Is Medtronic CEO Abrogating Responsibility Of His Company To Determine Device Safety?

It would appear so. If this is the case, this CEO and his board of directors should be dismissed as a danger to the public. The CEO, William A. Hawkins III, being a biomedical engineer, would take special blame for this distorted attitude.

In "Pre-emption' Cited as Major Case Is Tossed", Wall Street Journal, Jan. 7, 2009 we learn that a federal judge, U.S. District Judge Richard H. Kyle in Minneapolis, threw out lawsuits on behalf of thousands of patients with heart-defibrillator wires that have been shown to fracture and fail to function or dispatch potentially lethal shocks, concluding that a recent Supreme Court opinion made the dismissals inevitable.

Judge Kyle did allow that "the Court recognizes that at least some plaintiffs have suffered injuries from using Sprint Fidelis leads, and the Court is not unsympathetic to their plight," he wrote. Nevertheless, he said, the plaintiffs' remedy "lies with Congress."

Such a dismissal at his level is understandable on procedural grounds, but reflects problems in the laws and procedures rather than in the ability of rigorous, honest, uncorrupted medical science to help prevent such patient harm (and the need for resultant suits) in the first place.

In the article we also learn that:

At issue is the Sprint Fidelis defibrillator "lead," a wire that was the top such product world-wide when Medtronic Inc. pulled it from the market in October 2007. Defibrillators are electrical devices placed under the skin in a patient's shoulder. Connected to the heart, they have saved thousands of lives by sending out powerful jolts of electricity, restarting the normal pattern of an abnormally beating heart.

But defibrillators depend on the leads to carry that electricity to the heart, and the exceptionally thin wires have over decades tended to fail at a higher rate than the devices themselves.

The Sprint Fidelis had been surgically implanted in 268,000 patients world-wide when the Minneapolis company concluded it was fracturing at a higher rate than that of its more robust predecessor, the Sprint Quattro.When the wires fractured, some patients died, either allegedly because the defibrillator failed to dispatch electrical therapy to the heart or because the massive and multiple shocks may have caused patients' hearts to stop.

... Medtronic reports that its 42-month failure rate from all causes is 6.3%, far more than the 1.8% failure rate for its predecessor, the Sprint Quattro model 6947, at 48 months.

The obvious issue that exceptionally thin wires might fail at a higher rate in a living, moving body and heart is a key to understanding the major scientific issue here. It is one of medical and engineering common sense, both of which appear to have been lacking regarding this product (or perhaps were overruled by management fiat).

New and experimental drugs are known to pose risks. This is why pharmaceutical companies are required to do preclinical testing in animals, and, in fact, in good conscience would never presume to release a drug without years of extensive animal testing, even before the first human ever tries a new compound. It is realized that animal testing is a straightforward, first-tier way to eliminate the possibility a new drug is going to have 'hidden surprises' that could kill people.

In the WSJ we learn, however, that:

By early 2007, Sprint Fidelis was the lead used in 90% of new Medtronic patients, garnering about $1 billion in revenue since its introduction in late 2004.

The lead was marketed based not on any multiyear study in hundreds of human patients, but rather on "bench testing" of the product in a laboratory to determine how easily it might fail by putting multiple stresses on it.

Excuse me? Bench testing of a wire lead to be implanted in a beating human heart?

The key to this entire issue and how to help avoid it in the future lies in the last sentence.

That is a stunning admission if accurate.

As a physician and biomedical informaticist who did a clerkship in biomedical engineering in medical school, as an expert in building invasive cardiology information systems to in part evaluate cardiac device safety and efficacy, and as an NIH SBIR grant reviewer in the area of public health, had this been an NIH proposal for funding of development of the new wire I would have scored an application for such development of a defibrillator lead that lacked animal testing at the very bottom of the pile (lowest score).

I would also have argued vehemently at the roundtable discussion that the proposal needed revision to include such testing in a rigorous manner before it could even be considered seriously.

Apparently, private R&D in the device industry, funded by stockholders and insurance companies and patients themselves, does not undergo such rigorous review as proposals seeking public money.

If the WSJ account is accurate, and no animal testing was done, then real, live patients, not animals, became the front line for clinical testing of a new experimental device. Some paid with their lives.

If so, this is unacceptable.

The belief that bench testing (and likely computer modeling, per my post here on overconfidence in computing) of a device made with complex materials, themselves subject to the vagaries and uncertainties of materials science let alone living systems, is adequate for immediate in vivo use in humans is perhaps the biggest worldview gap between linear-thinking engineers and computer personnel on the one hand, and clinicians and life scientists on the other used to complexity and uncertainty in living systems. The linear, grade school level thinking about biomedical issues must stop.

If the WSJ account is accurate, the following questions must be asked:

• Who made the decision to not do animal testing? Why?
  
• Was input from clinicians, scientists or others that such testing should be done raised? If not, why not?
• Was such input if it occurred overridden? If it was overridden, did the managers who overrode it have appropriate biomedical backgrounds to have overridden it?
• Were profit issues a cause of lack of in vivo testing in animals of the new lead?
  
• Does biomedical engineering as a discipline forego animal testing of devices meant for human use? If so, why? If not, why was it overridden here?
  
• Did anyone in Medtronic object to release of this wire lead on the grounds of inadequate testing? If not, why not?
• If anyone did object to release, were such objections overridden, and who did the overriding based on what criteria?

We perhaps get to the root of the problem in this admission in the WSJ article - the familiar (to HC Renewal readers) issue of leadership:

Medtronic Chief Executive Bill Hawkins lauded the decision [to dismiss the lawsuits] as supporting "the principle that the U.S. Food and Drug Administration is the appropriate body to determine the safety and efficacy of innovative technologies."

Mr. Hawkins seems to be implying that Medtronic is not an appropriate body to determine the safety and efficacy of its products. It would appear he is abrogating primary responsibility for the safety of his company's product, putting that responsibility in the hands of a government agency. I can presume his Board of Directors agrees with this assessment.

This is wrongheaded, cavalier, and has been the basis of recent major individual and class action lawsuits against the pharma industry. The medical device industry should not get a pass.

It is the primary responsibility of a medical R&D and manufacturing company to do all it can to reasonably determine the safety of its experimental devices and their iterative "improvements" before seeking approval for sale and use in humans.

FDA's role is to simply assure that the determination meets sound scientific, biomedical and legal grounds. They are not, should not be, and cannot be a "safety determination subcontractor" to industry.

It seems both Medtronic and FDA failed on this case, in fact. I addressed why making FDA the ultimate arbiter of safety was, in fact, itself risible and cavalier, in my post "Staring Idiocy In The Face: The FDA As The Gold Standard, Or Tin Plated Emperor?" regarding musician Diana Levine's unfortunate loss of her arm from a misapplied drug injection.

In any case, anyone with medical training who has had responsibility for direct patient care would have little trouble understanding the principle of not passing the buck on safety. Mr. Hawkin's lack of this experience, I add, seems to show in his stunning passing of the buck for safety to government.

If I were on the board of this company, a management house cleaning would be in order.

-- SS

The "Scorpions in a Bottle" Shook Hands - A Secret Deal Between a Health Care System and a Managed Care Organization

The Boston Globe just published a series of investigative reports about a case that illustrates what went wrong with last 20 years' paradigm of health care reform. Remember how business-like management and competition were going to control health care costs (while improving quality and access)?

The reports focus on how Partners Healthcare, the health care system formed from the merger of the Massachusetts General Hospital and the Brigham and Women's Hospital, was able to use its position and prestige to improve its reimbursement. The key points from the key article:

- The merger occurred in a climate of deregulation and laissez faire, based on the theory that managed care would damp down hospital costs

Formed in an era of fervent deregulation, Partners has benefited throughout its history from remarkably limited government oversight, considering the vast impact of the merger on the medical marketplace. The administration of Governor William F. Weld never held a public hearing before approving the merger of the state's two biggest hospitals. And the state sharply curtailed regulation of hospital expansion in the 1990s, freeing Partners to dramatically expand into the suburbs, drawing patients and revenue from already struggling community hospitals.

Weld and the Legislature unleashed the forces that led to the creation of Partners when they ended the state's authority to regulate hospital rates in 1992. Beacon Hill wanted to force hospitals to jockey for contracts with savings-minded HMOs, which, at the time, sent their members only to select hospitals and doctors.

'I favor putting the scorpions in the same bottle . . . and letting them fight it out,' said Democrat Edward L. Burke, then cochairman of the Legislature's healthcare committee.

- The rationale for the 1993 hospital merger was cost control

But at the press conference announcing the deal in December 1993, leaders of the two hospitals said their alliance would only make them greater. They described twin ambitions underpinning their once unthinkable alliance: to build a high-quality healthcare system, and to save money. A lot of money.

They said their goal was to cut 20 percent out of their combined $1.2 billion annual budget, which meant saving $240 million a year.

'Put it this way,' said Dr. J. Robert Buchanan, who was then the head of Mass. General. 'We're pretty sure we've got to save 20 percent at minimum.'

The Boston Consulting Group, which helped facilitate the merger, told the hospitals that they could reduce annual costs by between 12 percent and 28 percent, according to a description of the consultants' analysis in a 1996 Harvard Business School study of the merger. Partners would not provide the consultants' recommendations to the Globe.

- But these plans soon went awry. The merged health care system did not control costs

But Partners made only a small fraction of the cuts. The company claims that the merger saved $200 million to $250 million - total - over five years.

Those savings came almost exclusively from administrative consolidation. The two hospitals have rarely collaborated on clinical operations. In fact, soon after the merger, Mass. General opened a new obstetrics unit that would compete with its sister hospital at a time of declining births in Massachusetts.

Partners' current management denies that saving such large sums was ever the intention, and argues the smaller amount they did save was a commendable achievement. Jay B. Pieper, then the Brigham's chief financial officer and now a Partners vice president, suggested there was no basis for the comments Buchanan made at the press conference.

'Everybody kind of scratched their head and said, 'Bob, what did you mean?' ' Pieper said.

According to Pieper and others, melding of medical services would not have saved much since each hospital had programs large enough to achieve economies of scale on their own. Consolidation would have inconvenienced patients and driven away top physicians, they said.

But Buchanan and other Partners founders told the Globe recently that their original intention had been the consolidation of services, at least for rare treatments, and possibly many more. The idea was "to have at least one superb major teaching hospital when all this is over," said Dr. Eugene Braunwald, Partners' former chief of research, who said that didn't happen because their finances never deteriorated to the point they had feared.

The year before his death in 1998, Partners cofounder Dr. H. Richard Nesson told the Globe that he was still looking for ways to consolidate.

'I do not believe, for example, that we should both be doing every kind of transplant,' Nesson said.

A decade later, Partners continues to offer an array of competing transplant programs, even though surgeons sometimes struggle to find enough work to keep skills sharp.

- As the merged hospital system concentrated its power, the state's biggest insurer abandoned any pretense of negotiating down its costs

It was the gentleman's agreement that accelerated a health cost crisis.

And Dr. Samuel O. Thier, chief executive of Partners HealthCare, and William C. Van Faasen, chief executive of Blue Cross Blue Shield of Massachusetts, weren't about to put it in writing.

Thier's lawyers cautioned that a written agreement between the state's biggest hospital company and its biggest health insurer that would make insurance more expensive statewide might raise legal questions about anticompetitive behavior, according to officials directly involved in the talks.

And so, in May 2000, the two simply shook hands on this: Van Faasen would give Partners doctors and hospitals the biggest insurance payment increase since Massachusetts General and Brigham and Women's hospitals agreed to join forces in 1993.

In return, Thier would protect Blue Cross from Van Faasen's biggest fear: that Partners would allow other insurers to pay less. Those who helped broker the deal say Thier promised he would push for the same or bigger payment increases for everything from X-rays to brain surgery from Van Faasen's competition, ensuring that all major insurers would face tens of millions in cost increases. Blue Cross called it a 'market covenant.

The deal, never before made public, marked the beginning of a period of rapid escalation in Massachusetts insurance prices, a Spotlight Team investigation has found, as Partners repeatedly used its clout to get rate increases and other hospitals tried to keep up. Individual insurance premiums have risen 8.9 percent a year ever since the "market covenant," state figures show, more than twice the annual rise in the late 1990s.

- Then the hospital system used its dominant position to extract higher reimbursement from other insurers

Dr. Harris Berman said he felt like he'd wandered into an ambush.

The chief executive of Tufts Health Plan thought he had been invited to the Prudential tower on Oct. 23, 2000, to continue contract talks with top Partners officials. Thier, the Partners chief, wanted a substantial increase in payments for medical services, $100 million more than Berman was willing to pay for the care of his members over three years.

But Thier was done talking. He told Berman that Tufts insurance would no longer be accepted at Partners starting April 1. It was a devastating blow to Tufts' business. Almost as soon as Berman left his office, Thier launched a million-dollar marketing campaign to drive the point home. Signs went up at Partners reception desks notifying Tufts members that their insurance would soon be denied. A new website told them how to switch insurers. A call center in Texas was set up to field questions from worried patients and doctors.

Within days, major employers and thousands of Tufts members began threatening to cancel their policies. Tufts surrendered in little more than a week.

'I finally concluded, in the middle of the night one night, that our very viability was at stake,' Berman recalled later.

The humiliation of Tufts became an object lesson for other insurers, a lesson they would not soon forget.

- The result was markedly higher health care costs, and a big premium to Partners

Blue Cross has increased the rate it pays Partners by 75 percent since 2000, far more than increases given to other teaching hospitals that mainly treat adults. Other insurers have boosted payments to Partners by a similar amount.

Ellen Zane, Partners' chief negotiator in 2000, said she didn't realize the extent to which other hospitals were not keeping up with Partners until she left to become president of Tufts Medical Center in 2004.

'It turned out that insurers didn't support all hospitals as we thought they would,' said Zane, who said her hospital won't survive if insurers don't substantially increase reimbursement rates. 'I was quite surprised by the rate disparity when I came to Tufts Medical Center. In some ways, it defied logic.'

Tufts' patients, on average, are sicker than either Mass. General's or the Brigham's, based on a standard measure of patients' average severity level. But Tufts Medical Center is paid about 35 percent less, according to confidential Blue Cross rate information obtained by the Globe.

The cozy deal between Partners and Blue Cross and Blue Shield is now the subject of a state investigation, nine years later, according to this Boston Globe article:

Governor Deval Patrick will convene a panel of top state officials Monday to look into whether a recently disclosed, eight-year-old agreement between Partners HealthCare System Inc. and Blue Cross Blue Shield of Massachusetts drove up healthcare costs, making it harder to extend healthcare insurance to all residents.

The panel will also look at current contract negotiations between Partners, the state's biggest health care provider, and healthcare insurers to see whether the negotiations might also create artificially high rates that threaten healthcare reform, officials said.

And the Globe editorialized, in a rather subdued way, that the sort of "negotiation" that occurred between Partners and the state's biggest insurer was not the best way to do things:

But this is more than a case of men and women in white jackets putting one over on the suits at Blue Cross Blue Shield of Massachusetts and the other insurers. Especially now that the state is committed to health coverage for all its residents, anything that pushes up overall costs is the state's business.

Still, the higher rates that Partners-affiliated institutions outside of Boston generally get from insurers push up the state's overall health bill each time a suburban resident has a procedure done at a Partners facility and not at a lower-cost community hospital.

In the long term, rate-setting should move away from the private contracts that providers and insurers carve out together to ones based more on performance, with the state setting an allowable range for each procedure. In the best of all worlds, such rates would be universal - covering Medicare and Medicaid as well as privately insured patients - and would thus end the systematic underpayment of hospitals like Boston Medical Center and Cambridge Health Alliance that serve more low-income patients.

During the 1980s, many "health care reformers" pushed to take control of health care away from the doctors' "guild," which was blamed for ever rising costs, and give it over to bureaucrats and managers. They would be able to fix the "market failure," and provide health care in a business-like manner. By having private entities compete and negotiate with each other, a brave new world of low cost, accessible, high quality health care would ensue. (See post here.) Or that was the idea, but then it went so wrong.

The case of the market dominance of Partners Healthcare in Massachusetts shows how health care organizations unfettered by regulation, run by businesspeople, maximized their own financial results, but simultaneously caused vigorously rising costs. Whether the brave new world improved quality or not is an open question.

But why did it all go so wrong? In this case, a key question is why did Blue Cross and Blue Shield of Massachusetts so readily surrender to Partners' demands? The only explanation provided by the Globe article was this:

As the state slashed oversight of healthcare, no private company was able and willing to moderate Partners' ambitions. Blue Cross, which now controls 60 percent of the health insurance market, was best positioned to do so but flinched at the possibility of a public tangle. As former Blue Cross executive Peter Meade said at a meeting of company executives in 2000 at which some urged a tougher stand against Partners: 'Excuse me, did anyone here save anyone's life today? We are a successful business up against people that save people's lives. It's not a fair fight.'

That doesn't make a whole lot of sense. Admittedly, Partners, composed of two very prestigious hospitals, was known for the excellence of its care. However, a "tougher stand" did not require trashing the hospitals' reputation. Partners was arguing that its two hospitals were so much more excellent than some of Boston's other excellent academic teaching hospitals that they deserved very special treatment. (Full disclosure: please note that as a medical student, I did several rotations at one of those other excellent medical centers, now the Beth Israel Deaconess Medical Center, and I did my internship and residency and another one of those excellent medical centers, now Boston University Medical Center.)

Why were Blue Cross and Blue Shield leaders unwilling to reply? And why have they continued to increase Partners' disproportionate reimbursement without second thoughts, as long as what they were doing did not see the light of day?

The fact that the deal was never put in writing, much less fought over in the media, suggests that those who signed it were uneasy about it. So why did they do it?

There are no clearer explanations, leaving only speculation. But watch Health Care Renewal for our speculation about why the "scorpions in the bottle" became best of friends.

Meanwhile, this case illustrates just some of the consequences of health care run by bureaucrats and managers operating in secrecy and unfettered by external accountability.

Pharma Takes Baby Steps in Health IT, learns CP/M

CP/M was the predecessor and template Bill Gates used (bought, in fact) for DOS, of course. CP/M is primitive, over three decades old, decidely "old fashioned", and to just be learning it today would decidedly make an organization appear a laughing stock.

In "Pfizer Project Looks at Side Effects", Wall Street Journal, Jan. 2, 2009 (subscription required), we learn that:

Drug maker Pfizer Inc. is joining with two Boston hospitals to test whether computerized patient records can be used in helping federal regulators detect dangerous drug side effects. [VERY innovative of them. Perhaps this George Jetson-ish idea came from their CEO, former head lawyer for McDonald's? - ed.]

Massachusetts General and Brigham and Women's hospitals are encouraging 30 of their doctors to report serious side effects to the Food and Drug Administration by making the reports part of their normal routine filling out electronic patient charts.

... "The public-health impact is much quicker recognition of problems with medicines," said Jeffrey A. Linder, a Brigham and Women's internist who is leading the three-month pilot. The two hospitals belong to the Partners HealthCare system.

Indeed. This article might better have been titled "An Experiment With The Obvious."

We also learn that:

Martin P. Solomon, another Brigham and Women's internist, said he had submitted only a half dozen reports in 32 years of seeing patients because the [written - ed.] reports took so long to fill out and send. Since the study began Dec. 9, Dr. Solomon estimates he has filed at least a dozen.

Removing inconvenience is simply good sociotechnical engineering for ultra-busy doctors. Workflow 101 for simpletons.

Sociotechnical refers to the interrelatedness of social and technical aspects of an organization. Sociotechnical theory therefore is about joint optimization, with a shared emphasis on achievement of both excellence in technical performance and quality in people's work lives.

Now, thirty doctors is rather a minority of doctors in these venerable institutions. The amount of data to be entered is rather straightforward:




The cost of this experiment is far less than the cost of one glossy drug ad:

Pfizer, which has agreed to pay the hospitals $226,806 for the project, has talked with a few other pharmaceutical companies beyond Lilly about expanding the Boston approach, said Michael A. Ibara, a drug-safety official at the New York company. Pfizer has given an additional $117,000 to support groups that developed the technology.

Even at these low figures, excuse me? "Pfizer has given an additional $117,000 to support groups that developed the technology?" What technology, exactly? The same technology I use to send reports of my Mac OS X application crashes to Apple, perhaps?

The question really is, why do we need a funded experiment with 30 doctors to do what EHR experts have been proposing as a possibility for decades, namely, improved postmarketing surveillance? All that's really happening is an increase in convenience away from using paper forms and mailing them. I presented this issue a decade ago as a simple side benefit of EHR, for example, at an Ethics & Public Policy Center conference on healthcare in Washington. It has been brought up over the years by many others. I brought up the possibility of linking to academic centers with EHR's at Merck as well to gather postmarket data, to no avail.

So, why is pharma taking the baby step of soliciting adverse events reports electronically through an incredibly miniscule, cheap study?

This initiative's lilliputian scope is laughable.

It's decades behind the times and the capabilities of modern information systems. It's as if pharma has decided to learn CP/M in 2009. This raises several questions:

• Why did this "experiment" not happen long ago?
  

• Why not go with a much stronger effort at collecting this data, which then opens up excellent opportunities for further research - as I pointed out in my 2003 paper "A Medical Informatics Grand Challenge: the EMR and Post-Marketing Drug Surveillance" (pdf, link)? I'm not sure what you can do in that regard with data from a mere 30 doctors.
  

• Why not spend pharma-sized money on the project to allow the above to occur? After all, billions of dollars are spent annually on "gifts" to doctors and DTC advertising. Direct to patient (consumer) marketing expenditures of Pharma – est. $30 billion / year. (The entire NIH budget not long ago - est. $28 billion/yr.)

• CRO's are moving to electronic CRF's (case report forms). What's the hangup on use of EHR's to report drug AE's in patients not involved in a clinical trial?
  

The best answer I can propose: perhaps such capabilities will provide information that pharmas would rather have become apparent in a much longer timeframe. Time is, after all, money.

However, such an initiative can provide great P.R. on just how leading edge pharma is becoming in leveraging the EHR. The Wall Street Journal article looks like something Pfizer's CEO would be proud to show grandma - and its marketing people to brag about to the public. I can't wait for the TV infomercial.

CP/M is, after all, a great operating system to tinker with when experimenting with computers to learn if they can help run an international business enterprise.

-- SS

BLOGSCAN -PharmaLot Bows Out

Say it ain't so, Ed. PharmaLot, one of the best health care blogs, in my humble opinion, and the premiere news blog about the pharmaceutical industry, is ending its run. Its author, Ed Silverman, took a buyout from the Newark Star-Ledger, the blog's parent organization. I hope somehow, somewhere, a replacement spring up, and that Ed Silverman goes on to bigger and better things. So long, Ed, we'll miss you.

The Health IT Clueless, Or, Mr. Obama Gets Wrong Cautions on HIT

Yet another "Health IT insta-pundit" article has appeared in national media.

In "Letter highlights hurdles in digitizing health records", Jan. 1, 2009 the Boston Globe reports:

David Blumenthal, a Harvard Medical School professor and director of the Institute for Health Policy at Massachusetts General Hospital/Partners Healthcare System who advised the Obama campaign on the issue, said the debate over whether existing technology is good enough has only emerged recently, with the prospect of a huge national investment in electronic health records. What seems to be happening, he said, is that passionate health technology advocates fear the country could get locked into an imperfect system.

"I think this really is a question of how good does it have to be before you pull the trigger," he told the Globe in an interview. "There's no correct answer to that, but for me, the evidence tips toward acting now, not with total abandon, but making a substantial but prudent investment in health IT."

All of the quoted commenters focus on "technology" in one aspect or another.

"It's immensely complicated," said Melissa Goldstein, a health policy professor at The George Washington University's School of Public Health and Health Services.

But Goldstein remains optimistic about the prospects of working through those [technology -ed.] complexities to create a functioning system. Data sharing is slowly improving, she said. "Remember when Apple didn't talk to WordPerfect and Microsoft Word? It's similar; it takes a long time to get there."

Sure, and interfacing two computers is as hard as brain surgery... lack of data sharing standards is a problem, but not the major problem towards implementing HIT effectively, in hospitals and offices, on the first attempt. And then improving it.

As it turns out, the technology and its "imperfection" is not the issue. In fact, the technology (e.g., hardware and software, controlled terminologies, storage and backup capabilities, etc.) has had the capability to afford significant improvements in healthcare for quite some years.

It's the "wetware" that's the problem - the thinking, the process, the people issues, the sociotechnical issues. The leadership, design, implementation and lifecycle methodologies, the devil in the details, the bull in a china shop approach, the business IT ideology inappropriately applied to healthcare, if you will.

It's not as if material on the real problems, on the true major bottlenecks, in making HIT work in real clinical settings has been lacking. My own site (started 1998, link) and the links to the many writings of numerous researchers and observers here, are straightforward examples. It's not as if the UK, for example, is not in severe trouble from their own admitted (e.g., Granger) early lack of appreciation for these issues, and that the travails in that country are unavailable to the public, let alone academia.

Maybe the contributors to this Boston Globe article hadn't seen the Joint Commission Sentinel Events Alert on HIT? (If not, why not?)

The focus of that alert was minimally on technology per se, and maximally on sociotechnical issues: inadequate planning, insufficient testing or training, failing to include front-line clinicians in the planning process, failure to consider best practices for HIT operationalization, failure to consider the costs and resources needed for ongoing maintenance, failure to consult product safety reviews or alerts or the previous experience of others, over-reliance on vendor advice, failure to carefully consider the impact technology can have on care processes, workflow and safety ... need I go on?

From that alert (and not from the Boston Globe's quoted pundits):

... The science of the interplay between technology and humans or ‘human factors’ is important and often gets short shrift [as in the advice President Elect Obama is getting - ed.],” says Ronald A. Paulus, M.D., chief technology and innovation officer, Geisinger Health System.

If not carefully planned and integrated into workflow processes, new technology systems can create new work, complicate workflow, or slow the speed at which clinicians carry out clinical documentation and ordering processes. Learning to use new technologies takes time and attention, sometimes placing strain on demanding schedules. The resulting change to clinical practices and workflows can trigger uncertainty, resentment or other emotions that can affect the worker’s ability to carry out complex physical and cognitive tasks.

Indeed. I also note that "emotions" are as far from "technology" as one can get.

Even "perfect" technology misimplemented or misused fails.




These systems are virtual clinical tools that happen to involve computers to facilitate healthcare, not IT cybernetic miracles that happen to involve clinicians. One can't develop a "system", even an imperfect one, in an environment of chaos on the ground duplicated in myriad hospitals and offices.

The stories of HIT mayhem and, dare I say, idiocy I frequently hear about HIT projects from doctors and RN's and other clinicians sometimes makes my hair stand on end. Clueless project leaders and vendors, lackadaisical and cavalier attitudes towards risk caused by this technology, boneheaded beliefs that one dataset fits all clinical specialties and geographic locations, and on and on. I experienced the same project and patient threatening idiocy a decade ago as a CMIO, and yet little appears to have changed.

It's been said that "irrational exuberance" is the behavior exhibited by people who know little about an area, but who have trust in others who seem to be experts and who themselves seem enthusiastic. (This is how our latest financial debacles occurred.) Prof. Blumenthal exhibits some caution, but the wrong caution in my opinion. This could perhaps be called "misguided exuberance."

President Elect Obama is getting fed cautions about health IT, but the wrong cautions.

That those advising President Elect Obama on health IT choose to focus on "technology" issues, not sociotechnical issues, shows that some are largely clueless about health IT, or perhaps conflicted.

It's so tiring to hear these shallow, hackneyed, see the leaves but miss the trees and miss the forest, grade school level explanations for the difficulties of health IT.

Make prudent investments in health IT? How about first making prudent investments in bringing the understanding of why HIT is so difficult up to, say, a college level?

Incidentally, one of our fetishes in academia is for peer review, whether it be of science (absolutely necessary) or opinion on social issues backed by observation (where peer review can create a form of censorship towards unpopular thought.)

As for peer review, could it be that "anecdotal" stories from all over the world of health IT mayhem and patient harm are irrelevant unless peer reviewed? Of course, such stories would likely not pass peer review for publication. Perhaps such accounts are deemed non politically correct or create uncomfortable cognitive dissonance regarding the omnipotence of computers. Perhaps this explains their scarcity in peer reviewed literature. (Thank god for the Web and for blogs).

I would ask each of the pundits in the Boston Globe article if they were aware of these issues and the literature describing them (if not, that's a real problem), and if they were aware, why they dismiss it or consider its relevance unworthy of mention in national publications and to the President Elect.

Let's hope Mr. Obama is smarter than the average HIT pundit.

-- SS

“Consumer Choice” and Complexity

One of the conservative mantras in recent years has been “consumer choice.” When Medicare Part D and Medicare Advantage Plans were designed, the availability of a variety of not-strictly-comparable plans was held to be a benefit to “consumers.” The Federal Employees Health Benefits (FEHB) program of health insurance plans available to federal employees and retirees was held up as an example of how “empowering the consumer” made for good insurance coverage – with federal employees having flexibility to change plans annually during enrollment “open season.”

I’ve been federally insured since the early 1980s. I’ve had the commonest federal health coverage since 1993 (Blue Cross Blue Shield Standard has the most enrollees with over half of those insured). However, this year BCBS Standard plan changes made me decide fast that I now needed to change my insurer. Coverage of out-of-network providers had been lowered markedly with a $7500 deductible for out-of-network surgeons. Although I haven’t had surgery in 50 years, I’m well aware you never know what weird malady you might get or what specific skills you might need, so that was a deal-breaker. [Incidentally, later on Congress became aware of this change and was irked – rightly – that OPM had allowed it. The change gave BCBS even more leverage over surgeons’ prices and could cost patients a bundle. Subsequently, for the first time in history, the federal enrollment deadline was extended this year and some BCBS changes were made – no $7500 deductible – but out-of-network coverage is still lower than previously and having evaluated the options, I am not interested any more in BCBS.]

I quickly eliminated a large number of my options. I was only willing to consider a nationwide plan not local insurers or HMOs. But intelligently comparing just the nationwide plans available to me took MANY hours. The insurance brochures follow a somewhat standardized format to aid comparability, but they comprise hundreds of pages. Happily, DC-based Consumers’ Checkbook publishes a first-rate, very helpful booklet each open season on making the selection. Even with that help, understanding my options was tedious, time-consuming, and dizzyingly mind-bending. [Each plan has its widely varying gotchas. Some insurers don’t pay network rates to a non-network provider at an in-network facility even if no one else is available. Others don’t want to pay for assistant surgeons. Some have low ceilings on hospice spending. Plans state catastrophic limits on spending, but sometimes pharmaceutical costs count toward the limit, sometimes not. And on and on . . .]

I narrowed it down to a few plans and have made a reasonable choice that I expect and hope to be pleased with. But, it’s all so complicated I’m still not certain that in the right (wrong) circumstances I might not have missed a gotcha. However, I believe I have chosen pretty well.

This year, comparing plans was a job that I (with an academic background, good health, and time) was willing and able to do. Realistically, most people are not able to evaluate sensibly such complicated options. I suspect most federal enrollees stayed with BCBS Standard this year even though with the changes they’d be better off in other available plans. I’m grateful I had time this year to do the work involved. Last year, I thought I probably should look at changing because of some other plan considerations. But I had a stressful and demanding job situation at that time, so I simply could not – and did not – do so. Most people are neither willing nor able to take the time to thoroughly read hundreds of pages and evaluate detailed options. So, they either rely on inertia (as I did last year) or they choose on something absolutely stupid – like the amount of the co-pay when they have a routine doctor visit.

Medicare Part D and Medicare Advantage plans put a similar burden on people. The old, ailing, or disabled are even less likely to be able to compare disparate, complicated plans. In the fictional ”consumer choice” fantasy world where everyone did take the time to choose intelligently, the aggregate time burden would be enormous. Here in the real world, most people don’t (and often realistically can’t) choose on the basis of considerations most material to them. They discover the adequacy of this year’s plan only if and when it ends up causing them problems – then they change in a subsequent year. Meantime, they may have incurred debt or been unable to meet medical needs. Most people are healthy. When plans are judged by last year’s experience, plans can keep most enrollees despite coverage gaps, because enrollees won’t uncover problems till they get sick (when plans are not sorry to have them switch away).

Although I’m happy to be in FEHB, I don’t think “consumer choice” is what has made FEHB better than much other health insurance. I think what has historically ensured its value is that federal provision of employee health benefits is fairly generous and that the Office of Personnel Management has looked out for federal workers. With OPM keeping a close eye, almost any plan selected has been a pretty decent choice (they fell down in their responsibility this year on the BCBS contract – the lame explanation of an OPM spokesperson can be found here. But FEHB is not, despite numerous claims, an advertisement for “consumer choice.” Consumer choice simply doesn’t have a chance of being a guarantor of quality without controlled, standardized, comparable policies.

The Conflicted Authors of the University of Minnesota's New Conflicts of Interest Policy

Te Minneapolis Star-Tribune published this story about the University of Minnesota's peculiar approach to updating its conflicts of interest policy:

A professor who is leading the University of Minnesota Medical School's effort to write tougher ethics rules was himself disciplined in 2004 for secretly steering a $501,000 research grant to his own company, according to university investigative reports obtained by the Star Tribune.

Dr. Leo Furcht, the chairman of lab medicine and pathology, was reprimanded for a "serious violation" of university conflict-of-interest policies in connection with a grant from Baxter Healthcare for stem cell research at the Medical School, according to the investigation, which the newspaper received through the state's public records law.

As a result, Medical School Dean Deborah Powell banned Furcht in May 2004 from any business-sponsored research for three years.

In 2007, Powell named Furcht to co-chair a task force to reform the Medical School's conflict-of-interest policy.

Furcht, a nationally known scientist and author, declined to comment. He said through a spokeswoman that the matter had been 'amicably resolved, and that there was nothing to be gained by talking about it.

Powell said in an interview that she chose Furcht for the task force because he had extensive experience with national professional organizations on devising conflict-of- interest rules. 'That seemed to me to be a compelling reason to appoint him to that role,' she said.

Also,

Powell said Friday she did not inform the rest of the task force members about the sanctions against Furcht. 'I did not think it was relevant,' she said.

The Strib's summary of the previous case against Furcht was as follows:

In the late 1990s, a colleague, Dr. Catherine Verfaillie, had made a breakthrough in stem-cell research. When the university declined to patent it, Furcht created his own company, MCL, and filed for the patent along with Verfaillie and another researcher.

In July 2000, Furcht lined up a research grant from Baxter to pay for more research, to be conducted in university laboratories, but did not disclose the deal to the university. Instead, Baxter paid the money, $501,000, to MCL.

Verfaillie said Friday she performed the research in her university lab, but did not receive the money. Eventually, she contacted the dean, triggering an investigation.

A panel of three faculty members investigated and concluded that Furcht 'committed a serious violation of the conflict of interest policy,' according to a Dec. 19, 2003, report.

Among other things, they found that Furcht 'knew or should have known' that he was required to disclose the financial arrangement with Baxter, because he had 'a significant financial interest' in MCL and the stem-cell technology.

'In fact, it appears Dr. Furcht stands to personally gain several million dollars from the pending sale of MCL,' the report said.

In November 2003, Furcht sold MCL for $9.5 million in stock, sharing 5 percent of the proceeds with the university.

The panel recommended that Furcht be disciplined and questioned whether he should retain his position as department chair. It also raised concerns that he may have misused his position 'to personally benefit him and his commercial interests,' and recommended further investigation.

A follow-on report published by the Star-Tribune revealed that the University had declined to provide the newspaper with the financial disclosures of the other members of the committee tasked with writing the new conflict of interest policy. When asked directly by the reporter,

Sixteen [of 26] responded (one could not be reached).

Ten said they had nothing to disclose and six reported various relationships with drug and medical device companies -- from royalties for inventions to grants for clinical research to equity stakes in start-up firms. (Furcht did not respond.)

Apparently, the members of the committee did not even reveal their financial relationships to each other. Gary Schwitzer, faculty in the University of Minnesota School of Journalism, wrote this in his Schwitzer Health News Blog,

I was asked by the dean to serve on that task force.

I never thought I would have to poll fellow task force members about their own past or present conflicts of interest, so I didn't.

No one ever told task force members - at least not me - about the history of Furcht and Powell. Maybe everyone else knew. But I was the outsider on this task force - the journalism guy from across the street.

I am disappointed and feel misled. I'm not sure that knowing these details up front would have changed anything about the task force report. But I do know I'd feel a lot better about the process had there been full transparency and disclosure up front - which is at the core of conflict of interest policies.

Finally, it turns out this is not the first time Dean Powell has made an appearance on Health Care Renewal. In 2007, we posted about how in addition to serving full-time as medical school dean, she has a part-time position as a member of the board of directors of PepsiAmericas, raising concerns about conflicts of interest. (See those raised by the director of the public health school's obesity center.) Although Powell suggested that her position on the board would be to provide "knowledge about obesity," she was not hired by PepsiAmericas as an obesity consultant. Instead, as a board member, her main duty is to protect the financial interests of the share-holders and the corporation as a whole. Were she really to mainly function as a "voice for nutrition," she would be violating her fiduciary duty to her share-holders, a duty, by the way, for which she her total compensation was $130,651 in 2007 (see this 2087 proxy statement).

So let's see... the University of Minnesota committee charged with drafting a new conflict of interest policy included members with conflicts of interests who did not reveal these conflicts to other members of the committee. Its chair had committed a "serious violation" of the current conflict of interest policy, which was known to the medical school dean who appointed him, but which was not revealed to the rest of the committee. That same medical school dean seems to have her own significant conflict of interest, a financial entanglement about which her previous pronouncements have been at best naive.

I have not been able to find much information about what the University of Minnesota committee has recommended. The Star-Tribune only noted, "The proposed policy bans gifts from industry, faculty ghostwriting in medical journals and elsewhere on behalf of industry as well as industry funding for courses that keep faculty updated in their fields. One proposal with wide appeal calls for public disclosure on the Internet of industry relationships." It is not clear to me what the policy says about the most lucrative and presumptively influential sorts of relationships faculty and administration members may have with industry, such as receiving royalties for patents, and serving as consultants, and on speakers' bureaus, advisory boards, and corporate boards of directors. One wonders whether a committee run and partially made up by people with conflicts who did not see fit to reveal them, and reporting to a dean with a hazy notion of the meaning of her own conflicts, would be capable of fairly addressing the most significant sorts of conflicts of interest.

The public and some of the apparently few unconflicted medical academics and practicing physicians who remain in business have become increasingly disillusioned as more and more leaders in academic and clinical medicine have been revealed as part-time paid marketers of drugs, devices, and for-profit medical services. Some academic medical institutions have responded by promising reform. But will "tough" new conflicts of interest policies crafted by the conflicted really provide meaningful reform? Will people who recoil from revealing their own conflicts really be trusted to police their colleagues' conflicts?

See additional comments by Margaret Soltan on the University Diaries blog.