' political influence within the organization than their brilliance or the likelihood they are likely to be fickle and jump ship even bigger pay. This influence is partially generated by their control over their institutions' marketers, public relations flacks, and lawyers. It is partially generated by their control over the make up of the boards of trustees who are supposed to exert governance, especially when these boards are subject to conflicts of interest and are stacked with hired managers of other organizations.

This article included no such attempts at balance. So it ended up more like propaganda for managers' current privileged position in health care than journalistic inquiry. It is sad to see reporting about important health policy issues devolve into propaganda to support the status quo, and those who personally profit the most from it. But perhaps those who work at the Reading Eagle hesitate to offend those who are making the most from the current system. It appears that the newspaer is owned by the Reading Eagle Company, and this, in turn is owned by the Barbey family, which according to Politico also

controls the publicly-traded lifestyle clothier VF Corporation (Nautica, Jansport, Wrangler, Timberland, Lee, Vans, etc.) and is ranked no. 48 on Forbes' list of America's richest families.

Discussion

We will not make any progress reducing current health care dysfunction if we cannot have an honest conversation about what causes it and who profits from it. In a democracy, we depend on journalists and the news media to provide the information needed to inform such a discussion. When the news media becomes an outlet for propaganda in support of the status quo, the anechoic effect is magnified, honest discussion is inhibited, and out democracy is further damaged.

True health care reform requires ending the anechoic effect, exposing the web of conflicts of interest that entangle health care, publicizing who benefits most from the current dysfunction, and how and why. But it is painfully obvious that the people who have gotten so rich from the current status quo will use every tool at their disposal, paying for them with the money they have extracted from patients and taxpayers, to defend their position. It will take grit, persistence, and courage to persevere in the cause of better health for patients and the public.

Roy M. Poses MDhttp://email@example.com:blogger.com,1999:blog-9551150.post-22170503948100181592016-05-15T11:28:00.002-04:002016-05-15T11:28:45.492-04:00New Jersey Confidential: the Almost Secret Membership of the RWJ Barnabas Health BoardA Hospital System Tries to Hide its Board of Trustees

The US Internal Revenue Service mandates disclosure of the membership of boards of trustees of non-profit corporations. Nonetheless, as reported by New Brunswick (NJ) Today, the leadership of the newly formed RWJ Barnabas Health system has been doing their best to keep the membership of its board of trustees secret.

The new organization created to function as the state's largest hospital chain is refusing to tell the public who serves on their Board of Trustees,...

To elaborate,

The two hospital networks officially combined to form a new conglomerate, the state's second largest employer, in a deal that was finalized on March 31.

But since then, the new group has refused to identify its board members, after stalling for nearly two weeks.

'Thank you very much for your interest. It is a policy at RWJBarnabas Health not to share the names of the Board of Trustees" read a peculiar April 12 email response from an anonymous address affiliated with Barnabas, firstname.lastname@example.com.

The anonymous email address has not responded to follow up inquiries from this newspaper, including one urging them to make the 'smart choice' and 'be transparent.'

This goes against at least the spirit of the law.

'If the organization has been recognized by the IRS as tax-exempt under one of the subsections under 501(c), there are a number of documents that organizations must make available that would include board lists,' said the leader of the Center for Non-profits.

The initial application, and the three most recent annual filings, must be made available for inspection or copying by members of the public at their place of business, according to the IRS.

In general, any organization that files a Form 990... must make its three most recent Form 990's and its Form 1023 available for public inspection without charge at its principal place of business,' reads the Center's website.

'All parts of the return, schedules and attachments must be made available during regular business hours at the organization's principal office and at any regional offices having 3 or more employees.

There is an exception to the requirement if a non-profit chooses to make the documents widely available by posting them on the internet.

The anonymous email address that cited the policy of having a secret board, and the media contacts listed on the press release announcing the merger between RWJ and Barnabas, have not responded to questions about whether their healthcare organization is in compliance with the IRS rules regarding making the forms available to the public.
This obviously also is a remarkable rebuff to those in health care who advocate maximum transparency.

A Futile Attempt at Secrecy

Some good investigative reporting by New Brunswick Today penetrated the flimsy veil set up by hospital system leadership. The system chairman turns out to be one Jack Morris:

Documents provided by the NJ Department of Treasury show that controversial developer Jack Morris was made the Chairman of the RWJ Barnabas board.

Morris is a close friend and ally of former State Senate President and convicted felon John Lynch, Jr., who ruled New Brunswick as Mayor from 1978-1990, and some contend still is a key player in statewide politics.

Morris had previously served as Chairman of the Robert Wood Johnson University Hospital (RWJUH) Board of Directors. Morris is also tied to Cooper Hospital Chairman George Norcross, the state's most notorious unelected political boss.

The vice-chairman is actually Marc Benson.

another real estate mogul was named the RWJ Barnabas board's Vice Chair, according to the documents, which were filed with the State Treasurer in November 2015, nearly half a year before the merger was finalized.

Marc Berson founded the Millburn-based 'Fidelco Group' in 1981, a 'private investment owner-developer of residential, commercial, retail, and industrial properties in New York, New Jersey, Florida and Ohio,' according to a press release announcing his election as Chairman of the Barnabas Health Systems board in 2014.

As for the rest of the board, they are,

The other 18 secret board members are:

Robert L. Barchi, (Rutgers University, New Brunswick)
 James C. Salwitz, MD (Robert Wood Johnson University Hospital, New Brunswick)
Murdo Gordon (Bristol-Myers-Squibb, Princeton)
Susan Reinhard (AARP Public Policy Institute, Washington, DC)
Nicholas J. Valerani (West Health Institute, La Jolla, CA)
John A. Hoffman (Wilentz, Goldman, & Spitzer, Woodbridge)
Alan E. Davis, Greenbaum (Rowe, Smith & Davis LLP)
Robert E. Margulies, Esq. (Margulies Wind, Jersey City)
Kenneth A. Rosen (Lowenstein Sandler PC, Roseland)
 Lester J. Owens (J.P. Morgan Chase, New York, NY)
James Vaccaro (Manasquan Savings Bank, Wall)
Albert R. Gamper, Jr. (Caliber Home Loans, Inc., Far Hills)
Anne Evans-Estabrook (Elberon Development Corporation)
Gary Lotano (Lotano Development, Inc., Toms River)
Steve B. Kalafer (Flemington Car and Truck Country, Flemington)
Brian P. Leddy (former Chairman of RWJUH Rahway, Cranford)
Joseph Mauriello (formerly of KPMG, Chester)
Richard J. Kogan (formerly of Schering-Plough Products, Inc., Short Hills)
Why the Futile Effort to Make Board Membership Secret?

It is certainly striking that a big non-profit hospital system would try to conceal the membership of its board of trustees. One might think the leadership should be proud of the board members, and the board members would be happy to advertise their community service.

This did not seem to be the case here. Once more we see how the new overlords of health care reflexively seem to choose secrecy over transparency, deliberately creating the anechoic effect which we have frequently discussed.

Perhaps the board wanted to avoid undue attention to the political connections of its new chairman, one of which was to a"convicted felon," and another of which was to Mr Norcross, whose apparent conflicts of interest in his role in the governance of a former UMDNJ hospital were discussed here. Parenthetically, an article in NJ.com on the merger noted that this new hospital system is a descendant of the now dissolved University of Medicine and Dentistry of New Jersey, UMDNJ (look here), an organization whose extensive troubles kept Health Care Renewal very busy in past years.

Perusing the list of the members of the board reveals two people with pharmaceutical connections that could be conflicts of interest, a few people with health care affiliations, but no obvious affinity for the patients and public in New Jersey whom the new hospital system is supposed to serve, and many lawyers and business people with no obvious affinity for the values of health care professionals.

However, as summarized by the National Council for Nonprofits,

the board of directors have three primary legal duties known as the 'duty of care,' 'duty of loyalty,' and 'duty of obedience.'

...

In sum, these legal duties require that nonprofit board members:

Take care of the nonprofit by ensuring prudent use of all assets, including facility, people, and good will; and provide oversight for all activities that advance the nonprofit's effectiveness and sustainability. (legal 'Duty of due care')

Make decisions in the best interest of the nonprofit corporation; not in his or her self-interest. (legal Duty of loyalty')

Ensure that the nonprofit obeys applicable laws and acts in accordance with ethical practices; that the nonprofit adheres to its stated corporate purposes, and that its activities advance its mission. (legal 'Duty of obedience')

So it is not obvious that these board members are particularly familiar with the nuances of the mission of a large academic hospital system, which includes delivering excellent patient care that puts individual patients first, particularly ahead of board members' self interest, and of its academic role, seeking and disseminating the truth. One wonders what sort of governance this sort of board will provide. Maybe the hospital leadership wanted to forestall such questions by keeping board membership as obscure as possible.

Speaking of the anechoic effect, while the new RWJ Barnabas Health system will be a very major player in NJ health care, and while trying to keep the board members of a non-profit health care system is rather a remarkable action, so far, only one local newspaper, and now your humble blogger seem interested. This is yet another example of the anechoic effect.

Comments

We have been writing now for a long time about the tremendous and growing dysfunction of US health care. Some now obvious reasons for its problems are poor leadership of ever larger and more powerful health care organizations, and failure of existing governance bidues to exercise stewardship over these organizations. We have discussed numerous previous problems with boards of trustees of non-profit health care organizations here. We have noted that board member may have conflicts of interest, and are often rich business executives who may be more interested in preserving the power and wealth of their fellow executives, including those generic managers who know often run large health care organizations, than defending vulnerable patients. These problems are compounded by the anechoic effect: information and opinions which might offend those currently in power and who stand to benefit most from the current system is kept very quiet, treated as a taboo subject, that is, made to have no echoes. This new case again suggests that these problems are not going away.

How many times must we say this?.... True US health care reform would vastly increase transparency, not just of prices, but of leadership and governance. True US health care reform would put the operation of US health care organizations more in the hands of people who have knowledge and experience in health care, and are willing to be transparent and accountable to support health care professionals' values. Furthermore, oversight and stewardship of these organizations should represent the patients and public which the organizations are supposed to serve.

Roy M. Poses MDhttp://email@example.com:blogger.com,1999:blog-9551150.post-18164126368556299882016-05-02T13:39:00.002-04:002016-05-02T13:39:40.673-04:00Who Benefits? - Hospital Profits and Quality May Fall, But Hospital Executives' Compensation Keeps RisingDespite recent attempts at health care reform, US health care dysfunction seems to proceed inexorably with ever rising costs, and continuing problems with access and quality. A likely reason is that those who find the current system personally profitable are in a position to resist real reform. The people who seem to gain the most from the status quo are top hired executives of big health care organizations.

In particular, stories about huge pay for hospital and hospital system managers continuously appear in the media. For example, starting in October, 2015, we saw the following headlines:

- Pittsburgh, PA, October, 2015: "Former Highmark CEO Made Nearly $10 Million in 2014, Tax Records Show"
- Regarding Rochester General and Unity health systems in Rochester, NY, November, 2015: "Here's Why Execs Got Millions After Health Merger"
- Regarding the CEO of North Shore-LIJ Health System in NY, November, 2015: "This Guy Makes $10M a Year to Head a Nonprofit"
- In Idaho, February, 2016, "Pay for 9 Treasure Valley Nonprofit Hospital Employees Hits or Tops $1 Million"

Even more interesting are stories that show massive compensation of executives despite their hospitals' apparent poor performance. Since October, 2015, we also found the following (in chronological order)

Let Go After "Uneven Financial Performance," CEO of Kaleida Health Got $1.6 Million of Severance in One Year, with More to Come

In November, 2015 the Buffalo (NY) New reported that James R Kaskie, the CEO of Kaleida Health, the "largest healthcare provider in Western New York," per its website, was "forced out" when

the board cited a need for a change in leadership amid an uneven financial performance for the system....

Nonetheless,

Kaleida Health paid $1.6 million in 2014 to its former CEO, James R. Kaskie, after forcing him out early last year, according to its most recent federal regulatory filing.

Also,

Kaleida will pay Kaskie 24 months of severance under the terms of Kaskie's employment contract with the system, John R. Koelmel, chairman of the Kaleida board, told The Buffalo News on Thursday.

Kaskie was paid 10 months of severance plus deferred compensation, which is the $1.6 million reflected in the latest regulatory filing. He will be paid 12 months of severance in 2015 and a final two months of severance in 2016.

Mr Kaskie was paid even better the year before:

Kaskie earned $1.9 million in 2013, his last year as CEO.

Furthermore, other executives who were let go after Mr Kaskie's departure also were very well paid,

Dr. Margaret W. Paroski, former executive vice president and chief medical officer, who was replaced by Lomeo after he took over as CEO last year, $763,552.

Joseph M. Kessler, former executive vice president and chief financial officer, who was replaced by Lomeo, $608,454.
The article explained that

Hospitals, corporations and other entities negotiate severance agreements as part of the employment contracts when they hire top executives
So not only to these executives earn top dollar, but their earnings continue even if they lose their jobs because of poor performance. When asked to explain these levels of remuneration, and contracts that allow executives to get continuing pay even after being "forced out" for "uneven financial performance," John R Koelmel, the chairman of the system's board, said

Companies pay at market. To recruit the best talent, you need to pay at least market.

Public Hospital MetroHealth Medical Center Scored Below Average on Patient Satisfaction and Quality, but CEO Got $1.1 Million

In March, 2016, Cleveland Ohio television station NewsNet5 reported

MetroHealth Medical Center is a public hospital that is supported with $32.4 million of taxpayer money--roughly 5 percent of the hospital's budget.

Also,

a check with a federal database of patient satisfaction levels and quality measures at hospitals across the country found MetroHealth fell below the national average.

Nonetheless, its CEO, Dr Akram Boutos, got $1.1 million in salary, and presumably considerably more in bonuses.

Dr J B Silvers, '"a nationally recognized expert on hospital CEO compensation and professor at Case Western Reserve's business school," who is a MetroHealth board member,

insisted that Dr. Boutros is being fairly compensated when compared to his peers.

Furthermore,

He admitted the salary is first tied to profits--then a series of other quality measures like patient care, diversity, hospital improvements and employee satisfaction.

But the ties to satisfaction and quality may not bind, because he then tried to explain away the quality and satisfaction data,

Silvers argues those surveys may be misleading.

'Populations like ours, Medicaid populations, uncompensated care--poor people tend to rate organizations lower,' said Silvers.

But then admitted it was really about the money,

'We have to have a target in terms of financial performance because if you don't make the money you can't be in business,' said Silvers.

In Massachusetts, "As Hospital Profits Fall, Executive Pay Soars"

In April, 2016, the Lowell (MA) Sun published a long report on local hospital executive compensation. It started

It has been a lean couple of years for the region's hospitals.

Drawn by the higher reimbursement rates that insurers pay to academic teaching hospitals, such as those in Boston, more physicians are affiliating themselves with those institutions. Patients are following, and so is the money.

Some community hospitals, including Lowell General Hospital and Emerson Hospital in Concord, saw profit margins drop by more than half from 2012 to 2014.

Other hospitals' financial indicators, like ratios of assets to liabilities, are also weakening,...

However,

As they look to weather those storms and protect their space in a rapidly changing health-care landscape, the boards of directors of the region's hospitals have doubled down on a key investment: their executives.

'Each organization has to make its own decisions about how it can best compete in the marketplace,' said Gary Young, director of Northeastern University's Center for Health Policy and Healthcare Research.

Senior executives of hospitals and health-care systems -- there's a competitive market for that kind of talent ... some would say when organizations run into trouble, they need to spend more to get leaders.'

So,

At Lawrence General Hospital, compensation paid to top non-physician administrators increased 41 percent from 2012 to 2014, according to tax documents. President and CEO Dianne Anderson, who heads the list, was paid a total package of $884,092 in 2014.

Also,

From 2012 to 2014, Lahey Health's non-physician executives saw a compensation increase of 36 percent. A large part of that increase was in the salary of Dr. Howard Grant, who was promoted from president and CEO of Lahey Clinic to president and CEO of the entire Lahey Health system. The system includes facilities throughout northeastern Massachusetts and southern New Hampshire. Grant received $1.7 million in 2014.

In addition,

Lowell General Hospital's executives saw a slightly smaller increase during that three-year span, at 18 percent, although CEO Normand Deschene remains the highest-paid hospital executive in the region with a package worth $1.9 million in 2014. The hospital also pays the taxes on retirement benefits, which are worth hundreds of thousands of dollars, for Deschene and several other executives.

The justifications for these increases in times of financial trouble were similar. For example, re Lawrence General Hospital,

'Because we're resource-limited, compared to (academic) hospitals, we're even more dependent in these challenging times to bring in somebody who can manage risk,' said Richard Santagati, chairman of Lawrence General's executive compensation committee. 'It takes a different breed and there's real competition for these people ... and once you have them there, you want to keep them because there's a learning curve there that is unique to each hospital.'

Re Lahey Clinic,

'Our executive compensation is comparable to the programs of other, similarly sized health networks and is reflective of the complex role of an executive leader at a leading health system,' Lahey Health said in a statement.

Finally, at Lowell General Hospital, the CEO defended his own pay:

'Lowell General has weathered significant changes in the delivery of health care,' Deschene said. 'At a time when many hospitals have failed, it's very crucial and critical that we have very talented individuals to lead the hospital.'

The Usual Talking Points Again Invoked

Hospital management used the usual talking points to justify the pay they received, As I wrote last year

It seems nearly every attempt made to defend the outsize compensation given hospital and health system executives involves the same arguments, thus suggesting they are talking points, possibly crafted as a public relations ploy. We first listed the talking points here, and then provided additional examples of their use. here, here here, here, here, and here, here and here.

They are:
- We have to pay competitive rates
- We have to pay enough to retain at least competent executives, given how hard it is to be an executive
- Our executives are not merely competitive, but brilliant (and have to be to do such a difficult job).
So in the stories above, we found, for example:

- Competitive Rates: "you need to pay at least market" (Kaleida), and "there's real competition for these people" (Lawrence General)
- Retention: "you want to keep them" (Lawrence General)
- Brilliance: "the best talent" (Kaleida), "very talented individuals" (Lowell General)

It appears that those justifying huge executive payments have all been handed these same talking points.

Yet none of them quite make sense. The brilliance argument is particularly suspect in cases like those above of CEOs whose hospitals' performance was clearly not brilliant according to the metrics supposedly used to judge them.

Economists Challenge the Management Dogma Justifying Huge Executive Compensation

Furthermore, these talking points seem to derive from decreasingly credible current management dogma about executive compensation propagated by business schools.

The Invisible Hand, or A Hand on the Scales?

For example, writing in the Independent during January, 2016, Ben Chu questioned the market fundamentalist theory that all employees pay has been perfectly chosen by the infallible invisible hand of the market:

When confronted with an outburst of public anger over massive corporate pay for a privileged few, a common response of the libertarian right is to invoke the economics of the free market.

Such spectacular rewards, we're informed, are delivered by individuals selling their labour in a free market. And because such pay levels were set through this natural process, no one has the moral right to question them. Further, to interfere with such natural processes would be economically inefficient, making us all worse off in the end.

Such contentions are based on

a venerable economic theory [that is] behind this kind of reasoning. At the end of the 19th century, the American economist John Bates Clark hypothesised that in a perfectly competitive economy, demand for labour is determined by its 'marginal productivity' and wage rates are determined by the 'marginal product' of labour.

To translate, if a firm can make a profit by adding another worker to its payroll, it will do so. And the amount a firm will be willing to pay for that labour in wages will be determined by the additional profit the individual worker adds to the company's bottom line. So if a worker adds a lot of profit, he or she can command a lot of compensation. But if they add only a little profit, he or she will get only a little. This means people with low personal productivity get small amounts. But people with high personal productivity (chief executives for instance) receive big bucks.

For a start, how does a company know what the marginal product of an individual worker is, or will be? This isn't something that is directly measurable. The vast majority of us work in teams; how is it possible for management to determine our individual contribution to the financial success of that team, or of that team to the company? How can a business know how much of the profit added was due to the individual's particular skills? The conditions necessary for the Clark theory that everyone gets what they 'deserve' don't exist.

But isn't the marginal product of bosses, who make big strategic decisions, easier to measure? The ASI cites the late Steve Jobs of Apple as an employee who was clearly worth a lot. However, there are plenty of other chief executives whose individual contribution is impossible to measure. Yes, the company's share price might have gone up. But was this because the boss was smart? Or just lucky?

Furthermore,

The economist Dani Rodrik, in his latest book Economics Rules, argues that such broad theories of income distribution by the market are best viewed as intellectual 'scaffolding', adding: 'They are shallow approaches that identify the proximate causes but need to be backed up with considerable detail'.

And there are other theories of wage determination that are likely to be relevant. One important one is bargaining theory. This suggests that those who have political power within a firm can extract more than those without it. Maybe the reason chief executives tend to get paid ever growing multiples of the pay of the average worker is not because they are 'worth it' but because they are powerful. As the economist JK Galbraith put it: 'The salary of the chief executive of a large corporation is not a market award for achievement. It is frequently in the nature of a warm personal gesture by the individual to himself.'

The Dangers of Pay for Performance

In a February, 2016, article in the Harvard Business Review, Cable and Vermeulen challenged the dogma that managers' (and in health care, physicians' and other professionals') pay should largely be based on "performance."

performance-based pay can actually have dangerous outcomes for companies that implement it.

They cited five points based on at least some research evidence to back up their contention.

1. Contingent pay only works for routine tasks. Companies should abolish contingent pay for their top executives because theirs is the least appropriate job for it. Decades of strong evidence make it clear that large performance-related incentives work for routine tasks, but are detrimental when the tasks is not standard and requires creativity.

***

2. Fixating on performance can weaken it. The goal of most executive incentive plans is to focus leaders on hitting goals and achieving outcomes. After all, that's why it's often called performance-based pay.' But as researchers have found, if you want great performance, performance is the wrong goal to fixate on.

Several studies have shown that when employees frame their goals around learning (i.e., developing a particular competence; acquiring a new set of skills; mastering a new situation) it improves their performance compared with employees who frame their work around performance outcomes (i.e., hitting results targets; proving competence; seeking favorable judgments from others).

***

3. Intrinsic motivation crowds out extrinsic motivation. When people feel intrinsically motivated, they do things because they inherently want to, for their own satisfaction and sense of achievement. When people are extrinsically motivated, they do things because they will receive bigger rewards. The goal of contingent pay is to increase extrinsic motivation – but intrinsic motivation is fundamental to creativity and innovation.

***

4. Contingent pay leads to cooking the books. When a large proportion of a person's pay is based on variable financial incentives, those people are more likely to cheat. In academic terms, we would put it this way: extrinsic motivation causes people to distort the truth regarding goal attainment.

When people are largely motivated by the financial rewards for hitting results, it becomes attractive to game the metrics and make it seem as though a payout is due. For example, different studies have shown that paying CEOs based on stock options significantly increases the likelihood of earnings manipulations, shareholder lawsuits, and product safety problems. When people's remuneration depends strongly on a financial measure, they are going to maximize their performance on that measure; no matter how.

***

 5. All measurement systems are flawed. Incentive plans demand that some metric be used as the trigger for a payout. The problem is that whatever package you construct – bonds, stocks, or bonuses – whatever performance criteria you decide on will be imperfect. For a complex job such as senior management, it is simply not possible to precisely measure someone's "actual" performance, given that it consists of many different stakeholders' interests, tangible and tacit resources, and short- and long-term effects. Even with HR executives clamoring for enhanced "people analytics" (and technology companies bending over backwards to deliver them) any measure you choose is going to be an inadequate representation of how you would like your CEO to behave.
Note first that these points suggest that the increased use of performance based pay for health care organizations' top managers may explain why many health care organizations actually perform so badly, and point 4 may help explain why pay for performance may actually help increase health care corruption.

Note further that pay for performance (P4P) for health care professionals has been strongly pushed by many health policy experts, yet all these points also seem applicable to that usage.

Conclusion - Change Will be Resisted

So even when non-profit hospitals and hospital systems perform poorly, their executives continue to receive ever greater remuneration. The executives, their public relations flacks, and their often compliant boards of trustees continue to cite the same stale talking points to justify their pay. Yet these talking points are based on market fundamentalist theory and business school dogma whose credibility is increasingly challenged. In the absence of anyone willing to confront them with these criticisms, the apologists for soaring health care executive pay continue to prattle their tired talking points.

Meanwhile, as corporate governance expert Robert A G Monks said in a 2014 interview,

Chief executive officers' pay is both the symptom and the disease.

Also,

CEO pay is the thermometer. If you have a situation in which, essentially, people pay themselves without reference to history or the value added or to any objective criteria, you have corroboration of... We haven't fundamentally made progress about management being accountable.

Moreover, top health care executives' power to make warm personal gestures to themselves correlates with the ability to defend this power, per Mr Monks,

People with power are very reluctant to give it up. While all of us recognize the problem, those with the power to change it like things the way they are.
So I expect that many hospital and health system CEOs, like leaders of other big health care organizations, may talk about health care reform, but will avoid talking about, and will likely oppose attempts at real reform using their command of their organizations' marketers, public relations flacks, lobbyists, and lawyers.

We need true health care reform that would enable leadership that understands the health care context, upholds health care professionals' values, and puts patients' and the public's health ahead of extraneous, particularly short-term financial concerns. We need health care governance that holds health care leaders accountable, and ensures their transparency, integrity and honesty. What we will get is endless resistance to such reform from those who personally profit from the current dysfunctional, and increasingly corrupt system.Roy M. Poses MDhttp://email@example.com:blogger.com,1999:blog-9551150.post-52446575911607645352016-05-01T02:02:00.000-04:002016-05-03T12:43:09.006-04:00JAMA LAYS AN EGG
JAMA LAYS AN EGG

Three months ago I took JAMA to task over a Viewpoint opinion piece about conflict of interest. The authors proposed dancing around the reality of financial conflict of interest in medicine by talking instead about confluence of interest. I countered with a proposal for the term competing interests, which would not paper over the problem. In that post I also included a letter I had sent to JAMA in response to the opinion piece, but which JAMA had declined to publish. I questioned whether JAMA had deep sixed all the critical replies it received.<o:p></o:p>

Now I can report that, in the April 26, 2016 print edition, JAMA has finally published one critical letter and a replyfrom the original authors. So JAMA didn't deep six everything. This new correspondence appears 174 days after print publication and 214 days after on-line publication of the original Viewpoint article. That glacial delay is problematic – it disables meaningful dialogue.<o:p></o:p>

The new critical letter is from a group in Europe, and it thoughtfully discusses weaknesses in the Viewpoint authored by Cappola and FitzGerald. These Viewpoint authors did not do justice to the critical letter in their reply. Moreover, they disclosed multiple potential competing interests, but they did not follow their own advice by clarifying why we should disregard those obvious competing interests. As we all know, the mere disclosure of competing interests does not by itself remove the problem. It can be a device for hiding in plain sight. Substantively, the reply from Cappola and FitzGerald is mostly hand waving and restatement of biased opinion, without real analysis or incisive thought.<o:p></o:p>

The closing sentences of their reply letter illustrate these issues: "Everyone has biases. Rather than present these pejoratively, as a clash of values that undermines validity, it seems more constructive to mine the complexity of these biases, present them in an accessible fashion, and seek to determine whether they are confluent with the interests of patients, scientists, and regulators who might base their decisions on the results of a given piece of work." The reference to complexity of biases concerns the matter of nonfinancial bias like fame and careerism in science. The reference to presenting biases in an accessible fashion concerns the ill-considered proposal to include a bias heat map on patients' consent forms. This idea rightly was panned by the European critics. Meanwhile, where did the compromised and disgraced key opinion leaders disappear to in all this wishful thinking? Where did the corrupt corporations disappear to? They paid billions of dollars in penalties for felony crimes and plea-bargained settlements. They have been airbrushed out of the Cappola-FitzGerald narrative. These authors come across like Bambi confronting Godzilla.

If this is the best that an associate editor of JAMA and a fellow of the Royal Society can do then JAMA needs a fix. This effort is too little and much too late.<o:p></o:p>

UPDATE 05-03-2016
Apparently the link to my earlier post is inoperative. My apologies. Here is a link that should work.
http://hcrenewal.blogspot.com/2016/01/jama-jumps-shark.html
Bernard Carrollhttp://firstname.lastname@example.com:blogger.com,1999:blog-9551150.post-67783836170010886432016-04-29T14:55:00.000-04:002016-04-29T15:06:03.009-04:00Back to Paper After U.S. Coast Guard EHR Debacle: Proof of Hegel's Adage "We Learn From History That We Do Not Learn From History"?I have become blue in the face writing about healthcare information technology mismanagement over the years. In fact, the original focus of my 1998 website on health IT (its descendant now at http://cci.drexel.edu/faculty/ssilverstein/cases) was on HIT project mismanagement.

If this industry actually had learned anything from history, I would not be reading nor writing about brutally mismanaged HIT endeavors in 2016. Sadly, that is not the case.

The Coast Guard, founded by Alexander Hamilton, has this as its motto and mission:

http://www.gocoastguard.com/about-the-coast-guard
Semper Paratus - Always Ready.

The Coast Guard is one of our nation's five military services. We exist to defend and preserve the United States. We protect the personal safety and security of our people; the marine transportation system and infrastructure; our natural and economic resources; and the territorial integrity of our nation–from both internal and external threats, natural and man-made. We protect these interests in U.S. ports and inland waterways, along the coasts, on international waters.

We are a military, multi-mission, maritime force offering a unique blend of military, law enforcement, humanitarian, regulatory, and diplomatic capabilities. These capabilities underpin our three broad roles: maritime safety, maritime security, and maritime stewardship. There are 11 missions that are interwoven within these roles.

It seems the Coast Guard personnel need personal protection from the HIT industry, for the motto of that industry, sadly appears to be something like "Stupra Acetabulus" (Screw the Suckers).

From Politico, one of only a few publications that in recent years has taken a critical approach to this industry and pulls no punches:

http://www.politico.com/story/2016/04/ehr-debacle-leads-to-paper-based-care-for-coast-guard-servicemembers-222412

EHR debacle leads to paper-based care for Coast Guard servicemembers
By Darius Tahir
04/25/16

The botched implementation of an electronic health records system sent Coast Guard doctors scurrying to copy digital records onto paper last fall and has disrupted health care for 50,000 active troops and civilian members and their families.

Five years after signing a $14 million contract with industry leader Epic Systems, the Coast Guard ended its relationship with the Wisconsin vendor, while recovering just more than $2.2 million from the company. But it couldn't revert back to its old system, leaving its doctors reliant on paper.

This state of affairs is simple inexcusable. It represents gross negligence and severe multi-axial incompetence at best - but likely primarily not by the Coast Guard, whose core competency does not include HIT.

There's no clear evidence the EHR disaster has harmed patients, and a Coast Guard spokesman said the use of paper records hasn't affected "the quality of health care provided to our people."

Proof by lack of evidence is not reassuring in a debacle of this kind. However, the Coast Guard admits that paper records aren't the clear and present danger the IT pundits make them out to be.

Politico is skeptical of the claim:

That seems unlikely. Without digital records, if a patient goes outside a Coast Guard clinic, it can take weeks for the paper record to follow him or her back to the Coast Guard, says Michael Little of the Association of the United States Navy. And since the Coast Guard primarily provides outpatient, rather than hospital, services, many of its patients seek outside care.

"It's one thing if you're doing paper-based [care] in Ohio, but what about if you're on paper records in [an] icebreaker or cutter in Alaska, and you need your gall bladder removed?" said Little, the organization's director of legislative affairs.

In this case, I disagree that the lack of records is so dangerous. There's the telephone, FAX machines, the patient himself or herself, and the hand-carried note. Used with care, those serve care reasonably well.

With the Department of Veterans Affairs weighing whether to buy a top-of-the-line commercial electronic health record and the Pentagon beginning a multibillion-dollar EHR implementation, the Coast Guard case displays how poorly the process can go for the government, even when the biggest names in health IT are involved.

Not just the government. I'd also argue that this shows that the "biggest names" are, at best, overextended, and at worst, badly needing external investigation as to their software development, customization, implementation and support practices, as well as hiring practices (e.g., see my August 15, 2010 post "EPIC's outrageous recommendations on healthcare IT project staffing"
at http://hcrenewal.blogspot.com/2010/08/epics-outrageous-recommendations-on.html) and contracting.

Reversion to a purely paper-based system is a rare event in the recent annals of electronic records, said Thomas Payne, a health IT expert at the University of Washington. "I can think of examples where that has happened, but in the last decade that is much less common."

I believe that is because of the general invisibility of, and immunity from, the risks and harms that occur from "making do" with bad health IT due to financial pressures. Hence one sees hair-raising examples like I wrote of at my Nov. 17, 2013 post "Another 'Survey' on EHRs - Affinity Medical Center (Ohio) Nurses Warn That Serious Patient Complications 'Only a Matter of Time' in Open Letter"at http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html where going back to paper to allow a complete rethinking of the EHR implementation would likely have been the safe response.

See also, for example, my July 2013 post "RNs Say Sutter's New Electronic System Causing Serious Disruptions to Safe Patient Care at East Bay Hospitals" at http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html (there are links there to still more examples).

The Coast Guard is tight-lipped about the causes, timeline and responsibility for the debacle. "Various irregularities were uncovered, which are currently being reviewed," a spokesman said.

The causes are all covered at http://cci.drexel.edu/faculty/ssilverstein/cases/, and have been since the late 1990s. In the alternative, the book "Managing Technological Change: Organizational Aspects of Health Informatics" (http://www.amazon.com/Managing-Technological-Change-Organizational-Informatics/dp/0387985484) by Lorenzi & Riley does likewise for an even longer period, since the mid 1990s - for those willing or able to learn from history and from the pioneers

There's no shortage of candidates: the service relied on five separate vendors to build the new system, and its own planning seems to have been at fault.

Lawmakers are looking into the matter, said a spokesman for the Senate Appropriations Committee, which is "monitoring the situation."

This is symptomatic, in my view, of the fact that there are a lot of "Beltway Bandit" IT consultant companies doing business, few of them very good.

Bungled implementation, followed by chaos

In September 2010, the Coast Guard bid out the contract to Epic Systems, then added an array of other contracts to software vendors and consultants to help implement it. Since 2010, the agency spent, on net, just more than $34 million on health IT.

In a January 2011 speech, Coast Guard Chief Medical Officer Mark Tedesco cited the success of Epic installations at Kaiser Permanente and Cleveland Clinic. He predicted that the Epic implementation would improve the health of its population and save money.

"Overall it's a cheaper system for us to run than to upgrade to [the next generation military EHR], because of what that would've meant to us infrastructure-wise and support-personnel wise," he said.

It's stunning to think what this says about the next-generation military EHR. The previous one was not very good, either (see my June 4, 2009 post "If The Military Can't Get Electronic Health Records Right, Why Would We Think Conflicted EHR Companies And IT-Backwater Hospitals Can?" at http://hcrenewal.blogspot.com/2009/06/if-military-cant-get-electronic-health.html).

Trouble, apparently, struck quickly. The solicitation for the EHR contract envisioned rolling out the software within six months at two to three pilot sites, before deploying it to a total of 43 clinics and the sickbays aboard the Coast Guard's fleet.

That didn't occur; the system never deployed to any clinic or cutter, said Eric Helsher, an executive with Epic. The next missed deadline was March 2012, which Trent Janda — the Coast Guard doctor serving as project leader — announced in a summer 2011 newsletter of the Uniformed Services Academy of Family Physicians.

One can only wonder what penalties the contract called for if the goals and timelines were not met. That software was not deployed even to any pilot sites is nearly unimaginable to me.

As Janda set the new goal, he acknowledged there had been "multiple hurdles and delays," and explained that the service had expanded its ambitions.

"Immediately upon award of the contract, we began a comprehensive analysis of the clinical workflows and existing information systems," Janda wrote. "Many of the weaknesses became apparent as we compared ourselves to industry standards and best practices. Frequently, a weakness would lead to others, ultimately leading to the need for an additional system. The work-flow analysis quickly grew into a system wide re-engineering project like a snowball rolling down the mountainside."

This sounds like a groundbreaking level of project mayhem and chaos, even for HIT.

The comment reveals that the agency failed to do necessary advance planning, says Theresa Cullen, an informatics executive with the Regenstrief Institute who formerly worked with Veterans Health Affairs and the Indian Health Service.

"They should have done a full needs assessment," she said. "One would have normally done the workflow evaluation prior to the release of the RFP."

If true, I believe it was an obligation of EPIC and the multiple contractors to have pointed that out to their future customer, and adjusted their bids accordingly, taking into account the time and resources needed for this type of work - or not placed a bid at all. Such deficiencies and what they mean towards project progress and failure are obvious - to anyone who's learned from history.

... Cullen also found it odd that the Coast Guard didn't hire consultants to implement the new system until September 2012. The service ended up hiring Leidos, which also maintained its old EHR.

The Coast Guard further complicated the process by deciding to team up with the State Department. Its original request was complicated enough, with installations spanning six time zones. The partnership with State meant implementing across 170 countries. (A spokeswoman for State said the agency was investigating its options, but refused additional comment).

The sheer number of sites led Cullen to question whether Coast Guard and State had devoted enough resources to the project. Between Epic and Leidos, the project was budgeted for roughly $31 million. That was "an inadequate amount of funding for what you're asking to do," she said. Consultants receive roughly $100 an hour, and Epic's work with clinicians is time-consuming.

Again, those hired knew, should have known, or should have made it their business to know that under such conditions, if true, project failure was the predictable outcome. They are supposed to be the HIT experts, after all, not the Coast Guard.

While a very efficient health care system could implement the EHR, she said, the Coast Guard lacks that reputation. She speculated that Epic intentionally underbid the contract. (Epic's Helsher said that "the contract was viable and we were fully motivated to lead a successful install.")

Someone is right, and someone is wrong. I leave it to the reader to decide who was correct and who wasn't.

Anecdotes of further delays pepper various newsletters and reports from 2012 through 2015. Server failures scuttled a pilot rollout in 2014, then developed into deeper problems, and last July the systems started failing on a more regular basis.

Perhaps the "anecdotes" need to be turned into "teachable moments" through legal discovery by federal law enforcement.

The Coast Guard advised retirees and dependents that month that, due to incompatibility between its EHR and the Department of Defense's new medication reconciliation system, they couldn't get their prescriptions filled at Coast Guard clinics.

Around Labor Day, Coast Guard health care personnel were directed to copy information from electronic files onto paper, for fear of losing their data.

That is just about the most pathetic sentence I've ever had to read in my 24 years in Medical Informatics.

... doctors are frustrated. One complained in the Uniformed Services Academy of Family Physicians newsletter of "unique challenges which seemed to revolve around many electronic record keeping changes." "The question we pose is, how is this affecting shipboard life?" Little said. "This is the most important thing that's happening right now in the Coast Guard."

My advice to the Coast Guard is to treat the IT invaders and consultants as it would a invading maritime fleet from a hostile nation.

The vendors who worked with the Coast Guard either don't know what went wrong, or aren't telling. Leidos — also the lead company implementing the Pentagon's EHR project — declined comment, as did Lockheed Martin, which was contracted to implement access to the EHR through mobile devices, and Apprio, which was to provide credentialing services.

I believe they have a very good idea of "what went wrong", and aren't telling (per the Fifth Amendment)? If they have "no idea" what went wrong, what, I ask, are they doing in the IT consulting business?

... The EHR giant [EPIC] says it's not entirely clear why the Coast Guard pulled the plug. But the situation wasn't Epic's fault, company executive Eric Helsher said.

They pulled the plug out of fear for their members' well-being, hopefully.

It seems everyone seeks to escape culpability, with the blame placed on the customer.

The Coast Guard spokesman said the decision was "driven by concerns about the project's ability to deliver a viable product in a reasonable period of time and at a reasonable cost."

It seems there's still some who don't continue down the sunk-cost fallacy road (https://www.logicallyfallacious.com/tools/lp/Bo/LogicalFallacies/173/Sunk_Cost_Fallacy) and are willing to walk away from bad HIT.

... In general, software contracts deserve more scrutiny, said Kingston, who served on the House Appropriations Committee. "These things don't get the scrutiny a weapons system does."

Considering the reputation of military costs, that's saying quite a lot. The lesson that should have been learned from history is that HIT is both exploratory, and a relative free-for-all.

Caveat emptor.

One last piece of (free!) advice for the Coast Guard leadership.

Read this paper:

Pessimism, Computer Failure, and Information Systems Development in the Public Sector. (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand). Cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT. linkto pdf

That may be the most valuable learning experience of all for their next attempt to implement EHRs.

-- SSInformaticsMDhttp://email@example.com:blogger.com,1999:blog-9551150.post-85593389625558237692016-04-23T22:47:00.001-04:002016-04-23T22:47:15.089-04:00John Stossel Discovers Health Care Dysfunction, Blames it on "Socialists" - Like Maurice Greenberg (AIG), John Thain (Merrill Lynch), Sanford Weill (Citigroup), and David H Koch? We have been ranting for a while about the dysfunctionality of the US health care system. Unfortunately, many people only realize how bad things are when they become patients, when they have bigger things to worry about than complaining. Furthermore, even if they complain, many patients may not feel they understand enough about what has gone wrong to suggest solutions.

Bad Customer Service at New York Presbyterian

This may not apply when media pundits, especially those with strong ideological views, become patients. So this week Fox News commentator and well known libertarian John Stossel disclosed his new illness, and vented his opinions about his hospital stay. Mr Stossel unfortunately developed lung cancer, although he was optimistic about his prognosis: "My doctors tell me my growth was caught early and I'll be fine. Soon I will barely notice that a fifth of my lung is gone."

However, he was not happy about his hospital's customer service:

But as a consumer reporter, I have to say, the hospital's customer service stinks. Doctors keep me waiting for hours, and no one bothers to call or email to say, 'I'm running late.' Few doctors give out their email address. Patients can't communicate using modern technology.

I get X-rays, EKG tests, echocardiograms, blood tests. Are all needed? I doubt it. But no one discusses that with me or mentions the cost.

Also,

I fill out long medical history forms by hand and, in the next office, do it again. Same wording: name, address, insurance, etc.

And,

In the intensive care unit, night after night, machines beep, but often no one responds. Nurses say things like 'old machines,' 'bad batteries,' 'we know it's not an emergency.'

Finally,

Some of my nurses were great -- concerned about my comfort and stress -- but other hospital workers were indifferent.
Unfortunately, long wait times, poor communications, excess paperwork, and misapplied technology are all too familiar problems to those in the health care system.

Moreover, this all was happening at one of the most highly rated US hospitals,

After all, I'm at New York-Presbyterian Hospital. U.S. News & World Report ranked it No. 1 in New York.

Were "Socialist Bureaucracies" Responsible?

Mr Stossel had his own ideas about the causes of these problems.

Customer service is sclerotic because hospitals are largely socialist bureaucracies. Instead of answering to consumers, which forces businesses to be nimble, hospitals report to government, lawyers and insurance companies.

Whenever there's a mistake, politicians impose new rules: the Health Insurance Portability and Accountability Act paperwork, patient rights regulations, new layers of bureaucracy...

Also,

Leftists say the solution to such problems is government health care. But did they not notice what happened at Veterans Affairs? Bureaucrats let veterans die, waiting for care. When the scandal was exposed, they didn't stop. USA Today reports that the abuse continues. Sometimes the VA's suicide hotline goes to voicemail.

Patients will have a better experience only when more of us spend our own money for care. That's what makes markets work.
A "Socialist Bureaucracy" with a VIP Penthouse?

I am sorry to hear Mr Stossel has lung cancer, and hope that his prognosis is indeed good. I am a bit surprised that a media celebrity who became a patient found big issues with "customer service" at such a prestigious hospital. After all, many big hospitals have programs to give special treatment to VIPs (for example, see these posts from 2007 and 2011).

In particular, back in 2012 we posted about the contrast between the VIP services specifically at New York - Presbyterian Hospital and how poor patients are treated there. Then we quoted from a 21 January, 2012 article from the New York Times focused on the ritzy comforts now provided for wealthy (but perhaps not very sick) patients at the renowned New York Presbyterian/ Weill Cornell Hospital. It opened,

The feverish patient had spent hours in a crowded emergency room. When she opened her eyes in her Manhattan hospital room last winter, she recalled later, she wondered if she could be hallucinating: 'This is like the Four Seasons — where am I?'

The bed linens were by Frette, Italian purveyors of high-thread-count sheets to popes and princes. The bathroom gleamed with polished marble. Huge windows displayed panoramic East River views. And in the hush of her $2,400 suite, a man in a black vest and tie proffered an elaborate menu and told her, 'I'll be your butler.'

It was Greenberg 14 South, the elite wing on the new penthouse floor of NewYork-Presbyterian/Weill Cornell hospital. Pampering and décor to rival a grand hotel, if not a Downton Abbey, have long been the hallmark of such 'amenities units,' often hidden behind closed doors at New York's premier hospitals. But the phenomenon is escalating here and around the country, health care design specialists say, part of an international competition for wealthy patients willing to pay extra, even as the federal government cuts back hospital reimbursement in pursuit of a more universal and affordable American medical system.

Additional amenities include:

A waterfall, a grand piano and the image of a giant orchid grace the soaring ninth floor atrium....

Also,

the visitors' lounge seems to hang over the East River in a glass prow and Ciao Bella gelato is available on demand....

An architect who specializes in designing such luxury facilities for hospitals noted:

'These kinds of patients, they're paying cash — they're the best kind of patient to have,' she added. 'Theoretically, it trickles down.'
It appears that someone failed to book Mr Stossel into the penthouse. Instead, he found out what service was like for the masses.

Perhaps this was why Mr Stossel railed at the "socialist bureaucracies" he perceived as running New York - Presbyterian Hospital. However, calling the hospital management "socialist" seems - not to put too fine a point on it - wrong.

A "Socialist Bureaucracy" Paying Millions to its CEOs?

First of all, New York Presbyterian is hardly a government agency. It is a private, non-profit corporation. Every year as such it files a form 990 with the dread US Internal Revenue Service. (The latest publicly available version is from 2013, here.) Obviously, US government agencies do not file with the IRS.

In fact, the New York Presbyterian system seems about as far from a federal government agency as one can imagine.

First, its top managers are paid like for-profit corporate executives. In 2014, we posted about the humongous compensation given to its previous, long-serving CEO, Dr Herbert Pardes, who received multi-million dollar compensation every year through his 2011 retirement, and then continued to receive several million a year from the system in his retirement. His successor, current CEO Dr Steven Corwin, received $3.6 million in 2012. (More recent compensation figures are not yet available.)

A "Socialist Bureaucracy" Dominated by Managers, with Stewardship by Top Financial Executives, and one of the Koch Brothers?

The current leadership of New York Presbyterian is dominated by businesspeople, not physicians, nurses, or other health care professionals. Only 10 of 33 listed senior leaders are health care professionals. The rest have administrative/ management or legal backgrounds and training. Many appear to be generic managers, that is, people with background and experience primarily in administration or management, but not in medicine, health care, public health, etc.

The hospital system's board of trustees was and is filled with some of the top business executives in the US, including some finance executives who have been cited as responsible for the global financial collapse/ great recession.

For example, we wrote about Mr Dick Fuld, a trustee until recently. Mr Fuld was the CEO who presided over the bankruptcy of Lehman Brothers, which heralded the beginning of the great financial crisis/ great recession of 2008 onward. Mr Fuld seemed to lack the sort of compassionate approach one might expect from someone charged with the stewardship of a big hospital system. He had once publicly said about those who sold Lehman Brother stock short: "what I really want to do is I want to reach in, rip out their heart, and eat it before they die."

Another recently retired board member was Sanford I Weill, architect of the mergers that created the now federally bailed out Citigroup. In 2014, we posted about how Mr Weill, contemplating retirement from the board of trustees of Weill Cornell Medical School, one of the two medical schools with primary affiliations with New York Presbyterian, managed to bequeath his board seat to his daughter, Ms Jessica Bibliowicz, also the CEO of a finance firm, National Financial Partners. Ms Bibliowicz now also seems to have Mr Weill's seat on the New York Presbyterian board.

Also, still on the board are two top finance CEOs who have been blamed for the global financial collapse. These are Maurice R Greenberg of the federally bailed out AIG, and John A Thain, CEO of the nearly collapsed Merrill Lynch (merged into Bank of America). See this post for more information about their roles in the global financial collapse.

Finally, one other board member is David H Koch, described by Wikipedia

Koch is an influential libertarian. He was the 1980 candidate for Vice President of the United States from the United States Libertarian Party and helped finance the campaign. He founded Citizens for a Sound Economy. He and his brother Charles have donated to political advocacy groups and to political campaigns, almost entirely Republican
With socialists like these ...?

Summary

I do not doubt that John Stossel found the customer service at New York Presbyterian not up to his expectations. And I actually have no doubt that New York Presbyterian has to operate within a complex health care system in which government bureaucracy plays a large role, and sometimes a counter-productive one. Furthermore, I have no doubt that the management of New York Presbyterian is very bureaucratic, and this may in part may be a reason for poor customer service, and other failings.

However, to say that the management and governance of the hospital system is "socialist" is dead wrong. In fact, like many other large health care organizations, the New York Presbyterian system appears to be run largely by "managerialists," that is generic managers who have little experience or background in health care, may have little understanding or sympathy for its values, and approach health care with the same management techniques that might be applied to selling soap powder. Furthermore, the stewardship of this particular hospital system seems to be largely up to some of the biggest, and loudest "capitalists," and one of the most prominent "libertarians" in the US.

But to someone with a hammer, most problems look like nails.

Maybe Mr Stossel needs to complain to Mr Koch.

In conclusion, I am glad that some of the problems in the dysfunctional US health care system are getting more public attention. However, now we need to calmly and rationally consider what is causing them and what to do about them without the blinders of ideology or vested interests.

IMHO, true US health care reform would put the operation of US health care organizations more in the hands of people who have knowledge and experience in health care, and are willing to be accountable to support health care professionals' values. Furthermore, oversight and stewardship of these organizations should represent the patients and public which the organizations are supposed to serve.

Roy M. Poses MDhttp://email@example.com:blogger.com,1999:blog-9551150.post-42292782565312440832016-04-22T11:59:00.000-04:002016-04-22T11:59:25.352-04:00Lown Institute/ Right Care Alliance 2016 ConferenceI am back from the annual Lown Institute/ Right Care Alliance meeting in Chicago. A considerable part of the meeting was devoted to issues that may be familiar to readers of Health Care Renewal.

Shannon Brownlee, in her keynote talk, "Introducing the Right Care Alliance," called our current US health care system "corrupt." She noted how clinical research has been "hijacked," (see our posts on the suppression and manipulation of clinical research). She noted how the multi-million dollar compensation of CEOs whose hospitals serve - not always well - primarily poor people (see our posts on executive compensation and mission-hostile management). She called for a national conversation to "expose the dark matter" of medicine, and right the wrongs of a new "gilded age."

The Right Care Alliance has a Vision Statement which calls for health care in which

Healthcare is a right, not a commodified privilege, and access to healthcare is universal, equitable, and affordable. Everybody in, nobody out.

There is meaningful public transparency around costs and outcomes that matter to patients and communities.

The science and practice of medicine is free of commercial bias and the profit motive.

among other imperatives.

Not to toot our own horns too much, but Dr Adriane Fugh-Berman of PharmedOut.org and I led a workshop on deceptive pharmaceutical and device promotion in the context of health care corruption.

Hopefully, much of the conference content will eventually show up on the web, but so far one nice video summary has been produced:

Roy M. Poses MDhttp://email@example.com:blogger.com,1999:blog-9551150.post-22113034830244259542016-04-13T16:36:00.000-04:002016-04-13T16:36:21.589-04:00The More Things Stay the Same - More Apparently Adulterated Heparin, This Time from Chinese RuminantsThe story of the contaminated heparin just will not go away. We first wrote about it in 2008 (see first post here, most related posts here, and the longer summary at the end of this post.)

Quick Summary

Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China. That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label. The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small "workshops" operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA. The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many patients who received got seriously ill or died. While there have been investigations of how the adulteration adversely affected patients, to date, there have been no publicly reported investigations of how the OSCS got into the heparin, and who should have been responsible for overseeing the purity and safety of the product. Despite the facts that clearly patients died from receiving this adulterated drug, no individual has yet suffered any negative consequence for what amounted to poisoning of patients with a brand-name but adulterated pharmaceutical product.

Here We Go Again

At the end of March, 2016, per Bloomberg,

Heparin tainted with unauthorized Chinese-made ingredients may be on the market in the U.S. and the Food and Drug Administration hasn't moved swiftly enough to prevent it, according to a congressional probe nearly a decade after hundreds of deaths were linked to sullied batches of the blood-thinning drug.

This possible contamination is different from the earlier one, when Chinese producers made crude heparin containing a deadly chemical. They may be using cow and sheep intestines to produce the raw material for heparin that is supposed to be derived only from the intestinal membranes of pigs, according to a letter the House Energy and Commerce Committee sent Tuesday to the FDA. The agency has known about the risky practice since 2007, around the time it discovered the chemically enhanced crude heparin, the panel said.

The FDA didn't react early on 'to credible evidence of non-porcine contamination of the Chinese heparin supply,' according to the letter, only putting out testing guidelines for pharmaceutical companies in 2012. Even after the tragedy of the chemically soiled heparin, the committee said, 'loopholes and exemptions that permit part of the Chinese drug supply chain to operate outside government scrutiny still remain.'

The committee charged that nothing much as changed since the 2008 episode of deadly heparin made from Chinese pigs

The letter from the House committee said the FDA dropped the ball on many fronts and may have allowed unsafe blood thinners to remain on the market longer than necessary. Regulators didn't properly or widely enough share information and didn't follow up on leads about tainted heparin from other governments, according to the letter. Agency investigators failed to inform others about dodgy crude heparin makers, the panel said. It also said the FDA didn't follow up on concerns that heparin with the chemical was recycled after the poison was removed and may have entered the U.S. market. The claims are based on documents that Baxter, Scientific Protein and FDA provided the committee as well as interviews with FDA employees, according to footnotes in the letter.

Also, efforts to investigate the 2008 problem seem to have failed,

The chemical, oversulfated chondroitin sulfate, was connected to 246 deaths and sickened hundreds of people who took the blood-thinning medicine, the FDA said at the time. Regulators never found at what point in the chain in China that the drug, sold in the U.S. by Baxter International Inc., was corrupted. The FDA closed its initial criminal investigation after it became difficult to obtain evidence in China, though it has since re-opened a related inquiry, according to the House committee. Baxter, which recalled its heparin in 2008, hasn't sold the anticoagulant since. It said at the time it was alarmed that the contamination appeared to have been deliberate, but had no proof of how it happened.

Now the problem appears to be more bovine. It appears that French regulators first noted the problem of imported heparin derived from Chinese cows.

The French National Agency for Medicines and Health Products Safety called non-pig blending a 'critical' violation in an inspection report released in February. France cited China's Dongying Tiandong Pharmaceutical Co. for making heparin with ruminant DNA, which includes cows and sheep. Dongying is registered with the FDA as a manufacturer of active ingredients and isn't on the agency's list of companies banned from importing to the U.S.

Yet, the FDA

considers heparin adulterated if it contains oversulfated chondroitin sulfate or non-pig material, according to an FDA document for the pharmaceutical industry on monitoring heparin quality. Material from cows could pose a risk because of possible contamination with mad cow disease.
Oddly enough, the Bloomberg article did not mention any criticism by the committee of the US based manufacturers who outsourced their heparin production to China.

Outsourcing Continues Unabated

In 2012 we noted that outsourcing by big multinational drug companies based in the US and other developed countries of active pharmaceutical ingredient (API) production to dubious manufacturers based in countries with much less robust regulation was continuing. I wrote then

To put it more directly, most so called pharmaceutical companies in the US and other developed countries have outsourced the actual manufacturing of drugs. Thus, most companies that appear to be pharmaceutical manufacturing companies are really just pharmaceutical marketing and development companies. (And not so much the latter, look here: Light DW, Lexchin JR. Pharmaceutical R&D; what do we get for all that money? Brit Med J 2012; 345: 22-25. Link here.) Pharmaceutical companies appear to be abandoning their core essence, but are content to market drugs under their logos without telling the patients who take them the real source of these products. This would appear to be a big scandal, but one that stays curiously anechoic.

In 2016, outsourcing of drugs by big multinational corporations with prestigious names seems to be continuing at a rapid pace. Per Bloomberg,

The U.S. depends heavily on China for medicine. Along with India, the country is one of the top two producers of base ingredients for drugs in the world, according to the National Academies of Sciences, Engineering, and Medicine.

There is still no clear way for US patients or doctors to identify outsourced medicines, and efforts to better regulate them seem feeble. Thus the danger that patients may be getting ineffective, adulterated, even deadly outsourced medicine in bottles with the logos of big, famous pharmaceutical companies seems to be ongoing.

The More Things Stay the Same

In 2012, we wrote

I have yet to see any discussion with pharmaceutical executives about why their companies hardly make drugs anymore. In the absence of such discussion, I can only speculate that most likely, this is first a product of financialization. Drug company executives, like most organizational leaders, have fallen under the spell that says their only goal should be to increase short-term revenues. It may be cheaper to buy drugs from perhaps dodgy outsourced suppliers rather than manufacturing them them themselves. Continuing stories like those above, and that of the contaminated Chinese heparin suggest that these outsourced drugs are cheap for a reason. It appears that to save money short-term, pharmaceutical executives may be abandoning their most central mission, to provide pure, unadulterated drugs.

The continuing story of outsourced pharmaceutical manufacturing provides yet more evidence that current management dogma may be literally toxic. Once again, I suggest that true health care reform requires leadership of health care organization who put patients' and the public's health ahead of short-term revenue (and the personal enrichment that may result).

It is likely that a number of policy changes will be needed to reduce the threats posed by contaminated or adulterated outsourced pharmaceuticals. There is one simple step that ought to be taken quickly to at least make the problem more transparent. In the US, most manufactured products have a label disclosing the country of origin. In parallel with that, all pharmaceutical containers, and all pharmaceutical labels and marketing materials ought to disclose the country in which the active pharmaceutical ingredient was manufactured, and the name and location of the company responsible for that manufacture.

There seems to be no need to rewrite or update this.

The fact that this problem has been known for 2008 year, but not clearly addressed, shows the pitiful state of American health care dysfunction. But those with vested interests in preserving the current system remain fat and happy, like the pigs of China.

 Appendix - Heparin Case Summary

- We have posted several times, recently here about the tragic case of suddenly allergenic heparin. Although heparin, an intravenous biologic anti-coagulant, has been in use for over 70 years, serious allergic reactions to it had heretofore been rare. Starting late in 2007, hundreds of such reactions, and 21 deaths were reported in the US after intravenous heparin infusions.All the heparin related to these events in the US was made by Baxter International.

- We then learned that although the heparin carried the Baxter label, it was not really made by Baxter. The company had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from a US company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart. (See posts here and here.)

- We found out that the Baxter International labelled heparin was contaminated with over-sulfated chondroitin sulfate, a substance not found in nature, but which mimics heparin according to the simple laboratory tests used in the Chinese facilities to check incoming heparin. (See post here.) Further testing revealed that the contamination seemed to have taken place in China prior to the provision of the heparin to Changzhou SPL. (See post here.) It is not clear whether Baxter International or Scientific Protein Laboratories had inspected most of the steps in the supply chain, or even knew what went on there.

- The Baxter and Scientific Protein Laboratories CEOs did not seem aware of where they got the heparin on which the Baxter International label was eventually affixed. But one report in the New York Times alleged that Scientific Protein Laboratories would not pay enough for heparin to satisfy any sources other than the small "workshops."

 - Leaders of all organizations involved, Baxter International, Scientific Protein Laboratories, Changzhou SPL, the Chinese government, and the US Food and Drug Administration, and the US Congress assigned blame to each other, but none took individual or organizational responsibility. (See post here.) Note that SPL was recently bought out and taken private, making its current leadership even less transparent (see post here). A 2010 inspection of an SPL facility by the FDA revealed ongoing manufacturing problems (see post here).

- Researchers (who turned out to have financial ties to a company which is developing an anti-coagulant drug that could compete with the heparin made by Baxter International) investigated the biological mechanisms by which the contamination of the heparin lead to adverse effects, but no one investigated further how the contamination occurred, or who was responsible. (See post here.)

- Hundreds of lawsuits against Baxter have now been filed, so far without resolution. (See post here.) Efforts to make documents to be used in these cases public so far have not succeeded (see post here).

- A government report which attracted little attention warned of the dangers of pharmaceutical ingredients made in China and subject to virtually no oversight. (See post here.)

- Despite requests from the US, the Chinese government did not investigate the production of the heparin that lead to the deaths (see post here.)

- In February, 2011, a congressional investigation of the case was announced, but results were unavailable until now (see above)

- In June, 2011, a jury returned the first verdict in a civil case about the contaminated heparin, awarding money from Baxter International and Scientific Protein Laboratories to the estate of a man who apparently died due to tainted heparin (see post here).Roy M. Poses MDhttp://email@example.com:blogger.com,1999:blog-9551150.post-1781774904595297532016-04-07T14:23:00.004-04:002016-04-07T17:08:00.875-04:00"Immersion Day" to Expose Hospital Board Members to Real Health Care for a Day - A Great Idea, but Why Should It Be News?
Last week, the New England Journal of Medicine published an article by Bock and Paulus describing an innovative program at Mission Health in Asheville, NC to expose health system board members to the real world of health care.(1) The article was nice, but begged an important question: why was such a program news?

The Immersion Day Program

 The article asserted:

The U.S. health care industry has long been beset by seemingly intractable problems: incomplete and unequal access to care; perverse payment incentives; fragmented, uncoordinated care that threatens patient safety and wastes money; and much more.

So the hypothesis on which the program was based was:

These challenges are particularly vexing to the people who oversee or set policy for health care organizations. The disconnect between health care in its intimate, real-world setting and the distilled information delivered in the boardroom or policy discussions is a key barrier to responsive governance and policymaking. Sometimes seeing with new eyes can lead to transformational understanding

In particular, the two physician authors of the article noted

Yet until 2013, none of our lay board members had ever been afforded the opportunity to see the complexities of care delivery, except when they were patients, visited someone in the hospital, or watched a TV show like Grey's Anatomy. Like most boards, we did our work in the boardroom. There, management and our four physician board members did our best to paint accurate pictures of our system's complexity: the workflows and the choreography, the opportunities for error, the forces behind increasing costs, and the good derived from serving all patients regardless of ability to pay. We shared our struggles and successes using PowerPoint presentations, graphs, spreadsheets, and patient statements.

So Doctors Bock and Paulus came up with the idea of providing basically provided a one-day clinical immersion program to members of the hospital system's board of directors.

we created 'Immersion Day,' when board members and thought leaders could spend 9 to 12 hours in scrubs, behind the scenes, immersed in the nuances of care delivery.

Board members went from pre-operative care, to the operating room, to intesive care, to surgical wards to rounds with "nephrologists, pulmonologists, trauma surgeons, and hospitalists, finally to the emergency department.

The board members apparently greatly appreciated thr program:

Board members have called their Immersion Day 'eye-opening and endlessly fascinating,' 'unforgettable and humbling,' even 'the best-spent day of my life.' One said, 'I learned more about hospitals and health care from my 10 immersion hours than 6 years sitting on our board.' Our staff benefits, too: when a physician or nurse meets a board member in scrubs, the encounter builds trust and admiration in both directions. Word spreads. Caregivers express gratitude that the board is spending time seeing what they do; many had never previously met a board member. Physicians' relationships with the board and management, though imperfect, are far better than they've been in years, despite ever-increasing challenges.

The authors are now trying to make the program available to journalists, and "state and federal policy makers." Their conclusion was:

we've built a transformative experience that can guide our board. Deep immersion in the work of our health system has strengthened governance and engendered trust in our community, staff, and physicians, while elucidating health care for policymakers. After three years of Immersion Days, we cannot imagine being governed by a board that hasn't seen so intimately how a health system works.

There are some obvious limitations to this article, which unfortunately were not addressed in the text. The article was entirely impressionistic. It presented no data about actual end results of immersion day, much less a comparison to any other kind of interevention.

Furthermore, the authors did not describe some important characteristics of their hospital system which may differentiate it from others. In particular, the management of Mission Health is much less generic than that of other hospitals. Half of the top hospital administrators have medical or nursing degrees. The CEO of the hospital is a physician. In fact, he was the second author of the article. Five of 21 directors (including the CEO) are physicians. So it is not clear how this program would work in a hospital whose management is dominated by people with business backgrounds.

Why Is This News?

But the article begged the questions of why this is news? The article stated that there is a big "disconnect" between what is discussed in hospital board rooms, and the health care that goes on in hospitals day by day. Furthermore, it stated that many hospital board members had no direct experience with health care. Instead, the article described the non-physician board members, who were by far in the majority, as "educators, attorneys, manufacturers, investors, and bankers." It did not say why the majority of people responsible for the governance of a health care organization had no direct familiarity with health care. That does not seem to make sense. So why did it take so long to try to give them such familiarity, and why would a program to do so be newsworthy?

The article also failed to note that the hospital in which the immersion program was initiated actually had a board that was more familiar with health care that the typical hospital board. Many hospital boards of trustees are completely dominated by "attorneys, manufacturers, investors, and bankers," that is, wealthy businesspeople without health care experience, and parenthetically probably without much familiarity with the context of the many less financially fortunate patients of their hospitals. Mission Health at least had a few physicians on its board.

We have posted some vivid stories about the skewed natures of hospital boards before. For example,
- the board of IU Health (Indiana), dominated by top executives and board members of large for-profit corporations (look here).
- the board of the Hospital for Special Surgery (New York), of whose 42 members, 23 had major relationships, often top executive positions or board memberships, just in large financial firms, including some which were responsible for the great recssion.
Other examples can be found here.

Hospital boards whose members are unfamiliar with health care may reflect hospital management that is similarly unfamiliar with health care. In fact, most hospitals and hospital systems, like most US health care organizations, are not led by health care professionals. Instead, they are led by generic managers, following the dogmas of managerialism.

We have frequently posted about what we have called generic management, the manager's coup d'etat, and mission-hostile management. Managerialism wraps these concepts up into a single package. The idea is that all organizations, including health care organizations, ought to be run people with generic management training and background, not necessarily by people with specific backgrounds or training in the organizations' areas of operation. Thus, for example, hospitals ought to be run by MBAs, not doctors, nurses, or public health experts. Furthermore, all organizations ought to be run according to the same basic principles of business management. These principles in turn ought to be based on current neoliberal dogma, with the prime directive that short-term revenue is the primary goal.

Of course, if top hospital leaders do not perceive their own unfamiliarity with health care as a problem, they are unlikely to perceive their boards' unfamiliarity as a problem too. So it really was news that at one hospital, the management thought it necessary to better educate their own board about what really goes on in hospitals outside board rooms and management suites.

At a really manageralist hospital, whose management is dominated by people with business backgrounds, which may lack any top managers who have any health care background, and whose board is dominated by wealthy businesspeople with backgrounds outside of health care, the management would likely not bother trying to improve their board members' or their own familiarity with health care. Were they to do so for some reason, I hypothesize that an immersion day for board members would have little effect. The apparent, but not clearly proven success of "immersion day" at Mission Health may be due to the important presence of health care professionals in top management and on the board of trustees, but may not generalize to most other hospitals.

In fact, the current leadership of hospitals and other health care organizations almost entirely by generic managers, reporting to boards made up almost entirely of generic managers, defies common sense. Although trying to give board members some rudimentary familiarity with the health care context, during one day of the year, is obviously better than nothing, it clearly is only a tiny bandage on a gaping wound. When one hospital deploys such a bandage, it is news. That most hospitals' managers and boards would not even think of deploying such measures is a scandal.

So as we have said endlessly,...

We need far more light shined on who runs the health care system, using what practices, to what ends, for the benefits of whom.

True health care reform would enable transparent, honest, accountable governance and leadership that puts patients' and the public's health over ideology, self-interest, and self-enrichment.

Reference
1. Bock RW, Paulus RA. Immersion day - transforming governance and policy by putting on scrubs. N Engl J Med 2016; 374: 1201-1203. Link here. Roy M. Poses MDhttp://firstname.lastname@example.com:blogger.com,1999:blog-9551150.post-47809681072649338902016-04-05T14:16:00.000-04:002016-04-05T14:26:29.820-04:00What is more important in healthcare, computers, or nurses and other human beings? Southcoast Health cutting dozens of jobs on heels of expensive IT upgradeThat I even have to ask the question on the title of this post is a tragedy and a scandal.

I've written a number of posts on this blog about hospitals laying off staff and even put in financial jeopardy due to EHR implementation, e.g., my June 2, 2014 post "In Fixing Those 9,553 EHR "Issues", Southern Arizona's Largest Health Network is $28.5 Million In The Red" at http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html and numerous others indexed under "healthcare IT costs" at query link http://hcrenewal.blogspot.com/search/label/healthcare%20IT%20cost.

This often occurs due to poor project planning, overconfidence, underestimation of complexity and even incompetence, that drives up electronic records system costs way over estimates.

It's happened again:

Southcoast Health cutting dozens of jobs on heels of expensive IT upgrade
Mar 30, 2016, 11:25am EDT
Updated Mar 30, 2016, 11:31am EDT

http://www.bizjournals.com/boston/blog/health-care/2016/03/southcoast-health-cutting-dozens-of-jobs-on-heels.html

Stung by losses linked to costly technology upgrades, Southcoast Health is laying off 95 employees just a year after finalizing a similar staffing cut.

The cuts represent 1 percent of Southcoast's 7,251 workforce, and will happen across the care provider's three hospitals in Fall River, Wareham and New Bedford. All levels of hospital staff will be affected, officials said.

Southcoast employees were notified of the cut Wednesday morning. The cuts come as the hospital negotiates a merger with Care New England, a four-hospital system in Rhode Island.

The care provider said the cuts stemmed from training costs associated with the installation of a $100 million records system, known as Epic. Similar operating challenges have been reported by other Massachusetts care providers in the midst of Epic upgrades and installations.

I note that $100 million can purchase an entire new hospital wing or facility.

Training costs, of all things, should have been factored into the original project plans. It's not as if this issue is an unknown in an industry and product extant for several decades now.

Also, IMO the word "challenges" should be altered to "challenged" to describe the institutional geniuses responsible for debacles like this.

Training costs for the system, which went live in October, contributed to a $9.9 million operating loss in the first quarter of fiscal 2016, which ended Dec. 31. Hospital executives said similar expenses have impacted the bottom line in the current quarter, which ends Thursday.

So, training costs for the EHR devoured profits from an increasing revenue stream as below, plus consumed enough to leave a near $10 million loss. Stunning.

"These financial challenges are attributable to higher-than-budgeted operating expenses, largely a result of our Epic implementation," said Southcoast president and CEO Keith Hovan, in a letter to employees. "During the first two quarters of this fiscal year, revenue has grown positively at a rate of 4 percent – a significant accomplishment, particularly given the lack of a flu season. However, expenses have grown at 6 percent during that time, which is an untenable variance that must be corrected."

I note that the hospital system might have realized their cost underestimations via reading the literature a bit, including but not limited to my completely free academic site at http://cci.drexel.edu/faculty/ssilverstein/cases (in existence in various flavors since 1998), and this very blog.

Hovan went on to ask employees for recommendations to reduce costs, going so far as to tell employees to reach out to him directly.

How about reducing IT expenditure and laying off IT personnel responsible for the cost underestimates? Costing is supposed to be a core competence of management information systems (MIS) personnel in those IT departments.

... Approximately 70 people were let go in October 2014, and another 35 were let go in January 2015.

The hospital still has 339 job openings for a number of clinical roles. Cohenno wouldn't detail what kinds of jobs the hospital was eliminating, but said employees affected by today's layoffs will be encouraged to apply to open positions.

Some consolation for being fired to maintain the good health of a computer.

The solution to this problem is for hospital executives to actually learn more about what they're getting into in HIT acquisition, implementation and operation, instead of simply believing the marketing hype coming from the HIT industry and its cybernetic hyper-enthusiasts.

That means reading far more than typical industry marketing BS, a.k.a. performing robust due diligence.

-- SS InformaticsMDhttp://firstname.lastname@example.com:blogger.com,1999:blog-9551150.post-24018067210013976292016-03-31T12:36:00.000-04:002016-03-31T12:36:04.623-04:00What You See Is Not What You Get - Purdue Pharma Executives Pleaded Guilty, but the Oxycontin Billionaires Went UnnoticedWhat you see if often not what you get.

Nine years ago, three top executives of Purdue Pharma pleaded guilty to criminal charges of "misbranding" Oxycontin. The case appeared to be a landmark. In previous years, top executives of large health care corporations rarely faced legal consequences when their companies misbehaved. Yet in the Purdue Pharma/ Oxycontin case, things were not what they seemed. Maybe that is why this case never did yield a new era of accountability for top corporate health care leaders.

Background - the Oxycontin Guilty Pleas

In 2007, we posted about the executives' guilty pleas. Relying on the New York Times coverage, we noted that the Department of Justice charged that the company used aggressive, deceptive marketing, including claims that Oxycontin had little potential for addiction, even though they then knew otherwise. Unlike many other settlements, the executives and the company admitted their dishonesty, although they were not apparently charged with fraud.

In a statement, the company said: 'Nearly six years and longer ago, some employees made, or told other employees to make, certain statements about OxyContin to some health care professionals that were inconsistent with the F.D.A.-approved prescribing information for OxyContin and the express warnings it contained about risks associated with the medicine. The statements also violated written company policies requiring adherence to the prescribing information.'

'We accept responsibility for those past misstatements and regret that they were made,' the statement said.
While no executives went to jail, the three who pleaded guilty,

Michael Friedman, the company's president, who agreed to pay $19 million in fines; Howard R. Udell, its top lawyer, who agreed to pay $8 million; and Dr. Paul D. Goldenheim, its former medical director, who agreed to pay $7.5 million.

appeared to be the top leaders of the company. So, at the time I concluded,

At least in the Purdue Pharma/ Oxycontin case top company leaders were prosecuted, pleaded guilty, and will personally have to pay substantial financial penalties. Maybe this will convince the leaders of health care organizations that deceptive marketing practices may not be in their long term interests. Up to now, it may have been too easy to be swayed by the enormous profits deceptive marketing can bring, and regard fines paid by the company as just a cost of doing business.
No Lasting Effects

I was much too optimistic. Alas, we have since documented numerous legal settlements, and other cases of at least alleged bribery, kickbacks, or fraud, in which the top organizational leaders who authorized or directed the questionable conduct never suffered any consequences for their actions. That is, they demonstrated impunity.

Meanwhile, Purdue Pharma has been in the news since 2007, and not in a good way. In particular, we noted that the company seemed to keep up manipulative, if not deceptive marketing efforts on behalf of its narcotic product. In 2010, Canadian medical students protested that their "education" about narcotics and pain management was influenced by Purdue marketing (look here). In 2012, we noted that a leading "key opinion leader" who had a key role promoting the liberalized, if not reckless use of narcotics to treat all sorts of chronic pain, and had financial relationships with numerous narcotic pharmaceutical manufacturers, including Purdue Phrama, later admitted that it was all "misinformation." Yet this aggressive promotion of narcotics was likely a major factor in the ongoing narcotic epidemic which has killed thousands in the US. And in January, 2016 we described how opposition to new CDC guidelines that suggested much more conservative use of narcotics seemed to be funded, if not orchestrated by narcotic pharmaceutical manufacturers, notably including Purdue Pharma. Finally, there have been many other stories about Purdue Pharma about which we failed to post.

One would think, however, that a company that admitted to a crime, and whose three top executives lost their jobs and also pleaded guilty to crimes, would at least change its ways, even if these guilty pleas and admissions did not inspire more attempts to hold top corporate health care leaders accountable.

An Assumption about Unaccountable Hired Mangers

But it turns out that some obvious assumptions that I and probably many other people made about the Purdue Pharma cases of 2007 were wrong. I implicitly assumed when I wrote my 2007 post that the three Purdue Pharma executives who pleaded guilty were the top leaders of the company.

Furthermore, as we have discussed elsewhere, the top executives of large, for-profit publicly held corporations, like most pharmaceutical companies, have become largely unaccountable. They may seem to exist in a bubble, in which they are hailed as visionaries, and paid exceedingly well no matter how their organizations perform. (Look here). However, many top hired corporate managers have mainly become "value extractors."

These executives are nominally accountable to their corporate boards of directors, which are supposed to represent the owners of the companies. However, most large pharmaceutical companies have numerous stockholders, who have no easy avenue to organize. Many of their stockholders, in turn, are mutual funds, retirement funds, etc whose shares in turn are owned by thousands more. These numerous, dispersed "owners" have little influence on corporate boards, who often functionally are dominated by cronies of the top management.

So when the three top Purdue executives pleaded guilty, at least it looked like in this case the unaccountable hired executives had been made accountable, if not to their boards of directors, at least to the courts.

But Who Owned Purdue?

But what you see is not always what you get. There was a hint buried in the NY Times article,

Between 1995 and 2001, OxyContin brought in $2.8 billion in revenue for Purdue Pharma, a closely held company based in Stamford, Conn. At one point, the drug accounted for 90 percent of the company's sales.

As part of the plea agreement, Purdue Frederick, a holding company for Purdue Pharma that is also closely held, pleaded guilty to a felony charge of misbranding OxyContin.

The article did not further discuss the meaning and implications of the twice used phrase, "closely held." I confess I missed it entirely. However, it seems to have meant that rather than being a public corporation with numerous, dispersed stockholders, the owners of Purdue Pharma and its parent were a smaller group, perhaps a group who should have been accountable for the actions of their executives. However, the NY Times did not further describe this group. Neither did reports in other outlets, such as the Wall Street Journal, CBS, or Time. Nor did a variety of other news stories that mentioned Purdue Pharma through 2010.

The Oxycontin Billionaires

There were a fewother clues available in 2007, but would have not been easily found at that time. After the case's resolution was disclosed, an article appeared in the Corporate Crime Reporter (but was presumably only available at that time by subscription.)

Purdue is a privately held, very secretive company based in Stamford, Connecticut.

It's controlled by the Arthur Sackler family. Arthur Sackler is the guy who, before he delivered OxyContin, brought to you the marketing for Librium and Valium. Walk on the mall in Washington and you walk by the Freer Gallery of Art and Arthur Sackler Gallery.

Art brought to you by Oxy.

New York Times correspondent Barry Meier is probably the most plugged in journalist on the topic. A couple of years ago, he wrote a book detailing the problem titled Pain Killer: A 'Wonder' Drug's Trail of Addiction and Death (Rodale Books, 2004.)

So apparently Purdue Pharma and Purdue Frederick were privately held, the Sackler family held a controlling interest, and the Sackler family were rich enough to have their name attached to an art museum.

The relationship between the Sackler family and Purdue got no other attention I could find until 2010. In March of that year, another member of the family, Dr Mortimer D Sackler died, and his NY Times obituary led off with evidence of his wealth, and philanthropy,

Mortimer D. Sackler, a psychiatrist who was a co-owner of the pharmaceutical company Purdue Pharma, makers of the controversial painkiller OxyContin, and whose lavish gifts to the Guggenheim Museum, the Metropolitan Museum of Art and Columbia University made him one of New York City's most prominent benefactors, died March 24 in Gstaad, Switzerland. He was 93 and had homes in London, Gstaad and Antibes, France.

The obituary also provided evidence of a direct relationship among the Sacklers, Purdue, and the development of Oxycontin.

The Sackler brothers were all doctors, and all businessmen as well. In 1952, while the three were working at the Creedmoor state psychiatric hospital, Arthur financed the purchase of a small drug manufacturer based in Greenwich Village, the Purdue Frederick Company, which Mortimer and Raymond Sackler ran as co-chairmen and which later became Purdue Pharma, now based in Stamford, Conn.

Then,

by the mid-1990s Purdue Pharma was still a small drug company. But with a new product, OxyContin, a powerful, long-acting, narcotic painkiller, the company hoped to join the ranks of industry giants. Indeed, by 2001 sales of the drug had reached nearly $3 billion and accounted for 80 percent of Purdue Pharma's revenue.

An obituary in the London Telegraph quantitated the wealth that the Sacklers obtained from Purdue a bit more,

The lavish scale of Sackler's generosity was indicated in The Sunday Times's "Rich List" for 2008, which noted that while he and his family owned a £500 million stake in the pharmaceutical business, Purdue Pharma, huge charitable contributions had cut their wealth to £300 million. Yet few knew much about the Sacklers apart from their association with the cultural institutions that bear their name.

However, I could find no echos of this story beyond these obituaries, and certainly none that prominently made their way into the health care world. In late 2011, about ten percent of a long piece by Fortune on Purdue made the Sackler's ownership and wealth clear, but did not discuss the implications.

The story only began to echo a little in 2014. That year, the prospect of a trial of a civil lawsuit against Purdue filed in the state of Kentucky, one of the most hard hit by the narcotic epidemic, promised to shake things up. A long Bloomberg story on the lawsuit was the first to suggest that the very wealthy Sackler family might bear some responsibility for how Purdue marketed Oxycontin, and the results on patients' and the public's health.

Kentucky lawyers plan another first for Purdue: They want to elicit testimony from the company's board, which is dominated by members of the Sackler family, the wealthy philanthropists who own the company and have until now remained largely untouched by the controversy tied to the blockbuster drug that netted their business billions of dollars.

It underlined the tightness of the ties between the Sackler's and Purdue. The family does not merely own a controlling interest, but dominates the company's governance.

Purdue today is owned through holding companies and family trusts for the benefit of Mortimer and Raymond Sackler's families, according to Raul Damas, a company spokesman. In all, nine members of the Sackler family are Purdue directors. In January, Raymond Sackler announced the appointment of Chief Executive Officer Mark Timney. None of the Sacklers has been named in the Kentucky suit.

Raymond, who remains on the board, and his children have been the most involved in the family business. His son, Richard, a physician, worked at Purdue for three decades before being named president in 1999. Now retired, he remains a director. A grandson, David Sackler, sits on the board and runs a family investment fund, Summer Road LLC, in New York. Raymond's other son, Jonathan, is a director, too.

By the way, the Bloomberg article also detailed another point (which had been mentioned in the obituaries and the CNN article). One member of the Sackler family was behind the aggressive, deceptive marketing campaign that sparked so many sales of Oxycontin. In fact, this Sackler brother could be viewed as the father of modern aggressive, deceptive pharmaceutical/ biotechnology/ device corporate marketing.

Raymond and Mortimer ran the company together. Arthur, the oldest, appears to have been primarily an investor and adviser.

Considered the father of modern pharmaceutical marketing, Arthur Sackler created the first medical-journal advertising insert to promote a drug and pushed for hiring sales reps long before they became as common in physicians' waiting rooms as out-of-date magazines. Purdue used many of Arthur Sackler's tactics when it introduced OxyContin, a time-released dose of the opioid oxycodone, in 1995.

CNN had gone into a bit more detail on Arthur Sackler's previous work:

Arthur, joined a small advertising agency that specialized in marketing pharmaceuticals. (He also funded his brothers' purchase of Purdue, according to a 2003 book by New York Times reporter Barry Meier called Pain Killer: A Wonder Drug's Trail of Addiction and Death.) Arthur was so successful that in 1997 he was one of the first people named to the Medical Advertising Hall of Fame, whose website credits him with helping 'shape pharmaceutical promotion as we know it today.' As early as the 1950s he was experimenting with TV marketing, and according to the entry, Arthur's scientific knowledge and ability to expand the uses for Valium helped turn it into the first $100 million drug ever. Arthur's philosophy was to sell drugs by lavishing doctors with fancy junkets, expensive dinners, and lucrative speaking fees, an approach so effective that the entire industry adopted it.

So at least this article credits Dr Arthur Sackler, of Purdue Pharma, with being one of the creators of the web of conflicts of interest that has ensnared many medical professionals in the last decades. Who knew?

Just to ice this cake, in later 2015, it became apparent that the Sacklers did not merely become wealthy from Purdue profits and Oxycontin sales. They became fabulously wealthy. Forbes listed the Sackler family that year as one of the 20 richest US families, estimating their combined wealth as $14 billion.

The Sackler family, which owns Stamford, Conn.-based Purdue Pharma, flew under the radar when Forbes launched its initial list of wealthiest families in July 2014, but this year they crack the top-20, edging out storied families like the Busches, Mellons and Rockefellers.

How did the Sacklers build the 16th-largest fortune in the country? The short answer: making the most popular and controversial opioid of the 21st century — OxyContin.

Purdue, 100% owned by the Sacklers, has generated estimated sales of more than $35 billion since releasing its time-released, supposedly addiction-proof version of the painkiller oxycodone back in 1995. Its annual revenues are about $3 billion, still mostly from OxyContin. The Sacklers also own separate drug companies that sell to Asia, Latin America, Canada and Europe, together generating similar total sales as Purdue's operation in the United States.

Forbes estimates that the combined value of the drug operations, as well as accumulated dividends over the years, puts the Sackler family's net worth at a conservative $14 billion.

Perhaps if the Kentucky lawsuit had gone to trial, these echos would have gotten even louder.

However, in December, 2015, Purdue settled the suit for $24 million, admitting no liability, and keeping the Sackler name out of the limited press coverage (although see this in STAT by Ed Silverman.)

I, for one, only found out about the Sackler / Purdue linkage when STAT published a followup in March, 2015. It turns out that in the run up to the Kentucky trial, a member of the Sackler family was actually deposed. This may have been the only direct discussion of the Oxycontin case by a member of the family.

The settlement required the attorney general to 'completely destroy' or return to Purdue all documents it received from the company or from any other party through a subpoena. The attorney general was given 60 days from the Dec. 18 agreement to comply. The agreement also prohibits the attorney general from sharing the documents with any other entity investigating or litigating against Purdue.

The attorney general's office destroyed millions of pages of documents within the 60-day period, according to spokesman Terry Sebastian.

While the attorney general destroyed the records in its possession, copies of some of those records remain under seal in the Pike County courthouse, including the Sackler deposition.

The STAT article noted that millions of pages of records from other Oxycontin litigation were destroyed or returned to the company as stipulated by previous settlements. This time,

STAT is making a motion to intervene in the settled Kentucky lawsuit. The motion was sent to the Pike Circuit Court Monday via overnight courier.

The motion argues that STAT and the public have a constitutional right to the records that trumps Purdue's interest in keeping them secret. The motion also states there is a substantial public interest in the case, citing the epidemic of drug addiction and related crime stemming from the abuse of OxyContin in Kentucky and other states. STAT is requesting the court make the documents available immediately.

We will see how this attempt to shine a little light on the long running Oxycontin story goes. I am not optimistic, since this long-running case has vividly shown how those who have the biggest vested interests in keeping our commercialized, overutilizing, over-marketed health care system going can use money and influence to keep it all so anechoic.

Summary

So now we see, dimly, reasons why the penalties handed out to "top" Purdue Pharma executives for the deceptive "misbranding" of a dangerous narcotic failed to end the impunity of top health care leaders. Those supposed "top men" were not really the top.

Just like in "Raiders of the Lost Ark,"

They were hired managers with fancy titles who worked for a secretive family which owned Purdue Pharma, which was apparently directly involved in the engineering of the aggressive, deceptive, "misbranding" sales campaign which sold so much Oxycontin, which became fabulously wealthy from the ownership of the company, and which managed to conceal their relationship to the company from nearly all prying eyes. So far, the family seems to either have befuddled or intimidated law enforcement sufficiently to prevent any direct consequences from befalling them.

This case vividly demonstrates, first, how those who have personally gained the most from our current dysfunctional health care system have often brilliantly covered up what they were doing (part of what we have called the anechoic effect). As long as we do not know where the money goes, and how it is made, we do not know what needs to be done to make things better. True health care reform requires bright sunlight to be shown on how the health care sausage is made, who makes it, and how they profit from it. As long as we the people let ourselves stay in the dark, we will continue to endure our woefully overpriced, inaccessible, mediocre quality, and all too often frankly corrupt health care system.

A piece this long and heavy deserves a musical interlude. Here is a live performance by the Dramatics of "What You See Is What You Get," (if only that were the case here).

 Roy M. Poses MDhttp://email@example.com:blogger.com,1999:blog-9551150.post-27974005356065498542016-03-30T11:44:00.007-04:002016-03-30T18:17:10.987-04:00Medstar Health CEO basically admits EHRs are unnecessary after hackers take out its HITIt's corporate spin, of course, but that's the plain meaning of what he says:

http://baltimore.cbslocal.com/<wbr></wbr>2016/03/29/medstar-paralyzed-<wbr></wbr>as-hackers-take-aim-at-<wbr></wbr>another-us-hospital/

For a second day, the region's second-largest health care system deals with a crippling computer virus. MedStar Health says it is making progress, but WJZ is learning some patients are still feeling the effects.

... Despite the challenges affecting MedStar Health's IT systems, the quality and safety of our patients remains our highest priority, which has not waned throughout this experience. Fortunately, the core ways in which we deliver patient care cannot be altered, manipulated or harmed by malicious attempts to disrupt the services we provide [that is, by taking down the EHRs -ed.]," Stephen R.T. Evans, MD, executive vice president, Medical Affairs and chief medical officer, MedStar Health. "Our ability to serve our patients and their families depends first and foremost on our caregivers, and their expert knowledge and compassion focused on each patient."

He likely does not realize just how correct his spin actually is.

-- SS

3/30/2016 Addendum:

This is not the first time for EHR outages at MedStar.

As in my May 16, 2015 post "Another day, another EHR outage: MEDSTAR EHR goes dark for days" at http://hcrenewal.blogspot.com/2015/05/another-day-another-ehr-outage-medstar.html, I cited Politico.

The doctor's observation I highlighted below is of interest.

4/9/15
http://www.politico.com/morningehealth/0415/morningehealth17818.html

MEDSTAR EHR GOES DARK FOR DAYS: MedStar's outpatient clinics in the D.C. and Baltimore area lost access to their EHRs Monday and Tuesday when the GE Centricity EHR system crashed. The system went offline for scheduled maintenance on Friday and had come back on Monday when it suffered a "severe" malfunction, according to an email from Medstar management that was shared with Morning eHealth.

"All of a sudden the screens lit up with a giant text warning telling us to log off immediately," a doctor said. "They kept saying it would be back up in an hour, but when I left work Tuesday night it was still down."

This doctor told us that the outage was "disruptive and liberating at the same time. I wrote prescriptions on a pad for two days instead of clicking 13 times to send an e-script. And I got to talk to my patients much more than I usually do.

But of course we didn't have access to any notes or medication history, and that was problematic." MedStar notified clinicians in the email that any information entered in the EHR after Friday was lost.

-- SS InformaticsMDhttp://email@example.com:blogger.com,1999:blog-9551150.post-65134036001614880952016-03-29T14:04:00.002-04:002016-03-30T18:17:32.654-04:00Bad health IT at Medstar Health: FBI probing virus behind outage (And: ka-ching! ka-ching! EHR costs continue their upward spiral)Once again, a definition of bad health IT:

Bad Health IT ("BHIT") is defined as IT that is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or evidentiary fitness, or otherwise demonstrates suboptimal design and/or implementation. (http://cci.drexel.edu/faculty/ssilverstein/cases/)

I observed bad health IT leading to HIT compromise, hospital chaos and paying of a ransom demand at my Feb. 18, 2016 post "Hollywood Presbyterian Medical Center: Negligent hospital IT leaders allow hacker invasion that cripples EHRs, disrupts clinicians ... but patient safety and confidentiality not compromised" at http://hcrenewal.blogspot.com/2016/02/hollywood-presbyterian-medical-center.html.

It's happened again, at least with regard to publicly-disclosed stories (there is no requirement for hospital disclosure, more on that below).

FBI probing virus behind outage at MedStar Health facilities - AP
By JACK GILLUM, DAVID DISHNEAU and TAMI ABDOLLAH March 28, 2016 10:04 pm
http://wtop.com/consumer-tech/2016/03/fbi-probing-virus-behind-outage-at-medstar-health-facilities/

WASHINGTON (AP) — Hackers crippled computer systems Monday at a major hospital chain, MedStar Health Inc., forcing records systems offline for thousands of patients and doctors. The FBI said it was investigating whether the unknown hackers demanded a ransom to restore systems.

A computer virus paralyzed some operations at Washington-area hospitals and doctors' offices, leaving patients unable to book appointments and staff locked out of their email accounts. Some employees were required to turn off all computers since Monday morning.

A law enforcement official said the FBI was assessing whether the virus was so-called ransomware, in which hackers extort money in exchange for returning a victim's systems to normal. The official spoke on condition of anonymity because the person was not authorized to discuss publicly details about the ongoing criminal investigation.

Not discussed is corporate accountability for deficient IT security.

"We can't do anything at all. There's only one system we use, and now it's just paper," said one MedStar employee who, like others, spoke on condition of anonymity because this person was not authorized to speak to reporters.

I note that if the cybernetic pundits were listened to, patients would now be considered at deadly risk due to paper records being used - not due to critical IT infrastructure being hacked and disabled. Yet it's impossible to disable paper charts en masse.

MedStar said in a statement that the virus prevented some employees from logging into systems. It said all of its clinics remain open and functioning and there was no immediate evidence that patient information had been stolen.

These must be honest thieves.

Of course, we hear the "patient care has not been compromised" line once more (http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised).

Company spokeswoman Ann Nickels said she couldn't say whether it was a ransomware attack. She said patient care was not affected and the hospitals were using a paper backup system.

The absurdity of this claim is that if patient care is not affected by returning to paper, then why did the hospital invest hundreds of millions on EHRs?

(Considering a increasing evidence base of clinician distraction and disaffection e.g., the Jan. 2015 Medical Societies letter to ONC as at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html, EHR-related errors, many of which would likely not occur under a well-staffed paper system e.g., as at http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html, and plentiful security breaches e.g., the many posts at http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy, I would also ask if patient care is in fact improved by the return to paper [1].)

When asked whether hackers demanded payment, Nickels said: "I don't have an answer to that," and referred to the company's statement.

Dr. Richard Alcorta, medical director for Maryland's emergency medical services network, said he suspects it was a ransomware attack. He said his suspicion was based on multiple earlier ransomware attempts on individual hospitals in the state. Alcorta said he was unaware of any ransoms paid by Maryland hospitals or health care systems.

The rather calmly-stated "multiple earlier ransomware attempts on individual hospitals in the state" suggests that

Hospitals are being targeted in an organized fashion, and

Costs to implement proper security will draw even more capital and resources from direct patient care and from real brick and mortar facilities, such as entire new hospital wings that would cost less than an EHR, to cybernetics of increasingly dubious value. (Past projected cost benefits are certainly being proven even more naive.)

Terrorism or just plain old crime, the medical driector asks...

"People view this, I think, as a form of terrorism and are attempting to extort money by attempting to infect them with this type of virus," he said.

God help us if true terrorists get in the act of cybernetically paralyzing hospitals.

Alcorta said his agency first learned of MedStar's problems about 10:30 a.m., when the company's Good Samaritan Hospital in Baltimore called in a request to divert emergency medical services traffic from that facility. He said that was followed by a similar request from Union Memorial, another MedStar hospital in Baltimore. The diversions were lifted as the hospitals' backup systems started operating, he said.

It used to be that patient diversions were due to doctors and nurses having too many sick patients they are caring for. Here it seems due to doctors having to many sick computers to deliver proper patient care.

MedStar operates 10 hospitals in Maryland and Washington, including the MedStar Georgetown University Hospital, along with other facilities. It employs 30,000 staff and has 6,000 affiliated physicians.

That's a lot of paralysis.

Monday's hacking at MedStar came one month after a Los Angeles hospital paid hackers $17,000 to regain control of its computer system, which hackers had seized with ransomware using an infected email attachment.

Hollywood Presbyterian Medical Center, which is owned by CHA Medical Center of South Korea, paid 40 bitcoins — or about $420 per coin of the digital currency — to restore normal operations and disclosed the attack publicly. That hack was first noticed Feb. 5 and operations didn't fully recover until 10 days later.

Hospitals are considered critical infrastructure, but unless patient data is impacted there is no requirement to disclose such hackings even if operations are disrupted.

I won't even comment on why a US hospital is owned by a Korean medical center. The statement "unless patient data is impacted there is no requirement to disclose such hackings even if operations are disrupted" implies yet another blind spot in the unregulated health IT industry. Add that to the blindness towards close-calls and actual harms, and you have a field being pushed on the population under penalty by those somewhat deaf, dumb and blind to the downsides.

Computer security of the hospital industry is generally regarded as poor, and the federal Health and Human Services Department regularly publishes a list of health care providers that have been hacked with patient information stolen. The agency said Monday it was aware of the MedStar incident.

All I can hear is "ka-ching! ka-ching!" as the costs to fix the poor computer security in the hospital industry accrues.

How much will patient care suffer as a result of the diversion of yet more resources to cybernetics?

As I've written before, stories like this support a serious rethinking of the entire healthcare IT hyper-enthusiast movement to whom the considerable downsides (even patient death) are just an unfortunate "bump in the road" (http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html), or perhaps more accurately, the healthcare IT hyper-enthusiast religion.

-- SS

[1] I've written that paper for many clinical settings, including highly specialized forms as I implemented highly successfully in invasive cardiology (http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story), needs reconsideration, relieving clinicians of clerical work and employing data entry clerks to enter the data. This would be supplemented by far less expensive document imaging systems for 24/7 availability, and computerized lab results retrieval - the latter with appropriate humans on the receiving end to prevent the "silent silo" syndrome of lab results returned to a computer silo but missed by clinicians due to being very busy and due to unreliable/fatiguing cybernetic alerting. A lot of workers can be paid for by saving $50 or $100 million on software.

3/30/2016 Addendum:

This is not the first time for EHR outages at MedStar.

As in my May 16, 2015 post "Another day, another EHR outage: MEDSTAR EHR goes dark for days" at http://hcrenewal.blogspot.com/2015/05/another-day-another-ehr-outage-medstar.html, I cited Politico.

The doctor's observation I highlighted below is of interest.

4/9/15
http://www.politico.com/morningehealth/0415/morningehealth17818.html

MEDSTAR EHR GOES DARK FOR DAYS: MedStar's outpatient clinics in the D.C. and Baltimore area lost access to their EHRs Monday and Tuesday when the GE Centricity EHR system crashed. The system went offline for scheduled maintenance on Friday and had come back on Monday when it suffered a "severe" malfunction, according to an email from Medstar management that was shared with Morning eHealth.

"All of a sudden the screens lit up with a giant text warning telling us to log off immediately," a doctor said. "They kept saying it would be back up in an hour, but when I left work Tuesday night it was still down."

This doctor told us that the outage was "disruptive and liberating at the same time. I wrote prescriptions on a pad for two days instead of clicking 13 times to send an e-script. And I got to talk to my patients much more than I usually do.

But of course we didn't have access to any notes or medication history, and that was problematic." MedStar notified clinicians in the email that any information entered in the EHR after Friday was lost.

-- SS

InformaticsMDhttp://firstname.lastname@example.com:blogger.com,1999:blog-9551150.post-46361266845227493572016-03-25T12:40:00.001-04:002016-03-25T12:40:06.784-04:00Will There Ever Be Enough Straws to Break Corporate Health Care Managers' Impunity's Back? - Novartis Settles Yet Again, This Time for Bribing DoctorsUmpteenth verse, same as the first...

As just reported by Bloomberg,

Novartis AG said it agreed to pay $25 million to settle a U.S. Securities and Exchange Commission case that claimed the Swiss drugmaker paid bribes to health professionals in China to increase sales from 2009 to 2013.

In particular,

The SEC detailed a number of Foreign Corrupt Practices Act violations where Novartis employees provided items of value to health-care professionals in China, under the supervision of complicit managers. It also cited examples of how the company improperly recorded as legitimate expenses payments employees made for travel and entertainment, conferences, lecture fees, marketing events, educational seminars and medical studies.

For some vivid examples,

In one example cited in the SEC order on Novartis, a sales representative at the drugmaker's Sandoz China subsidiary submitted a $1,154 receipt to buy holiday gifts for 25 health-care professionals, which was instead used to pay for their spa and sauna sessions. A regional sales manager approved the purchase, the SEC said.

The SEC order also cited how Sandoz China sponsored 20 health-care professionals to attend a 2009 medical conference in Chicago. During the trip, the company paid for the group's recreational activities such as a Niagara Falls excursions, $150 in 'walking around' money for their spouses, and cover charges to a strip club. The group was accompanied by a Sandoz China senior manager and other staff, according to the SEC.

So, thus far, the allegations were that Novaris bribed Chinese physicians to use their products, and the bribes includes gifts, travel money, and admission to a strip club. It is likely that these bribes induced the physicians to unnecessarily or excssively prescribe Sandoz drugs to patients, leading to excess expenses, overtreatment, and quite likely adverse effects that should have been prevented.

As per the Wall Street Journal, and as usually happens in such cases, Novartis was allowed to settle without "admitting or denying the findigs." In the Bloomberg article, a Novartis spokesperson gave the usual vague response,

'The issues raised by the SEC, which relate to our subsidiaries in China and go back as far as 2009, largely pre-date many of the compliance-related measures introduced by Novartis across its global organization in recent years,' Novartis spokesman Eric Althoff said in an e-mailed statement Thursday.

The implication was that the company no longer does these bad things, but did not include a promise not to do them. And, of course, just like in many, many other health care cases, and in many, many other cases involving big, powerful, or influential organizations, no one at a top management level went to jail, or even suffered any negative consequences, even for such sleazy allegations as those in this case. Finally, partially because the amount of this settlement was so small related to the financial bulk of the company involved, this case was relatively anechoic, only reported in the small items in the business press.

Summary

As we are distracted by bloviating billionaires and other spectacles on the US 2016 campaign trail, we continue to accumulate evidence of the corruption of large health care organizations and the impunity of their leaders. Yet this evidence remains anechoic, even given the apparent recidivism involved. For example, it was only in last November that we discussed what were then the latest misadventures by Novartis and its leadership. At that time, our post included these section headings covering 2014-15:

- Japanese Health, Labor and Welfare Ministry Found that Novartis Concealed Serious Adverse Effects
- Novartis Executive Pleads Guilty to Bribing Polish Official
- Novartis Subsidiary Sandoz Settles Allegations that it Misrepresented Pricing Data to US Medicaid
- Express Scripts Settles Allegations that it Accepted Kickbacks from Novartis
- Novartis Settles US Allegations of Kickbacks to Enhance Sales of Multiple Drugs

Furthermore, in that post we also documented Novartis' previous record. In March, 2014, we had noted:
- Italian authorities had fined Novartis and Roche for colluding to promote the use of an expensive opthamologic treatment
- the NY Times published interviews with physicians ostensibly showing how Novartis turned them into marketers for the drug Starlix
- Japanese investigators charged Novartis with manipulating clinical research
- Indian regulators canceled a Novartis import license, charging the company with fraud.

Also, in 2013, Novartis was fined for anti-competitive practices in its marketing of Fentanyl by the European Commission (look here), and in 2011 its Sandoz subsidiary settled allegations of misreporting prices in the US for $150 million (look here) Other Novartis misadventures from 2010 and earlier appear here. So Novartis has quite an impressive, if not infamous record of ethical failures.

Yet no Novartis top manager suffered any negative consequences then (although one apparent mid-level company manager at the Polish subsidiary did plead guilty), and all these previous episodes apparently did not suggest a pattern of recidivism to US authorities this time sufficient to attempt to impose any negative consequences on higher level managers. Meanwhile, Novartis executives continue to be paid handsomely. The 2015 Novartis executive compensation report listed over 51 million Swiss francs paid

Also, this goes on while large health care companies continue to pay out dizzying amounts to physicians, health care professionals, hospitals and academic institutions, which partially may secure their loyalty. Novartis, for example, which ProPublica lists as only the 28th biggest payer to physicians, paid out $31.7 million in 2013-14 just to US physicians. The 2015 Novartis board of directors included Dr Nancy C Andrews, the Dean of the Duke Medical School and Vice-Chancellor for Academic Affairs at Duke University, Dr Dimitri Azar, Dean of the College of Medicine at the University of Chicago, Illinois, and Dr Charles L Sawyers, a professor and department chair at Weill-Cornell Medical School. I am unaware that anyone of them have publicly raised any concerns about Novartis' recent misadventures, although I am also unaware whether anyone has publicly asked them such questions.

No wonder that ordinary US (and other countries' citizens) feel that they are trapped in a hopeless economic situation by rigged systems designed to benefit from the corrupt insiders. No wonder that someone of them are seeking the protection of some of those powerful insiders. But I digress...

In terms of health care, as we have said like a broken record (if anyone remembers what that means), or, if you prefer, where every verse is same as the first...

There seems to be increasing recognition that the continuing rise in US health care costs is unsustainable, and that these costs are not buying us good health care. There are calls to avoid unnecessary, and sometimes harmful care. Yet there is a persistent disconnect between how continuing dishonest behavior by health care organizations, impunity of their leaders, and lack of accountability by their board members fuel rising costs, shrinking access, and bad outcomes for patients.

To truly reform health care, we will have to at least recognize the causes of the current dysfunction. Recognizing how health care dysfunction is created by unaccountable, dishonest leadership should lead to true reform that would promote well-informed, honest, accountable leadership that puts patients' and the public's health ahead of personal gain.

Our musical interlude ("second verse, same as the first,") Herman's Hermits, Henry VIII

Roy M. Poses MDhttp://firstname.lastname@example.com:blogger.com,1999:blog-9551150.post-47851187467190934012016-03-20T16:38:00.000-04:002016-03-22T15:03:27.054-04:00There They Go Again - the New England Medical Journal Publishes another Rant, this Time about Power MorcellationIn 2015, we noted (here and here) that the New England Journal of Medicine seemed to have been reduced to publishing rants about "pharmascolds" who are paranoid about conflicts of interest. Now there they go again....

Background

The sad story about the risks of power morcellation for the treatment of fibroids has received considerable media attention. The state of play through July, 2014 was described in a series of articles in the Cancer Letter of July 4, 2014. (Look here.)

Uterine fibroids are a common affliction of women. Their preferred surgical management had changed from open surgery to minimally invasive surgery, sometimes robotically performed, and often incorporating a device called a power morcellator to pulverize the fibroids, allowing the use of small incision. However, after a patient at the Brigham and Womens' Hospital (BWH) in Boston, part of the Partners Healthcare system, was found to have disseminated sarcoma post power morcellation, most likely because the machine spread tumor cells throughout her abdomen, the US Food and Drug Administration (FDA) issued an advisory against using the procedure morcellation, and despite some controversy, the procedure is now uncommonly used.

The patient so severely affected was Dr Amy Reed, an anesthesiologist at the BWH. Her husband, a cardiothoracic surgeon at BWH, launched a campaign to reduce the use of power morcellation. His pursuit of this campaign underlined an important part of the history,

The use of power morcellation was effectively allowed by the FDA in the absence of any controlled trials meant to assess its safety or efficacy in this context. The device was deemed moderate risk and approved through the 510(k) process because it appeared similar to previously allowed devices, even though older devices were not used to remove fibroids. The Cancer Letter quoted Dr David Challoner, who was on a relevant Institute of Medicine (IOM) committee, saying allowing the device on the market was

one more example of the clearance of a device for a use, not approval, based on predicates already in the market, that is, prior morcellators for other uses

The New England Journal of Medicine Weighs In - with a Special Pleading

Once again, NEJM national correspondent Dr Lisa Rosenbaum had a contrarian view(1). As we discussed here and here, last year Dr Rosenbaum wrote three commentaries suggesting the importance of conflicts of interest in health care had been overblown, especially with respect to medical journals.

This time, she argued that the FDA overreacted to the tragic case of Dr Amy Reed. In particular, she was afraid that the risks of power morcellation were exaggerated, and based on poor quality data,

Several experts argued that these risk estimates were too high and that it was riskier to expose 100,000 or so women per year to open procedures rather than laparoscopic ones. Since the rarity of LMS precludes a randomized trial, however, risk estimates had to be based primarily on retrospective case series of varying rigor. Some studies were poorly stratified for risk factors such as age, and others spanned decades during which diagnostic criteria for LMS had changed.

Dr Rosenbaum failed to mention that the lack of good data about the risks of power morcellation stemmed from the lack of any large, well designed randomized controlled trials done to assess its benefits and harms. Of course, since the device's use was allowed by the FDA 510(k) process without any requirement for trial data, there was no incentive for device companies, at least, to do such trials.

Nonetheless, Dr Rosenbaum also argued the benefits of power morcellation were downplayed.

the benefits of morcellation are largely invisible and thus 'unavailable.' Who sees the women who undergo a minimally invasive procedure, recover quickly, and avoid losing income? What does a pulmonary embolus, a wound infection, or a hemorrhage that didn't happen look like? You can't post pictures of these nonevents on social media. But their nonoccurrence is why we ought to be celebrating.

A March 18, 2016 article asked my opinion about Dr Rosenbaum's use of the clinical evidence.

'She talks about the data concerning the possible harms of power morcellation and argues that that data comes from relatively low-quality studies, not randomized, controlled trials, and that it is hard to tell the actual rate of harms, in particular, the dissemination of cancer. On the other hand, Dr. Rosenbaum implies that the benefits of power morcellation are well known.'

'She writes initially that power morcellation allows the treatment of fibroids to be 'done more efficiently and effectively,' she later implies that power morcellation is less invasive, leads to quicker recovery, avoids income loss, and furthermore, reduces the likelihood of pulmonary embolus, wound infection, or hemorrhage.'

'However, she doesn't provide any data about these ostensible benefits. A quick search suggested that there are no good randomized, controlled trials that assessed benefits. Her argument that we have abandoned a beneficial treatment based on poor quality and perhaps exaggerated the data about its harms—that does not seem to be supported by any clear data about its benefits.'

I rendered that opinion on March 18 before I read a Cochrane Collaboration review of minimally invasive surgery versus open surgery for fibroids(2). However, that review does not seem to contradict my statements above. The review included some patients who were treated using power morcellation, but apparently did not find any studies that assessed patients treated only with power morcellation with those treated only with an alternative. Even so, it only included nine studies that enrolled a total of 808 patients. Thus, I think it is reasonable to say that there have not been any large, well-done randomized controlled trials of power morcellation versus other treatments of fibroids. Even so, while the review found some advantages for minimally invasive surgery versus open surgery in terms of short-term post-operative pain and length of hospital stay, it did not address pulmonary embolus, wound infection, or hemorrhage directly. So while Dr Rosenbaum was right to say that the evidence from clinical research about the magnitude and nature of harms of power morcellation was relatively weak, the evidence about its benefits is also weak. Thus, Dr Rosenbaum's argument that the harms have been exaggerated while the benefits were overlooked was based on a logical fallacy, special pleading.

This special pleading seemed the basis for her claim that

women may suffer more from its [power morcellation's] disuse.

So, as I was quoted by the Cancer Letter,

'The NEJM is perhaps the most prestigious, most highly regarded English-language medical journal in the world,' Poses said. 'It is, in many cases, viewed as the standard for scholarly medical journals. I am a bit surprised that it published a commentary by its own national correspondent that appears to make an argument—about benefits and harms of treatment and policymaking about treatment—that does not have a clear discussion of the data that support or fail to support either the benefits or the harms of the treatment.'

More Arguments, Less Justification

Dr Rosenbaum insisted that her concerns were about the question,

How do you use data to clarify tough trade-offs when the most compelling narratives paint evidence-based reasoning itself as an anathema?

However, she did not demonstrate an approach to policy making on power morcellation that was more evidence-based than what has transpired so far.

In addition, Dr Rosenbaum decried challenges to health care innovation from "the power of tragic stories," and the title of her commentary ("N-of-1 policymaking") suggested that the the FDA approach to power morcellation was based on a single tragic story. Yet an FDA spokesperson insisted in the March 18, 2016 Cancer Letter article,

The FDA evaluated the available data at the time and determined that it was of sufficient quality and reliability to support our November 14, 2014 decision.

Furthermore, Dr Rosenbaum expressed concerns that power morcellation met its "demise" because of unwarranted concerns about the "greedy corporation," "medicine's corruption," and "industry greed." Yet she ignored arguments that these concerns were not unreasonable.

First, the commentary ignored claims that power morcellation procedures were very lucrative, e.g., those in the 2014 Cancer Letter article

'This is a very lucrative procedure.' [Dr] Noorchashm, [Dr Reed's husband] said. 'The procedure itself bills $30,000 to $50,000, depending on the center.'

Nor did she argue against the assertion in the same article that device companies used political influence to promote their very expensive product,

There is a very strong pressure from the device industry to get into the market quickly.

The device companies have been able to make [the 510(k) process that allowed power morcellation] survive politically over the ensuing 40 years.

Also, Dr Rosenbaum's NEJM commentary failed to counter the assertion by Dr Noorchashm that the device manufacturers concealed the risks of power morcellation.

Device manufacturers clearly knew of the cancer risk. You can see warnings about malignant tumors in the Ethicon and Karl Storz user manuals. Clearly, their lawyers had warned them to put them there to avoid liability. The bottom line is that these manufacturers knew of this hazard, but neither reported it back to the FDA, as would have been the safe and responsible thing to do.(3)

Finally, according to the March 18, 2016 Cancer Letter article, while Dr Reed has apparently sued the BWH, and Dr Rosenbaum admitted she is on "faculty" at the BWH, neither she, the NEJM, nor the BWH will say whether she is currently being paid by the BWH. Particularly,

the hospital declined to provide information on Rosenbaum's title and whether she is a full-time faculty member, citing personnel policies.

My response (in the Cancer Letter article) was

'I can see that the hospital would not want to reveal her salary, if in fact she has one, and that has privacy implications,' Poses said. 'But I don't understand why the hospital would not be able to simply tell you whether or not she is employed there and in what capacity.'

Thus, the latest commentary in the New England Journal of Medicine by National Correspondent Dr Lisa Rosenbaum used special pleading to argue for an expensive medical device with dubious benefits but which no more dubious evidence suggests may cause cancer. The commentary also decried the device's critics as unreasonably concerned about "greed" and "corruption," even though the device is clearly expensive, there are at least creditable allegations that the device makers used political influence to promote it and concealed its risks, and ironically the commentary itself obfuscated whether Dr Rosenbaum has a major financial relationship to the hospital that is being sued in connection with use of that device there.

Thus, this latest New England Journal of Medicinearticle, like those by the same author in the same journal which we have discussed before (here and here), seems more like a rant in a political blog than a scholarly article in the US' and perhaps the world's most prestigious scholarly medical journal. What is going on at the NEJM? What has happened to its editorial standards? Why should it continue to inspire such trust?

ADDENDUM (22 March, 2016) - See also comments in the 1BoringOldMan blog.

References

1. Rosenbaum L. N-of-1 policymaking - tragedy, trade-offs, and the demise of morcellation. N Engl J Med 2016; 374: 986-990. Link here.
2. Chittawar PB, Franik S, Pouwer AW et al. Minimally invasive surgical techniques versus open myomectomy for uterine fibroids. Cochrane Library 2014. Link here.
3. Dyer O. US surgeon who campaigned against potentially dangerous device receives legal threat. Brit Med J 2014; 349: g5577. Roy M. Poses MDhttp://firstname.lastname@example.com