Those Goddamn Plaintiff's Trial Lawyers Are to Blame for EHRs That 'Tattle' on Doctors - And Harm Patients

It seems the EHR technophiles are starting to notice one of the side effects of EHR technology: the liabilities EHRs impose on users.

Interestingly, those liabilities are presented below as the fault not of a cavalier industry receiving extraordinary governmental and regulatory accommodation compared to other healthcare sectors that, among other issues, have allowed it to (see hyperlinks for more information):

• Disregard practices of good software engineering, product safety and human factors issues (usability),
  
• Ignore tenets of good information presentation yielding literal reams of 'legible gibberish' masquerading as medical records that confuse attorneys on both sides of the Bar as well as clinicians,
  
• Flout proper conduct of human subjects experimentation e.g. without informed consent,
• Avoid appropriate methodologies for medical device trials (all the while promoting the data these devices generate as 'revolutionizing healthcare'),
• and more as covered on this site and at my Drexel University educational site at this link.
  

Instead, the liabilities are presented as the fault of plaintiff trial lawyers, who need to be disempowered through yet another special accommodation for health IT.

My comments are interspersed in [red italics]:

Feb. 8, 2012
The Wall Street Journal
MarketWatch
Healthcare IT Expert Exposes Hidden Risks of Lawsuits Due to Electronic Health Record

Spokesperson Says Electronic Health Records May Give Crippling Access to Physician's Actions and Increase the Need for Defensive Medicine

[Crippling access to physician's actions? That is an odd combination of terms - ed.]

DELRAY BEACH, Fla., Feb 8, 2012 (GlobeNewswire via COMTEX) -- Since the American Recovery and Reinvestment Act (ARRA) passed in February 2009 and caused a digital tsunami in the healthcare industry, physicians have been scrambling to comply with the requirement to switch to electronic health record systems. (EHRs) While many in the healthcare industry laud the use of EHRs to improve quality of care and analyzing patient outcomes, Dr. Sam Bierstock, founder of Champions In Healthcare, points out significant concerns regarding increased vulnerability to medical legal claims that may result from the use of EHRs without major tort reform that would relieve physicians of an onslaught of malpractice suits.

"EHRs unquestionably have the potential to improve patient safety and the quality of care delivered, but what few people realize is that using an EHR exposes physicians to an Orwellian level of analysis of every single act while doing their job," said Bierstock, who has advocated and pioneered the use and benefits of EHRs for more than 30 years." EHRs, however, can also be audited to examine how long it took them to act after an abnormal lab result came in, if the doctor checked on on-line references before making a clinical decision, what was said in every email and how long the doctor took to respond, and even how long the doctor looked at a screen or scrolled down to read an entire document.

[Why, exactly, this is a bad thing, I do not understand; it seems hypocritical. After all, any data collected that can help improve healthcare has been deemed golden - up to now - ed.]

Physicians are exposing themselves to an unacceptable level of scrutiny and analysis of their use of computers that may serve to encourage malpractice suits.

["Unacceptable level of scrutiny" is largely a code phrase for audit trails and other 'metadata', i.e., automatically generated computer data that shows who accessed or modified a document or other data, when, from where, etc. I ask - access to this data is unacceptable to whom? Injured patients? - ed.]

Meaningful tort reform is essential to getting the maximal benefit from these wonderful systems.

[Wonderful systems, when even the IOM admits we don't know the level of harm they cause, the NIST indicates they are poorly usable, and so forth as here? - ed.]

According to Bierstock, the problem runs even deeper because during his career as an industry consultant with Champions in Healthcare, and as a speaker at healthcare events he has noticed that the vast majority of physicians are still not aware of the complex requirements imposed upon them by the Health Information Technology for Economic and Clinical Health (HITECH) Act even though it has been a law for more than two years.

[I agree with the statement "imposed upon them", but this imposition was largely at the hands of the HIT pundits, the 'Ddulites' (technophiles who ignore technology's downsides, the opposite of 'Luddites', link), and various species of non-medical profiteers - ed.]

"I talk to many physicians who have no idea they can suffer financial, civil and even criminal penalties (i.e. jail) for non-compliance.," said Bierstock. "I have been asked to speak about this topic many times, but beyond HITECH, it's my opinion that similarly, doctors and hospitals don't yet fully realize their medical legal vulnerability associated with the use of EHRs.

[They will learn, fast, with Medical Informatics specialists such as myself on patients' side instead of on the side of the health IT industry - ed.]

This will be the case until there is major tort reform, which has unfortunately been thwarted by the influence of American Trial Attorneys and their associations."

[You see, it's all the fault of the evil Plaintiff's Bar - ed.]

Bierstock noted that in an effort to stimulate physicians and hospitals to install and use EHRs, The American Reinvestment and Recovery Act of 2009 also authorized the Centers for Medicare and Medicaid Services (CMS) to issue guidelines which define what is "Meaningful Use" of an EHR - guidelines which must be met in order for hospitals and doctors to receive financial incentive payments for using EHRs, or be penalized by having Medicare or Medicaid payments reduced for failure to meet the guidelines.

[Unfortunately, they did not formulate guidelines for safety. Thus, as Sharona Hoffman, JD notes in MEANINGFUL USE AND CERTIFICATION OF HEALTH INFORMATION TECHNOLOGY: WHAT ABOUT SAFETY?, "General system safety is a property that is attainable only through rigorous processes for development and evaluation. However, the regulations do not address certification of EHR vendors’ software development processes or even require vendors to analyze and mitigate potential safety hazards. Furthermore, ATCBs will use testing requirements developed by the National Institute of Standards and Technology (NIST) that are apparently intended only to determine whether systems include certain features. Passing such tests is not sufficient to ensure that those features function properly in the long term and under varied operating conditions." - ed.]

Bierstock believes that if physicians are expected to embrace EHRS, they should be allowed to do so in a manner that maximizes the benefits of these systems to the delivery of care and to the benefit of their patients without worrying about giving unlimited ammunition to trial lawyers.

[Perhaps the EHR pundits should have foreseen this eventuality before pushing the current administration to mandate national EHR rollout. It didn't take a rocket scientist to do so - ed.]

"Quite simply, physicians may be in a situation that leaves them vulnerable to litigation and threatens loss of their professional standing and personal assets -- all because an external evaluator [e.g., a trial lawyer, judge or jury -ed.] may not think the physician lived up to arguable standards in the digital age," said Bierstock. "Overall, EHRs are the litigator's proverbial golden goose. They are to malpractice attorneys what the electron microscope is to microbiology."

[In other words, EHRs deserve yet another special accommodation, this time regarding legal Discovery, in addition to the many other special accommodations this industry has received. In fact, EHRs make available only that which they are designed to, and discoverability of that information is a Federal matter under the Federal Rules of Civil Procedure (FRCP) governing e-discovery - "On December 1, 2006 the Federal Rules of Civil Procedure were revised to address numerous e-discovery issues. Rules 16,26,33,34,37 and 45 require attorneys to pay specific attention to electronic discovery issues. E-Discovery practices and strategies need to be reviewed and aligned with the updated rules to ensure compliance." - ed.]

I find requests for additional special accommodations for EHR's over other medical devices and IT in other industries (e.g., airplane black boxes and cockpit recorders that monitor the every move of pilots) to be illustrative of the concept "be careful, you may get what you wish for."

That plaintiff trial lawyers are blamed for quite properly using the Federal Rules of Civil Procedure to assure justice for victims of medical malpractice, including EHR-related medical malpractice, is outrageous.

It seems the pundits might be starting to panic, after realizing the "data utopia" that is going to "revolutionize medicine" has a downside.

-- S. Silverstein, MD

Feb. 14, 2012 Addendum:

It seems the clinical data itself generated by today's health IT - garnered while putting patients at risk and costing many billions of dollars - might not be anywhere near as trustworthy as advertised by the technophiles.

See "It Seems We Are Not The Only Ones Bumping Up Against EHR Data Quality Issues. PCEHR Implications Are Worth Considering" at the Australian Health Information Technology blog by Dr. David More, MB PhD FACHI, and the JAMIA articles he references.

Dr. More observes:

... If ever there was an example of “garbage in, garbage out” in operation this has to be it. There has to be a great deal of care taken as we move from the most simplest data sharing to more complex efforts.

-- SS

"The Banks Can Do It, Why Can't Hospitals?"

I have often heard the refrain that while away from one's home in Terre Haute, one can withdraw money from an ATM machine in Timbuktu. So, why can't my medical records from birth be called up instantly from the Timbuktu Regional Hospital if I fall unconscious at the Festival au Désert and forgot my wallet?

In other words, computing in the banking industry is perfected, so why can't healthcare get its act together? (Irrespective of the sea change of difference between simple financial data and incredibly complex medical data.)

Not so fast, health IT Ddulites:

New York Times
February 9, 2012
Users of Citibank Bill-Pay App Charged Twice
By BEN PROTESS

A program error at Citibank was not detected for months.

Citigroup’s effort to become “the world’s digital bank” has encountered a snag. ["Glitch" is the health IT-specific term - ed.]

A technical bug caused Citi, the nation’s fourth largest bank by deposits, to double the charge for customer payments in recent months. Some customers using their iPads to settle their cable bill or mortgage payment, for example, actually paid twice, according to customers and a bank official.

The problem, which began in July but went undetected by the bank until December, prompted bogus payments big and small. Some customers quickly spotted the redundant transaction and complained to Citi, while other consumers were caught off guard when the bank recently notified them of the discrepancy. The snag even led some unsuspecting customers to overdraw their accounts, though a bank spokesman said that was rare.

Citi has traced the error to its nascent iPad application. Other mobile applications and the bank’s broader online bill payment system were immune from the problem, the bank said.

But a few clients who were charged twice said they had not used an iPad to pay bills. And the Citi spokesman declined to disclose the number of customers caught up in the mishap, saying only that it amounted to “a limited number of clients.”

[It would appear that Citi was not in complete control of its systems; the systems were in control of Citi - ed.]

Instead, the spokesman said that fewer than 2 percent of Citibank transactions executed through an iPad were counted twice. The spokesman would not elaborate on the number of iPad transactions at Citi, citing concerns about releasing proprietary data.

[2% of a very large number is still a large number - ed.]

... While Citi may be the first company to stumble with the iPad, it is far from the only bank to encounter electronic hiccups. Customers have long been befuddled by accidental A.T.M. withdrawals and so-called transaction gaps, where a customer pays online but the transaction fails to process. A number of regional banks have also double-dipped with customer payments and even JPMorgan Chase, the nation’s biggest bank, recently had a minor brush with duplicate online withdrawals.

The mishaps, while minor, underscore the risks that customers face when banks wade into the fledgling world of online banking.

[That's peanuts compared to the risks they face when hospitals wade into the fledgling world of electronic medical records and CPOE - ed.]

While banks are scrambling to please customers who prefer clicking a mouse to dealing with tellers, the industry is learning that new technologies come with some growing pains.

“It’s a challenge for banks to keep up with the device proliferation — everything is moving very fast,” said David Albertazzi, a senior analyst with Aite Group, which advises financial institutions on technology and regulatory issues. “It is very important that financial institutions balance speed-to-market versus safety and soundness.”

[Healthcare seems immune from that wise caveat. 'Full steam ahead, icebergs be damned' seems the siren call for IT in that domain - ed.]

... Last year, JPMorgan Chase owned up to its gaffe, a technical hitch with an online cash transfer system, within a day. “People make mistakes. Unfortunately, we made one twice,” Ryan McInerney, Chase’s chief executive of consumer banking, told customers, who received a $25 cash bonus for their troubles.

[Every excuse term in the book's been used here - growing pain, hiccup, snag, bug, hitch, flaw - except one - 'incompetence' - ed.]

Citi’s response, however, appears to have been not nearly as prompt. The error began in July, within days of the bank introducing its gleaming new iPad application. The coming-out for the application included a press release announcing the “new standard for digital banking” with a “one-of-a-kind app.”

... “EBusiness professionals at retail banks — and other financial institutions — should pay close attention to what Citibank has done, particularly its willingness to experiment and try out new ideas in a brand-new channel,” Forrester Research, a technology research company, said in a report.

[Healthcare IT is a big experiment, except it's not just dollars and cents that can get farkled - ed.]

But almost immediately, a smattering of anonymous customers began posting concerned comments online, wondering whether it was their own fault — the product of double-clicking. Then fingers began to be pointed at the bank. One online commenter posting on the company’s Apple store Web site called the application “very unreliable.”

In late December, the bank tracked the error to an internal flaw. A technical command on the bank’s iPad application, it turned out, was wrongly set to redo transactions that had initially failed.

The bank began alerting customers to the snag in mid-January, and made another round of calls this week, including to clients who say they had not paid their bills through the iPad.

... Citi has had other technology problems in the last year. Last summer, the bank disclosed that hackers had stolen the names and addresses of hundreds of thousands of North American credit card customers. A week later, the bank revised its estimates, saying that about 80 percent more customers had been ensnared than previously thought.

The breach, which did not include Social Security numbers or security codes, was a lesson for Wall Street firms. Big banks, experts say, are now more reluctant to estimate the scope of a problem in case the numbers grow.

“It’s very challenging to really pinpoint the number of customers affected,” Mr. Albertazzi said. “It’s the nature of the beast.”

If these growing pains, hiccups, snags, bugs, hitches, and flaws are the "nature of the beast" in electronic banking systems, one can only wonder why banking is held up to be the "gold standard" that healthcare has to equal.

Healthcare has a long tradition and obligations to implement new technologies with the greatest of caution and care, using clinical trials based on the scientific method, and with informed consent. Banking lacks such traditions. The healthcare IT industry has largely abandoned them.

While a bank's computing may make a mistake with a decimal point, a hospital's computer errors can injure or kill people.

The current rush to universal health IT needs to slow down. Further, HIT industry pundits need to stop making comparisons to other industries that are both irrelevant and unwarranted.

-- SS

The Texas TMAP Trial as Illustration of a Systematic Stealth Marketing Campaign

Before it was abruptly ended by a sudden settlement for $158 million, the trial in Texas of a suit alleging unethical marketing of the drug Respirdal (risperidone) by the Janssen subsidiary of Johnson and Johnson opened yet another window on organized stealth marketing campaigns in health care. (Note that we first discussed this case here in 2006, and that this trial and the case was ably covered in detail on the 1BoringOldMan blog.) 

Even so, given all the recent attempts to dismiss critics of the pharmaceutical industry as "pharmascolds," (e.g., here), and to otherwise uphold the current status quo in our dysfunctional health care system, I thought it would be useful to rediscuss this case to show how systematic stealth marketing threatens the ideals of rational, evidence-based health care.

Evidence-based medicine may simply be viewed as medicine based on evidence and logic tempered with humanity. A slightly longer definition is practice based on the best evidence from clinical research derived from systematic searches, critically reviewed, used to maximize individual patients' benefits and minimize their harms according to their values.

In contrast, brief summaries of sworn testimony during the trial, and of a key report by an expert witness suggested how a commercial health care organization, in this case, the Jennssen subsidiary of Johnson and Johnson, could organize a stealth marketing campaign to promote practice based on deception and falsehoods, entangled in illogic and emotional and psychological manipulation. This was all done to market a product which could not so easily be supported by evidence and logic.

Deception and Falsehoods: Suppression of Medical Research

A Bloomberg report of the last day of the trial showed how the Respirdal stealth marketing campaign used the now classic mechanism of suppression of medical research:

Johnson & Johnson officials hid three studies showing some patients using Risperdal developed diabetes while claiming the antipsychotic drug didn’t cause the disease, a witness testified.

As early as 1999, Johnson & Johnson’s Janssen unit had researchers’ findings that about half the patients taking Risperdal in a study comparing its risks to those of Eli Lilly & Co.’s Zyprexa antipsychotic drug developed diabetes after a year on the medication, Joseph Glenmullen, a psychiatrist and Harvard Medical School instructor, told a Texas jury yesterday.

That study concluded Risperdal caused 'medically serious weight gain' that led study subjects to develop diabetes, Glenmullen testified in the trial of the state of Texas’s lawsuit over Janssen’s marketing of the drug. At the same time, Janssen salespeople were telling doctors that researchers concluded the drug didn’t cause the disease, Glenmullen added.

In particular,

Glenmullen, testifying as an expert for the state, told jurors Janssen officials didn’t turn over Study 113, which found Risperdal posed a higher diabetes risk than Zyprexa, to the U.S. Food and Drug Administration when regulators began probing links between anti-psychotic medications and the disease in 2000.

The drugmaker also didn’t turn over the results of two other later studies that found Risperdal and Zyprexa posed comparable diabetes risks to the FDA.

Suppression of research is a severe threat to evidence-based medicine because it can severely bias the clinical evidence base on which it depends.
Deception and Falsehood: Ghostwriting

A summary of the 86 page report by Professor David Rothman commissioned by the Texas Attorney General published in the Houston Press provided this example of ghostwriting:

A member of J&J's Speakers Bureau, [University of Texas Professor of Psychiatry Dr Alexander] Miller collected at least $82,000 from Janssen and its contractors. He declined to comment for this story, saying he may be called as a witness in the lawsuit.

Miller was a 'guest author' for one of Janssen's ghostwritten articles. Upon receiving the manuscript, Miller wrote, 'Yes, I am happy to be included as a co-author. I made a few minor edits and comments in the manuscript.'

In addition, another article in the Houston Press summarizing the issues before the trial provided this overview of the ghostwriting process:

As described in the AG's expert witness report, a company called Excerpta Medica was hired to draft some of Janssen's Risperdal articles.

In 2003, according to Rothman, Excerpta Medica issued 'Risperidone Publication Program Status Reports,' indicating that 30 of the 145 articles to be published had authors listed as 'to be determined.'

Rothman also examined what he considered a signature ghostwritten piece meant to boost Risperdal's pediatric profile; the study is included in the 2010 parameters.

Rothman cited a barrage of e-mails between Excerpta Medica and J&J in crafting the article. At one point, an Excerpta Medica employee wrote, 'It would be very helpful to receive some guidance in relation to the flow, format and subject in this paper and whether you think this is too marketing oriented or not, in order to prepare a next draft. Besides that we would like [to] have some suggestions for external authors on this paper. Maybe [a] U.S. and a European KOL? Your input will be much appreciated.''

The article eventually appeared in a 2007 volume of the European Journal of Child and Adolescent Psychiatry. For a lead author, J&J scored a heavy hitter: Dr. Peter Jensen, former associate director of child and adolescent research at the National Institute of Mental Health, and the founding director of the Center for the Advancement of Children's Mental Health at Columbia University. Now with the Mayo Clinic, Jensen declined to comment for this story.

This indicates the scope of this particular ghostwriting initiative: 145 articles were planned.  Thus, ghostwritten articles could comprise a major proportion of the apparently scholarly literature relevant to Risperdal.  Ghostwriting is fundamentally deceptive because it allows marketing to appear in the guise of scholarly work.  Ghostwritten reviews can deceptively shift the focus from the questions that need to be addressed by the evidence-based process to benefit patients to those whose answers would benefit marketers.


Deception and Falsehoods: Key Opinion Leaders
Emotional and Psychological Manipulation: Creation of Conflicts of Interest

An important element of most stealth marketing campaigns is the creation of key opinion leaders.  These are academics or professionals who can promote products in the guise of unbiased expertise. 

A summary of the 86 page report by Professor David Rothman commissioned by the Texas Attorney General published in the Houston Press provided the example of Dr Steven Shon:

As the head of the state's mental health agency, Shon was perhaps Janssen's most crucial key opinion leader; his influence in pushing ­Risperdal was invaluable.

He accepted at least $47,000 from Janssen and its medical ghostwriter, Excerpta Medica, and signed an agreement to be a member of Johnson & Johnson's Speakers Bureau. Rothman writes, 'The medical director of the state's mental health agency should not be serving as an official spokesperson for a pharmaceutical company whose product state agencies are purchasing.'

The company paid for his trips across the country, and even overseas, to promote ­Risperdal as a safe and effective medication. (But the romance between Janssen and Shon was not without its bumps; Shon would get 'upset' if the checks he accepted from Janssen were made out to the MHMRA instead of directly to him. Apparently, those were more difficult to funnel into his personal account.)

Shon retired in 2005, allowing him to collect his taxpayer-funded pension. He moved to Las Vegas, where he's the director of psychiatry for a mental health and substance abuse clinic called Harmony Healthcare.

Shon was so influential that Janssen grew paranoid and possessive when it learned that other companies sought his partnership as well. When J&J employee Yolanda Roman heard that Eli Lilly had flown him to their headquarters on a private jet, she wrote, "Steve I suppose is enjoying the vast attention and response he can command from Industry...Obviously, Steve has the right to be served by all Industry, let's hope he remains fair [and] balanced and remembers who PLACED HIM ON THE 'TMAP' MAP."

Meanwhile, another employee busted out the caps-lock to warn that "WE WILL NOT LET LILLY OR PFIZER PREVAIL WITH OUR MOST IMPORTANT PUBLIC SECTOR THOUGHT LEADER."

Similarly, a Bloomberg report of Dr Shon's trial testimony included:

Johnson & Johnson’s Janssen unit paid a Texas mental health official to speak around the U.S. about state guidelines on prescribing antipsychotic drugs that gave preference to medicines like the company’s Risperdal, the official said.

Steven Shon accepted honorariums to fly to Arizona, Florida and New Jersey to discuss Texas guidelines developed in 1999 advising doctors that a newer class of drugs like Risperdal were a “first choice or option” for schizophrenia, he testified today in state court in Austin.

Also,

Attorneys for Jones questioned Shon, who served as medical director of the Texas Department of Mental Health and Mental Retardation until he involuntarily retired in 2006.

Shon testified that he served on Janssen advisory boards, was a board member of a Janssen publication called 'Mental Health Issues Today' and was a continuing medical education speaker in programs sponsored by the company.

Shon was asked about six trips in which he got honorariums of $3,000 from Janssen to discuss the TMAP project. In several cases, he kept those payments, he said.

In testimony yesterday, a Texas Medicaid investigator said Shon signed several consulting agreements with Janssen, and the company paid him $47,587 over several years.

Dr Shon's value to Janssen derived from his position as the respected leader of the state's mental health agency. While he was apparently paid by Janssen marketers who saw him as an ally, his marketing was all the more effective because it seemed to come from an unbiased expert. As such it was deceptive.

The Institute of Medicine report on conflicts of interest defined them as "a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest." The report, and indeed much of the discussion of conflicts of interest in health care assumes that most secondary interests are "-within limits - legitimate and even desirable goals." For example, an academic physician who also was a basic scientist could be paid by a pharmaceutical company to do a specific assay on samples used in research. In that case, the payments could conceivably create a risk that the academic's professional judgment in a clinical setting would be unduly favorable to the products of the company. However, the relationship hardly seems intended to cause such a bias. Notions that conflicts of interest are "inevitable" but "manageable" may stem from consideration of conflicts of interest like this.

However, conflicts of interest deliberately created as perverse incentives may be much more consequential, and as this example shows, perhaps not rare. It appears that Janssen paid Dr Shon not to do some task that was unrelated to how he fulfilled his primary entrusted responsibilities as director of mental health, but in order to influence how he fulfilled them. We have noted previous examples in which corporate marketers consider paid key opinion leaders as sales people (see posts here and here). Such conflicts are deliberately created so that the recipient of payments uses his or her entrusted responsibilities to serve the vested interests of the payer may be deceptive, as noted above.  Furthermore, by being intended to induce changes in how the payee performs his or her primary responsibilities, these conflicts are particularly likely to lead to abuse of these entrusted responsibilities. Given that the Transparency International definition of corruption is abuse of entrusted power for private gain, we need a new and more incisive term to described this variety of conflicts of interest.

The motivation of key opinion leaders by created conflicts of interest can result in powerful manipulation of the key opinion leaders, but more importantly of their audience. 

Emotional and Psychological Manipulation: Intimidation

Another Bloomberg report included testimony about how someone who attempted to blow the whistle about the Respirdal stealth marketing campaign was intimidated:

Allen Jones testified yesterday in state court in Austin, Texas, that he was an investigator in the Pennsylvania Office of Inspector General in 2002 when he looked into an unregistered bank account run by Steven Fiorello, the pharmacist. Fiorello was on a Pennsylvania committee weighing whether to require doctors to give priority to newer, more expensive drugs like Risperdal in state-funded treatment of mental-health patients, Jones said.

Jones, 57, said he found a $4,000 check from J&J’s Janssen unit to Harrisburg State Hospital that was sent “\'to the attention of' Fiorello. The check covered a Fiorello trip to New Orleans to discuss Pennsylvania’s drug guidelines. Another check for $1,766 to the hospital account was sent 'in care of' of Fiorello, Jones said. Fiorello controlled the account and didn’t register it with the state, Jones said.

'The account was used to deposit money from drug companies,' Jones said yesterday in the trial’s third day of testimony. 'There were real problems here. On many levels, the account was improper.'

Janssen also paid $2,000 directly to Fiorello as an honorarium for his speaking at a company-sponsored event in 2002, Jones said. Jones said he followed the money trail and explored efforts by Janssen to promote, on a state-by-state basis, Texas guidelines favoring drugs like Risperdal. The funds sent to the hospital account helped pay travel expenses for programs related to setting up the Texas guidelines in Pennsylvania, he said.

The state adopted the guidelines that favored Risperdal in 2003, Jones said.

Note that this testimony appears to be about yet another KOL paid to promote guidelines that would in turn promote the marketing of Respirdal. So this is yet another case of a conflict of interest apparently deliberately created to influence the individual's primary responsibility.

However, then

Jones said his boss told him to ease off his probe. He said he was told, 'Stay away from the drug companies. This is a personnel issue. Stay away from the drug companies, stay away from TMAP.


Jones said his boss said, 'Drug companies write checks to both sides of the aisle. Stay away from it.' His boss told him that 'morally and ethically I was correct, but politically, this was dead.'

Jones said that later he was removed as the lead investigator from the case, and he was 'marginalized completely.' He continued to pursue the case on his own time, and spoke to the New York Times for a story that ran Feb. 1, 2004. He said he was fired for talking to the newspaper.

So Jones was intimidated to the extent that he lost his job. Note further that the implication is that this intimidation stemmed from yet more conflicts of interest created by Janssen, payments to politicians. This underlines how stealth marketing campaigns become complex systems.

Note further that in retrospect, Jones' complaints were deemed true by a court of law and a state commission:

Fiorello, once the chief pharmacist for Pennsylvania’s public welfare department, was convicted in December 2008 of felony conflict-of-interest charges for taking payments from drug companies, including Janssen and Pfizer Inc. He was sentenced to 18 months of probation and fined $3,000. He also paid more than $27,000 in civil fines after the Pennsylvania Ethics Commission cited him.

In a sense, intimidation and created conflicts of interest are two sides of the same coin.  Both involve the deliberate imposition of incentives, either positive or negative.  These incentives are designed to further marketing aims and organizational interests, not to improve patient care or public health, or advance science.  Thus they are powerful tools of emotional and psychological manipulation.
Summary

Note that even the brief summaries of trial evidence suggested how systematic the campaign was, and how within it, the elements of deception and falsehoods (instead of evidence), and emotional and psychological manipulation (instead of logic and humanity) were predominant. This should be added to previous discussion of stealth marketing campaigns, including such examples as that of Neurontin here).

Stealth marketing campaigns are complex examples of how behavior meant to further vested interests may directly threaten evidence-based practice, physicians' professionalism, and ultimately patients' and the public's health.

There have been many calls (e.g., see recent posts here and here) for increased "collaboration" among health professionals and academics and industry.  Often they are justified by the need for "innovation," while resulting conflicts of interest are deemed "manageable."  The current examples show how the vested interests of health care organizations operating within a laissez faire, anything goes environment may make such collaboration poisonous.

A Critical Review of a Critical Review of e-Prescribing ... Or Is It CPOE?

In PLoS medicine, the following article was recently published by researchers at the University of New South Wales in Australia:

Westbrook JI, Reckmann M, Li L, Runciman WB, Burke R, et al. (2012) Effects of Two Commercial Electronic Prescribing Systems on Prescribing Error Rates in Hospital In-Patients: A Before and After Study. PLoS Med 9(1): e1001164. doi:10.1371/journal.pmed.1001164

The section I find most interesting is this:

We conducted a before and after study involving medication chart audit of 3,291 admissions (1,923 at baseline and 1,368 post e-prescribing system) at two Australian teaching hospitals. In Hospital A, the Cerner Millennium e-prescribing system was implemented on one ward, and three wards, which did not receive the e-prescribing system, acted as controls. In Hospital B, the iSoft MedChart system was implemented on two wards and we compared before and after error rates. Procedural (e.g., unclear and incomplete prescribing orders) and clinical (e.g., wrong dose, wrong drug) errors were identified. Prescribing error rates per admission and per 100 patient days; rates of serious errors (5-point severity scale, those ≥3 were categorised as serious) by hospital and study period; and rates and categories of postintervention “system-related” errors (where system functionality or design contributed to the error) were calculated.

Here is my major issue:

Unless I am misreading, this research took place in hospitals (i.e., "wards" in hospitals) and does not seem to focus (if even refer to) discharge prescriptions.

I think it would be reasonable to say that what are referred to as "e-Prescribing" systems are systems used at discharge, or in outpatient clinic/offices to communicate with a pharmacy selling commercially and not involved in inpatient care.

From the U.S. Centers for Medicare and Medicaid Services (CMS), for example:

E-Prescribing - a prescriber's ability to electronically send an accurate, error-free and understandable prescription [theoretically, that is - ed.] directly to a pharmacy from the point-of-care

I therefore think the terminology used in the article as to the type of system studied is not well chosen. I believe it could mislead readers not experienced with the various 'species' of health IT.

This study appears to be of an inpatient Computerized Practitioner Order Entry (CPOE) system, not e-Prescribing.

Terminology matters. For example, in the U.S. the HHS term "certification" is misleading purchasers about the quality, safety and efficacy of health IT. HIT certification as it exists today (granted via ONC-Authorized Testing and Certification Bodies) is merely a features-and-functionality "certification of presence." It is not like an Underwriter Labs (UL) safety certification of an electrical appliance that the appliance will not electrocute you.

(This is not to mention the irony that one major aspect of Medical Informatics research is to remove ambiguity from medical terminology, e.g., via the decades-old Unified Medical Language System project or UMLS. However, as I've often written, the HIT domain lacks the rigor of medical science itself.)

I note that if this were a grant proposal for studying e-Prescribing, I would return it with a low ranking and a reviewer comment that the study proposed is actually of CPOE.

That said, looking at the nature of this study:

The conclusion of this paper was as follows. I am omitting some of the actual numbers such as confidence intervals for clarity; see the full article available freely at above link for that data:

Use of an e-prescribing system was associated with a statistically significant reduction in error rates in all three intervention wards. The use of the system resulted in a decline in errors at Hospital A from 6.25 per admission to 2.12 and at Hospital B from 3.62 to 1.46. This decrease was driven by a large reduction in unclear, illegal, and incomplete orders. The Hospital A control wards experienced no significant change. There was limited change in clinical error rates, but serious errors decreased by 44% across the intervention wards compared to the control wards.

Both hospitals experienced system-related errors (0.73 and 0.51 per admission), which accounted for 35% of postsystem errors in the intervention wards; each system was associated with different types of system-related errors.

I note that "system related errors" were defined as errors "where system functionality or design contributed to the error." In other words, these were unintended adverse events as a result of the technology itself.

The authors conclude:

Implementation of these commercial e-prescribing systems resulted in statistically significant reductions in prescribing error rates. Reductions in clinical errors were limited in the absence of substantial decision support, but a statistically significant decline in serious errors was observed.

The authors do acknowledge some limitations of their (CPOE) study:

Limitations included a lack of control wards at Hospital B and an inability to randomize wards to the intervention.

Thus, this was mainly a pre-post observational study, certainly not a randomized controlled clinical trial.

Not apparently accounted for, either, were potential confounding variables related to the CPOE implementation process (as in this comment thread).

In that thread I wrote to a commenter [a heckler, actually, apparently an employee of HIT company Meditech] with a stated absolute faith in pre-post studies that:

... A common scenario in HIT implementation is to first do a process improvement analysis to improve processes prior to IT implementation, on the simple calculus that "bad processes will only run faster under automation." There are many other changes that occur pre- and during implementation, such as training, raising the awareness of medical errors, hiring of new support staff, etc.

There can easily be scenarios (I've seen them) where poorly done HIT's distracting effects on clinicians is moderated to some extent by process and other improvements. Such factors need to be analyzed quite carefully, datasets and endpoints developed, and data carefully collected; the study design and preparation needs to occur before the study even begins. Larger sample sizes will not eliminate the possible confounding effects of these factors and many more not listed here.

The belief that simple A/B pre-post test that look at error rate comparisons are adequate is seductive, but it is wrong.

Stated simply, in pre-post trials the results may be affected by changes that occur other than the intervention. HIT implementation does not involve just putting computers on desks, as I point out above.

In other words, the study was essentially anecdotal.

The lack of RCT's in health IT are, in general, one violation of traditional medical research methodologies for studying medical devices. That issue is not limited to this article, of course.

Next, on ethics:

CPOE has already been demonstrated in situ to create all sorts of new potential complications, such in at Koppel et al.'s "Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors", JAMA. 2005;293(10):1197-1203. doi: 10.1001/jama.293.10.1197 that concluded:

In this study, we found that a leading CPOE system often facilitated medication error risks, with many reported to occur frequently. As CPOE systems are implemented, clinicians and hospitals must attend to errors that these systems cause in addition to errors that they prevent.

CPOE technology, at best, should be considered experimental in 2012.

In regards to e-Prescribing proper, there's this: Errors Occur in 12% of Electronic Drug Prescriptions, Matching Handwritten and this: Upgrading e-prescribing system can bump up error risk to consider; in other words, the literature is conflicting, confirming the technology remains experimental.

This current study confirmed some (CPOE) errors that would not have occurred with paper did occur with cybernetics, amounting to "35% of postsystem errors in the intervention wards."

In other words, patient Jones was now subjected to a cybernetic error that would not have occurred with paper, in the hopes that patients Smith and Silverstein would be spared errors that might have occurred without cybernetic aid.

Even though the authors observe that "human research ethics approval was received from both hospitals and the University of Sydney", since patient Jones did not provide informed consent to the experimentation with what really are experimental medical devices as I've written often on this blog [see note 1], I'm not certain the full set of ethical issues have been well-addressed. It's not limited to this occasion, however. This phenomenon represents a pervasive, continual world-wide oversight with regard to clinical IT.

Furthermore, and finally: of considerable concern is another common limitation of all health IT studies, which I believe is often willful.

What really should be studied before justifications are given to spend tens of millions of dollars/Euros/whatever on CPOE or other clinical IT is this:

The impact of possible non-cybernetic interventions (e.g., additional humans and processes) to improve "medication ordering" (either CPOE, or ePrescribing) that might be FAR LESS EXPENSIVE, and that might have far less IT-caused unintended adverse consequences, than cybernetic "solutions."

Instead, pre-post studies are used to justify expenditures of millions (locally) and tens or hundreds of billions (nationally), with results sometimes like this affecting an entire country.

There is something very wrong with this, both scientifically and ethically.

-- SS

Note:

[1] If these devices are not experimental, why are so many studying them to see if they actually work, to see if they pose unknown dangers, and to try to understand the conflicting results in the literature? More at this query link: http://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20experiment

Addendum Feb. 10, 2012:

An anonymous commenter points out an interesting issue. They wrote:

The study was flawed due to its failure to consider delays in care and medication administration as an error caused by these experimental devices.

Delays are widespread with CPOE devices. One emergency room resorted to paper file cards and vacuum tubes to communicate urgency with the pharmacy. Delays were for hours.

I agree that lack of consideration of a temporal component, i.e., delays due to technology issues, is potentially significant.

I, for example, remember a more than five-minute delay in getting sublingual nitroglycerin to a relative with apparent chest pain due to IT-related causes. The problem turned out to be gastrointestinal, not cardiac; however, in another patient, the hospital might not be so lucky.

Addendum Feb. 12, 2012:

A key issue in technology evaluation studies is to separate the effects of the technology intervention from other, potentially confounding variables which always exist in a complex sociotechnical system, especially in a domain such as medicine. This seems uncommonly done in HIT evaluation studies. Not doing so will likely inflate the apparent contribution of the technology.

A "control ward" where the same education and training, process re-engineering, procedural improvements, etc. were performed as compared to the "intervention ward" (but without actual IT use) would probably be better suited to pre-post studies such as this.

A "comparison ward" where human interventions were implemented, as opposed to cybernetic, would be a mechanism to determine how efficacious and cost-effective the IT was compared to less expensive non-cybernetic alternatives.

-- SS

Health IT: Ddulites and Irrational Exuberance

The title is not a typo.

I've often tried to explain the phenomenon of irrational exuberance where computers are concerned, especially in the domain of health IT.

In face of the literature references provided throughout this blog, including at posts such as this reading list and at sites such as here, one would think rational people would temper their exuberance somewhat, at the very least towards rapid national rollouts - as opposed to constrained, controlled experiments until the industry learns how to get the technology "right."

However, more than a decade of writing has had little effect.

I've also attempted to explain the phenomenon of irrational exuberance on a belief in technological determinism, on industry propaganda, on unquestioning IT faith being a quasi-"religion", and on profiteering or other quid pro quo. (The latter, I'm certain, is operative to an extent.)

I have now come across a term, though, that I believe accurately encapsulates the phenomenon of unquestioning beliefs that health IT + clinician automagically --> a "revolution" in medicine.

It may be a character trait. The trait has been described by the term "Ddulite." (Pronounced, I would say, 'da-dew-light'.) It is obviously a play on "Luddite" with the fist four characters backwards.

Apart from its historical meaning, a Luddite is "one who is opposed to change, especially technological change" (Merriam-Webster).

A Ddulite, on the other hand, is the opposite of a Luddite. A Ddulite is:

A person who prefers new tech to old tech even when the old tech is better--more functional

or alternately:

A person with a preference for higher tech solutions even in cases where lower tech alternatives have greater and more appropriate functionality.

My own definition, especially in healthcare:

Hyper-enthusiastic technophiles who either deliberately ignore or are blinded to technology's downsides, ethical issues, and repeated local and mass failures. [1]

Such people ignore the downsides, even if the downsides are deadly - in which case I believe it justified to describe Ddulites as "radical technophiles."

The Ddulite simply assumes if it's new technology, it has to be better, no matter the evidence because, well, it's new technology.

In other words, irrational exuberance in IT in general, and HIT specifically, is not merely a belief, it's a character trait, perhaps an ideology.

That could help explain why some otherwise very bright people, even people who promote evidence-based medical practice, seem to become blind and deaf in regard to HIT, as in the recent comment thread on my post "KevinMD: How algorithm driven medicine can affect (make more dangerous, actually) patient care."

When it comes to evidence-based IT practice, a Ddulite is eager to provide extraordinary special accommodation towards IT flaws, ethics, known dangers, etc. Someone of this ideology finds it exceptionally easy to dismiss or ignore any and all evidence that could contradict the technology's powers to "transform" medicine, and perhaps even worse (for patients), that could contradict its infallible beneficence.

Unfortunately, IT is not a magic bullet ... it can be just a bullet, period, unless "done well", an undertaking of almost wicked complexity.

Being a Ddulite can, in fact, lead to recklessness and negligence. A transition to IT must always respect the findings of Social Informatics (PDF): see especially Sec. 3.1 'Key Social Informatics Ideas' starting on pg. 117. The transition must be done - especially in a scientific domain - in a scientific manner.

In medicine, that means applying the rigors of medical research, medical science and medical ethics to the conception, design, implementation and lifecycle of health IT, with all that implies. This is certainly not the state of the HIT enterprise in 2012, which is largely based on a management information systems, i.e. merchant-computing, paradigm.

People who offer unquestioning loyalty to cybernetics, and who reflexively accuse those who are circumspect about commercial health IT of being "Luddites" who proffer "anecdotes", perhaps need to look in the mirror. They then need to think critically as to whether their reflection demonstrates Ddulite characteristics.

Unquestioning loyalty to the Empire: In A Mirror, Darkly

-- SS

Feb. 19, 2012 addendum:

Also see my post "Health IT Ddulites and Disregard for the Rights of Others" that adds another observation about the Ddulite mindset.

Notes:

[1] On mass IT failures repeatedly ignored, see "Pessimism, Computer Failure, and Information Systems Development in the Public Sector", Shaun Goldfinch, University of Otago, New Zealand, Public Administration Review 67;5:917-929, Sept/Oct. 2007.