Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT

A paper I recently wrote on a critical issue in healthcare IT was rejected on first pass by the Medical Informatics academic community.

The paper concerns the profound lack of publicly available data on unintended adverse consequences of healthcare IT and proposed steps that could be taken by ethical clinicians and others to remediate this gap.

I have decided not to make "revisions", feeling the "problems" with the paper were likely more about its topic than its substance or format, making the topic unpublishable in the medical informatics literature. I am therefore making the paper available publicly.

It is entitled "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT." The full paper is available via Scribd at this link:

http://www.scribd.com/doc/28747771/
(MS Word .doc format).

Only this month has the FDA even acknowledged patient injury and deaths due to health IT problems, and admits their numbers are likely the "tip of the iceberg" (in a future essay I will explain my reasoning as to why I believe their numbers may be three orders of magnitude or more off the mark and perhaps four orders of magnitude off when HIT goes national).

About the paper:

Abstract:

Case reports, systematic statistical data and other information on unintended consequences (UC’s) of healthcare information technology (HIT) is relatively scarce despite ample literature on potential HIT benefits. This impedes optimal efforts at computerization of healthcare, and can and should be remediated.

Objectives: To illustrate the relative scarcity of information on HIT UC’s, suggest contributing factors, and recommend tactical measures for improvement such as better user reporting of HIT UC’s and better diffusion of existing literature on the phenomenon.

Methods: A number of recent indicators for scarcity of UC information were compiled and possible reasons described. Examples of suboptimal adverse results disclosures in related domains (e.g., the pharmaceutical industry) that may hold lessons for HIT were included.

Results: UC information on HIT is relatively scarce likely due to a variety of influences and complex interactions among and between medicine, informatics, government and industry that, left unaddressed, may lead to delays or other harm to good faith efforts to computerize informational aspects of healthcare delivery and research.

Conclusions: The relative scarcity of definitive information on the extent of HIT UC’s should be addressed in a responsible and ethical manner by clinicians, regulators and other stakeholders if this technology is to be successfully rolled out nationally.

While some reviewers commented on paper organization and formatting issues, which is fair, the most striking review comments received were these:

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.

and

Proposing a classification of sources of UC [unintended consequences - ed.] and analysis of reasons for undereporting of each type in the resulting classification could be a useful addition to the field.

I do not recall reading many, if any, articles about the covering up of healthcare IT dangers in major city newspapers. Further, it's hard to "classify UC's" when there is scant data available about them in the first place. I feel it's more important, as I did in the paper, to propose reasons for underreporting of unintended consequences in a global fashion and propose remediation steps, not perform a useless exercise of classifying that which is tightly suppressed.

I have the experience of being one of a very few medical informatics professionals to publicly challenge the HIT hysteria beginning over a decade ago at a website at this link and observing the reactions of the informatics community to that site. In addition to that experience, here are a few more points on why I think the paper unpublishable by the informatics community due to its controversial, HIT business-unfriendly topic:

One reviewer opined they'd recognized the writing style and:

... may have seen the paper prepublished on a blog somewhere.

Coming from supposed information experts who must be aware of search engines and their indexing of blogs (this blog's stories uniformly coming up very high in Google searches, for instance), this comment was remarkable.

It would seem the smart thing to have done would have been to prove their hypothesis false in a five-minute effort rather than slandering me to the editor. Further, if they'd recognized my writing, they'd surely have known I once ran a scientific library and was well aware of such publication issues, and write for this blog as well on the ethical issues concerning scientific publication. I propose the reason behind that comment was hostility.

Finally, a reviewer offered this gem:

Out of curiosity, I also wonder why all the web sites cited were accessed on the same date [the date of paper submission - ed.], if the date was noted at all.

Coming from a community of supposed computing and information experts regarding the stated dates when cited websites were "last accessed", I could only shake my head.

Peer review being somewhat of an echo chamber regarding controversial social issues in healthcare informatics (i.e., against the flow of the HIT business) , I turn the paper over to the court of public opinion.

Fortunately, the paper will likely get far more exposure where it matters - i.e., outside the academic informatics orthodoxy - via web based dissemination than via publication in rarified informatics journals.

-- SS

Who was at fault here? UK Woman left to die after computer decision support blunder

Who was at fault here? Those who modified the fall height parameters, those who designed the decision support system such that it could override life threatening problems based on a single parameter, endusers, their managers, or all?

Or was the problem the syndrome of inappropriate confidence in computers (SICC syndrome)?

I opine all of the above, in this cautionary tale:

Woman left to die after 999 ambulance blunder
By Laura Donnelly, Health Correspondent
Telegraph.co.uk
Published: 9:00AM GMT 21 Mar 2010

An investigation into a woman’s death has exposed a catastrophic decision by ambulance chiefs which may have cost hundreds of lives.

The blunder arose when call centre staff were not warned of flaws with a computer system that prioritises emergencies before dispatching ambulances.

Bonnie Mason, 58, fell down the stairs and died from a head injury after 999 controllers in Suffolk failed to identify her situation as “life-threatening”.

An investigation by The Sunday Telegraph has uncovered a critical danger placed in the software used by most ambulance services. For years, 999 calls in life-threatening situations like Mrs Masons’s were accidentally “downgraded”, with call handlers told not to send the most urgent response.

While some services spotted the risk, ordering operatives to override the computer’s orders manually, five of England’s 12 ambulance trusts did not allow call handlers to upgrade such calls [A belief that "the computer is omniscient" seems to be the only basis for such an exclusion of human judgment - ed.] They include the East of England ambulance service, which covers Suffolk and which only identified the risk after Mrs Mason’s death.

The danger in the system was created by the country’s most senior ambulance officials as they altered the program used by most control centres in an attempt to manage demand for 999 services.

Most ambulance services use an international computerised system designed in America. In the US version, a fall of more than 6ft receives the maximum priority response. However, the government committee which governs its use in this country decided that such cases should be deemed less urgent [what were they thinking? - ed], and excluded from an eight minute category A target response time.

In doing so, they created a potentially lethal flaw in the system. It meant that if a call involved a fall of more than 6ft it was designated a lower priority – a category B response – despite the presence of life-threatening conditions which were supposed to receive the most urgent category A response.

[NOTE: If the other life threatening conditions were ignored by the computer system after its "first-pass" look at the height of the fall, then who actually created the most severe flaw is unclear to me, those who altered the parameter or those who designed the overall decision support logic - ed.]

As a result, Mrs Mason lay unconscious for more than 38 minutes. The first ambulance sent to her home in the village of Eye, Suffolk, was diverted to attend to a drunk woman who had fallen on a pavement 22 miles away in Thetford, Norfolk. Because the inebriated woman had fallen at ground level, her situation was prioritised over that of Mrs Mason [perhaps because their was no entry of a "height of fall" - ed.], who was close to death by the time paramedics arrived. The East of England ambulance service, which also covers Bedfordshire, Cambridgeshire, Essex, Hertfordshire and Norfolk, said its operatives were instructed never to “override” the advice of the automated system.

Ambulance dispatchers instructed to "never override the advice of the automated system?" Simply stunning if true.

Read the whole story at the link above.

On another note: government committees have rarely worked well in domains where critical thinking is essential. (I can't wait for the comparative effectiveness committees using flawed data from flawed EMR's to start their work. I'd written about that issue here.)

Finally, "Our policy is to always trust the computer" is not a way to run life-critical healthcare services. Ever.

-- SS

King Pharmaceuticals Settles and One Columnist Writes that Such Settlements are Not the Answer

Here we go again.  The latest settlement in the parade was made by the Alpharma subsidiary of King Pharmaceuticals, as reported by Reuters:

Alpharma Inc, a unit of King Pharmaceuticals (KG.N), has agreed to pay $42.5 million to resolve allegations that it gave kickbacks to doctors to prescribe the pain drug Kadian and misrepresented its safety and effectiveness, the Justice Department said on Tuesday.

Kadian, which is based on morphine [that is, a long-acting preparation of morphine], is used to treat chronic moderate to severe pain.

We have ranted frequently about how settlements like this, which simply impose costs on large organizations that can easily be regarded as costs of doing business, but impose no penalties on the people who authorized, directed, or implemented bad behavior, do nothing to deter future bad behavior. Now at least we have company (see recent example of rant here). Last week, a commentary by An Woolner on Bloomberg, included:

Examples abound that these companies keep breaking rules and violating laws to make and market their products, no matter how many times they are caught, fined and forced to promise to go straight.

Yet,

The biggest fine ever imposed in U.S. history, $2.3 billion against recidivist Pfizer, represented a mere 14 percent of the revenue stream from selling the drugs at issue over seven years. [see our post here.]

So immune to criminal sanctions was the New York-based company that it launched its off-label Bextra campaign at the same time the company was pleading guilty to doing precisely the same thing with other drugs. The anti-inflammatory medication was later yanked from the market because of increased risk of heart attacks and stroke.

So,

What’s to be done?

The government can essentially kill a company by pushing for the parent firm to be barred from government work, which would include Medicaid and Medicare.

Teaching a Lesson

That would teach the company a lesson. But it would also hurt the millions of people who depend, in Pfizer’s case, on products from Accupril to treat congestive heart failure to Zyvox when you have certain pneumonias or infections.

And then there are those thousands of company employees who do good, honest work and who would suddenly find themselves in already massive unemployment lines.

Instead,

The challenge is to find a way to make it not worthwhile to break the rules.

Executives Behind Bars

Throwing a few company executives in jail might do the trick. On occasion, sales managers and physicians have been prosecuted.

As for top managers at pharmaceuticals, six have been convicted or pleaded guilty, mostly for misbranding or promoting off-label uses, according to the Justice Department.

Winning felony convictions is tough to pull off because you have to prove they had specific intent to commit fraud. As with any white-collar crime, that is tricky.

But there is a way around that obstacle, and the FDA announced this month that it would go that route to focus on pharmaceutical executives, the Wall Street Journal reported.

The Food and Drug Act allows misdemeanor convictions without proof of intent to do wrong.

That is an awesome power and it can be easily abused. The timing of the FDA announcement suggests that it’s a response to critics in Congress and a brutal Government Accountability Office report that the division operates without scrutiny or, well, accountability.

And yet, used for the right cases, the misdemeanor prosecution of an executive or two who set up incentives for the sales force to push drugs illegally and withhold information about devices from regulators just might do the trick.

Nothing else has yet.

To which I say, amen.

Study: Researchers with Glaxo ties favored Avandia

As mentioned in my previous post on the MIT controversy surrounding an economist's testifying to Congress on healthcare policy without revealing possible economic conflicts of interest that could affect his views, frequently expressed on this blog are concerns about undisclosed conflicts of interest and their corrosive effects upon healthcare (query link).

One major question that arises is the degree to which conflicts of interest can affect the integrity of the scientific literature. Answering this question is more a matter of social science research rather than biomedical inquiry.

One internal medicine resident at the Mayo Clinic took on this challenge and published such a study, a systematic review, in the British Medical Journal. It is entitled "Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review" (BMJ 2010;340:c1344).

Mayo Clinical researchers led by the resident, Amy Wang, examined more than 200 articles that appeared after an analysis in the NEJM linked Avandia to a 43 percent increased risk of heart attacks, and a subsequent clinical trial found no greater danger of heart disease. The results are fascinating. From a summary in the Philadelphia Inquirer:

"We aimed to determine whether financial conflicts of interest with pharmaceutical manufacturers could be fueling this fire," wrote the researchers, led by Amy Wang, a resident in internal medicine at the Mayo Clinic in Rochester, Minn. "From our findings, it appears that the answer is yes.

From the BMJ article itself, free full text available as of this writing at link above:

For each article, we sought information about the authors’ financial conflicts of interest in the report itself and elsewhere (that is, in all publications within two years of the original publication and online). Two reviewers blinded to the authors’ financial relationships independently classified each article as presenting a favourable (that is, rosiglitazone does not increase the risk of myocardial infarction), neutral, or unfavourable view on the risk of myocardial infarction with rosiglitazone and on recommendations on the use of the drug.

The "and elsewhere" can be a valuable addition to the capabilities of today's researchers, often enabled via the internet (e.g., non-literature based resources such as conference brochures, personal web pages, corporate and other financial disclosures. etc.) when articles themselves prove unrevealing.

Overall, this is a straightforward methodology, and while potentially subject to bias and expertise issues, nonetheless seems an excellent new contribution to the needed social research on undisclosed COI's.

As to results (see the full article for statistical details I am omitting here):

Of the 202 included articles, 108 (53%) had a conflict of interest statement. Ninety authors (45%) had financial conflicts of interest. Authors who had a favourable view of the risk of myocardial infarction with rosiglitazone were more likely to have financial conflicts of interest with manufacturers of antihyperglycaemic agents in general, and with rosiglitazone manufacturers in particular, than authors who had an unfavourable view. There was likewise a strong association between favourable recommendations on the use of rosiglitazone and financial conflicts of interest. These links persisted when articles rather than authors were used as the unit of analysis, when the analysis was restricted to opinion articles or to articles in which the rosiglitazone controversy was the main focus, and both in articles published before and after the Food and Drug Administration issued a safety warning for rosiglitazone.

While causality is not proven, these results are still stunning. Per the Inquirer's summary:

... Almost 90 percent of scientists who wrote positive articles, reviews, or commentaries about Avandia had financial ties to London-based Glaxo, the study published in the British Medical Journal found.

Almost three of every four authors who expressed negative views of the drug had no financial ties to manufacturers of diabetes medicines, while just 6 percent of those with positive opinions of the drug received no funding or fees from industry.

The authors cite prior literature also demonstrating an associations of COI with pro-industry views (references 2-6; #2 is regarding the mid 1990's calcium channel blocker controversy).

The authors observe that:

In the past decade, research and policy has focused on this association [between COI and pro-industry views - ed.], leading to important progress in policies to manage and encourage disclosure of such financial conflicts of interest.

Their findings about the effects of this "progress" was particularly disappointing, that only about half of the articles carried conflict-of-interest statements:

Of the 202 eligible studies (10 reported original research, 91 were letters, editorials, or commentaries, and 101 were reviews, meta-analyses, or guidelines), 108 articles (53%) included a conflict of interest statement. [The other 47% did not - ed.]

One wonders about the publishers of the articles themselves omitting COI statements, either acknowledging possible COI's or confirming that no COI's exist.

... A total of 90 (45%) of the 202 articles were authored by individuals who had financial conflicts of interest. Of the 90 studies with conflicts of interest, 69 (77%) had a statement disclosing the conflict of interest in the article itself. The other 21 studies with financial conflicts of interest (23%) did not disclose these relationships, which were discovered through searching other publications by the same author or the internet. Three (14%) of these 21 studies published a statement declaring no conflicts of interest. [Oops - ed.]

So, almost one quarter of articles with author COI did not disclose that fact, and several misrepresented the issue.

Finally, the pharmaceutical company's view, also published in the Inquirer article cited above:

A Glaxo spokeswoman said the company posted information and results from all its clinical trials on its Web site.

"It's vital that people have trust in the way we do research and the way it's made public," Jo Revill, Glaxo spokeswoman, said yesterday. "Part of that is sharing data. What we have done is develop policies that will have disclosure and encourage disclosure."

"Encouraging" disclosure of COI's is far too weak a stand for a pharmaceutical company to take on such a critical issue, in my view.

The Mayo researchers wisely conclude:

Disclosure rates for financial conflicts of interest were unexpectedly low, and there was a clear and strong link between the orientation of authors’ expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies. Although these findings do not necessarily indicate a causal link between the position taken on the cardiac risk of rosiglitazone in patients with diabetes and the authors’ financial conflicts of interest, they underscore the need for further changes in disclosure procedures in order for the scientific record to be trusted.

Finally, I add that these findings are not too surprising. It's human nature not to bite the hand that feeds you. Money is also a powerful stimulant to the brain's rationalization (as opposed to rational) centers.

We as a culture do truly need to understand the potential corrosive effects on the scientific literature of dysfunctions such as ghostwriting, financial and other conflicts of interest, publish-or-perish pressures of academia, and other such social issues.

These practices also simply need to be abolished, for as I have written before on these pages ("Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?"), once a "critical mass" of faux knowledge is put into circulation via the scientific literature, even the ostensibly impartial experts' views can become tainted, dependent as they are on that very same scientific literature. Even worse, we don't know what that critical mass is - or whether we've reached it already.

-- SS

Fatty Liver: It's not Just for Grown-ups Anymore

The epidemic of non-alcoholic fatty liver disease (NAFLD) is one of my favorite topics on this blog, due to the liver's role as the body's metabolic "grand central station", as Dr. Philip Wood puts it. The liver plays a critical part in the regulation of sugar, insulin, and lipid levels in the blood. Many of the routine blood tests administered in the doctor's office (blood glucose, cholesterol, etc.) partially reflect liver function.

NAFLD is an excessive accumulation of fat in the liver that impairs its function and can lead to severe liver inflammation (NASH), and in a small percentage of people, liver cancer. An estimated 20-30% of people in industrial nations suffer from NAFLD, a shockingly high prevalence (1).

I previously posted on dietary factors I believe are involved in NAFLD. In rodents, feeding a large amount of sugar or industrial seed oils (corn oil, etc.) promotes NAFLD, whereas fats such as butter and coconut oil do not (2). In human infants, enteric feeding with industrial seed oils causes severe liver damage, whereas the same amount of fat from fish oil doesn't, and can even reverse the damage done by seed oils (3).

So basically, I think sugar and industrial oils are major contributors to NAFLD, and if you look at diet trends in the US over the last 40 years, they're consistent with the idea. Industrial oils are harmful due (at least in part) to their high omega-6 content, which is problematic partially because it disturbs normal omega-3 metabolism. A potential solution to fatty liver is to reduce sugar, replace industrial oils with natural fats, and ensure a regular source of omega-3. I've posted two anecdotes of people rapidly healing their fatty livers using diet changes* (4, 5).

I recently came across a study that examined the diet of Canadian children with NAFLD (6). The children had a high sugar intake, a typical (i.e., high) omega-6 intake, and a low omega-3 intake. The authors claimed that the children also had a high saturated fat intake, but at 10.5% of calories, they were almost eating to the American Heart Association's "Step I" diet recommendations**. Busted! Total fat intake was also low.

High sugar consumption was associated with a larger waist circumference, insulin resistance, lower adiponectin and elevated markers of inflammation. High omega-6 intake was associated with markers of inflammation. Low omega-3 intake was associated with insulin resistance and elevated liver enzymes. Saturated fat intake presumably had no relation to any of these markers, since they didn't mention it in the text.

These children with NAFLD, who were all insulin resistant and mostly obese, had diets high in omega-6, high in sugar, and low in omega-3. This is consistent with the idea that these three factors, which have all been moving in the wrong direction in the last 40 years, contribute to NAFLD.


* Fatty liver was assessed by liver enzymes, admittedly not a perfect test. However, elevated liver enzymes do correlate fairly well with NAFLD.

** Steps I and II were replaced by new diet advice in 2000. The AHA now recommends keeping saturated fat below 7% of calories. Stock up on those skinless chicken breasts! Make sure there isn't any residual fat sticking to the meat, it might kill you. I do have to give the AHA credit however, because their new recommendations focus mostly on eating real food rather than avoiding saturated fat and cholesterol.