Elan, Eisai Settle for Related Reasons

The parade of legal settlements of bad behavior by major health care organizations marches on. The latest to shuffle by are Elan Corp, based in Ireland, and Eisai Inc, based in Japan, for actions taken in the US.  According to Bloomberg:

Elan Corp. will pay $203 million and a U.S. unit of the Irish drugmaker will plead guilty to a misdemeanor charge to resolve an investigation of its marketing of the epilepsy medicine Zonegran.

Elan will pay $102.9 million to resolve civil claims and $100 million in criminal fines and forfeitures, according to the U.S. Justice Department. Japanese drugmaker Eisai Inc., which bought the drug from Elan in 2004 for $128.5 million, also will pay $11 million to settle civil claims.

The Elan Pharmaceuticals unit will plead guilty in federal court in Boston to a charge of misbranding Zonegran, which was approved by U.S. regulators for treatment of epileptic seizures in adults over age 16, the Justice Department said yesterday in a statement. Dublin-based Elan promoted Zonegran for uses including mood stabilization, bipolar disorder, migraine headaches, weight loss and seizures in children.

'Elan’s off-label marketing efforts targeted non-epilepsy prescribers and the company paid illegal kickbacks to physicians in an effort to persuade them to prescribe Zonegran for these off-label uses,' according to the statement.

The details were:

In 2002, EPI [Elan Pharmaceuticals Inc] 'came under significant financial pressure' because of an investigation of its financial practices by the U.S. Securities and Exchange Commission that caused shares to drop to $2 from $65 in six months, according to the criminal charge. In evaluating its options, EPI 'decided to retain Zonegran because of its large potential for growth, particularly in unapproved areas,' prosecutors said.

EPI then trained its sales staff to promote Zonegran for off-label uses, including for children, pain, psychiatric disorders, migraines and movement disorders, prosecutors said. Letters sent to pediatricians described how to administer Zonegran to a child by putting a capsule’s contents into applesauce, according to the document, which EPI will admit to in its guilty plea.

Doctors with the potential to write many prescriptions were invited on expense-paid trips to Bermuda, Key Largo, Florida, Banff in Alberta and Tucson, Arizona, to hear speeches on off- label uses, according to the charge. Sales 'increased dramatically,' rising 80 percent from August 2001 to August 2002, while 2003 revenue increased 87 percent over the previous year, prosecutors said.

So here we ago again, another week, another multi-hundred million dollar settlement. Once again, the settlement is of charges of deceptive marketing practices and kick-backs to physicians. Once again, the settlement involves criminal charges and a corporate integrity agreement, but does not involve any negative consequences for any individual who authorized, directed, or implemented the unethical practices.

We have noted recent cases, one in which a corporate executive was banned from doing business with the federal government, another in which a corporate executive was indicted, but not yet tried on criminal charges.  However, in most cases, the parade of legal settlements made by health care organizations has just marched on, sometimes including guilty pleas to criminal charges, often involving charges of kickbacks, fraud, conspiracy, and other colorful offenses. Most of these settlements entailed fines or other payments by the organizations that may seem huge, but were fractions of the amounts made by the practices that lead to the charges that were settled.  With the few exceptions above, (plus one other known exception, the disbarment from federal business of three former executives of Purdue Pharma, story here), almost never have the cases involved penalties for any individuals who authorized, directed, or implemented the misbehavior.  We have also been saying (seemingly endlessly, but most recently here) that such settlements may be viewed by organizations as merely the costs of doing business, and so until the actual people who were involved in the bad behavior suffer some negative incentive or penalty, expect the behavior to continue. 

Health care costs keep rising, access keeps declining, quality gets worse. We moan and wring our hands, but as long as we allow the rot to worsen, and the muck to grow, expect these trends to continue until the whole smelly mess collapses of its own weight (with all those rich executives escaping to their mansions.)

If we really want high quality accessible, reasonably priced health care, we need true health care reform that reduces concentration of power in large organizations, and makes health care organizations' leadership accountable, ethical, and transparent. That will not be easy.
(FULL DISCLOSURE - I own 3200 shares of Elan.  This is the only health care stock I own.  I have held it a long time, not bothering to sell since the shares have been worth little for years.  This has provided a lesson about how the share-holders of big health care corporations rarely profit from the executives' risk taking.) 

Why I Shouldn't Read Non-Systematic Review Articles: Special Pleadings and Undercover Authors

I usually resist looking at non-systematic review articles in medical journals, but because the title interested me, and things seem to be getting slow this holiday season, prompted by an update email from the American Journal of Medicine, I looked at Ram CVS. Beta-blockers in hypertension. Am J Cardiol 2010: 106: 1819-1825. (Link here.)

The Ram Article in Praise of Vasodilating Beta-Blockers

The article focused on the results of meta-analyses:

Concerns have also been raised by meta-analyses in which β blockers were reported to have a suboptimal effect on reducing stroke risk and increasing the risk for new-onset diabetes compared with other antihypertensive agents.

The article discussed several meta-analyses in which beta-blockers, [a specific class of blood pressure lowering drugs] but mostly atenolol (mostly sold generically), usually combined with a diuretic, were compared with other antihypertensive drugs, usually including angiotensin converting enzyme inhibitors (ACEIs) and calcium channel blockers. But after discussing these comparative results, the author jumped to descriptions of another group of drugs which were not included in any of these comparative studies. This was the category of vasodilating beta-blockers, consisting of labetolol (mostly sold generically), carvedilol (Coreg, GlaxoSmithKline [GSK]), and nebivolol (Bystolic, Forest Laboratories. Based on physiologic studies of these drugs and trials in which they were compared with placebo, but not on studies which directly compared clinical outcomes of patients given these drugs or other kinds of antihypertensives, Dr Ram reached conclusions that they were a better alternative:

The review of the evidence provided herein confirms that there are valid reasons to question the utility of certain β blockers in treating hypertension. However, many of the perceptions about β blockers are derived from data obtained from studies of traditional agents or combinations of diuretics and β blockers. Evidence suggests, and the guidelines concur, that there are intrinsic differences among members of the β-blocker class. Indeed, the vasodilatory β-blockers, which have generally not been included in comparative meta-analyses, lower blood pressure to a similar degree as other antihypertensive drugs, may provide better central aortic pressure reductions than traditional β blockers, and are associated with neutral or favorable metabolic effects.

Special Pleading

Dr Ram's questioned the old-fashioned beta-blocker atenolol (perhaps only when added to a diuretic)  based on the results of meta-analyses which attempted to compare it to other drugs. Such meta-analyses could suggest that atentolol (again, perhaps only in combination with a diuretic) might be in some way less preferable than the other drugs to which it was compared. However, the meta-analyses did not address the vasodilating beta-blockers at all. Dr Ram concluded that they were preferable based on different kinds of and probably less definitive evidence. He did not seek to compare such studies done on the vasodilating beta-blockers to similar studies done on the conventional beta-blockers.  Thus it seems his conclusions were based on a double standard.

In the vocabulary of logical fallacies, this was an example of a special pleading:

Special Pleading is a fallacy in which a person applies standards, principles, rules, etc. to others while taking herself (or those she has a special interest in) to be exempt, without providing adequate justification for the exemption.

Here was more reason not to bother reading a narrative review articles to learn how to better practice clinical medicine.  They often are based on idiosyncratic, if not biased evidence used to support illogical arguments.

But having read so far, I wondered why the authors of this article were so happy to use a double standard as the basis of their arguments.

Undercover Author

Those paying attention may also now be wondering why I referred to the authors in plural, when the citation lists only one author. The clue is at the end of the article:

Acknowledgment

I would like to thank Tamalette Loh, ProEd Communications, Inc. (Beachwood, Ohio), for her editorial assistance and literature validation in the preparation of this report.

Sensitized as I have been to the many recent discussions of ghost-writing, I immediately wondered who Ms Loh is, and what sort of "editorial assistance and literature validation" she provided. So first I looked at what her company, ProEd Communications does, wondering if its business is to help syntactically challenged academics and professionals write better sentences and more organized papers.

The ProEd Communications web-site states:

ProEd Communications balances diverse perspectives—clinical, regulatory, marketing, and customer—to create compelling messaging to maximize a product's potential.

So it appears that ProEd Communications does not provide independent editorial services. Instead, it is a medical education and communications company (MECC) which works mainly to market its clients' products, and further, its clients are essentially only pharmaceutical companies:

Of the world's 50 largest pharmaceutical companies, ProEd has worked with 18 in the past 3 years and currently supports projects for 7 of the top 10 largest pharmaceutical companies, as ranked by MedAdNews (2008).

Furthermore, a few minutes on Google reveals that Ms Loh seems to specialize in papers on anti-hypertensives, particularly Coreg (carvedilol), one of the three drugs in the vasodilating beta-blocker group favored by Dr Ram. In fact, two other papers whose authors she assisted sounded hauntingly familiar.

Let me first display the quote above from the Ram paper:

Concerns have also been raised by meta-analyses in which β blockers were reported to have a suboptimal effect on reducing stroke risk and increasing the risk for new-onset diabetes compared with other antihypertensive agents.

Now see this quote from Frishman WH, Henderson LS, Lukas MA. Controlled-release carvedilol in the management of systemic hypertension and myocardial dysfucntion. Vasc Health Risk Management 2008; 4: 1387-1400.  (Link here):

However, concerns have been raised recently from hypertension meta-analyses regarding suboptimal outcomes with use of beta-blockers, specifically atenolol, compared with outcomes for other antihypertensive drug classes.

Also see this relatively similar quote from McGill JB. Optimal use of beta-blockers in high-risk hypertension: a guide to dosing equivalence. Vasc Health Risk Management 2010; 6: 363-372. (Link here):

Concerns about the use of β-blockers as first-line agents for hypertension have been raised because of a 2005 metaanalysis that found β-blockers do not significantly reduce
cardiovascular events, especially stroke, compared with other antihypertensive drug classes

Furthermore, read this discussion of Coreg by Ram:

Carvedilol is a nonselective β blocker with α1 receptor–blocking activity and no intrinsic sympathomimetic activity. Clinical data suggest that carvedilol reduces systemic vascular resistance in patients with hypertension.

Here is Frishman et al:

Carvedilol is a third-generation, vasodilatory beta-blocker that nonselectively blocks both the beta 1- and beta 2-adrenergic receptors.... vasodilatory beta-blockers can lower blood pressure by reducing systemic vascular resistance (SVR)

Both Frishman et al and McGill are very positive about Coreg.  Although the emphases of the three articles are different, they have organizational similarities.  Again, all three were written with the assistance of Ms Loh.

At the end of the Frishman article we again find:

The authors would like to thank Tamalette Loh, PhD, ProEd Communications, Inc.®, for her medical editorial assistance with this manuscript.

At the end of the McGill article we find:

Editorial assistance, specifically revisions to the final draft, was provided by Tamalette Loh, PhD, at ProEd Communications, Inc.®, whose services were also funded by GlaxoSmithKline. Dr Loh’s revisions were reviewed and approved by Dr McGill.

Note that now it seems that Ms Loh has a doctoral degree, of unclear kind. Note also that now it seems that GSK, the manufacturer of Coreg, funded Dr Loh's work on the McGill article.

Dr McGill further disclosed:

Dr McGill is a consultant for GlaxoSmithKline and a speaker for AstraZeneca and Forest Pharmaceuticals. Financial support for medical editorial assistance was provided by GlaxoSmithKline, Philadelphia, Pennsylvania.

Finally, in another article, about angiotensin converting enzyme blockers combined with diuretics to treat hypertension (Egras AM, Ram CVS. Reduced cardiovascular risk and healthcare expenditures with angiotensin receptor blocker/ hydrochlorthiazide. Am J Pharmacy Benefits 2010; 2: 127-135. Lin here. ), Dr Ram acknowledged:

Dr Ram is in the speakers’ bureau pool of Cogenix, ProCom, and Genesis, which manage medical education programs for Bristol-Myers Squibb, GlaxoSmithKline, and Novartis.

The series of articles above demonstrated a phenomenon I have not seen explored before. All articles were written with some sort of assistance from an employee of a MECC, perhaps partly funded by a company which marketed a drug which was the subject of all the articles. The assistance was openly acknowledged.  The three articles had some remarkable similarities not explained by an overlap among their listed authors.  This suggested that the ostensible editorial assistant they had in common was substantively involved in the content of the papers, that is, was truly an author. Her presence was not ghost-like. However, the substance of her contribution may have been downplayed.  So let's call her an "undercover author."  (If someone has a better term, please leave a comment to that effect.)

Summary

So the reasons I rarely read narrative review articles except to make teaching points about health care dysfunction are:
- They often are based on idiosyncratic, if not biased selections of data
- They may employ logical fallacies to make their points
- They may be written by people with conflicts of interest, that is, with financial arrangements with companies seeking to market products, particularly drugs and devices.

My conclusions for health care professionals are: be very skeptical of non-systematic review articles, look for evidence that they are parts of stealth marketing campaigns, and do not assume all conflicts of interest are disclosed and all authorship roles revealed.

My conclusions for journal editors are: strictly demand more complete disclosure of conflicts of interest, or risk losing the trust of your readers.

My conclusions in general: until we start to sweep away the pervasive web of conflicts of interest that is draped over medicine and health care, expect further discombobulation.

"Good Managers" And Complex Technological Projects - Recipe for Poor Results?

Once more on the topic of CIO’s and other health IT leaders lacking in solid healthcare informatics and clinical credentials, there’s this letter in today’s WSJ that I think says it all about complex technological projects, including (perhaps especially) healthcare IT.

Emphases mine:

Wall St. Journal
Letter to the Editor
Dec. 16, 2010

Manhattan Spirit for Cyber Defense

In “How to Fight and Win the Cyberwar” (op-ed, Dec. 6), Mortimer Zuckerman uses the analogy of the Manhattan Project to build the atomic bomb in World War II and suggests forming a “Cyber Defense Administration” (CDA).

We need to keep in mind how the Manhattan Project managed to succeed in achieving its objectives. The direction and top management of the project was by scientists like Robert Oppenheimer, who understood the scientific details of the project, and project director Gen. Leslie Groves, who made sure the scientists got what they wanted. This is not like any bureaucracy in the U.S. government today.

I would visualize a CDA more as a TSA- or EPA-type bureaucracy with a politically sensitive lawyer or bureaucrat at the top, and having to go down two or more administrative levels before you find the first Ph.D.-level computer scientists with a history of serious research and publications in computer/network security. The head of the CDA would probably be clueless about the computer science details and would have no basis for making rational decisions. This is a field where the devil is in the details, and to truly understand those details requires much more than bureaucratic and political skills.

Whoever created the Stuxnet worm that attacked Iran’s nuclear program’s computers probably was not managed by a bureaucrat, but by a team of very high-level scientists who clearly understood the details. Countries like China often have real experts running their organizations, not just politically smooth bureaucrats who go from job to job with a false theory that a “good manager can manage anything.”

In reality, especially in a field like cyber security, a good manager can only manage what he understands. Our bureaucrats will lose the cyberwar against scientists who understand the details.

Dallas Weaver

Huntington Beach, Calif.

It is a bureaucratic conceit to think that a "good manager" can manage major healthcare IT projects - or pharmaceutical companies - or anything else outside their core competencies.

This holds true even assuming, at best, that one of their "core competencies" is competency itself (warning: PDF).

-- SS

New York Times: Panel Set to Study Safety of Electronic Patient Data

New York Times author Milt Freudenheim has published an interesting article on health IT:

"Panel Set to Study Safety of Electronic Patient Data" (Dec. 13, 2010, link)

In the article Mr. Freudenheim presents various viewpoints on health IT safety and usability, and reports on an upcoming Institute of Medicine (IOM) Committee on Healthcare IT safety.

In general, the expressed viewpoints reported upon are consistent with the position in the Healthcare IT Ecosystem of those quoted. I wish to add some commentary to a number of those stated positions.

Mr. Freudenheim observes:

Taking a fresh look at such concerns, the Institute of Medicine created the Committee on Patient Safety and Health Information Technology to run a yearlong study and issue recommendations. The 16-member panel is meeting for the first time on Tuesday in Washington.

(This new IOM Committee is in addition to a 2009 study by the National Academies/National Research Council that concluded that "Current Approaches to U.S. Health Care Information Technology are Insufficient", which has largely been invisible. The IOM is the health arm of the National Academies.)

I would add that this Committee is at least a decade late. That it is occurring at all seems to be at the behest of a multitude of complaints and "blows of the whistle" from clinicians who increasingly depend (either voluntarily or by coercion) on this technology to provide safe care.

I would also add that it is my hope the IOM committee with not be overly politicized, considering the stated unconditional exuberance of the past two administrations towards health IT, and that a wide variety of stakeholders will be heard. (For instance, as a medical informatics specialist whose mother was injured as a result of HIT interference with clinician communications, will I be allowed to testify?)

Mr. Freudenheim then relates the points of view of stakeholders.

In February, the F.D.A. said it had received 260 reports of malfunctions related to health information technology “with the potential for patient harm,” including 44 reported injuries and six reported deaths in 2008 and 2009. The malfunctions were reported voluntarily to the agency, mainly by hospitals.

“Because these reports are purely voluntary, they may represent only the tip of the iceberg,” said Dr. Jeffrey Shuren, a senior F.D.A. policy and enforcement official.

I'd written about this at "FDA on Health IT Adverse Consequences: 44 Reported Injuries and 6 Deaths, Probably Just Tip of Iceberg" where I noted:

This is a technology almost universally touted as inherently beneficial, right up to our most senior elected leaders, who are now pushing this unproven technology under threat of penalty for non-adopters.

Healthcare IT irrational exuberance can perhaps be illustrated in statements such as this:

“We have the capacity to transform health with one thunderous click of a mouse after another,” said (former) HHS Secretary Michael Leavitt - 2005 HIMSS Summit

I also opined at "If The Benefits Of Healthcare IT Can Be Guesstimated, So Can And Should The Dangers" that one could, as a type of thought experiment, extrapolate from these numbers to guesstimate the effects of universal health IT in the US. The results were startling, even if just an experiment:

[We might have] 880,000 injuries per year, 120,000 deaths when universal HIT use is achieved ... 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.

Unfortunately, national policy has been set up to now on wishful thinking. As I stated, the IOM meeting is coming none too soon.

The NYT article then reports on a statement made by ONC Chair David Blumenthal:

“All options for assuring safety are on the table,” said Dr. David Blumenthal, the Obama administration’s national coordinator for health information technology.

Yet Dr. Blumenthal is clearly an adherent to unbridled exuberance about health IT. At "Science or Politics? The New England Journal and the 'Meaningful Use' Regulation for Electronic Health Records" I wrote:

... In the NEJM article "The 'Meaningful Use' Regulation for Electronic Health Records", David Blumenthal, M.D., M.P.P. (ONC Chair) and Marilyn Tavenner, R.N., M.H.A. (10.1056/NEJMp1006114, July 13, 2010) available at this link, the opening statement is (emphases mine):

The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

I think it fair to say those are grandiose statements and predictions presented with a tone of utmost certainty in one of the world's most respected scientific medical journals.

Even though it is a "perspectives" article, I once long ago learned that in writing in esteemed scientific journals of worldwide impact, statements of certainty were at best avoided, or if made should be exceptionally well referenced.

I note the lack of footnotes showing the source(s) of these statements.

I also note the lack of mention of literature refuting or potentially refuting these statements of certainty. [Followed by a list of such literature just off the top of my head - ed.]

Dr. Blumenthal then appeals to authority:

Dr. Blumenthal said health information experts like Dr. Donald M. Berwick, the Medicare and Medicaid administrator, and Dr. Brent James, of Intermountain Healthcare, based in Salt Lake City, “agree that electronic health records will improve the safety of care.”

I am unaware of the expertise of Dr. Berwick and Dr. James in this domain, and the peer reviewed literature they've written that supports such a statement while soundly refuting literature written by other experts that indicates otherwise.

(Perhaps at Intermountain, custom systems that took decades to develop utilizing their Medical Informatics expertise do show safety gains, but such systems and the lessons learned building them are not easily portable to a country's worth of organizations and practitioners, especially under HITECH timeframes.)

Freudenheim then quotes Blumenthal as stating:

“At the same time, any time you change the world you create risks,” Dr. Blumenthal said in a telephone interview last weekend.

This sounds typical of utopian ideology. Yes, any time you change the world you create risks, but you should not attempt to change the world cavalierly and blindly to those risks. (That's the path the National Program for Health IT in the United States has been on, until the IOM meeting was called.) Idealists tend to believe the collateral damage that is caused by utopian experiments (e.g., communism) are a necessary sacrifice to achieve the utopia. Such values are both abhorrent and alien to medicine.

“We want to make sure that implementation is as safe as it can be and all safety benefits are realized.”

Blumenthal's been painted into a corner by tons of complaints on HIT safety; ONC must act, even if just putting on a show about safety considerations. If there were true concern for safety he'd recommend slowing down HITECH timelines until the industry gets its act together and our understanding of HIT usability, safety, and other issues is resolved; cf.: statements of HIMSS leaders on 'needing to be patient' for the industry to get healthcare IT right:

As I'd written about HIMSS admissions of health IT unsuitability to task at "NIST Provides Healthcare IT Industry with Remedial Undergraduate Computer Science Education":

... What have been their product design and development practices, such that leaders of their own trade group HIMSS (as I pointed out in other posts) opine we should be "patient" for them to figure it all out about how to do health IT better and they need more time, and that the technology does not support its users properly due to lack of efficiency and usability of EMRs currently available? (As at my July 2010 post "The National Program for Healthcare IT in the U.S., and the Elephant in the Living Room".)

Further, from the NYT article:

He [Blumenthal] said that if the Institute of Medicine “concludes that regulation is an important part of this fabric of assuring safety, we will want to balance regulation and innovation as we do in every marketplace.”

That he even needs to make such a statement is likely revealing of biases on regulation, which seem aligned to the industry. To wit:

“The policing of design by a third party or agency, however well intended, will likely stifle innovation and inhibit the growth and development of electronic health records in the future,” said Carl Dvorak, executive vice president of Epic Systems, which has built electronic records systems for Kaiser Permanente and other large health care and hospital groups.

There is a lack of evidence supporting such a statement (e.g., pharma has been regulated for decades, as is its clinical IT). The fact that NIST has just delivered Computer Science 101-level usability guidelines to the HIT industry in its recent report “NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records” to help solve the HIT unusability crisis also suggests that 30+ years of un-regulation did not facilitate ‘innovation.’

In fact 'unregulation' appears to have led to prima facie innovation failure and paralysis as far as usability is concerned.

Unusable health IT might as well not exist as far as clinicians are concerned. It is a menace to the safe practice of medicine. This is a first principle.

Per the NYT, the industry trade group HIMSS has gone mum:

The industry has recently avoided speaking out on a role for the F.D.A. In a statement for this article, the Healthcare Information and Management Systems Society, a Washington-based industry group, said only that it “supports the administration’s decision to ask the Institute of Medicine to study this complex issue and report back over the next 12 months.”

They are certainly not taking a leadership role on this issue. In my humble opinion they will allow regulation, only kicking and screaming and being dragged into it by force. Patients come second to profits - the only factor that will be "stifled" as vendors are coerced to make better products.

The NYT article goes on:

Last month, in protest of one common industry practice, the American Medical Informatics Association said “hold harmless” clauses in many purchasing contracts were unethical. The clauses typically absolve manufacturers of responsibility for any errors or misuse.

“We said we value innovation, but we don’t value it more than safety,” said Kenneth W. Goodman, a University of Miami bioethicist who headed an association advisory group on patient safety.

It took a lot of writing and politicking to get AMIA to this point as well, at least to express it openly (cf.: my efforts here).

Finally, with regard to the IOM meetings on HIT safety, there will be industry stakeholders in attendance such as CCHIT and EPIC.

I believe they should be held to scientific standards of delivery. If they deliver marketing-based spin, they should be called to present scientific evidence for their stance – and not just “positive” evidence. They should be made to refute “negative” evidence as well, not ignore it.

In summary, I welcome the New York Times bringing these issues to the public.

I also welcome IOM's entry into studying HIT safety. While a "Committee on Patient Safety and Health Information Technology" should have been convened years ago, it's better late than never. (Except for patients already injured or killed, of course.)

The results may remain as invisible as the aforementioned National Research Council study. I also doubt the Committee's findings will change hearts and minds. Idealism, profit motive, and irrational exuberance are hard to rectify.

But their effects on people's behaviors can - and should - be regulated.

-- SS

Addendum Dec. 17:

Healthcare Renewal blog to IOM: I have the information of the type you apparently seek on HIT-related injury. My Drexel Univ. site on HIT failures that's been around since 1999 comes up in the first few hits of Google searches on that subject, and has a banner at the top about my mother:

(click to enlarge, or go to site)

Anyone at IOM listening?

-- SS

The Lancet Emphasizes the Threats to the Academic Medical Mission

We just discussed an important article in the Lancet calling for major global reforms of health care education.(1)  An accompanying editorial(2) argued for the critical importance of upholding the mission of higher education, because that mission is critical to human civilization:

Louis Menand has investigated the current role of the modern university in his startlingly powerful book, The Marketplace of Ideas. Menand argues that: 'The pursuit, production, dissemination, application, and preservation of knowledge are the central activities of a civilisation.' More importantly still, 'the ability to create knowledge and put it to use is the adaptive characteristic of humans'. The goal of the university is 'to make more enlightened contributions to the common good'.

The editorial argued strongly for the revitalization of the university's mission:

'It is the academic's job in a free society to serve the public culture by asking questions the public doesn't want to ask, investigating subjects it cannot or will not investigate, and accommodating voices it fails or refuses to accommodate.'

The education of doctors, nurses, and public health workers must seek to: strengthen the overall intellectual culture of a society; define principles for public aspiration; give life to and enlarge the best and most proven ideas of the age; refine the grounds for the private exchanges that take place in our lives; facilitate the exercise of political power; and enable professionals to detect what is important and discard what is irrelevant, accommodate oneself with others, have common ground between colleagues across societies, ask good questions and find the means to answer them, and have the resources to adapt to national and global circumstances. Some readers might recognise that these words are adapted from John Henry Newman's On the Scope and Nature of University Education.

In England, Newman argued for the university as a centre of intellectual liberty, a vital force for progress in society. Menand writes about the university as a 'zone of autonomy'. The importance of tertiary education as a means to advance health, reason, democracy, and justice needs to be rediscovered.

But arguing so forcefully for upholding the academic mission makes sense only if that mission is under threat. The Lancet editorial only briefly alluded to why this might be:

What this Commission argues for is nothing less than a remoralisation of health professionals' education. For decades, health professionals have colluded with centres of power (governmental, commercial, institutional, even professional) to preserve their influence. The result? A contraction of ambition and a failure of moral leadership.

While the original article by Frenk et al suggested that health professionals' education has shortcomings, it did not argue that the academic mission is threatened.  Although the message of the accompanying editorial is that the mission needs a strong defense, it did not clearly explain the extent of the threat to it. 

However, this blog, Health Care Renewal, is largely concerned with threats to health care's core values, including threats to the mission of academic medicine, largely from concentration and abuse of power.  The largest set of threats come from the ascendancy of financial goals amidst the commercialization of health care (mentioned briefly both in Frenk et al and the editorial).  We have discussed the nature of the threats in detail.  For example,

• Abandonment of traditional prohibitions of the commercial practice of medicine - In the US, a Supreme Court decision was interpreted to mean that medical societies could no longer regulate the ethics of their members.  Until 1980, the US American Medical Association had  ruled that the practice of medicine should not be "commercialized, nor treated as a commodity in trade."  After then, it ceased trying to maintain this prohibition.  The result was increasing, now rampant commercialization.  See posts  here and here.
• Making money takes precedence over education -  A recent survey showing that more than half the faculty at multiple US medical schools felt they were valued more for how much money they brought in than their teaching or patient care abilities (here), confirming previous anecdotal reports (see here). 
• The medical school re-imagined as a biotechnology company -  In 2000, a Vice President of the American Association of Medical Colleges(3) wrote that research universities must respond to "societal demands that they become engines of economic development…."  Many universities now defend lax conflict of interest policies with similar arguments.  For more details, go here.
• Faculty become employees of industry - For numerous examples of this and other kinds of conflicts of interest, go here.  A survey by Campbell et al suggested that approximately two-thirds of medical academics get significant payments from industry.(4)
• Academics become "key opinion leaders" paid to market drugs and devices - Marketers regard "key opinion leaders" as salespeople who appear more credible because of their professional guise.  See anecdotal evidence here.  
• Control of clinical research given to commercial sponsors - A study by Mello et al showed how universities' grant administrators are willing to sign contracts giving commercial sponsors control over key aspects of human research studies.(5)  See post here. 
• Conflicts of interest allow manipulation and suppression of clinical research - Commercially sponsored research design, implementation, and dissemination are often manipulated to favor the sponsor's interests.  When such manipulation fails to produce favorable results, the results may simply be suppressed.
• Academics take credit for articles written by commercially paid ghost-writers - Such ghost-writing is often part of organized stealth marketing campaigns. 
• Whistle blowers are discouraged, or worse, and academic freedom is damaged.  Discussion of some examples of what may happen to whistle blowers is here.  The survey mentioned earlier (here) showed that about one-third of faculty fear they may be punished for speaking  out. 
• Leadership of academic medical centers by businesspeople - Ill-informed management may result from leaders who have no background or training in actual health care. 
• Leaders of teaching hospitals and universities become millionaires -  A recent example is here, and more may be found here.  Leaders of academic medical centers and the parent universities of medical schools often make more than $1 million a year in the US.  When such amounts are in play, executives may focus more on short-term measures that lead to even more pay than on upholding the mission. 
• Medical school leaders become stewards (as members of boards of directors) of for-profit health care corporations - A recent example is here, and a summary of how we discovered this phenomenon in 2006 is here.   The conflict of interest is severe because directors of for-profit corporations are supposed to have unyielding loyalty to the interests of the corporation and its stockholders, although they are frequently accused of acting mainly as cronies of the top hired executives (see here and here).
• Leaders of failed finance firms become stewards of academic medicine - We have found numerous examples, recently here, here, and here, of top executives and/or board members of the finance firms who helped bring on the global financial collapse also being trustees of medical schools, academic medical centers, or their parent universities.  Such "stewards" may bring to the academic environment the "greed is good" culture now pervasive in finance. 

So the threats are real and substantial.  However, their scope generally generally gets little attention.  Even when specific threats appear in the academic literature, their importance may be soft-pedaled, and their confluence with other threats ignored.  Of course, trying to discuss the full breadth and depth of these threats, as we endeavor to do on this blog, threatens in turn those who have personally profited from the current system.  Hence, we frequently cite the anechoic effect, the phenomenon that important threats to health care's core values are often just not discussed in polite company.

Therefore, we applauded the article by Frenk et al for concatenating some of the most important challenges to health care professionals' education, and we now applaud the Lancet editorial for emphasizing the threat to the academic medical mission.  We hope that these two articles, appearing in one of the most prestigious and well-read medical journals, will help to combat the anechoic effect.  Meanwhile, we will continue to blog about threats to core values in the hope that discussing them will lead to solutions.
References

1.  Frenk J, Chen L, Bhutta ZA, Cohen J, Crisp N, Evans T et al. Health professionals for a new century: transforming education to strengthen health systems in an interdependent world.  Lancet 2010; 376: 1923-1958.  Link here.
2.  Horton R. A new epoch for health professionals' education.  Lancet 2010; 376: 1875-7.  Link here.
3. Korn D. Conflicts of interest in biomedical research. JAMA 2000; 284: 2234-2237. Link here.
4. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. Llink here.
5. Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352: 21.  Link here.

"Health Professionals for a New Century": Calling for "Ethical Conduct," a "New Professionalism," and Improved "Stewardship" and "Social Accountability"

A major article just published in the Lancet urged global reform of health care education  [Frenk J, Chen L, Bhutta ZA, Cohen J, Crisp N, Evans T et al. Health professionals for a new century: transforming education to strengthen health systems in an interdependent world.  Lancet 2010; 376: 1923-1958.  Link here.]

The problems it recognized included

• "Pitifully modest" spending for health professional education, compared to overall health spending
• Health care systems that are "dysfunctional and inequitable," due in part to "commercialism in the professions," leading to "breakdown ... especially noteworthy within primary care, in both poor and rich countries."
• For profit medical education leading to "a so-called de-Flexnerisation process ... in which low-quality professional schools might be proliferating...."
• Health care corruption, e.g., "the Indian press has reported illegal payments by new private schools seeking accreditation...."

The solutions it advocated included
- Fostering "ethical conduct" by professionals, developing a "new professionalism," earning trust "steered by ethical commitment and social accountability."
- Improving "stewardship mechanisms, including socially accountable accreditation"

It is nice to be in such good company.  While the report was written in the subtle, diplomatic language of international public health, it was the only such authoritative report to appear in a widely circulated, highly respected medical journal that I can recall that was this direct about the seriousness of such problems.

In fact, not only is little spent on actual medical education within academic medical institutions, but faculty members are valued more for the money they bring in than for their teaching.  Commercialism in health care has been institutionalized in the last 30 years (for discussion of its history in the US, look here, here, and here.)  The Transparency International Global Corruption Report of 2006 asserted "the scale of corruption is vast in both rich and poor countries," yet has gotten almost no notice in medical, health care research, and health care policy circles.  In 2009, the US Institute of Medicine published a detailed report including fairly strong recommendations on Conflict of Interest in Research, Education and Practice.  The anechoic effect, however, has dictated that discussion of striking examples of mission-hostile management, conflicts of interest, and outright crime and corruption is simply not done, especially in medical, health care, or health policy venues and journals.  The 2006 TI and 2009 IOM reports have infrequently been cited, and their recommendations have widely been ignored.

I do hope that the appearance of a publication as authoritative as the article by Frenk et al leads to some soul-searching by the leaders of health care around the world.  They need to realize that despite the article's measured tones, the problems really are severe, and even more broad than the article implied.  We have discussed in detail how health care education (and all of health care) are hurt by concentration and abuse of power, by governance that lacks accountability, integrity, and transparency; by leadership that ignores the context, core values and mission, promotes self-interest and conflicts of interest, and sneers at ethics; and by results such as suppressed and manipulated research, deceptive and dishonest education (look here, here, and here for examples), stifling of academic freedom and whistle-blowers, then dissatisfied, burned out faculty (here), and finally the final common pathway of rising costs, declining access, and poor quality.  

It is heartening that the importance of our concerns has been corroborated in such a notable venue.  I hope this report gathers less dust than the 2006 Transparency International Global Corruption Report and the 2009 Institute of Medicine conflict of interest report.

I suggest that to truly reform health care education (and health care itself), we will have to attend to the sorts of problems we write about on Health Care Renewal.  On one hand, we will need to improve the stewardship, governance, and leadership of health care education itself, and reduce the pervasive conflicts of interest that ensnare the faculty.  On the other, we will need to make sure education prepares students to deal with these problems in health care at large.

It would be nice if the appearance of the Lancet article signifies that help will soon be at hand to tackle the huge amount of work that needs to be done, in the face of likely withering opposition from those who have enriched themselves from the dysfunctionality of the current system.  We at Health Care Renewal will continue to try to draw attention to these issues, accompanied I am sure by our fellow bloggers (as are listed in the right hand column).  However, a small group of voluntary "citizen journalists," and health care professional curmudgeons cannot solve this problem on our own. I hope we will soon have some more support.

ADDENDUM (14 December, 2010) - See also comments by Paul Levy on the Running a Hospital blog.

NIST Provides Healthcare IT Industry with Remedial Undergraduate Computer Science Education

The National Institute of Standards & Technology (NIST) has published a guide entitled:

NIST Guide to the Processes Approach for Improving the Usability of Electronic Health Records

It is available free at this link in PDF: http://www.nist.gov/itl/hit/upload/Guide_Final_Publication_Version.pdf (hat tip to an AMIA colleague for posting the URL on an AMIA mailing list.)

The NIST was commissioned by HHS/ONC to study Health IT issues such as usability and report on them.

I find the publication both welcome, and pitiable.

As I started to read ch. 6, for example, I observed material that is suitable for undergraduate computer science instruction:

6. User-Centered Design Process in EHRs

User-centered design is a bedrock principle for creating usable systems and devices. [You don't say? - ed.] One of the most common reasons why systems are poorly designed is that designers and developers fail to engage users in appropriate ways at appropriate times. [Hear that, my young Paduan learners? - ed.] At its core UCD is a process that relies on systematic understanding of users and their environments, and iterative design and testing based on user performance objectives. (Details on usability testing are provided in Section 9.)

UCD has been shown to be effective in many fields. In aviation, for example, this method has been used to develop cockpit navigation displays for low-visibility surface operations. [22] By taking the limitations and capabilities of the flight crew into account, navigation errors have decreased by almost 100%. The adoption of UCD has also been shown to be effective in the design of personal computers. When working on a redesign of the laptop computer, a UCD process was employed. Users were asked to offer feedback about the current model and to offer input about ways to improve the current design. User-centered design was successful in increasing market share, brand equity, and customer satisfaction. [23] In fact, user-centered design has been elevated to an ISO standard. [24] UCD serves to engineer improved human performance into a system or device, and has been crystallizing for several decades as a design philosophy. [25]

While there is no singular model of UCD, the instantiations embody the following principles:

• Understand user needs, workflows and work environments
• Engage users early and often
  
• Set user performance objectives
• Design the user interface from known human behavior principles and familiar user interface models
• Conduct usability tests to measure how well the interface meets user needs
• Adapt the design and iteratively test with users until performance objectives are met

[HHS needs ONC to commission NIST to provide schooling for the HIT industry on these bons mots? - ed.]

As an iterative process, UCD is a cycle that serves to continually improve the application. For each iteration, critical points and issues are uncovered which can be improved upon and implemented in subsequent releases. An illustration of the UCD process is included in Figure 1.

"User centered design process in EHR's." Undergraduate-level computer science 101 instruction from NIST for the healthcare IT industry? (click to enlarge)

Here is Figure 1:

User centered design 101 (click to enlarge)

I might even have used this in teaching high school students about computer programming.

Readers can download the entire report at the above URL.

I find this publication, or, rather, the need for it to exist at all in 2010, remarkable. Absurd and an embarrassment, in fact. Master of the Obvious [1] material that apparently was not so obvious to this industry.

This is after all a multi-billion dollar industry making claims its products will "revolutionize medicine" and other exceptional claims (but without exceptional evidence). These claims have been pushed so hard that many tens of billions of dollars (with penalties) have been earmarked to either entice -- or coerce -- physicians and hospitals to use these products.

What has this industry, including vendors and highly paid management consultants and contractors, been doing, exactly, for the past thirty+ years?

What have been their product design and development practices, such that leaders of their own trade group HIMSS (as I pointed out in other posts) opine we should be "patient" for them to figure it all out about how to do health IT better and they need more time, and that the technology does not support its users properly due to lack of efficiency and usability of EMRs currently available? (As at my July 2010 post "The National Program for Healthcare IT in the U.S., and the Elephant in the Living Room".)

That HHS needs NIST to provide undergraduate level remedial teaching to the multibillion dollar health IT industry is a very poignant commentary indeed on the priorities of that industry regarding engineering rigor, talent management, attention to safety, and other factors affecting human lives.

These observations speak strongly to the need for regulation for this industry, for a talent management and trade association shakeup of major proportions, and most especially for an awakening of our government servants to exactly what the real situation is with respect to HIT on the ground.

12/14/10 addendum: it struck me that the Guide might need another chapter. I suggest a chapter entitled:

"Listening to informatics experts when they say your product will kill people, instead of firing them."

-- SS

[1] This was another pithy line from my early medical mentor, pioneering cardiothoracic surgeon Victor Satinsky, MD at Hahnemann Medical College.