Is Healthcare IT a Solution to the Wrong Problem?

In a study published in the Nov. 25, 2010 New England Journal of Medicine entitled "Temporal Trends in Rates of Patient Harm Resulting from Medical Care", Landrigan N Engl J Med 363;22, it was found that medical error rates were not dropping:

In a study of 10 North Carolina hospitals [from January 2002 through December 2007], we found that harms remain common, with little evidence of widespread improvement. Further efforts are needed to translate effective safety interventions into routine practice and to monitor health care safety over time.

Unfortunately, I don't believe that the article differentiated between computerized hospitals and paper-based ones. Nor were the subject hospitals selected on the basis of computerization or non-computerization:

We conducted a retrospective study of a stratified random sample of 10 hospitals in North Carolina ...

... All acute care North Carolina hospitals listed in the American Hospital Association (AHA) database except those providing exclusively pediatric, rehabilitation, or psychiatric care were eligible for selection for the study. These hospitals were stratified according to the AHA’s definition of the facility as small, medium, or large; urban or rural; and teaching or nonteaching. The number of hospitals that underwent randomization for inclusion in each stratum reflected the proportion of national discharges from that type of hospital. If an invited hospital declined to participate, another closely matched hospital was randomly invited to participate in its stead.

While the extent of EHR/CPOE and other clinical IT adoption was not measured, some of the hospitals studied would likely have adopted and/or been using clinical IT in various capacities during the study period. The IT might have been expected to contribute to lower error rates over time.

Although that is admittedly speculation, there is a more important point to be made.

Many of the identified errors seem to have little to do with record keeping, but instead with human factors.

From the New York Times article "Study finds No Progress in Safety at Hospitals" covering the NEJM article:

... Landrigan’s study reviewed the records of 2,341 patients admitted to 10 hospitals — in both urban and rural areas and involving large and small and teaching and nonteaching medical centers ... Among the preventable problems that Dr. Landrigan’s team identified were severe bleeding during surgery, serious breathing trouble caused by a procedure being performed incorrectly, a fall that dislocated a patient’s hip and damaged a nerve and vaginal cuts caused by a vacuum extraction device used to help deliver a baby.

The findings were a disappointment but not a surprise, Dr. Landrigan said. Many of the problems were caused by the failure of hospitals to use measures that had been proved to avert mistakes and prevent infections from urinary catheters, ventilators and lines inserted into veins and arteries.

The chart of "harms" in the article, both those deemed "non-preventable" and those deemed "preventable" reads like a textbook of medicine, e.g.:

Cardiac arrest, shock, myocardial ischemia, acute respiratory failure, acute renal failure, hemorrhage, thromboembolic venous event, hematoma, pancreatitis, ileus, stroke or intracerebral hemorrhage, withdrawal symptoms, catheter-related bloodstream infection, urinary tract infection, surgical-site infection, clostridium difficile colitis, surgical anastomosis failure, wound dehiscence, failed procedure, unplanned return to surgery, fetal neonatal complication associated with delivery, hypothermia, pressure ulcer, catheter complication, etc.

It seems unlikely a missing or illegible chart was the cause of many of these adverse events. (In fact, the study was done retrospectively from the patient charts.)

Thus, expectations for major quality improvements in healthcare from the hundreds of billions spent on health IT might be vastly overstated based on false assumptions about the causes of adverse events.

Many of the above adverse events seem not highly amenable to correction via cybernetic information retrieval systems. They might be amenable, though, to improved nursing and ancillary staffing (perhaps I should say 'elimination of understaffing'), decreased work hours, improved CME, and better supervision of trainees ($100's of billions of dollars being spent for IT would surely buy a lot of those items).

What I found striking was this:

“A third of the errors in the intensive care unit disappear when residents work 16 hours or less,” Dr. Landrigan said, although he noted that senior residents often work longer hours.

That being the case, health IT that created heavier workloads and cognitive overload of residents already struggling under sleep deprivation might actually increase the risk of error.

It would seem national healthcare IT may be a 'solution' to the wrong problems in 2010.

We perhaps should better be focusing on human problems not amenable to cybernetic intervention before we start a national medical IT experiment, in the hope that major changes will somehow be effected by the magic of computers.

-- SS

Health Insurers Sanctioned, Fined

It has not been a good few weeks for big US health insurance companies.  First was a report (e.g., per the Wall Street Journal) that three companies had been suspended from selling Medicare Advantage plans:

The U.S. government's Medicare program has ordered three health insurers--Universal American Corp. (UAM), Health Net Inc. (HNT) and Arcadian Health--to stop marketing to and enrolling new members in their Medicare Advantage health and prescription-drug plans, saying the companies violated regulations.

In particular,

Universal American was told to stop marketing to and enrolling people in its Medicare Advantage plans effective Dec. 5. The action doesn't affect current members or the enrolling of beneficiaries in the company's stand-alone Medicare prescription-drug plans.

Health Net had to suspend the marketing of and enrollment in its Medicare Advantage plans and stand-alone Medicare prescription-drug plans as of Friday, as the government said the company's conduct poses a 'serious threat' to enrollees. The sanction doesn't affect the status of current enrollees, however.

In a letter Friday to Theodore Carpenter, head of Universal American's Medicare Advantage business, the Centers for Medicare and Medicaid Services alleged the company has a 'longstanding pattern of prohibited marketing practices targeted to highly vulnerable populations in violation' of federal law and guidelines as well as contractual terms with CMS.

Universal American is a 'chronic poor performer' with respect to the regulations, according to CMS, which said the company's agents engaged in aggressive sales tactics and abusive behavior, and misled or confused beneficiaries or misrepresented the plan.

The agency's letter to Health Net government-programs executive Scott Kelly said the company's conduct 'poses a serious threat to the health and safety of its enrollees,' as a result of the company's 'intractable failure to provide its enrollees with prescription drug benefits in conformance" with laws, guidelines and contract terms.' CMS cited a 'history of non-compliance.'

Then, the state of California fined and ordered restitution from multiple companies, as reported by the San Francisco Chronicle:

State regulators Monday fined seven of California's largest health insurers nearly $5 million for systematically failing to pay doctors and hospitals fairly and on time.

The California Department of Managed Health Care issued the fines following an 18-month audit in which investigators looked at a small but statistically significant sample of claims. The investigation found the plans were paying on average about 80 percent of the claims correctly, far below the legal threshold of 95 percent.

'Our clear and consistent message is that California's hospitals and physicians must be paid fairly and on time,' said Cindy Ehnes, director of the Department of Managed Health Care, which is charged with regulating the states' health maintenance organizations, or HMOs.

In addition to the fines, the companies must pay the doctors and hospitals restitution that is expected to run into the "tens of millions of dollars," Ehnes said. The plans will also be required to come up with a plan to correct the problem and submit to future audits.

Failing to pay providers properly makes it tougher for them to survive in the struggling economy, Ehnes said. 'If providers are not paid, patient care and access suffer,' she said.

Regulators fined Anthem Blue Cross and Blue Shield of California $900,000 each. United/PacifiCare was fined $800,000 and Kaiser Foundation Health Plan and Health Net were both hit with fines of $750,000.


The fines for Cigna and Aetna were $450,000 and $300,000, respectively, for a total of $4.85 million.

Please note that some of these companies have become "frequent flyers" on the Health Care Renewal blog.  Anthem Blue Cross in California is a subsidiary of WellPoint. WellPoint, in particular, just appears again and again on Health Care renewal.  A list of all posts about that company is here, and see this post for a list of past ethical and management missteps.  Health Net appeared in both stories above, and appeared on Health Care Renewal here.  Posts on Aetna are here.

Having been writing for this blog now for several years, I am struck by how often the conduct of particular health care organizations has been discredited, without any discernible effect on the organization's leadership or course.  It is particularly striking how the attention paid and pay given to the leaders of some health care organizations contrasts with the public record of their organization's bad behavior.

In particular, contrast the long catalog of misbehavior by WellPoint, noted above, with the enormous earnings of the company's CEO (more than $13 million in 2009), and her status as a prominent speaker on health care policy (see post here). 

In the laissez faire, anything goes, wild, wild west economy of today, spearheaded by the financial service companies that lead us to the global economic collapse, it seems that ethical leadership counts for nothing.  This is bad when it applies to the leadership of financial services, whose bad leadership can cost us all a lot of money.  It is worse when it applies to health care, whose bad leadership can cost us our health and our lives.

As I have said ad infinitum, to really reform health care, we will need to get accountable, ethical, transparent leadership of health care organizations.

When Robo-Medicine Replaces Dr. Welby, Watch Out

At "The Trouble With Robo-Lending", WSJ, Nov. 13, 2010 Amir Bhidé wisely notes, contrary to the seductive memes of statistical model religionists, that:

"High-touch gave way to high-tech. Statistical models that took no heed of specific circumstances replaced the bankers' on-the-spot judgments"

and that:

"Robo-lending and the securitization it facilitates lead to the misallocation of capital and economic instability."

Wait until "Robo-Medicine" hits, where on-the-spot judgments about medical care get replaced with statistical models of treatment, for example, in the form of electronic medical records-hosted "decision support" based on "comparative effectiveness research."

We apparently have not yet learned our lessons from the financial crisis regarding statistical legerdemain in fields where statistics should never replace human judgment. It's only money.

However, the fundamental truths within the adage "there are three kinds of lies: lies, damned lies, and statistics" will become exceedingly and painfully clear from the medical mayhem that results when Robo-Medicine replaces Dr. Welby.

-- SS

Academic Medical Center Crime Wave?

Every large group or organization has a few bad apples.  My web searches constantly turn up stories of individuals working in health care who behave unethically or commit crimes.  I do not generally discuss these cases on Health Care Renewal, since they seem unavoidable, and their sporadic appearance does not necessarily have anything to do with systemic problems in health care.

However, in the last week, I noted four cases of rather exceptionally bad behavior by individuals working in large hospital systems, and the severity and proximity of these cases made me wonder if they reflect some new trend.

Pennsylvania State University Faculty Member Charged with Rape

As reported by PennLive.com,

Former Derry Township, Dauphin County, doctor Dr. Robert L. Yarwood stands accused of using his position and influence to addict two of his patients to painkillers and raping them multiple times.

Yarwood, 56, has been charged with more than 42 criminal counts, including rape and sexual assault, stemming from allegations made in 2008 by two women, ages 40 and 45.

He is accused of giving narcotics to the women to 'exert psychological force,' said Fran Chardo, Dauphin County first assistant district attorney.

'The case, speaking abstractly, is very disturbing because of the trust relationship between the patient and the doctor,' Chardo said. 'It’s a violation of trust.'

In an interview with The Patriot-News, one of the women said she had visited Yarwood several times over the course of a year. He was prescribing her pain medication, which she eventually became addicted to. Then, she said, he raped her. 'I was paralyzed. I was in shock,' she said. 'I trusted him.'

At the time of the allegations, Yarwood was an obstetrician and gynecologist at the Penn State Milton S. Hershey Medical Center, which he joined in the late 1990s. In August 2008, the medical center was apprised of the investigation and immediately suspended Yarwood from having contact with patients.

$5 Million Embezzlement from Columbia University Medical Center

As reported by the Wall Street Journal,

A 48-year-old Bronx man has been arrested and charged with grand larceny for allegedly stealing nearly $4.5 million from Columbia University over the course of two months, authorities said Monday.

George Castro is accused of adding a TD Bank account belonging to him as a payee in the Columbia University Medical Center's accounts payable system, netting payments of $3.4 million in October and $1 million in November, authorities said. Mr. Castro, whose relationship with the university is unclear, was arrested Wednesday.

A law-enforcement official familiar with the case said Mr. Castro had $200,000 in cash in his possession when he was arrested and had withdrawn $140,000 the day before his arrest. According to a criminal complaint, Mr. Castro told investigators the money 'just appeared' in his bank account and that he had gotten 'greedy.'

Duke Surgeon and Surgical Department Business Manager Accused of Embezzlement

As reported by WRAL.com,

A former Duke University surgeon and manager have been charged with stealing $267,000 from the university, police said Tuesday.

Dr. Eric Joel DeMaria, 51, of 1101 Tacketts Pond Drive in Raleigh, and John William Cotton, 39, of 7228 Loblolly Pine Drive in Raleigh, were each charged with embezzlement of more than $100,000. Cotton also was charged with obtaining property by false pretense.

Cotton was arrested last Wednesday, and DeMaria surrendered to police Tuesday morning. Both have been released on $25,000 bonds.

DeMaria was director of Duke's bariatric surgery program, while Cotton was a business manager in the surgical department at Duke University Hospital, according to Michael Schoenfeld, Duke's vice president for public affairs.

Office Worker Accused of Stealing $3.8 Million from Memorial Sloan-Kettering Cancer Center

As reported by the New York Post,

A former worker at Memorial Sloan-Kettering stole nearly $4 million from the cancer center in a massive scheme that involved ordering a boatload of unnecessary printer cartridges and reselling them, authorities said.

The loot from the elaborate scam was used to fund a lavish lifestyle that allowed $37,000-a-year receiving clerk Marque Gumbs to move from a Bronx housing project to a luxurious Trump high-rise in the suburbs.

Gumbs, 32 -- who was arraigned yesterday in Manhattan Criminal Court on charges of grand larceny and criminal possession of stolen property -- allegedly began his scheme in 2004 by ordering extra toner cartridges and reselling them.

In one astounding stretch from October 2009 through August 2010, Gumbs ordered $1.2 million worth of toner that wasn't usable for any machine at the hospital, authorities said.

His alleged ruse cost the hospital $3.8 million.

Summary

So here is the box-score. Reported in one week were three alleged theft/ embezzlement schemes with values from $267,000 to $5 million, and one alleged series of multiple rapes. The alleged perpetrators included two academic physicians (one in surgery, one in obstetrics-gynecology), two hospital staff, one in management, and a person with an unclear relationship to the hospital. All involved large, prestigious academic medical centers.

So, again, maybe these were just coincidences. However, it may be that there is a real trend toward bigger and more spectacular thefts and embezzlements from big, not for profit health care institutions.  The most likely explanation is simply that the increasingly huge amounts of money flowing through such institutions attracts those who go to where the money is, and that the increased complexity of the bureaucracy of ever-growing health care institutions makes it easier to hide such thefts.  At least, this odd string of cases should prompt more questions about the conventional wisdom that it is good for health care organizations to grow ever larger. 

However, just to be speculative, note that three of these incidents occurred at institutions whose leadership has attracted our attention before.  We discussed conflicts of interest affecting one Columbia academic leader here, and the prevalence of leaders of failed financial services companies on the New York-Presbyterian board here.  We discussed a leader of two of the firms most involved in the global financial collapse who was also the chairman of the board of Duke University here.  A quick skim of Memorial Sloan-Kettering's Board of Overseers (in its 2009 annual report) showed the presence of at least two leaders of failed financial services firms heavily involved in the global financial collapse (E Stanley O'Neal, former CEO of Merrill Lynch, and Sanford I Weill, former CEO of Citigroup).  The speculation is that as academic medical centers and hospital systems and their parent universities have increasingly been recipients of the "stewardship," and hence immersed in the culture of the financial services industry, particularly firms which contributed to the global financial collapse, the culture of health care became increasingly laissez faire, anything goes, wild, wild west, and so it got easier for the wrong people to be hired, and for the wrong people to pull off truly spectacular capers.

I submit that the first criterion for being a trustee or director, and hence ostensibly a steward of an academic medical institution should be devotion to the mission of the organization, not size of one's contribution.

"Unreasonably Dangerous" Heparin

It is time for an update on the case of the deadly contaminated heparin sold by Baxter International, which has received much less attention than seems warranted given its human costs (81 lives).  How the heparin was contaminated, and how the contaminated heparin ended up being sold as a US Food and Drug Administration approved American product are still unknown.  Despite the fact that the outcome of this case were so bad, it received disproportionately little attention when it was first made public, and now seems to have become nearly anechoic.

Case Summary 

Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China. That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label. The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small "workshops" operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA. The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many patients who received got seriously ill or died. While there have been investigations of how the adulteration adversely affected patients, to date, there have been no publicly reported investigations of how the OSCS got into the heparin, and who should have been responsible for overseeing the purity and safety of the product. Despite the facts that clearly patients died from receiving this adulterated drug, no individual has yet suffered any negative consequence for what amounted to poisoning of patients with a brand-name but adulterated pharmaceutical product.  (For a more detailed summary of the case, look here, and for all our posts on this topic, look here.)

Civil Cases Plod Forward
If there is any ongoing official investigation of this case, it has not been made public.  Civil cases filed by patients allegedly injured by the heparin, or by relatives of patients who died allegedly from the heparin, seem to be proceeding at a glacial pace.  However, there is one development in one set of civil cases worthy of note.  As reported two weeks ago by Alicia Mundy in the Wall Street Journal:

A state court in Illinois has granted a partial summary judgment to two plaintiffs suing Baxter International Inc. over contaminated blood thinner, saying that some of the company's heparin was 'unreasonably dangerous.'

The suit involves tainted imported heparin ingredients from China that caused a public health crisis in 2008, and were linked to more than 80 deaths in the U.S. and many other serious allergic reactions.

Some 300 cases nationwide against Baxter and its main ingredient supplier, Wisconsin-based Scientific Protein Laboratories LLC, were consolidated in Chicago in Cook County Circuit Court.

Both companies have said that they weren't negligent and weren't responsible for the deadly reactions among patients.

The Illinois judge's ruling, dated Wednesday, involved a motion for partial summary judgment that named only Baxter. The motion was filed on behalf of two plaintiffs in the consolidated cases, one of whom died.

The ruling cites statements by Baxter's corporate quality vice president and the president of the company's medication delivery division that the heparin was defective.

Baxter argued in its defense that a jury should address the question of whether a product is 'unreasonably dangerous.' The company noted that the two Baxter executives who agreed in depositions that the heparin was defective aren't doctors or scientists. However, Judge Jennifer Duncan-Brice wrote that the issue before her wasn't whether heparin actually caused the death or injury to the plaintiffs, but just whether the product was, as a matter of fact, contaminated.

The most basic responsibility of a pharmaceutical company is to produce pure, unadulterated product.  As the current director of the US Food and Drug Administration wrote in this week's New England Journal of Medicine, the agency's "modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law, more than a quarter of a century in the making, that prohibited interstate commerce in adulterated and misbranded food and drugs."  However, in the 21st century, drug companies are increasingly failing to produce unadulterated products, and the FDA is having increasing difficulty assuring patients that the drugs they take meet even the most basic safety standards. 

I submit that corporate cultures increasingly influenced by the arrogant, greedy, amoral leadership of the financial services industry that lead us to the brink of another depression are also leading us to the brink of a poisonous era in health care.  Corporate leaders intent on cutting costs, and paying themselves as much of the resulting proceeds as possible, may see quality and safety as just another cost cutting target.  Corporate leaders brought up in the culture of finance, but untrained and inexperienced in engineering, science, and medicine find it all too easy to ignore quality and safety and focus on the bottom line.  (It is ironic that in the quote above, Baxter International's attorneys made light of the judgments of the company's own executives because they are not physicians or scientists.)

Meanwhile, society seems to have been so mesmerized by the mantra that laissez faire capitalism will lead to miraculous "innovation" that we do not even attend to instances in which it lead instead to death.

As we have said until being blue in the face, as long as the leaders of health care organizations are not held accountable for the results of their decisions on health care quality, cost, and access (even in such extreme quality violations as those resulting in multiple patient deaths), we can expect continuing decisions that sacrifice quality, increase costs, and worsen access, but that are in the self-interest of the people making them.


To really reform health care, we must hold health care organizations and their leaders accountable (and not blame all the problems on doctors, other health care professionals, patients, and society at large).

BLOGSCAN - This Book is Haunted

We have posted quite a bit about ghost-written articles, that is, ostensibly scholarly articles appearing in medical and health care journals with apparently prominent authors that were really written mainly by medical writers hired by companies to market particular products, usually drugs.  Now we hear of a case of a ghost-written book.  Our fellow bloggers have covered this well.  See posts here and here by Professor Margaret Soltan in University Diaries, and here on Inside Higher Ed; here by Dr Daniel Carlat on the Carlat Psychiatry Blog; here by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog; and here by Alison Bass on the Alison Bass blog.  Ghost writing is often an important component of stealth marketing schemes, and serves not only to deceptively market products, but to deceptively increase the influence and prestige of the "key opinion leaders" who enable the practice.  Be skeptical about the medical literature, and particularly skeptical by any academic who seems to have written more articles than would be humanly possible.

ADDENDUM (2 December, 2010) - As suggested by the comment below, see also posts here and  here on the 1BoringOld Man blog.  Also see an additional post by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

American Medical Schools Are "Only In It for the Money" Say Their Faculty

We recently discussed the plight of young medical faculty.  It appears that their plight is even worse than we imagined.

Last month, an abstract was presented at the Annual  Conference on Research in Medical Education at the Annual Meeting of the Association of American Medical Colleges, in a session entitled "Your Career is More than Your Specialty."  The citation would be: Pololi L, Ash A, Krupat E.  Faculty Values in the Culture of Academic Medicine: Findings of a National Faculty Survey.

The authors described a large survey, of over 5000 faculty at 26 US nationally representative medical schools, done as part of the National Initiative on Gender, Culture, and Leadership in Medicine (known as C ‐ Change) project.  The overall response rate was good (53%).   Here are the striking results:

51% agreed that 'the administration is only interested in me for the revenue I generate'; 31%; that 'the culture of my institution discourages altruism'; 31%, that other people have taken credit for my work'; and 30% that 'I am reluctant to express my opinion for fear of negative consequences.' Half perceived that the institution does not value teaching and 27% that it does not reward clinical excellence; Over half disagreed with the statement that their own values are aligned with those of the institution. Also, 30% had seriously considered leaving academic medicine and 46% their own institution, both in the prior year.

These results show that US medical education is in moral crisis, and probably close to catastrophe.  These results should provoke shame and outrage, and cause widespread discussion. On the other hand, it is remarkable that they were allowed to see the light of day at all, given the persistent strength of the anechoic effect.  Pololi and colleagues obviously never got the message that one is never ever supposed to discuss such things in public.

Instead of being about discovery and dissemination of knowledge, the fundamental mission of education, a majority of large sample of faculty surveyed says American medical schools are about making money.  Instead of putting teaching first, half of the faculty said their institutions explicitly do not value teaching. Instead of supporting free speech, free enquiry, and academic, a significant minority of faculty say that are afraid to speak out.

It is no wonder that nearly half of the faculty are considering leaving.

On Health Care Renewal, we have discussed evidence, mostly anecdotal, about the rot within the foundations of medicine and health care.  (Note, posts on conflicts of interest, often affecting medical school faculty and leadership, are here; we have posted about how academic medicine has often allowed suppression and manipulation of research;  posts on excessive compensation of health care executives, including those of academic institutions, not based on upholding the academic mission are here.)  Now it appears that the rot is so severe that the whole edifice is about to fall down.

Our foolish transformation of the calling and profession of medicine into a business (see posts here and here)  at a time when businesses were taken over by the arrogance, greed, unscrupulousness, and amorality that lead to the global financial collapse will surely also lead to a global health care collapse if something is not done very soon.

We need a new effort much bigger than but at least as influential as the Flexner Report to re-imagine academic medicine again as valuing teaching, learning, research and patient care, while regarding its financing only as the means to reach those ends.

The Carnegie Foundation sponsored the original Flexner Report, and the Rockefeller Foundation then hired Dr Flexner to reform medical education (see Mitka M.  he Flexner Report at the century mark:  a wake-up call for reforming medical education .  JAMA 2010; 303(15):1465-1466. Link here.) Will anyone or any organization have the courage to sponsor a new, bigger, and likely much more contentious effort?

Meanwhile, the academic leaders who have personally profited from and colluded with the transformation of the system into one that is only in it for the money should resign. The few remaining leaders will need to draw upon all their honesty, integrity, knowledge, and determination to rebuild the system.

Finally, shame on all of us for letting us get to this place.

With apologies to the late Frank Zappa and the Mothers of Invention.

The Economist, Information Privacy, Microsoft, and Technological Determinism: An Online Debate

At The Economist, an online "debate" entitled Health 2.0 has been posted (link). It poses a debate between two experts.

In this case, the debate is between Peter Neupert, Corporate vice-president, Microsoft Health Solutions Group, vs. Deborah Peel, MD, Founder, Patient Privacy Rights and leader of the Coalition for Patient Privacy.

The readers are asked to vote upon whether they agree or disagree with this statement:

This house believes that any loss of privacy from digitising health care will be more than compensated for by the welfare gains from increased efficiency.

Note the phrase "will be."

Readers are also permitted to post comments.

My response was as follows:

30/11/2010 19:16:26 pm

Dear Sir,

The premise of this entire debate is logically fallacious, in fact begging the question.

This statement implies proven or inevitable "gains" from health IT. This is far from certain.

Health IT such as electronic medical records systems and computerized order entry systems (CPOE) remain highly experimental medical devices. They are unregulated devices as well. Their effects on medical care can be toxic, and patients are exposed to these effects without informed consent. The "gains" attributed to them are increasingly doubted in a growing body of literature.

See

"Common examples of healthcare IT difficulties" at http://www.ischool.drexel.edu/faculty/ssilverstein/cases/

and

"2009 a pivotal year in healthcare IT"
at
http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc...

for exposure to some of this literature.

In essence, management information systems and other business computing-derived approaches, customs and traditions for software design, development and lifecycle have proven ill suited in healthcare. Clinical computing and business computing are conflated; yet, they are two fundamentally different subspecialties of computing.

Further, medicine is a scientific discipline, yet the approach to IT in healthcare has been nearly devoid of science and critical thinking.

Sacrificing privacy for a dream that may or may not be true is not good social policy.

In the aftermath of the latest Wikileaks disclosures, a scientific approach - such as assertions about the beneficence of IT in healthcare not being made without strong, robust scientific evidence and without consideration of the downside evidence not being proferred so freely - would be a fine start.

S. Silverstein, MD
Drexel University
College of Information Science and Technology
Philadelphia, PA USA.

I found the position of Peter Neupert (Corporate vice-president, Microsoft Health Solutions Group) defending the motion particularly concerning:

Consumers must trust that the organisations they are engaged with are accountable and will respect—and protect—the privacy of their data.

"Must trust?"

I find this remarkable in the context of repeated violations of "trust" I've noted at this blog such as at my posts:

• "Networked EMR's and Healthcare Information Security: Practical When Massive IT Security Breaches Continue?",

• "Networked, Interoperable, Secure National Medical Records a Castle in the Sky?",

• "Operation Aurora And a Widespread Reluctance to Discuss IT Flaws: Is Universal Healthcare IT Really a Good Idea in 2010?",

• "Medical data breach of the week - but your EMR data is secure, trust us, we're IT experts",

• "Insurers Test Data Profiles to Identify Risky Clients",

• and others.

Neupert's view is especially paternalistic and naive in the context of Wikileaks repeatedly and recently leaking hundreds of thousands of supposedly secure documents, stolen from U.S. intelligence by at least one known person and probably others. If the Pentagon and U.S. intelligence cannot keep information secure, how can lowly hospital IT departments?

The moderator's initial comments are also disturbing:

... Supporters argue that health information technologies have advanced to the point that such [security] concerns are vastly overblown. After all, do not financial data flow freely and with little incident over digital systems? On this argument, any loss of privacy will be more than offset by efficiency gains. In arguing for the motion, Peter Neupert of Microsoft, a software firm, insists that digital medicine must be centred on the patient—rather than, say, the doctor or the insurer, as is often the case today [this 'centered on the patient' meme sounds good, but what exactly does it mean? - ed.] —and that medical information must be as mobile as the patient. If that is the case, he argues, it is not merely the efficiency of health systems that will improve but also the value of health care—and perhaps health outcomes too.

MR VIJAY V. VAITHEESWARAN
Correspondent, The Economist

Note the statements of absolute certainty - "will be more than offset by efficiency gains", "will improve", etc. They remind me of the statements made in the NEJM by the Director of ONC, Dr. David Blumenthal, as I wrote at "Science or Politics? The New England Journal and The 'Meaningful Use' Regulation for Electronic Health Records":

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

On that I had commented:

Even though it is a "perspectives" article, I once long ago learned that in writing in esteemed scientific journals of worldwide impact, statements of certainty were at best avoided, or if made should be exceptionally well referenced. I note the lack of footnotes showing the source(s) of these statements.

The meme of technological determinism, that computerization in medicine is synonymous with, and will deterministically provide "improvements", no matter what the evidence, is quite concerning coming from a company as profoundly large and influential as Microsoft.

Further, the complete omission of consideration of the adverse clinical consequences (let alone mere information breaches) that may occur along the way to cybernetic utopia in healthcare is very disturbing. These are experimental medical devices, are unregulated, and are used without patient informed consent. Yet the IT industry seems to opine as if these systems are only to be used on experimental lab rats.

These systems produce "legible gibberish" of no clinical use to clinicians, but take clinician time to generate through distracting "clickorrhea." For example, just the placement of an IV and fluid infusion generates a half page of nonsense:

Actual "legible gibberish" from an ED EHR report, major health IT vendor. Half a page on how an IV was started and a saline infusion given. (How many distracting clinician mouse clicks did it take to produce this?) Click to enlarge.

Addendum 12/8/10 - From "Hidden Malpractice Dangers in EMRs", Steven I. Kern, Esq., Medscape.com:

Too Much Information

... Pages of repetitive documentation can be more time-consuming to review than brief, handwritten notes. When important information is embedded in paragraphs of boilerplate, it can easily be overlooked. The chance of missing critical data increases.

Overlooking important information is, of course, a significant cause of malpractice. A positive finding embedded in a string of negative findings can easily be missed.

Ironically, my own mother was injured as a result of EHR-related disruption not long ago. Further, just the initial two and a half weeks of hospitalization generated more than 2,800 laser printed pages of "legible gibberish" (which cost just under $1000 to obtain; Kinko's should only have it so good).

A fellow physician I know well related:

From: [redacted name of MD]

Good Lord! I am so sorry to see this and hope your Mom gets better. You must be furious.

May I add to the cacophony? My wife went to [another local hospital's] ER for emergency transfusion. Their Emr displayed someone else's info under her name & SSN. Had I not been there she would have received incorrect treatment.

My wife went to [yet another hospital] for hip replacement. After surgery, while she slept off her anesthesia, a nurse came in and started injecting her. I asked and learned it was insulin. I stopped the nurse (with difficulty). My wife's not diabetic. Her screen showed someone else's orders. Had I not been there she might have died.

So keep up the good work... please!

[redacted name of MD]

How many other patients have been injured or killed as a result of EHR's?

In fact, we really don't know how many adverse events related to EHR's occur. As the Joint Commission itself admits in its Sentinel Events Alert #42, Safely implementing health information and converging technologies: "There is a dearth of data on the incidence of adverse events directly caused by HIT overall." I further wrote on this issue in a paper "A Dearth of Data on Unintended Consequences of Healthcare IT" here.

Is this a proper environment for national rollout of these clearly experimental medical devices, one should ask?

The memes of technological determinism and health IT "white-as-driven-snow" beneficence seem as difficult as vampires to eradicate.

Yet if this technology is to achieve the benefits of which it is capable via remediation of current IT industry customs, traditions and practices, these memes must be challenged and defeated.

Regarding health IT in the real world, reality matters.

-- SS

A Confidentiality Clause or an Oath of Fealty?

The advancement of modern scientific medicine depends on the search for and dissemination of truth. Academic medicine, like the rest of academia, ought to be based on openness, transparency, and academic freedom. The 1940 American Association of University Professors (AAUP) Statement of Principles on Academic Freedom and Tenure opened with:

The common good depends upon the free search for truth and its free exposition.

Yet we have written about dark clouds of secrecy spreading over medicine and health care. The increasingly powerful leaders of health care increasingly use opacity and secrecy to keep what they are doing out of the public eye. We have frequently discussed the anechoic effect, how it is just not done to discuss certain topics, particularly those related to the adverse effects of bad (ill-informed, incompetent, self-interested, conflicted, or corrupt) leadership and bad (opaque, unaccountable, mission-hostile, unethical) governance of health care organizations.  People may feel it is unseemly to speak badly of renowned institutions such as hospitals and universities.  People with conflicts of interest may not be inclined to criticize those who pay them.  Now people employed by contemporary health care organizations may have to pledge theri silence to keep their jobs.

The latest story in this regard comes from Virginia Commonwealth University (VCU), which includes VCU Health Systems, and MCV Hospital and Physicians.  (Full disclosure: I was a VCU full-time faculty member from 1987-1994, and still am on the adjunct faculty.)  In 2008, the VCU President resigned after the university's secret research contract with a tobacco company, and the President's own position on the board of directors of another tobacco company were revealed (see blog post here and others here).

Michael Rao, the President since 2008, is now under outside review after it was revealed that he required his staff to sign a secrecy pledge.  The story appeared in the Richmond Times-Dispatch:

Virginia Commonwealth University President Michael Rao asks employees who work in his office to sign an unusual confidentiality agreement that bars them from talking about what they observe about him or his family.

The prohibition goes beyond the standard agreement that university employees sign acknowledging that they can't disclose personal or proprietary information.

The agreement, a copy of which was obtained by the Richmond Times-Dispatch, covers interactions at Rao's office and at his residence. It bars disclosure not just to the news media, family or friends, but also to colleagues, 'clergy and attorneys, or to any other person not otherwise identified.'

'I agree that any such disclosure in violation of this nondisclosure agreement could result in irreparable damage and harm to VCU, President Rao, and/or his family'" the agreement states. 'Any such violation or anticipated violation' would entitle Rao to seek 'injunctive relief' in Richmond or Henrico County circuit courts.

VCU spokeswoman Pam Lepley said she could not comment immediately yesterday.

Several current or former employees of the president's office confirmed that they had been asked to sign the agreement, including Kimberley Busch, Rao's former scheduler.

She described it as a 'what happens in the president's office stays in the president's office' agreement.

The newly uncovered confidentiality clause provoked strong criticism:

Raymond D. Cotton, a Washington attorney who specializes in higher-education governance, said such a confidentiality agreement is highly unusual and goes against the culture of openness and transparency in higher education.

'There is this concept of academic freedom that is broader than the First Amendment,' he said.

In fact, since Virginia Commonwealth University is a state-supported institution, the confidentiality clause may be unconstitutional, as reported by WTVR:

Kent Willis with the Virginia American Civil Liberties Union said the agreement doesn't pass constitutional muster.

'A public employee, no matter where they are in the government, has a right to speak out on matters of public concern,' Willis said. 'That's a U.S. Supreme Court case, it's guaranteed to every public employee by the First Amendment to the Constitution.'

Willis said there are numerous legal issues raised by the contract. But, he said, the bottom line problem with the contract 'is the attitude. This is a contract that says 'I'm not transparent. I don't want you to know what is going on. I'm running a closed shop.''

Times-Dispatch columnist Michael Paul Williams wrote:

VCU, we have a problem. This confidentiality agreement does not inspire confidence. The lack of transparency only gives the appearance that someone's hiding something.

He also further quoted Kent Willis:

Rao's contract 'fails to address this whistle-blower right and could create conflicts for employees, who are silenced by the employment contract,' yet have a constitutional right to speak out on some matters, Willis said.

And as Willis points out, even if a person's constitutional right trumps the contract, how many employees are willing to take that risk?

'Particularly disturbing is the prohibition against talking to an attorney,' he said. 'If an employee believes something illegal is going on at work, an attorney is precisely the person he or she should be talking with.'

We just posted about how a pharmaceutical company included a confidentiality clause in a consulting contract, suggesting the deliberate creation of a conflict of interest in order to prevent criticism of the company's products or practices. 

However, in several ways, the present example is more insidious.  First, it involves a university, whose mission is to discover and disseminate the truth.  Thus, as noted above, the confidentiality agreement subverts the university's core mission.  Second, it was required of full-time employees who wanted to keep  their jobs, making choose between secrecy and unemployment.  Third, it was particularly harsh, addressing incipient as well as actual disclosure, and including injunctive relief as well as the threat of  termination.  Fourth, it protected not just the organization and its products, but personally protected the organization's leader and his family.  It was not just a contract, but an oath of fealty, as if the CEO were nobility, or even royalty.

The good news is that this confidentiality agreement now sits in the glare of sunlight.  One does wonder, however, how many other such agreements are already in force so that the would be nobility who now run too much of health care to avoid any embarassing revelations about what their leadership really is about.

We are a long way from the transparency that true health care reform requires. 

Citizen Journalism: Why I Blog on Healthcare Informatics

I am teaching my current students about alternate media, a.k.a. citizen journalism, also known as "blogging", in a course on organizational and social aspects of healthcare informatics.

I am using a (de-identified) personal experience as an example of why alternate media is valuable in getting "inconvenient" memes into circulation.

In addition to recent articles such as "The Problems with Peer Review" (in the British Medical Journal by Mark Henderson, Science Editor, the Times, London. BMJ 2010;340:c1409), "Ghostwriting at Elite Academic Medical Centers in the United States" (LaCasse & Leo, PLoS Medicine, February 2010, Volume 7, Issue 2) and others about ghostwriting and other ills affecting the conventional biomedical literature, I provided my students the personal example below.

I thought the example might be interesting to blog readers as well.

Here is the example I used with my students:

Regarding a paper I wrote a few years ago and that I ultimately simply posted on Scribd, "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT" (link), an anonymous peer reviewer had this to say when I submitted it to "journal XYZ":

Comments to the Author

This paper addresses a potentially important issue but adds little that is new or that goes beyond what a reader might find in a major city newspaper. Proposing a classification of sources of UC and analysis of reasons for undereporting of each type in the resulting classification could be a useful addition to the field.

This was certainly an ironic if not bizarre comment. A paper on a scarcity of data on unintended consequences of health IT due to a "closed culture" in the HIT industry does not add anything new "beyond what one might find in a major city newspaper?"

Unfortunately, the anonymous peer review process does not allow me to ask what newspaper this reviewer reads, but it was clear to me this reviewer was 1) attempting to prevent the paper's publication and 2) "moving the goalposts" to delay it or have the focus on scarcity removed by seeking for me to "propose a classification of sources of UC" (tangential or even irrelevant to the paper's topic).

I felt it likely the review of a revised paper by this reviewer would have led to negative comments on any proposed classification schema.

Worse, was this, in a dialog via several emails I've condensed for readability. It is very likely it came from the same reviewer above:

EDITOR OF JOURNAL XYZ: I suggest Scot that you modify this into an editorial. One reviewer recognized the writing and asked me if this may have been pre-published on a blog. Any possibility for that?

In other words, I was being accused by the anonymous reviewer of possibly violating the ethics of journal publication and the contract I signed to not pre-publish (the journal has exclusive rights).

My response:

SS: No, this work was entirely original, written from a clean slate, and was not pre-published on a blog. I would think the reviewers would know me better than that in terms of integrity.

The editor shot back:

EDITOR: My response as well. Good - looking forward to the edits. Happy snow day

I reminded the editor:

SS: Not to mention the extensive footnotes showing where I sourced my material. In an age of search engines, I have to ask the following:

- was the person who raised this concern so technologically limited they were unable to search themselves to answer their own question?
- did this person have such a lack of trust they felt compelled to make such a statement?
- did this person raise this due to bias against the fundamental thesis of the paper?

I think it's fair to say there is very, very strong pushback against articles such as this being published. I have to consider whether it's worth my while to continue, or to withdraw the paper.

At which point I received the following revealing comment from the editor:

EDITOR: I think, Scot, that you have a talent for sniffing out problems, dangers, risk, failures and by addressing them in your head on ways, you are likely to make enemies. You are doing a valuable job, but you have to realize that people are threatened by you. That's why the respond in this manner. Not that it is excusable, but it is understandable.

I decided it was not worth revising the paper due to that reviewer's comments and the editor's observations, and therefore disseminated the paper via the Healthcare Renewal blog and Scribd.

(I note that "making enemies" by directly confronting possible risks of a new technology in healthcare suggests skewed priorities among those so affected.)

While I believe the current Wikileaks web exposures have gone insanely too far, as those incidents involved exposure of sensitive material held illegally that could people to be harmed, damage international relations, and cause other unforeseen ill effects, the web has proven valuable for dissemination of one's ideas that have not been able to escape the gravity of the sometimes "peer review Black Hole."

-- SS