Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost - Supreme Court-Style

At my Sept. 2010 post "The Dangers of Critical Thinking in A Politicized, Irrational Culture" I wrote:

... It's the EMR "anecdotalists" (as opposed to the "Markopolists") who say that "anecdotes" of HIT-related injury are meaningless. They deem reports of safety issues and HIT-related misadventures and risk as simply "anecdotal", and that "anecdotes don't make evidence" (or "anecdotes don't make data").

For "anecdotes" of patient harm due to medical devices even from the most reliable of sources to be counted as "evidence" of device risk, apparently, the stories need to be blessed with Statistical Holy Water. The Holy Water must also be of a brand approved by the academic pundits.

For me, this is no longer merely a professional debate. My elderly relative became one of those "anecdotes" in May last year.

I address the casual, Dogbert-style, waving-of-the-hand "Bah!" dismissal of health IT harm "anecdotes" at numerous other posts as well, such as "EHR Problems? No, They're Merely Anecdotal" and "Health IT: On Anecdotalism and Totalitarianism".

Bah! Your Health IT adverse events reports are anecdotes, and anecdotes don't make data!

In those posts I also mention how Australian informatics professor Dr. Jon Patrick had essentially hit the flaws of this argument out of the Southern hemisphere with a short editorial in the journal "Applied Clinical Informatics" entitled "The Validity of Personal Experiences in Evaluating HIT." That essay is free at the link and is worth reading.

Interestingly and thankfully, the "anecdotes are meaningless" crowd have now lost, and lost big - Supreme Court style. In fact, the U.S. Supreme Court has shown far more common sense than many esteemed academics and industry pundits.

As noted in this post at Derek Lowe's pharmaceutical industry "In the Pipeline" blog, the company that made "Zicam", a zinc-based over-the-counter cold remedy, tried to defend shareholder suits that the company withheld case reports of Zicam causing permanent loss of smell via arguing that such reports "did not reach a level of statistical significance", i.e., were "anecdotal." The case went to the U.S. Supreme Court.

The Supreme Court would have none of that argument:

"Matrixx�s [Zicam's manufacturer - ed.] premise that statistical significance is the only reliable indication of causation is flawed. Both medical experts and the Food and Drug Administration rely on evidence other than statistically significant data to establish an inference of causation. It thus stands to reason that reasonable investors would act on such evidence.

The full court decision is at this link: http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf (PDF file), but a passage I consider key to this issue is as follows:

... We conclude that the materiality of adverse event reports cannot be reduced to a bright-line rule ... Because adverse reports can take many forms, assessing their materiality is a fact-specific inquiry, requiring consideration of their source, content, and context.

This is common sense incarnate. It applies not just to drugs, but to medical devices, to health IT, and to other domains as well.

In essence, it is saying that adverse events reports, especially repeated ones, from trustworthy sources are not to be lightly dismissed, but should serve at the very least as red flags that there may be a systemic problem requiring further investigation.

One wonders how and if public healthcare IT vendors will begin disclosing "anecdotal" reports of their products causing patient harm to their own stockholders.

One also wonders if the academic anecdotalists (up to the level of the chair of the Office of the National Coordinator for Health Information Technology at HHS) will cease their unfettered dismissal of health IT AE reports as mere "anecdotes" and therefore let's roll out this 100% beneficent technology nationwide ASAP:

"Nothing [ONC has] found would give them any pause that a policy of introducing EMR's could impede patient safety." - David Blumenthal

That sounds a bit like the refrain of the makers of Zicam.

One might also wonder if the anecdotalists merely lack common sense, or are using this form of epistemological dementia to obscure conflict of interest.

On a final note, my favorite comment at the aforementioned "In the Pipeline" blog story is this by anonymous commenter "Still Scared of Dinosaurs":

One of the most important ideas real statisticians must get into their heads is "Thou shalt not worship the 0.05 threshold". The whole concept of "statistical significance" for AEs is idiotic and the fact that Matrixx based any part of their defense on it indicates that their stupidity did not end when they named the company.

Perhaps this Dilbert cartoon is apropos to the Supreme Court decision:


-SS

Addendum:

I thought it appropriate to share these thoughts with the leadership of the Joint Commission, the organization that accredits healthcare organizations in the United States:

From: Scot Silverstein
Sent: Sunday, March 27, 2011 10:41 AM
To: MGiuntoli, Anita; Chassin, Mark; Schyve, Paul; Legaspi, Shirley
Cc: Ross Koppel; 'David Kreda'
Subject: Re: MATRIXX INITIATIVES, INC., ET AL. v. SIRACUSANO ET AL.

Not a complaint this time [about health IT failure - ed.], but an observation.

The JC has noted health IT risks in the Sentinel Events Alert "Safely implementing health information and converging technologies" of 2008.

The company that made "Zicam", a zinc-based over-the-counter cold remedy, tried to defend shareholder suits that the company withheld case reports of Zicam causing permanent loss of smell via arguing that such reports "did not reach a level of statistical significance", i.e., were "anecdotal." The case went to the U.S. Supreme Court.

The Supreme Court would have none of that argument:

"Matrixx�s [Zicam's manufacturer] premise that statistical significance is the only reliable indication of causation is flawed. Both medical experts and the Food and Drug Administration rely on evidence other than statistically significant data to establish an inference of causation. It thus stands to reason that reasonable investors would act on such evidence.

The full court decision is at this link: http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf (PDF file), but a passage I consider key to this issue is as follows:

... Because adverse reports can take many forms, assessing their materiality is a fact-specific inquiry, requiring consideration of their source, content, and context.

This is common sense incarnate. It applies not just to drugs, but to medical devices, to health IT, and to other domains as well.

I believe JC should start to pay serious attention to "anecdotal reports" of health IT-caused patient injury, and consider reliable reporting of these events as an Accreditation standard.

As I noted in my July 2009 JAMA letter to the editor "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" in response to Koppel and Kreda's JAMA article on HIT industry practices, "hold harmless" and "gag" clauses must go, and be replaced with proactive reporting of healthcare IT-related "events."

Scot Silverstein

-- SS

The Institute of Medicine Releases Reports on Practice Guidelines and Systematic Reviews Which Generate Few Echoes

Two days ago, the prestigious US Institute of Medicine released two reports on important health care issues, clinical practice guidelines and systematic reviews.  Systematic reviews of the relevant clinical research have been advocated by evidence-based medicine proponents as the appropriate basis for clinical and policy decisions.  Clinical practice guidelines have been advocated by many health researchers, policy makers, and clinicians as the best way to encapsulate the evidence to inform clinical and policy decision making.  Both reports suggested series of standards for how systematic reviews and clinical practice guidelines should be developed. 

These topics are of general importance to clinicians, health services researchers, and health policy makers.  The Institute of Medicine, part of the US National Academy of Sciences, is one of the most authoritative sources of opinion on medicine and health care.  Therefore, one would think that these reports would have gotten wide notice, and would hardly required Health Care Renewal to create some echoes.

However, a Google News search today produced only six "hits" relevant to these reports, including the original press release.  All are in specialized medical/ health care news outlets.  None are in the national media, and none are from major medical/ professional journals or societies. 

Let me suggest a theory about why these two major reports have generated so few echoes so far.  Let me quote from the summary of the report on clinical practice guidelines:

Most guidelines used today suffer from shortcomings in development. Dubious trust in guidelines is the result of many factors, including failure to represent a variety of disciplines in guideline development groups, lack of transparency in how recommendations are derived and rated, and omission of a thorough external review process. To be trustworthy, clinical practice guidelines should:
� Be based on a systematic review of the existing evidence;
� Be developed by a knowledgeable, multidisciplinary panel of experts and representatives from key affected groups;
� Consider important patient subgroups and patient preferences, as appropriate;
� Be based on an explicit and transparent process that minimizes distortions, biases, and conflicts of interest;
� Provide a clear explanation of the logical relationships between alternative care options and health outcomes, and provide ratings of both the quality of evidence and the strength of recommendations; and
� Be reconsidered and revised as appropriate when important new evidence warrants modifications of recommendations.
Additionally, as reflected in the committee�s standards for developing trustworthy clinical practice guidelines, guideline development groups optimally comprise members without conflict of interest. The committee recognizes that in some circumstances, a guideline development group may not be able to perform its work without members who have conflicts of interest�for example, relevant clinical specialists who receive a substantial portion of their incomes from services pertinent to the guideline. Therefore, the committee specifies that members of the guideline development group who have a conflict of interest should not represent more than a minority of the group.

So it seems that the report on clinical practice guidelines emphasized two issues highly relevant to Health Care Renewal, the need for transparency in guideline development, and the need to avoid conflicts of interest affecting the development process. The two first standards for guidelines are about transparency and minimization of conflicts of interest.  Similarly, the report on systematic reviews also included fairly tough standards to minimize conflicts of interest.

We on Health Care Renewal go on and on about the need to maximize transparency in health care, and particularly in health care leadership and governance, and about the need to disassemble the now pervasive web of conflicts of interest that has entangled health care.  However, as we know, these are not popular topics among the leadership of health care, which includes many individuals who have greatly benefited from lack of transparency and pervasive conflicts of interest.  We know these topics make these leaders, and many of those who report to, or work or associate with them very uncomfortable.

So unfortunately, I am not surprised that the two new and likely authoritative reports from the Institute of Medicine, despite that organization's prestige, have started off relatively anechoic.  It also unfortunately likely that they will remain relatively anechoic. 

In 2009, the IOM issued an authoritative report on conflicts of interest in medicine and health care which suggested fairly tough standards to decrease such conflicts and their influence (also see post here).  Since 2009, I just found 53 citations to that report in the medical literature using the ISI Web of Science, for a rate of 27/year.  In 1999, the IOM issued a report on medical errors, "To Err is Human."  Since then, it has received 1374 citations, a rate of 115/year. 

As we noted above, the topic of conflicts of interest seems to make the powers that be in health care very uncomfortable.  In contrast, "To Err is Human" was widely interpreted to mean that physicians make a lot of dangerous errors, and the best way to decrease them is to impose more controls by bureaucrats, managers, and executives (even if that was not its intent).  Thus, that report could be twisted to fit the talking points of the powers that be, and hence has been anything but anechoic.

So while Health Care Renewal is hardly a powerful tool for creating publicity, I thought we should try to get the word out about the new IOM reports on clinical practice guidelines and systematic reviews.  Every little bit helps.

Meanwhile, the deathly quiet reception these reports have gotten so far emphasizes the need to combat the anechoic effect.  As long as the powers that be can command billions of dollars to influence the health care conversation through their marketing, public relations, and lobbying departments, expect the discussion not to question what they do, and how they benefit from the status quo to the financial and health detriment of patients and the population.

We will not be able to truly reform health care until we can speak openly about what threatens health care values and what needs to be done about these threats.

A Jury Finds Johnson and Johnson's Risperdal Marketing "Willfully Deceptive," but What Will It Take to Change Company Leadership?

For Johnson and Johnson, it's deja vu all over again, as reported by the Spartansburg (SC) Herald Journal:

A Spartanburg jury decided that Johnson & Johnson and a subsidiary violated South Carolina's Unfair Trade Practices Act, but the company will wait until damages are determined next month before it decides whether to appeal the jury's decision.

Also,

The jury decided Tuesday the company willfully violated the act by sending a 2003 letter to doctors that attorneys for the state said sought to minimize the risk of hyperglycemia � or high blood sugar � and diabetes reported by patients using Risperdal.

The letter was sent to about 700,000 doctors nationwide � 7,200 of those in South Carolina.

The jury decided that warning labeling included with the drug was also willfully deceptive.

This is not the first such lawsuit involving Risperdal,

South Carolina's lawsuit was the fourth state lawsuit to go to trial.

In West Virginia, claims involving Risperdal were dismissed with prejudice last December following the company's appeal.

In October, a jury in Louisiana awarded almost $258 million in civil penalties to the state. Janssen will appeal that decision.

In a jury trial in Pennsylvania in June, a judge dismissed the state's case against Janssen.

Note that we posted about the Louisiana verdict here.

The hits, they just keep on coming for Johnson and Johnson, which has been recalling a dizzying array of products due to manufacturing problems.  A new recall was just announced today, and there have been 20 separate recalls since mid-2009.

Just eight days ago we contrasted the opulent compensation given the Johnson and Johnson CEO in 2010 (about $29 million) with the company's poor financial performance, seeming inability to make pure, unadulterated, safe products as manifested by multiple recalls, and ethical problems as indicated by legal settlements and guilty pleas. Today we have added another recall, and a jury verdict against the company finding its marketing was deceptive.  So the cognitive dissonance evoked by comparison of executive pay and corporate dysfunction continues. 

Is there any degree of organizational dysfunction that could possibly induce a health care corporate CEO to feel shame for continuing to extract millions from the flailing beast?  Is there any degree of disconnection between executive compensation and corporate performance that could possibly induce complacent corporate boards to feel shame for enriching the hired executives who presided over the mess?

Probably not.  The events surrounding the global financial collapse suggested that somehow expecting corporations to regulate themselves was at best foolishly naive (e.g., see here).  Presumably former US Federal Reserve Chair Allan Greenspan really thought that markets could regulate themselves, and that fraud could not exist because markets in his idealized view would punish it themselves,

he didn't believe that fraud was something that needed to be enforced or was something that regulators should worry about....

But then he later admitted: 

Those of us who have looked to the self-interest of lending institutions to protect shareholder's equity � myself especially � are in a state of shocked disbelief

We do not yet seem to be at the point that will we generate enough "shocked disbelief" about the misbehavior of current health care organizations to realize that they will not police themselves, and a true health care reform movement will have to figure out how to reasonably regulate them.  (I submit that perusing the archives of Health Care Renewal will suggest that we should have been at that point years ago.)

If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

Despite Poor Financial Results, Diminishing Pipeline, Multiple Settlements of Legal Cases, Outgoing Pfizer CEO Got Over $24 Million

It is the season for share-holders' meetings of big US publicly held corporations, and as the proxy statements prepared for these meetings, prepare for more eye-popping, jaw-dropping examples of executive compensation. 

Pfizer's 2010 CEO Compensation
The AP (via the Wall Street Journal) just noted the compensation given to Jeffrey Kindler, the outgoing (in 2010) CEO of Pfizer, Inc, the world's largest pharmaceutical company:

Former Pfizer Inc. Chairman and CEO Jeffrey B. Kindler may have left the world's largest drugmaker abruptly last December, but he didn't leave empty-handed thanks to a compensation package valued almost $22 million.

Kindler received a 60 percent increase last year over his 2009 compensation, according to an Associated Press analysis of a Pfizer regulatory filing Tuesday.

The New York-based drugmaker gave Kindler a salary and performance-related bonus totaling $4.9 million, a $4.5 million severance payment and more than $12 million in stock and option awards. The company also will continue his health coverage for 12 months 'at active employee rates,' the filing said.

In fact, perusal of the new 2011 Pfizer proxy statement shows that Kindler, who stepped down on 5 December, 2010, made even more based on Pfizer's own calculations, $24,688, 849. Curiously, Ian Read, the CEO after 5 December, and previously Group President, Worldwide Pharmaceutical Business, received $17,396,112, despite only being CEO for 26 days.

Pay for What Kind of Performance?

These opulent pay packages stand in contrast to Pfizer's performance under Kindler and its financial results in 2010:

Kindler was ousted by Pfizer's board unexpectedly Dec. 6 after four years of languishing share prices and several failures of promising drugs in late testing, including a successor to cholesterol fighter Lipitor, the world's top-selling drug. Pfizer will lose U.S. patent protection in November for Lipitor.

Also,

Pfizer's 2010 net income fell 4 percent to $8.26 billion, or $1.02 per share. Revenue totaled $67.81 billion, up 36 percent, thanks to $18.1 billion from sales of Wyeth products.

Its stock price slipped 4 percent to close 2010 at $17.31, while the Standard & Poor's 500 index climbed 12.8 percent.

Furthermore, the compensation given the former and current CEO also stood in sharp contrast to Pfizer's amazing track record of recent unethical behavior.   Pfizer paid a $2.3 billion settlement in 2009 of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post here).  Pfizer was involved in three other major cases from then to early 2010, including two involving settlements of fraud charges, and one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post here).  The company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post here).  Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York in early 2011 (see post here).   Just yesterday a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see this story in Bloomberg).

Despite Pfizer's recent dismal financial performance, clotted drug pipeline, and unfortunate ethical/ legal track record, the company's board compensation committee reported thus:

The Committee believes that Pfizer�s executive compensation program implements and achieves the goals of our executive compensation philosophy. Pfizer�s executive compensation philosophy, which is set by the Committee, is to align each executive�s compensation with Pfizer�s short-term and long-term performance and to provide the compensation and incentives needed to attract, motivate and retain key executives who are crucial to Pfizer�s long-term success.

Who Provided "Stewardship" of Pfizer?
So I had to ask: who were these people who thought that compensation of over $24 million was somehow "aligned" with declining profits, declining revenues, little output of new drugs, and multiple legal settlements of charges like fraud and violating the RICO act?

Here is a list of Pfizer's board of directors in 2010, and some relevant affiliations, taken from Pfizer's web-site, and where indicated, elsewhere (color coding to be explained below)

- Dennis A. Ausiello, M.D. -
Jackson Professor of Clinical Medicine at Harvard Medical School and Chief of Medicine at Massachusetts General Hospital since 1996.
Member of the Institute of Medicine....
Director of TARIS BioMedical, Inc.
(per Research!America bio) advisor to drug delivery and biosensing start-up companies Entra, BIND Biosciences, and Seventh Sense Biosystems, Inc., to drug-discovery startup companies Promedior and Pulmatrix, to Proventys, an evidence-based medicine delivery system, and to Ore Pharmaceuticals and Polaris, investment and venture capital companies working in the biotech and device area.

- Michael S. Brown, M.D. -
Distinguished Chair in Biomedical Sciences since 1989 and Regental Professor since 1985 at the University of Texas Southwestern Medical Center at Dallas.
Member of ... the Institute of Medicine,....
Director of Regeneron Pharmaceuticals, Inc.

- M. Anthony Burns -
Chairman Emeritus since 2002, Chairman of the Board from 1985 to 2002, Chief Executive Officer from 1983 to 2000, and President from 1979 to 1999 of Ryder System, Inc., a provider of transportation and logistics services.
Life Trustee of the University of Miami.

- Robert N. Burt -
Retired Chairman and Chief Executive Officer of FMC Corporation, a chemicals manufacturer, and FMC Technologies Inc., a machinery manufacturer....
Life Trustee of the Rehabilitation Institute of Chicago

- W. Don Cornwell -
Chairman of the Board and Chief Executive Officer of Granite Broadcasting Corporation from 1988 until his retirement in August 2009 and Vice Chairman until December 2009.
(per Wallace Foundation web-site) He previously served as vice president, investment banking division, of Goldman Sachs.

- Frances D. Fergusson, Ph.D. -
President Emeritus of Vassar College since 2006 and President from 1986 to 2006. Served on the Mayo Clinic Board for 14 years, the last four years as its Chairman, and as President of the Board of Overseers of Harvard University from 2007 through 2008.

- William H. Gray III -
Co-Chairman of GrayLoeffler, LLC (formerly the Amani Group), a business advisory and consulting firm. Chairman of the Amani Group from 2004 through September 2009.
Currently Director of ... J. P. Morgan Chase & Co.

- Constance J. Horner -
Guest Scholar from 1993 until 2005 at The Brookings Institution....

- James M. Kilts -
Founding Partner, Centerview Partners Management, LLC, a private equity firm, since 2006.
(Per Centerview Partners web-site) Centerview Partners' investment banking advisory business serves some of the largest companies globally in a broad range of industries, with particular expertise in Food & Consumer Products, Financial Institutions, General Industrials, Healthcare, Media & Entertainment ....
The firm has executed many significant transactions in recent years, including:
Altria's $113 billion spin-off of Philip Morris International, its $62 billion spin-off of Kraft and its $11.7 billion acquisition of UST...
Facet Biotech's $722 million sale to Abbott Labs;
OSI Pharmaceuticals' $4.0 billion sale to Astellas Pharma;

- George A. Lorch -
Chairman Emeritus of Armstrong Holdings, Inc., a global manufacturer of flooring and ceiling materials,....

- John P. Mascotte -
Retired President and Chief Executive Officer of Blue Cross and Blue Shield of Kansas City, Inc.,...

- Suzanne Nora Johnson -
Retired Vice Chairman, Goldman Sachs Group, Inc.,...
Director of American International Group, Inc., .... Board member of the American Red Cross, The Brookings Institution, ... and the University of Southern California.
(per Milken Institute web-site) on the board of numerous not-for-profit organizations, including ... RAND Health ....
She is on the Advisory Board of Councilors of Harvard Medical School

- Ian C. Read -
President and Chief Executive Officer since December 2010.

- Stephen W. Sanger -
Chairman of General Mills, Inc.
Currently Director of ... Wells Fargo & Company.

- William C. Steere, Jr. -
Chairman Emeritus of Pfizer Inc. since 2001.
Currently Director of Health Management Associates, Inc.
Director of the New York University Medical Center ...; and Member of the Board of Overseers of Memorial Sloan-Kettering Cancer Center.

Of Pfizer's 14 directors (excluding its CEO), seven have or had leadership positions at teaching hospitals, academic medical centers, medical schools or their parent universities. Three have or had leadership positions at other influential non-profit health care organizations. 


Two had leadership positions at potentially competing pharmaceutical or biotechnology companies.

Two had leadership positions at companies that finance pharmaceutical, biotechnology and other health related companies.

One had a leadership position at a health insurance company.

One had a leadership position at a for-profit hospital operating company.

Four had leadership positions in financial services corporations, including some that were implicated in the global financial collapse, and/or required massive federal bail-outs to avoid collapse.

It seems that every time we look at the boards of directors or trustees who are supposed to provide stewardship to a troubled health care organization, we see a similar pattern.  Just as we recently said about the Johnson and Johnson board, ....
 
Summary
 
So here we have the latest striking case that indicates the confluence of forces that can lead to health care dysfunction. Not only has the compensation given to health care leaders got so large that it is per se a cause of increased health spending, but also, and more importantly, such compensation often provides perverse incentives that perpetuate mismanagement, raising costs and lowering quality. This situation appears to be enabled by governance (or "stewardship") by individuals who are often fellow members of the CEOs' club, and hence who may feel more sympathy with the executives they are supposed to supervise than the stockholders whose financial interests they are supposed to protect, or the public whom the companies' products and services are supposed to benefit. Moreover, these individuals often have conflicts of interest which may mitigate against objective scrutiny of the executives they are supposed to oversee. Finally, these individuals often may come from corporate cultures which do not espouse the values that we in health care are supposed to uphold. (See this post and its links for other examples of the sorts of people who are supposed to provide stewardship to health care organizations.)


So to repeat once more-

I strongly believe that there needs to be much more investigation, academic, journalistic, and perhaps legal, of the identity, nature, and culture of the leaders of health care, and their relationships. A few bloggers cannot do it all. Obviously, the anechoic effect mitigates against medical and health care academics looking into their own leaders. However, failing to understand who is leading our march to the brink of health care failure ought not to be something such academics would want on their conscience.

Finally, and obviously, health care organizations need leaders that uphold the core values of health care, and focus on and are accountable for the mission, not on secondary responsibilities that conflict with these values and their mission, and not on self-enrichment. Leaders ought to be rewarded reasonably, but not lavishly, for doing what ultimately improves patient care, or when applicable, good education and good research.

If we do not fix the severe problems affecting the leadership and governance of health care, and do not increase accountability, integrity and transparency of health care leadership and governance, we will be as much to blame as the leaders when the system collapses.

ADDENDUM (23 March, 2011) - See also comments by Merrill Goozner on the GoozNews blog.

Millions to Health Insurance CEOs, But Blame Everyone Else for Rising Health Care Costs

The revelations about the huge golden parachute given the outgoing CEO of ostensibly non-profit Massachusetts Blue Cross Blue Shield induced some public discussion about the disconnect between executive compensation and the mission of health care organization (see most recent post here).  Several other recent stories should generate more discussion on these issues. 

First, new proxy statements revealed the compensation of executives of two large for-profit health care insurers/ managed care companies.  In alphabetical order,

Cigna

As reported by the AP, via ABC news, the CEO got a big raise:

Cigna Corp. CEO David M. Cordani's total compensation more than doubled in 2010, his first year as leader of the nation's fourth-largest health insurer, and a period in which the company's earnings, revenue and enrollment all climb.

Cordani, 45, received compensation valued at $15.1 million last year from the Philadelphia managed-care company, according to an Associated Press analysis of a regulatory filing Friday.

That included a $1 million salary, a performance-related bonus totaling more than $7.3 million and stock and option awards adding up to $6.7 million.

In 2009, Cordani's compensation was $6.5 million, but he did not serve for the entire year. Note that according to the 2009 proxy, the previous CEO, H Edward Hanway, received $12,236,740 in total compensation in 2008, his last year as CEO.

What was the rationale for the huge rise in Cordani's compensation from 2009 to 2010? (And implicitly, the fairly large increase compared to Hanway's compensation in his last year?)

The company said in its proxy statement filed with the Securities and Exchange Commission that Cigna 'effectively executed on its growth strategy under Cordani's leadership last year.

'Revenue rose significantly in 2010, reflecting strong premium growth in (Cigna's) ongoing business segments,' the proxy said.

Cigna earned about $1.35 billion, or $4.89 per share, on $21.25 billion in revenue in 2010. That was up from $1.3 billion, or $4.73 per share, on $18.41 billion in revenue in 2009. The insurer's medical membership climbed 4 percent to 11.4 million people compared to the final quarter of 2009, when it fell more than 5 percent. That helped raise premiums and fees in health care, the insurer's largest segment.

Also,

Cigna shares climbed 4 percent to close 2010 at $36.66, while the Standard & Poor's 500 index rose 12.8 percent.

So to recap, Cigna's current CEO's total compensation doubled in a year while earnings and the stock price rose about 4%.

WellPoint

Also reported by AP, via the Washington Post, the CEO got a small raise (but ended up with compensation similar to Mr Cordani's above):

The president and CEO of health insurer WellPoint Inc. received a 3 percent boost in total compensation in 2010 even as the company�s profit and enrollment numbers slipped during a transitional year for U.S. health care companies.

The Indianapolis-based insurer awarded Angela Braly a total pay package worth $13.4 million up from $13.1 million in 2009. Wellpoint disclosed the compensation � which includes salary, bonus and other awards � in a filing with federal financial regulators late Friday.

On the other hand, the company did not do so well financially:

The insurer�s profit fell sharply last year compared with 2009, when the sale of its NextRx subsidiary contributed $2.2 billion in after-tax income. Medical enrollment also slid 1 percent last year to 33.3 million members.

So what was the rationale for even a small raise (over an already huge compensation package)?

In the company�s filing, Wellpoint�s board of directors highlighted accomplishments by management, including reducing general expenses by 3 percent.

Also,

A Wellpoint spokeswoman stressed Friday that the company�s pay formula rewards executives for improving enrollee health, boosting share prices and meeting other pre-set goals.

'For the CEO, almost 90 percent of total target compensation is based on company performance and is tied to meeting established goals,' Kristin Binns said in a statement.

So while Cigna did slightly better financially than last year, its CEO's total compensation doubled to well over $10 million, and while WellPoint did slightly worse financially than last year, its CEO's total compensation increased, again remaining well over $10 million.  It seems that the leaders of top health care organizations will continue to get richer, no matter how well their organizations performed financially, let alone what effect they had on patients' and the public's health.
So What Drives Up Health Care Costs?

Just to distract from CEOs getting increases in their already huge compensation that seem disproportionate to any reasonable measure of their companies' financial performance, health care insurers continued to deny any responsibility for the rise in health care costs.

For example, the San Francisco Chronicle published a story entitled, "Insurer Wants Focus on What Drives Up Health Costs," which had a familiar ring:

When health insurers notify members that rates are going up - often in the punishing double-digits - they typically blame rising medical costs.

They say the problem really isn't theirs; it's all the other pieces of the health-care puzzle that drive up costs that must be passed on to customers.

Don't blame you, don't blame me, blame that fella behind the tree.
It went on to name all the usual suspects (color-coded for comparison below):

Insurers say their costs grow in part because of new medical technologies and the rising price of pharmaceutical products and medical equipment.

The consolidation of hospitals and doctors into large networks also makes it hard to keep prices low, as do waste, fraud and malpractice, they say. The system also lacks incentives for hospitals and doctors to curb costs. For example, they can charge twice by repeating tests and procedures, and by readmitting patients.

Insurers also say they lose money with policies people buy on their own, as opposed to group coverage from employers. Because the individual policies are more expensive, healthier people tend to avoid them, leaving insurers with a sicker pool.

Poor reimbursement from government programs such as Medi-Cal also forces insurers to raise private insurance prices to make up the slack, they say.

Finally, as people get older and fatter, they gobble up more health care resources.

'When you're looking at growth in premiums, the largest engine of that growth are those medical costs,' said Charles Bacchi, executive vice president of the California Association of Health Plans, which represents health insurers. He said critics who claim that insurers raise prices to increase profits and pad executive salaries are wrong, and that insurers' average profit margin has remained at 3 to 5 percent for years.

First, note that the executive compensation, the administrative costs, the marketing, public relations and lobbying costs all come off the top of revenues before any profits are generated, and before any possible dividends get paid to stock-holders.   I suspect that the insurance industry spokespeople immediately switch the topic to profits and investors' results to distract from those who really make money from health insurance companies, the top executives, and all those managers, bureaucrats, marketers, public relations people, and lobbyists who never touch patients and never deliver any care.  As Wendell Potter has written, many people like to blame government bureaucrats for health care's problems. They may deserve some blame, but not any more, and perhaps less than corporate bureaucrats and executives.

Recall further what Wendell Potter described in Deadly Spin. All those health insurance corporate public relations people were earning good salaries in part based on their ability to distract the public and policy-makers from the insurance companies' roles in health care dysfunction. Potter wrote (p. 110):

Rather than admit responsibility for the failures, insurance executives pointed the finger of blame at their customers, the 'consumers' of health care, and, of course, the providers of care. In introducing the concept of their new silver bullet - consumer driven health care - insurance executives claimed that the 'real drivers of health care costs' (one of my CEO's favorite expressions) were the people who sought care when they really didn't need it and the doctors and hospitals who were all too willing to provide this unnecessary care. Sure, the aging population and expensive new technology were also factors, but the main culprits were people who just didn't realize how expensive health care had become.

Note the similarities among the "real drivers of health care costs" promulgated by the corporate PR people and the defense of the health insurers' role mounted above (some of the more obvious color-coded). Note that the defenses never explain why the insurance companies seem unable to negotiate prices down, and why they all use the physician payment schedule derived from the recommendations of the secretive RUC.

For some final irony, the Chronicle found an academic who was not too hard on the health insurance companies:

Glenn Melnick, a health economist at the University of Southern California, sympathizes with many of the insurers' arguments.

He blamed rising costs mainly on higher prices charged by hospitals and doctors, which account for the largest portion of health care spending.

The reporter did not note Prof Melnick's full title, Professor and Blue Cross of California Chair in Health Care Finance. Oops.

So in summary, health care costs continue rising, access keeps declining, and there is no evidence of improvements in quality. Large health care organizations blame each other for the problems, but nearly all of them continue to make their top executives extremely rich. Although the amounts diverted to these executives cannot solely account for the rise in health care costs, the perverse incentives given those who lead health care are likely a major cause of the problems. A health care system run by leaders who are comfortable becoming extremely rich while the health care crisis worsens is a likely recipe for dysfunction.

We now know commercial health insurers deploy well paid public relations departments to use stealthy if not downright deceptive means to distract those who want to address what really causes health care dysfunction (see this post.) It is likely that all large health care organizations use similar stealth advocacy strategies. These strategies have successfully distracted the conversation away from problems with health care leadership and governance, at least until now.

As we have said before, far too often the leaders of not-for-profit health care institutions seem more interested in padding their own bottom lines than upholding the institutions' missions. They often seem entirely unaware of their duty to put those missions ahead of their own self-interest. Like the financial services sector in the era of "greed is good," health care too often seems run by "insiders hijacking established institutions for their personal benefit." True health care reform would encourage leadership of health care who understand health care and care about its mission, rather than those who see a quick way to make a small fortune.

Furthermore, we need an open discussion of the real issues related to health care dysfunction, not one stifled by the anechoic effect, spun by corporate PR, and dominated by "third parties" whose conflicts of interest are hidden. 

How Academic and Government "Anecdotes Are Not Data" Ideologues Kill People

I'm already receiving comments that, regarding Prof. Jon Patrick's detailed expos� of the dangers of ill-suited-for-purpose ED EHR's, Patrick's observations are:

... not really valid because they're not peer reviewed; they're just anecdotal.

Only an egghead could pen such words.

I always get hives immediately after eating strawberries. But without a scientifically controlled experiment with all the right peer review, it's not reliable data. So I continue to eat strawberries every day, since I can't tell if they cause hives.

I'd already written about anecdotalist refrains at my Mar. 7, 2011 post "Australian ED EHR Study: Putting the Lie to the Line "Your Evidence Is Anecdotal, Thus Worthless" Used by Eggheads, Fools and Gonifs." In that essay I cite Dr. Patrick himself on "anecdotal evidence", regarding which he hit the ball out of the Southern Hemisphere in an editorial in "Applied Clinical Informatics" entitled "The Validity of Personal Experiences in Evaluating HIT."

Aside from the fact that eggheads also don't seem to care about the issues of faulty peer review, especially in profitable biomedical sectors, such as at "The Lancet Emphasizes the Threats to the Academic Medical Mission" with its embedded links, and "Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?", there's this simple fact:

Public health catastrophe warnings from responsible sources don't need peer review, they need investigation.

Yes, there were those pesky, off-narrative journalistic reports that the Japanese nuclear reactors were not entirely safe, that Bernie Madoff was a fraud, that mortgages for everyone was not a good idea, that the O-rings couldn't stand sub-freezing temperatures, that the the foam that broke off the Columbia launch tank caused a danger, and that the Titanic didn't have enough lifeboats, but they weren't peer reviewed...so we ignored them. Saved us a lot of money, too.

-- SS

Addendum:

At my post "Real" Medical Informatics: What Does a Problem List of Typical Health IT Look Like, Part 2", I opined:

If the purpose of Medical Informatics is the improvement of healthcare (as opposed to career advancement of a small number of academics through publishing obscure articles about HIT benefits while ignoring downsides in rarified, echo-chamber peer reviewed journals), then:

• Who are the "real" medical informatics specialists, and;
  

• Who are the poseurs?

... researchers like Jon Patrick who address real-world issues of great import to patients on HIT risks, and further go public on the web with their work without the full blessings of some dusty journal (and those like Ross Koppel who also directly address the downsides, and others who make available to the public material such as on blogs like this and this, papers like this and sites like this) are the former.

Those who deem only "peer reviewed" articles worthy of daylight, and everything else - especially and particularly reports of downsides - "anecdotal" (the anecdotalists) are the latter.

I stand by this assertion.

Finally, I ask: at what point does ignoring work such as Prof. Patrick's, if patient harm is caused by the system he reviewed, constitute reckless endangerment and perhaps criminal negligence by hospital and government officials?

-- SS

Addendum Mar. 23:

As if on cue, this story appeared in the WSJ:

March 23, 2011

Japan Ignored Warning of Nuclear Vulnerability

TOKYO�Japanese regulators discussed in recent months the use of new cooling technologies at nuclear plants that could have lessened or prevented the disaster that struck this month when a tsunami wiped out the electricity at the stricken Fukushima Daiichi power facility.

However, they chose to ignore the vulnerability at existing reactors and instead focused on fixing the issue in future ones, government and corporate documents show. There was no serious discussion of retrofitting older plants with the alternative technology

I guess the "vulnerability reports" just weren't peer reviewed, therefore meaningless - or not reviewed by the "right" peers.

This sounds like our own FDA, ONC office and Institute of Medicine (via the Committee on Patient Safety and Health Information Technology), "choosing to ignore" health IT "vulnerabilities" (such as the aforementioned) and focusing on future issues such as comparative effectiveness research, "the common good", etc. instead.

I call this attitude "reckless endangerment" and hope plaintiff attorneys are paying close attention.

-- SS

EHR Legible Gibberish - Another Example, the ED EHR Allergy List

My brain-injured mother was admitted to a suburban hospital (recently acquired by the "big hospital" where her EHR-related injuries of 2010 had occurred) Saturday morning.

She was again in a confusional state (delirium) of unknown cause, probably recurrent infection.

Of note, almost every time I see hospital EHRs, I note a problem.

In my Jan. 2011 post on this issue at the same organization, "EHR Problems? No, They're Merely Anecodotal; the Truth Must Be That I Attract Bad Electrons and Stale Bits" I observed a nurse-stated "glitchy-ness" that day that manifested as unreliability in pulling up the patients' current med lists. I had to be the conduit of my mother's meds, despite having gone through them in detail for computer entry in the exact same ED just 24 hours prior after a fall:

... My mother was having a repeat of the ischemia to the brain or "TIA" (transient ischemic attack, i.e., threatening to have a stroke), only this time the ED EHR itself was also having a TIA.

This was not the "FirstNet" ED EHR by Cerner forensically analyzed by Dr. Jon Patrick (as I wrote about here), but another ED EHR, by a company whose ICU physiological monitoring system I once as CMIO struggled with due to repeated, unexplained crashing.

On this most recent ED visit/admission to the satellite just days ago, I noted another problem with the ED EHR system (the same one that started my mother's travails at the main facility in May 2010, and now in use at the satellite).

When the ED nurse brought up my mother's allergies, they were repeated over and over and over on the ED screen, in a long recurrent list dozens of lines long, as if they'd been cut-and-pasted multiple times at each visit. She apologized to me. See images of a printout I later demanded, below (names of hospital, patient, EHR, and EHR screen layout digitally redacted):

Allergy list, page 1 (excerpted from an on-screen continuous list). Click to enlarge.

Allergy list, page 2 (excerpted from an on-screen continuous list). Click to enlarge.

Allergy list, page 3 (excerpted from an on-screen continuous list). Click to enlarge.

Note that on-screen these appeared as a long, confusing list.

The repetition made the list near useless to the ED personnel (for example, they don't have time to look for the one crucial item that ISN'T a duplicate in the mess).

Legible gibberish indeed.

The ED RN just asked me about my mother's allergies, saying she wanted to make sure no mistakes occurred. This is an appropriate attitude - the only appropriate attitude - or a clinician. Fortunately, I'm a doctor and know the allergies well.

The hospitalist then called me that night suggesting she would give my mother Levaquin, an antibiotic. For the umpteenth time I had to tell a doctor at these facilities my mother was allergic to Levaquin. This was in fact one of my complaints on my April 2010 warning letter to the hospital's CEO and CMO on EHR deficiencies I'd noted in my mother's care. This was just one month prior to her catastrophe, when a critical heart medication "disappeared" in the ED EHR, causing a cascade of medication continuity failure.

Yesterday I insisted the duplicate entries be removed (more precisely, "made inactive" - they still appear, but in a different color than "active" entries).

It is, on first principles, inherently harmful to the public to have critical patient data stored in disarray in an Emergency Room electronic health record.

See the above images, and ask if this is what you'd want busy ED doctors to have to wade through to figure out if a drug they're about to administer might injure or kill you.

-- SS

Post legal-threat addendum:

I'd originally posted actual screen shots (PHI and hospital name redacted) of the allergy lists provided to me by an ED attendant upon my request as my mother's POA.

On April 8, 2011, however, I received a threatening letter from the attorney representing the hospital claiming these screens were viewed by the client as "copyrighted and proprietary information" that I had "misappropriated" (stolen).

(This raises the question as to who, exactly, the "client" is - the hospital, or the EHR vendor?)

In any case, I was asked to "retract from the blog the copyrighted and proprietary information" under threat of the hospital "pursuing all remedies under the PA Trade Secret Act and Federal Law." Further, I was accused of "inappropriate behavior" in trying to protect my mother from further EHR-related accidents.

I have now done as asked, only posting the allergy information and dates without the background EHR screens, the only component that could reasonably be viewed as protected IP (i.e., of the EHR vendor).

I had a followup discussion with a senior nurse involved in the EMR project about those screens and the legal threats, which I viewed as potential retaliation aimed at discriminatorily denying my mother and I use of public accommodations, i.e., the hospital, through intimidation. (If my seeking records legitimately was "inappropriate behavior", who knew what else I might be falsely accused of to "discourage" my return?)

I was informed with a straight face that the allergy repetition was a "feature", not a bug.

The problem was "the nurse in the ED", who did not understand they needed to "look at the dates" to understand the allergy list. ["Blame the user" is typical in this domain - ed.] This senior nurse clearly had an amateur's understanding of HCI and clarity of presentation of information - or was simply talking down to me.

I provided a reminder that with 20 years of Ivy academic, big hospital (much larger than hers) and Big Pharma experience in this domain, I found her arguments specious.

Amateurism on presentation of information is a factor that promotes EHR-related error. (It is my hope the original ED nurse is not punished for protecting patients instead of "protecting the computer" and its faults.)

-- SS