Another Episode in the Series: HIT Failure

At "Indiana Power Surge" I wrote about the dangers of EHR "glitches" that do, but should not, cause catastrophic failure of clinical IT systems that clinicians are increasingly dependent upon to deliver healthcare.

Heart-lung machines, for example, do not generally have "unscheduled downtime" during surgery. It would not be tolerated.

With EHR's, though, here we go again:

June 6, 2009

Hospital stricken by computer glitch
Staff forced to keep records by hand

By CHELSEA CONABOY Monitor staff

Concord Hospital CEO Mike Green said the hospital has been struggling for a week with computer system failures but, as of yesterday, everything was working again.

Green said the hospital was adding memory to its storage area network on May 28 and something went wrong - possibly because of faulty hardware or a bad installation. [It is remarkable that the cause seems unknown - ed.] In the days that followed, the systems that access that network began to fail.

Those used by nurses and pharmacists in the hospital and by providers to make orders for lab work [i.e., CPOE - ed.] and other tests crashed.

"People had to revert to paper processes," Green said. "It was a lot of work, particularly for pharmacists who had to do things manually that are ordinarily done by the electronic system." [The increased risk of error in the mayhem is not insignificant - ed.]

The systems that handle electronic medical records and financial information in physicians' offices weren't affected.

The hospital financial system, which processes about $1.5 million in charges each day, was briefly offline but quickly repaired, Green said.

He said staff members were working around the clock to correct the problems and to ensure that the quick shift to manual processes posed no safety concerns for patients [as I've written before, HIT crashes NEVER, EVER seem to present safety concerns - see "Health IT Failure Never Puts Patients at Risk" - ed.]

The systems are new, some installed within six months, and are state of the art for the industry.

"It's remarkable how quickly you become reliant on that technology," he said. [I'm not so sure what's remarkable about it when you get rid of paper. Clinicians have to record their orders, findings and observations, etc. somewhere - ed.]

Green said the issues highlighted the fact that some nurses at the hospital have only ever used electronic processes for keeping patient charts and don't have the experience of using manual systems to fall back on when the systems crash. The hospital plans to create training and procedural standards for what to do in case that this happens again. [Why in god's name wasn't it done before?- ed.]

Green did not have an estimate for how much the computer crash would cost the hospital, though he said it was something that would be accounted for through minor adjustments in the organization. He said patients were not likely aware of the problems.

"This was a painful learning experience," he said. "Between dealing with H1N1 and dealing with this, I am very confident in saying we are the best prepared hospital in the state to deal with any disaster." [This seems a bit of a non-sequitur. They apparently don't really know what went wrong with the IT, and they claim they're prepared to deal with any disaster? - ed.]

This organization recently won an award for IT excellence:

Concord Hospital’s Michael Green nationally awarded for leadership and commitment to utilize information technology to enhance patient care

January 22nd, 2009

Michael B. Green, president and CEO of Concord Hospital, has been selected as one of three winners of the CEO IT (Information Technology) Achievement Award by Modern Healthcare magazine and Healthcare Information and Management Systems Society. [HIMSS - ed.]

A panel of judges consisting of two CEOs and three chief information officers or IT experts chose three winners from a pool of 48 nominees. This year’s winners will be spotlighted in the February 16th issue of Modern Healthcare. Green is one of 18 winners of the award since its creation in 2003.

Concord Hospital’s Michael Green nationally awarded for leadership and commitment to utilize information technology to enhance patient care

This hospital is an IT award winner. I fear what's going to happen at hospitals with far less IT savvy deal when they deal with this increasingly complex and critical technology in coming years.

-- SS

6/19 Addendum:

I've had an exchange with Concord Hospital's CIO, Deane Morrison RPh, which I am posting here with permission. He wrote me a polite letter expressing concern that my post was downplaying Concord's HIT accomplishments. We had this exchange:

Deane,

I believe you misconstrue my post. I am an HIT supporter - but in recent years have concerns the field has moved too fast.

I am pointing out that your hospital won an award for IT excellence, reproducing a paragraph about that, yet still has problems with the technology. I do this in the context of my concerns about what will happen at hospitals without the IT savvy yours has in future years. In that sense, I am complimenting your organization, with a few nitpicks that, believe me, are relatively minor compared to your competitors.

I am an HIT expert going back many years (see my bio page in the link below), was a CMIO in both hospital and pharma serttings, and know that there are universal problems in both clinical IT and research IT. I also spent time at Comdisco working on disaster recovery and business continuity solutions for hospitals and know the complexities of that.

As to risk/benefit, I have written volumes at the 10-year-old website now hosted at Drexel, again at the link below [link -ed.] My concerns are that HIT can finally produce the benefits long claimed (decades!) for it, and in fact have achieved those benefits in projects I led - with a caveat - only if done well. There is a lot of meaning as I'm sure you well know behind those two words, from vendor origins to implementation to lifecycle management.

It sounds like you've done HIT very well (I hear really terrible stories from my colleagues and grad students in operational HIT positions almost daily these days), but yet you are still faced with the unexpected events predicted by those in the field of social informatics with any ICT (information & communication technology) - the unthinkable and chaotic things that find a way to happen despite good planning.

Again, my concern is about the hospitals who are not award winners and yet who are being rushed into HIT by the provisions in the ARRA.

If you would like me to add a comment or address some specific concern, please let me know.

CIO Morrison then wrote me back:

Scot,

Thank you for your reply. I clearly misconstrued the intent of your blog. I very much agree with you that our society as a whole and the leadership of our country do not understand how hard it is to successfully implement clinical IT technology.

At Concord I've never contended that what success we've had has been related to the systems we have choosen. Rather I've tried to emphasize for our leadership that its the people (It & clinicians) who work on the projects that make the difference. We have invested in a CMIO (Dr. Joel C. Berman). He has three other MD's working part time. We have a 4 person nursing informatics team. And we have a very large IT department. And even with that we are still vulnerable to the hiccups that come with increasong reliance on technology. So all in all I believe that well installed IT technology will result in a better healthcare system but I aslo very much agree with you that we can not underestimate the amount of hard work its going to take to get us there.

Deane Morrison, RPh
CIO
Concord Hospital
Concord, NH

It is a pleasure to communicate with CIO's who understand what's strategic and what's tactical in healthcare and HIT. I replied:

Deane,

Thanks. You've made an interesting comment:

"... Rather I've tried to emphasize for our leadership that its the people (IT & clinicians) who work on the projects that make the difference."

Indeed. I expressed this years ago by observing that "healthcare IT projects are complex medical/social projects that happen to involve computers, as opposed to complex IT projects that happen to involve clinicians."

You are way ahead of many of your competitors in pointing out to your leadership what's strategic in IT (the right people with the right skills) vs. what's transient and tactical (the right package, platform etc.). Technologic determinism prevails (i.e., computers solve problems, automatically, and people are interchangeable cogs in an IT project).

In my opinion we as a nation need more CIO's in hospitals who share these insights about people.

-- SS

Yale, Van Gogh's "The Night Cafe" and Personal Property: What's Mine is Mine, and What's Yours is Mine

At Healthcare Renewal and at numerous other healthcare blogs, we write about academic and industry conflicts of interest, malfeasance, and other topics in the hopes that there are leaders within organizations who might correct the wrongs that result from such conflicts and behaviors. (That is, when it is not those same leaders behind the scandals in question.)

Our efforts are based on the assumption (perhaps, more correctly, a hope) that the problems within organizations are not organic and ideological, and that they are in some fashion amenable to correction internally and externally via exposure to sunlight.

What if we're wrong?

A story caught my eye about my Medical Informatics alma mater. A Frenchman, Pierre Konowaloff, is suing Yale for return of a famous Van Gogh painting that was confiscated from his family in the early 1900's by totalitarians, psychopaths who created what proved to be one of the most oppressive and murderous regimes in history (the Soviet Union).

In return, Mr. Konowaloff was countersued by Yale.

Yale alleges that the confiscation of the painting by the Soviets was A-OK because "international law was not violated" [by the confiscation - ed.], therefore Yale has legitimate and unchallengeable dibs on the painting.

"International law" was not violated? This response is beyond stunning.

I had to retrieve my jaw from the floor after reading the story:

Wall Street Journal
June 3, 2009

Yale Sued Over Van Gogh Painting Seized by Soviets

By JOSEPH PEREIRA

A descendant of the onetime owner of a famed Van Gogh painting has sued Yale University in an effort to reclaim the artwork from the Ivy League school.

In a lawsuit filed in U.S. District Court in New Haven, Conn., Pierre Konowaloff alleged that the university should have known the painting—"The Night Café"—had been confiscated from his great-grandfather, Ivan Morozov, a Russian industrialist and aristocrat, during the Communist takeover of Russia in the early 1900s.

The 1888 painting was subsequently sold by the Soviet government to a European gallery. Stephen Carlton Clark, a Yale alumnus, bought the painting from a gallery in New York in the early 1930s and bequeathed it to Yale in 1961.

In his suit, Mr. Konowaloff, who lives in France, accuses the university of engaging "in a policy of willful ignorance" that amounts to "art laundering," and asks the court to declare him the rightful owner. Aware of Mr. Konowaloff's intention to claim the painting, Yale filed a lawsuit of its own last March in federal court in New Haven.

In its suit, Yale asserted ownership of "The Night Café," claiming that the nationalization of the painting by Communist Russia -- while at odds with capitalism -- did not violate international law. Yale stated in its lawsuit that "it was accepted at the time, as it is now, that the sales by the Soviet government were valid, as were later acquisitions of the paintings."

In other words, rather than doing the right thing, Yale is claiming that the theft of personal property by the Soviets was OK by them. (While Yale is well known to have a culture far to the left and many of its leaders and faculty probably sympathize with communists, Hitler also "nationalized" the artwork and other property of individuals. Would Yale find those actions in accordance with "International law?" One can only wonder.)

Van Gogh's "The Night Cafe"

Now, if this were a one-off event, it would not be as illustrative of a systematic ethical decay that I fear exists in the hallowed Ivy halls. However, Yale has recently been fined $7.6 million after an investigation by NIH, NSF, DOD and others into misuse of research money by faculty. I wrote about that event at "Lux et Veritas, or Trust But Verify? Yale discovers eDiscovery", and the powerpoint from within Yale outlining the issues was eye-opening.

Here is a synopsis of the outcome:

Yale University Pays $7.6 Million to Resolve False Claims Act Allegations (PDF)

—excerpted from U.S. Dept. of Justice press release, Dec. 23, 2008

Yale University has entered into a civil settlement agreement with the federal government in which it will pay $7.6 million to resolve allegations that it violated the False Claims Act and the common law in the management of federally-funded research grants awarded to the university between January 2000 and December 2006. The grant awards were made by approximately 30 federal agencies and entities, including NIH, NSF, DOE, DOD, and NASA.

The investigation focused on allegations involving two types of mischarges to federal grants. Both types of mischarges arose as violations of the basic principle that recipients of federal grants are allowed to charge to each grant account only “allocable” costs, which are costs that relate to the specific objectives of that grant project.

The first allegation involved cost transfers and the requirement that costs transferred to a federal grant account must be allocable to that particular grant account. The settlement resolves allegations that some Yale researchers at times improperly transferred charges to a federal grant account to which those charges were not allocable. Researchers allegedly were motivated to carry out these wrongful transfers when the federal grant was near its expiration date and they needed to spend down the remaining grant funds. Federal regulations require that unspent grant funds be returned to the government.

The second allegation involved salary charges and the requirement that charges to federal grant accounts for researcher time and effort must reflect actual time and effort spent on a particular grant. It was alleged that some Yale researchers submitted time and effort reports, for summer salary paid from federal grants, that wrongfully charged 100 percent of their summer effort to federal grants when, in fact, the researchers expended significant effort on unrelated work.

Researchers allegedly were motivated to carry out these wrongful salary charges by the fact that they are not paid their academic-year salary by Yale during the summer. The only salary received by these researchers during the summer was the result of the effort they charged to federal grants. Absent the alleged grant mischarges, the researchers would not have been paid.

The $7.6 million payment comprises two components: $3.8 million in actual damages for the false claims, and $3.8 million assessed as penalties for the false claims.

Taxpayer money was used as they pleased until caught. What's mine is mine, and what's yours is mine.

Yale's clinical operations have seen federal investigation once before which I wrote about at "Insufficient IT Management Depth Results in Justice Dept. Investigation, Millions of Dollars in Fines." That story was more about IT incompetence rather than malfeasance, however.

I've had my own personal experiences with these "what's mine is mine, and what's yours is mine" property-rights attitudes at Yale. Perry Miller, Director of Informatics, Kenneth Kidd, Professor of Genetics, and Carolyn Slayman, Deputy Dean for Academic and Scientific Affairs, waged a rather one-sided and extortionary battle to misappropriate my intellectual property, a computer program I'd authored as faculty, assisted by a lawyer in Yale's Office of General Counsel -- who for good measure was in fact unauthorized to practice law in Connecticut at that time. Ex-colleague faculty Richard Shiffman "purged" me, Stalin style, by telling recruiters who called that I didn't exist - one of those recruiters, unfortunately for him, happened to be a detective I retained. I wrote up the story in detail at this site. Dr. Kidd in particular was a principal in the now-defunct Human Diversity Genome Project in which he and others promised indigenous tribes their genetic materials would not be misappropriated for others' gain and profit. (I found that position risible considering my circumstances. Kidd's research raised further issues as I wrote at "Informed consent, exploitation and developing a SNP panel for forensic identification of individuals.")

University officials right up to President Richard Levin (in the WSJ recently lamenting the decrease in the value of Yale's endowment from $24 billion to $17 billion), said they could do nothing to help me, even though I was being badgered for my software and actually blackmailed (through denial of confirmation of my training and faculty time at Yale to potential employers).

You would think a university with an endowment in the billions of dollars could have protected its own junior faculty from senior faculty predators, and you'd also think it could return a Van Gogh to the heir of a man who had it stolen by thugs who later murdered tens of millions of their own citizens.

Ironically, when I was Yale School of Medicine junior faculty in Yale Center for Medical Informatics, I was charged with teaching postdoctoral fellows about NIH ethics guidelines. The tenured senior faculty I was working for just didn't have the time.

Now, I may simply be a "disgruntled former Yale faculty member" after nearly having my career destroyed by these people in what was the most disappointing experience in my life, bar none, but the pattern of "what's mine is mine, and what's yours is mine" seems to be all too commonplace in Yale's case. From Bloomberg's coverage of the same Van Gogh story:

Yale Sued Over Van Gogh Work By Man Claiming to be Russian Heir

June 4, 2009
By Cary O’Reilly

... Konowaloff’s claim is the latest litigation accusing Yale of improperly possessing artwork or historic artifacts. The Republic of Peru sued Yale in December seeking a collection of artifacts excavated from Machu Picchu and other sites by university scientists and researchers.

I'd written about Machu Picchu here:

... Peripherally related in the scientific sense but perhaps closely related in the ethical and ideological sense, I've just discovered via a recent newspaper that Yale has some additional problems of late regarding property: "Peru demands return of Machu Picchu treasures by Yale", Miami Herald, July 25, 2007, by Tyler Bridges (now a Peruvian resident). Yale apparently went so far as to interpret the laws of a foreign nation, which is, of course, Yale's right as a sovereign entity, the People's Republic of Yale, it would seem:

Key documents include a 1912 Peruvian decree stating that Peru reserved the right to request the objects' return, and a 1916 letter that [Yale professor/explorer Bingham] wrote to the National Geographic Society about the artifacts from the 1914-15 expedition. ''Now they do not belong to us, but to the Peruvian government, who allowed us to take them out of the country on condition that they be returned in 18 months,'' Bingham wrote. Yale officials have said that Peruvian law in force in 1912 does not require the university to return objects from Bingham's expedition that year.

Perhaps less credible is this additional allegation from Bloomberg:

... Yale and a secretive student society known as the Order of Skull & Bones were sued in February by the descendants of the 19th century Apache Indian warrior Geronimo. The family claims a group of Yale students may have stolen some of Geronimo’s remains in 1918 and taken them to Yale’s campus. The university denies the allegation and says it has no connection to Skull & Bones.

Then there's Yale's Taliban Man incident per John Fund at the WSJ. The former deputy foreign secretary of the Taliban was taken as a student at Yale in 2006 while at the same time the school blocked ROTC training from its campus and argued for the right of its law school to exclude military recruiters.

I fear other Ivy universities also lack a sense of basic ethics, both at the individual faculty level and collectively, i.e., including the leadership. I'd written about the ghastly events regarding the Duke lacrosse team affair at "A Truly Appalling Lawsuit Against Duke University." Harvard Medical Schools's own ombud had written an article in JAMA in the late 1990's entitled "Authorship: the coin of the realm, the source of complaints", outlining the commonality of fights over IP between faculty and students, and admitted in a response to my Letter to the Editor that this could not be prevented by administration (which in my view translates to, "the administration's worse than the faculty in this regard.")

Others at Healthcare Renewal and related blogs have written about ethical lapses at other major universities as well.

In summary, if both the majority of the faculty as well as the administration of our major universities never learned as children about respecting others' property, and pass these attitudes along to future academics and future captains of industry, the bloggers will be unable to teach them very much. We will continue on a course of periodic academic and industry healthcare (and other) scandals of increasing scale, along with the wasted talent, resources and opportunity these scandals represent.

-- SS

Addendum: after such a grim report, I thought I'd throw in something pleasant. Here is a friend I feed at the nearby park, one of six, in fact, Mute Swan cygnets (babies). The parents like me so much, they've offered me food in return - lovely clumps of fresh tender grass, which to them is a delicacy:

Cygnus olor - click to greatly enlarge these adorable fuzzballs

It's a great picture, but it's not a Van Gogh. Since I once worked at Yale, however, let's hope they don't claim the photo is theirs.

-- SS

6/10/09 Addendum:

Remarkably, there is apparently someone in the health IT community who was offended by the posting of the photo of the cygnet I feed (done, of course, as "comic relief"), as I have been informed. One can only wonder if violations of intellectual property and civil rights by universities, or patent safety concerns by faulty EHR's cause equal offense.

Open letter to Mark Leavitt, Chairman, Certification Commission for Healthcare Information Technology on Penalties For Use of Non-"Certified" HIT

A remarkable Bill (ASSEMBLY, No. 3934, STATE OF NEW JERSEY, 213th LEGISLATURE) has appeared in NJ that would prohibit the sale or use of healthcare IT not "certified" (i.e., feature-qualified) by the industry-founded and connected group "Certification Commission for Healthcare Information Technology" (CCHIT). The Bill calls for monetary civil penalties for such sale or use:

A civil penalty or civil fine is a term used to describe when a state entity or a governmental agency seeks monetary relief against an individual as restitution for wrongdoing by the individual.

I previously wrote about CCHIT in a series of linked posts that start here: A very troubling post about the CCHIT (Certification Commission for Healthcare Information Technology).

I have now written the following open letter to Mark Leavitt, MD, PhD, Chairman, Certification Commission for Healthcare Information Technology.

To: "Mark Leavitt"
Date: Sunday, June 07, 2009 02:10PM
Cc: Robert O'Harrow, Jr., Washington Post, and various AMIA working group mailing lists (CIS - clinical info systems, POI - people & organizational issues, OS - Open Source, and ELSI - Ethics, Legal & Social Issues)

June 7, 2009

Mark Leavitt, MD, PhD
Chairman, Certification Commission for Healthcare Information Technology
www.cchit.org
[6/8/09 - contact info from www.markleavitt.com removed per critique in response below -ed.]

Re: NJ HIT Bill at http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM by Assemblyman Harb Conaway, Jr., District 7, and Upendra Chivukula, District 17

Dear Mark,

The NJ Bill at http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM by Assemblyman Harb Conaway, Jr., District 7, and Upendra Chivukula, District 17, calls for making it a violation of law to sell HIT not "certified" by CCHIT . Penalties are called for. The bill states:

... No person or entity, either directly or indirectly, shall sell, offer for sale, give, furnish, or otherwise distribute to any person or entity in this State a health information technology product that has not been certified by the Certification Commission for Healthcare Information Technology.

As used in this section, "health information technology product" means a system, program, application, or other product that is based upon technology which is used to electronically collect, store, retrieve, and transfer clinical, administrative, and financial health information.

b. A person or entity that violates the provisions of subsection a. of this section shall be liable to a civil penalty of not less than $1,000 for the first violation, not less than $2,500 for the second violation, and $5,000 for the third and each subsequent violation, to be collected pursuant to the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.).

I and others find this bill remarkable. It really calls into focus the HIT community's concerns about CCHIT and its political connections, especially pursuant to the article " The Machinery Behind Healthcare Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records " of May 16, 2009 in the Washington Post by Robert O'Harrow Jr.

I therefore seek answers to the following questions:

1. Do you approve of the proposals in the bill at http://www.njleg.state.nj.us/2008/Bills/A4000/3934_I1.HTM ?

2. Did you, or anyone in a governance or leadership position at CCHIT, play a role in sponsorhip of this bill, through financial contributions, lobbying, advocacy for its proposals, and/or other means to prohibit sale of non-CCHIT certified HIT?

3. Did anyone with governance or leadership roles in CCHIT's founding or affiliated organizations (e.g,, HIMSS, CITL, and others) or business associates of such people, play a role in the bill's sponsorhip, through financial contributions, lobbying, advocacy for its proposals, and/or other means to prohibit sale of non-CCHIT certified HIT?

4. Did anyone (person or company) in the HIT industry, broadly speaking, who could directly profit from such a bill becoming law play a role in sponsorhip of, or advocacy for this bill?

I believe candid and transparent answers to these questions are important in giving the HIT community confidence that CCHIT primarily serves the public interest, not interests of an HIT lobby.

-- SS

6/8/09

Dr. Leavitt has candidly responded. I take his word on these issues at face value, having done business with him a bit over a decade ago (supporting the purchase of his company's EHR, Logician, for Christiana Care over the opposition of the IT department which preferred another vendor):

From: "Mark Leavitt"
Date: 06/08/2009 02:51AM
cc: cis-wg@mailman.amia.org, poi-wg@mailman.amia.org, os-wg@mailman.amia.org, els-wg@mailman.amia.org, oharrowr@washpost.com,sreber@cchit.org
Subject: RE: Bill to make illegal the sale or use of non-CCHIT "certified" systems

Scot,

Here are the answers to your questions:

1. No, I do not approve of this legislation -- which I'm reading for the first time in your email. Our goal, stated in almost every presentation I've given, and to which I've adhered in my leadership of the Commission, has always been to unlock positive incentives for health IT adoption. The bill does not fit that model at all, and it is a bad idea.

2. Neither I personally, nor CCHIT as an organization, have lobbied, advocated, sponsored, or had anything to do with that bill. We were unaware of it until it started showing up on listserves Friday. The bill has never been mentioned in any of our Trustee, Commission, or staff meetings.

3. Trustees, Commissioners, and Work Group members serve in a volunteer capacity at CCHIT. We require disclosure of conflicts of interest, but we do not monitor all activities in their 'day jobs' or other volunteer roles. "HIMSS, CITL, etc" are not affiliated with CCHIT, and we don't know about all their advocacy activities. I'm not privy to the information you seek.

4. This question presumes that I would know everything that "anyone in the HIT industry, broadly speaking" has done regarding the bill. Naturally I do not have that knowledge either.

Now that I've responded, the AMIA listserve members can stop reading here, while I go on to chat with Scot.

Scot, in 15 years of medical training and practice followed by 25 years of healthcare informatics, I've encountered very few people -- and certainly no university professors -- who acted so disrespectfully toward me. Being a veteran of health IT, it's easy to find people who have worked with me or know me well, and to ask them about my integrity. Or to talk to some of the other 50 or so Commissioners who've served or the hundreds of work group volunteers. Shouldn't an informatics scientist do a modicum of research before undertaking a potentially harmful procedure such as attacking a person's or organization's reputation? Reading a news article by Mr O'Harrow does not qualify as due diligence. Would you let your informatics students get away with that before recommending a major, potentially disruptive or destructive IT project?

From your own blogging I see that your "early medical mentor, cardiothoracic surgery pioneer Victor P Satinsky, MD, believed in public embarrassment as a tool to fight bureaucracy and discrimination ." Well, that helps me understand. And your blogging about your frustration when you sought employment with a commercial EHR vendor http://hcrenewal.blogspot.com/2009/02/nextgen-and-vendordoctor-dialog-yet.html explains even more. Knowing that, I forgive you for your tone and for inappropriately disclosing my home address and cell phone to everyone on these lists. I would be pleased to engage in a civil, rational debate with you along the lines of "EHRs -- do the benefits outweigh the risks?" C'mon out to the farm here sometime -- you know the address, and the dog's friendly -- or we could do it on the web.

Finally, my apologies to everyone on the mailing lists that Dr. Silverstein chose to include in his investigative journalism broadcast. If you object to his use of AMIA mailing lists for this kind of activity, you could let him know.

Mark Leavitt, MD, PhD
Chairman, CCHIT

My response was simple:

To: "Mark Leavitt"
Date: 06/08/2009 05:24PM
cc: cis-wg@mailman.amia.org, poi-wg@mailman.amia.org, os-wg@mailman.amia.org, els-wg@mailman.amia.org, oharrowr@washpost.com,sreber@cchit.org
Subject: RE: Bill to make illegal the sale or use of non-CCHIT "certified" systems

Mark,

I thank you for the answers to my questions.

> Knowing that, I forgive you for your tone and for inappropriately disclosing my home address and cell phone to everyone on these lists.

Mark, that information came from your page at http://www.markleavitt.com/ which I found on a google seach for "Mark Leavitt." Image attached. I believed that to be your professional contact info.

As to the rest of your response, you appear to attempt to discredit my arguments through ad hominem. I refer you to this page:

http://www.nizkor.org/features/fallacies/ad-hominem.html

Translated from Latin to English , "Ad Hominem" means "against the man " or "against the person."

An Ad Hominem is a general category of fallacies in which a claim or argument is rejected on the basis of some irrelevant fact about the author of or the person presenting the claim or argument. Typically, this fallacy involves two steps. First, an attack against the character of person making the claim , her circumstances, or her actions is made (or the character, circumstances, or actions of the person reporting the claim ). Second, this attack is taken to be evidence against the claim or argument the person in question is making (or presenting). This type of "argument" has the following form:

1. Person A makes claim X.
2. Person B makes an attack on person A.
3. Therefore A's claim is false.

The reason why an Ad Hominem (of any kind) is a fallacy is that the character, circumstances, or actions of a person do not (in most cases) have a bearing on the truth or falsity of the claim being made (or the quality of the argument being made).

Ad hominem, sadly, is not debate.

Neither is appeal to authority .

Scot

Truth be told, I actually offered no arguments in my email message. I was asking very probing questions with concern they would be ignored, or responded to with "spin" as here, and their tone offended him. Fair enough.

I was a bit disappointed, however, by the "The lady doth protest too much, methinks" ad hominem embellishments to an otherwise candid and convincing response.

Such are the risks of directness and disruptive innovation, however.

-- SS

6/9 Addendum:

Additional views on the NJ Bill are at ePatients.net at "David Kibbe & Mark Leavitt:Openness vs. Opacity" and "Dossia, Microsoft HealthVault & Google Health: Illegal in NJ?". There are some now-familiar themes regarding CCHIT civility in those posts.

6/10 Addendum:

As a result of a link sent by a commenter, I am adding the post "The Kibbe/Leavitt Rumble in the High Tech Jungle!" to the list of interesting views in the 6/9 addendum above.

Indiana Power Surge: The Hospital Computing Backwater And The Need to Reform IT Before IT Reforms Medicine

In the three part series "Healthcare IT Backwater: The $20 Billion Abyss?" I lamented that hospitals are often an IT backwater, and the backwater mentality would severely hamper efforts to "reform healthcare" via IT:

Merriam-Webster:

Main Entry: back·wa·ter

Pronunciation: \-ˌwȯ-tər, -ˌwä-\

Function: noun

Date: 1629

- an isolated or backward place or condition

Computing is not a hospitals' core competency, salaries for IT personnel are usually lower than in other industries, and talent mismanagement in hospitals is far worse than in other sectors where IT is critical (e.g., health IT recruiters retained by hospitals have traditionally been generalists, or worse, recruiters with attitudes such as this):

I don't think a degree gets you anything," says healthcare recruiter Lion Goodman, president of the Goodman Group in San Rafael, California about CIO's and other healthcare MIS staffers. Healthcare MIS recruiter Betsy Hersher of Hersher Associates, Northbrook, Illinois, agreed, stating "There's nothing like the school of hard knocks." In seeking out CIO talent, recruiter Lion Goodman "doesn't think clinical experience yields [hospital] IT people who have broad enough perspective. Physicians in particular make poor choices for CIOs. They don't think of the business issues at hand because they're consumed with patient care issues," according to Goodman.

The end result of the hospital IT backwater mentality is stories such as this:

Indystar.com

Hospital is forced to turn away patients

Methodist Hospital went "on diversion" early Tuesday for the first time in its 100-plus years, sending ambulances that came to its doors to other hospitals.The diversion lasted until about 3 a.m., Wide said.

A power surge knocked out Clarian Health's computer system Monday afternoon, derailing the hospitals' ability to access electronic health records for patients, said Clarian spokesman James Wide. Staff members at Methodist and Indiana University Hospital had to enter patients' records by hand.

By about 1 a.m. Tuesday, a backlog of paperwork led Methodist and IU hospitals to stop accepting patients who arrived by ambulance. Walk-in patients were still accepted. The diversion lasted until about 3 a.m., Wide said.

This raises a number of questions:

• Which power system "surged?" Shouldn't hospitals be protected from such "surges?"
• Was any other equipment "knocked out?" CCU/ICU monitors? Ventilators? Heart-lung machines? If so, why were they not protected? If they were not knocked out but the EHR was, why?
  
• What computers, exactly, were knocked out? Does not sound like the workstations, which would be rebooted quickly. Therefore must have been data center servers...and if so...
• Why were the EHR servers vulnerable to "power surges"?
• Or was this EHR a remote hosted ASP arrangement and did the surge occur at the service provider...in which case, the above question also applies?
• Where were the backup systems? Were there backup systems?
  
• Who performed the "backlog of paperwork?" Was it clinicians backloading the paper data into the system? -- in which case a power surge would have turned doctors into the world's most highly trained data entry clerks?
  

Of course, there was the usual refrain by non-clinical management, as I wrote at "Health IT Failure Never Puts Patients at Risk", that such outages are just minor blips on the radar. In another account of this story:

WTHR.com Eyewitness News

Power surge forces hospitals to divert new patients

Updated: June 2, 2009 07:57 AM

Indianapolis - Methodist and Indiana University Hospitals are back open and accepting new patients.

Monday around 3:45pm a massive power surge hit the hospitals crashing their computer system. IPL responded quickly to assist with bringing the system back online.

In the meantime, the hospitals began doing things on paper, like patient charting, that had been done by computer.

There was no disruption in patient care, however, around 1am Tuesday both hospitals decided to stop taking new patients [that's not a "disruption in patient care?" - ed.]

As of 3:15am most of the primary care system was back up and running and Methodist starting taking some new patients. I.U. Hospital continued to divert patients for some time.

As of 7:00am all patient primary care systems were up and running and both hospitals were completely open to new patients. Officials say there will be no impact on elective surgery Tuesday.

Here is the candid translation of the statement that "There was no disruption in patient care" by a total EHR crash, making records and probably CPOE unavailable and forcing clinicians and administrative assistants back to paper and pencil (fortunately, paper charts and pencils require at most only a flashlight and hand-cranked sharpener for read and write access):

"By the grace of God, no patients were harmed (that we know about in the confusion right now, or will admit to even if we did know) among our own patients or those diverted, in the chaos that ensued after the HIT systems went down from a power surge that we should not have been susceptible to in the first place."

As I wrote in Part 2 of the aforementioned series, I reiterate that HIT should be treated as experimental, not as a drop-in panacea for healthcare's ills. In its present state is is perhaps as likely to exacerbate those ills. This is probably not technology that should be deployed en masse at present. We cannot afford as a society to learn how to do this by trial and error.

-- SS

Was a Private Equity Takeover of Bausch and Lomb Meant to Conceal Its Legal Settlements of Cases of Eye Infections?

This week, the Associated Press reported on yet another way health care corporations may keep information that reflects poorly on their products out of public view. The story involved fungal eye infections that particularly afflicted users of a specific contact lens cleaning solution:

More than 700 lens wearers in the United States and Asia say they were exposed to a potentially blinding infection known as Fusarium keratitis while using ReNu with MoistureLoc, a new-formula multipurpose solution for cleaning, storing and moistening soft contact lenses.

Sometimes, the damage was irreparable. Seven people in Florida, Maryland, New York, Oregon, Tennessee and West Virginia had to have an eye removed. At least 60 more Americans needed vision-saving corneal transplants.

The U.S. Centers for Disease Control and Prevention confirmed 180 cases in 35 states from June 2005 through September 2006, when the agency's dedicated surveillance stopped, according to Dr. Benjamin Park, a CDC epidemiologist. CDC continued to hear of sporadic, unconfirmed cases in the months after MoistureLoc was withdrawn, Park said.

'Surveillance usually captures the tip of the iceberg and sometimes it captures a larger tip than other times,' Park said in an interview.

Among out-of-court settlements reached in May was a potential bellwether case brought by Andrea Martin, a Broadway actress and comedienne whose eye was scarred. In Colorado, a corneal transplant ended a race-car driver's career. In Baltimore, a chimney-sweep business owner who lost an eye got hooked on painkillers.

Leading eye doctors and government scientists concluded that MoistureLoc, launched in 2004 with novel disinfectant and moisturizing ingredients, was the only lens solution that contributed to the outbreak. Yet the mechanics of how it caused the problem are still not fully clear.

AP alleged that Bausch and Lomb kept the cases out of public view by using a previously unknown (at least to me) strategy:

Contact lens maker Bausch & Lomb Inc. had an overriding reason for going private in 2007: It wanted to handle a devastating recall of its flagship lens cleaner, its chief executive said, 'without a lot of outside distraction.'

Over the past year, away from the glare of public scrutiny, the optical products company has quietly settled nearly 600 fungal-infection lawsuits — with dozens more individual claims yet to be resolved. The cost so far: Upward of $250 million.

With some fungal lawsuits still unresolved, the prospect of Bausch & Lomb's health care nightmare being aired in court has not entirely faded — which heartens some lawyers and doctors.

'The truth has been very carefully buried, and it appears to have been buried going back to the beginnings of the outbreak,' said Dr. Arthur Epstein, who was chairman of the American Optometric Association's contact lens and cornea section during the highly publicized crisis.

'All settlements were predicated on silence about the clinical findings and blame and so forth. My hope was that what actually happened would become part of public record in a courtroom. That way, we'd be able to learn from it and move on and make sure it never happened again.'

When Bausch & Lomb was acquired by private equity firm Warburg Pincus for $3.67 billion in October 2007, Chief Executive Ronald Zarrella said the deal would allow the company 'to pursue the growth path we were on ... without a lot of outside distraction.'Zarrella retired last year.

'hey can do all this out of the public eye — guys like me aren't sitting there scrutinizing the financial impact of every single settlement,'said analyst Jeff Johnson of Robert W. Baird & Co. in Milwaukee. 'you can completely focus on your brand and on doing what's right by the patient.'

So, if I understand this correctly, after Warburg Pincus took the company private, it was no longer required to file certain reports with the US Securities and Exchange Commission (SEC), including reports that would have had to acknowledge the multiple settlements the company made of cases alleging adverse effects of its contact lens solution. What is striking is the allegation by the AP that "taking the company" private was a strategy meant to conceal the settlements of these cases, (rather than a strategy implemented to fulfill other aims, which had the side effect of diminishing reporting of these cases' results.)

Again, I am hardly an expert, but relatively opaque private equity firms like Warburg Pincus seem to have become increasingly influential in the US economy, and to have an increasing role in health care. In 2007, we had posted how private equity firms running nursing homes, including Warburg Pincus, seemed to contribute to the opacity of their operations. More recently, we posted about how leaders of private equity, and of other kinds of firms in the finance arena, seem to also increasingly be leaders to which medical schools report.

One final note... A quick tour through the Warburg Pincus website reveals how involved the firm is in health care. The firm claimed that as a "direct equity investor in healthcare for more than 30 years, Warburg Pincus has invested more than $4 billion in approximately 120 healthcare companies." Furthermore, the firm seems quite intertwined with the leadership of academic medicine. It has a Life Sciences Advisory Board, of which three of four members are current leaders in academic medicine. The most prominent, Dr Michael Rosenblatt, Dean of the Tufts University School of Medicine, did not disclose this relationship in several versions of his biography published on the university web-site. (See the Tufts administration version here, and the Tufts Medical Center version here.)

Oh, what a tangled web we have weaved in health care, a web that continually frustrates transparency and makes it hard to figure out who was responsible for what when things go wrong.

If The Military Can't Get Electronic Health Records Right, Why Would We Think Conflicted EHR Companies And IT-Backwater Hospitals Can?

The publication "The Machinery Behind Healthcare Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records" on May 16 2009 in the Washington Post (my comments here) exposes a massive lobby that has grossly over-represented the benefits of healthcare IT, committed a cross-disciplinary invasion of medicine, and created a myth about HIT's supposed transformative powers in curing healthcare's ills.

Since its publication in the Post I have become concerned that the research literature that exists extolling healthcare IT may be tainted by corporate influence. The phenomenon of tainted biomedical literature is certainly familiar to readers of Healthcare Renewal and other medical blogs regarding pharmaceuticals and medical devices.

Electronic health records systems can facilitate, not revolutionize, medicine when led by competent experts cross-trained to a meaningful extent (i.e., graduate level or beyond) in both clinical medicine and information science and technology, e.g., biomedical informatics professionals. Even these professionals must often expend much effort in "managing the mismanagement" by incompetent and/or conflicted IT and hospital leadership. (An example of a tightly run and highly specialized project in a high risk medical subspecialty that did have tangible clinical and some financial returns, via identification of poorly performing medical devices -- not something the medical device industry cares for -- is here. This type of project is not easily portable.)

Making yet another case for how the concept of national electronic health records is probably a bad idea at this point in time with respect to our understanding of health IT and its social-technical interactions and challenges, it appears the military's EHR system AHLTA is simply a disaster. [Note: this is not to denigrate the military, and I am very thankful to all who serve and defend our country and freedoms. HIT problems seem unfortunately universal - ed.] All of the preventable elements I've written about are present: unreliability to due inadequate attention to resilience engineering, a mission hostile user experience, time-wasting, demoralization of clinicians, and a cornucopia of other predictable (to informatics experts) consequences when health IT is managed by anyone other than experts.

Just as our economy and culture are now falling apart at the seams as a result of decades of mismanagement and corruption, from micro to macro levels, in most domains (borrowing a phrase from Rev. Jeremiah Wright, "the chickens are coming home to roost"), so the wages of incompetence and corruption in healthcare and healthcare IT are rearing their ugly head. This is the situation in the setting of a relatively constrained patient population (primarily active military personnel and families):

U.S. Medicine - the Voice of Federal Medicine

May 2009

Electronic Records System Unreliable, Difficult to Use, Service Officials Tell Congress - By Sandra Basu

WASHINGTON—AHLTA, the Department of Defense’s $4 million [sic - that should be $4 billion - ed.] electronic medical record system, continues to be difficult for military physicians to use, according to top military health leaders who spoke at a House Armed Services subcommittee hearing at the end of March.

At a Congressional hearing titled “AHLTA is ‘Intolerable,’ Where do we go from here?” top Department of Defense and service leaders told members that medical personnel are hampered by an electronic medical record system that, among other issues, is slow, difficult to use, unreliable and frequently crashes.“Being the first service to vigorously support the fielding of AHLTA five years ago, we faced a near mutiny of our healthcare providers, our doctors, our nurse practitioners, physician assistants and others last summer,” Army Surgeon General Lt. Gen. Eric Schoomaker, MC, USA, told committee members at a joint hearing held by the Military Personnel Subcommittee and the Terrorism, Unconventional Threats and Capabilities Subcommittee.

Committee members also voiced concern about how the system was impacting provider morale and patient care. “The committee has heard from military doctors and nurses who use AHLTA that it is unreliable, difficult to use and has decreased the number of patients they can see each day. We have also heard that medical professionals leave the military because of their frustration with AHLTA,” said Rep. Joe Wilson, R.-S.C., ranking member of the Military Personnel Subcommittee of the House Armed Services Committee.

Difficult for physicians to use. Intolerable. Slow. Unreliable. Frequently crashes. Near mutiny. Morale. Affecting patient care, decreasing patient load. Can it get worse?

Yes:

A Troubled System

AHLTA is currently deployed worldwide to 70 hospitals, 410 clinics and 6 dental clinics. In addition, the system is used in 14 theater hospitals and 208 forward resuscitative sites.

While Army, Navy and Air Forcer medical leaders who testified all stressed the importance of an electronic medical record [perhaps due to lobby influence and myth-making? - ed.], they all expressed frustrations with AHLTA. Dr. Schoomaker told committee members that medical personnel, particularly specialists, often “spend as much or more time working around the system as they do with the system.” He said that the services are still not effectively able to seamlessly access complete data of patients from the battlefield between the military treatment facilities and the Department of Defense and the Veteran’s Administration.

Last year he said he knew he had a problem when he asked a physician who is a self-described “super user” of the system whether she was a “super fan” of the system and she responded that she was not. “When our best and most faithful users of AHLTA could not admit to being fans of the system, I knew we were really having serious problems,” Dr. Schoomaker said.

When the Army's Surgeon General observes that clinicians "spend as much or more time working around the system as they do with the system", and that the superusers are not enthusiastic about the system, and a Congressional hearing is held entitled "where do we go from here?" (it's clear to this author that they have no clue), one should start to very critically question basic assumptions about health IT. Who said it's a powerful tool to improve healthcare and reduce costs? Who said it's ready for national dissemination? What conflicts do such individuals have with the health IT industry?

He blamed the system’s failures on a lack of a clear-cut strategy for implementing AHLTA—a problem he believes still exists. “In my opinion, the failures of AHLTA can be attributed to the overall lack of a clear, actionable strategy and poor execution from its genesis. As a result of the MHS’s lack of an information management/information technology strategy up to this point, theArmy Medical Department has been largely frustrated by a number of obstacles that continue to impede the system’s capabilities and functionality,” he said.

He also said that the services should have a greater input in decision making regarding AHLTA. “Military health system information technology investments and solutions should be transparent to the services sitting here at the table and should be jointly governed, meaning that we with service input are treated as principal customer clients of the system and that we are heard and acted upon promptly,” he said.

As a faculty member in a College of Information Science and Technology where undergraduates and graduate students are taught the importance of information science and consideration of the needs of end users as a primary enabler of IT success, how can there be a "lack of an information management/information technology" strategy in this national health IT project? How can there have been a lack of input into decision making by the services in the development and deployment of AHLTA?

Leaders from the Navy and Air Force detailed the challenges that their personnel face in using AHLTA. “Almost all of the providers I spoke to relate to the system going down unexpectedly, recently at least once a week,” Navy Deputy Surgeon General Rear. Adm. Thomas R. Cullison, MC, USN, told committee members. He added that while no one would like to return to paper records, providers are “largely dissatisfied” with the system and that the system slows down their clinic time. “Most of our providers say they have to stay later in the afternoon to finish up notes simply because it slows down clinic time,” he said.

Air Force Deputy Surgeon General Maj. Gen. Charles Bruce Green, USAF, MC, told the committee that Air Force primary care physicians spend about 40 percent of their time working with AHLTA versus 60 percent of their time with patients. On the other hand, specialists are “working around the system trying to find new solutions,” since the system does not address the needs unique to their practices. In his written testimony, Dr. Green said that the problems associated with AHLTA have resulted in “low productivity and provider morale.”

Forty percent of clinician time spent tinkering with balky computers? This should be astonishing to any reader unfamiliar with these issues, and an eye opener to our governmental representatives not just regarding the military, but regarding the entire lobby-promoted scheme to force clinicians to adopt HIT by 2014 or suffer financial penalties.

Specialists "working around" the system (thus risking the dangers of workarounds of HIT deficiencies observed by Koppel and others) because it does not meet the needs of their subspecialties? No surprises here. After reading about issues in development of domain specific healthcare information systems for high risk subspecialties (such as here), it should be obvious that the business IT-dominated health IT industry as it currently exists cannot fill such needs.

More importantly, I feel the AHLTA project is an illustration of what will be reproduced, thousands or tens of thousands of times over, in hospitals and physician practices all over this country as we proceed in a national EHR initiative based on false premises borne of the health IT lobby.

The Problem

Then-Assistant Secretary of Defense for Health Affairs S. Ward Casscells, M.D., told committee members that many of the problems that AHLTA has suffered have been “self-inflicted wounds,” due to software contracts with vendors that were “poorly written.” “We have had, over the past decade, contracts that were poorly written from the standpoint of performance, they have loopholes in them that permitted delays. We have, in some instances, lax oversight of some of these contracts,” he said.

Unbelievable. Hospitals sign HIT contracts putting all liability for system defects on clinicians, and that gag them from disclosing defects outside their organizations. The military's HIT contracts apparently had additional flaws that are probably pervasive in the commercial sector as well.

... In moving forward to rectify AHLTA problems, DoD has adopted a Unified Strategy Regional Distribtion Approach, a three-phased plan for reshaping the electronic health system. In written testimony, Dr. Casscells explained this strategy seeks to “improve provider satisfaction, improve reliability and strengthen data sharing throughout DoD and Department of Veterans Affairs healthcare delivery continuum and with private healthcare providers.” The first phase of the approach will focus on “stabilizing performance, reliability and the core infrastructure,” of the system according to Casscell’s written testimony.

"I want to be wary of overpromising. We have done that in the past [indeed, the entire HIT industry has massively overpromised for decades - ed.], but I am excited about this. I think there is a chance here that we can once again be leaders for the nation in electronic health records, as was the case several decades ago. I would like to think that a year or two from now, you will agree with me that AHLTA has gone from intolerable to indispensible,” Dr. Casscells told committee members.

Tommy J. Morris, acting director in DoD’s office of the Deputy Assistant Secretary of Defense for Force Health Protection and Readiness Programs, said that the only service that nonconcurred with their proposed blueprint to overhaul AHLTA was the Army [not exactly an unimportant stakeholder - ed.]

Dr. Schoomaker, on his part, challenged the notion that there was actually a “strategy” in place for rectifying AHLTA. “Mr. Morris has got a plan, he does not have a strategy. We asked for a strategy. A plan is just one element of a larger strategy. We asked for a strategy and our involvement in that strategy, so with respect, that is what we in a sense partially nonconcurred with,” Dr. Schoomaker said.

"I've got a plan." How familiar a refrain that is in a time of mass societal mismanagement.

If I were a politician examining health IT, I'd really start looking into how our government became convinced health IT was not only a worthwhile investment, but an "economic stimulus." As with our friends up north, it seems to be primarily a stimulus for poseurs and dyscompetents to come out of the woodwork, disrupt healthcare providers, and then collect massive fees for the "favor."

In consideration of the above, I ask:

If the military, with its internal discipline and ability to take over entire modern countries with just a few thousand soldiers lost, and its constrained patient population (active military personnel and families generally free of complex and chronic illnesses) can't get electronic health records right, why would anyone think inept and sometimes corrupt EHR companies, dyscompetent hospital IT departments, and reckless and cavalier hospital executives can?

I reiterate my concerns that the "AHLTA experience" will become all too familiar to hospitals and physician practices throughout this country, unless sanity and rationality is restored to our thinking about health IT.

-- SS

"Man's Best Hospital," Run by the Boss of a MECC (Medical Education and Communications Company)?

In January, 2009 we posted about how the CEO of Blue Cross Blue Shield (BCBS) of Massachusetts and of Partners HealthCare, made a secret oral agreement that BCBS would pay Partners at a higher rate than that given to other hospitals.

Why BCBS would want to pay so much to this one hospital system was never clear. Partners does include some extremely prestigious hospitals, including the Brigham and Womens Hospital, and the Massachusetts General Hospital, ("Man's Best Hospital" in the House of God), but there are some other very prestigious teaching hospitals in Boston that were not blessed by BCBS' largess.

We speculated about one possible cause: the leadership of the two organizations may have felt they had more in common with each other than with the constituencies of their own organizations. A few leaders of each organization had direct ties to the other. Many leaders of both organizations were simultaneously leaders of finance, the same sector that has brought us what is now called the Great Recession. Leadership of both organizations had conflicted loyalties. The organizations' CEOs at the time, and many members of their boards had divided loyalties and apparent conflicts of interest. For example, Jack Connors, the chair of the Partners HealthCare board, is also the Chairman Emeritus of marketing communications company Hill, Holliday, Connors, Cosmopoulos Inc, whose clients include pharmaceutical and pharmacy benefits manager CVS / Caremark, and is also a member of the board of directors of Covidien, a medical device company.

The Boston Globe just published a report that Mr Connors had even more intense conflicts that had not heretofore been made public.

He's chairman of New England's largest healthcare company, and that position atop Partners HealthCare has tested the limits of Jack Connors's considerable corporate dexterity.

Though he has no background in medicine, Connors has been Partners' chief overseer, champion, and its most public face for 13 years.

[One board member] is the cofounder and chairman emeritus of Partners' advertising firm. That would be Jack Connors. And that potential point of conflict has been disclosed....

But to the chagrin of some former board members, never brought up for board review was Connors's stake in a leading medical education firm whose sale in 2004 made Connors a very wealthy man.

Nor has the board notified public officials of Connors's ownership of a fledgling home healthcare firm that has directly solicited Partners' hospitals for business.

Connors and top Partners officials defended the decision not to publicly disclose Connors's potential conflicts, saying that because Partners did not directly contract with either of Connors's firms there were no conflicts to report. Connors also defended his right to be an entrepreneur in the healthcare business while also chairing Partners' board, and strongly denied ever using his position for personal or financial advantage.

The larger company, M/C Communications, grew to become the biggest commercial provider of continuing education to physicians in the decade between its inception in 1994 and when Connors sold it in 2004. It profited hugely from an exclusive commercial relationship it maintained with Harvard Medical School, whose faculty teach at seminars the company holds. Partners' signature institutions, Massachusetts General Hospital and Brigham and Women's Hospital, are major teaching affiliates of Harvard Medical School.

In addition, M/C Communications benefited financially from millions of dollars in sponsorship revenue paid it from major pharmaceutical firms eager to play to this professional audience.

Connors said he was under no obligation to disclose his ownership of M/C Communications to the Partners board. He said that while there is an 'affiliation' between Harvard Medical School and the two Partners hospitals, there is no formal contract between them.

Connors said he informed Partners executives of his ownership of M/C Communications, and that they determined it did not warrant disclosure to the full Partners board.

'There is no contract between Partners and Harvard,' Partners said in a statement to the Globe.

Connors made a name for himself as an executive with Hill, Holliday, Connors, Cosmopulos, the Boston advertising company that he helped found and guided throughout a long career. Less well known is that he made most of his fortune from M/C Communications, which he sold to Bain Capital for $450 million in 2004.

The sale was the largest of a private healthcare-related company in Massachusetts that year, according to TM Capital Corp., an investment banking company. Connors, who led an investor group that bought the firm outright for $13 million in 2000, made about $250 million from its sale.

After his 2004 windfall, he founded a company that helps elderly patients readjust to life at home after a hospitalization.

That company, Dovetail Health, has - Connors acknowledged - solicited business from hospitals owned by Partners. And Connors confirmed that after Dovetail executives failed to convince Blue Cross Blue Shield of Massachusetts to contract with the firm, he personally spoke to the giant insurer's president, Cleve L. Killingsworth, on Dovetail's behalf. Partners and Blue Cross Blue Shield regularly negotiate over $2.5 billion worth of medical business a year.

Connors acknowledged in an interview that it might have appeared 'inappropriate' to some for him to pitch Killingsworth. But he said the conversation stemmed from a shared belief that new ways must be found to reduce frequent return trips of elderly patients to the hospital. More recently, however, he said he does not believe his approach to Killingsworth was inappropriate.

So let's try to recap this.

While Jack Connors has been chairman of the board of Partners HealthCare, the largest and most prestigious hospital system in Massachusetts, he also ran an advertising agency that did business with Partners, and has been on the board of Covidien, a medical device company. Both of these relationships he disclosed to his fellow board members, although no one seemed troubled by them.

However, while a Partners board member, Connors was also the founder, and ultimately profited very handsomely from the sale of M/C Communications. M/C Communications apparently begat M/C Holding Corporation, which in turn owns M/C Communications and Pri-Med Institute LLC. M/C Communications now describes itself as " established in 1994 and has become a leading provider of medical education event management solutions for health care professionals and others around the globe." M/C Communications runs Pri-Med, which is described thus: "Pri-Med is a platform for science and medicine that includes meetings, resources, online, and new media tools designed to meet the information and education needs of today’s practicing physician." Pri-Med markets itself to industry, presumably the pharmaceutical, biotechnology, and device industry, "Sixty percent of doctors’ offices restrict rep access, making it more challenging than ever to get in front of your customers. But with Pri-Med, you get to meet clinicians in a professional environment where they seek you out. More than 66% of attendees say they come to Pri-Med events to meet you, industry representatives." So Connors' company was a medical education and communication company (MECC), which provided what appeared to be educational programs to physicians that in fact were also sold to the health care industry as marketing opportunities.

So Partners HealthCare, which includes two of the world's most prestigious teaching hospitals, has been run by the boss of a MECC? Say it ain't so.

Not only did Connors own a company that had an exclusive contractual relationship (as described above) with the Harvard faculty who staff the main Partners HealthCare hospitals, that company was engaged in marketing the products of sponsoring drug and device companies disguised as education. Finally, Connors denied that this presented any kind of conflict of interest, because Partners HealthCare has no explicit contract, just an "affiliation" with Harvard Medical School.

Finally, just to ice the cake, Connors' latest venture is a home health care company that did business with Partners, and tried to do business with BCBS, spearheaded by Connors' direct conversations with the BCBS CEO.

Jack Connors thus seems to have just become the latest poster boy for leaders of health care organizations who put their personal financial interests ahead of their responsibilities to those organizations, and function as a power elite whose collective interests trump those of the constituents of the organizations they run.

Quoting from BoardSource, the main duties of the leader of any US not-for-profit are:

Duty of Care

The duty of care describes the level of competence that is expected of a board member, and is commonly expressed as the duty of 'care that an ordinarily prudent person would exercise in a like position and under similar circumstances.' This means that a board member owes the duty to exercise reasonable care when he or she makes a decision as a steward of the organization.

Duty of Loyalty

The duty of loyalty is a standard of faithfulness; a board member must give undivided allegiance when making decisions affecting the organization. This means that a board member can never use information obtained as a member for personal gain, but must act in the best interests of the organization.

Duty of Obedience

The duty of obedience requires board members to be faithful to the organization's mission. They are not permitted to act in a way that is inconsistent with the central goals of the organization. A basis for this rule lies in the public's trust that the organization will manage donated funds to fulfill the organization's mission.

By leading companies that did direct business with Partners and its staff, and failing to disclose that he was doing so to his fellow Partners board members, Connors appeared to have violated the Duty of Loyalty.

By running a MECC that helps drug and device companies market to physicians in the guise of education, using faculty from the academic teaching hospitals that he lead, Connors seems to have mocked the mission of the academic hospitals within Partners, and thus appeared to violate the Duty of Obedience.

This episode certainly does suggest that health care, and the organizations involved in this case, are lead by an "old-boy network," as one person interviewed for the Globe article suggested. More than just an old-boy network, they seem to be lead by chummy members of the power elite whose collective personal interests supersede the missions of the organizations they are supposed to steward. When this happens, is it any surprise that health care becomes less accessible, more expensive, and of lower quality?

Yet challenging the power elite that are increasingly revealed as controlling much of health care seems to be something that one cannot talk about when discussing health care reform. However, failing to address this problem will likely doom any effort, no matter how well intentioned, to improve health care.

Hat tip to and see comments by Alison Bass on the Alison Bass Blog.

ADDENDUM (3 June, 2009) - See also comments by Dr Daniel Carlat on the Carlat Psychiatry Blog.

More Documents About the Selling of Seroquel Show How Research Was "Subordinated to Commercial Goals"

We posted earlier this year about how documents produced on discovery and recently unsealed during litigation suggested how AstraZeneca handled clinical research data in the marketing of its atypical anti-psychotic drug Seroquel (quetiapine). A new crop of documents has just been released, providing yet more insights, as reported by the St Petersburg (Florida) Times:

Behind the scenes at the global pharmaceutical company AstraZeneca, the team in charge of the blockbuster antipsychotic Seroquel had one mission: make the multibillion-dollar seller even bigger.

To that end, internal company documents released Wednesday show how the British drugmaker hid unfavorable study results, promoted unapproved uses and even considered pitching the drug as less likely to lead to suicidal thinking than competitors'.

In particular,

Documents suggest Seroquel studies were repeatedly subordinated to commercial goals.

When a study in 2002 failed to show that Seroquel's sustained release formula was any more effective than a placebo in treating schizophrenia, orders from the top were to keep the results 'in strictest confidence.'

When a scientist in England wanted to study the weight gain in rats on Seroquel, AstraZeneca declined to fund the research, saying 'we could wind up with results that are not clearly advantageous.'

In one discussion, it was suggested that authors of potentially helpful research reports who raised too many questions, slowing publication, should be asked to step down.

A researcher who pressed for results of an unfavorable trial was rebuffed for weeks before being given 'three or four sentences describing high-level results.'

AstraZeneca marketers were jealous of what they saw as competitor Lilly's ability to cast questionable study results in a positive light. 'They (Lilly) are able to spin the same data in many different ways through an effective publications team,' according to a 2003 memo. 'Negative data usually remains well hidden.'

As Seroquel's sales soared, documents reflect an ongoing struggle between the safety and marketing teams over the potentially damaging issue of weight gain. In 2000, the company's scientists said data did not support the marketing claim that Seroquel resulted in only 'limited' weight gain. Close to 23 percent of the people who took the drug gained more than 7 percent.

Despite the safety team's objections, the word 'limited' remained on Seroquel's label for two more years.

This is a reminder how beleaguered we advocates of evidence-based health care (EBHC) have become. The idea of EBHC was that health care decisions for individual patients, and policies for groups of patients ought to be guided by critical review of the best available evidence from clinical research, guided by knowledge of biology and the biopsychosocial context of health, and informed by patients' values and preferences. The idea still makes sense to me, but it only works if physicians, patients and policy-makers have access to an unbiased sample of clinical research studies, so that studies with are not selectively suppressed to support vested interests. Although critical review can account for inevitable trade-offs, compromises, and errors in how studies are designed, implemented, and analyzed, the clinical epidemiological methods it uses are really not designed to root out falsehoods and deliberate deception.

However, the ongoing story of Seroquel, and many other cases discussed on Health Care Renewal suggest that when clinical research is sponsored by those who can profit from the product or service it evaluates, that research is prone to suppression and manipulation. Although I believe there are many honest scientists who work for pharmaceutical, biotechnology, device, health information technology and other health care corporations, it seems they often have to answer to marketers whose only goal is to sell more product.

As long as clinical research is sponsored and run by the people who can profit directly from selling the products and services the research is meant to evaluate, the ideal of evidence-based health care becomes less attainable.

As we have said before, suppression and manipulation of research amounts to post-hoc abuse of research subjects who volunteered their participation believing that it would advance science and health care.

Furthermore, suppression and manipulation of research can deceive physicians into prescribing tests and treatments that will fail to help, or even harm patients, and deceive patients into thinking that they are getting the best possible tests and treatments, when, again what they are getting is ineffective or even harmful.

In my humble opinion, there is an increasingly strong argument that clinical research should not be controlled, and probably should not be done at all by organizations with vested interests in the research producing results favorable to their products.