Another Echo of the Case of the Deadly Heparin - A Report on the Perils of Out-Sourcing Drug Production

In 2008, we published multiple posts on how heparin made as an "active pharmaceutical ingredient" in China under apparently primitive conditions, contaminated accidentally or deliberately, was sold in the US bearing the label of a large American pharmaceutical company.  Ultimately, many patients were sickened, or died.  A summary of our posts on the topic, in smaller type, is below.

Case Summary

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

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

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

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

- Leaders of all organizations involved, Baxter International, Scientific Protein Laboratories, Changzhou SPL, the Chinese government, and the US Food and Drug Administration, and the US Congress assigned blame to each other, but none took individual or organizational responsibility. (See post here.)

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

- Hundreds of lawsuits against Baxter have now been filed, so far without resolution.  (See post here.)

Now, as reported to date only on the PostScript blog, a US government report on problems with active pharmaceutical ingredients made in China has appeared.

A new report (pdf) by the U.S. China Economic and Security Review Commission stresses the safety risks to Americans posed by pharmaceutical ingredients made in China.

According to the report, issued by a group that advises Congress on the economic and trade implications of U.S.-China relations, found that the U.S. is the number one destination for Chinese pharmaceutical raw material exports – a $2.2 billion business each year. The U.S. relies heavily on Chinese products not only for over-the-counter drugs but for active pharmaceutical ingredients (API) found in prescription drugs.

And the report makes clear that China has neither the will nor the systems in place to monitor its exports.

This begs the question that most of the coverage of the deadly heparin also begged.  Are American pharmaceutical companies so besotted with the need for cost-savings that they are willing to buy active pharmaceutical ingredients with unknown provenance overseas as if they were a pig in a poke?  If so, why do we allow company leadership to potentially sacrifice quality, and sell adulterated drugs just to enrich their bottom lines (and their executives' salaries)? 

Cerner - Fuqua School of Business 'Corporate Ethics 101' Paper and Website Disappear

On April 16 at "Healthcare IT Corporate Ethics 101: A Strategy for Cerner Corporation to Address the HIT Stimulus Plan" I wrote about a Duke Fuqua School of Business paper (apparently authored by a Cerner official) promoting a business strategy of regulatory manipulation to restrain the free market for HIT products.

The paper, and the Fuqua School of Business web page "Past Papers" on which the paper was promoted, have both disappeared as of this April 18 writing.

I have posted an image of the "Past Papers" page and updated my link to an archived copy of the paper, but the scrubbing of the Fuqua site and removal of the paper is interesting.

-- SS

Addendum Apr. 19 -

A former HIMSS staffer related to me that I am likely blacklisted from the HIT vendor industry as a result of my writings on health IT on this site and at my academic site dating to 1999, via verbal exchanges and even in writing among HIT organizations. It could explain why my CV's been uniformly ignored by that industry since the early 2000's.

If so, so be it. Who else might be on that blacklist, I wonder?

Also, didn't Richard Nixon get into a bit of trouble for maintaining such a list after it was discovered?

Health Information Technology Basics From Calif. Nurses Association and National Nurses Organizing Committee

I have never before seen a document like the one entitled "Health Information Technology Basics", by the Institute for Health & Socio-Economic Policy, California Nurses Association and the National Nurses Organizing Committee. It is available at this link (PDF).

It is long but contains rather interesting views on the issue of health IT, management and clinicians (nurses).

I find the following passages of particular interest as they reflect views we express on this blog, and attack the notion of cybernetic miracles being wrought:

Skill is the ability, drawn from education and experience, to do something expertly. It can also be defined as the effective exercise of professional judgment in non-routine situations.

Following prescribed rules, as a machine would, makes an employee competent to perform tasks, but it doesn’t make the employee skilled. They can do their job as long as there are no surprises. But when something unexpected happens, the rules break down, and caring for patients means facing the unexpected every day. Only skilled health professionals can cope with the unexpected. To know what to do, they have to rely on their own judgment. The exercise of judgment is the essence of skill.

... Much health information technology is skill-degrading. As the work of health professionals becomes increasingly automated, they lose the ability to do their jobs without HIT. To make matters worse, they’re expected to keep pace with machines. They serve the machines rather than doing the more gratifying work of patient care, and ultimately they’re compensated less well.

And this:

Displacement [pf people by machines] is hard to spot because it’s unlikely to appear as a one-to one correspondence; that is, you probably won’t find a robot sitting in your colleague’s chair tomorrow. It’s more likely to happen piecemeal, over an extended period, and through attrition.

• The job of patient care will be redefined, privileging technical over clinical skills.
• The hospital will begin to hire more HIT specialists and fewer RNs.
• Functions performed in the past by health professionals will be fragmented and reallocated between machines and less-skilled employees.
• Increased technical efficiency will enable the hospital or HMO to expand without expanding its workforce.

And this:

Use of any hospital technology must be consistent with safe, therapeutic, and effective patient care. Health information technology is a complete unknown in this regard. It’s an enormous social experiment designed by computer scientists and implemented by hospital administrators. HIT hasn’t grown organically from the needs of patients but has been imported from other industries. Known as enterprise resource planning, it’s adapted from similar technology designed to manage business operations on a massive scale and already being used to run the world’s largest corporations.

Caring for patients isn’t business. It requires compassion, judgment, and advocacy. Because RNs have the moral right and legal duty to advocate for patients, they have to be able to override the automated decision-making of HIT designed to serve business interests.

RNs have to work collectively to control health information technology rather than trying to fix it. It’s important to recognize that tinkering can’t fix HIT because its primary purpose is to mechanize, or routinize, patient care. It’s designed to quantify the unquantifiable, to replace the patient with an imaginary statistical norm. High-quality healthcare can’t be mechanized because it depends on people—on patients and caregivers—and people are infinitely more complex and capable than computers can ever be.

Amen to that.

Read the entire document for a union-oriented view of health IT. It contains many truisms regarding HIT irrational exuberance and the control issues of the healthcare management class.

-- SS

If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers

In 2005 the RAND corporation ‘guesstimated’ figures for healthcare IT benefits based on existing, limited data sets (http://www.rand.org/pubs/research_briefs/RB9136/index1.html).

Their methods and results were contested, such as by the Heartland Institute (as here). Recent studies also put the RAND assumptions including those about flawless implementation and acceptance in serious doubt (as here).

Similarly, the often-quoted 2000 Institute of Medicine (IOM) report "To Err is Human" used several small studies to extrapolate a death rate due to medical mistakes at 98,000 per year. That report was challenged by medical informatics pioneer Clement McDonald, MD in a 2000 JAMA article "Deaths Due to Medical Errors Are Exaggerated in Institute of Medicine Report" here, PDF.

However, the refutation didn't stop anyone who could benefit from quoting such numbers from touting them, including those pushing healthcare IT. In fact figures such as these have been used as a bludgeon to affect national policy on healthcare IT.

If the benefits of HIT can be guesstimated, so can and should the dangers.

The true incidence of health IT-related medical errors, injuries and deaths from IT error, poor design, cognitive overload, clinical disruption, etc. is unknown. The Joint Commission in its 2008 Sentinel Events Alert advised that "There is a dearth of data on the incidence of adverse events directly caused by HIT overall" (as here).

As a thought experiment, presented here are some estimated corrective factors that might shed some light on the actual figures for HIT-related injuries and deaths "on the ground" when national, universal HIT deployment is achieved.

The thought experiment:

Jeffrey Shuren, MD, JD of FDA mentioned reports of 44 injuries and 6 deaths over 2 years that are likely the "tip of the iceberg" at the Feb. 25, 2010 HIT Policy Committee Adoption/Certification Workgroup on IT safety (http://hcrenewal.blogspot.com/2010/02/fda-on-health-it-adverse-consequences.html).

Ross Koppel, PhD at the same Feb. 25 IT safety conference opined that "We don't know 99 percent of the medication ordering errors that are made [due to difficulty in recognition, lack of proper studies and other factors - ed.]. If 100 percent of the known errors were reported, that would be 1 percent of the [true] total. But the data suggests that the maximum on voluntary reporting is about 5 percent. So 5 percent of 1 percent that is what we know is reported...."

Now, some estimated corrective factors:

• Due to a severe lack of awareness by physicians and healthcare organizations of FDA as a "go-to" organization to whom to report HIT-related medical errors and harm, let us assume FDA is privy to only 1/100 of the known injuries and deaths due to HIT (mostly reported locally). That's probably a conservative figure. Corrective factor = 100x

• Based upon figures from "Electronic Health Records in Ambulatory Care — A National Survey of Physicians", NEJM 359:50-60, July 3, 2008, let us roughly estimate that 10% of doctors/organizations are using HIT "meaningfully" (or better term, "in good faith") in 2010. Corrective factor for HIT-related errors that cause harm = 10x for universal use nationwide.

• Per Koppel, only a maximum of 5% of medication errors are voluntarily reported at all. Assuming similar figures for [medication and other] HIT-related errors that cause harm, corrective factor = 20x

• In approximating the actual number of HIT-related medication errors based on reported numbers, we would need to multiply reported figures by 100x per Koppel (since only 1% of HIT-related medication errors are recognized as HIT-related). However, from the JC Sentinel events alert figures from the United States Pharmacopeia MEDMARX database from 2006, only 1.25% (i.e., approximately 1%) of medication errors actually cause harm, so reported figures on medication errors require no corrective factor regarding patient harm (corrective factor for HIT-related medication errors that cause harm = unity = 1x).

• Although the learning curve never becomes flat in part due to clinician unfriendliness of the software, newcomers to HIT will for a number of years be more error-prone and experience more HIT-related adverse outcomes than experienced users and organizations. Conservatively assume a corrective factor = 2x.

Overall, that creates a corrective factor of 100 x 10 x 20 x 2 = 40,000

Multiply the FDA figures per year (22 injuries and 3 deaths) by this factor = 880,000 injuries per year, 120,000 deaths when universal HIT use is achieved.

Merely multiply by 4,000 for a guesstimate of current figures at ~10% diffusion.

This assumes no major changes occur with regard to the technology's risks, such as via the accelerated interdisciplinary research in biomedical informatics, computer science, social science, and health care engineering recommended by the National Research Council in their Jan. 2009 report on HIT (http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12572), and via other studies and improvements that might be made.

The way this industry operates, however, e.g., as in my post "Healthcare IT Corporate Ethics 101", the National Research Council-recommended changes are unlikely in the near future.

While this is a mere thought experiment, the result certainly suggests we need to know the actual rates of HIT-related patient harm, and act to understand and minimize these events.

In setting national healthcare policy, we should not rely on thought experiments - but even more importantly, we should not be relying on guesswork and wishful thinking as we are currently.

-- SS

What Me Worry, Redux - Another Leader Prospers Despite Questions about His Organization's Ethics and Performance

We have posted lately (here and here) about how leaders of health care organizations seem to be getting even richer despite questions about their organizations' ethics or performance.  Here we go again. 

The news about UnitedHealth over the years has provided plenty of examples of organizational behavior that did not fit the company's stated lofty goals, per its "Social Responsibility" page:

UnitedHealth Group's mission is to help people live healthier lives.

Social responsibility begins with us–and how we do business. Every day, our 75,000 employees strive to find smart ways to promote healthier lives in our communities.

On its "Mission and Values" page:

Our mission is to help people live healthier lives.

* We seek to enhance the performance of the health system and improve the overall health and well-being of the people we serve and their communities.
* We work with health care professionals and other key partners to expand access to quality health care so people get the care they need at an affordable price.
* We support the physician/patient relationship and empower people with the information, guidance and tools they need to make personal health choices and decisions.

However, a few years ago, we posted repeatedly about a block-buster scandal that lead to the ouster of the UnitedHealth CEO, Dr William McGuire. As we discussed, (here, here, and here from 2006 with links backward) Dr McGuire received outrageously lavish remuneration, which stood in stark contrast to the previous UHG mission's pledge to "make health care more affordable."  Controversy has swirled over the timing of huge stock option grants given to Dr McGuire (see post here), leading to his resignation in October, 2006 (see post here). Later, McGuire agreed to pay back some of those options, although that reportedly still left him with more than $800 million worth of options (see post here).  Iin 2009, we posted about the final settlement of the back-dating scandal, which cost UnitedHealth $895 million, and Dr McGuire $30 million and the cancellation of 3.6 million stock options. 

Also,

• as reported by the Hartford Courant, "UnitedHealth Group Inc., the largest U.S. health insurer, will refund $50 million to small businesses that New York state officials said were overcharged in 2006."
• UnitedHalth promised its investors it would continue to raise premiums, even if that priced increasing numbers of people out of its policies (see post here);
• UnitedHealth's acquisition of Pacificare in California allegedly lead to a "meltdown" of its claims paying mechanisms (see post here);
• UnitedHealth's acquisition of Sierra Health Services allegedly gave it a monopoly in Utah, while the company allegedly was transferring much of its revenue out of the state of Rhode Island, rather than using it to pay claims (see post here)
• UnitedHealth frequently violated Nebraska insurance laws (see post here);
• UnitedHealth settled charges that its Ingenix subsidiaries manipulation of data lead to underpaying patients who received out-of-network care (see post here).

However, it being proxy season, the Washington Post just reported current UnitedHealth CEO Stephen J Helmsley's compensation,

$8.9 million, up from $3.2 million in 2008. The 2009 total included a salary of $1.3 million, which was unchanged from the previous year, and a cash bonus of $2 million, up from $1.8 million the year before. It also included $5.6 million attributed to stock-related awards.

But that was not the only money Mr Helmsley reaped from his job at UnitedHealth:

The chief executive of UnitedHealth Group, one of the nation's largest health insurers, reaped almost $100 million from exercising stock options last year, the company reported Thursday.

Stephen J. Hemsley exercised 4.9 million options in February 2009 at a gain of $98.6 million, the company said in a regulatory filing. The options were awarded almost a decade earlier.

$98.6 million here, $98.6 million there, and soon you have some real money. How did the UnitedHealth board rationalize making Mr Helmsely such a wealthy man?

The compensation committee of UnitedHealth's board believed that Hemsley's 2009 compensation package 'was appropriate to recognize Mr. Hemsley's overall leadership in positioning the Company for long-term success in a very difficult overall economic environment,' UnitedHealth said in the report filed with the SEC Thursday.

The committee credited Hemsley with 'enhancing the Company's reputation, ethical culture and tone at the top.'

'Although Mr. Hemsley's total compensation is below the median as compared to other CEOs in the Company's peer groups, the Compensation Committee and Mr. Hemsley agree that it is sufficient to motivate and retain him,' the company reported.

Note first that some of the issues listed above (after the back-dated options scandal) accruef on Mr Helmsley's watch as CEO, which began in 2006.   They did not enhance the company's reputation, or seem to be evidence of an enhanced "ethical culture and tone." 

The rationale to have given Mr Helmsley so many stock options in 1999 as to give him a nearly $100 million dollar profit in 2009 was not stated.

Moreover, as noted in the 2010 proxy statement,

Mr Helmsley is President and Chief Executive Officer of UnitedHealth Group and has served in that capacity since November 2006. he has been a member of the Board of Directors since February 2000. Mr Helmsley joined the Company in 1997 as Senior Executive Vice President. He became Chief Operating Officer in 1998, was named President in 1999, and served as President and Chief Operating Officer from 1999 to November 2006.

So it was on Mr Helmsley's watch as Chief Operating Officer that all of the events and issues listed above occurred. Tell me again about that "enhanced ethical culture?"

So I say it again. Clearly we see examples of both profoundly perverse incentives and a complete lack of accountability and responsibility affecting the leadership of major health care organizations. Is it any wonder that these organizations continue to act unethically, and that the costs of the goods and services they provide rise continuously?

If we truly want health care that is accessible, of high quality, at a fair price, and more importantly, if we want health care that is honest and focused on patients, we need to provide health care leaders with clear, rational incentives in these directions, and make them fully accountable for their actions, and the courses of their organizations under their leadership.

Healthcare IT Corporate Ethics 101: 'A Strategy for Cerner Corporation to Address the HIT Stimulus Plan'

Combination in restraint of trade: An illegal compact between two or more persons to unjustly restrict competition and monopolize commerce in goods or services by controlling their production, distribution, and price or through other unlawful means. Such combinations are prohibited by the provisions of the Sherman Anti-Trust Act and other antitrust acts.

I have written on these blog pages that the IT industry has staged an invasion of the healthcare professions.

One of these invasions has to do with the ethics of the IT industry, ethics at odds with medical ethics and the Hippocratic oath. The HIT industry is characterized by an overarching interest in profits and cavalier attitudes towards HIT-related adverse clinical events through sales of inferior products (domestically as well as abroad) based on archaic technologies, exaggerated claims of benefits, ultra-aggressive marketing, and legalized suppression of adverse events information about unproven, non-secure, largely experimental health IT medical devices.

I find it truly remarkable, more than 20 years into consumer availability of the GUI, that in the 2009 publication "Principles and Proposed Methods of EMR Usability Evaluation and Rating" (PDF) the major HIT trade group HIMSS admits that:

Electronic medical record (EMR) adoption rates have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available.

Unbelievable. What has this industry been doing for the past few decades?

Worse, the health IT industry is entirely unregulated and has pushed to maintain that status quo. Now the HIT industry may be clamoring for industry regulation as a means of restraint of trade as described below.

The public is beginning to wake up to the vendor and HIT trade group puffery, at least with regard to security hazards and exaggeration of the benefits:

Electronic health records prompt security, costs concerns
Richmond Times-Dispatch
By Tammie Smith
Published: April 5, 2010

The thought of one's personal medical information being just a computer click away does not sit well with many consumers. In a March 2009 survey of 1,238 randomly selected adults by the Kaiser Family Foundation, the Harvard School of Public Health and National Public Radio, 59 percent of respondents didn't think confidentiality of electronic medical records could be assured ... 76 percent thought it was likely that an unauthorized person would get access to medical records online.

... While there are anecdotal stories of electronic health records improving outcomes, the data are mixed on whether they save money. A Harvard Medical School study published in the American Journal of Medicine last year linked 2003-2007 cost and quality data for 4,000 hospitals, including the 100 "most wired" hospitals. The researchers concluded that the electronic health records systems in place so far "might modestly improve" quality quality but produced no savings on administrative or overall costs.

'Anecdotal'? 'might'? 'modestly'? Is that worth spending hundreds of billions of dollars on, at a time when the healthcare system is struggling to make ends meet, I ask?

Unfortunately, the public and healthcare regulators need a further awakening about the Healthare IT industry's ethics.

A profoundly disappointing lesson in the ethics of the healthcare IT sector (and the B-schools as well) can be gleaned from the following, a paper written by a Cerner employee and two health industry colleagues for a Duke Fuqua School of Business course.

The course is "Health Economics & Strategy (HLTHMGMT 326), Distance Executive MBA" (syllabus here in PDF). The course's stated purpose:

We will apply the tools of economics and strategy to address the challenges and opportunities of today's health care managers and policy makers. We will begin most classes with analysis of recent news, then discuss a case, and conclude with additional insight on the application of economics and strategy.

The paper is entitled -

"A STRATEGY FOR CERNER CORPORATION TO ADDRESS THE HIT STIMULUS PLAN" (PDF).

*** April 18 NOTE: the paper apparently has been scrubbed and is no longer available from the above link as it was on April 16. A copy is here (PDF).

It is actually highlighted at Duke professor David Ridley's page "Duke University Fuqua School of Business: Past Papers."

*** April 18 NOTE: the "Past Papers" page has also seemingly been scrubbed. This is how it looked two days ago:

(click to enlarge)

This appears to be a Final Paper for an online MBA program course for executives. These are therefore not just students in the academic sense; as in my own healthcare informatics courses, I've had 'students' who concurrently were executives and managers in healthcare companies and organizations.

All three authors are listed at business networking site LinkedIn.com:

• Dan Aycock - appears as Business Strategist at Cerner
• Aparna Prasad - MBA Candidate at The Fuqua School of Business, Duke University
• Barri Stiber - Administrative Fellow at Legacy Health - formerly Senior Analyst at The Advisory Board Company

The paper is emblazoned with the Cerner corporate logo on its cover page and could be mistaken for an official document:

Paper's cover page. Click to enlarge

From the paper, an example of HIT corporate ethics (and business school ethics as well):

Electronic health records (EHRs) have the potential to improve the healthcare system through several means including reduced medical errors, better coordination of care, and reduced costs. However, adoption of EHR systems in the U.S. has been slow; only 1.5% of acute care hospitals have comprehensive EHR systems.

While the Bush administration made efforts to spur adoption of these systems, the Obama administration’s American Recovery and Reinvestment Act of 2009 (ARRA) has pushed EHR adoption to the fore with over $20 billion dollars in incentives. With such a large infusion into a relatively small market the effects of the stimulus package have enormous strategic implications for EHR vendors.

This paper seeks to clarify these implications, understand the strengths and weaknesses of various players in the industry and recommend a strategy for Cerner Corporation to maximize its profit from the stimulus package and thereby secure a dominant position in the HIT industry.

... We recommend that Cerner collaborate with other incumbent vendors to establish high regulatory standards, effectively creating a barrier to new firm entry. Other strategic recommendations to capture market share, facilitate EHR adoption, and improve Cerner’s operational readiness are detailed and framed within an implementation plan.

I am going to highlight one key sentence for emphasis:

We - recommend - Cerner - collaborate - with - other - incumbent - vendors - to - establish - high - regulatory - standards, effectively - creating - a - barrier - to - new - firm - entry.

Did I read that correctly?

The paper goes on to explain:

... With the introduction of stimulus funding, this industry is ripe for disruptive innovation, which could significantly change the competitive landscape. Examining Christensen’s work on disruptive innovation outlined in Figure 6, the primary factor that will influence the entry of new HIT vendors is regulation.

Therefore, the technology standards and definitions of “meaningful use” which are under development have the potential to raise or reduce barriers to entry, limiting or enhancing the ability for disruptive innovations to enter at a lower performance point. When asked about which competitors the organization is most concerned about, a Siemens Executive indicated “it is these new guys who could come in and undercut prices with substandard products.”

["New guys" ="substandard"? This from a company that apparently fired an informatics physician for raising concerns that a substandard ICU system was going to kill patients - ed.]

Therefore, incumbent firms, like Cerner, have strong incentives to influence regulation in their favor, keeping barriers to entry high.

[Influence in their favor, not in the favor of patients, to maintain the industry oligarchy? - ed]

In other words, to stifle disruptive innovation and prevent newcomers from entry into the HIT business, large HIT vendors should influence regulation towards high standards impossible for newcomers to meet.

NOT that they should influence regulation for the sake of patient safety!

This student is apparently a Cerner strategist seeking an MBA. His colleague Barri Stiber was a Senior Analyst at The Advisory Board Company, a company that serves "nearly 3,000 progressive organizations worldwide—health care, health benefits, and educational organizations alike—providing innovative solutions to their most pressing challenges such that they can “hardwire” best-practice performance."

This paper raises a number of questions:

• Does this paper reflect a strategy that would amount to illegal restraint of trade and/or fall under the federal RICO act, through knowingly and willfully advancing a lobbying strategy to strangle fair competition?

• Were any of these authors on Cerner's payroll when this was written?

• Are Mr. Aycock or other authors giving such advice to Cerner management presently?

• Did or does Cerner use this paper or derivatives thereof internally?

• Does this paper reflect on the business ethics of Cerner or other large HIT vendors? Will they openly condemn its ideas as both wrong minded and monopolistic, using their influence to create a market adverse to smaller competitors - not to mention the paper's seeming lack of concern for what really matters - the "customer" (patients)?

• Did or does this paper reflect a more widespread healthcare IT large player collusion on restraint of trade?
  

• Is this how the Advisory Board company conducts its business in advising healthcare organizations?

• What type of professor would exalt a paper via posting it as an example for other students to emulate, a paper whose basic premise is unethical, or at the very least on the precipice of unethicality?

• Does this professor teach such ethics?

• Why was this paper not returned to its authors with a big, red "F" on it? That's what I would have done.

• What other papers are accepted by this professor that demonstrate similar business "strategies" in other sectors?

Finally, and perhaps most importantly:

• Does this paper reflect, or did it influence, current Cerner or other large HIT vendor business strategy?
  

Recent developments are consistent with that, i.e., Cerner starting to acknowledge need for regulation, per the Feb. 2010 story "FDA Considers Regulating Safety of Electronic Health Systems" by the Huffington Post Investigate Fund, http://huffpostfund.org/stories/2010/02/fda-considers-regulating-safety-electronic-health-systems).

From that article:

.... Yet some inside the industry favor stepped-up scrutiny. One major vendor, Cerner Corporation, which has voluntarily reported safety incidents to the FDA in recent years, signaled its support for a rule that would make those reports mandatory. Cerner has reported potential safety concerns because it is the “right thing to do,” a company official said.

I was puzzled by that turnaround.

Perhaps now I know from where it arose.

It certainly is the "right thing to do." It's the right thing to do to enhance profits and enforce restriction of market entry by "disruptively innovative" newcomers.

Those newcomers might actually hold the answers to improving healthcare IT and reducing costs through fair, free market competition, saving lives and money the healthcare system dearly needs. (For example, see my post "Hospitals Under the Knife: Sacrificing Hospital Jobs for the Extravagance of Healthcare IT".)

-- SS

Addendum Apr. 16 -

A commenter speculates that:

... When I did my MBA, back in the day, we were one of the first programs to have a working business background as a requirement for admission. From that base I would make the following guesses:

• The people were not only on the company payroll, but also were having their tuition paid for by the company.
• This document was widely circulated within the company,
• The document was highlighted as a means for the university to curry favor with the company thus increasing recruits or for financial gain.

... The modern remote MBA program is in many instances simply a way to check a box for employees on the fast track to senior management. Often papers are written with the support of the company and access to department heads who contribute to material turned in.

From my experience this is not some theoretical exercise, but a document that, even retiled, will be used internally to drive policy.

While that is speculation, it is certainly plausible; nothing would surprise me in the health IT industry.

Addendum Apr. 19 -

A former HIMSS staffer related to me that I am likely blacklisted from the HIT vendor industry as a result of my writings on health IT on this site and at my academic site dating to 1999, via verbal exchanges and even in writing among HIT organizations. It could explain why my CV's been uniformly ignored by that industry since the early 2000's.

If so, so be it. Who else might be on that blacklist, I wonder?

Also, didn't Richard Nixon get into a bit of trouble for maintaining such a list after it was discovered?

-- SS

WaMu Worry? - More Overlaps Between "Stewards" of Failed Financial Firms and the Leadership of Health Care Organizations

Investigations of the failures of major US financial corporations during the global financial meltdown continue to paint a picture of bad leadership.  The latest failed corporation to get public attention was Washington Mutual (WaMu).  As described by the Los Angeles Times,

Before Washington Mutual collapsed in the largest bank failure in U.S. history, its executives knowingly created a 'mortgage time bomb' by making subprime loans they knew were likely to go bad and then packaging them into risky securities, a congressional investigation has found.

In some cases, the bank took loans in which it had discovered fraudulent activity -- such as misstated income by borrowers -- and rolled them into mortgage securities sold to investors without disclosing the fraud, according to the report released Monday by the Senate's Permanent Subcommittee on Investigations.

The investigation strongly suggested that WaMu leaders ignored questions about their practices:

According to the Senate report, WaMu executives were aware in 2006 of problems at its Southern California subprime unit, Long Beach Mortgage Co. Excerpts of internal e-mails and reports offer a stark and unvarnished view of the warning signs that were dismissed as the bank tumbled toward failure.

The company's chief risk officers called Long Beach Mortgage, the subprime subsidiary the firm used to stage its rapid growth in home lending, 'a real problem for WaMu.' Stephen Rotella, WaMu's former chief operating officer, described the unit as 'terrible.'

The company and its Long Beach unit 'used shoddy lending practices . . . to make tens of thousands of high-risk home loans that too often contained excessive risk, fraudulent information or errors,' according to a subcommittee memo.

Making money in the short-term was more important than long-term consequences:

Internal company documents highlighted the profit pressures. 'In 2007, we must find new ways to grow our revenue. Home Loans Risk Management has an important role to play in that effort,' read a late 2006 message from the unit's chief risk officer to the risk management team.

A June 2008 review by the bank's main regulator, the Office of Thrift Supervision, found a 'culture focused more heavily on production volume rather than quality.'

Top employees could become members of the company's President's Club, which offered lavish, all-expense-paid trips to Hawaii or the Caribbean, the subcommittee found.

A vivid anecdote about this culture of greed was described by Politco,

In the years before it became the largest bank failure in American history, mortgage lenders at Washington Mutual liked to party hearty at the company’s annual retreats.

But a 2006 WaMu retreat produced one of the more cringe-worthy moments of the mortgage meltdown: Lenders, on the eve of their industry’s collapse, singing 'I Like Big Bucks' to the tune of Sir Mix-a-Lot’s 1992 hip-hop hit 'Baby Got Back.'

'I like big bucks and I cannot lie/You mortgage brothers can't deny,' sang the WaMu rappers.

The presentation, which included cheerleaders moving in time to the music, and choreographed moves by the singers, continued:

'That when the dough roles in like you're printin’ your own cash/
And you gotta make a splash/
You just spends/
Like it never ends/
Cuz you gotta have that big new Benz/
All of that bling you're wearin'/
Shining so bright peoples starin'/
It's crazy, I gotta ski Aspen/
That's all I'm askin''

The former CEO of WaMu, Kerry Killinger, was called to testify, but asserted that he was unaware of what was going on, according to a column in the Seattle Times:

Tuesday at the congressional grilling of the Washington Mutual brass on how they ran a respected, 119-year-old bank into the ground, another defense was tried: No one knows anything.

Former CEO Kerry Killinger said his bank's failure wasn't his fault (it was the economy and also the government.) But for a guy who ran the joint for 18 years, he seemed not all that clued in about what his company actually did.

Much of the questioning from a panel of U.S. senators was about WaMu's now well-known history of bundling up crappy, subprime loans, sprinkling them with fairy dust and selling them as investments on Wall Street.

The U.S. Senate Permanent Subcommittee on Investigations said it had evidence that WaMu rushed to unload some of these loans precisely because the bank knew they were rotten.

When asked about this, Killinger said he couldn't recall (they always say that). But he also said something that floored me: He never knew much about WaMu's business of securitizing subprime loans for sale on Wall Street.

Even though WaMu did it to the tune of $77 billion worth from 2000 to 2007.

'I was just simply not involved in any of those,' Killinger shrugged.

They were only the fuel for the fire that burned down the U.S. economy!

OK, well, moving on then. Killinger was asked about how even people inside WaMu considered the subprime securities coming out of WaMu's Long Beach Mortgage to be 'the worst paper in the market.'

Blank look. News to him.

How about how WaMu loan officers in various offices were involved in fraud, cutting and pasting false names on borrowers' bank statements or fabricating assets, just to move more subprime loan product?

Can't remember the specifics, said the guy who was in charge.

On it went, nearly two hours of I-have-no-knowledge or I-can't-recall.

Earlier a lower-ranking risk officer at the bank testified he'd come to Killinger in 2004 and made an 'impassioned argument' to take a stand against rampant fraud in the loan industry.

'Blow the whistle,' the guy said he urged Killinger. 'Say we at Washington Mutual will not participate any further.'

A senator asked Killinger about this. You're the CEO, the senator said. This is your bank. Didn't someone telling you there were serious fraud problems send chills up your spine?

Eh. He answered blandly that he of course tried to fix any problems. But chills? His demeanor was more Alfred E. Neuman: What, me worry?

It turns out that for his allagedly clueless leadership, Mr Killinger was paid enough to make him very rich, as per a quote from the investigation's report, via the Atlanta Journal-Constitution.

WaMu’s CEO (Kerry Killinger) received millions of dollars in pay, even when his high risk loan strategy began losing money, even when the bank began to falter, and even when he was asked to leave his post. From 2003 to 2007, Mr. Killinger was paid between $11 million and $20 million each year in cash, stock, and stock options. That’s on top of four retirement plans, a deferred bonus plan, and a separate deferred compensation plan. In 2008, when he was asked to leave to leave the bank, Mr. Killinger was paid $25 million, including $15 million in severance pay. $25 million for overseeing shoddy lending practices that pumped billions of dollars of bad mortgages into the financial system. Another painful example of how executive pay at U.S. financial firms rewards failure.

It was all gut wrenching, but perhaps the connection with health care iss not obvious. Let me explain.

A question not addressed by the congressional hearings so far was how the people ultimately responsible for the direction and financial health of Washington Mutual, the company's board of directors, allowed a CEO self-described as clueless become rich while a culture of greed produced an enormous number of questionable loans which ultimately drove the company into bankruptcy. Based on the report and testimony so far, on its face the case is strong that the WaMu board must have been one of the most irresponsible groups of supposed corporate stewards yet uncovered.

A list of the 13 board members who presided over the company's final collapse can be found in the company's 2008 proxy report.

Several of them turn out also to have been or be leaders of health care organizations:

- Thomas C Leppert, director since 2005, "the Mayor of Dallas, Texas," is also a member of the board of directors of the Baylor University Health System. (see this link)

- Charles M Lillis, director since 2005, was also on the board of Medco Health Solutions Inc

- Regina T Montoya, director since 2006, then the Chief Executive Officer of the New America Alliance, is now senior vice president and general counsel for the Children's Medical Center in Dallas, Texas. (see this link)

- Margaret Osmer-McQuade, director since 2002, then President of Qualitas International, is a member of the Board of Overseers of Weill Cornell Medical College. (see this link)

- Orrin C Smith, director since 2005, then President and Chief Operating Officer of Starbucks Corporation, is a member of the University of Washington UW Medicine Strategic Initiatives Committee. (see this link)

So, in summary, members of the board of directors of the failed Washington Mutual, which seemingly collapsed in a fog of greed and irresponsibility, currently sit on the boards of a medical school, a teaching hospital, and a pharmacy benefits management corporation, and on a strategic initiatives committee of another medical school, while another is an executive of another teaching hospital. People whose "stewardship" allowed an apparently clueless CEO to become rich while a corporate culture with the theme, "I Like Big Bucks" drove their company into bankcrupty now also lead some of the most prestigious US health care organizations.

Here is yet another example of how the leadership culture that so badly failed the financial sector was tied to the leadership of health care. (We posted here about how the board of the bankrupt Lehman Brothers also leads multiple health care organizations, and here how the leaders of how some of our major universities that house medical schools overlap with the leadership of other questionable financial corporations.)

We have another vivid illustration in the aftermath of the global economic collapse, and in an ongoing health care crisis, how some of the problems of health care, and academic medicine in particular, may have been at least enabled by leadership more used to working in an increasingly amoral marketplace than to upholding the academic mission. All health care organizations, for-profit and not-for-profit, those in the US and those in other countries, need leaders who value their health care and academic missions more than simply the money they may bring in.

Is H. Stephen Lieber, CEO of HIT Industry Trade Group HIMSS, Misinformed or Simply Lying?

In the Wall Street Journal article today entitled "Can Technology Cure Health Care?" by erstwhile WSJ reporter Jacob Goldstein, H. Stephen Lieber, CEO of the health IT trade group HIMSS disputes the idea that "electronic medical records systems focus on billing [and other administrative tasks] at the expense of patient care" and says:

[These systems] are "primarily designed for improving clinical outcomes, and a secondary benefit is that they improve administrative efficiencies."

Is Mr. Lieber misinformed, or worse, could he simply be lying?

In fact, these systems do neither of these things, as repeated studies are showing such as I aggregated in "2009 a Pivotal Year in Healthcare IT" at http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=2009, and as in this new 2010 study report in Health Affairs:

Electronic Health Records' Limited Successes Suggest More Targeted Uses

The team, led by Harvard Medical School professor Catherine M. DesRoches, surveyed more than 3,000 U.S. community hospitals to assess factors such as inpatient costs and mortality and readmission rates. Here are their findings:

Understanding whether electronic health records, as currently adopted, improve quality and efficiency has important implications for how best to employ the estimated $20 billion in health information technology incentives authorized by the American Recovery and Reinvestment Act of 2009. We examined electronic health record adoption in U.S. hospitals and the relationship to quality and efficiency. Across a large number of metrics examined, the relationships were modest at best and generally lacked statistical or clinical significance. However, the presence of clinical decision support was associated with small quality gains. Our findings suggest that to drive substantial gains in quality and efficiency, simply adopting electronic health records is likely to be insufficient. Instead, policies are needed that encourage the use of electronic health records in ways that will lead to improvements in care.

... the researchers determined that the technological systems, as currently implemented, do not have a significant impact on improving care and reducing costs, DesRoches said.

A key phrase is "as currently implemented." To that, I'd add "as currently designed under the leadership of the HIT industry", which is to say, poorly.

I commented on this report in my prior post "Yet Another Study Shows Health IT Does Not Bat The Ball Out of the Park; And, is HIT an Issue of States' Rights?" at this link.

These results are also in line with the 2009 National Research Council report, the highest scientific authority in the U.S. that involved Octo Barnett and other health IT pioneers. The NRC report calls current approaches to health IT "insufficient" and calls for major redesign of health IT to support clinicians' cognitive needs.

From the NRC report:

Most importantly, current health care IT systems offer little cognitive support; clinicians spend a great deal of time sifting through large amounts of raw data (such as lab and other test results) and integrating it with their medical knowledge to form a whole picture of the patient. Many care providers told the committee that data entered into their IT systems was used mainly to comply with regulations or to defend against lawsuits, rather than to improve care. As a result, valuable time and energy is spent managing data as opposed to understanding the patient.

And this was from the country's most advanced centers in terms of healthcare IT.

As to cost savings, there's the Nov. 2009 “Hospital Computing and the Costs and Quality of Care: A National Study” (Amer J Med 123:1; 40-46) by Himmelstein and Woolhandler at Harvard Medical School, that also concluded “as currently implemented, hospital computing might [very] modestly improve process measures of quality but not administrative or overall costs."

There's also the June 2009 Wharton School of Business article "Information Technology: Not a Cure for the High Cost of Health Care" that I wrote about at this HC Renewal post.

Typical of the recalcitrant, recidivist IT industry, Lieber goes on to blame doctors:

"... there is a resistance on the part of some to recognize the professional clinical advantage that these systems give them, many default to 'This is designed for billing, not clinical outcomes.'"

Never does he consider that doctors might have good reasons to avoid the technology - as in, to protect the lives of the patients in their trust. (When they see user-hostile HIT products from major vendors such as these, who can blame them?)

He then waves off "glitches" - the kind that result in untold clinician inconvenience and disruption, and have resulted in an unknown but "tip of the iceberg" rate of patient injury and death per the FDA - by stating that:

"There is a range of systems out there, just as in any kind of product line, ranging from poor to mediocre to excellent."

His merchant computing, card tabulator/data processing mindset reveals itself in this statement. Unfortunately, health IT, as in other medical devices, IS NOT JUST ANY KIND OF PRODUCT LINE. Malfunctions and poor design do not simply cause a truckload of candy bars to be delivered to the wrong merchant.

As in pharma and other medical devices, when trade group leaders of the HIT medical device companies are unaware of current research, dismiss it, and blame end users, or simply are liars, that industry deserves serious academic and governmental scrutiny.

-- SS

Yet Another Study Shows Health IT Does Not Bat The Ball Out of the Park; And, is HIT an Issue of States' Rights?

At "2009 a Pivotal Year in Health IT" I aggregated a number of reports and articles from that year shedding needed critical light on the irrational exuberance surrounding computers in medicine, an exuberance that seems to consider clinical professionals with years of hard training and expertise as simpletons who should bow to the cybernetic miracles created by the health IT cartel.

The critical reviews continue in 2010. Here's another in Health Affairs from a team at Harvard: Electronic Health Records' Limited Successes Suggest More Targeted Uses. The team, led by Harvard Medical School professor Catherine M. DesRoches, surveyed more than 3,000 U.S. community hospitals to assess factors such as inpatient costs and mortality and readmission rates.

Here were their findings:

Understanding whether electronic health records, as currently adopted, improve quality and efficiency has important implications for how best to employ the estimated $20 billion in health information technology incentives authorized by the American Recovery and Reinvestment Act of 2009. We examined electronic health record adoption in U.S. hospitals and the relationship to quality and efficiency. Across a large number of metrics examined, the relationships were modest at best and generally lacked statistical or clinical significance. However, the presence of clinical decision support was associated with small quality gains. Our findings suggest that to drive substantial gains in quality and efficiency, simply adopting electronic health records is likely to be insufficient. Instead, policies are needed that encourage the use of electronic health records in ways that will lead to improvements in care.

On that last point, I disagree; it's not the use of HIT that needs to be encouraged, it's the remediation of HIT that needs to be encouraged/enforced to make HIT useful. More below.

The authors also report:

Hospitals with comprehensive electronic health record systems were compared with those with no or basic electronic systems, and the team only found slight differences in areas such as length of stay and surgical infection prevention.

Overall, the researchers determined that the technological systems, as currently implemented, do not have a significant impact on improving care and reducing costs, DesRoches said.

“Having a system is not enough,” DesRoches added. “We can’t expect that hospitals are just going to plug these systems in, and suddenly you’re going to see large improvements. [Not according to our President and the heads of HHS and ONC, who've explicitly stated that health IT will produce all sorts of technologically deterministic miracles - ed.] The systems are only going to be as good as how people are using them.”

I would differ from the authors on the last point, that "the systems are only going to be as good as how people are using them.” The authors seem to assume that health IT is a perfected technology.

I would say that "the results are only going to be as good as the systems clinicians are forced to use."

If the systems are crap, then the results of their use will be crap.

The authors concluded that "the study’s findings should not deter future technological advances in keeping medical records.

In fact, I think with results such as these, improving health IT through technological advancement is an absolute imperative. To do so, however, will require major advances in the health IT industry itself - its methodologies for health IT development and validation, its qualifications for leadership, and its regulation.

“With the amount of attention and money that the federal government is putting into this issue, I don’t think we can do anything but move forward at this point,” Desroches said.

Again, I disagree with the author's white-flagged surrender to the diktats of the Federal Government. The Federal takeover of health IT via the establishment on ONC by HHS made me uncomfortable when it occurred in 2004, and it is increasingly clear why.

When serious doubts are thrown on a technology being pushed on a critical profession and a nation's critical services, the imperative should be on slowing down and fixing the problems before spending hundreds of billions more dollars in a massive federal push, a push that even includes federal coercion in the form of Medicare penalties for non-adopters.

As studies like this show, HIT medical devices are experimental, yet increasingly serve as governors of medical care. They are "governors by cybernetic proxy", I might add. These devices put the federal government, and the health IT vendors as well, with their "best practices" criteria, directly in the exam room. This is done without true patient informed consent.

The rights to govern the practice of medicine reside with the states, not the Federal government. (Drug and device safety were made an exception via FDA regulation, but health IT is entirely unregulated, demonstrating incompetence at best on the part of the federal government in a matter critical to healthcare).

Perhaps the states need to take up the issue of federal pressure to implement experimental health IT. Health IT is technology that seeks to govern the practice of medicine but does not seem to have significant ROI the way it is designed and implemented today. It does, however, have a definite but unknown incidence of harm (the FDA's data on patient injury and death attributed to bad IT are suspected to be just the "tip of the iceberg" according to the FDA itself). Perhaps states' rights need to be invoked in order to slow the out-of-control, federally fueled locomotive.

It seems that federal imperatives to:

• coerce clinicians to purchase experimental products of commercial health IT companies under duress of federal penalty (much as consumers are going to be forced to purchase health insurance from commercial insurance companies under threat of penalty, although at least those products are not experimental);
  
• determine"meaningful use" criteria;
• determine who can "certify" the technology;
  
• set up federal "Regional Extension Centers" (REC's) and a national Health Information Technology Research Center (HITRC);
  

and the HITECH act itself represent a huge power grab that tramples states' rights to regulate the practice of medicine.

-- SS

You Can Judge a Culture By How They Treat Their Dead...

This article does not speak highly of the IT culture and the dead. Considering the IT culture that has invaded healthcare and whose tools are increasingly being mandated in treating the living, this article is another cause for concern:

Organs removed without consent after IT blunder

Bereaved families will be told that organs were removed from their loved ones without consent after a blunder affecting Britain’s donor register.

By Patrick Hennessy and Laura Donnelly
The Telegraph
10 Apr 2010

The records of 800,000 people were affected by an error that meant their wishes about the use of their organs after death were wrongly recorded.

An investigation has found that 45 of those for whom wrong records were stored have since died – and in approximately 20 cases organs were taken where consent had not been given.

Andy Burnham, the Health Secretary, said today he deeply regretted the distress caused to bereaved families of people whose organs were removed without consent following a huge blunder affecting the UK donor register.

He said: "I want to assure the millions of people on the organ donor register that they can have full confidence that only their accurate information will be discussed with their families, and that their wishes will be respected.

I'm not sure why people should "have full confidence" in a system where a huge blunder was made on the words of a politician ...

"I have asked NHS Blood and Transplant to take immediate steps to identify and contact all affected families. This process is under way and will be completed as quickly as possible.

Considering how poorly the NHS has managed its health computing on a national scale, I would not be reassured.

"I have asked Professor Sir Gordon Duff of Sheffield University to carry out a review to find out why this has happened, prevent mistakes like this being made again and ensure all necessary steps are taken to maintain confidence in the organ donor register."


Donors can give permission for any of their organs to be taken, or provide more specific agreements. A glitch in the system more than a decade ago removed the distinctions expressed by people.

... The error occurred in 1999, when data held by the Driver and Vehicle Licensing Agency, which includes a request for consent in applications for a driving licence, was transferred to the organ registry.

Allow me to reveal how this 'glitch' that removed critical data happened: careless, cavalier, undereducated, arrogant, overempowered IT personnel in HIT leadership roles.

Allow me to reveal how the 'glitch' was not discovered in over a decade: careless, cavalier, undereducated, arrogant, overempowered IT personnel in HIT leadership roles.

Joyce Robins, from the pressure group Patient Concern said: "This Government has got an absolutely dreadful record when it comes to data, but it is absolutely horrific that such sensitive details were handled in such a careless way."

If the dead are treated this poorly, what does this say about the wishes of the living?

The NHS is about to contact approximately 20 families who allowed organs to be taken from their relations after being misinformed about what consent had previously been given.

It is illegal to remove organs without prior consent from the person who died or their next of kin. A view is sought from relations before decisions are taken. In the cases where errors were made, it is understood that families were asked for permission, but their decisions were based on misinformation about the wishes of their relations.

Unbelievable.

After detecting the fault last year, NHS Blood and Transplant, which holds the organ donation register, was able to correct 400,000 of the flawed records. But 400,000 more people will shortly be contacted to be told that the wrong information may be held about them, and asked to provide consent again.

Just a little 'glitch', affecting nearly a million people. Nothing for the IT personnel to be concerned too much about.

Until fresh consent is obtained, organs will not be taken from any of those people in the event of death.

Let's hope the delays in organ availability don't create more dead people.

The mistake came to light when NHS Blood and Transplant (NHSBT) wrote letters to new donors thanking them for joining the register, and outlining what they had agreed to donate. Respondents wrote back to say the information was wrong.

Sick, living patients might not have the opportunity to tell their doctors the information in the eRecord has been corrupted or erased.

The point of this case is that the utmost care needs to be used in managing health data and healthcare information systems. The results of errors are not boxes of candy bars shipped to the wrong location.

As long as the culture of IT dominates in healthcare, IT being characterized by an arrogant, recalcitrant, recidivist culture whose failure rates are downright terrible even on non-healthcare projects, I'd frankly rather use paper.

Paper doesn't suffer 'glitches' that alter hundreds of thousands of fields of critical information en masse.

-- SS

A "Very Well Paid Boob" on the Harvard Corporation?

The ongoing investigation of the global financial collapse may also shed some indirect light on what has gone wrong with health care.  Consider the recent testimony by two leaders of the nearly failed, then bailed out global financial giant Citigroup, as reported by the New York Times. One of the leaders was Robert Rubin,

Robert E. Rubin, the former Treasury secretary, faced withering questions from the panel, the Financial Crisis Inquiry Commission, for his spare expressions of remorse. Repeatedly playing down his role as chairman of the executive committee of Citigroup’s board, he was met with anger and disbelief.

'You were either pulling the levers or asleep at the switch,' Philip N. Angelides, the committee’s chairman, told him.

Mr. Rubin stopped short of accepting personal responsibility. He grudgingly conceded that a few savvy investors saw the crisis coming, asserting that nearly everyone in the financial services industry had failed to see a dozen powerful forces — from excessive debt levels to trade imbalance — come together in a perfect storm.

'We all bear responsibility for not recognizing this, and I deeply regret that,' Mr. Rubin said.

Mr. Rubin’s stance left several members of the panel angry. Mr. Rubin earned more than $100 million during a decade at Citigroup.

Mr. Angelides, a former California state treasurer and a fellow Democrat, did not buy it. 'You were not a garden-variety board member,' he said. 'I think to most people chairman of the executive committee of the board of directors implies leadership. Certainly $15 million a year guaranteed implies leadership and responsibility.'

Attempts by Mr Rubin (and to some extent, former Citigroup CEO Charles O Prince III) to disavow responsibility met with more derision. For example, yesterday, see a New York Times editorial:

The latest public hearings of the Financial Crisis Inquiry Commission, held last week, made headlines for eliciting more apologies from financiers who presided over the market collapse.

You may recall a similar flurry last year, when Lloyd Blankfein, the chairman and chief executive of Goldman Sachs, was widely credited for having apologized for his firm’s role in the financial crisis.

We did not buy it then; Mr. Blankfein never said what he was sorry for or to whom he was apologizing. And we are not buying it now.

Mr. Prince says he 'could not' foresee the impending collapse, when he could have and should have seen it coming. Certainly, others did. Mr. Rubin has said that under his employment agreement, he was not responsible for the bank’s operations. But he was a towering figure at Citi, a source of its credibility and prestige. That implies responsibility, no matter what his contract said. Add all that to the 'I wasn’t the only one' context of both men’s comments, and their regret translates as, 'We feel bad about an accident we were powerless to prevent.'

Except that the financial crisis was not an accident and they were not powerless. The crisis was the result of irresponsibility and misjudgments by many people, including Mr. Prince and Mr. Rubin. Citi, under their leadership, epitomized the financial recklessness that ruined the economy.

A Seattle Times columnist was even more harsh, calling Rubin a "very well paid boob," and:

Rubin was barely contrite and went back to his meme of 'who knew?,' adding the unintended comedic line about how leaders shouldn't be responsibility for the 'granularity' of little things -- such as $40 billion in essentially fraudulent collateralized debt obligations. Rubin was being paid more than $100 million as a senior adviser to Citi while it headed toward collapse and a $45 billion taxpayer rescue. So 'granularity' is in the eye of the beholder.

Commission vice chairman Bill Thomas said, 'Apparently you get to the top without having had to experience anything the people underneath you do. You don't have a comprehension. You're not informed, but you get to make all this money on the upside, but there's no downside.'

Indeed. Rubin and Citigroup epitomize the public policies and the corporate practices that brought the economy to the brink of a new depression.

As Bill Clinton's Treasury Secretary, Rubin championed financial deregulation and the financialization of the economy as manufacturing was hollowed out. Among other things he helped keep derivatives from being regulated and encouraged the creation of 'too big to fail' institutions such as Citi. Rubin led the battle to dismantle Glass-Steagall, so Citi and its giant siblings could gamble in investment banking, while also doing commercial banking and insurance. An alum of Goldman Sachs, Rubin was fine with big compensation for executives, even if their leadership wrecked the bank (Prince walked away with $120 million). Funny how Rubin was offered the lucrative Citi position after he left such 'government service.'

So what does this tell us about health care? As we noted before, while Robert Rubin is no longer on the board of Citigroup, he has been a member of the Harvard Corporation since 2001. The Corporation is ultimately responsible for the US' oldest and most prestigious university, its equally prestigious medical school and teaching hospitals. Yet under Rubin's stewardship, Harvard's endowment has fallen a prodigious amount, and Harvard and its Partners Healthcare hospital system have faced charges of conflicts of interest and various sweetheart deals. Perhaps this is to be expected when the ultimate steward may be a "very well paid boob."

While Rubin's impressive resume and wealth in 2001 may have provided a rationale for his appointment to the Corporation, what would be the rationale for his continuing service?

As we have pointed out, as the world economy was driven to near ruin by "masters of the universe," some of the same also became leaders of academia and academic medicine in their spare time. Maybe this made sense 10 or 20 years ago, but why does it still make sense? On the other hand, now that we understand how bad the leadership of finance really was, it is a little easier to understand why the leadership of health care has become so bad.

Pfizer Settles One Lawsuit, Loses Another, Pays its CEO $13.7 Million

It's deja vu all over again for Pfizer Inc, the world's largest pharmaceutical company.

Settlement of Suit Alleging Neurontin Risks Concealed

Pfizer has kept busy in court defending against charges that a company it acquired promoted Neurontin (gabapentin) for uses not approved by the US Food and Drug Administration (FDA), and not well supported by the evidence.  Most recently, it was convicted by a jury in California of being a racketeering influenced and corrupt organization (RICO) because of a long-term "racketeering conspiracy" involving Neurontin marketing (see post here). Now additionally, according to the Wall Street Journal,

Pfizer Inc. said it reached a settlement agreement in a wrongful-death lawsuit brought by a woman who claimed her husband's use of the antiseizure drug Neurontin caused him to commit suicide in 2002.

The suit was brought by Linda Shearer of Berkshire County, Mass., whose husband, Hartley Shearer, was prescribed Neurontin to control the effects of his paralysis. The suit alleged Pfizer promoted this use of the drug even though it wasn't approved by U.S. regulators. The suit alleged Pfizer knew the drug was associated with a risk of suicide, but failed to properly warn of the risk.

The new wrinkle here is that Pfizer did not defend a suit that alleged the company knew of a potentially fatal side-effect of the drug, but failed to disclose that risk.

Jury Awarded Damages for Treatment of Whistle-Blower

Meanwhile, the Hartford Courant reported:

A former Pfizer scientist who claims she has been paralyzed by a virus designed at the pharmaceutical company's laboratory in Groton was awarded $1.3 million by a federal jury in Hartford Thursday following a trial that raised questions about safety practices in the dynamic field of genetic engineering.

The amount of the settlement awarded to molecular biologist Becky McClain of Deep River will likely increase in coming days. After about day of deliberation, the jury also awarded McClain punitive damages, to be determined by U.S. District Judge Vanessa L. Bryant, and awarded fees to McClain's two Connecticut lawyers, Bruce E. Newman and Stephen J. Fitzgerald.

McClain claimed in her suit that she was inadvertently exposed through work by a former Pfizer colleague in 2002 or 2003, to an engineered form of the lentivirus, a virus similar to the one that can lead to acquired immune deficiency syndrome, or AIDS.


She further claimed that Pfizer wrongly fired her in 2005 for complaining about laboratory safety to the U.S. Occupational Safety and Health administration and to co-workers.

Ultimately, the jury was not permitted during the 12-day trial to hear argument supporting McClain's claim of a causal link between her disability and virus research done at her laboratory in Groton.

The jury based its verdict on evidence concerning McClain's two remaining claims: that her dismissal violated Connecticut's whistle blower law and McClain's free speech right. Her lawyers contended her complaint to federal safety regulators amounted to a whistle blower complaint and that her discussion of safety issues with fellow workers was free speech.

So, after being convicted by a jury of being a "racketeering influenced and corrupt organization," (RICO), and settling civil and criminal fraud charges for an unprecedented $2.3 billion (see post here), and after many other allegations, settlements, and convictions (look here),  Pfizer failed to defend one action, and lost another that argued Pfizer tried to hide information which put the company and/or its products in an unfavorable light.

In fact, Even Pfizer CEO Jeffrey Kindler could not put much of a spin on the company's recent record. As reported by Duff Wilson in the New York Times,

The world’s largest drug company, Pfizer, has handled mergers badly, invented too few drugs and left its reputation in disrepair after two criminal cases.

And that is the assessment of its own chief executive.

CEO's Multi-Million Dollar Compensation
But while all this was going on, the company did disclose (as mandated by the US Securities and Exchange Commission [SEC]) that CEO Kindler is continuing his acquisition of riches.  As reported by the AP (via USAToday).

The chief executive of drug giant Pfizer Inc., Jeffrey Kindler, received a 2009 compensation package valued by The Associated Press at $13.7 million, down 7.6% from 2008, as the board reduced the stock awards he received, citing economic pressures.

The world's biggest drugmaker paid Kindler, 54, a salary of $1.6 million, up just $25,000 from the year before. But his performance bonus was bumped up to $3.5 million from $3 million in 2008, according to a filing this week with the Securities and Exchange Commission.

Most of Kindler's compensation comes from long-term awards of stock options and restricted shares. The total fell 17% to $8.1 million in 2009, from $9.8 million, even though they were granted in late February, a month after Kindler announced plans to buy Wyeth for $68 billion, a sound strategy to counter Pfizer's looming revenue plunge.

Kindler's other compensation — a variety of perks — totaled $449,731. That included $190,725 for Kindler's use of corporate aircraft as required by Pfizer's board, $43,099 for use of a car, $7,690 for financial counseling and $1,217 for home security.

Even admitting that Kindler's compensation last year was slightly decreased from last year's not so small fortune, there still seems to be a huge disconnect between the company's ethical woes, legal settlements, and guilty pleas and its CEO's rewards. Once again, it seems that leaders of large health care organizations never face real accountability for their company's bad behavior. It almost goes without saying that in the two cases summarized above, no one who authorized, directed, or implemented the actions leading to the settlements or damages seems to have had any negative consequences.

So once more with feeling.... In the US, we have put much of our health care system in the hands of very large organizations, for-profit and not-for-profit, without holding these organizations and their leaders accountable for their actions. The results have been increasingly rich leaders who often behave like a new aristocracy, and repeated bad behavior by the organizations they lead.

Our latest effort at health care "reform" has continued to rely on large private organizations, while so far not adding to their or their leaders' accountability. In my humble opinion, if we really want to reform health care so as to improve quality, increase access, control costs, and support professionalism, we will have to make our new health care oligarchs accountable.

Postscript - Pay for Health Care Reform Lobbying?

By the way, a commentary in The [New London, CT] Day suggested an explanation for why Kindler was so richly paid last year:

It takes pages and pages of a company securities filing to explain and justify all the bells and whistles of Kindler's 'annual incentive award,' a complicated stew of stock options and deferred payments and plain old salary.

From all of this, Timothy P. Carney of the Washington Examiner found one juicy tidbit, which especially titillated industry bloggers.

It turns out Kindler's salary increase, from $1.57 million to $1.6 million, was based in part, the compensation committee suggested, on his success in making a deal with President Obama that protected the drug industry from some of the more onerous proposals of health care reform.

Praising Kindler as an effective lobbyist in, among other things, heading off legislation that would allow the importing of cheaper prescription drugs, the committee said: 'These efforts included constructive participation in the U.S. legislative process to advance Pfizer's goals of achieving a more rational operating environment.'

Or, he kept a finger in the dike against health care reform.

Indeed, a recent report by the Sunlight Foundation, a private nonprofit dedicated to more transparency in government, indicates Kindler's extensive role in negotiating a deal for the drug companies with the Obama administration and Senate Finance Committee Chairman Max Baucus.

It turns out Kindler's name turns up four times on last year's White House visitor logs.

The final deal Kindler helped craft promised $80 billion in cost cutting by the drug companies but blocked much more onerous reform measures for the industry, like lowering prescription drug prices through Medicare negotiations, re-importation of drugs from other countries with lower prices and quicker release of generics onto the market.

The cost-saving of such measures, if allowed to occur, could have been in the hundreds of billions of dollars, according to government analysis.

Kindler, as the pay committee says, did good.

Several of our fellow bloggers have suggested that an installment of the Public Broadcasting Service (PBS) program "Frontline" will show just how much of the recent US health care reform effort was the product of health care corporate CEOs (e.g., see this post on GoozNews, and this post on Managed Care Matters). We shall see once the program airs, but maybe Mr Kindler's salary was a good value for Pfizer, but a very bad one for the rest of the country.