Here is some sense on healthcare IT from the European Union, echoing a number of themes I've written about at Healthcare Renewal and my academic site on HIT difficulties and failures.

These themes revolve around the consideration of healthcare information systems (increasingly used to mediate many aspects of medical care delivery) as medical devices requiring regulation by transparent and impartial authorities - i.e., without conflicts of interest; the importance of regulation due to the adverse consequences caused by ill designed and/or poorly implemented HIT; the need for validation and postmarketing surveillance of the performance of these systems; and vendor accountability.

From the Swedish Medical Products Agency:

Improving patient safety in the EU: Many Medical Information Systems should be classified as Medical Devices

Thursday, June 18, 2009

Correctly functioning Information Technology (IT) systems for health care is a prerequisite for ensuring patient safety. However, applicable regulation is rarely applied, mainly due to the lack of useful guidelines on how to classify the IT-systems [guidelines whose formulation has been resisted for many years by the HIT industry, I might add - ed.] A national working group in Sweden has prepared a guidance report that will help increase compliance with the Medical Device regulation in the EU, thus improving patient safety.

An increasing number of serious incidents, with IT-systems involved, have been reported from the health care sector in recent years [but largely covered up in part due to contractual gag clauses on HIT sales and resultant violations of healthcare leadership fiduciary responsibilities - see this link - ed.] In most of these cases, existing regulatory regimes have not been applied, either by manufacturers or by health care providers. As a result, the assessment of safety issues has become unclear because the manufacturer’s responsibility is vague. [It's not vague; it's contractually absent - ed.]

For this reason, in 2008 the Swedish Medical Products Agency (MPA) initiated a national working group with the aim of providing guidelines for the classification of IT-systems intended to be used in health care. The working group has now prepared a report, intended to serve as guidance for both manufacturers and end-users. At present, there are no guidelines of this kind in Sweden, or the rest of Europe.

“Many parties, including the European Commission, have expressed interest in our work. We believe that it will improve the quality and safety of medical information systems. [Finally -ed.] A common approach to product classification is key” says Lennart Philipson, Scientific Director.

One important conclusion from the working group is that the Medical Device Directives is the most suitable regulation to be applied.

“Our market surveillance of medical information systems will be based on the conclusions in the report from now on. If a system falls within the definition of a medical device, the requirements for CE-marking [Conformité Européene, a branding mark - ed.] shall be applied” says Mats Ohlson, Chairman of the working group.

Manufacturers need to adapt to applicable standards when it comes to quality systems, risk management and usability. They will also need to establish post-market surveillance routines to regularly assess products on the market.

The working group consisted of members from the Swedish Medical Products Agency, the National Board of Health and Welfare, the Swedish Association of Local Authorities and Regions, Swedish Medtech, the Swedish Standards Institute, Swedish Electrical Standardization and notified bodies through Intertek Semko.

A report entitled "The Medical Products Agency’s Working Group on Medical Information Systems: Project summary" is available in English translation at this link (PDF).

Download and read the entire report.

Highlights:

A general opinion of the health care providers represented in this Working group is that from a patient safety point of view, it is desirable that stand alone software and systems intended to, directly or indirectly, affect diagnosis, health care and treatment of an individual patient [what I have referred to a "mediating aspects of care" - ed.] shall be regulated under a Product Safety Regulation.

The Working group has not been able to define any other appropriate regulation than the Medical Device Directive when it comes to the definition of such systems. Adherence to the Medical Device Directive is important so that manufacturers and clients can work with the same intentions. [I would add that the intentions are not exactly the same; the manufacturers' intentions are, by necessity, to maximize profits - ed.] This project report serves as one step towards the clarification regarding which conditions that shall apply.

The Working group believes that software intended for a medical purpose must be regarded as a "device" [indeed - ed.] and expressions such as "project", "service" and similar must be avoided describing a Medical Information System. This approach has advantages since a product safety regulation, such as the Medical Device Directive, can be applied and the product will have:

• a defined intended use
• defined and documented specifications
• a manufacturer with a clear responsibility until the delivery is accepted
• a controlled ”Post Market” surveillance

Furthermore, the Working group believes:

• that the Medical Device Directive shall be applicable for software and systems that fulfills the definition of a medical device
• that the manufacturer of the intended systems shall follow the appropriate validation method [e.g., as in the pharma industry's IT - ed.] in the Medical Device Directive
• that the level of risk shall be assessed, motivated and control the classification and verification method
• that applicable standards shall be followed for design, verification and validation regarding software and information systems that are medical devices
• that there is no legal requirement that manufacturers of devices in the lowest device classes must have certification for their operational processes to fulfill the Medical Device Directive. The Medical Products Agency has in these cases no mandate to formally demand certification, such as for instance ISO 13485. However, in reality it is still necessary to have some form of a functional quality management system to manage a proper design process for software systems [due to the fact that patients, ethical issues, and human rights issues are involved - ed.] as well as the necessity to fulfill the Post Market Requirements including Vigilance reporting.
• that the prerequisite for a successful and fair application of the regulation assumes that health care providers demands that such systems shall be CE‐marked and be regarded as medical devices
• that a controlled and standardised verification method when performing installation work in a user’s network, supported by the manufacturer, is an essential supplement to the manufacturer’s CE‐marking and a prerequisite for an acceptable safety level when using the device.

This section gets to the heart of the matter regarding electronic medical records:

8.2.3 Electronic patient records

Electronic patient record systems are more than an archive for just documents, they also have features for compiling and transferring information to be used for decision making. Patient records are the basis for documentation and planning of diagnosis, therapy and follow‐up, especially when it comes to drug prescriptions and recommendations. [These caveats include CPOE systems as well - ed.]

It is becoming more common that electronic patient record systems and other systems are interconnected, for instance imaging systems or laboratory systems. It is obvious that such systems should not be regarded as “purely administrative”; instead they have the characteristic features that are typical for medical devices. They sort, compile and present information on patients’ treatments and should therefore be regarded as medical devices in accordance to the definition.

Since the electronic patient record system often replaces/constitutes the user interface of “traditional” medical device systems, the call for 100% accuracy of the presented information is increased. Patient record systems have crucial impact on patient safety, and this has been proven to be the case after a series of incidents that has been reported to the Swedish National Board of Health and Welfare. [It would be interesting to know more about this "series of incidents" - ed.]

Finally, in the June 20, 2009 Wall Street Journal article "The Myth of Prevention", Abraham Verghese, Professor and Senior Associate Chair for the Theory and Practice of Medicine at Stanford, echoed several Wharton professor's doubts about the cost savings and ultimate value of electronic medical records, touted as the cybernetic savior of healthcare:

... I have similar problems with the way President Obama hopes to pay for the huge and costly health reform package he has in mind that will cover all Americans; he is counting on the “savings” that will come as a result of investing in preventive care and investing in the electronic medical record among other things. It’s a dangerous and probably an incorrect projection.

HIT can be a facilitator (not a replacement or revolutionary tool) to physicians, if done well, and not overdone to the point of costing far more than entire new hospitals or hospital wings. There is no replacement for a physician with a strong background in the preclinical and clinical sciences, ethics, critical thinking, and the scientific method. Computers are not a miracle. They can help provide facts, but cannot fundamentally turn a poor physician into a Marcus Welby. Verghese on that issue:

To come back to my favorite painting: a computer cannot take the place of the doctor in Fildes’s painting ["The Doctor", 1891, see below - ed.]; an electronic medical record (EMR) may or may not save money (it won’t be anywhere as much as is projected) but what it will do is ensure that we doctors, nurses, therapists, particularly in hospitals will be spending more and more time focused on the computer, communicating with each other, ordering and getting tests, buffing and caring for our virtual patient—the iPatient is my term for this phenomenon—while the patient in the bed wonders where everybody is. Having worked exclusively for the last seven years or so in hospitals that have electronic medical records (EMR), I have felt for some time that the patient in the bed has become an icon for the real focus of our attention, the iPatient. Yes, electronic medical records help prevent medication errors [only when done well, see Koppel - ed.] and are a blessing in so many ways, but they won’t hold the patient’s hand for you, they won’t explain to the family what is going on.

"The Doctor", 1891 (Sir Luke Fildes, 1843-1927)

I will go a step further. It is now clear that the promises of massive savings from electronic medical records, usually originating from vendors based on hearsay or cherry-picked, favorable but flawed studies that dismiss a growing body of other literature (such as in Cerner CEO Neil Patterson's hyper-ebullient piece here), have been deliberately manufactured by a lobby of industry pundits.

It is only now that I more fully comprehend the origins of and motivations behind the "we will revolutionize medicine" fervor exhibited by HIT company CEO's, such as I experienced and wrote about starting back in the 1990's. From my 1999 essay "What is Medical Informatics, and Why is it an Important Specialty":

... A letter I had written [in Feb. 1999 - ed.], "Broken Chord" published in the journal Healthcare Informatics, further amplifies the skills and experience issue. The letter addressed issues of skills, insights, and roles of MIS personnel in healthcare settings. I described a Microsoft Healthcare Users Group conference attended predominantly by healthcare MIS staff and vendors, where I observed a panel discussion moderated by the CEO of HBOC [before he was found to be cooking the books - ed.] and composed of several other industry CEO's. The panel was discussing how they would revolutionize healthcare through their leadership in information technology.

During the Q&A period I asked the audience how many really felt they would revolutionize medicine through their leadership in IT. Several hundred--almost all in the audience--raised their hands. I then asked how many had ever taken care of patients or examined any textbook of medicine, such as Harrison's Textbook of Internal Medicine or the Merck Manual. A minority of hands went up. This suggested, in my view, a striking deficiency of knowledge, experience and insight on the part of the de facto clinical information technology leadership, complicated by rather cavalier attitudes regarding the essential role of clinical expertise.

I believed what I was hearing to be irrational exuberance, not manufactured exuberance.

Quality improvements are possible under the most controlled of environments, such as here (such projects are not easily portable, unfortunately). Massive cost savings? When organizations are spending upwards of $100 million just for system implementation, not including ongoing lifecycle costs, massive savings projections from HIT are risible.

One would think that after Madoff, Stanford and other recent financial confidence scandals, that bright people would be more skeptical of "massive returns, always and forever" promises, but that does not appear to be the case. With regard to mass savings, I make the prediction that in 2014, as in the UK today, our government, healthcare management, and medical professionals will realize, Madoff style, that they've been had.

So, Health IT Industry executives, pundits, and consultants, can we drop the grandiose "we will revolutionize medicine!" and "massive savings" myths, and focus on facilitating clinicians and on quality improvement, please?

6/22/09 Addendum


The U.S. Food and Drug Administration (FDA) and Sweden's Medical Products Agency are no strangers.

Don't know much about history

Don't know much biology
Don't know much about a science book
Don't know much about the french I took.
(Wonderful World, sung by Sam Cook)

This is becoming the theme song for executives of health care corporations. We have posted about a series of cases in which major health care corporations suddenly seemed unable to carry out their core business functions, a phenomenon I am going to start calling "core business incompetence." Some recent examples:
- Baxter International apparently failed to check the purity of heparin it bought from a foreign supplier; the contaminated heparin resulted in approximately 81 deaths. (See post here.)
- A major Genzyme manufacturing facility had multiple quality problems, resulting in the production of a very expensive, but contaminated biologic medication. (See post here.)
- Three Johnson and Johnson manufacturing facilities had multiple quality problems, resulting in the production of contaminated batches of over-the-counter medications for children. (See post here.)
- Aetna made mathematical errors in computing the rates it proposed charging; WellPoint made computer errors that exposed sensitive policy-holder information. (See blog post here.)

Manufacturing pure, unadulterated medicines is a core function of a drug company. Correctly calculating policy-costs and correctly handling patient data are core functions of health insurance companies. But in the above cases, three large pharmaceutical companies and two large insurance companies could not perform these core functions competently.

Radiation Sickness from CT Scans
In the last few days, more details of what appears to be another example of core incompetency afflicting a major health care organization has surfaced. The details were reported by Walt Bogdanich in the New York Times. Here is the summary:

When Alain Reyes’s hair suddenly fell out in a freakish band circling his head, he was not the only one worried about his health. His co-workers at a shipping company avoided him, and his boss sent him home, fearing he had a contagious disease.

Only later would Mr. Reyes learn what had caused him so much physical and emotional grief: he had received a radiation overdose during a test for a stroke at a hospital in Glendale, Calif.

Other patients getting the procedure, called a CT brain perfusion scan, were being overdosed, too — 37 of them just up the freeway at Providence Saint Joseph Medical Center in Burbank, 269 more at the renowned Cedars-Sinai Medical Center in Los Angeles and dozens more at a hospital in Huntsville, Ala.

The overdoses, which began to emerge late last summer, set off an investigation by the Food and Drug Administration into why patients tested with this complex yet lightly regulated technology were bombarded with excessive radiation. After 10 months, the agency has yet to provide a final report on what it found.

But an examination by The New York Times has found that radiation overdoses were larger and more widespread than previously known, that patients have reported symptoms considerably more serious than losing their hair, and that experts say they may face long-term risks of cancer and brain damage.

So not to mince words, in this sad case, many patients seem to have been subject to radiation poisoning from a diagnostic x-ray procedure (not from radiation therapy for cancer.) Most people (and physicians) may have not previously thought that radiation poisoning was a possible harm from a single diagnostic CT scan.

A Design Failure?

Moreover, it appears that the radiation poisoning did not result from some freak accidents or malfunction:

The review also offers insight into the way many of the overdoses occurred. While in some cases technicians did not know how to properly administer the test, interviews with hospital officials and a review of public records raise new questions about the role of manufacturers, including how well they design their software and equipment and train those who use them.

Also,

None of the overdoses can be attributed to malfunctions of the CT scanners, government officials say.

At Glendale Adventist Medical Center, where Mr. Reyes and nine others were overdosed, employees told state investigators that they consulted with GE last year when instituting a new procedure to get quicker images of blood flow, state records show. But employees still made mistakes.

As a result, hospital officials said, a feature that technicians thought would lower radiation levels actually raised them. Cedars-Sinai gave a similar explanation.

'There was a lot of trust in the manufacturers and trust in the technology that this type of equipment in this day and age would not allow you to get more radiation than was absolutely necessary,' said Robert Marchuck, the Glendale hospital’s vice president of ancillary services.

A GE spokesman, Arvind Gopalratnam, said the way scanners were programmed was 'determined by the user and not the manufacturer.' GE, he added, has no record of Glendale seeking its help setting up the new procedure in 2009.

Most of the known overdoses, including the biggest, occurred on scanners made by GE Healthcare. At two hospitals that use Toshiba scanners — Los Angeles County-U.S.C. and South Lake in Florida — officials said the manufacturer suggested machine settings that ultimately produced too much radiation. Representatives of Toshiba agreed to be interviewed in their California office but abruptly canceled.

In particular,

To this day, no one at Cedars-Sinai knows who programmed the scanners that delivered the overdoses, officials there say. But in written statements to The Times, hospital officials said they had figured out how they might have occurred.

Normally, the more radiation a CT scan uses, the better the image. But amid concerns that patients are getting more radiation than necessary, the medical community has embraced the idea of using only enough to obtain an image sufficient for diagnosis.

To do that, GE offers a feature on its CT scanner that can automatically adjust the dose according to a patient’s size and body part. It is, a GE manual says, 'a technical innovation that significantly reduces radiation dose.'

At Cedars-Sinai and Glendale Adventist, technicians used the automatic feature — rather than a fixed, predetermined radiation level — for their brain perfusion scans.

But a surprise awaited them: when used with certain machine settings that govern image clarity, the automatic feature did not reduce the dose — it raised it.

As a result, patients at Cedars-Sinai received up to eight times as much radiation as necessary, while the 10 overradiated at Glendale received four times as much, state records show.

GE says the hospitals should have known how to safely use the automatic feature. Besides, GE said, the feature had 'limited utility' for a perfusion scan because the test targets one specific area of the brain, rather than body parts of varying thickness. In addition, experts say high-clarity images are not needed to track blood flow in the brain.

GE further faulted hospital technologists for failing to notice dosing levels on their treatment screens.

But representatives of both hospitals said GE trainers never fully explained the automatic feature.

In a statement, Cedars-Sinai said that during multiple training visits, GE never mentioned the 'counterintuitive' nature of a feature that promises to lower radiation but ends up raising it. The hospital also said user manuals never pointed out that the automatic feature was of limited value for perfusion scans.

A better-designed CT scanner, safety experts say, might have prevented the overdoses by alerting operators, or simply shutting down, when doses reached dangerous levels.

Summary: Core Incompetence
To summarize, GE diagnostic CT scan machines apparently were designed so that they could deliver so much radiation that their use could cause radiation sickness. The machines had no built in safeguards to limit the dose of radiation. Users, that is, X-ray technicians, could program the machine so as to deliver dangerous radiation doses, but GE did not warn them that this was the case, nor provide a machine feature that would give a real-time warning of incipient overdose.

Thus it appears that GE, which has been described as "the world’s biggest maker of health care imaging and information technology systems," failed in its core function of designing and manufacturing safe diagnostic x-ray machines. (Presumably the same might be said of Toshiba, but the NY Times report does not include so much detail about problems with its machines.)

A straightforward explanation of the magnitude of the core incompetence was provided by one of the patients who got radiation sickness:

To Mr. Heuser, it is unconscionable that equipment able to deliver such high radiation doses lacks stronger safety features.

'When you are in a car and it backs up, it goes beep, beep, beep,' he said. 'If you fill the washing machine up too much, it won’t work. There is no red light that says you are overradiating.'

It really seems like we are seeing an epidemic of core incompetence by major US health care corporations.

I can only speculate about why this occurring. One explanation is that the organizations may be lead by people who do not understand the health care context, and do not understand the scientific, engineering, and technical issues involved with core competence. Many health care corporations have come to be lead by people with no experience or background in relevant areas.

For example, the current, and often acclaimed CEO of GE is Jeffrey Immelt, who "earned a B.A. degree in applied mathematics from Dartmouth College in 1978 and an M.B.A. from Harvard University in 1982." The leader of GE Healthcare is John Dineen, who "is a graduate of the University of Vermont where he earned Bachelor's degrees in biology/genetics and computer science," and "joined GE in 1986 as a telecommunications engineer."

Another, even more speculative explanation is that many major US and global health care organizations seem to have been infected with the virus of putting short-term financial results ahead of everything else, leading to cutting of costs and particularly human expertise in the areas most core to the organizations' functions, and pushing for hurried results even at the expense of clear thinking, carefully engineering, and consideration of the effects on patients and other humans of the resulting mistakes.

Hopefully, further investigation will reveal more about what went wrong in this case. Meanwhile, I say again, again, again,...

As long as "imperial CEOs" can continue to get extremely rich while presiding over incompetence and stupidity, if not worse), we can expect the foolishness to continue. Meanwhile, the foolishness drives up costs and drives down quality of health care for the poor suffering patients, let alone the physicians and other health care professionals who must deal with it.

To really reform health care, we need to provide incentives for competent, honest leadership, and make that leadership accountable for its shortcomings.

Postscript - Why the Rush to Aggressive Treatment?

The NY Times article described the rush to get one of the afflicted patients to the CT scan:

on the morning of July 4, when a 52-year-old executive producer of films, H. Michael Heuser, arrived in the emergency department with stroke symptoms.

A 'code brain' was immediately called, signaling a life-or-death situation. A blood clot in the brain can be dissolved with medicine, but doctors must do it within several hours, before brain cells die from a lack of oxygen. So Mr. Heuser was rushed into a room with several CT scanners, where he underwent one brain perfusion study and at least one more later. A CT perfusion scan, which lasts about 45 seconds, can identify a stroke through a series of blood flow images.

Mr. Heuser did have a stroke, from which he would recover. But other parts of his body inexplicably began to break down.

However, there is no clear evidence that such a rapid and drastic approach is really that good for patients. A recently updated Cochrane review concluded: "In patients with acute ischaemic stroke, immediate anticoagulant therapy is not associated with net short or long-term benefit. Treatment with anticoagulants reduced recurrent stroke, deep vein thrombosis and pulmonary embolism, but increased bleeding risk. The data do not support the routine use of any the currently available anticoagulants in acute ischaemic stroke." However, many physicians seem to advocate the drastic approach based on some controlled trials that showed at best small improvements in average neurological function for patients receiving rapid anti-coagulation (and which were done before anyone thought about radiation sickness as a possible harm of the approach.) Once again, an aggressive, technological, expensive approach, possibly advocated by people who stood to gain financially from it, may not be as advantageous as it appears.

Again, 'tis the season for legal settlements. From the Newark Star-Ledger,

New Jersey and Pennsylvania-based medical company Synthes reached a settlement today over the company's alleged financial conflicts of interest, which officials are calling a landmark deal, state officials announced today.

The attorney general's office launched an investigation early 2008 into Synthes, which produces devices for treating spinal trauma, to determine whether physicians were financially benefiting from conducting clinical trials on the company's products. Under the agreement, Synthes will no longer pay trial physicians with company stock and must disclose all payments to the physicians and whether the physicians have a financial stake in the outcome of the trial.

Attorney General Anne Milgram, who said such provisions were the first of their kind, said conflicts of interest are common within the medical community.

'It is outrageous that doctors who are testing and, in many cases, recommending the use of certain high-risk medical devices are being compensated with stock in the very companies that make the devices,' said Milgram. 'All patients -- but especially those considering high-risk devices such as spinal disc replacements -- deserve honest, objective clinical trial information about the products available.'

She also criticized the Food and Drug Administration, saying the federal agency was not vigilant enough in regulating Synthes, a $3.2 billion global company.

'Medical device makers have a duty to make certain that clinical trial results are accurate and unbiased,' Milgram said. 'In creating these financial incentives for doctors, Synthes and the rest of the industry have done the exact opposite. Going forward, if the industry will not address this problem voluntarily, we most certainly will.'

What will they think of next? We have seen plenty of cases in which physicians have been given payments that could influence their clinical decision making by companies with products or services to sell. Often, such payments are not disclosed. This is one of the few times I have seen physicians other than those on corporate boards, however, receiving payments in company stock. This would seem to be a new low. It surely would provide a more powerful incentive to make the studies' results favor the company's products than would mere cash payments. At least the settlement will stop this practice, and force disclosure of company payments.

The statements by the state Attorney General were particularly and admirably direct.

However, once again we see some familiar patterns. While human beings authorized or committed the acts that got the organization in trouble, rarely do these people seem to suffer any negative consequences. At most, the organization may pay a fine. In this case, the fine was, in corporate terms, tiny. However, even a large fine, however, may come out of dividends or the stock price, dispersing the cost to stock-holders, or out of salaries across the board. Thus, those who got the organization into trouble are unlikely to feel pain from it. Perhaps because of reverence for all organizations related to health care, and fear that the bankruptcy of any health care organization, even a health care insurance company, will leave patients in the lurch, prosecutors do not seem inclined to actually prosecute such organizations. The net effect, though, seems to be that dishonest executives of health care organizations can continue to act with impunity.Until bad leadership of health care organizations leads to negative consequences for those practicing it, health care leadership can be expected to continuously degrade.

With apologies to the late Frank Zappa... even though we are going through the dog days of summer, the parade of health care troubles in the news is never ending, so I thought I would recap some of the more interesting issues discussed by some of my fellow health care skeptic bloggers.

We have discussed the ongoing decline of primary care. On DB's Medical Rants, Dr Robert Centor takes on the topic: "The system has, without consciously meaning to, held primary care in contempt." The result is a "quiet rebellion: of primary doctors.

We have discussed whether the currently fashionable idea of "accountable care organizations" (ACOs) might turn out to be a cover for health care oligopolies. See what Paul Levy, CEO of the Beth Israel/ Deaconess Medical Center said about them in his blog, Running a Hospital.

We frequently talk about the manipulation or suppression of clinical research studies by those with vested interests in the results pointing in a particular direction. On the Hooked: Ethics, Medicine and Pharma blog, Dr Howard Brody wondered why the FDA will not even reveal the identities of the clinical researchers who did the studies on which it based its decision to approve the Infuse bone growth enhancement device.

Prof Carl Elliott has done an outstanding job investigating commercially funded and implemented clinical research. Dr Brody reviewed his new book, White Coat, Black Hat. In the Carlat Psychiatry Blog, Dr Daniel Carlat reviewed Prof Elliott's new article in Mother Jones on how a pharmaceutical company sponsored drug trial went badly awry.

We asked whether the former CEO of a for-profit hospital chain who resigned after the company paid a > $1.7 billion penalty to settle charges of fraud would be a proper candidate to be governor of Florida. After Rick Scott won the Florida Republican primary, Maggie Maher, writing in the Health Beat blog, took on Scott's dubious past as prologue to a worrisome future.

Well I'm about to get sick
From watchin' my TV
Been checkin' out the news
Until my eyeballs fail to see
I mean to say that every day
Is just another rotten mess
And when it's gonna change, my friend
Is anybody's guess

So I'm watchin' and I'm waitin'
Hopin' for the best
Even think I'll go to prayin'
Every time I hear 'em sayin'
That there's no way to delay
That trouble comin' every day
No way to delay
That trouble comin' every day
- Frank Zappa

In December, 2009, we updated the story of Swiss-based medical device company Synthes and the marketing by its Norian division of a bone cement. At that time, US authorities charged the company with use of an unapproved product in about 200 patients, three of whom suffered untimely deaths. At that point, four US based Synthes executives had pleaded guilty to charges related to this affair.

Last week, another shoe dropped. As reported by the Associated Press,

A medical devices company will admit criminality and pay the maximum $23 million fine for illegally testing bone cement on about 200 spinal patients, three of whom died in surgery, U.S. prosecutors said Monday.

Norian Corp. trained surgeons to conduct unapproved clinical tests of its bone cement from 2002 to 2004, subverting U.S. Food and Drug Administration safeguards, prosecutors said. The trials were stopped after the third patient death, they said.

The cement, which is used to fill in bone defects, is approved for use in the arm but not the load-bearing spine, authorities said. The surgeries often involved older patients with compression fractures, they said.

The results are:

Norian will plead guilty to conspiracy to impede FDA functions, a felony, and 110 misdemeanor counts of interstate shipping of misbranded Norian XR. Synthes will plead guilty to the same misdemeanor shipping count.

As part of the agreement, Norian will be sold to an outside buyer, the parent company said.

Imposing divestiture of the offending subsidiary was unusual, according to the Philadelphia Inquirer:

Forcing a divestiture of a business unit in a plea agreement was precedent-setting for the U.S. Attorney General's Office in the Philadelphia area, spokeswoman Patricia Hartman said Monday.

Officials with the Office of the Inspector General in DHHS said the divestiture should send a message to other health-care companies that Synthes' behavior had grave consequences.

'Criminal conduct can result in a company getting rid of part of their business,' Greg Demske, a top official with the Inspector General, said Monday. 'This is an egregious case, and it made us firm in our belief that we should draw a line here,' he said.

If it remained a subsidiary of Synthes, Norian would be excluded from participating in Medicare and other government-funded health care programs, which would be potentially devastating to its business. According to a divestiture agreement released Monday by the U.S. Attorney in Philadelphia, Synthes has to sell Norian by May 24.

The assets of Norian would not be allowed to be transferred to another part of the Synthes 'corporate family' as part of the divestiture, Demske said.

Synthes will update the government monthly on its plans to divest Norian, and if it fails to sell the company by the May deadline, it can be fined $10,000 a day.

So does this case signal a new toughness by US authorities in cases of bad behavior by health care corporations?

According to the Wall Street Journal, Synthes officials were not exactly quaking in their boots because of these penalties, as their spokesperson said Synthes "does not expect this settlement to have any significant financial impact." Synthes would only be liable for fines of "about $24.3 million in total." That pales in comparison to the "company['s] posted total sales of $3.4 billion last year." As for the divestiture of Norian, the WSJ reported, "a spokesman said Monday that the Norian unit is mostly active in product development and isn't actively selling products. That business has fewer than 100 employees,...."

In fact, company leadership did not seem to realize that they did anything wrong, despite the company and four executives pleading guilty to crimes, actions involving the death of three patients,

'Synthes remains committed to operating in accordance with the highest legal and ethical standards, and bringing closure to this matter will permit the company to focus on its mission to improve patient care,' the company said.

Furthermore, while this is one of the few cases in which some company executives actually may have to pay penalties (after pleading guilty to at least misdemeanors), the big fish appeared to get away. As we discussed last year, an unindicted "person no. 7" was alleged to have set up the scheme to "test" the bone cement in a clinical series. Person No. 7 was at that time identified as the company CEO. That CEO, according to the Philadelphia Inquirer last year, was one Mr Hansjorg Wyss, noted to have a fortune estimated at $5.7 billion, making him the richest man in Philadelphia, and the 83rd richest man in the world, according to Forbes magazine. (See this post.) The settlement of this case would apparently have no impact on his immense wealth.

So although this case has some unusual wrinkles, and may yet yield some negative consequences for some of the people involved in the direction and implementation of the wrong-doing, it would appear to leave unscathed the person who has personally profited the most from the company, and its actions, including its less savory actions. There is progress here, but only a little.

Once again, it appears that in the eyes of the law, top corporate leaders are different from you and me. They appear immune from the penalties that lesser individuals may suffer. They have impunity to continue to amass wealth even wealth that results from actions that were deemed illegal. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

Everyone loves a parade, and so the parade of legal settlements by prominent health care organizations continues. The latest to march into view is Wright Medical Group, as reported by Bloomberg:

Wright Medical Technology Inc. agreed to pay $7.9 million to resolve U.S. criminal and civil investigations into whether it paid kickbacks to induce doctors to use its hip and knee devices.

Prosecutors in Newark, New Jersey, today charged Wright with conspiring to violate a federal anti-kickback statue through consulting contracts with orthopedic surgeons. The U.S. agreed to drop the case in 12 months if a monitor agrees that Wright has reformed the way it hires consultants.

Wright, based in Arlington, Tennessee, also agreed to a $7.9 million civil settlement with the Justice Department and inspector general of the Health and Human Services Department to resolve fraudulent-marketing claims. The company entered into a five-year corporate integrity agreement.

Here we go again. A company is accused of giving kickbacks, aka bribes, to individual doctors, in this case orthopedic surgeons, to get them to use the company's products. Such payments clearly violate medical ethics (especially doctors' obligations to put the interests of patients ahead of their personal financial interests), leading to decision making not in the best interests of the patients. However, the penalty to the company itself is minuscule, only a fraction of the company's revenue, according to Google Finance, in 2009, just under $500 million. As we have noted endlessly before, financial penalties to corporations are diffused among all shareholders and employees, and possibly customers and patients.

Do we really expect that this penalty will change anything, or deter future bad behavior by this or any other company?

But our government continues to treat the corporate employees who authorize, direct, or implement bad behavior like this as essentially above the law. In this case, like in many others we have discussed previously, no one who authorized, directed or implemented the bad behavior will have to pay any sort of penalty or suffer any sort of negative consequences. Does anyone in their right mind believe that Wright Medical really is

pleased to announce these agreements and look[ing] forward to working with the independent monitor as we continue our commitment to the highest standards of ethical and legal conduct

That was a quote from Wright Medical CEO Gary D Henley. He may be pleased to announce the agreements, since they really amount to such a tiny pinprick of a penalty. After all, Mr Henley will be able to to continue to use Wright Medical's revenues, virtually unaffected by this penalty, to justify his compensation (per the 2009 proxy statement, $2,036,517 in 2009, and his continuing accumulation of wealth, e.g., 436,601 shares of stock, currently valued at $13.86/ share according to Google Financial.)

I leave an assessment of what the company's previous commitment to "the highest standard of ethical and legal conduct" was to our dear readers.

We will not have true health care reform until we end the unholy alliance between big government and big health care organizations, that is, health care corporatism. Then, maybe, we can make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

An odd story that appeared earlier this month linked several people we have discussed on Health Care Renewal.

On one hand, we posted about how Dr David Polly, a spine surgeon at the University of Minnesota, testified before the US Congress in support of research on treatments of bone injuries afflicting US soldiers. He did not then reveal that he had been paid more than one million dollars for consulting by Medtronic, the manufacturer of a bone growth product used to treat such injuries, also the source of payments of his expenses for the trip to Washington. At the time, we suggested this case was a reminder to be skeptical about academics who are really stealth health policy advocates for industry.

On the other hand, in a post about renewed payments by makers of artificial joints to orthopedic surgeons after the US government advocated a series of deferred prosecution agreements as a cure for such apparent conflicts of interest, we quoted Dr Charles Rosen, "Nothing will change until someone goes to jail. It’s a big game."

The link between them appeared in two related articles. First, the Minneapolis Star-Tribune reported on the appointment of another Medtronic consultant to a top leadership post in the US Department of Veterans Affairs:

In a Sept. 28 letter to Veterans Affairs Secretary Eric Shinseki, Sen. Charles Grassley asks whether Dr. Stephen Ondra's 'policy advice and decisions at the VA are vulnerable to potential conflicts of financial interest' given his prior relationship with the Fridley-based medical technology giant.

Ondra and Medtronic mutually severed their financial relationship in July 2008. But just prior to that, Medtronic paid him $3.6 million in royalties related to spine-surgery instruments, according to financial disclosure forms he submitted to the VA.

It appears that Medtronic lobbied hard for the appointment of its former consultant:

While noting that Ondra is not a Medtronic employee, Grassley characterized the surgeon's relationship with the company as 'unambiguous and substantial.' Further, Grassley notes that Ondra 'was able to penetrate the political establishment at its highest level to obtain a senior position at the VA' because of his previous ties to the company.

The details are:

Ondra's candidacy for his current post was supported by Medtronic Chief Executive William Hawkins III, who wrote a letter of recommendation to Secretary of Defense Robert Gates on his behalf. This was at the suggestion of Dr. S. Ward Casscells III, who was then assistant secretary of defense for health affairs, according to a series of internal e-mails obtained by the Star Tribune.

'I have known Dr. Casscells for many years and was comfortable in approaching him on this topic,' Hawkins wrote in a Jan. 16, 2009 e-mail to the then-head of Medtronic's $3.5 billion spine device business, Steve La Neve. (La Neve left that position earlier this year in a corporate reorganization.)

La Neve replied a day later that Ondra wanted to meet with him or with Hawkins before a reference letter was sent, 'so that it can capture his work on appropriate industry-physician relationships and transparency.'

(It is not clear whether the last sentence above is meant to be an ironic pun about regulatory capture.)

A post on Pharmalot explains what Dr Ondra's first priority was once he got his government job:

Within a few days, however, Ondra objected to the proposed nomination of another spine surgeon, Charles Rosen, as US Surgeon General. Why? As founder of the Association of Medical Ethics, Rosen publicly questioned consulting ties between doctors and device makers and, for his trouble, allegedly suffered retaliation by members of the American Academy of Orthopaedic Surgeons (see this). In a January 21, 2009 email exchange with Davd Polly, a University of Minnesota professor who was another Medtronic consultant, Ondra acknowledged never having heard of Rosen, but reacts viscerally to a recent story in The Orange County Register that details Rosen’s self-appointed role as a watchdog.

'Since this individual is toxic and dangerous I would leave nothing to chance,' he responds to Polly, who had forwarded the newspaper story to Ondra. Polly, by the way, is a nationally known spine surgeon who came under congressional scrutiny for his work several years ago for the device maker, something that Rosen had criticized (look here). 'This moment in history is too important to our country to let such a disreputable and dangerous person continue his self-promotion crusade,' Ondra continues. 'I would encourage you and any other physicians and citizens to weigh in on this to HHS and public health.'

Got that? Medtronic pays Dr Ondra millions. Medtronic pushes for Dr Ondra's appointment to a top VA leadership position. Once in that position, Dr Ondra confers with another million dollar Medtronic consultant, and then works to block the appointment as Surgeon General of a known foe of the cozy web of conflicts of interest that afflicts medicine. Thus do conflicts of interest work to promote the capture of government by special interests.

The Pharmalot post concluded with this opinion:

'It’s obvious that Dr. Ondra benefited from his relationship with Medtronic. And since he worked to kill off the nomination of Chuck Rosen, Medtronic’s main critic, I can see how Medtronic benefited from Dr. Ondra,' says Paul Thacker, a former Grassley staff investigator and US Army specialist. 'What I don’t understand is how I and other veterans have benefited from all this back-door dealing. What’s in it for us?'

That is a good question. It appears that nothing was in it for veterans, or the US public. But everything was in it for Medtronic and the doctors it pays so well. I would submit that it is the readiness of big health care corporations to create conflicts of interest that seduce physicians to put their loyalties to their corporate sponsors ahead of the public interest that is toxic and dangerous.

This convoluted story suggests the urgent need for full disclosure of all relationships between physicians and others who make decisions and wield influence in health care on one hand, and health care organizations on the other hand. If physicians want their health policy efforts to be met with anything other than guffaws and cynical eye rolls, they need to seriously consider swearing off the sorts of cushy corporate relationships that Dr Ondra and Dr Polly embraced.