The Greedy Leading the Greedy - Multimillionaire Former Johnson and Johnson CEO Approved Huge Compensation for JP Morgan Chase CEO After Company Paid $20 Billion in Legal Settlements

JP Morgan Chase CEO Got Huge Raise Despite Company's Recent Huge Legal Settlements

The current compensation set by the board of directors of JP Morgan Chase for CEO Jamie Dimon, $20 million a year, has attracted some attention (e.g., see this commentary by Matt Taibbi), especially given the contrast between his raise and the $20 billion or so the company had to pay out last year in settlements of allegations of unethical practices.  A New York Times opinion piece rushed to Mr Dimon's defense

in the world of executive compensation, especially when viewed from the rarefied perspective of other chief executives, and more broadly on Wall Street, Mr. Dimon’s pay — and how it was determined — is not only defensible, but laudable.

Also,

I spoke this week to several people with direct knowledge of the board’s discussions about Mr. Dimon’s pay. They said that the compensation committee went through an exhaustive process to determine the right level and that the board considered the likely negative reaction. 'We were mindful of it, but it didn’t influence our decision,' said one, who like the others, spoke only on condition of anonymity. 'Some people were going to criticize us unless we paid him nothing. We were trying to do the right thing.'

The author did conclude with a quote from Rep Peter Welch (D - Vermont),

This isn’t really about Jamie Dimon. It’s about a whole culture of immunity for the consequences of your actions.

A Retired Pharmaceutical CEO Who Also was Hugely Compensated Despite his Company's Troubles Set Dimon's Pay

We have frequently discussed how the culture of immunity, or impunity found in finance may carry over into health care, since now many extremely rich  leaders of finance firms sit on boards of trustees of health care institutions like hospitals and hospital systems, universities and their associated medical schools and teaching hospitals, and health related foundations, and boards of trustees of health care corporations.

In this case, maybe the culture carried over from health care to finance.

The NY Times article noted

 The compensation and management development committee of JPMorgan Chase’s board has three members, all seasoned business luminaries in their own right. Lee R. Raymond, the chairman, is the former long-serving chairman and chief executive of Exxon Mobil. Stephen B. Burke is chief executive of NBCUniversal. William C. Weldon is the former chairman and chief executive of Johnson & Johnson.

Mr Weldon is the former pharmaceutical representative who rose to CEO of giant pharmaceutical/ biotechnology/ device company Johnson and Johnson.  Despite the appellation of business luminary above bestowed by the author of the NYT article, we noted here how many settlements have been made by, fines assessed against, and other adverse legal actions affecting Johnson and Johnson in the recent past.  Our lengthy summary of such cases is appended at the end of this post.

Yet Mr William Weldon, the outgoing CEO on whose watch most of the misbehavior resulting in the legal actions listed in the appendix below occurred, retired with a huge retirement package, after receiving extremely generous compensation prior to that.   The retirement package was estimated to be worth from $143 to $197 million (look here).  In 2010, his total compensation was $29 million (look here).   According to the 2012 Johnson and Johnson proxy statement, his 2011 total compensation was greater than $26 million. As far as I can tell, Mr Weldon never suffered any negative consequences for his company's sorry record, and retired a very rich man.

Yet the luminous Mr Weldon got to make the decision about how much to pay Mr Jamie Dimond after his company's recent sorry record.

Summary

So it appears that the top hired executives of health care and finance organizations, and the so-called stewards sitting on their boards of directors are all blending together.  Together they are in charge of assuring that top hired executives get richer and richer even while the companies they lead commit seemingly endless strings of ethical and sometimes legal offenses.


Is this any way to run health care, or the economy?

As I have repeated ad nauseum,

Many of largest and once proud health care organizations now have recent records of repeated, egregious ethical lapses. Not only have their leaders have nearly all avoided penalties, but they have become extremely rich while their companies have so misbehaved.

These leaders seem to have become like nobility, able to extract money from lesser folk, while remaining entirely unaccountable for bad results of their reigns. We can see from this case that health care organizations' leadership's nobility overlaps with the supposed "royalty" of the leaders of big financial firms, none of whom have gone to jail after the global financial collapse, great recession, and ongoing international financial disaster (look here). The current fashion of punishing behavior within health care organization with fines and agreements to behave better in the future appears to be more law enforcement theatre than serious deterrent.  As Massachusetts Governor Deval Patrick exhorted his fellow Democrats, I exhort state, federal (and international, for that  matter) law enforcement to "grow a backbone" and go after the people who were responsible for and most profited from the ongoing ethical debacle in health care.

Again, true health care reform would make leaders of health care organization accountable for their organizations' bad behavior.

Appendix - Johnson and Johnson Recent Legal Record

2010

- Convictions in two different states in 2010 for misleading marketing of Risperdal
- A guilty plea for misbranding Topamax in 2010
2011

- Guilty pleas to bribery in Europe in 2011 by Johnson and Johnson's DePuy subsidiary
- A guilty plea for marketing Risperdal for unapproved uses in 2011 (see this link for all of the above)
- A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post here)
2012

- In 2012, testimony in a trial of allegations of unethical marketing of the drug Risperdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers. After these revelations, the company abruptly settled the case (see post here).
-  Also in 2012,  Johnson & Johnson was fined $1.1 billion by a judge in Arkansas for deceiving patients and physicians again about Risperdal (look here).
-  Also in 2012, Johnson & Johnson announced it would pay $181 million to resolve claims of deceptive advertising again about Risperdal (see this post). 

2013

-  In 2013, Johnson & Johnson settled case by shareholders alleging that management made misleading statements and withheld material information about manufacturing problems (see this post)

-  In 2013, Johnson & Johnson Janssen subsidiary pleaded guilty to a charge of misbranding Risperdal, and settled for a total of $2.2 billion allegations that it promoted the drug for elderly demented patients and adolescents without an indication, and despite evidence of its harms (see this post). 

-  In 2013, Johnson & Johnson DePuy subsidiary agreed to settle with multiple plaintiffs for $2.5 billion allegations that it sold defective mental-on-metal artificial hip, and hid evidence of its harms .

- In 2013, Johnson & Johnsonn Janssen subsidiary was found by two juries to have concealed harms of its drug Topamax (see this post for this and above case).

- In 2013, Johnson & Johnson Ethicon subsidiary's Advanced Surgical Products and two of its executives agreed to settle charges by US FDA that is sold mislabeled products used to sterilize equipment such as endoscopes (see this post).

- In 2013, Johnson & Johnson fined by European Commission for anticompetitive practices, that is, collusion with Novartis to delay marketing generic version of Fentanyl (see this post). 

Putting Finance Executives in Charge of Health Care? - What Could Possibly Go Wrong?

A US News and World Report article affirms what we have previously written, that those charged with the stewardship of US hospitals are even more inclined now to hire top managers with little or no health care experience or credentials. 

Putting Finance Managers in Charge

They particularly seem to favor executives drawn from the world of finance.

Just to make it really clear, the exposition started with the article title,

Wanted: Hospital CEOs Without Health Care Experience 

The article drew on some of the figures about executive hiring which we discussed in December, 2013,

It’s expected that two-thirds of hospital CEOs hired this year will have little to no health care experience, according to Black Book Rankings, which last year conducted a poll of 1,404 human resource officers and board members of health care organizations

However, the new article profiled some examples,

.When Carlos Migoya was hired in May 2011 to run Jackson Health System, Miami-Dade County’s safety net hospital system, he had no health care experience. A career banker, Migoya took over.....

Also,

Mike Keating, CEO of Christ Hospital in Cincinnati, previously was an investment banker.;Robert Meyer, president and CEO of Phoenix Children's Hospital, came from the consulting world;...

The article stressed that hospital boards think a background in finance is particularly valuable.

Hospital board and HR directors are looking for non-industry productivity, business development and financial management experts with heavy technological expertise. 

Also,

[executive vice president and managing principle at Cejka Executive Search. Paul]  Esselman  notes that boards increasingly 'are looking at leaders from managed care, the payer side or from finance or banking.'

Why Hospital Boards Favor Finance Executives

banking, like health care, is heavily regulated and that two decades ago banking went through significant consolidation, which hospitals today face.

So,

[ managing partner of Black Book Rankings Doug] Brown says leaders that come from productivity-focused fields and sectors that have endured consolidation are particularly suited for running hospitals today. Those in financial services may prove useful in today’s climate, as 'there are a lot of troubled hospitals,' he says.

As we noted before, the article suggested that those who hire hospital executives think their most important challenges s included  -

'Communication is now more important than ever,; says Paul Esselman

the opportunities come in delivering its service or business lines to ever-expanding distribution channels.

says [former investment banker Mike] Keating. 'The key in health care is how you go about executing and executing well.'

[former banker Carlos] Migoya put in place operational reforms, including bringing in 'a lot of people with for-profit experience' to maintain expense controls, monitor operations, collect payments more quickly and pay its own bills sooner to gain prompt-payment discounts. Then, 'we realigned procurement,' he says, adding 'we motivate our procurement department with incentives,' which 'dramatically improved' Jackson Health’s process, time and costs. Meanwhile, the system outsourced pharmaceutical management, saving $15 million a year....

Note that these examples are all about management process and financial outcomes, NOT about clinical processes, quality of care, or patient outcomes.  (The only mention of anything close to clinical management was a plan to outsource same.)

Left unsaid is that the boards charged with the stewardship of hospitals are now mainly composed of business executives, often heavily weighted with those in finance. 

Summary - What Could Go Wrong?

Of course, former bankers, and others from the world of finance may not really know much about clinical work, quality of care, or patient outcomes.  They may not have been picked because they care about such issues, nor socialized with the "patient first" mantra which health professionals are supposed to support. 

Worse, it seems that those who choose hospital executives may not be thinking about the recent history of finance.  True, it shares with health care the presence of regulation and increasing consolidation.  However, as we all started to realize in 2008, the leaders of finance helped bring on the worst financial crisis since the great depression.  More than five years since the beginning of this new great recession, US median income is dropping adjusted for inflation, while income inequality has tremendously increased.  Finance executives have been prime proponents of financialization, the theory that increasing shareholder value, which really seems to translate into increasing organizational short term income and increasing executive compensation are more important than any other outcomes.  Thus seems to correspond to the discussion above about financial and management objectives sans any notion of what is good for patients.

Even more disturbing is all the anecdotal evidence that business management, particularly in finance, has been gripped by overarching greed.  Pope Francis called it the "idolatry of money."  (look here).

In his graphic memoir of his days as a successful Wall Street trader, Sam Polk called it wealth addiction, . 

I noticed the vitriol that traders directed at the government for limiting bonuses after the crash. I heard the fury in their voices at the mention of higher taxes. These traders despised anything or anyone that threatened their bonuses. Ever see what a drug addict is like when he’s used up his junk? He’ll do anything — walk 20 miles in the snow, rob a grandma — to get a fix. Wall Street was like that. In the months before bonuses were handed out, the trading floor started to feel like a neighborhood in 'The Wire' when the heroin runs out.

He was not the first to describe wealth addiction:

 Wealth addiction was described by the late sociologist and playwright Philip Slater in a 1980 book, but addiction researchers have paid the concept little attention. Like alcoholics driving drunk, wealth addiction imperils everyone. Wealth addicts are, more than anybody, specifically responsible for the ever widening rift that is tearing apart our once great country. Wealth addicts are responsible for the vast and toxic disparity between the rich and the poor and the annihilation of the middle class. Only a wealth addict would feel justified in receiving $14 million in compensation — including an $8.5 million bonus — as the McDonald’s C.E.O., Don Thompson, did in 2012, while his company then published a brochure for its work force on how to survive on their low wages. Only a wealth addict would earn hundreds of millions as a hedge-fund manager, and then lobby to maintain a tax loophole that gave him a lower tax rate than his secretary.

Physicians swear oaths to put patient care ahead of all else.  While we may be far from perfect in our adherence to these oaths, I would like to think that when health care organizations were lead by health professionals, many tried to put patient care first  Yet professional managers, not health care professionals now lead health care.

.In 1988, Alain Enthoven advocated in Theory and Practice of Managed Competition in Health Care Finance, a book published in the Netherlands, that to decrease health care costs it would be necessary to break up the "physicians' guild" and replace leadership by clinicians with leadership by managers (see 2006 post here). Thus from 1983 to 2000, the number of managers working in the US health care system grew 726%, while the number of physicians grew 39%, so the manager/physician ratio went from roughly one to six to one to one (see 2005 post here). As we noted here, the growth continued, so there are now 10 managers for every US physician.

The managers who first took over health care may have had some health care background.  Now it seems that health care managers are decreasingly likely to have any health care background, and increasingly likely to be from the world of finance.  Can anyone seriously believe that finance managers taught to put short-term revenue first, and who may often be wealth addicts who practice the idolatry of money in charge of health care is going to improve anything other than those same managers' wealth?

As I have said before,  true health care reform would put in place 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.

But this sort of reform would challenge the interests of managers who are getting very rich off the current system.  So I am afraid the US may end up going far down this final common pathway before enough people manifest enough strength to make real changes.

The CareFusion/ Denham/ NQF Case - the Plot Thickens

The story about CareFusion, its financial relationships with Dr Charles Denham, and his alleged role in promoting a CareFusion product through standards produced by the National Quality Forum has gotten even more complicated.  This means that the tasks faced  by National Quality Forum leaders who asserted their intent to improve their conflicts of interest policy in response to this case just got more complex.

Background

As we most recently discussed here, the basics of the case were:
-  The case became public with an apparently routine legal settlement between CareFusion and the US Department of Justice
 -  the CareFusion settlement for $40.1 million was made in response to allegations that kickbacks were made to promote ChloraPrep, a solution meant for preoperative and other health care skin cleaning
-  the Department of Justice news release also alleged that payments were made to a corporation called Health Care Concepts to conceal kickbacks made to its owner, Dr Charles Denham
-  the implication was that Dr Denham was supposed to influence a standard writing committee run by the National Quality Forum, a well known organization that promotes quality improvement, issues authoritative practice standards, a form of clinical practice guidelines, and has contracts with the US government for quality of care activities
-  the draft of the standard written by the committee allegedly included the use of ChloraPrep, although mention of that specific medication was removed in a revision
-  NQF leaders asserted that after hearing of the case from the DOJ, the organization severed ties with Dr Denham and the non-profit organization he runs,  established a policy not to accept money from funding organizations whose leaders are on its committees, reviewed all the standards set by the committee of which Dr Denham was co-chair, and twice revised its conflict of interest policy.

I opined that the NQF response to this case was more open and pro-active than responses by many other organizations to cases involving conflicts of interest, although there was still room for the NQF to further strengthen its conflict of interest policies.

The Plot Thickens

Since last week, three more articles on the case have appeared, in Modern Healthcare, the WBUR CommonHealth blog, and on ProPublica.  These pointed out additional disturbing aspects of the case.

Dr Denham's and CareFusion's Relationships with the NQF Were Even More Complex than Heretofore Revealed

According to ProPublica,

in response to questions from ProPublica, the Quality Forum divulged that Denham’s nonprofit was one of its contributors, and that in 2007 and 2008 it received $485,000 in donations from a foundation affiliated with Cardinal Health, a company that spun off CareFusion in 2009.

Also,

Between 2006 and 2009, Denham’s nonprofit donated $725,000 to the Quality Forum. The group and Denham had a five-year contract, but the Quality Forum declined to provide a copy or explain the terms, saying only that it was ended three years early, in 2010, after concerns about Denham emerged. 

Not only did the non-profit help fund the NQF, it was directly involved in relevant NQF activities,

According to [Dr Denham's attorney Lawrence] Gondelman, Denham’s nonprofit was obligated to provide financial and staff support for Quality Forum projects, including evidence-based medicine reviews, hosting webinars and creating multimedia presentations about the safe practice recommendations.

 Furthermore, while the NQF asks committee members to disclose conflicts of interest verbally at the start of each meeting, again according to ProPublica,

Both [Dr Patrick] Romano and Dr. Peter Pronovost, who leads a patient safety institute at Johns Hopkins Medicine, said they had been unaware of Denham’s financial ties with CareFusion. Quality Forum officials said Denham never reported them, nor did he mention them during the 2009 meeting when members were asked to disclose their financial relationships, the transcript shows.

'He clearly lied,' Dr. Christine Cassel, the Quality Forum’s president and CEO told ProPublica. 'He just didn’t say anything about any of his business relationships.'

The Clinical Evidence in Support of the CareFusion Product Denham Touted was Dubious

According to ProPublica's review of a transcript of the meeting about the NQF standards that Denham co-chaired,

At the safe practices committee session on Aug. 19, 2009, Denham twice appears to reference the New England Journal of Medicine study, the meeting transcript shows. Although he did not cite the study or ChloraPrep by name, Denham remarked that research to be published soon in a 'major journal' would show the effectiveness of the 2 percent chlorhexidine antiseptic.

CareFusion's ChloraPrep is apparently the only well known 2 percent chlorhexidine antiseptic.

However, the same article pointed out that the study too was affected by conflicts of interest. Its authors "all reported ties to Cardinal Health,' the company from which CareFusion was spun off.  Furthermore, ProPublica charged that Dr Denhams company was involved with the financing of that study.

Also, per an interview with Brian Johnson, publisher of MassDevice.com, WBUR reported:

the government says there are several ways this study did not use accepted protocols. For example, a member of the company’s sales and marketing staff reviewed the data from the clinical trial and edited the final study. Prosecutors also say the company failed to 'review, evaluate and report safety information' and failed to obtain and maintain accurate records showing all financial transactions from CareFusion to Dr. Rabih Darouiche, the lead investigator on the study.

Thus, it appears that this study may have been manipulated (in particular, by a company marketer's editing) to make its sponsor's product look more favorable (in this case, particularly by ignoring data about safety and adverse effects)

 NQF Went Farther to Endorse CareFusion's ChloraPrep than Was Heretofore Appreciated

 According to the WBUR interview,

The NQF didn’t adopt a recommendation of Chloraprep but Denham hosted webinars with Dairouche under the NQF brand for hospital staffers that absolutely endorsed Chloraprep. So while it didn’t end up in the official financial recommendations, there certainly was influence. 

However, according to ProPublica things were even more complicated.  Denham promoted ChloraPrep in not one, but two instances,

At the safe practices committee session on Aug. 19, 2009, Denham twice appears to reference the New England Journal of Medicine study, the meeting transcript shows. Although he did not cite the study or ChloraPrep by name, Denham remarked that research to be published soon in a 'major journal' would show the effectiveness of the 2 percent chlorhexidine antiseptic.

[Dr Peter] Pronovost said it wasn’t necessary to actually identify ChloraPrep because it was well known as the product with the 2 percent chlorhexidine formulation.

The committee members agreed that chlorhexidine was an effective antiseptic – guidelines by the Centers for Disease Control and Prevention (CDC) say so as well. But studies show it also works in other concentrations and combinations.
Discussion turned to recommendations for preventing infections caused by central lines, the thin tubes inserted into a vein to deliver fluids or medications. Dr. Gregg Meyer of Massachusetts General Hospital in Boston, the co-chair of the committee with Denham, brought up the forthcoming study.

'Chuck (Denham) made me aware of it,' Meyer said. He then asked Pronovost, a leading expert on preventing central-line infections, what he thought

The final report did delete the specific reference to ChloraPrep as the preferred method for preparing surgical sites,

.After the meeting, when the committee’s draft report was published in late 2009, a recommendation for preparing surgical sites to prevent infection did not name ChloraPrep but did specify its telltale formula – a 2 percent chlorhexadine and alcohol antiseptic.

That draft recommendation was challenged by 3M, a company that makes a competing product. A scientific review of the evidence by a Quality Forum ad hoc committee found a lack of clear evidence to support one skin prep product over another. As a result, the recommendation to use the ChloraPrep formulation on surgical sites didn’t make it into the final 2010 safe practices report. 

However, the final report did appear to endorse ChloraPrep for reduction of central line infections,

 On the separate issue of reducing central-line infections, the 2009 draft report endorsed a chlorhexidine antiseptic but did not specify any one concentration – just as the committee decided. Yet the final 2010 report does call for a 2 percent chlorhexidine and alcohol antiseptic like ChloraPrep. 

Also, again per ProPublica, the NQF seemed to have been roped into other efforts run by Dr Denham to promote ChloraPrep,

Although Quality Forum officials seemed surprised to learn this last week from ProPublica, the group is listed as a co-host, with Denham’s nonprofit, of a webinar where the 2010 safe practices guidelines for central-line and surgical site infections are presented.

The presentation, posted on the website of Denham’s nonprofit, states that the Quality Forum recommends the ChloraPrep formulation to protect against both central-line and surgical site infections.    

CareFusion also cites the Quality Forum’s endorsement in at least one brochure on its website.

Summary: a Longer Row to Hoe

It looks like NQF will have to deal with even more specifics if it wants to prevent future compromises of its standards due to conflicts of interest and manipulation of the clinical research evidence base.

It will have to consider:
-  Whether individual disclosures of conflicts of interest can be trusted
-  Whether it is prepared to deal with the apparently nearly infinite variety of conflicts that creative minds can produce to promote vested interersts
-  How to be appropriately skeptical of clinical evidence used to devise standards when such evidence is now so susceptible to manipulation and/or suppression to further vested interests
-  How to better recognize the various kinds of machinations that the conflicted may endeavor to promote their interests

Again, my question is whether it may just be better to ban individuals with conflicts of interest from roles in which they may influence standards in favor of vested interests, rather than continuing to try to "manage" the complex web of conflicts and the actions they may produce generated by an increasingly commercialized and simultaneously poorly regulated health care system.

By the way, if anyone in other organizations is sitting back thinking this is just an NQF problem, they ought to think again.  As we have discussed, the web of conflicts of interest, both individual and institutional, is vast, and the extent of manipulation and suppression of the clinical research base is equally vast.  Every health care decision maker, health policy decision maker, and health care organization is confronted by similar problems which may differ only in the details.

Again, I applaud the NQF for trying to deal with these issues upfront, and hope that others will learn from the lessons this case provides.

Martin Health System, Florida: Our EHRs were out for two days, but patient care has not been compromised, sayeth Pinocchio

This is yet another post in my ever-growing "our EHRs went out due to IT incompetence, and chaos ensued, but patient care has not been compromised" series (see query link: http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised):

Martin Health System looking into network outage that slowed hospital operations
Posted: 01/24/2014
By: Meghan McRoberts
http://www.wptv.com/dpp/news/region_martin_county/martin-health-system-looking-into-network-outage-that-slowed-hospital-operations

MARTIN COUNTY, Fla.-- Martin Health System is looking into what caused some computer hardware to fail Wednesday, leading to network outage in all of the Martin Health System hospitals.

Things were back to normal Friday morning, according to hospital spokesperson, Scott Samples.

Translation: for two days there was a complete network outage, with no EHRs, email, CPOE etc.

But since Wednesday night patients say the atmosphere around the hospital was chaotic.

Patients likely noted doctors and nurses running like headless chickens.  I note that chaos and safe medical care are not good bedfellows.

Hospital staff, doctors and nurses access the computer system to read patient charts and medical information. Without it, they were left digging into paper documents.

The paper documents left laying around would have best had scanty, sparse patient information, since the computer in computerized hospitals has become the primary source of truth.  (One might think such a system, including the network, would be hardened against failure, but a two-day outage, as per other outages at the query link above, show this is often not the case.)

Samples says this led to some minor inconveniences around the hospitals, where some patients received their meals later than normal. Some outpatient appointments could not be scheduled, and extra nurses and administrative staff were brought in to help with the increased work load.

No medication or treatment was jeopardized.

There we have it.  In Pinocchio-like fashion we hear the obligatory "we lost all our information systems, which are our central nervous system for patient care, but patient care has not been compromised" statement from hospital PR.  This statement is questionable on its face. 

The risk of accident was significantly increased on its face.

New patients information was taken down on paper, and put into the system on Friday. Samples says there was a back up computer for data from former patients.

The future will be in question depending on the quality, or lack thereof, of this "backload" of patient information that was collected during what patients themselves described as "chaos."

Of course, according to the IT pundits paper itself, even under ideal circumstances, is so risky that tens or hundreds of millions of dollars per hospital has been spent to replace it.  Someone is not being truthful.

The hospitals that experienced the outage were Martin Medical Center, Martin Hospital South, and Tradition Medical Center.

But patient safety risk was not compromised at any of them, so sayeth the figure below.

All our EHRs and other clinical IT were unavailable for two days ... patients reported chaos ... we had to delay or cancel appointments and bring in extra clinical staff to maintain order ... but patient safety was not compromised, except for some late lunches!

Pinocchio must be working at a lot of hospitals. When EHRs are out, patient safety is compromised. This is not open for debate, it is an "on its face" issue. These systems need hardening so as to be up and available 100%. Period. People responsible for outages need to be held accountable, including in a court of law if patients are injured or die as a result. Period.

Finally I note that, with the corporatization of healthcare and with population of executive offices by lightweights with unquestioning faith in "cybernetic miracles", the credo of my early 1970's medical mentor, cardiothoracic surgery pioneer and educator Victor P. Satinsky, MD (link) - "Critical thinking, always, or your patient's dead" - is more valuable than ever.

-- SS

WINDY CITY BLUES

WINDY CITY BLUES

There is an academic ethics mess brewing in the windy city… at The University of Chicago. It involves a start-up Chicago corporation, a star statistician in the medical school, seed money in the form of NIH research grants, the American Psychiatric Association, and the chairman of the APA’s DSM-5 Task Force. It involves the appearance of self-interested bias in the DSM-5 process. It involves a recidivist pattern of failure to disclose material conflict of interest. And it involves academic journal editors (JAMA and JAMA Psychiatry) who did not do the right thing when the perps were outed.

I broke the story on this site back in November, right after a confession appeared on-line in JAMA Psychiatry by the gang of five perps (Robert Gibbons, Ellen Frank, David Kupfer, Paul Pilkonis, and David Weiss) . Indeed, it was I who had alerted the journal. Others have since weighed in here and here and here, for instance. The definitive summary and Timeline were the work of Dr. John M. (Mickey) Nardo here. Of course, readers of JAMA Psychiatry would never know that the authors were outed. The editors (Howard Bauchner for JAMA and Joseph Coyle for JAMA Psychiatry) allowed the authors to make it seem like they were making a spontaneous admission of nondisclosure, and they acquiesced in the withholding of key information that I had given to the journal.

It gets worse. We now know that the chair of the DSM-5 Task Force (Dr. David Kupfer) failed to disclose his financial conflict of interest on at least 4 occasions (#s 13, 15, 16, 19 in the Nardo Timeline). On two of those occasions he was representing the DSM-5 team and the APA! These lapses undermine his repeated assurances that COI issues were under control in DSM-5. If the chairman of the DSM-5 Task Force does not have his own act together concerning COI disclosures, then what are his assurances worth? Nevertheless, the APA released a statement that tried to whitewash Dr. Kupfer’s nondisclosures. They need to recalibrate their ethical compass.

The methods adopted in this affair are classic: Peddle unproven psychiatric screening scales backed up by black box statistics (a distressing specialty of Dr. Gibbons); publish a glowing report in JAMA Psychiatry, which you have infiltrated (Ellen Frank and Robert Gibbons are on the editorial board); get your corporate people inside the DSM-5 process (David Kupfer, Robert Gibbons, Paul Pilkonis); slant the DSM-5 process to endorse, however weakly, the kind of products you intend to market; start a corporation without telling anybody and establish a website  with advance marketing that touts your new academic publication in JAMA Psychiatry while highlighting Dr. Kupfer’s key role in DSM-5; loudly proclaim (see page 4) the advent of population-wide screening but before doing any serious field trials or acknowledging that most positive screens will be false positives. This is the usual dodgy hand waving of wannabe entrepreneurs, whose vision is obscured by dollar signs. Oh, and did I mention regulatory capture of NIMH for over $11 million in funding while not producing a product worth a tinker’s damn?

In response to all this adverse commentary, the authors and the journal editors have gone to radio silence. They must be hoping it will blow over.  If anything, their silence has provoked even more searchlight questions that focus on what is happening at The University of Chicago.

For instance, who is bankrolling this start-up corporation? Last summer they brought on board an executive named Yehuda Cohen who is a mover and shaker in Chicago business circles. I am sure he doesn’t work for peanuts. He set up a website that must be staffed to respond to queries from consumers and professionals. Plus, the corporate office appears to be located in prime commercial space at 217 N Jefferson #600, Chicago IL 60661; phone 312-878-6490. E-mail: info@adaptivetestingtechnologies.com (from the website: you can find a picture of the neighborhood on Google). So, they are racking up significant operating expenses already. Heaven forfend that these expenses might be covered directly or indirectly by their NIMH funding! Are the responsible administrators at NIMH and at The University of Chicago looking and auditing?

It is also unclear whether they have a sound or even a legal business plan. Where will the high powered computing needed for their expansive applications be conducted? Do they have a computing facility at the corporate office? Or do they intend to perform the commercial computing through the NIH-supported Center for Health Statistics at The University of Chicago, which Dr. Gibbons personally directs? If so, did the University sign off on that plan? Is NIH aware of the plan?

In late November I asked NIH about the ownership of the data bases and algorithms on which the corporation relies for the business plan. I received a reply from NIH outlining the applicable federal policy and stating “We understand that the data are deposited and made available to the community per request through the Center for Health Statistics.” That had to be what Dr. Gibbons told them. Notice that no mention was made of the algorithms. I have replied to NIH, asking them to clarify the status of the algorithms, without which the data bases alone are of little use. I also pointed out to NIH that there is no mention of this public access option in any of the publications from these authors or on the corporate website. This situation is typical of the dissembling style we have seen before from Dr. Gibbons and Dr. Kupfer – lacking in candor and transparency.

The more one looks, the more questions arise. Is The University of Chicago being taken for a ride? Is NIMH being taken for a ride? Are we all being taken for a ride? Can we please have some transparency here? Can we please have some psychometric standards here? Will the APA step up to the plate? Will NIH step up to the plate? Will The University of Chicago step up to the plate?

Physician whose mother had heart surgery reflects on sane EHR use

The following from a physician I know, an ED physician, on the care their mother received at a major academic medical center's teaching hospital using EHR.

Emphases mine:

Mom just had aortic valve at hospital [name redacted] associated with [redacted] Medical School.  EHR used was [major EHR vendor name redacted] but it clearly had been pushed into the background......

1) Every ICU patient also had a printed chart in a notebook (paper) medical record book kept at the nursing station.  Just like the old days. It was the most commonly used source of info to the residents and staff.

2) Not once did I see an EHR physically come between a patient and a staff member (as opposed to nearly every encounter where I work).

3) Mom's (and every ICU patients) plan for the day was outlined in magic marker directly on the glass doors and windows and updated during rounds....available for immediate reference, not buried in an EHR.

4) Her clinical info was accurate....... it was dictated and not fabricated from pick lists or dot phrases.

5) Clerks put in the data and Dr's orders......apparently they long ago figured out the nonsense called CPOE and let the clerks do it.

I suspect many major University hospitals have worked around the workflow barriers and most egregious documentation sins.  The doctors there (at least in that Cardiothoracic ICU) have enough clout that they can just say HELL NO.  Those of us working for less astute/ non cutting edge community hospitals run by "also ran" healthcare corps are left to bear the crosses ONCHIT and the EHR industry have dumped upon us.

I am grateful to the folks at [hospital] for an excellent job on my mom and demonstrating that efficient healthcare pushes the EHR (as currently sold and configured) to the back burner.

Oh, [EHR name redacted] still is loaded with those prefilled templates and copy/ paste pull forward geared for upcoding.....but these "top of the food chain" docs just didn't waste their time with them.

Having had to gut and remediate really, really terrible health IT for invasive cardiology and cardiac surgery years ago (http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story), and revise workflows to relieve busy clinicians with critically-ill patients from the stupidity and time-sink of fiddling with balky computers with poorly-designed software, I identify with this physician's observations and beliefs.

As I've stated in previous posts, most clinicians need to be relieved of clerical tasks associated with computers, especially data entry and ordering, not just surgeons.

If the data is really that valuable, hiring clericals to do clerical work should remain a true bargain, with massive return on investment.

If that is not the case, then the data is really not that valuable.

-- SS

Putting in the Ski Lifts - National Quality Forum Leaders Improve Conflict of Interest Policies in Response to CareFusion Case

The complex case that came to light with reports of a legal settlement by CareFusion of allegations that it paid kickbacks to promote its ChloraPrep product just got even more complex, but now also a bit more hopeful, and hence much more hopeful than most of the cases we discuss..

Background


As we noted yesterday, the CareFusion settlement seemed routine when it was first briefly reported in the media.  Then Modern Healthcare published a series of articles about its ramifications, the latest appearing today.

In summary prior to the latest article,
-  the CareFusion settlement for $40.1 million was made in response to allegations that kickbacks were made to promote ChloraPrep, a solution meant for preoperative skin cleaning
-  the Department of Justice news release also alleged that payments were made to a corporation called Health Care Concepts to conceal kickbacks made to its owner, Dr Charles Denham
-  the implication was that Dr Denham was supposed to influence a standard writing committee run by the National Quality Forum, a well known organization that promotes quality improvement, issues authoritative practice standards, a form of clinical practice guidelines, and has contracts with the US government for quality of care activities
-  the draft of the standard written by the committee allegedly included the use of ChloraPrep, although mention of that specific medication was removed in a revision

We noted that the NQF policy on conflicts of interest for its standard writing committees seemed somewhat weak.  The current (October, 2013) policy asks members to internally disclose conflicts and recuse themselves from " discussion of the applicable measure or measures, and in some instances competing and related measures."  However it does not ban members with conflicts, nor require public disclosure of conflicts.  We also noted that NQF has several board members who have full-time leadership positions with health care corporations, financial firms that invest in health care, or health care trade associations, and NQF received funding from pharmaceutical companies and their in-house foundations.  Thus NQF appears to have its own institutional conflicts of interest. 

So we thought that the case raised questions about how well NQF standards are protected from the influence of conflicts of interest, and whether they should remain so influential in the absence of stronger protections?

NQF Clarifies its Conflicts of Interest Policies

As reported by Modern Healthcare, it took only a day for the NQF to issue yet another press release to clarify its conflict of interest polcies.  In particular,

I n response to concerns that the community raised about the evidence base underlying Safe Practice #22 and Dr. Denham’s inordinate interest in this particular Safe Practice, NQF took the following steps in early 2010:

• Severed its relationship with Dr. Denham who has not been involved in any other NQF work since March 2010;
• Made a decision to refuse offers for financial support from Dr. Denham’s foundation, discontinuing a 2008 - 2013 grant agreement that had more than three years remaining ;
• Determined that it would not enter into grant agreements where the funder is on the endorsement committee, even as a non-voting member;
• Reviewed committee reports that Dr. Denham was involved in to be certain that he did not influence their outcome; NQF staff believe that he did not; and
• Updated and enhanced its conflict of interest policy – in 2010 and again in 2013;

So NQF appeared to react ad hoc to concerns that Dr Denham was too avid about the use of a particular product.  Its response included strengthening its COI policy and banning one particular type of conflict, receiving funding from an organization controlled by a member of a standard writing committee.  However, as we noted above, the 2013 policy still has its weaknesses.  

Furthermore, an NQF executive volunteered to inform me that while the current written COI policy does not require public disclosure, in practice the organization requires public verbal disclosure of conflicts at the beginning of each committee meeting, and that the transcripts of these disclosures are available on the organization's website.  However, how to reach these disclosures is not obvious, and I so far have not been able to find the transcript that supposedly contains the disclosures for the meeting which Dr Denham co-chaired


Summary and a Few Optimistic Thoughts (Rare as They are for Us)

What I must say is now most unusual in the CareFusion/ Dr Denham/ NQF case is that NQF leadership, rather than  hunkering down in a defensive posture we have seen many other leaders adapt, seems to be trying to take steps toward addressing problems posed by conflicts of interest affecting its standard setting, guideline development, and quality assurance.  First, it is clear that NQF leaders did react to concerns about Dr Denham, and did somewhat tighten up their conflict of interest policies in response to them.  Second, it is clear that they are willing to listen to public questions and criticism, and at least consider further change in response to them.  They thus appear far more open than do leaders of many other organizations.

IMHO, NQF leadership is to be congratulated for this more transparent approach.  If only the leaders of other health care organizations would do as much. 

Since they do seem open to criticism and change, in the spirit of constructive criticism, I do hope that NQF leaders might also consider:
-  further strengthening their conflict of interest policy for standard setting committees, particularly by minimizing the number of committee members with conflicts, and banning individuals with conflicts from chairing committees, as per the IOM report on standards for trustworthy clinical practice guideline development
-  increasing transparency about conflicts of interest, particularly by making disclosures for all projects available without complex web searching
-  decreasing institutional conflicts of interest by refusing funding from health care corporations whose revenues might be affected by the content of standards and guidelines, and reducing conflicts affecting NQF board members and executives

Health care leaders who see transparency and reduction of conflicts of interest as important goals show us that true health care reform might actually be possible.

ADDENDUM (24 January, 2014 - I was told that many people may need an explanation of the title.  "Putting in the ski lifts" is a shortened version of an old college saying.  The location for the ski lifts was a place that is traditionally very hot, think fire and brimstone.  The phrase refers to an extremely improbably event.  Sorry about any confusion.   

Our Man in the NQF? - CareFusion Settles Kickback Allegations for $40.1 Million and Government Alleges They Meant to Manipulate National Quality Forum Standards

What appeared to be yet another entry in the march of legal settlements turns out to be more interesting than it first appeared.

The Basic Story: Off-Label Marketing 

The story was initially briefly reported in the media.  A report in the Seattle Post-Intelligencer on 9 January, 2014, was perhaps the most complete,

CareFusion, a manufacturer of medical and surgical supplies and medical devices, has agreed to settle charges of illegal marketing practices and kickback payments for promoting sales of the company’s surgical preparation solution, Chloraprep.

Under the terms of the settlement with Washington, other states, and the federal government, CareFusion will pay a total of $40.1 million.

In particular,
 

When the FDA approves a surgical solution such as Chloraprep as safe and effective, its manufacturer can’t market or promote it for an 'off-label' use – any use not approved by the FDA.

Chloraprep was approved for specific inpatient hospital procedures, including the preparation of a patient’s skin prior to surgery or an injection. The FDA rejected its use for prepping the skin prior to inserting catheters into veins for administering medications, or cleaning the skin as part of closing wounds.

The lawsuit alleges that from Sept. 1, 2009 to Aug. 31, 2011, CareFusion promoted Chloraprep for improper uses. CareFusion also allegedly publicized unverified information about Chloraprep during the same time period, Ferguson said.

So this follows a template we have seen before, most recently here.  A company promotes a drug or device for "off-label" uses.  While physicians are legally allowed to prescribe a drug or use a device for reasons other than its official indications, companies are not legally allowed to promote such uses.  Sometimes it turns out that the drug has benefits that outweigh its harms when used off-label, in which case the violation could be considered technical.  In other cases, the drug might turn out to be useless or even net harmful when used off-label, so the violation indicates putting revenue ahead of patients' welfare.  

The reporting on the CareFusion Chloraprep settlement did not clearly suggest that the off-label use was harmful to patients.

Allegations of Kickbacks to Promote Off-Label Use, but How?

It gets more interesting.  The Post-Intelligencer also noted,

The states also contend that in 2008 CareFusion’s predecessor corporation entered into agreements that CareFusion assumed legal and financial responsibility for. This included payments to Health Care Concepts Inc., payments that were allegedly made to hide kickbacks to the physician-owner of HCC for promoting and influencing providers to use Chloraprep, he said. This violates federal and state anti-kickback laws.

Now the allegations also include kickbacks to the "physician-owner" of a company to facilitate off-label promotion.  So the issue goes beyond a technical violation of the law.  The Post-Intelligence report, however, did not make clear what Health Care Concepts Inc actually did to contribute to off-label promotion.

A quick attempt to find out more about this company via the web was not fruitful.  There are lots of companies/ organizations called Health Care Concepts or some variant.  The most relevant may be this one, which lists CareFusion as a "partner" on its main web-page.  What this company actually does is a bit unclear.  Its business model is described as "a private incubator of early products, services, and technologies, as well as an accelerator of mature solutions that will be taken to scale." What that has to do with off-label promotion of a product of a big established company like CareFusion is not clear.  How this company could have influenced providers is not clear, given that it is not an advertising firm, public relations firm, or medical education and communication company (MECC).

So what is going on here?  

Allegations of a $11.6 Million Payment to Manipulate the National Quality Forum Standards


Yesterday, 21 January, 2014, Modern Healthcare began to explain the mystery.   

Many healthcare companies have been accused of paying kickbacks to influence physicians' medical decisions, but one major supplier allegedly tried to steer an entire industry by influencing the recommendations of the National Quality Forum

The NQF, which reviews medical evidence and makes recommendations for improving healthcare, acknowledges that a well-known patient safety advocate is alleged to have received millions of dollars to promote a surgical sterilization product while co-chairing an NQF committee that suggested hospitals use that product. 

Federal officials say Dr. Charles Denham, co-chair of NQF's Safe Practices Committee in 2010, received $11.6 million from San Diego-based CareFusion to promote the company's ChloraPrep line of skin-preparation products. Denham's committee at the NQF also recommended surgeons use ChloraPrep products to prevent surgical infections, the NQF said.

The allegations about the role of Dr Denham in the NQF also did appear in the the official US Department of Justice press release.

Allegations of Bogus Contracts, and Non-Denial Denials

The allegations produced some non-denial denials (in the phrase found in All the President's Men).

Dr Denham responded, but through a lawyer:

A statement from Denham's attorney, Larry Gondelman of Powers Pyles Sutter & Verville in Washington, said reports that the underlying lawsuit involved Dr. Denham were 'blatantly false.'

Denham was not accused of wrong-doing in the whistleblower lawsuit, and Gondelman said Denham has and continues to cooperate with investigators in the case.

Note that while the attorney denied that Dr Denham was named in the underlying lawsuit, he did not apparently specifically deny the allegations.

The NQF also reponded,

 An NQF review committee removed the reference to the specific product before final publication of 'Safe Practices for Better Healthcare' in 2010.

'An NQF ad hoc review did not find sufficient evidence to support one skin preparation over another,' a statement from the organization said. 'The ad hoc review effectively served its role of rapidly responding when a potential issue is identified.'

Note that the NQF press release did not deny that the CareFusion money was given to Dr Denham's organization, nor that the NQF report might have promoted the use of a class of products in which CareFusion's Chloraprep resides.

A follow-up story in Modern Healthcare noted that Dr Denham confirmed the payment of the money to his company, but not its purpose,

 Renowned quality expert Dr. Charles Denham confirms that CareFusion paid his company more than $11 million, but Denham says he was surprised to see the U.S. Justice Department describe the money as kickbacks intended to influence national quality-of-care guidelines published by the National Quality Forum.

Dr Denham's lawyer confirmed the payment, but did not further explain it:

Denham's lawyer, Larry Gondelman of Powers Pyles Sutter & Verville in Washington, acknowledged that CareFusion did pay Denham's company under two contracts. 

And,

Gondelman said the $11.6 million paid to Denham's company covered 'an array of services' and that he could not elaborate.

Again, note that Mr Gondelman did not specifically deny that the money served as a kickback.

Meanwhile, the Department of Justice alleged something more elaborate, and nefarious, 

The Justice Department, though, says the contracts were written to look as though CareFusion was buying consulting, software development and strategic marketing services, as well as the completion of three unnamed projects. The value of the deals, the government alleges, far exceeded the fair-market costs of those services, and that one of the actual purposes of the deals was to conceal kickbacks to Denham while he served on the National Quality Forum.

Interval Summary

So what is clear so far is that:
-  CareFusion agreed to a $40.1 million settlement of allegations that it provided kickbacks to promote off-label use of its product.
-  CareFusion paid $11.6 million to Health Care Concepts
-  Health Care Concepts is run (and possibly owned) by Dr Charles Denham, who chaired a National Quality Forum committee that recommended use of CareFusion's product ChloraPrep in a performance standard and the final version of the NQF standard recommended use of a group of products including ChloraPrep

We have frequently discussed how health care corporations may promote goods, particularly drugs and devices and services through deceptive and unethical practices, including inducements ranging form creation of conflicts of interest to outright bribes and kickbacks.   We have also discussed the influence of individual and institutional conflicts of interest on clinical practice guidelines.  This has become an important enough problem for the US Institute of Medicine to weigh in with standards for trustworthy guidelines that markedly limit such conflicts of interest. 

This case seems notable because it may link the problems of deceptive and unethical promotion with the influencing of clinical practice guidelines.  It is particularly notable because the organization generating the guidelines in question, the National Quality Forum, has become large, influential, and authoritative.  Re the latter point, the latest Modern Healthcare article affirmed,

The NQF is a standards-setting organization for the healthcare provider industry. It holds the exclusive contract to provide Medicare and Medicaid with recommendations on a national quality-of-care strategy and the measures used to gauge improvements.

In fact, while the NQF performance standards can function as guidelines, they also may be bases for pay for performance schemes that attach real incentives to guidelines, which could become perverse if the guidelines have been manipulated.

Can the NQF Defend Against Conflicts, and If Not, Should it Remain So Authoritative?

So the big question is whether the NQF, given its unique influence, has any meaningful approach to prevent its standards from being influenced by conflicts of interest?

The NQF does have a recent conflicts of interest policy. However, according to my reading, it neither bans committee members with conflicts of interest, nor even requires public disclosure of conflicts of interest.  All it seems to require is that committee members disclose conflicts internally and voluntarily recuse themselves from deliberations which may be affected by them.  Although the policy states that conflicts of interest may be made public, I could find nothing in the report which Dr Denham co-authored about conflicts of interest or competing interests affecting any of the authors, including Dr Denham

Furthermore, a very quick look at information publicly available on the NQF web-site suggests the organization itself may have major institutional conflicts of interest.  The NQF is one of those "public-private partnerships" that have become all the rage.  Several members of its board of directors have leadership positions in large health corporations, financial firms with large health care interests, or trade associations for large health care corporations: 

- Elizabeth J. Fowler, PhD, JD, is Vice President, Global Health Policy, in the Government Affairs & Policy group at Johnson & Johnson.

- Robert Galvin, MD, is Chief Executive Officer, Equity Healthcare, at The Blackstone Group.

 - Karen Ignagni, President and Chief Executive Officer of America’s Health Insurance Plans (AHIP), is the voice of health insurance plans....

- J Mark Overhage MD, PhD,  Chief Medical Informatics Officer, Health Services, Siemens Healthcare


Thus it is conceivable that they could personally profit, and that their organizations could institutionally profit from standards that favor their organizations' interests.  

Furthermore, NQF receives funding from the US government and private foundations, but also from pharmaceutical companies and their in-house foundations:

the Bristol-Myers Squibb Foundation, the Cardinal Health Foundation, Pfizer Inc., Sanofi-aventis,...

Unless the current case leads to big changes in the prevalence of conflicts of interest among the NQF board, the continuation of its institutional conflicts of interest generated by its sources of funding, and its weak policy on conflicts affecting committee members, the question becomes whether it should continue to have such an authoritative role?

As we have said over and over, pervasive conflicts of interest affect health care decision-makers and policy makers and the organizations within which they function.  Such conflicts threaten to put various private interests way ahead of patients' and the public's health.  If we really want health care that will put patients' and the public's health first, we need to end such arrangements that favor private gain.  

 Roy M. Poses MD on Health Care Renewal

ADDENDUM (23 January, 2014) - A closer re-reading of the NQF conflict of interest policy made it clear that recusal is not voluntary, and that conflicts of interest may be revealed publicly, but that such disclosure is not mandatory.  The paragraph above dealing with these issues was revised accordingly.  

Five Years Into Compelled National Adoption of Electronic Medical Records, Which Were Advertised As Capable Of Only Good, ONC Issues Safety "Suggestions"

Ten years after creation of the ONC office, and almost five years into compelled national adoption of health IT under HITECH (financial penalties soon start to accrue for non-users or non-adopters of "certified" systems and in at least one state, denial of medical licensure), the HHS's Office of the National Coordinator for health IT released the cutely-named "SAFER" guides ("Safety Assurance Factors for EHR Resilience").

That's progress.  (A previous ONC leader, for instance, had opined that the FDA’s injury findings related to health IT that appeared in the Internal FDA memorandum on HIT risks were merely “anecdotal and fragmentary”;  see my April 2, 2011 post "Making a Stat Less Significant: Common Sense on 'Side Effects' Lacking in Healthcare IT Sector" at http://hcrenewal.blogspot.com/2011/04/common-sense-on-side-effects-lacking-in.html.)

While these Guides are a welcome first step, I observe:

These Guides are really an admission HHS and the pundits have been pushing a technology, at best, of an unknown safety profile onto medicine and onto the public.  (The harm profile is becoming better understood, e.g., see the ECRI Institute Deep Dive Study on health IT risk at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html, a study not just remarkable for its results but also for its strange regulator and press invisibility).  I guess that's par for the course in today's world.

I also opine these guides would not have appeared at all, if not for grass-roots efforts in exposing health IT dangers over the years.

That said, more on the guides, and a link to them:

http://www.healthit.gov/policy-researchers-implementers/safer

SAFER Guides

The SAFER guides consist of nine guides organized into three broad groups. These guides enable healthcare organizations to address EHR safety in a variety of areas. Most organizations will want to start with the Foundational Guides, and proceed from there to address their areas of greatest interest or concern. The guides identify recommended practices to optimize the safety and safe use of EHRs. The content of the guides can be explored here, at the links below, or interactive PDF versions of the guides can be downloaded and completed locally for self-assessment of an organization’s degree of conformance to the Recommended Practices. The downloaded guides can be filled out, saved, and transmitted between team members.

The overall purpose:

This guide is designed to help safely manage the individual and organizational responsibilities in a complex "sociotechnical" healthcare organization.

(I note that "sociotechnical" is not really a decriptor of an organization; rather, it is a descriptor of inter-related issues in a healthcare organization.  More properly, a healthcare organization is an entity where implementation of health IT requires "consideration of many sociotechnical issues", or, "is an organization that is sociotechnically complex".  I also note a somewhat loose use of the scientific term "Informatics" in the guides, e.g., "Informatics-type department."  But, whatever.  When a word is used in healthcare today, it means, paraphrasing what a character in a Lewis Carroll book said to a woman named Alice, just what the healthcare leadership chooses it to mean - neither more nor less. (The irony is that Medical Informatics is a field that has as one of its major core competencies the defining of precise language and definitions.)

Read the Guides at the above link, but these "guides" are really a set of "Health IT 101", Masters-of-the-Obvious rules of thumb, presented in a "sparse display" format.

For instance:

• The highest-level decision makers (e.g., boards of directors or owners of physician practices) are committed to promoting a culture of safety that incorporates the safety and safe use of EHRs.

• An effective decision-making structure exists for managing and optimizing the safety and safe use of the EHR.

• Staff members are assigned responsibility for the management of clinical decision support (CDS) content.

• Practicing clinicians are involved in all levels of EHR safety-related decision making that impact clinical use.

I won't display them further.

While this is not an unwelcome development, here are the caveats:

1.  Disclaimer on page 1 of "Organizational Responsibilities" document:

In some instances, Meaningful Use and/or HIPAA Security Rule requirements are identified in connection with recommended practices. The SAFER Guides are not intended to be used for legal compliance purposes, and implementation of a recommended practice does not guarantee compliance with Meaningful Use, HIPAA, or other laws. The SAFER Guides are for informational purposes only and are not intended to be an exhaustive or definitive source. They do not constitute legal advice or offer recommendations based on a healthcare provider’s specific circumstances. Users of the SAFER Guides are encouraged to consult with their own legal counsel with regard to compliance with Meaningful Use, HIPAA, and other laws.

"For informational purposes only?"

Wow.  I feel SAFER already ... (too late for my mother, though).

Who is going to evaluate whether hospitals are carrying out these recommendations properly?    Joint Commission?  FDA?  As it appears now, the answer is ... nobody.

In effect, these "guidelines" are issued for "self-assessment" in a regulatory vacuum, with no validation of compliance, no reporting requirements, no formal surveillance, etc.  Hiring the right people, doing all these things, and doing them effectively, is not cheap.

Translation: these guidelines are safely ignored, to be put on a shelf somewhere.

2.  The focus of these documents seems to put the responsibility for health IT safety on the customer/user.  Problem is, the ability to compensate for the deficits of fundamentally poorly designed and bad health IT is limited, just as a "safe flying practices" manuals for pilots cannot compensate completely for faulty aircraft design.  Especially if the manuals are for "self assessment" and there is no FAA-mandated oversight, testing and operational surveillance ...

3.  Thus, these guides appear to be a "baby step" in the true sense of the word, and "tension management" in the political sense, a term used by my claimed-Communist sociology professor several decades ago to refer to government actions that made it appear, falsely, that the government was truly "doing something" for the people.  While I am certainly not a Communist, he had a point...

In summary, while welcome, at best a "milk and toast" award needs to be given to HHS and its health IT arm, ONC for these guidelines.

-- SS

Computers + a few docs can manage "an entire city", and other cybernetic miracles

The computing aboard the Apollo spacecraft, that provided computation and electronic interfaces for guidance, navigation, and control of the spacecraft that went to the moon, was primitive by today's standards.   From Wikipedia (http://en.wikipedia.org/wiki/Apollo_Guidance_Computer):

The Apollo flight computer was the first to use integrated circuits (ICs). While the Block I version used 4,100 ICs, each containing a single 3-input NOR gate, the later Block II version (used in the crewed flights) used 2,800 ICs, each with dual 3-input NOR gates.  [Today's CPUs alone have millions of logic gates and can have billions of transistors, http://en.wikipedia.org/wiki/Transistor_count - ed.]  The ICs, from Fairchild Semiconductor, were implemented using resistor-transistor logic (RTL) in a flat-pack. They were connected via wire wrap, and the wiring was then embedded in cast epoxy plastic.

... The computer had 2048 words [2K - ed.] of erasable magnetic core memory and 36 kilowords of read-only core rope memory. Both had cycle times of 11.72 micro-seconds. The memory word length was 16 bits: 15 bits of data and 1 odd-parity bit. The CPU-internal 16-bit word format was 14 bits of data, 1 overflow bit, and 1 sign bit (ones' complement representation).

Today's computers that you buy in WalMart have several million times more memory and long term storage, and are thousands or millions of times faster.  Very roughly, a cycle time of 11.72 microseconds or 0.00001172 seconds/cycle translates out to about 85,324 cycles/second = 85 KHz = 0.085 MHz.  Today's computers have clock speeds in the GHz (1 GHz = 1,000 MHz = 1,000,000 KHz) and do far more per clock cycle than the Apollo guidance and navigation computers.

Therefore, we should be going to the moon millions of times faster, and millions of times cheaper, requiring millions of less man-hours of work, now than in 1969, no?

This, of course, is bizarre and absurd, but it is the type of wild (il)logic received by Presidents and Congress and other national leaders regarding healthcare computing:

http://www.healthcareitnews.com/news/mu-creates-medical-bridges-nowhere

MU creates 'medical bridges to nowhere'
Clinton Foundation event draws industry heavyweight who would change meaningful use if he could
January 15, 2014

As far as Patrick Soon-Shiong is concerned, the $34 billion health IT and electronic medical record incentive program was a grave misstep for the healthcare industry -- but not necessarily for the reasons one might think.

Soon-Shiong, MD, who serves as chairman and chief executive officer of healthcare IT company NantHealth and heads the Chan Soon-Shiong Family Foundation, said one of the biggest failures that led to the creation of the Meaningful Use EHR Incentive Program was an inherently flawed mindset of how we view the healthcare industry.

"Nobody has looked at healthcare as a systems approach," he said, speaking at the Clinton Foundation's 2014 Health Matters Conference Tuesday.

I don't think that "nobody" has looked at healthcare via a systems approach, but the point is well-taken.

... The meaningful use program, Soon-Shiong opined, incentivized providers with a process issue, not an outcomes issue -- so what big effect does that have on patient care? The effect, he said, could be much bigger.  

All we need is to do a few things with computers and interopearability, and...

... Soon-Shiong then opted to act on his own, privately. He sold two of his companies, Abraxis BioScience and American Pharma Partners, took $1 billion from the sales and starting building an integrated, interoperable clinical operating system. This system, he says, talks to any software.   

The operating system has been up and running for three million people with cancer and used by some 8,000 oncologists for the past three years, said Soon-Shiong. "We've built in a software system that actually takes 10,000 cancer protocols and provides for the doctor in real time the knowledge of which cancer protocol to give to the patient."  

He then went further, inking deals with Verizon and AT&T to build an electronics company that created boxes that could talk to each other -- blood pressure machines, pulse oximeters, you name it. Soon-Shiong and his team wrote to the APIs of 6,000 medical devices made from every different vendor, and went into hospitals with a real-time wireless, biometric connect box. "We are now capturing 3 billion vital signs, real-time, self-populating in the electronic medical record," he explained. Device connectivity is now operational at more than 250 hospitals, according to NantHealth officials, 120 of those being Epic sites.

And now ... Presto!

... Soon-Shiong and his team also have an Internet-based telemedicine device with a four-to-five way video conferencing ability.

"If you look at this from a systems perspective, if you can now manage a patient from a home, a clinic, hospital and through a supercomputer do the genomic analysis in 47 seconds, which we've now accomplished," said Soon-Shiong, "you then have an engineered system for the nation."

Here's where we go off the cliff of Cybernetic Miracles:

... He continued, "You have the ability to create what I call, 'NORADs' of healthcare. You then have the ability to create a building with three cardiologists, 10 oncologists, two pathologists, one pediatrician that can manage an entire city."  

3 cardiologists, 10 oncologists, 2 pathologists, 1 pediatrician + computers can manage an entire city.

Remotely.

Strap yourself in for the next departure from your local spaceport to the moon.  We have the high-speed computing and the Internet, after all ...

For related health IT and moon illogic, see my 2007 presentation to the IEEE Medical Technology Policy Committee "To The Moon In A Hot Air Balloon:  Why Is Clinical IT Difficult?" at http://www.cci.drexel.edu/faculty/ssilverstein/IEEE_12102007.zip.

-- SS

More Pharmaceutical Misadventures - Actelion Damages Upheld, Genzyme (Sanofi Subsidiary) Settled, Merck Fined

The march of legal settlements by large health care organizations goes on, albeit with ever more quiet footsteps as the number of journalists available to amplify their sounds declines.  Last week we noted the shutdown of PharmaLot, a journalistic blog edited by Ed Silverman that was one of the few that reported fearlessly on the pharmaceutical industry, warts and all.

So we dedicate this round up of legal settlements by pharmaceutical companies announced last month, December, 2013, to Ed Silverman, who reported on two of the cases below, and whose reports have been silenced by the shutdown of the PharmaLot web-site by its corporate owner.

In alphabetical order by name of the pharmaceutical company,

Actelion $40.7 Million Damages for Keeping Possibly Competitive Drug Off the Market Upheld

This story was reported by Ed Silverman on Pharmalot, and by the San Francisco Chronicle.  The basics, according to the latter article, were:

A state appeals court has upheld $407 million in damages against the Swiss biotechnology giant Actelion and its executives for buying a Bay Area company and using it to thwart another firm's plans to market a competing hypertension drug in the United States.

The drug, Fasudil, is manufactured by Ashai Kasei Pharma Corp of  Japan for treatment of pulmonary arterial hypertension, an often fatal disease of the lung arteries. In June 2006, Asahi signed a licensing agreement with the South San Francisco biotech firm CoTherix, which agreed to develop oral and inhaled versions of Fasudil and seek regulatory approval in the U.S. and Europe.

Less than five months later, Actelion bought CoTherix, paying a premium price of more than $400 million, and announced soon afterward that it was dropping plans to develop Fasudil. Actelion's own drug, Tracleer, dominates the U.S. market for treatment of the same disease and generates more than $1 billion in revenue a year.

Note that the federal appeals court judge, Terence Bruiniers, found that the actions by Actelion were not only anti-competitive, but may have harmed patients,

'By impeding the development of Fasudil, Actelion not only sabotaged a competitive and foreseeably profitable commercial venture, but prevented a drug with the potential for alleviating the suffering of patients with life-threatening and debilitating diseases from reaching the market,' Bruiniers wrote.

Further note that in this civil lawsuit, it appears that the top executives who engineered the anti-competitive actions that may have harmed patients will actually face negative consequences.  The judge also said,

the jury was entitled to conclude that three Actelion executives - CEO Jean Paul Clozel, chief scientific officer Martine Clozel, and Simon Buckingham, director of corporate and business development - had shown a disregard for the rights of Asahi and its customers and were liable for $30 million in punitive damages, about 10 percent of the executives' net worth.

Sanofi Subsidiary Genzyme Settled Charges of Encouraging Unapproved Internal Use of SepraFilm for $22 Million

The longest version of this story appeared in the Tampa Bay Times.  The basics were: 

 A Massachusetts-based biotechnology company has agreed to pay $22.28 million to resolve allegations brought by whistle-blowers in Tampa and Miami that it marketed an inappropriate use for a surgery medication, U.S. government attorneys said.

Genzyme, a corporation known for its research into drugs for rare genetic diseases, is paying the settlement in a lawsuit over Seprafilm, a material it manufactures for use in the operating room.

According to court documents, Genzyme sales representatives encouraged doctors to use the product in a manner not approved by the U.S. Food and Drug Administration, leading to improper claims for reimbursement from hospitals.

The details were:

 According to court documents, Seprafilm is intended to be applied during open surgery to prevent organs and muscle tissue from sticking together. However, the whistle-blowers and lawyers for the federal government alleged that Genzyme sales representatives taught doctors to use it in less invasive procedures — such as laparoscopic or 'keyhole' surgeries — by mixing it into a liquidlike 'slurry' that could be injected into the body.

Apparently the sales representative who blew the whistle in this case "recognized that this was a potential danger."  It certainly seems possible that the unapproved use of this material modified to be injected within the body might have resulted in harm to patients, and that at least its harmfulness when used in this manner had had never been tested.  However, in this litigation as supported by the US Department of Justice the plaintiffs were "not required to prove ... that patients had been harmed."

Note that unlike the civil case above, and as is typical of federal lawsuits against big health care organizations, those company employees who authorized or directed the questionable actions did not suffer any negative consequences.

(Added on 19 January, 2013) - Further note that as the article implied, but did not emphasize, since 2011, Genzyme has been owned by Sanofi.  Sanofi's last three major settlements since 2007 were summarized here. 

Merck Fined 15.3 Million Euros for Smear Campaign Against Generic Competition

This case was reported by Ed Silverman on PharmaLot, and briefly by Reuters,

The French competition authority said on Thursday it had fined Schering-Plough, now owned by Merck, 15.3 million euros ($21 million) over what it called a smear campaign against generic competition to Subutex, its drug for opioid addiction.

It also handed out a fine of 414,000 euros to parent Merck and another of 318,000 euros to British supplier Reckitt Benckiser for anti-competitive behaviour in staging the campaign in late 2005.

Note that while this case did not involve any implications of physical harm to patients, it seemed to involve active deception.

Summary

First, as we have said for years, legal actions like those listed above may or may not result in huge financial penalties, and rarely result in penalties for individuals who authorized, directed or implemented the actions in question, but do serve as markers of the extent of misbehavior by large health care organizations.  Such misbehavior may have adverse consequences for patients and for public health and the health care system.

Second, also as we have said for years, such actions mark the problem, but are unlikely to deter future problems.  In fact, many large health care organizations have settled strings of cases since we started trying to keep track of them (and may not have done so completely).  For example, the Genzyme, hence Sanofi settlement this year is at least the fourth major settlement by this company since 2007. 

Settlements resulting in fines imposed on a company as a whole are diffused, paid by stockholders, employees, and patients, and hence are likely to be regarded as a cost of doing business by top  management.  Managers, however, often are given huge financial incentives for all actions that increase short term revenue.  So managers are likely to continue to enable or direct bad behavior as long as it can bring in lots of revenue at no personal risk.

Third, while there has been a modest increase in discussion of ill-informed, mission-hostile, self-interested, conflicted, or even criminal or corrupt management since we started Health Care Renewal, the increasing plight of journalism seems to be making these issues more anechoic.  The shutdown of PharmaLot and the silencing of its archives is another reminder of how public relations and marketing are now overwhelming disinterested reporting (see this report by Pro Publica).

If we really want to reverse the downward spiral of our ever more expensive, less accessible, and lower quality health care system, we first have to preserve our ability to identify and loudly discuss its problems.

Roy M. Poses MD for Health Care Renewal