Wednesday, July 21, 2010

The National Program for Healthcare IT in the U.S., and the Elephant in the Living Room

The National Institute of Standards and Technology (NIST) has begun to address deficient clinical IT usability. A PDF with presentations on the topic from the recent NIST conference on HIT usability is here (warning: very large, 26 MB).

There is a critical "meta-issue" that's being ignored regarding usability, though, yet it is the elephant in the living room.

First, I will detail the elephant, then ask the simple, logical question that arises (the "inconvenient" question that nobody seems to be able to give a straight, non-marketing-spin answer to).

Here are the details of the elephant.

First, poor usability ---> increased risk to patients.

This is a first principle; it is not open to debate.

Now:

If NIST is just now getting involved in "improving HIT usability" (the improvement of which should have occurred at least two decades ago);

While HIMSS's former Chairman of the Board admits the technology remains experimental:
... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better;

While HIMSS itself admits in this 2009 PDF that

"Electronic medical record (EMR)!adoption rates have been slower than expected in the United States, especially in comparison to other industry sectors and other developed countries. A key reason, aside from initial costs and lost productivity during EMR implementation, is lack of efficiency and usability of EMRs currently available";

While the National Research Council (the highest scientific authority in the U.S.) last year reported that :

"Current Approaches to U.S. Health Care Information Technology are Insufficient" and that the technology "does not support clinicians' cognitive needs." The study was chaired by Medical Informatics pioneers Octo Barnett (Harvard/MGH) and William Stead (Vanderbilt);

While it's not just the user experience that's the problem, either...

Insurers are starting to recognize this, e.g., "NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks" ;

While hospitals and vendors cannot yet manage the technology reliably - how many medical mistakes have/will occur as a result of screw ups like this one, now confirmed to have occurred at a religious-denomination hospital chain headquartered in the Great Lakes region of the U.S.?


This patient won't get a second chance, either.

The above issues are the elephant in the living room. Or, shall I say, in the Boardrooms and meeting rooms where health IT is planned and discussed?


Health IT is great stuff, guys; it might actually work well one day!
Let's roll it out nationally and penalize those Luddite doctors
who refuse to "use it meaningfully" because it's not very usable.
Oh, just ignore that strange creature over there in the corner .
..


Considering the size and weight of the elephant, here is my question:

Why are we rolling out this technology nationally under penalty of Medicare garnishment?

I cannot get a straight, unspun answer to that question.

Perhaps we need Bill O'Reilly to ask these questions of health IT officials on his FOX News program, The O'Reilly Factor, where spin is attacked relentlessly (the "No Spin Zone.")

-- SS

Tuesday, July 20, 2010

Barry Chaiken, MD, MPH: "Let's be patient" with experimental devices that harm patients

At an interview of Barry Chaiken, MD, MPH, FHIMSS, former Chairman of the Board of health IT trade group HIMSS and chief medical officer of Imprivata, a company specializing in healthcare IT security, Chaiken pleads for the following special accommodations for Health IT relative to other medical sectors:

... We’re still learning, in healthcare, about that user interface. We’re still learning about how to put the applications together in a clinical workflow that’s going to be valuable to the patients and to the people who are providing care. Let’s be patient. Let’s give them a chance to figure out the right way to do this. Let’s give the application providers an opportunity to make this better.

[Why are the health IT applications bad to begin with, I ask? - ed.]

I note the following.

  • If 'we're' still learning (and I don't include people with genuine clinical computing expertise in that subgroup, but it does include the plethora of amateurs in the commercial health IT industry), then the technology is experimental.
  • Worse, it's unregulated - a major special accommodation in and of itself.
  • These sentiments about "being patient" would be appropriate - if the subjects of this experimental technology that vendors need to be "given a chance" to make better were experimental lab rats.

Instead, the subjects of the experimental technology are unwitting, unconsenting human beings, who are being used as experimental test subjects for software development, and being put at risk, injured and indeed killed by the disruptions these experimental technologies cause.

Under these realities, the position presented by Chaiken is, in my opinion, ethically perverse.

That such sentiments come from someone who holds the MD degree and who I assume took the Hippocratic oath in some form is stunning.

In the health IT industry, "Primum non nocere" seems to have been replaced with "Kybernetik über alle."

Further, the commercial health IT vendors have had the good part of five decades to "get it right." How long is long enough?

Their software is unavailable for detailed evaluation and open critique of the user experience by impartial experts, unlike open source EHR's like VistA CPRS, demo version available at this link where anyone can:

  • Download the latest version of CPRS today and get access to new features including graphing functionality
  • Use the software as if you were a provider by entering orders, entering documentation, retrieving reports (and graphs) and viewing alerts and notifications that help with decision support
  • Learn first hand how VA’s electronic health record system works

Personally, I've had to use stealth simply to obtain and post graphical representations of some simply inexcusable commercial HIT interface sins (link). Why should a secretive industry be given additional special accommodation?

Dr. Chaiken goes on to state:

Let’s hold them accountable if they don’t [make the applications better]. Absolutely, hold them accountable if they don’t; and the marketplace, I hope, will be able to make those choices and hold them accountable when they don’t. But, we’re still learning.

Again, I'm not sure who the "we're" refers to, but "holding companies accountable" will not really help victims of the experiments who are seriously injured or killed.

A better solution, as I have written on this blog (such as at my Nov. 2008 post "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" and at other sites as well:

Protect patients. Constrain the health IT experiment temporally and geographically, and apply the laws, customs and regulations of medical experimentation until this industry "has learned" whatever lessons Chaiken thinks they need to learn, e.g., from decades of Medical Informatics, Social Informatics, Computer Science, HCI and other research. None of these fields - last time I looked - are classified or protected intellectual property. Share information on patient adverse outcomes and near misses, instead of concealing them and contractually gagging users from openly speaking about problems.

That would be the ethical approach.

Further, how many more decades should we wait for the health IT industry to figure out how to look for better leaders beyond the "school of hard knocks" bias that's existed for at least the past decade? How many substandard health IT leaders were placed in hospitals the past few decades as a result of outrageous attitudes like these below from the major recrutiers, centered on spreading the wealth?

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

[No, that line about 'being consumed with patient care issues' as a strike against health IT leadership didn't come from a Scott Adams business-idiot parody cartoon - ed.]

As in clinical medicine itself, if you're going to be anywhere near patient care and making decisions affecting its delivery, a degree damn well "gets you something."

At about the same time the above appeared in Healthcare Informatics, a generalist IT recruiter wrote me this:

... What is happening to MDs trying to change careers is providing a window into broader issues about professionals in society today - narrow training, pigeonholing in the marketplace, difficulty making lateral and cross-industry transition, what a handicap it is to be creative, entrepreneurial, or cross-disciplinary in the current marketplace, and the wasted intellectual capital represented by the high caliber of individuals who can't find ways to fruitfully plug themselves into the marketplace.

I continue to be amazed at this general phenomenon...the remarkable quality of a number of candidates I've met, and the lack of recruiters' ability to get them in the door of good companies. The interesting part of the story is that when I am able to get access to high level execs in some of these companies (not just IT, but devices, pharmaceuticals, etc. also) they are dismayed at the quality of those that they hire. They know that something is wrong in how the recruitment process is working. (eg, one of the major device cos. just devoted the time of 1 FTE in Human Resources to 'finding innovative ways of identifying and recruiting good talent into the company.')

Whose fault were the outrageous, deleterious hiring practices prevalent in this industry that contributed materially to its production of substandard products, hiring practices that persist to this day? (See example here.)

Why should we be "patient", and "give them [yet more chances] to figure out the right way to do this", and why should patients permit themselves to continue to be guinea pigs to such a sloppy, cavalier industry?

I note that Chaiken's credentials appear to fit the template, as colleague Roy Poses describes at various posts including here, of an "executive isolated from the real world of health care" and member of the superclass. From the interview linked above:

... According to your LinkedIn profile, you’re CMO for Imprivata, CMIO for Symphony Corporation, and CMO of DocsNetwork. You’re on a couple of advisory boards, you own a vineyard, and you just finished your term as chair of the HIMSS board.

Perhaps that helps explain the mantra of "computers [and profit] first, patients second."

Finally, in answer to my own question above "Why are the health IT applications bad to begin with", I suggest complacency, incompetence, willful ignorance, and negligence (including criminal negligence) as possible answers.

-- SS

Addendum:

The following in today's WSJ caught my eye ("What we've learned from the Gulf spill", Michio Kaku, July 20, 2010):

The nagging question is: Why did it take so long? Why couldn't they have capped the leak months ago? For three agonizing months, BP's engineers and executives were essentially making things up as they went along, conducting a billion dollar science project with the American people as guinea pigs. The basic science of stopping oil leaks at 5,000 feet below sea level should have been done years ago.

Concepts are similar. With just a few edits, we have this:

The nagging question is: Why is it taking so long? Why couldn't they have learned to create useful health IT decades ago? For at least thirty agonizing years, Health IT vendors' engineers and executives were essentially making things up as they went along, conducting a multibillion dollar science project with the American people as guinea pigs. The basic science of producing safe, effective, usable health IT should have been done years ago.

-- SS

Monday, July 19, 2010

Not Your Average Joe's Health Plan

A Denver Post article offered a brief glimpse into the health benefits of corporate leaders, on the unusual occasion of a former CEO now in legal fight for the health benefits in the style to which he had become accustomed:
Poor Joe. He's not getting the health-care benefits he was promised.

His former employer merged with another company, and then another, and then another. And, you know how it goes after a slew of mergers. Suddenly the new, conglomerated monster just doesn't care about retirees any more.

Joe isn't going to sit back and take it like an average Joe. He's suing his former employer in U.S. District Court in Manhattan for breach of contract, breach of faith, breach of fiduciary duty and even promissory estoppel.

The Joe in question was really:
Lord & Taylor's CEO.

Joseph E. Brooks of Greenwich, Conn., lorded over a fourfold increase in sales at Lord & Taylor, expanding to 46 from 19 locations.

His career and Lord and Taylor's course after that were checkered, perhaps contributing to the current dispute:
But that was a long time ago. And Macy's Inc., the current parent company, is resisting some of his medical claims.

Brooks didn't get a deal like this from Filene's, where he served as president before joining Lord & Taylor. Or Ann Taylor, where he went on to generate shareholder lawsuits and shopper hate mail after demanding lower prices from suppliers and higher prices from customers, destroying both quality and value at the same time.

Brooks also made his son president of Ann Taylor, sparking cries of nepotism. And then his son got snagged trying to slip by U.S. Customs without paying duties on pricey watches and was forced to resign. The senior Brooks subsequently resigned as well. A 1992 Newsday article called him 'as egotistical and extravagant as he was brilliant.'
What Health Care Benefits Do CEOs Get?

What had Brooks been promised as CEO of Lord and Taylor?
In 1983, Lord & Taylor's corporate parent told Brooks it sought to provide 'great comfort to executives knowing that their medical costs are fully reimbursed by the Corporation.' The company told Joe it was a lifetime guarantee.

CEOs should never, ever, have to worry about health care.

Here are some details about his benefits:
And for nearly 27 years, substantially all medical costs have been fully covered, even premiums.

We're not just talking doctors' visits, hospitals, medications and tests. We're talking all travel and ancillary expenses associated with care, too.

We're talking first-class transportation, accommodations and meals while being treated at the Mayo Clinic and the Duke Diet and Fitness Center. We're talking expenses for a companion or personal aide, too.

We're also talking 'cosmetic services (surgery, medications, injections, creams and the like)' dental care, gym memberships, personal trainers, vitamins, massages — all paid by Joe's former employer for the rest of Joe's life.

Oh, and if any of these benefits have tax consequences, we're talking gross-up payments to cover that, too.
Why should we be concerned about the extravagant health plans given to top corporate executives? 

The Implications

We noted in 2009 that the Goldman Sachs 2009 proxy statement indicated that top executives of that now controversial company received health plans worth about $40,000 each. 

My concern then were not how much the costs of the plans contribute to top corporate leaders' compensation packages. Such packages are generally already so outrageously huge that providing $40,000 rather than $13,000 worth of health insurance is a trivial increase. My concern was not that plan recipients' demands for health care will collectively increase health care costs, because they likely include only a tiny portion of the population.


My main concern, instead, was how much these plans further insulate already cocooned top executives from the vicissitudes of daily life, particularly related to coping with our current dysfunctional health care system. What benefits executive health care plans provided were not clear from the 2009 story about Goldman Sachs.  However, this year's case of Joe Brooks does suggest that the plans paid for every expense that could be conceivably health related. 

As I worried then, it now does appear that such plans could completely insulate executives from having to deal with the managed care/ health insurance bureaucracy which frustrates patients seeking particular services, but not necessarily the most expensive, or least beneficial services. Furthermore, such plans may completely insulate executives from the various other vicissitudes of managing our currently dysfunctional health care system.  (By the way, that is why it seemed amazing that the CEO of Pfizer had to put up with some of the common vicissitudes when he went to a hospital for an elective procedure, an experience he publicly talked about with an almost charming naivete, given that he runs such a powerful health care organization which has been so influential in shaping our US "health care reform," see post here.)

Such executives isolated from the real world of health care might thus not have gut level appreciation of how dysfunctional the health care system has become for even insured patients. Since top executives often are disproportionately influential members of the "superclass," their disconnection from the realities of dysfunctional health care is likely to translate into little real support by the powers that be for meaningful health care reform. There support may be further retarded by the influence of their fellow superclass members whose personal fortunes depend on the status quo in health care.

Real improvement of health care may depend on finding leaders who have better understanding of the plight of real people.
 
Two Postscripts
 
Note: the Goldman Sachs 2010 proxy indicates that the executive health plans given to the five most highly paid executives cost up to $56,927.  
 
Also note that despite the effect that executive health plans may have on the thinking of those with the most power to influence health care policy, the plans have been of little interest to health care services and policy researchers.  I have not been able to find a single article in these literatures on the subject.  This appears to be yet another version of the anechoic effect, that certain inconvenient truths (to borrow from former US Vice President Al Gore) are not subjects of polite discussion of health care, lest the results excessively disturb the powers that be.

Prosecuting Doctors for Importing IUDs from Canada, but Still No Penalties for Selling Adulterated Heparin from China

Here in Rhode Island, the big health care story recently was the use of unapproved intra-uterine devices (IUDs) by some local obstetrician-gynecologists (OB-GYNs).  The first nuanced summary of the story which just appeared in the Providence Journal, written by Felice Freyer, suggested how the consequences of possible misconduct in health care depend on the clout of those involved.

The Unapproved IUDs

Here are the main points. The issue that caused so much local controversy was the use of unapproved IUDs:
Ten Rhode Island medical groups with 28 doctors told the Health Department that they bought IUDs, a form of birth control, from a foreign source, at prices about half what they had to pay for IUDs approved for use in the United States. Many had stopped using the unapproved devices long before the Health Department began its investigation in June.

Here is what we know about the actual devices they implanted:

An IUD is a T-shaped device that can fit in the palm of a woman’s hand. To prevent pregnancy, doctors insert it into the uterus, where it can stay for years. There are two types available in the United States: the ParaGard copper IUD and the Mirena hormonal IUD. Mirena, the more costly and more popular brand, has a coating of a progesterone-like drug that reduces heavy menstrual bleeding.
Unapproved IUDs Made by an American Company in Finland and Sold in Canada

Most of the "unapproved devices" the doctors were using were apparently made in Finland by an American company.
In most cases, the doctors were using Mirena, which is made at a factory in Finland by an American company, Bayer Healthcare Pharmaceuticals. Only when it comes through approved channels can doctors and patients be assured that a product meets FDA standards. But it is unclear whether Bayer –– or anyone –– makes a version of Mirena that does not meet those standards.
The doctors imported the devices from far-away, exotic Canada.
Most of the devices apparently came from Canada, where the government negotiates with drug and device makers to keep prices low.

There is no reason to suspect the devices were counterfeit, or defective.
'If they’re really from Canada and from a reputable pharmacy, it should be exactly the same thing [as the FDA-approved version],' said Sheryl Ruzek, a retired public health professor at Temple University and vice chair of the board of the ECRI Institute, a nonprofit organization that evaluates medical procedures and products. 'My hunch is the patients were not harmed,' she said.
Potential Negative Consequences for the Physicians

However, the RI physicians are in big trouble for importing them:
In Rhode Island, the state boards that regulate physicians, nurses and nurse-midwives are investigating all those involved. If any are found guilty of unprofessional conduct, they could face disciplinary action such as a reprimand or license suspension. The state attorney general’s office has a Medicaid fraud unit, but declined to comment. The U.S. Attorney also had no comment.
US doctors in other states have also been importing IUDs, and also are in big trouble:
So many doctors were importing IUDs or considering doing so that the American College of Obstetricians and Gynecologists recently took an official stand, issuing an advisory opposing the use of imported devices.

In 2006, the California Department of Health found that eight doctors had used imported IUDs in some 850 women.

In October 2009, an Arkansas doctor was indicted by a federal grand jury for using non-FDA-approved versions of Mirena. He was charged with violation of the Food, Drug & Cosmetic Act, health-care fraud (for allegedly billing Medicaid for the unapproved devices) and money-laundering (for the way he allegedly handled Medicaid reimbursements). The doctor, Kelly Dean Shrum, has not yet come to trial, but potential penalties include fines and imprisonment.

Summary, and the Contrast with the Case of the Adulterated, Fatal Heparin
So to summarize, doctors who imported IUDs from Canada that appeared to be identical to those sold with FDA approval in the US, and were made in Finland by an American company at the same factory in which the US approved IUDs were made have gotten into major trouble with state and federal authorities. There is no clear evidence that the IUDs caused any harm to patients.

I am not defending the doctors' actions. However, contrast the treatment they are likely to receive with another case we have frequently discussed.

We last blogged about the case of Baxter International's adulterated heparin here.  In 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.

Yet everyone from state health departments to the federal authorities have jumped into the case of the unapproved IUDs imported, but from Canada, and apparently identical to the IUDs sold in the US.  There is, at least so far, no evidence that the IUDs were defective or dangerous, and no evidence they have harmed patients.  One doctor has been prosecuted for violating the Food, Drug and Cosmetic Act, and for health care fraud and money-laundering.  No one working for Baxter International (or for the identified organizations within its supply chain) has been prosecuted for anything.

What the...?   I do not object to discipline and prosecution of individual doctors who appear to have broken the law.  But why are we so vigorously pursuing individual doctors for an apparently technical violation of laws that did patients no apparent harm, when we are not pursuing health care corporate executives for selling adulterated drugs that likely killed patients? 

F Scott Fitzergald wrote that the "very rich are different from you and me," and it appears that very rich health care leaders have impunity when it comes to conduct that let patients be harmed and die. 

Real health care reform would make top health care leaders as accountable as we now make individual doctors.

Sunday, July 18, 2010

The Avandia Spin Cycle Continues Even After the FDA Safety Hearings

We have posted multiple times about Avandia (rosiglitazone), GlaxoSmithKline's star-crossed glucose-lowering drug.  While Avandia has received considerable media coverage, we focused on two questions: 1 - what are the benefits and harms of rosiglitazone as a treatment of type 2 diabetes, and therefore for which patients under what circumstances should this drug be used? 2 - what barriers have prevented physicians and patients from getting the best possible answer to the first question, and what can be done about them?  (See recent post here.) 

In particular, the Avandia case has illustrated how those with vested interests in the success of a health care product have done their best to obscure information that might threaten its success, even when doing so obscures the information that physicians and patients need to make the best possible decisions.  At one point, (in 2007, no less) we called this the "Avandia spin cycle."

Avandia once again has been in the news after the US Food and Drug Administration's hearings on the safety of the drug.  These hearings were so well covered in the media that a lengthy summary would be superfluous.  However, their main points demonstrated the persistence of the Avandia spin cycle:
- An FDA reviewer felt that "the company's misreadings of the ... Record trial ... were so profound, he concluded, that they 'suggest serious flaws with trial conduct.'" (per Gardiner Harris writing in the New York Times)
-A former FDA reviewer "withheld from regulators a study showing its Avandia diabetes drug may cause heart attacks." (per Bloomberg News)
- GlaxoSmithKline's forerunner SmithKline Beecham "secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda."  However, "the study also provided clear signs that it [Avandia] was riskier to the heart.  But instead of publishing the results, the company spent the next 11 years trying to cover them up." (per Gardiner Harris writing in the New York Times.
- "Government experts and a panel of medical advisers repeatedly voiced skepticism on Tuesday about the trustworthiness of GlaxoSmithKline, which makes the controversial diabetes drug Avandia." (per Gardiner Harris again writing in the New York Times.)

So the Avandia saga has brought to the front pages the concerns we have had with suppression and manipulation of clinical research, especially when pursued by health care organizations with vested interests in the results of specific research projects coming out a certain way, and how they have been enabled by those with conflicts of interest.  Doctors thus should be worried whether those of us who try to practice evidence-based medicine have been fooled into practicing pseudo-evidence-based-medicine.

Those commenting on the story focused on the need for transparency when clinical research is funded and run by the corporations whose products are being evaluated.
-  "GlaxoSmithKline, the maker of Avandia, can't be trusted to report adverse clinical results fairly.  The company must be watched like a hawk as additional trials that it sponsors go forward."  (NY Times editorial)
-  "What America should demand in return for ... [generous patent] protection is that the FDA be able to make an honest evaluation of the efficacy of drugs.  When drug companies make this impossible by suppressing test results, not only do they violate their fundamental obligation of honesty with the public, their customers and their regulator, but they also break the bargain they have struck in return for the protection of their intellectual capital."  (Former NY Attorney General Eliot Spitzer in Slate.)

Instead, as I have written before, maybe we ought to consider whether those with vested interests in drugs or devices ought to be running clinical research meant to evaluate their own products.

 Ironically, while this discussion of how the Avandia spin cycle first began to revolve were going on, others were still trying to add revolutions (per minute).  In particular, a Reuters story noted:
Three influential groups of doctors who treat diabetes urged patients not to stop taking Avandia, saying on Thursday that while news about the controversial drug may be frightening, it would be worse to suddenly stop taking it.

That is odd, given that Avandia has never been shown to improve clinical outcomes for patients with diabetes, and that there are many other drugs that control blood sugar which appear to be safer. But wait, there is more,
The Endocrine Society, American Diabetes Association and the American Association of Clinical Endocrinologists worried that patients may be afraid to take Avandia.

'Patients should continue taking all currently prescribed medications unless instructed otherwise by their health care provider,' Dr. Robert Vigersky of the Endocrine Society said in a statement.

'Stopping diabetes medications can cause significant harm and result in higher levels of blood glucose that may cause severe short term health problems and could increase the risk of diabetes-related complications in the long term.'

Would not it make more sense to advise patients still on Avandia to consult with their doctors urgently about possible alternatives?  Meanwhile, it does not seem irrational to be afraid of taking Avandia, given the increasing evidence about its harms, and increasing evidence that what we know about its harms may be an under-estimate.

So I wondered why these august medical societies seemed so unaffected about the doubts about Avandia's safety, and about the evidence offered to support its use that the latest news ought to generate. It turns out that all three of the medical societies get financial support from, -- wait for it --, GlaxoSmithKline.

The Endocrine Society lists GSK as one of its Corporate Liaison Board Members. The American Diabetes Association lists GSK as one of its Banting Circle Supporters, that is, those that give at least $1,000,000 a year. The American Association of Clinical Endocrinologists lists GSK as a member of its Corporate AACE Partnership. (I was not able to find out the total amount contributed by GSK to either the Endocrine Society or the AACE.)

So once again, the loudest voices in support of the product come from those used to, and perhaps dependent on financial support from its manufacturer. As a physician, I have been particularly disappointed that our medical societies, whose missions are ostensibly to support our professional values, seem to act more and more like marketers for the companies whose contributions, rather than members' dues increasingly support them.

The cycle keeps spinning.

For further thoughts on the latest in the Avandia case, see this post by Howard Brody on the Hooked: Ethics, Medicine and Pharma blog, and this by Alison Bass on the Alison Bass Blog.

Friday, July 16, 2010

The New York Times Reports A University President's Conflict of Interest

Three months ago, we discussed the controversy at the University of Michigan about  the university president's position on the board of directors of the big pharmaceutical, medical device and medical supply company Johnson and Johnson as a potential conflict of interest that could have influenced her decision to make the campus smoke-free.  (Johnson and Johnson makes drugs to aid in smoking cessation.)  I argued that by the Institute of Medicine definition, President Coleman did have a conflict of interest, and while it was not possible to tell whether it influenced the smoke-free decision, the issue with conflicts is that they constantly raise the possibility of undue influence on decisions.

Now this issue has made it to the big time.  New York Times reporter Duff Wilson, wrote in the Times' Prescriptions Blog
The University of Michigan medical school became the first in the nation last month to say it would refuse any funding from drug companies for its continuing medical education classes. The decision could cost it as much as $1 million a year, but it was worth it, the medical school dean said, for education to be free from potential bias.

At the same time, Mary Sue Coleman, president of the entire University of Michigan, sits on the board of directors for the pharmaceutical giant Johnson & Johnson. Last year, the company paid her $229,978 — roughly half in stock and half in cash — for attending a limited number of meetings, corporate filings show.

Conflict of interest? Conflict of policies? If the med school and mere professors could be tainted by drug money, what about the university president?

She says no. Responding to questions on Ms. Coleman’s behalf Monday, Kelly E. Cunningham, a spokeswoman for the university, said the president satisfied the policy by disclosing her outside work. Ms. Coleman has never had to recuse herself from any discussion or action at the university because medical purchasing and investment decisions are so remote from her, Ms. Cunningham said.

'The same is true at J&J,' she added. 'There has never been a discussion or decision at the board level that involved something related to the UM. But, of course, if there were, she would recuse herself.'

The story was picked up by the Detroit Free Press, which reiterated the official line that President Coleman's role on the Johnson and Johnson board did not pose a conflict:
A student group at the University of Michigan is calling on President Mary Sue Coleman to resign from her seat on the Johnson & Johnson board of directors, saying it's a conflict of interest.

But Coleman has no plans to resign, and university officials say her role on the board is not in conflict with university operations. Last year, she earned nearly $230,000 for her board duties. Coleman's U-M salary is about $550,000.

'It's essential that U-M have a voice and interact with the business world,' said Rick Fitzgerald, a U-M spokesman. 'She thinks it's her duty to understand what the commercial world is doing.'

So, as I did last time, let us turn to the Institute of Medicine's definition of conflict of interest (in a health care context) found in its report, Conflict of Interest in Medical Research, Education, and Practice.
Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest. Primary interests include promoting and protecting the integrity of research, the quality of medical education, and the welfare of patients. Secondary interests include not only financial interests....

I asserted then that President Coleman has a conflict of interest. Her primary interests as President of a university are to uphold the university's academic mission, and as President of a university that includes a medical school, a school of public health, and an academic medical center, also to uphold the integrity of patient care and public health practice. Her secondary interest as a member of the board of directors of a public, for-profit corporation is her fiduciary duty to that corporation and its stockholders, which means she must "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.] Such unyielding loyalty to the shareholders of a pharmaceutical and medical device company clearly creates a risk of influencing judgments or actions that could affect the corporations' sales or operations, economic or health policy, or the general environment in which it operates. Many of the judgments of or actions performed by the leader of a medical school, public health school, and academic medical center could so so, and are thus at risk of being so unduly influenced.

As the IOM report said, though,
a judgment that someone has a conflict of interest does not imply that the person is unethical. Such judgments assume only that some situations are generally recognized to pose an unacceptable risk that decisions may be unduly influenced by considerations that should be irrelevant.

However, note that the sorts of decisions that may be influenced by a conflict of interest go beyond just those that involve the specific secondary interest causing the conflict. So the University spokesperson's statement that the president would recuse herself from any decision at the university that directly involved Johnson and Johnson, but that no such decision has ever been necessary, missed the point.

Meanwhile, the university's insistence that the president's part-time position at Johnson and Johnson is justified by the need to "have a voice and interact with the business world" rings hollow. There are many ways a president could do that which do not involve getting corporate pay (and for "unyielding loyalty"). It rings especially hollow at a university that has identified corporate funding for continuing medical education as an unacceptably bad conflict of interest.

But then again, conflicts of interest are known to create confused thinking, and such confused thinking is likely to be prevalent at an institution that has one set of rules for the little people, and another for the top leaders.

Maybe this story in the New York Times will lead to some discussion about whether it is good for academic medical institutions to tolerate this previously "new species of conflict of interest" (as we termed it in 2006).

FDA MAUDE Database: Patient Outcome - Death

I present another health IT problem case from the FDA's voluntary MAUDE (Manufacturer and User Facility Device Experience) database below.

From FDA's description of MAUDE:

  • MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19.
  • The on-line search allows you to search CDRH database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE is scheduled to be updated monthly and the search page reflects the date of the most recent update. FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed by technical or clerical difficulties.
  • MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester.

I somehow missed the following case when I wrote the Oct. 2009 post 'Our Policy Is To Always Have Unabashed Faith In The Computer ... Except When It Screws Up, And Then It's The Doctor's Fault' but I have added it there as well:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1656460
CERNER MILLENIUM POWERCHART CPOE
Event Date 11/19/2006
Event Type: Death
Patient Outcome: Death

The medication review screen of the subject device does not specify the exact dose in milligrams of combination medications. For example, narcotics are combined with tylenol in at least two strengths. Liquid narcotic tylenol-oxycodone combination is reported in ml, not mg. The exact dose of tylenol is not specified and requires knowledge of the combination medication dose in the volume specified.

Certain fields of the grid do not specify the volume, but rather state "date/time" requiring another click or pop up screen. The immediate knowledge of tylenol dosage in mg is directly related to understanding and preventing excessive doses. In the subject, 10 ml of acetaminophen-oxycodone is indicated as having been given 3 times over 4 hours. That means that 1950 mg of tylenol was administered in 4 hours while the patient was in a state of starvation and receiving other medication that increase the effects of tylenol.

This dose would equate to 11,700 mg of tylenol over 24 hours, nearly 3 times the maximum daily dose in otherwise health people. In the ensuing days, the patient developed acute renal failure, presumably acute tubular necrosis, and died. In the absence of other etiology, the excess tylenol was the culprit. This was not considered as etiology ante-mortem. The counterintuitive screen impaired the professionals. The pharmacist did not recognize and stop the medication, the nurses administered it, and the excessive dose, clinically meaninglessly listed as a volume of 10 ml -given 3 times in 4 hours- of acetaminophen-oxycodone, was missed by the physicians. Adverse events have been ascribed to "user error" by vendors.

The device offers a potent propensity to life endangering oversights. There are other screens on this device which present information that interfere with clinically useful visualization of data.
[Who designed these screens, I ask? Clinicians, or business IT personnel used to designing inventory systems for widget control? - ed.] The data does not flow to the professionals. It is not represented in a meaningfully useful manner.

The professionals need to hunt for it. As such, the user unfriendly screens [see this link on mission hostile HIT - ed.] impair safe medical care consistent with the impediment to expedient professional understanding of what, exactly, is the dose of medication and how much was administered to the patient. This sentinel case of death is directly attributed to user unfriendly screens on this device.

How many cases like this, as well as "near misses" related to health IT go unreported, nationwide and worldwide?

As in my paper "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT",
nobody really knows; these devices are unregulated with no requirements for reporting.

However, let's roll it out nationally anyway, because HIT will deterministically "revolutionize" medicine. Just ignore those spoil-the-party, man-behind-the-curtain prattle from writers like these.

We can safely ignore all contrarian research and literature, of course, as we all know HIT will revolutionize medicine from the definitive certainty of HHS in "The 'Meaningful Use' Regulation for Electronic Health Records", NEJM, Blumenthal and Tavenner (10.1056/NEJMp1006114, July 13, 2010):

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.

[Except for those who
haven't - ed.]


And our government's called BP Energy Company cavalier?

I offer no additional comments.

-- SS

Thursday, July 15, 2010

NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks"

The Insurance Industry is catching on that EMR's and other clinical IT are not exactly the cybernetic miracles they're sometimes held out to be, for example as implied in this statement from HHS in the July 13, 2010 NEJM that-

... EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers.

NORCAL Mutual Insurance Company, for example, produces a near-monthly publication entitled "Claims Rx." Its purpose:

The goal of Claims Rx is to help physicians better recognize their medical professional liability risks and implement strategies to minimize those risks. The topics addressed here are derived from numerous sources including closed malpractice claims analyses, emerging liability trends and current medical literature. Each issue is meticulously reviewed by an editorial board consisting of physicians, nurses, risk management specialists and attorneys with a mind toward optimal patient safety and proactive risk management.

The October 2009 issue, found at this link in PDF, is entitled "Electronic Health Records: Recognizing and Managing the Risks." It contains advice to physicians to limit their liability, reduce errors, and presents de-identified examples of HIT-related horror stories.

Some of the advice offered includes:

Electronic health records (EHRs) hold great promise of improving patient safety and decreasing medical liability exposure, but their use is creating a variety of new risk management and patient safety issues.

For some reason, the "great promises" made over the past fifty years still seem elusive...but we'll get it right some day...(perhaps when these issues among others are solved).

Some of these issues are directly associated with EHRs (e.g., providers disregard warnings generated by the EHR), but many of the risk concerns associated with EHRs are analogous to problems that currently exist in paper documentation systems.

The marketing puffery that today's EMR's are vastly superior to paper might be just that - marketing puffery.

In this month’s Claims Rx we present a number of shorter-than-usual case studies that exemplify various aspects of unsafe EHR documentation and communication practices. The scenarios are based on NORCAL closed claims, facts presented in appellate opinions, research findings and the observations of NORCAL Risk Management Specialists.

What many of the examples show is that EHRs do not eliminate many of the dangerous documentation and communication practices that have historically led to patient injury and malpractice lawsuits.

I would add "EHR's in their present form do not eliminate dangerous practices", designed as if they were clinical data inventory systems by business-IT eggheads rather than as clinical tools "of, by and for clinicians." (One might ask why we are about to spend 100+ billion dollars on them in national rollout the next few years.)

Consequently, while it is important to address new issues that arise with EHRs, many of the risk management recommendations that apply to a paper-based documentation system remain valid.

This Claims Rx will discuss the risks associated with various aspects of EHRs and will provide guidance for instituting policies and procedures designed to enhance the quality and safety of patient care, while diminishing professional liability risk.

A number of case examples then follow. I will reproduce two, but all can be read via downloading the PDF at the link above.

Saving Images in the Wrong Patient’s Chart

Just as an image can be misfiled or lost in a paper system, it can be misfiled in an electronic one. However, as the following case shows, it can be less obvious that an image has been misfiled in an electronic system.

Case Study

Patient #1 and patient #2 both presented to the Emergency Department (ED) complaining of abdominal pain. CT scans of the abdomen and pelvis were completed for both patients. A radiology tech mistakenly gave patient #2’s images the identification number assigned to patient #1 and uploaded the images into the Picture Archiving Computer System (PACS).

A short time later, the tech realized his mistake and called the on-duty teleradiologist to tell him about the mistake and request that the mislabeled images be deleted from the system. However, the on-duty teleradiologist did not have access to delete images from the PACS; this had to be done by the PACS administrator. The tech then corrected the labeling problem and sent the images out to the teleradiology service for a preliminary review and resent the correctly labeled images to the PACS.

Patient #1’s PACS file now contained both his own and patient #2’s images. A few days later the tech told his supervisor about the mislabeling, and assumed that the supervisor would remedy the problem. Pursuant to hospital policy, the tech should have immediately contacted the PACS administrator.

The teleradiology service reported that patient #1’s CT scan was normal. Patient #2’s CT scan, however, showed a large tumor (about the size of a grapefruit) on the patient’s kidney. The service faxed the reports to the radiology department at the hospital.

The next morning, the on-duty radiologist reviewed the PACS images from the night before. He disregarded the teleradiology service reports because they did not correspond to what he saw in the PACS. Because patient #2’s scan had been completed before patient #1’s, patient #2’s images were the first series in his file.

The on-duty radiologist noted the large tumor and dictated a note. Because patient #2’s images still carried patient #1’s identification number, the radiologist’s report was assigned to patient #1.

Patient #1 was subsequently seen by a number of specialists for the supposed tumor on his kidney. Seven days after the CT scan, he underwent a nephrectomy [lovely- ed.]. During the surgery, no mass could be positively identified on his kidney by his surgeons. Postoperatively, no tumor was identified in the removed kidney and pathology returned benign.

(Please note, once the filing mistake was recognized, patient #2 was notified and underwent a timely and successful nephrectomy.)

[In other words, through serendipity only one person was harmed, not two - ed.]

One wonders how many "cases" like this will arise out of the major-vendor EHR upgrade flaw that is claimed to have led patient data to go into wrong charts at not one, but several hospitals:

HIStalk Monday Morning Update 7/12/10

From Holy Smoke: “Re: Cerner. Misidentification incidents have been reported with Cerner PowerChart and Millenium in hospitals in Indiana, Michigan, and others after a Cerner upgrade. Entries are placed in the wrong electronic chart and reviewed data is for the wrong patient.” Unverified. I saw nothing in the FDA’s Maude database, so if it’s happening, customers should file an experience report.


(See my July 11, 2010 post '
Health IT and 'High Regulatory Standards': Criminal Negligence for Implementing Defective Systems That Put Data in the Wrong Charts?').

Next from NORCAL:

Checking the Wrong Box

In the following case, the appearance of the computer screen probably played a role in the medication error.

Case Study

A patient presented to his primary care physician (PCP) for the treatment of headaches and episodes of altered consciousness. The PCP prescribed amitripyline at 10 mg nightly. The PCP told the patient to escalate the dosage by 10 mg every three to four days until the pain was relieved, but not to exceed 50 mgs without consulting him.

When creating the prescription, the PCP intended to check off the 10-mg box in the computerized physician order entry (CPOE), but inadvertently checked the 100-mg box, which was right above it. In the medication instructions section, he indicated that five pills could be taken per night, so the patient would not have to return to the pharmacy and pay an additional co-pay if he ultimately needed the larger dose.

The pharmacist had noticed that the dose seemed high and requested that a call be made to the PCP prior to it being dispensed. A nurse at the PCP’s office picked up the call, and because she was very busy that day, told the pharmacy to dispense the medication as it had been ordered — she did not check the dose. Three days later, the patient took five of the 100-mg pills together. Early the next morning, the PCP was contacted by an emergency department (ED) physician who reported that the patient was in the ED reporting dizziness, an altered state of consciousness, an inability to coordinate his movements and a rapid heartbeat.

He was further informed by the ED physician that the patient had taken five 100-mg amitripyline tablets. The PCP then checked the patient’s record and realized his mistake.

[It's serendipitous that the patient was not in the morgue when the mistake was realized - ed.]

Read the rest of the cases and the explanations at the Electronic Health Records: Recognizing and Managing the Risks "Claims Rx" document from NORCAL here (PDF).

In these cases, both technological and "people" issues were responsible for the malpractice events.

However, healthcare is an extremely complex endeavor requiring exquisite attention to detail (or your patient's dead).

These IT systems could have been designed to provide cognitive, ease-of-use, and known-error revision (or at least known-error flagging) support to clinicians that could have helped prevent these errors.

HIT designers need to do their part if they want to be considered part of the clinical team.

If they don't do their part voluntarily and stop with the mission-hostile,1970's-paradigm "inventory system of widgets" health IT, as I've written before, they will increasingly find themselves part of that team in an involuntary manner - as defendants in litigation.

Finally, due to issues such as: an utter lack of governmental regulation of the HIT industry and a lack of defect and error reporting requirements; contractual gag and hold-harmless clauses (as raised by Penn researchers Koppel and Kreda in JAMA here); physician fear of hospital retaliation such as sham peer review for HIT whistleblowing especially now that more physicians are becoming hospital employees; and other causes, there is no reliable data on the incidence of EHR-related medical errors and malpractice.

As in my paper "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT", there is also no reliable data on "near misses" or potential IT related mishaps that were averted by serendipity. These near misses expose patients to risk. With no reporting, there is no systematic data that can be used for remediation and prevention.


I thus present once again the following thoughts from my post
Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records":

I believe we should hold off national Health IT roll outs until we:

  • learn sufficiently from failures such as the UK CfH and our own military's AHLTA debacle on how to avoid same, which can injure and kill patients and wastes massive money and resources healthcare can ill afford, and more importantly that can be better used elsewhere - such as care of the poor;
  • improve the technology's usability, safety and efficacy through the years of Medical Informatics and other disciplinary research needed, that was short circuited through the invention of the ONC office by Bush (although national HIT then remained a goal, not a mandate), and the 'militarization' of ONC under Obama whereby HIT was unilaterally declared a proven technology and mandated for national rollout;
  • end the contractual and fear-based censorship of information on health IT problems, and patient injuries and deaths related to the devices; and
  • meaningfully regulate these devices that have increasingly become governors of care delivery.
I have written extensively on these topics at this blog, at my academic website on health IT failure, and other sources (see list at end of my bio).

When there are significant doubts about a medication or medical device, we ought not push for national rollout.


Health IT devices have gotten special accommodation, and it's not on the basis of any rigorous science I am familiar with.


-- SS

Wednesday, July 14, 2010

Eli Lilly CEO on “America’s Growing Innovation Gap”

In “America’s Growing Innovation Gap”, WSJ, July 9, 2010, Eli Lilly CEO John C. Lechleiter, Ph.D. writes that:


“…the most important elements are the seeds of innovation, which equate to talented people and their ideas.”


He then suggests these people are “highly skilled immigrants” abroad.


In my own circle of friends, I know American pharma industry cast-offs who are both brilliant and talented. One with dual MS degrees in mathematics and computer science from a major university, one a skilled bioinformaticist I've had teach my healthcare informatics students as guest lecturer, one a brilliant programmer who could be considered the grandfather of computer image manipulation, another with years of expertise in pharma knowledge discovery.


Then there's me – former Director of a Merck R&D support group and of The Merck Index - with degrees in medicine and post-doctoral specialization in biomedical informatics and information science, plus I'm an extra-class amateur radio licensee who understands complex technology at a level far beyond that of the usual pharmaceutical company worker.

Yet no donuts for us. In recent years the pharmaceutical industry won’t grant any of us the courtesy even of an interview.

However, in Mar. 2009 as I documented here, I did receive an email solicitation from Lilly that read as follows ("sic's" are mine):

“Your Help Is Requested for a Eli Lilly Career Opportunity! (sic) I am a member of the Staffing Team at Eli Lilly. I were referred to me (sic) as person who specializes in pharmaceutical based informatics. I wanted to reach out to me (sic), to see if you maybe able (sic) to recommend anyone that could qualify for the below position (sic)."

I was not exactly inspired by this solicitation, perhaps written by one of the "highly skilled immigrants" Lechleiter covets.

Nor was I inspired by the earlier solicitation I documented at my Jan. 2009 post "What, Me Worry? Lilly Fined Over Zyprexa, Should Be Fined For eRecruitment Inanity As Well?"

I suggest if Mr. Lechleiter wishes to close America’s purported "innovation gap", he spend some time away from the executive castle and perhaps review some resumes – and the job solicitations his company proffers – in his HR department.

A cause of the "innovation gap" may be leadership xenophilia, at the expense of the American born-and-raised scientists the pharma industry is so fond of discarding.

-- SS

Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records"

In the NEJM article "The 'Meaningful Use' Regulation for Electronic Health Records", David Blumenthal, M.D., M.P.P. (ONC Chair) and Marilyn Tavenner, R.N., M.H.A. (10.1056/NEJMp1006114, July 13, 2010) available at this link, the opening statement is (emphases mine):

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.

I think it fair to say those are grandiose statements and predictions presented with a tone of utmost certainty in one of the world's most respected scientific medical journals.


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.

I also note the lack of mention of literature refuting or potentially refuting these statements of certainty. I can think of more than a few examples of the latter just off the top of my head [ref. 1-15 below, certainly not a comprehensive list but merely skimming the surface].

In politics, however, no such sourcing is necessary. It's easy for a politician to say "Free markets will not give us the healthcare system we want" or, conversely, "I never heard about the DOJ's selective dismissal of charges against people intimidating voters at a voting site in Philadelphia."

So, did the NEJM publish fact, or political platitude?

Can someone provide a list of peer reviewed, rigorous studies that back the assertions of certainty in 10.1056/NEJMp1006114, and override the body of literature that could cast doubt on these assertions of certainty?

Since it's people's lives at stake, not an inventory of widgets, I've promoted the idea of holding off on national roll outs until we:

  • learn sufficiently from failures such as the UK's NPfIT (National Programme for IT) in the NHS and our own military's AHLTA debacle on how to avoid same, which can injure and kill patients and wastes massive money and resources healthcare can ill afford, and more importantly that can be better used elsewhere - such as care of the poor;
  • improve the technology's usability, safety and efficacy through the years of Medical Informatics and other disciplinary research needed, that was short circuited through the invention of the ONC office by Bush (although national HIT then remained a goal, not a mandate), and the 'militarization' of ONC under Obama whereby HIT was unilaterally declared a proven technology and mandated for national rollout;
  • end the contractual "hold vendor harmless clauses" (see Koppel and Kreda's 2009 JAMA article here), and fear-based censorship of information on health IT problems, patient injuries and deaths related to the devices; and
  • meaningfully regulate these devices that have increasingly become governors of care delivery.

I have written extensively on these topics at this blog, at my academic website on health IT failure, and other sources (see list at end of my bio).

When there are significant doubts about a medication or medical device, we ought not push for national rollout.


Health IT devices have gotten special accommodation, and it's not on the basis of any rigorous science I am familiar with.

-- SS

References: (hyperlinks to these and others can be found at my medical informatics teaching sites here and here):

1. Health IT Project Success and Failure: Recommendations from Literature and an AMIA Workshop by Bonnie Kaplan and Kimberly D. Harris-Salamone. From the May/June 2009 issue of JAMIA.

2. "E-Health Hazards: Provider Liability and Electronic Health Record Systems.” Hoffman and Podgurski’s followup paper on EHR medical and legal risks

3. Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. Ross Koppel, PhD, et al, Journal of the American Medical Association, 2005;293:1197-1203

4. Electronic Health Record Use and the Quality of Ambulatory Care in the United States. Arch Intern Med. 2007;167:1400-1405. The authors examined electronic health records (EHR) use throughout the U.S. and the association of EHR use with 17 basic quality indicators. They concluded that “as implemented, EHRs were not associated with better quality ambulatory care.”

5. Pessimism, Computer Failure, and Information Systems Development in the Public Sector. (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand)

6.
Bad Health Informatics Can Kill. his site contains summaries of a number of reported incidents in healthcare where IT was the cause or a significant factor. It comes from the Working Group for Assessment of Health Information Systems of the European Federation for Medical Informatics (EFMI).

7. The U.S. National Research Council’s "Current Approaches to U.S. Health Care Information Technology are Insufficient."

8. The UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program.

9. Gateway reviews of the UK National Programme for IT from the Office of Government Commerce (OGC) (released under the UK’s Freedom of Information Act).

10. A report on the serious problems with the Department of Defense’s AHLTA system, Electronic Records System Unreliable, Difficult to Use, Service Officials Tell Congress. (This system, as I wrote here, is slated for abandonment. I cannot imagine it was greatly improving outcomes).

11. A New York Times report “Little Benefit Seen, So Far, in Electronic Patient Records” on Jha’s research at the Harvard School of Public Health, that compared 3,000 hospitals at various stages in the adoption of computerized health records and found little difference in the cost and quality of care.

12. An American Journal of Medicine paper “Hospital Computing and the Costs and Quality of Care: A National Study” by Himmelstein and Woolhandler at Harvard Medical School, that also concluded “as currently implemented, hospital computing might [very] modestly improve process measures of quality but not administrative or overall costs."

13. A Milbank Quarterly article “Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" by Greenhalgh, Potts, Wong, Bark and Swinglehurst at University College London.


14. Health Affairs, 29, no. 4 (2010): 639-646 Electronic Health Records’ Limited Successes Suggest More Targeted Uses, Catherine M. DesRoches et al.

15. NORCAL Mutual Insurance Company: "Electronic Health Records: Recognizing and Managing the Risks" (PDF
here)

Addendum 7/14:

I think this statement at "The Road to Hellth" blog in a post entitled "Meaningful Ruse" that cites my posts is apropos:

... Meaningful use entered our vocabulary in early 2009 as part of a $20+ billion gift from doctors, hospitals and the taxpayers to the needy folks at Cerner, GE, Siemens, Allscripts, Epic and other purveyors of complex, expensive and difficult-to-use and potentially even dangerous medical software products.

-- SS

Tuesday, July 13, 2010

New CMS Chief Donald Berwick: a Trojan Horse for Quackery?

On July 7, President Obama appointed Dr. Donald Berwick as Administrator of the Centers for Medicare and Medicaid Services (CMS). Dr. Berwick, a pediatrician, is well known as the CEO of the non-profit Institute for Healthcare Improvement (IHI), which "exists to close the enormous gap between the health care we have and the health care we should have — a gap so large in the US that the Institute of Medicine (IOM) in 2001 called it a 'quality chasm'.” Dr. Berwick was one of the authors of that IOM report. His IHI has been a major player in the patient safety movement, most notably with its "100,000 Lives Campaign" and, more recently, its "5 Million Lives Campaign."

Berwick's CMS gig is a "recess appointment": it was made during the Senate's July 4th recess period, without a formal confirmation hearing---although such a hearing must take place before the end of this Senate term, if he is to remain in the position. A recent story suggested that Obama made the recess appointment in order to avoid a reprise of "last year's divisive health care debate." The president had originally nominated Berwick for the position in April, and Republicans have opposed "Berwick's views on rationing of care," claiming that he "would deny needed care based on cost."

A "Patient-Centered Extremist"

If there is a problem with the appointment, it is likely to be roughly the opposite of what Republicans might suppose: Dr. Berwick is a self-described "Patient-Centered Extremist." He favors letting patients have the last word in decisions about their care even if that means, for example, choosing to have unnecessary and expensive hi-tech studies. In an article for Health Affairs published about a year ago, he explicitly argued against the "professionally dominant view of quality of health care":



I think it wrong for the profession of medicine—or any other health care profession, for that matter—to “reserve to itself the authority to judge the quality of its work.” I eschew compromise words like “partnership.” For better or worse, I have come to believe that we—patients, families, clinicians, and the health care system as a whole—would all be far better off if we professionals recalibrated our work such that we behaved with patients and families not as hosts in the care system, but as guests in their lives. I suggest that we should without equivocation make patient-centeredness a primary quality dimension all its own, even when it does not contribute to the technical safety and effectiveness of care.

A new definition. My proposed definition of “patient-centered care” is this: The experience (to the extent the informed, individual patient desires it) of transparency, individualization, recognition, respect, dignity, and choice in all matters, without exception, related to one’s person, circumstances, and relationships in health care.

Does this mean that Dr. Berwick would also eschew professional, i.e., expert, judgment in favor of patients' wishes? In a word, yes:

Evidence-based medicine sometimes must take a back seat. First, leaving choice ultimately up to the patient and family means that evidence-based medicine may sometimes take a back seat. One e-mail correspondent asked me, “Should patient ‘wants’ override professional judgment about whether an MRI is needed?” My answer is, basically, “Yes.” On the whole, I prefer that we take the risk of overuse along with the burden of giving real meaning to the phrase “a fully informed patient.”

Dr. Berwick is not so naive as this opinion might suggest. He envisions a "mature dialogue" in such a case, and argues that "if, over time, a pattern emerges of scientifically unwise or unsubstantiated choices...then we should seek to improve our messages..." He also admits that there might be an occasional patient whose demands are so unreasonable that "it is time to say, 'No'." That exception, he argues, should not dictate the rule.

There are situations in which most civilized people would agree with Dr. Berwick's view of 'patient-centeredness'. In both the Health Affairs article and in his recent address to the 2010 graduating class of the Yale School of Medicine, he offered real examples of petty, arbitrary hospital rules causing unnecessary sorrow for patients and their loved ones. It is in such contexts that he makes a convincing case that health professionals ought to behave "as guests in their lives." In an interview for the New York Times, he argued:


We don’t have a standard of services or processes that are comfortable for patients. We have built a technocratic castle, and when people come into it, they are intimidated.

Nothing to disagree with there. To create that standard, moreover, would not undermine settled medical practice ethics---it would celebrate them, even as it rightly embarrasses the profession for having taken so long to do so.


Enter the Woo

Eschewing the scientific basis for modern medical practice, however, is another matter. In February of 2009, Dr. Berwick gave a 'keynote' address at the IOM and Bravewell Collaborative-sponsored Summit on Integrative Medicine and the Health of the Public. He shared the podium with Mehmet Oz, Dean Ornish, Senator Tom Harkin, and other advocates of pseudoscientific health claims. I wrote about the conference at the time, mainly to call attention to its misleading use of the term "integrative medicine": literature emanating from the Summit characterized it as "preventive" and "patient-centered," whereas the only characteristic that distinguishes it from modern medicine is an inclusion of various forms of pseudomedicine.


I noticed that Dr. Berwick was on the speaker roster, which I found disappointing: I imagined that he had either gone over to the Dark Side or, perhaps, was sufficiently naive about the topic to have been duped; or, more likely, that he had cynically accepted the offer to further his ambitions. I didn't bother to listen to his speech until the CMS appointment was announced a few days ago.

It is troubling, to say the least. Dr. Berwick did not argue, as he had in the NYT piece, that "If we doctors feel a person is going to make unwise choices, we have to take on the responsibility of being teachers, educators and informers." Rather, he praised his fellow speakers, most of whom were spouting nonsense, for their "reach" and "eloquence." He praised the IOM for its "glorious record...in pursuit of better designs in health care...traditional, allopathic curative care and now migrating into this distinguished and important new arena." He mentioned homeopathy and acupuncture, not to wonder why they should be promoted as effective, but merely to warn that they will fail---presumably in some economic sense---if they try to compete with each other for reimbursement.

Such language, and Dr. Berwick's very presence at the Summit, were a far cry from advocating "patient-centeredness." What they amounted to was a generous endorsement of pseudoscientific practices and of the socio-political movement that promotes them. Even granting some naivete on his part (he called himself "an amateur at this topic"), he must have known this. Such an endorsement, unlike tearing down the "technocratic castle," has ethical implications at least as profound as those that Dr. Berwick tacitly or explicitly relies upon to support his arguments for patient-centeredness.

"Physicians have no Immunity to Moral or Ethical Constraints"

The relevant medical ethics treatises (reviewed here) are in substantial agreement that it is unethical for physicians to prescribe scientifically implausible methods or to refer patients to other practitioners for the same purpose. They are also in agreement that it is unethical to prescribe a placebo to a patient while claiming that the treatment has specific biologic activity---a point that has been vigorously argued in the UK this year, with regard to homeopathy. These ethical tenets are not mere odes to nerdy, sciency thinking; they are matters of honesty and integrity---fundamental bases for ethical interactions between physicians and patients.

In 1983, philosophers Clark Glymour and Douglas Stalker published an article in the New England Journal of Medicine titled “Engineers, cranks, physicians, magicians.” They framed modern medicine as follows, comparing it to what was then called "holistic medicine" (the article is quoted extensively here):



Medicine in industrialized nations is scientific medicine. The claim tacitly made by American or European physicians, and tacitly relied on by their patients, is that their palliatives and procedures have been shown by science to be effective. Although the physician’s medical practice is not itself science, it is based on science and on training that is supposed to teach physicians to apply scientific knowledge to people in a rational way.

The practice of medicine in the United States and in other industrialized nations is a form of consultant engineering...

That statement is just as accurate now---even more so, in this era of Evidence-Based Medicine---as it was nearly 30 years ago, even if some might find the likening of medicine to engineering displeasing. Nor is it at odds with almost any definition of "patient-centeredness," other than one that presumes that the patient's desires trump the physician's ethics:



A physician engineer can act as consoler; nothing in either logic or social psychology forbids it. But certain combinations are impossible or extraordinarily unlikely. A physician engineer cannot honestly claim powers of magic or occult knowledge. The principles governing scientific reasoning and belief are negative as well as positive, and they imply that occult doctrines are not worthy of belief. Moreover, physician engineers have no immunity to moral or ethical constraints. On the contrary, they are by training and by culture enmeshed in a tradition of rational thought about
the obligations and responsibilities of their profession.

Dr. Berwick---if he really believes what his presence and words at the "Integrative Medicine" Summit imply---is playing with ethical fire. (If, as I hope, he doesn't really believe those things, he's playing with ethics of another kind). Will we begin to see pseudomedicine "integrated" into Medicare and Medicaid? That is certainly the expectation of those who observed Dr. Berwick's performance at the Summit, and who appear intent to hold him to his word.

KA

Two other blogs that have addressed this issue are:

Dr. RW: Not only evidence based medicine but science based medicine may take a back seat in Donald Berwick's vision for patient centered care

Dr. David Gorski: Dr. Donald Berwick and “patient-centered” medicine: Letting the woo into the new health care law?