Same Old, Same Old - Johnson and Johnson Settles Charges it Concealed Adverse Effects of Risperdal, Vaginal Mesh Device, Pleads Guilty to Selling Adulterated Tylenol, Announces CEO Got 48% Raise to $25 Million

adulterated drugs adverse effects Alex Gorsky crime deception Johnson and Johnson legal settlements manufacturing problems William Weldon

Same Old, Same Old - Johnson and Johnson Settles Charges it Concealed Adverse Effects of Risperdal, Vaginal Mesh Device, Pleads Guilty to Selling Adulterated Tylenol, Announces CEO Got 48% Raise to $25 Million

Unknown 3/19/2015 Komentar

We have devoted a lot of bytes over the years to the stream of allegations and ethical questions about Johnson and Johnson, the giant pharmaceutical/ biotechnology/ device company, and resulting legal actions.  Meanwhile, the company has bestowed a gushing stream of money on its top executives.  Its almost spring, 2015, and it seems nothing has changed.

Johnson and Johnson's Latest Legal Misadventures

Jury Verdict that Company Concealed Harms of Risperdal

Let us start with the latest legal news about J&J.  In late February, 2015, as reported on the PharmaLot blog by Ed Silverman,

In a setback to Johnson & Johnson , a Philadelphia jury decided the health care giant must pay $2.5 million in damages for failing to warn that its Risperdal antipsychotic could cause gynecomastia, which is abnormal development of breasts in males. The lawsuit was brought by the family of an autistic boy who took the drug in 2002 and later developed size 46 DD breasts, according to a lawyer for the family.

The case has drawn attention for a few reasons. For one, this was the first lawsuit claiming J&J hid the risks of gynecomastia to go to trial after a handful of cases were settled in recent years. The trial also served as a reminder that J&J paid $2.2 billion two years ago to resolve criminal and civil allegations of illegally marketing Risperdal to children and the elderly.

Moreover, former FDA commissioner David Kessler served as a paid expert witness for the family and testified that J&J knew about the risks associated with Risperdal, but failed to disclose the data showing the extent to which youngsters may develop gynecomastia. In a report prepared for a 2012 case that was settled, Kessler wrote that J&J’s Janssen unit, which marketed the drug, had violated the law.

Note that the central allegation in this case was not simply that the drug had adverse effects, but that the company knew about these effects, and hid them.  In my humble opinion, since we entrust pharmaceutical companies to provide safe and effective products, withholding information about adverse effects is a fundamental violation of this trust. 

As noted above, this follows on another case with a much bigger financial settlement about questionable marketing of Risperdal. In addition, as the PharmaLot post noted, there are many more individual cases like this one waiting in the wings, "J&J says there are about 1,200 such lawsuits filed in courts around the country,..."

Jury Verdict that Company Concealed Harms of  Vaginal Mesh Device

Similarly, as reported by Reuters in early March, 2015,

A California jury on Thursday ordered Johnson & Johnson's Ethicon Inc unit to pay $5.7 million in the first trial over injuries blamed on the TVT Abbrevo, one of numerous transvaginal mesh products that are the subject of thousands of lawsuits.

Following more than three days of deliberations in Kern County, California, jurors found Ethicon liable for problems with the TVT Abbrevo's design and for failing to warn about its risks, according to a lawyer for plaintiff Coleen Perry.

Perry was awarded $700,000 in compensatory damages and an additional $5 million in punitive damages after jurors in the Bakersfield court found Ethicon's conduct amounted to 'malice,' her lawyer said.

Again, note that this lawsuit was not merely about the adverse effects of, in this case, a device, but about allegations that the company knew about these effects, but hid them.  My comments about violation of a fundamental trust above apply. 

Again, this is but one of the earlier cases of a cohort that may number 36,000.

Company Pleads Guilty to Selling Adulterated Tylenol

Finally, as reported in mid-March, 2015, by Reuters,

A Johnson & Johnson subsidiary pleaded guilty on Tuesday to selling liquid medicine contaminated with metal and agreed to pay $25 million to resolve the case, the U.S. Department of Justice said on Tuesday.

The subsidiary, McNeil Consumer Healthcare, pleaded guilty to one federal criminal charge in the case.

In 2010, the company launched mass recalls of certain children's over-the-counter-medicines, including Infants' Tylenol and Children's Motrin, made at its Fort Washington, Pennsylvania plant.

It was the latest in a series of recalls at the time. There were far-reaching multiple recalls from 2008 to 2010 involving hundreds of millions of bottles and packages of consumer brands such as Tylenol, Motrin, Rolaids, Benadryl and other products due to faulty manufacturing. The recalls kept widely used products such as Children's Tylenol off pharmacy shelves and seriously tarnished J&J's once-sterling reputation.

In addition to metal particles getting into liquid medicines, there were moldy odors and labeling problems.

Furthermore, as emphasized in a report in the Philadelphia Business Journal, this case also involved allegations that the company seemed to conceal the problem.

McNeil, after receiving the consumer complaint, did not initiate or complete a 'corrective action preventive action' plan as required by the federal government.

The federal government also alleged other instances in which McNeil found metal particles in bottles of infants' Tylenol at its Fort Washington facility, but failed to initiate or complete a corrective action plan.

Note that in this case, the company pleaded guilty and so could not claim it was merely settling to put the case behind it.  Furthermore, note that this was not the first case arising from charges that the company sold adulterated products made in the Pennsylvania and other factories (for example, see this post.)   We posted frequently about a long string of recalls of presumed defective or adulterated Johnson and Johnson products (here, here, here and here).  Again, in my humble opinion, we we trust drug companies to sell pure, unadulterated products.  Selling adulterated products again fundamentally violates this trust.

Unfortunately, these three cases, like many of the legal settlements we discuss, involved relatively small penalties that only accrued to the company as a whole.  The monetary penalties, while they may seem large to regular citizens, could appear as relatively trivial costs of doing business to company management.  Furthermore, no individual who authorized, directed, or implemented the behavior identified in these cases suffered any kind of penalty.  So these cases added to the many examples of the impunity of managers of large corporations who almost never seem to bear any legal responsibility for their actions.  In the case of Johnson and Johnson managers, this is all the more striking, since the current cases are just the latest in a very long string.  (See Appendix below for a list of Johnson and Johnson legal misadventures we have discussed since 2010.)


Johnson and Johnson CEO's Latest Raise


Finally, a day later, the Wall Street Journal reported on the continuing good fortune of the Johnson and Johnson CEO, to be contrasted with the company's poor fortunes in the courts of law.

Johnson & Johnson said Chairman and Chief Executive Alex Gorsky’s total compensation jumped 48% to $25 million last year, lifted by an increase in stock and option awards. Mr. Gorsky’s stock and option awards rose to a total value of $13.6 million from $8.7 million a year earlier. The board also raised Mr. Gorsky’s base salary to $1.5 million from $1.45 million in 2013, and the CEO also benefited from a jump in pension value.

In a filing Wednesday, the pharmaceutical giant said Mr. Gorsky’s compensation increase was based on the board’s conclusion that J&J successfully executed near-term priorities, exceeded financial goals and built on momentum in its pharmaceutical business.

As a result, J&J awarded Mr. Gorsky an annual performance bonus of 135% of target and long-term incentives at 130% of target. Awards at J&J are capped at 200% of target.

The article noted that at least one other top Johnson and Johnson manager also was raking it in.

Paulus Stoffels, world-wide chairman of Pharmaceuticals, made $18.3 million last year, more than double his 2013 total compensation, boosted by a stock award of $10.7 million.

Funny, the board's rosy view of Mr Gorsky's performance seemed totally uninformed by the company's latest legal misadventures.

(By the way, to anyone who would argue that many of these misadventures were the results of behavior that occurred before Mr Gorsky became CEO, note that his official company biography stated that he joined the company's Executive Committee in 2009, implying some shared responsibility for overall company management since then.)

Same Old, Same Old

A few weeks back, one of our commentators complained that our posts have a certain sameness.  Unfortunately, we agree.  We keep seeing variants of the same sorts of outrageous stories in the news media that we began to post about in 2004.   The problems are not getting better.  Perhaps they are getting worse.

In particular, we have previously contrasted this particular company's recurrent legal and ethical problems with its top managers' accumulating wealth.  In 2011 we posted about the contrast between previous Johnson and Johnson CEO William Weldon's enlarging fortune and political influence with some of the earlier legal cases that raised questions about the trustworthiness of the company.

But the point of this blog is not to come up with titillating stories to make people chuckle.  The point is to challenge the continuing, severe problems afflicting the leadership and governance of health care, the resulting incompetent, unethical, and sometimes criminal behavior, and the downstream effects on patients' and the public's health.  Do not blame the messenger for the sameness of the problem.  Blame those who are getting wealthy and powerful from the ongoing decline in health care. 

If we truly want to see more accessible, more effective, less costly health care in our life times, we need to first call out the bad leadership that has kept such aspirations at bay for so long, and second start to hold current leadership accountable for the mess they have made.


Appendix - Johnson and Johnson Legal Record since 2010-
2010
- Convictions in two different states for misleading marketing of Risperdal
- A guilty plea for misbranding Topamax
2011
- Guilty pleas to bribery in Europe  by Johnson and Johnson's DePuy subsidiary
- A guilty plea for marketing Risperdal for unapproved uses  (see this link for all of the above)
- A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post here)
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).
-  Johnson & Johnson was fined $1.1 billion by a judge in Arkansas for deceiving patients and physicians again about Risperdal (look here).
-  Johnson & Johnson announced it would pay $181 million to resolve claims of deceptive advertising again about Risperdal (see this post).
2013
-  Johnson & Johnson settled case by shareholders alleging that management made misleading statements and withheld material information about manufacturing problems (see this post)
-  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).
 -  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 .
- 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).
- 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).
- Johnson & Johnson fined by European Commission for anticompetitive practices, that is, collusion with Novartis to delay marketing generic version of Fentanyl (see this post).
2014 
- Johnson & Johnson DePuy subsidiary settled Oregan state charges that it marketed the ASR XL metal-on-metal hip joint prosthesis without disclosing its high failure rate (see this post). 

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Increasing Bad Press for Today's Healthcare Information Technology - Deserved and Overdue

forbes health affairs healthcare IT difficulties healthcare IT risks HealthcareDive.com

Increasing Bad Press for Today's Healthcare Information Technology - Deserved and Overdue

Unknown 3/17/2015 Komentar

Here are three candid, quite revealing articles about the distaste for today's health IT that appeared recently.  I will address each,

The first seems like pure deja vu (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):

1.  Forbes:  Pentagon's $11 Billion Healthcare Record System Will Be Obsolete Before It's Even Built -  March 3, 2015
http://www.forbes.com/sites/lorenthompson/2015/03/03/military-healthcare-11-billion-record-system-will-be-obsolete-before-its-even-built/

... No doubt about it, the project managers understand how to speak the language of acquisition reform.  However, a close look at what their site proposes to do for the 9.6 million active-duty warfighters and dependents in the military healthcare system reveals that this effort is going to fail.  It will probably be better than what it replaces, but it will lag far, far behind the kind of performance that users of internet-based technologies have come to expect.  So soldiers and sailors and airmen and marines — and their dependents — aren’t going to get the quality of care they deserve, and some will suffer mightily as a result.

In order to understand why the modernization initiative is doomed to failure, you need only grasp the significance of two key phrases the program office uses in its approach to industry for proposals.  First, it says it is seeking a “state-of-the-market” electronic health record system.  Second, it says whatever it selects will be an “off-the-shelf” product.  In other words, it is seeking to acquire an electronic health record system that already exists in an industry noted for its antiquated approach to the movement of information.  Furthermore, despite the program office’s insistence that it will avoid getting locked into reliance on a single monopolistic vendor, the project manager told Politico he envisions the contract as “an extensive prenup and no divorce.”

In other words, what I have described for years as a "business computing" oriented approach to clinical computing - an approach as guaranteed to fail as confusing psychiatry with neurosurgery because they both treat brain disorders, and trying to treat a brain tumor with psychotherapy or a personality disorder with a scalpel.  Specifics matter.

Sounds like vendor lock to me.  The business model the program is pursuing resembles a proprietary enterprise software system of the sort that many major hospitals have installed.

If you don’t know what an enterprise software system is, the first sentence in Wikipedia’s entry on the subject gets to the point: “Enterprise software…is purpose-designed computer software used to satisfy the needs of an organization rather than individual users.”  Got that — rather than individual users?  This approach to information system design is a throwback to the pre-internet days of mainframe computers.  In fact, the dominant version currently in use by private healthcare providers relies on upgrades to software developed nearly half a century ago at the Massachusetts General Hospital.

It's not a throwback to the mainframe era.  It represents the now-obsolete but still dominant, defective control-mentality acculturation and over-empowerment of information technologists (e.g., http://dl.acm.org/citation.cfm?id=563354&coll=portal&dl=ACM).  This acculturation is a remnant not of mainframe days but of the card tabulator data processing era (http://hcrenewal.blogspot.com/2008/05/seedie-society-for-exorbitantly.html).

2.  Health Affairs:  Where Is HITECH’s $35 Billion Dollar Investment Going? - March 4, 2015
http://m.healthaffairs.org/blog/2015/03/04/where-is-hitechs-35-billion-dollar-investment-going/

by Sen. John Thune, Sen. Lamar Alexander, Sen. Pat Roberts, Sen. Richard Burr, and Sen. Mike Enzi
 
On April 16, 2013, we released “REBOOT: Re-examining the Strategies Needed to Successfully Adopt Health IT,” outlining concerns with implementation of the Health Information Technology and Economic and Clinical Health (HITECH) Act. Specifically, we asked: What have the American people gotten for their $35 billion dollar investment?

Two years after releasing the white paper, and six years since enactment of the HITECH Act, the question remains. There is inconclusive evidence that the program has achieved its goals of increasing efficiency, reducing costs, and improving the quality of care.

I note that the statement "there is inconclusive evidence that the program has achieved its goals of increasing efficiency, reducing costs, and improving the quality of care" is a euphemistic way of saying "there is conclusive evidence that the program has not achieved its goals of increasing efficiency, reducing costs, and improving the quality of car."

We have been candid about the key reason for the lackluster performance of this stimulus program: the lack of progress toward interoperability. Countless electronic health record vendors, hospital leaders, physicians, researchers, and thought leaders have told us time and again that interoperability is necessary to achieve the promise of a more efficient health system for patients, providers, and taxpayers.

Instead, according to physician surveys, electronic health records (EHRs) are a leading cause of anxiety for physicians across the country. The EHR products are not meaningful to physicians, which is clear when you consider that half of all physicians will have their Medicare payments cut in 2015 for not adopting government benchmarks for EHRs. ... After spending $28 billion so far of the $35 billion total taxpayer investment, significant progress toward interoperability has been elusive.

Sadly, our elected officials still don't quite understand that the largest drawback to today's health IT is not lack of interoperability, but lack of basic operability (usability). 

However, $7 billion of the HITECH $35 billion is still available to waste in order to learn that lesson.

... In listening to the concerns from EHR vendors and EHR users from across the care continuum, ONC has taken an important turn under the leadership of Dr. Karen DeSalvo. The previous ONC leadership did not understand the difficulty and enormity of creating government-approved products in a market that struggled to exist before government incentives arrived.

As a result, our nation’s health care providers are stuck with the huge cost of unwieldy systems trying to conform to government mandates. They are stuck adopting EHR systems which don’t fit into their established workflows. And if they actually want to share their patients’ data, they are stuck with even more costs imposed by vendors.

At the center of all this is the patient who must sit quietly in the exam room looking at her physician use a computer instead of directly talking with her, who likely has seen no better access to her own data, and who is struggling to understand why her doctor has such a difficult time getting her lab results.

This is not exactly an endorsement of ONC's prior leaders.  Perhaps the aforementioned "previous ONC leadership" should have read this blog more carefully.  Or the Wall Street Joutnal where I spelled these outcomes out in 2009.  Emphases mine:

http://www.wsj.com/articles/SB123492035330205101

Feb. 18, 2009

Dear WSJ:

You observe that the true political goal is socialized medicine facilitated by health care information technology. You note that the public is being deceived, as the rules behind this takeover were stealthily inserted in the stimulus bill.

I have a different view on who is deceiving whom. In fact, it is the government that has been deceived by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants.

For £12.7 billion the U.K., which already has socialized medicine, still does not have a working national HIT system, but instead has a major IT quagmire, some of it caused by U.S. HIT vendors.

HIT (with a few exceptions) is largely a disaster. I'm far more concerned about a mega-expensive IT misadventure than an IT-empowered takeover of medicine.

The stimulus bill, to its credit, recognizes the need for research on improving HIT. However this is a tool to facilitate clinical care, not a cybernetic miracle to revolutionize medicine. The government has bought the IT magic bullet exuberance hook, line and sinker.

I can only hope patients get something worthwhile for the $20 billion.

Scot Silverstein, M.D.
Faculty, Biomedical Informatics
Drexel University Institute for Healthcare Informatics
Philadelphia

These were easy predictions to make based on experience and papers such as this.

Finally:

3.  HealthcareDive.com, Has the AMA lost its mojo?  - March 9. 2015
http://www.healthcaredive.com/news/has-the-ama-lost-its-mojo/372532/

As the mainstream media has begun to realize that organized physicians groups are doing all they can to resist adopting EHRs, the coverage of the dispute has revealed just how little impact their efforts—​led by the AMA—​are achieving in accomplishing their goals.

The AMA has come out vehemently against the Meaningful Use program and the high velocity with which the HHS and Congress want doctors to adopt EHRs, and they have written countless letters, position papers and blueprints for reform to announce their displeasure. Moreover, more than 30 other physicians groups have signed on to their copious letters. A recent USA Today piece quoted the incoming chief of the AMA about EHRs.

"Physicians passionately despise their electronic health records," says Lexington, KY, emergency physician Steven Stack, the American Medical Association's president-elect. "We use technology quickly when it works … Electronic health records don't work right now."

A 2013 AMA/RAND study revealed that EHRs are at the root of the modern doctor’s dissatisfaction with his job.

I note that up until relatively recently, the AMA was largely a defender of today's EHR technology.  They certainly got what they wished for...

"Physicians believe in the benefits of electronic health records, and most do not want to go back to paper charts," said Dr. Mark Friedberg, the study's lead author and a natural scientist at RAND, a nonprofit research organization. "But at the same time, they report that electronic systems are deeply problematic in several ways. Physicians are frustrated by systems that force them to do clerical work or distract them from paying close attention to their patients."

In fact, I believe this oft-made statement about "most do not want to go back to paper charts" is incomplete and misleading.  In terms of retrieving data such as labs and images, most probably would not want to go back to paper.  On the other hand, most probably would like to be able to document and enter orders on paper and have clerical personnel transcribe that information into computers - instead of the physicians being the clerical persons themselves, and gratis.

... According to a piece on Wall Street Cheat Sheet, there could be a couple of reasons why the AMA seems to keep getting shut out—​namely the AHA and the Blues.

While the AMA had $19 million to lobby Congress, the American Hospital Association—​which represents providers who took a financial hit after the last ICD-10 adoption delay—​spent $20.75 million last year to lobby lawmakers. Big insurer Blue Cross and Blue Shield, which would also benefit from wide adoption of EHRs and ICD-10, spent $21.3 million in 2014. That's a combined $42 million, more than double the AMA's effort.

Now, factor into that the extreme amount of influence wielded by the tech sector—​Google alone spent $17.5 million in lobbying Congress in 2014—​and the scent in the wind becomes easy to identify. The tech sector stands to make billions from EHR creation and management. Insurers need ICD-10 and EHRs to bring better cost management into their industry, enabling them to spend less as they pay for more care for more patients. Finally, hospitals need the tech because the ACA is bringing millions of new patients into their doors, and the old pegboard and paper systems that doctors are trying to cling to just won't work for hospitals that see tens of thousands of patients each month.

The AMA has set up a showdown on ICD-10 and EHRs that it will lose, and lose big, because it just plain does not carry the muscle it used to.

In other words, medicine has been invaded by the Information Technology industry and the profiteers who stand to benefit from that technology, with the bulk of the work being performed by clinicians, for free and to patient detriment.

This seems a clear formula for clinicians to simply refuse to use health IT altogether for data entry and demand a return to paper data recording with clerical transcription, but alas, it's likely too late for a revolt like that.

As health IT continues to get well-deserved and long-overdue bad press like this, one wonders if our culture will start to recover from the state of health IT delirium it is in.

I am in doubt.

(See my Jan. 20, 2011 post "Healthcare IT delirium" at http://hcrenewal.blogspot.com/2011/01/healthcare-it-delirium.html for more on that issue).

-- SS

3/16/15 Addendum:

A physician actually proposes physicians be paid for clerical work:

Pay doctors and nurses for the time they spend charting
http://www.kevinmd.com/blog/2015/03/pay-doctors-nurses-time-spend-charting.html

-- SS

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An ironically titled session by ECRI Institute: "Would You Bet Your Mother's Life on the Safety of Your EHR?"

ecri institute healthcare IT risks HIMSS Ronni Solomon William Marella

An ironically titled session by ECRI Institute: "Would You Bet Your Mother's Life on the Safety of Your EHR?"

Unknown 3/17/2015 Komentar

An ironically titled session by ECRI Institute "Would You Bet Your Mother's Life on the Safety of Your EHR?" is being held at the annual Health Information Management Systems Society (HIMSS) meeting by Ronni Solomon, JD and William Marella, MBA of the ECRI Institute on April 13, 2015 (http://www.himssconference.org/event.aspx?ItemNumber=36765).

It is announced in the HIMSS press release below in Healthcare IT News.

I should probably be the keynote speaker to that session, as I am suitably qualified to speak of that exact issue.  My mother and I lost such a "bet" (http://hcrenewal.blogspot.com/2013/09/on-ehr-warnings-sure-experts-think-you.html).

It's about time these topics were surfaced, but I still feel there is far too little public awareness of the risks of bad health IT.

http://www.healthcareitnews.com/news/ridding-ehrs-dangerous-often-undetectable-bad-data 
Ridding EHRs of dangerous, often undetectable, bad data

March 13, 2015

As the healthcare industry continues toward its goal of making all patient health records electronically accessible, a health system’s safety increasingly is determined by the quality of its EHR implementation.


Last November ECRI Institute, a non-profit organization that uses scientific methods to test medical products, rated “incorrect or missing data in electronic health records and other health IT systems” as the No. 2 hazard that will put patients at risk in 2015.

“Once inaccurate data gets into the electronic health record, it’s hard to get it out,” said Ronni Solomon, executive vice president and general counsel for ECRI Institute. “That’s a challenge, and the less detectable it is, the higher the risk. You don’t know it’s in there.”

Such incorrect information probably has far more impact than it did on paper, I believe; computer output is often uncritically taken as gospel, and is often cut-and-pasted to newer records without patient interaction, thus propagating an error of omission, commission or data loss or corruption (due to malfunction).

The negative impact of bad data in electronic health records is both immediate and long-lasting. “In the short-run, bad data in the system limits the effectiveness of clinical communications and the effectiveness of decision support,” added William Marella, ECRI’s executive director, PSO operations and analytics. “And basically it undermines people’s confidence in the system.”

Especially the clinicians' confidence, which is already low (e.g., see my Jan. 28, 2015 post "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).

Solomon and Marella will conduct an educational session at HIMSS15 in April on how healthcare organizations can apply safety science to IT and informatics to improve patient safety.

The first step they can take is to strip control of critical health IT decisions from the business-IT personnel and put heath IT under the aegis of medical leadership, especially medical leadership that contains formally-educated Medical Informatics and related professionals.  (This admittedly and unfortunately has a very low chance of happening due to hospital politics and power structures.)

“Would You Bet Your Mother's Life on the Safety of Your EHR?” is designed to help attendees create a framework for planning and implementing IT strategies, processes and tools to increase the safety of healthcare patients.

Both Ms. Solomon and Mr. Marella are aware of what happened to my mother.  I wonder out loud if the title is based on, at least in part, that incident.

... “The promise of these systems is that they’re going to make the health care system more efficient and ultimately more safe,” Marella said. “Now the administrators in hospitals and health systems that have financed these systems want a return on their investment.”

Perhaps the administrators should have done due diligence on the realities of this technology before investing the money.

The session will cover how organizations can: establish an infrastructure for identifying and responding to patient safety problems; assess safety challenges facing health IT users and implementers; identify partnerships that can accelerate safety improvements; and analyze opportunities to use informatics to prevent adverse events.


“What we’re trying to do in this talk is get in front of the IT leaders of these institutions and help them understand where patient safety people are coming from and how we can bridge these two silos within the health system, because they will both be more effective working together,” Marella said.

I add that all of these goals should have been met prior to a national rollout and, at each organization, prior to subjecting patients to these technologies, but I speak common sense, which in medicine is no longer common.  Thus, sessions like this one in 2015.

Perhaps this could be the theme poster for the session.

-- SS

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Health Care Run by Those "Who See the Practice of Medicine as a Set of Economic Transactions," or as a "Moral Endeavor?"

generic management generic managers market fundamentalism

Health Care Run by Those "Who See the Practice of Medicine as a Set of Economic Transactions," or as a "Moral Endeavor?"

Unknown 3/10/2015 Komentar

Calls are getting louder for restoring medicine and health care as a calling that puts patients first, versus a business that puts money first.  For example, in the conclusion of her opening talk for the 2015 Lown Institute Annual Conference: the Road to RightCare, Shannon Brownlee said, [with italics added for emphasis]

So today I stand before you not as a writer turned health policy expert turned health care activist, though I’m still all of those things. I stand before you as a mother, a wife, a daughter . . . and a citizen. I stand before you filled on the one hand, with dismay . . . and on the other hand with a full measure of hope. I stand here to welcome you to the work we are all doing to transform healthcare.

And our first step is to name our task. It is not just stamping out overuse, though we must do that. It is not just ensuring that patients get the care they need. Though that is unfinished business.

Getting to the right care also requires that we recognize the historic choice we face between opposing world views. On one side are those who see the practice of medicine as a set of economic transactions, and healthcare as just another business. This side thinks the market solves all ills. This side sees the health professions as the labor needed to run a highly profitable industry. You are the 'providers' of services -- the help. Patients are revenue. Excuse me, 'consumers.'

On the other side of this divide are those who see healthcare as a moral endeavor. This side seeks to serve both patients and the common social good. This side knows that ignoring the patient as vulnerable human being is the quintessential failure of our system. This side acknowledges our need for hospitals, and for companies to manufacture drugs, and devices, and scalpels and surgical gloves. But the delivery of healthcare should not be designed for their benefit.

If we want to get to the right care, we must begin to envision a vastly different system. A just system. A system whose purpose is to serve patients and communities. A system that is not just reformed, but radically transformed.

The purpose of this conference, the reason we are all here today, is to find our way towards that transformation.

[The above was reprinted with Ms Brownlee's permission.]

On Health Care Renewal, we have long been showing the consequences of health care run by generic managers who believe the business school dogma of promoting "shareholder" value, even when their organization has no shareholders, by putting short term revenue ahead of all else.  They are backed by market fundamentalists who believe all of human life can be reduced to business transactions.  The results have been very profitable to some, particularly to the very same generic managers, in terms of every rising executive compensation untethered to any clear evidence for these managers' achievements, beyond making money.  I have suggested that this has become a major cause of health care dysfunction, of ever rising costs, shrinking access, and threatened quality.  True health reform, or transformation, to use Ms Brownlee's term, would restore the priority of patients' and the public's health, and return health care to those who see it as a calling, not just a way to get rich. 

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A "PR Pawn" Confounds the Public Relations Burnishing of Texas Health Resources and its CEO

Ebola virus generic management generic managers public relations Texas Health Presbyterian Hospital Texas Health Resources

A "PR Pawn" Confounds the Public Relations Burnishing of Texas Health Resources and its CEO

Unknown 3/06/2015 Komentar

The Ebola virus epidemic in Africa is hopefully winding down.  The uproar, if not panic, over Ebola virus in the US has been eclipsed by the latest  internet craze.  However, we are still learning from the echoes of the brief, and thankfully very localized US experience with Ebola.

In particular, the country's response to the virus should continue to inspire unease about how our supposedly market based, managerially focused health care non-system can handle real public health threats.

Background - Ebola at Texas Health Presbyterian

Starting on October 2, 2015, we discussed numerous concerns about whether problems with leadership or management at Texas Health Presbyterian hospital, part of the Texas Health Resources system, contributed to the poor outcomes of its Ebola patients.  First, InformaticsMD raised questions about whether a badly designed or implemented electronic health record at the hospital enabled the initial misdiagnosis of Eric Duncan, the first patient to present with the Ebola virus on US soil.  These questions were reinforced when hospital managers gave conflicting responses on this issue.  He expanded on these questions here.

A week later, I wrote about the "mystery of the discharged Ebola patient," asking:  why don't we know yet exactly what happened when our Ebola patient zero first appeared?  I wondered then whether a decision by management to shift the health system's emphasis from acute care to "population health management," whatever that is, might have lead to problems addressing what was a severe, acute medical problem (albeit with public health implications.)    About a week later, I wrote about the questions raised by inconsistencies in hospital managers' statements, about Mr Duncan's clinical status and the failure to initially accurately diagnose his infection, about the hospital's readiness to handle Ebola patients, and about whether hospital professional staff may have been silenced by administrators, and if so, why?


By late November, 2014, a Texas Health Presbyterian nurse had gone public with accusations that the initial care of Mr Duncan had been chaotic; Mr Duncan had died; and two nurses who cared for him after he was admitted after his second emergency visit to Texas Health Presbyterian had contracted Ebola infections; but no new Ebola cases had been diagnosed in the US, and Ebola was starting to fade from the media.   At that time, I wrote that the three questions above remained unanswered.  However, Texas Health Resources, the parent system for Texas Health Presbyterian, had hired Burton-Marsteller, a big public relations firm, and  managers of both companies generated considerable verbiage, but no specific answers and no real enlightenment.  Hospital managers had already pointed their fingers elsewhere, at the US Centers for Disease Control and Prevention (CDC) for inadequate guidelines, unnamed third parties for exploiting the crisis, and the media for sensationalizing it. Hospital managers had sponsored a pep rally, but the health professionals who appeared there either seemed to stick to talking points, or remained "tight lipped."   The hospital settled a lawsuit filed by Mr Duncan's relatives, and Micahel Barden, the THR president, submitted to an interview in which he boasted of a "high level of communication" and asserted the system had "maintained the trust level," but did not supply any specifics.

Since November, 2014, no further specifics have appeared about what happened at Texas Health Presbyterian.

The Public Relations Burnishing of Texas Health Resource Management

Instead, since October, 2014, a series of events and media reports seemed more about burnishing the management of Texas Health Resources, and particularly its CEO, Barclay Berdan, than about learning from the problems that occurred when the US first encountered the Ebola virus.

On November 29, 2014, Modern Healthcare published an interview with Mr Berdan including leading questions like:

Has this Ebola crisis caused you to take a broader look at hospital-acquired infections?

How were you able to maintain high staff morale throughout this crisis?

The answer to that last question was particularly upbeat:

It was really important to make sure that we had a high level of communication and that we maintained trust inside the organization while we were in many cases being attacked from the outside, as the world moved from science to political science to social science to superstition and fear. That helped us keep the morale of the organization up and to keep people focused on the fact that we had a lot of patients to take care of.

Even though our patient census dropped by 20%, we told everybody we weren't going to reduce staffing. We were going to keep people working at their regular rates and times. We kept everybody really focused on this challenge, that we had to stay strong and get through this period of time.

Note that this implied communications had always been good, trust had always been maintained, and morale had never declined. There were no followup questions, particularly whether staff morale could have seemed good because dissent had been silenced? 

On December 5, 2014, the D Healthcare Daily reported on an event in which Mr Berdan participated, and treated him as an honored expert.  Berdan was quoted, for example,

The best thing you can do—if you’re a local hospital, if you’re a rural hospital or an urban hospital—is to try and figure out how to manage the safety of your employees, the safety of your institution, the safety of patients who may present with, in this case, a disease that already causes people great fear.

The article trumpeted how selflessly Berdan has led THR to teach other hospitals about Ebola, with the underlying assumption that it had valuable lessons to teach:
 

THR has shared what it’s learned with other hospitals, both in North Texas and across the country. It held a webinar with 1,200 medical professionals to share what it learned and changed....

On December 5, 2014, D Healthcare Daily also noted that at the event, an award was given to caregivers who dealt with ebola at Texas Health Presbyterian, but who accepted the award on their behalf? 

Barclay Berdan, CEO of Texas Health Resources, was center-stage on Tuesday at the Sheraton downtown, flanked by more than a dozen staffers representing the 100-plus caregivers who helped treat the three Ebola patients in October.

The Dallas Regional Chamber presented the caregivers of Texas Health Presbyterian Dallas with the Courage of Public Service Award, an annual recognition that honors groups or officials who 'demonstrated significant leadership on important issues.'

After Berdan gave his little speech, next up on stage were:

Texas Health Resources Board Chair Anne Bass and Presbyterian Hospital Board Chair Stan Rabin walked up first,... 

Although the actual caregivers were supposedly being honored, airtime and coverage went to board chairs.

Then last month (February, 2015), it began again. Another interview with Mr Berdan appeared in D Healthcare Daily. It allowed Mr Berdan to pontificate on issues like the hospital system's growth plans, and to go back to the idea of population health as more important than acute care,

I think we’re looking always to find good opportunities to improve the health of the people in the communities we serve, and that’s our mission. In fact, we have really changed the scope and direction of our organization over the last four or five years from being a great acute care hospital company—you referenced all of our hospital properties in North Texas—to really being a health company.

Ebola, and the questions I raised above, were not featured. 

Finally, in the March issue (available in late February, 2015), D Magazine published, "How Texas Health Managed its Ebola Crisis," focused, of course, on CEO Barcaly Berdan. It featured a large color photograph of Mr Berdan.  It seemed to suggest that the most important issue was maintaining the reputation of the hospital system, rather than for example, being transparent about and learning from mistakes. It featured a big informal portrait of Mr Berdan, and started with how Mr Berdan managed the first news conference about Ebola, rather than, for example, the details of Mr Duncan's encounters with THR.

To Berdan, it was important to show that Presby—one of Dallas County’s largest and busiest hospitals—was safe and open for business.

The article described Berdan as an "unassuming man who speaks with confidence and fatherly authority," an "able communicator," a man whose "word is his bond," and eventually, "a battle tested CEO." It stated that "the treatment of Duncan - and the safety of the men and women who volunteered to care for him - rested squarely on his shoulders." Yet, of course, Mr Berdan's highest degree was an MBA, from University of Chicago, no less. He may have had a public relations battle, but he did not have to walk into a room containing a highly infectious Ebola patient. He actually should not have had any authority over the actual treatment of Mr Duncan. That should have been in the hands of the patient's doctors and nurses.

The article obliquely addressed the unanswered questions, but did provide substantive answers. Why was Mr Duncan not diagnosed accurately?

Privacy laws prevented the hospital from discussing the care provided Duncan until he permitted them to....

Was the hospital prepared to take care of Ebola patients?

We were moving in parallel with the CDC's ongoing recommendations....

Were health professionals silenced? The hospital paraded four nurses in front of 60 Minutes' cameras:

On the evening of Oct. 26, wearing blue scrubs and seated in front of a jet-black background, nurses Sidia Rose, John Mulligan, Richard Townsend, and Krista Schaefer offered a poignant and moving narrative of Duncan’s treatment. It was the most substantive account offered to that point.

The final section of the article was entitled, "On the Mend." Again, the emphasis was on PR.

THR had positive momentum. Once a pin-cushion, its public reputation was improving.

The hospital settled a lawsuit with Mr Duncan's relatives for an undisclosed sum. After the settlement was announced, Mr Duncan's nephew proclaimed:

This facility is an outstanding facility, and we as humans are not perfect.

Maybe getting a big sum of money can make one more philosophical about human imperfections.

The article ended up describing how

North Texas seems to have appreciated the efforts of THR under Berdan....

It all sounded so rosy, at least for a few days.

A "PR Pawn" Strikes Back, or, Nina Pham Administers a Corrective

Only a few days after the D Magazine piece appeared, the Dallas Morning News published an article about Nina Pham, the first THR nurse to have been infected with Ebola virus after caring for Mr Duncan.  Pham had never previously been portrayed as a dissident, and had been seen in the media as a young professional gamely facing down the virus and supporting her fellow nurses.  Now, however, rather than participating further in the feel good celebration of THR and Mr Berdan, Ms Pham announced she would be suing the hospital and THR.

She says the hospital and its parent company, Texas Health Resources, failed her and her colleagues who cared for Thomas Eric Duncan, the first person in the United States diagnosed with Ebola.

'I wanted to believe that they would have my back and take care of me, but they just haven’t risen to the occasion,' Pham told The Dallas Morning News

Pham reaffirmed the contention that Texas Health Presbyterian was not prepared to care for Ebola patients.

In her 90-minute interview, Pham described working in chaotic surroundings at the hospital with ill-prepared nurses who received little guidance on how to treat Ebola and protect themselves.

In particular,

She said the extent of her Ebola training was a printout of guidelines that her supervisor found on the Web.

And

The day Duncan moved to ICU, Pham said, she and the charge nurse went in with double gloves taped to double gowns and wore double booties and a face shield. The hospital did not have hazmat-type suits, and Pham said her neck was always exposed.

'We’ve had nurses that I’ve worked with that worked in other states, and they worked in hazmat suits for flu and H1N1,' Pham said. 'Why aren’t we wearing hazmat suits for Ebola?'

After days of asking, Pham said, the nurses were given hazmat suits. She said all the decisions to upgrade the protective gear and precautions were made by the nurses 'on the fly.'

 Meanwhile, the nurses devised their own hazardous waste area. In a room adjacent to Duncan’s, the nurses set up a place to take off their protective gear and shower after caring for him. In another nearby room, they placed bags of dirty linens, towels and other soiled items.

Finally,

while she became the American face of the fight against the disease, the hospital’s lack of training and proper equipment and violations of her privacy made her 'a symbol of corporate neglect — a casualty of a hospital system’s failure to prepare for a known and impending medical crisis.'

She also contradicted much of the feel good public relations speak found in the articles above.  The D Magazine article had referred to Pham and the other nurses who care for Mr Duncan as "the men and women who volunteered to care for him."  In contrast, the Dallas Morning News article said "she did not volunteer to care for Duncan, but felt she couldn't say no."

During the crisis, Pham was seen in a video where she appeared gamely optimistic.  However,

She says that Texas Health Resources violated her privacy while she was a patient at Presbyterian by ignoring her request that 'no information' be released about her. She said a doctor recorded her on video in her hospital room and released it to the public without her permission.

While the hospital argued that Pham gave permission to make the video,

The day Pham was transferred to NIH, a notation was made in her medical file that 'she does not have the mental capability to make end-of-life decisions,' [Pham's attorney Charla] Aldous said. But PR people from Texas Health were trying to talk to her for a media release 'about how much she loves Presbyterian,' Aldous said.

Texas Health, with a PR firm’s help, developed a slogan — 'Presby Proud' — aimed at restoring the community’s faith in the beleaguered hospital.

Before Pham’s flight to Maryland on Oct. 16, she said, a doctor wearing a video camera under his protective hood came into her room and said he was filming her for educational purposes. Pham said she did not give permission for the video, which was released to the media.

'Thanks for getting well. Thanks for being part of the volunteer team to take care of our first patient,' a man’s voice said in the video. 'It means a lot. This has been a huge effort by all of you guys.'

'I could tell they wanted me to stay just because they kind of knew, they could see I was getting better. They wanted that ‘yes we cured her’ kind of attitude. They wanted a win, especially after a loss.' - Nina Pham

Charla Aldous, Pham’s attorney, put it all more simply:

Texas Health Resources 'used Nina as a PR pawn.'

Summary

So it looks like back to the drawing board for the public relations flacks who have been defending the "reputation" of Texas Health Resources, and, in my humble opinion, mainly the reputation of its CEO, Barclay Berdan.  After questions about its preparedness for and the care of Ebola patients, and about whether managers overrode and silenced health care professionals, the hospital system had put on a big public relations campaign, in concert with a big outside PR firm.  Yet all the questions have now resurfaced as one of the hospital nurses put before the public as brave yet ever loyal to "Presby" now says she was turned into a "PR pawn." 

Of course, the immediate response by the hospital and the CEO were to trot out the old talking points.  In the Dallas Morning News article, spokesman Wendell Watson said,

Nina Pham bravely served Texas Health Dallas during a most difficult time.  We continue to support and wish the best for her, and we remain positive that constructive dialogue can resolve this matter.

Later, as again reported by the Dallas Morning News, CEO Barclay Berdan tried to refute Ms Pham's contention that her privacy was violated by saying:

We adhered to HIPAA rules in determining what information to share publicly.  

But HIPAA rules are notoriously hard to interpret and implement.

Also,

We had Nina's consent to share the information about her that was released.

But she had contended she was too ill, and confused on pain relief medicines to give informed consent, and aspects of her record apparently corroborate that. 

So the questions about what was going on at THR persist.  The latest twist in the story does emphasize how important public relations has become to contemporary hospital managers.  One cannot avoid the notion that most of what went on in the C-suites of Texas Health Presbyterian and Texas Health Resources in response to the presence of three Ebola patients was about public relations, protecting the reputation of the hospital, and particularly celebrating its very well paid MBA CEO.  Of course if leaders focus on public relations, maybe they will not do such a good job supporting the health care professionals who actually care for patients, and ultimately supporting the patients' and the public's health.

So as I said a while ago about this case, the rise of generic managers who value, among other things, favorable public relations perhaps to the detriment of patient care, threatens the US' ability to care for acutely ill patients, especially in the context of new or epidemic diseases.  True health care reform would restore leadership by people who understand the health care context, uphold health professionals' values, are willing to be held accountable, and put patients' and the public's health ahead of self-interest.

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