NYU Faculty Vote No Confidence in their President

Faculty at large American universities, in which most of the country's medical schools and teaching hospitals are embedded, are becoming increasingly concerned about the leadership and governance of their organizations, and whether the universities are putting their academic (and clinical) missions ahead of other concerns, like making money and rewarding top executives.

In January, 2013, we discussed a an informal, anonymous vote faculty at the University of Miami medical school expressing no confidence in their dean and his chief lieutenant.

The NYU No Confidence Vote

The faculty of a major component of another big US university have just openly voted no confidence in their president, and are raising questions about their board of trustees.  The setting was New York University.  Some background comes from a New York Times article this month:

 Embarking on an ambitious expansion at home, constructing a network of new campuses around the globe, wooing intellectual superstars and raising vast amounts of money, John Sexton of New York University is the very model of a modern university president — the leader of a large corporation, pushing for growth on every front.
 

To some within N.Y.U., Dr. Sexton is a hero who has transformed the university. The trustees have thanked him by elevating his salary to nearly $1.5 million from $773,000 and guaranteeing him retirement benefits of $800,000 a year.

But to others, he is an autocrat who treats all but a few anointed professors as hired help, ignoring their concerns, informing them of policies after the fact and otherwise running roughshod over American academic tradition, in which faculty members are partners in charting a university’s course.

'He has a very evangelical sense of purpose,' said Andrew Ross, a professor of social and cultural analysis, 'that does not extend beyond the concept that the university should be an entity of his own making.' 

'I think,' he added, 'when other administrations see that they say, Well that’s what leadership should be. And when faculty see that they say, That is not what university leadership should be. It’s the style of a maverick C.E.O.'

The debate over Dr. Sexton’s presidency will come to a head this week. The faculty of the university’s largest school, Arts and Science, has scheduled a five-day vote of no confidence. Given Dr. Sexton’s international stature, the vote may serve as the most important referendum yet on the direction of American higher education. 

President Sexton lost the no-confidence vote, as noted in another NY Times article a week later:

The vote, 298 to 224 (with 47 abstaining), took place via electronic balloting from Monday through Friday. Full-time tenured and tenure-track professors were asked to respond to the statement: 'The faculty of Arts and Science has no confidence in John Sexton’s leadership.' Voter participation was 83 percent.

Top Executives Usurp Power from Faculty

An op-ed in the NY Times by a leading dissenting faculty member further explained the issues.  He charged that the President ignored faculty concerns about an ambitious plan to expand the physical plant of the university:

How did Dr. Sexton lose the confidence of so many faculty members? By ignoring us. Of course, many professors everywhere feel overlooked by today’s generation of jet-setting university presidents. But we have very specific complaints: above all, Dr. Sexton has consistently refused to address concerns about plans to expand N.Y.U. offices and dorms into the part of Greenwich Village south of Manhattan’s Washington Square Park, where many of us live. 

This expansion plan is known as N.Y.U. 2031, indicating the year in which all the building will be complete. The very name told us that we’d be living on a construction site for a couple of decades.

Not surprisingly, this did not go over very well with many faculty members. We were also concerned about where the money would come from to pay for this expansion, as no business plan for the project has been made public.

Thirty-nine departments and schools passed resolutions last year against the 2031 plan. These resolutions were typically passed unanimously or nearly unanimously. And yet Dr. Sexton’s response was a deafening silence.

Academic Values, Particularly Academic Freedom and Free Speech Ignored

Furthermore, the faculty were concerned about plans to expand the university overseas to nations not known for their vigorous support of academic freedom and free speech:

 Many of us are also concerned with Dr. Sexton’s plans to expand N.Y.U. overseas, including branch campuses in Abu Dhabi and Shanghai, with inadequate faculty involvement or oversight. It is doubtful that faculty members would have chosen to build campuses in countries where academic freedom, and free speech generally, are so parlous. 

Executives Enriching Themselves at University Expense

Finally, the faculty were concerned about top university executives immodestly enriching themselves from the coffers of a non-profit university:

As the faculty vote approached, more trouble arose for Dr. Sexton in the form of news reports about lavish compensation for NY administrators.  The central but by no means sole figure in this scandal is Jacob J Lew, the Obama administration’s new Treasury secretary, who worked at N.Y.U. in the early 2000s for a salary that eventually reached $900,000, larger even than Dr. Sexton’s at the time. 

Mr. Lew received loans to buy a nice home, which apparently were largely forgiven. He also received a severance of some $700,000 when he left for a well-paid position at Citigroup. Severance? For someone who leaves voluntarily?

 Dr. Sexton himself is to receive a salary of more than $1.4 million this year, and a 'length of service' bonus of $2.5 million in 2015. (Full disclosure: the university gave me a set of mugs when I completed 25 years of teaching.) And he will receive $800,000 a year after he retires. 

Other top administrators make similarly extravagant salaries. Some experts believe there may even be something illegal in the way Dr. Sexton has rewarded them; N.Y.U.’s chapter of the American Association of University Professors has asked New York States’s attorney general to investigate. 

All of which raises a question for many N.Y.U. faculty members: Should administrators be able to enrich themselves like this at educational institutions? N.Y.U. is not a Wall Street firm, but a tax-exempt university that gets millions in taxpayer dollars, not least from student loans. In fact, our students have the highest total debt load of any university in the country. Rather than expanding, or paying huge salaries to top administrators, why doesn’t N.Y.U. do more to help its alumni pay off their debts?

Forsaking the Academic Mission

An article in Inside Higher Education underlined how the dispute is really about the mission of the university in this brave new corporate era:

As Rebecca Karl, an associate professor of East Asian studies and history recently told Inside Higher Ed, 'We’ve become very critical of the whole idea of ‘expand or die,’ which of course is a corporate maxim, but we don’t understand why it needs to become our maxim.'

Also,

 Mark Crispin Miller, a professor of media, culture and communication in NYU's Steinhardt School of Culture, Education and Human Development, who has been an outspoken critic of the Greenwich Village plan [said]. 'The fact is we see NYU as a school, we see our mission as educational. Sexton and the trustees who support him view NYU as a bundle of assets whole value they will apparently do anything to maximize on paper. We believe that this approach is destroying this university.'

By the way, maybe in retrospect the trustees' role should not be so surprising.  Back in 2011 we posted about a group of extremely rich corporate and finance leaders who attacked critics of their growing power as "imbeciles," among other terms.  Several of the individuals featured in the news article which inspired this post were trustees of New York University.  These included   Kenneth Langone and John Paulson.  A quick look at the list of current trustees shows that it includes  many top leaders of finance firms, including firms whose actions were alleged to have helped cause the great recession/ global financial collapse or have been subsequently accused of other financial shenanigans, e.g., Steven S Miller, a Vice President of JP Morgan Chase, and Maurice Greenberg (a life trustee), former leader of AIG, E John Rosenwald Jr (a life trustee), Vice Chairman Emeritus of JP Morgan Chase, and William R Salomon (a life trustee), honorary chairman of Citigroup.

Summary

In summary, the issues that inspired the no-confidence vote against the President of New York University appeared to be allegations that university:
-  administration usurped power, particularly from the faculty
-  administration used this power to put corporate priorities, like expansion for its own sake, and increasing short-term revenue ahead of the academic mission
-  administration took advantage of their power to enrich themselves
-  trustees, who are supposed to exert stewardship that ensures the university upholds its mission, instead aided and abetted all this

All of these should be very familiar issues to Health Care Renewal readers.  We have discussed the rise of generic managers of health care organizations, trained supposedly in general management skills, but not in health care, and indifferent at best to the values of health care professionals.  At times their power has gotten so great as to constitute a manager's coup d'etat.   We have discussed how managers of health care organizations often put short-term revenue ahead of all other concerns, sometimes called financialization.  In doing so, they may end up perpetrating mission hostile- management.  We have discussed how managers are able to command often outrageous levels of  executive compensation.   Boards of trustees, who are supposed to exert stewardship over the organization, and see that its leadership upholds its values, often come from management backgrounds themselves, and are at best clueless about, if not hostile to the mission. 

It is time for university faculty to defend their institutions' mission.  Students, alumni, and patients at academic medical centers, medical school clinics, and of academic health professionals ought to be equally fervent in support of the academic and academic health care missions.  Academic medicine needs to be lead and stewarded by people who understand that mission, value it, uphold it, and are accountable for that.  These leaders and stewards should eschew management fads, cronyism, and excess personal enrichment.

Maybe the vote of no confidence at NYU is a small step on the path back to the academic and academic medical missions.  But do not expect those who are enriching themselves in the current system to go quietly.

ADDENDUM - see also this post by Prof Margaret Soltan on the University Diary blog.

Boulder Community Hospital computer system crash: Either you're in control of your information systems, or they're in control of you

Yet another health IT crash, "prolonged" this time, from some unspecified "glitch":

Boulder Community Hospital computer system crash frustrates patients
Officials say it could take until Friday for outage to be resolved
By Brittany Anas
Camera Staff Writer
Posted:   03/18/2013 07:23:23 PM MDT
Updated:   03/18/2013 07:24:16 PM MDT

A prolonged computer system outage is preventing Boulder Community Hospital from accessing patient records -- making it difficult for people to schedule surgeries, get test results and make appointments for routine blood work.

Meditech, the system used by the hospital to manage patient records, went down in the middle of last week. It could take the hospital until Friday to get the system back up, said Rich Sheehan, spokesman for Boulder Community.

That fits my definition of "prolonged."

While information technology officials are investigating what caused the outage, Sheehan said patient records are protected and hospital officials don't believe they've been hacked. 

That's not very reassuring, considering the length of the outage.

The outage affects the hospital, its Foothills campus, eight laboratories and six imaging centers. 

Patients are on its face put at-risk ... for example, I know of several deaths of infants and adults from delayed x-ray reports alone ... but the clinicians, not the IT seller or hospital IT staff, are liable.

"We know medical care is important to people, so we understand the concerns those in the community have," Sheehan said. "We have a lot of people working on this, doing the best they can to solve this problem in a safe manner and as quickly as possible." 

"We know medical care is important to people?"  No, really?

In the meantime, the hospital is using manual paper record-keeping systems and traditional paper charts for its inpatients. Hospital officials say the system allows them to continue treating patients, provide diagnostic services and collect important clinical information that will be entered later into each patient's electronic health record.

But that concerns Eroca Lowe, whose mother was in the hospital Thursday through Sunday with gallbladder pain.

Lowe said the outage made it extremely difficult for doctors and nurses to do their jobs while hunting down lab results. She criticizes the hospital for not having a backup computer system and resorting to paper records.

"That's not a hospital in 2013," she said.

It's a good bet the paper records and HIM personnel managing them are not what they used to be pre-computer.

... Dina Huber said it took her and her significant other six days to schedule an appointment for a hernia surgery because the system used for scheduling is down.

"If they can't keep their computer system running, how can we trust them to perform surgery?" Huber said.

Fortunately, surgeons perform surgery ... not computers, IT staff or management.  Doctors, as the enablers of healthcare, don't need computers to save lives.

However, making their job harder is not a good idea.

A physician who works at Boulder Community Hospital, speaking on the condition of anonymity, said he doesn't think the outage is compromising the health or safety of patients. But, he said, the backup response "seems a little haphazard, and it's not an organized plan." He said physicians are left chasing down records.

If a prolonged outage "is not compromising safety", then why did the hospital spend tens of millions on computers?

Sheehan said the hospital is prioritizing accuracy and patient safety while getting the records system up and running. 

Once it's running again, there is significant risk of data now recorded manually being lost, thus again increasing error risk.

"We apologize for the delays, but this was an unavoidable situation," Sheehan said.

("We apologize for the chilly water, but this was an unavoidable situation." - Captain of the HMS Titanic?)

If an injury occurs, how will that sound to a jury?

Let me answer that:  like bull***.  

My response to Mr. Sheehan and Meditech, and the IT personnel involved:  "Either you're in control of your information systems, or they're in control of you."

It seems the latter clearly applies here.

I pray nobody gets injured ... and that the principals don't end up before plaintiff attorneys I've educated on the issues of bad health IT.

-- SS

Doctors' Dubious Excuses for Taking Pharmaceutical Companies' Money

Pro Publica has updated their database of payments by pharmaceutical payments to physicians and organizations.  It now has data from 15 companies totaling more than $2 billion from 2009 to 2012.

To accompany Pro Publica's report, a number of news outlets wrote about payments given to local or regional doctors.  These included, in semi-random order, the Los Angeles Daily News (via the Inland Valley Daily Bulletin), the Salt Lake (City, Utah) Tribune, the San Jose (California) Mercury News, NewsChannel5 in Nashville, Tennessee, the Pasadena (California) Star-News, the Bergen and Passaic, New Jersey Record Herald via NorthJersey, the Philadelphia Inquirer, and the Columbus (Ohio) Dispatch.

The combined reports showed that many physicians, including prominent academics and community practitioners, are still getting a lot of money from pharmaceutical firms.  Since Pro Publica was only able to get data from some US drug companies, albeit those who accounted for 47 percent of US drug sales, it is likely that many more doctors than those in the data base got such payments, and the doctors in the data base may have gotten more money from companies that do not report their payments.  In addition, it is likely that many more doctors get similar payments from medical device companies, health care information technology companies, and other for-profit corporations that promote health care products and services.  

We had discussed Pro Publica's initial reporting from its database here.  While there is evidence that most payments to doctors by pharmaceutical companies are intended to promote marketing, we discussed here how some doctors rationalized their payments as fully professional and proper.

Now the updated reporting has provided many examples of - not to put too fine a point on it - physicians making dubious excuses for their acceptance of payments, often large, from pharmaceutical companies. Their themes included

It's Education, What Could Possibly Go Wrong?

From Pro Publica,

[Dr Rakesh] Jain, of Lake Jackson, Texas, has earned $582,049.  [Dr Vladimir] Maletic, of Greer, SC, made $527,850, according to Dollars for Docs.

So,

Jain said he loves teaching and delivers the same lectures about drugs and medical conditions regardless of whether a drug company is paying him.

'I am not a marketer, I am an educator,' Jain said.

Also

Maletic said he speaks about treatments for mood disorders, schizophrenia and sleep-wakefulness disorders because he believes that 'good quality education about pharmaceutical products may be beneficial to both physicians and their patients.'

The LA Times found someone with a similar opinion.

'Pharmaceutical companies used to take doctors to dinner, but that was banned years ago,' said Dr. Arthur Chanzel Jeng, an infection control specialist at UCLA-Olive View Medical Center in Sylmar.  'Now they must provide some educational content.'

Jeng was paid $80,500 by Pfizer last year for several speaking engagements. As an infection control specialist at Olive View, he and others in his field are concerned about drug resistant diseases and the limited number of antibiotics. Drug companies have little incentive to produce new antibiotics, he said, so if they do, physicians in his field want to know more about the drugs. That's why he agrees to speak.

'We (speakers) provide education when a new antibiotic does get released,' he said. 'There needs to be education among doctors on how to use this new antibiotic.'

In addition, the Salt Lake Tribune noted that 

[Dr Eliot] Brinton received two of the single largest payments in Utah, both in excess of $85,000, for promoting drugs by GlaxoSmithKline, ProPublica’s database shows. He describes the lectures as educational and based on science.

'I love the science and I love to teach. And doctors are glad to better understand the drugs and how to use them. I’m careful not to act as a cheerleader,' he said. 'If I’m a shill for the drug company I lose my integrity and integrity is really all I have to offer my patients and the drug companies.'

The physicians above all asserted that since their activities were "educational," they must be worthwhile.

Note that the ostensibly educational activities described above all appear to be "drug talks," that is talks sponsored by the drug companies, probably through speakers' bureaus, and given probably not as part of formal, accredited continuing medical education.  Since the publication of "Dr Drug Rep" in the New York Times in 2007, the public has learned that such talks mainly include content provided by the pharmaceutical companies, and are meant by the companies as marketing exercises.  From that case we also learned that physicians who deviate from the marketing message do not last long on speakers' bureaus.  (See posts here and here.) 

In addition, pharmaceutical companies often pay physicians deemed to be "key opinion leaders," whose opinions are promoted supposedly for their brilliance and erudition.  However, as noted here and here, the companies buying their services believe they have bought the services of sales people.    Evidence about key opinion leaders actually performing like marketers has come from documents revealed during litigation (e.g., see this recent example of a huge monetary settlement made of charges that GlaxoSmithKline, a major multinational drug company committed fraud among other things, and in the course of its unethical activities used key opinion leaders as marketers).   Also, see the Neurontin marketing plan (see post here), and the Lexapro marketing plan (see post here) for examples of how company keaders view key opinion leaders as marketers.

Given the volume of evidence about drug talks, speakers' bureaus, and the marketing purposes of key opinion leaders, the assertion that because they were in some sense educational, these doctors' corporate financed talks were worthwhile is at best a silly excuse.

More formally, it may arise from a logical fallacy.  The doctors appeared to be arguing that education is an unalloyed good.  However, obviously not all education is good education, or unbiased education. Specifically in this case, logic, and evidence from several cases in which pharmaceutical companies' intentions as documented in communications revealed in litigation (see examples here) suggest that these companies pay physicians for education that they believe serves marketing purposes.Thus the doctors seem to be using the composition fallacy, the logical fallacy that an entire class (in this case, all of education) can be judged by some of its members (examples of unbiased, accurate, good education.) 

It's Research, What Could Possibly Go Wrong? 

Similarly, the doctors who get paid to do research say it's all about the research.  The Salt Lake Tribune reported on

CRI LifeTree Research, which has received at least $3.4 million in drug company payments since 2009, according to ProPublica. 

Co-founder Lynn Webster, an anesthesiologist, is listed as having received the single largest payment in the state: $1,687,771 from Cephalon, a big maker of pain medications. Only three other doctors in the country received more from Cephalon.

Nationally, Webster is among the top 50 for single largest payments received, behind marquee hospitals, such as the Mayo Clinic, Cleveland Clinic and Duke and Harvard Universities.

A nationally recognized expert in pain management, Webster is under investigation by the U.S. Drug Enforcement Administration, which is looking into opioid overdose deaths of patients of his former pain clinic. A Senate Committee is probing his financial ties to Big Pharma.

Webster insisted,

Research payments to him cover overhead and other costs, including his salary as a lead researcher, he said. 

'Research inevitably leads to better education, better systems and better therapies — things that are indispensable for medical advancement and quality care,' he said. 

The Pasadena Star-News provided this version,

Pasadena-based plastic surgeon John Edward Gross received more than $770,000 from Allergan, the maker of Botox and some breast implants.

In 2011-12, Allergan paid Gross to conduct research, consult, serve on health care panels and business travel.

'What I'm doing for Allergan is to advance breast surgery,' said Gross, a board certified surgeon and a former chemical engineer. 'Much of the research you do is industry-supported. They have a motivation to make better and new products.'

It is pretty amazing to see the notion that all clinical research is irreproachable in print.  We and others have documented huge numbers of cases and volumes of evidence that clinical research may be manipulated, and, if necessary, suppressed to support the commercial goals of those who make products or provide services assessed by such research.  In fact, the prestigious Institute of Medicine's report on Conflict of Interest in Medical Research, Education and Practice included the recommendation (4.1) that "individuals may not conduct research with human participants if they have significant financial interest in an existing or potential product or a company that could be affected by the outcome of research."  Given the volume of this evidence, the assertion that all pharmaceutical company clinical research should be irreproachable is just plain silly.

Again, formally the physicians' arguments, if they should be dignified with that name, seem to arise from the same logical fallacy discussed above.  The underlying argument seems similar to that made above about education: "I am doing research.  All research is good, unbiased, helpful to patients.  So what I am doing is good, unbiased, helpful research."  So it appears the composition fallacy again was in play.

It's Not Really My Money

The San Jose Mercury News provided this example,

The database links Dr. Gurkirpal Singh to more than $248,000 in Pfizer payments it lists for speaking, consulting, travel and meals since 2009. He said all the money went to Institute of Clinical Outcomes Research and Education in Palo Alto, where he is the chief scientific officer. Singh said the money paid for research.

'I receive nothing -- let me be very clear on that,' said Singh, who is an adjunct clinical professor at Stanford University.

The Columbus Dispatch added,

 Dr. Henry Nasrallah, a psychiatrist at the University of Cincinnati, netted $647,341 in speaking and consulting fees from drug companies, ranking him as Ohio’s top recipient of such payments over that four-year period. Cincinnati’s College of Medicine put that money toward his $222,232 annual salary.
'The (pharmaceutical) companies have a signed agreement with the university for my activities, not with me personally,' Nasrallah wrote in an email to The Dispatch.

'This is another reason why I maintain scientific and clinical impartiality about the various drugs I teach, because I do not have a direct personal gain,' wrote Nasrallah, a former chairman of Ohio State University’s psychiatry department.

Really, the boss doesn't care whether he brings in any money?

These doctors seem to be denying that money is fungible.  In other words, they seem to be arguing that money going to the organizations that pays them is different from money going directly to them, and that their bosses do not in fact care whether their activities bring any revenues to the organization.  This just flies in the face of common sense.

Someone Needs to Pay

NewsChannel5 was able to interview the top earner on the Pro Publica list, Dr Jon W Draud, who said among other things, 

it was only fair to accept payments for his speaking engagements because it makes up for what he would otherwise make while working at his practice.

 'It's not essential, I suppose, but I consider it a reasonable, fair compensation for being gone and traveling, and spending time away from my home and family,' Draud said.

If Dr Draud was providing education, a useful service, it seems reasonable that someone should pay for it.  However, he appears to beg the question of who should pay for it?  Underlying this question is the concern that since it was pharmaceutical companies, not students, who were paying, the education was being done primarily to benefit the former, through marketing, rather than the latter.  The apparent argument, that because it is not reasonable to get paid for services, any source of payment is acceptable, is again just plain silly. 


Who Cares About Money?

NewsChannel5 also reported that Dr Draud said

 accepting so much money did not create a conflict of interest between him and his patients. He said the information he gives out was not biased towards the drug companies.

However, the Institute of Medicine report on Conflict of Interest in Medical Research, Education and Practice defined conflict of interest as "circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest."  Asserting that receiving over $1 million could not create even a risk that his educational presentations were biased towards the interests of those who gave him that money seems like simple denial.  

The FDA Said it Was True

Top earner Dr Draud also said according to NewsChannel5,

 It has to be vetted by the FDA as being fair, balanced and non-biased toward the pharmaceutical company....

From the Philadelphia Inquirer, re Dr Warren S Joseph, a podiatrist who received over $650,000

Joseph acknowledged the payments in an email to Philly.com.

'All of my lectures given for the Pharma industry follow strict FDA guidelines and are consistent with the corporate integrity agreements entered into between the companies and the government,' Joseph said. 'There is full disclosure of this fact at all lectures.'

 These justifications appear to be just plain wrong.  As far as I know, the US Food and Drug Administration does not pre-approve "drug talks" given by physicians for pharmaceutical companies.

By the way, the statement by Dr Joseph approaches self parody.  As we have discussed, corporate integrity agreements are usually the products of legal settlements of charges of wrongdoing.  Drug companies do not sign such agreements because of previous good behavior.  Moreover, I have never heard of such an agreement that required pre-approval of drug talks, either. 

 Trust Me, I'm an Expert

 As reported by NorthJersey,

One of the top recipients in North Jersey was Thomas Dayspring, an internist and expert in cholesterol management, who earned just under $400,000 from Merck and GlaxoSmithKline. Dayspring said he was paid for lectures at conferences for doctors arranged by the drug companies, as well as continuing medical education programs.

'I’ve logged over 2 million miles, all over the world and in all 50 states,' said Dayspring, who served as the director of the North Jersey Institute of Menopausal Lipidology in Wayne until last summer. 'Guys like me who are nationally known attract a big audience. Not every speaker can trot out a CV like mine.'

New Jersey, you gotta love it.  The most charitable characterization of this is an appeal to authority, albeit an amazingly egotistical one. 

Summary

 Two years after Pro Publica's report, pharmaceutical companies are continuing to pay substantial sums to physicians and other health professionals, nominally for education and research.  Because these arrangements are financially beneficial to the professional recipients of the money, and likely financially beneficial via their marketing effects  to the companies that provide the money , it should be no surprise that they are continuing in the absence of any regulatory restrictions.

What is saddest about the latest reporting is the silliness of the excuses made by the conflicted physicians.  Professionals with four years of education post-college, and multiple years of experience, and who are often respected as academics or practitioners ought to be able to reason and argue better than they did in the examples above.  Of course, people who make a lot of money often come to believe they really deserve it.  And conflicts of interest produce conflicted thinking.  As Joe Collier wrote in the BMJ, " people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult." (Look here.)

The IOM  report  on conflicts of interest suggested full disclosure of all payments that could be considered conflicts of interest, banning clinical research by conflicted individuals, prohibiting academic physicians from giving "drug talks" whose content was provided by industry, and developing methods to fund continuing medical education independent from industry.  This report, and its recommendations have gotten scant attention, maybe because they would threaten a status quo that enriches conflicted health professionals and the companies that create these conflicts.  However, in my humble opinion, implementing all the report's recommendations would only be a beginning down the road of restoring the integrity of clinical care, teaching, and research.  

Bad Science (and Perhaps Conflict of Interest) At ONC / HHS

This article recently appeared, quoting Jacob Reider, M.D., chief medical officer at ONC on an upcoming Health IT Safety Plan:

Health Data Management

http://www.healthdatamanagement.com/news/HIMSS13-ONC-HIT-safety-plan-45809-1.html 

ONC Sets Early Summer for Release of HIT Safety Plan

The Office of the National Coordinator for Health Information Technology anticipates releasing a final health information technology safety plan by early summer, officials announced on March 5 at HIMSS13 in New Orleans.

ONC released a draft plan in December and accepted public comment until February 4. The draft followed an Institute of Medicine report that ONC commissioned that highlighted the need for better understanding of the HIT impacts on safety, as well as shared responsibilities among all stakeholders to improve safety, Jodi Daniel, director of the ONC office of policy and planning, said during an educational session.

There is little doubt that use of I.T. results in fewer medical errors, particularly medication-related because of electronic prescriptions and clinical decision support, noted Jacob Reider, M.D., chief medical officer at ONC. “It’s obvious that in many areas there will be fewer errors, but at the same time, in other areas there will be more errors.” Consequently, a priority of the plan will be implementing a framework to help the industry better understand what the trouble areas will be as I.T. use increases.

Less than 1 percent of patient safety events are related to HIT, Reider contended, but the industry needs more data to better understand the level of harm from such events and how to improve the technology. HIT-related errors, he reminded the audience, are not always the fault of vendors; providers can introduce risk when customizing their systems.

The upcoming safety plan release is fine and good, but I, for one, wonder if it can be trusted.

The level of bias and lack of knowledge of the domain, evidence of incomplete research, and/or poor scientific judgement inherent in the statements I bolded above are disturbing.  They are also  reminiscent of the problems in the ONC-authored paper discussed at this link.

First:

• There is little doubt that use of I.T. results in fewer medical errors

On the contrary, there is significant well-researched doubt in that the evidence is quite contradictory.  Let's cite the IOM's 2012 report on health IT risk:

… “For example, the number of patients who receive the correct medication in hospitals increases when these hospitals implement well-planned, robust computerized prescribing mechanisms and use barcoding systems. But even in these instances, the ability to generalize the results across the health care system may be limited. For other products— including electronic health records, which are being employed with more and more frequency— some studies find improvements in patient safety, while other studies find no effect.   

IOM (Institute of Medicine) 2012. Health IT and Patient Safety: Building Safer Systems for Better Care (PDF). Washington, DC: The National Academies Press.

Let's quote one of the IOM study panel members, an international authority on safety, Dr. Richard Cook:

... HIT's cornucopia has been promised repeatedly since the 1960's. Nothing like the promises has materialized.  Indeed, the IOM committee that was commissioned to evaluate the best evidence on this subject found no persuasive evidence that HIT improved patient safety. I know because I was there. 

The body of literature here also contains relevant studies contradicting Dr. Reider's quoted, dispositive statement.

Next:

• It’s obvious that in many areas there will be fewer errors

This statement requires no response, but I'll respond anyway.  

In science, stating something is "obvious" (i.e., what is referred to at the site "36 Humorous Methods of Proof" as "Proof by obviousness") is, on its face, bad science.

Next:

• Less than 1 percent of patient safety events are related to HIT

The aforementioned IOM report was quite clear on the following:

... Several reasons health IT–related safety data are lacking include the absence of measures and a central repository (or linkages among decentralized repositories) to collect, analyze, and act on information related to safety of this technology. Another impediment to gathering safety data is contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events. These barriers limit users’ abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes. In addition, some vendors include language in their sales contracts and escape responsibility for errors or defects in their software (i.e., “hold harmless clauses”). The committee believes these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.

... The magnitude of the risk associated with health IT is not known.

Likewise, FDA has concluded that what they know on HIT-related patient safety events is likely "the tip of the iceberg"  due to systematic impediments to knowing, as has the ECRI Institute who has only now begun to study the issue with any degree of rigor.  (The results are of great concern to anyone who should know, or should have made it their business to know, as at this link.)

Perhaps Dr. Reider needs a lesson on basic epistemology:  "We simply don't know what we don't know."

Finally:

• HIT-related errors, he reminded the audience, are not always the fault of vendors; providers can introduce risk when customizing their systems.

I find it remarkable that a government official uses a public/industry platform HIMSS to defend an industry, while at the same time stating more study is needed to understand the causative factors of harm from the industry's products.

This raises the question of conflict of interest, and the possibility this official is not impartial or trying to be "fair" but aiming towards protecting an industry he once worked for - and to where he's likely to return at some point.  (See Roy Poses' posts on "revolving doors" for examples of that.)

From his government biography here:

Dr. Jacob Reider
Director, Office of the Chief Medical Officer

Jacob Reider, MD is a family physician with 20 years of experience in health information technology and special interest in clinical innovation, user experience, and clinical decision support. His background includes leadership roles in nearly all facets of the health IT domain – from small start-up companies to academic facilities, primary care medical groups, and large health IT development organizations. Dr. Reider has served as a member of the Board of Trustees of the American Medical Students Association, the Society of Teachers of Family Medicine, and has served in directorial positions on boards of several innovative health IT companies.

  
I note I do not find evidence of formal medical informatics education, which selfsame ONC recommends for leadership roles in health IT (see my Dec. 2009 post "ONC Defines a Taxonomy of Robust Healthcare IT Leadership"), but I do find roles such as:

Chief Medical Informatics Officer
Allscripts
June 2009 – January 2011 (1 year 8 months)

Medical Director
Allscripts
March 2007 – June 2009 (2 years 4 months)

Chief Medical Officer
MedRemote (Now Nuance)
November 1999 – December 2002 (3 years 2 months)

One might reasonably wonder what personal gains might accrue to Dr. Reider from the promotion of health IT - which includes downplaying its current risks - from an influential government perch.  (I for example held many Merck stock options after my late 2003 departure.  They remained underwater until expiration, but even a a $10 or $20 increase in stock price could have bought me, say, a new sports car or even house.)

I also note that the former CEO of Allscripts, Glen Tullman was, in fact, a close confidant of our current President and advisor on health IT during his first campaign:

A tireless advocate of technology in medicine, Tullman has been featured in virtually every major news outlet. An early supporter of fellow Chicagoan Barack Obama, Tullman introduced him to the Electronic Health Record (EHR) and served on his finance and healthcare committees during the 2008 presidential campaign.

Is it any wonder, then, that my expectation is that the forthcoming ONC HIT safety plan will be biased towards industry, reflect poor science and incomplete/selective research, and overall be a whitewash?

I'll be presenting on issues such as this to the Plaintiff's Bar.  They seem to be the last protectors of people's/patient's rights where clinical IT is concerned - a role they seem most familiar with in other sectors.

I emailed Dr. Reider a link to this post with a request that if he has robust evidence to support his assertions that is not publicly available, to please release it.

-- SS

Mar. 16, 2012 Addendum: 

A correspondent asked me the following that I thought deserved mention beyond the comments section:

"How would he know, exactly, when we know, that they never tallied the thousands of e-Rx errors from a national Siemens defect that was disclosed only at the Brown Medical Center Hospitals (Lifespan) but was a systemwide defect; nor from the Cerner convert to e-Rx defect that was evident at the Trinity Health System; and millions of other errors from when the e-Rx system was unavailable. Or, do they simply do not count those?"

My response?  No, they probably consider those "anecdotal." 

-- SS
 

IRS faces class action lawsuit over theft of 60 million medical records

Try this with paper records.  This is spectacular (as in, spectacularly alarming) if true:

IRS faces class action lawsuit over theft of 60 million medical records

The Internal Revenue Services is now facing a class action lawsuit over allegations that it improperly accessed and stole the health records of some 10 million Americans, including medical records of all California state judges.

According to a report by Courthousenews.com, an unnamed HIPAA-covered entity in California is suing the IRS, alleging that some 60 million medical records from 10 million patients were stolen by 15 IRS agents. The personal health information seized on March 11, 2011, included psychological counseling, gynecological counseling, sexual/drug treatment and other medical treatment data.

"This is an action involving the corruption and abuse of power by several Internal Revenue Service agents," the complaint reads. "No search warrant authorized the seizure of these records; no subpoena authorized the seizure of these records; none of the 10,000,000 Americans were under any kind of known criminal or civil investigation and their medical records had no relevance whatsoever to the IRS search. IT personnel at the scene, a HIPPA facility warning on the building and the IT portion of the searched premises, and the company executives each warned the IRS agents of these privileged records," it continued.   According to the case, the IRS agents had a search warrant for financial data pertaining to a former employee of the John Doe company, however, "it did not authorize any seizure of any healthcare or medical record of any persons, least of all third parties completely unrelated to the matter," the complaint read.

The class action lawsuit against the IRS seeks $25,000 in compensatory damages "per violation per individual" in addition to punitive damages for constitutional violations.  Thus, compensatory damages could start at a minimum of $250 billion.

According to the linked Courthousenews.com piece, the class is represented by attorney Robert E. Barnes of Malibu, California.   The Complaint is reported to state that the IRS' data theft was so enormous it affects "roughly one out of every twenty-five adult American citizens."

If a government agency decides to steal medical records, I'd rather the records be on paper than electronic. I think it's inarguable that it is a lot harder for 15 people to haul 60,000,000 paper charts away than a few hard disks.

Mass theft of records must be factored into the risk/benefit ratio of electronic health records.  See other posts on this topic at the label index terms below.

Addendum:  the Complaint is here (PDF).

-- SS

Minimizing Legal Liability or Upholding the Mission? - the Markingson Case Redux

There are new, and troubling developments in the long running case of Dan Markingson, the psychiatric patient and research subject who committed suicide while enrolled in a trial of anti-psychotic drugs at the University of Minnesota nearly 10 years ago.

Summary of the Case

A good quick summary of this case just appeared in the Center for Law and Bioscience blob out of the Stanford Law School. 

Dan Markingson – a vulnerable, psychotic young man – was forced to choose between enrolling in a Pharma-funded drug study or being involuntarily committed (in other words, locked up).  A UMN [University of Minnesota]  doctor enrolled him in the study despite having just determined that Dan 'lack[ed] the capacity to make decisions regarding [his] treatment,' rendering it highly unlikely that Dan could have given valid informed consent to participate.  As Dan's mother, Mary Weiss, observed his mental condition deteriorating, she repeatedly tried to have Dan removed from the trial – at one point asking  'Do we have to wait until he kills himself or someone else before anyone does anything?'  But the UMN co-investigators in the drug study refused to terminate his participation.  Shortly after Ms. Weiss made her desperate plea, Dan Markingson killed himself by cutting his own throat.

Our most recent (2011) post on the case was here.  In it we also noted that there was reason to think:
-  The design of the controlled trial was flawed.
-  Financial conflicts of interests may have influenced the trial investigators' actions, particularly their questionable enrollment of Mr Markingson in the trial and their retention of him in it despite his apparent clinical deterioration.
Despite that, when bioethicists and the University of Minnesota called for a new investigation of the trial and what happened to Mr Markingson, the university rebuffed them.

Worse, as detailed in a 2012 post in the Center for Law and Bioscience blog, not only did university officials rebuff this call, but the university general counsel, who had been operating at the heart of this case, appeared to threaten the leading bioethicist dissident, Dr Carl Elliott:

 After Carl Elliott, the University of Minnesota bioethicist, refused to drop the matter, Rotenberg asked the university’s Academic Freedom and Tenure Committee to take up the question of '[w]hat is the faculty[’s] collective role in addressing factually incorrect attacks on particular university faculty research activities?' – a question that appeared both to accuse Elliott of 'factually incorrect attacks' and to call for some unspecified action to 'address' them.  Other faculty, including the president of the Minnesota chapter of the American Association of University Professors, viewed this as an attempt to intimidate Elliott into silence.  If so, it backfired.  The story ended up in the press, putting the Markingson case back in the public eye and once again making the University of Minnesota look really bad.

New Evidence Unearthed

In 2013, Dr Elliott made public what may be important new evidence in the case.  As summarized by the Minneapolis Star-Tribune,

The professor, Carl Elliott, says he has obtained consent documents for two separate schizophrenic patients that appear to be exact copies — not just in the subjects’ apparent replies, but in the positions of the lettering on the pages.

Elliott said it is improbable that separate patients would provide identical responses to the questionnaire, which includes open-ended questions about the risks and requirements of clinical research. And that, he said, raises questions about whether the university was really examining patients to determine their ability to consent to research.

 One crucial question about the case is how a patient who was actively psychotic - out of touch with reality - could give true informed consent to participation in a drug trial.  These new documents suggest major irregularities in the process used in the trial to assure that patients did give informed consent. 

Furthermore, as reported by the Minnesota Daily, other documents that Dr Elliott found suggested problems with records that related to whether study investigators would have had legal authority to access Mr Markingson's medical records, also suggesting major problems with trial administration. 

These documents, unknown until recently, suggest new concerns with how the study in which Mr Markingson was enrolled, and during which he died, was run.  Yet, the University of Minnesota's official response to them, once again orchestrated by university counsel Mark Rotenberg, attacked the legitimacy of the documents (and indirectly, attacked Prof Elliott again), as reported by the Star-Tribune,

the university’s general counsel, Mark Rotenberg, challenged the authenticity of the documents and disagreed that study recruiters failed to obtain proper and independent consent from mentally ill patients.

'I am challenging these allegations directly,' he said. 'We have no reason to believe the consent forms were prepared inappropriately.'

As Matt Lamkin wrote in the Stanford Law and Bioscience blog,  the University's responses all through this case have been focused  not on the welfare of patients, maintaining the trust of research participants, or the integrity of clinical trials, but on the legal defense of  the University and its leaders

Despite all this (and much more), the University has never acknowledged any errors or taken any disciplinary action related to the Markingson case and has repeatedly rejected calls for an independent investigation.  That’s probably because from the start the University has handled this case as a litigation matter.  Rather than trying to determine whether there were problems with the way its personnel treated Markingson, the University has focused on minimizing its potential liability.  Accordingly, the University appears to run every inquiry related to the case through the office of its General Counsel, Mr. Rotenberg.  When Carl Elliott (my mentor as a grad student at UMN) wrote a damning article about the case in Mother Jones, the University’s response came from Rotenberg.  When UMN bioethicists called on the University’s Board of Regents to launch an independent investigation, the Regents deferred to Rotenberg.  Not surprisingly, he declined.

When you turn to your lawyer, you’re going to get a particular kind of response.  The GC isn’t in a position to take an objective look at the circumstances.  He’s an advocate.  His role is not to make sure the client has conducted itself ethically, but to minimize the client’s risk.  Asking your lawyer to respond to allegations of wrongdoing is like asking your PR flacks to do so.  Their job is to make their clients look good, not to make sure they’ve acted properly.

Note that this still begs the question of who the client is.  Is it the university, or the university's leaders?

Furthermore, as Mr Lamkin pointed out, the general counsel would appear to have a conflict of interest.  It may be he has an interest in defending his own actions, as well as those of his client(s), whether they are the university, its leaders, or both. 

In addition to Mr. Rotenberg’s role as the University’s top defender and advocate, there is another reason he cannot impartially consider requests for an investigation: the General Counsel’s Office is an important player in some of the disturbing events at issue.  As noted above, Rotenberg himself has been accused of attempting to intimidate and silence the bioethicist who has most doggedly sought an investigation.  The University’s lawyers are also responsible for the disgraceful silencing of Markingson’s mother, Mary Weiss.  After avoiding liability by arguing the University was immune from suit, these lawyers then threatened to force Weiss – whose son had died in a University doctor’s 'care – to pay the University’s legal costs of some $57,000.  The University used that threat as leverage to get Weiss to forgo an appeal of the trial court’s decision.

So as the University continues to refuse any new consideration of this this seemingly never-ending case, Dr Elliott has posted an online petition calling for an outside investigation.   We will see how Mr Rotenberg reacts to this.

Summary


A very troubling aspect of this case is that it has shown that the university leadership has seemed to care, at best, more about fending off litigation than upholding the university's mission.  The mission of the university is supposed to be discovering and disseminating the truth in a spirit of free inquiry.  Added to the mission of medical schools and university teaching hospitals is taking good care of patients, and putting the patients' interests ahead of all other concerns.  Yet, in this case, university leaders have not seemed to care whether in their haste to push back legal liability they were stepping on their faculty's academic freedom and free speech, the integrity of the medical research done at the university, and most importantly the rights of their patients and research subjects.  Furthermore, it is not clear whether they mainly feared the impact of litigation on the university, or how litigation might actually end up holding them accountable.

As Dr Judy Stone wrote in her Scientific American blog,

  it appears that UMN believes, as do many other institutions, that protecting itself from scandal and its consequences comes first and foremost and that, like the big banks, that it is too big to be punished.

Again, note that UMN cannot itself believe or protect.  People acting ostensibly on its behalf may have been protecting themselves from scandal, and believing that the size and status of their institution gave them, the leaders, impunity.

The case of Mr Dan Markingson is a continuing reminder that to reform health care, health care organizations need to be lead by people who put the health care mission first and are willing to be accountable for that mission.   I hope that eventually there is an honest investigation of this case, and a commitment to reform based on its conclusions.

See additional thoughts from Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog, on the 1BoringOldMan blog, on the Periodic Table blog, and last but certainly not least, many comments by Dr Carl Elliott on the Fear and Loathing in Bioethics blog. 

JAMA: "Improving the Electronic Health Record—Are Clinicians Getting What They Wished For?" - No, But Utopia Arrives Soon

At a new JAMA piece "Improving the Electronic Health Record—Are Clinicians Getting What They Wished For?", former Columbia U. and now NIH medical informaticist James J. Cimino, MD points out issues with the documentation that results from health IT systems.

A preview of the first page of this short Viewpoint piece is available free at this link.  It includes the observation that:

... There is no question that computerization has made patients’ records more available and legible. With respect to completeness, however, there are now complaints that the record is too complete: electronic notes are deemed by many clinicians as being full of extraneous details and obscuring important aspects of a patient’s condition

Dr. Cimino goes on to state that:

Empirical observational studies of clinicians have shown ways to improve EHR functionality ... Similar research on clinical documentation processes is needed to advance this crucial EHR component.

These are excellent observations.

The issue I have with the piece is - and I am finding this true of many articles critical of today's health IT - the ending, which I'm finding to often be PR.  Or, perhaps it would be more accurate to call the endings of late a "salvage operation-style" attempt to save face for the informatics community, who let this domain be overrun by the corporate IT sector and terrible products that violate many of the precepts of design of good health IT learned during five decades of research.

Cimino concludes an otherwise constructive piece with this statement:

... Rather than complain about the challenges [a euphemism if ever I saw one - ed.] they have introduced, clinicians should recognize that current EHRs are illuminating the opportunities for the next generation of systems that will support clinicians as active partners across the spectrum of health care settings and tasks. The resulting improvements in documentation will, in turn, support patients, administrators, and researchers as we move towards a true learning health system.

I note this assertion is at complete odds with the dictum I was taught from my earliest medical mentors, and that no amount of wishful thinking will banish:

"Critical thinking always, or your patient's dead." (Cardiothoracic surgery pioneer Victor P. Satinsly, M.D., Hahnemann Medical College, Philadelphia, early 1970s.)

Translating the statement into plainer English, it seems to me that Cimino is saying this:

"Doctors, shut up, stop complaining about the chaos and patient/professional risk today's bad health IT is causing, take the medicine your betters have prescribed for you, and don't be uncompromising patient advocates as patients are secondary in this quest to reach IT-based Healthcare Utopia - which we will reach come version 2.0."

(This comes, ironically, at a time when physicians are starting to get a voice, e.g., Twitter's #EHRbacklash.)

In my view, this salvage mentality sprinkled with euphemisms and Utopian rhetoric spoils an otherwise constructive piece.  This type of language and utopian predictions about HIT have also appeared in other major medical publications by informatics and healthcare leaders (including top governmental office holders), as for example here.

Now, I know Jim Cimino and he is a good scientist.  However, I truly wish the non-scientific, "wait for version 2.0", utopian P.R. would stop.  As a member of the Medical Informatics profession myself, it's actually become embarrassing.

-- SS