FDA Decides Regulating Implantable Defibrillator Medical Devices a "Political Hot Potato"; Demurs

Well, not exactly, but they have decided regulation of another medical device is a political hot potato, and demurred on enforcing regulation:

Health IT.

Health IT are medical devices.

FDA's Chair of the Center for Device and Radiological Health, Jeffrey Shuren, MD JD, stated this explicitly on Feb. 25, 2010 (see testimony to the HHS Health Information Technology HIT Policy Committee at this PDF) that:

... Under the Federal, Food, Drug, and Cosmetic Act, [that regulates all drug, medical devices, etc. in the United States - ed.] HIT software is a medical device. Currently, the FDA mandates that manufacturers of other types of software devices comply with the laws and regulations that apply to more traditional medical device firms. These products include devices that contain one or more software components, parts, or accessories (such as electrocardiographic (ECG) systems used to monitor patient activity), as well as devices that are composed solely of software (such as laboratory information management systems).

That leaves no doubt that these are medical devices. However, he also stated:

To date, FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices.

In other words, this medical device receives special accommodation over all others,such as heart stents, defibrillators, spine and knee implants, etc., all of which have been in the news in recent years for major defects and malfunctions, up to and including causing patient deaths. The extent would have likely been far, far worse had these gadgets been unregulated.

One should ask: why the special accommodation for health IT medical devices? What are the underlying politics, and who is behind them? Especially when FDA is aware of potential risks that may only be the "tip of the iceberg?"

The selective reluctance to enforce the FD&C Act persists to this day. See for example this link regarding his statements just a few days ago here in Philadelphia: Will FDA Regulate EHR's? :

Speaking at the first annual PharmEHR Summit in Philadelphia on April 7, Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health at the FDA, said his agency could change its traditional hands-off approach to EHRs, but he acknowledged that the potential of FDA regulation raises serious clinical issues [the only clinical issues I can think of are in holding vendors accountable for patient injury - ed.] and is a “political hot potato.” “As of right now we’re not regulating EHRs, and it may turn out that we won’t,” he said.

Likely translation: FDA regulation of health IT will never happen.

One implication is that health IT quality, safety, efficacy, privacy, security, and other issues about these systems will remain subject to HHS and industry caprice.

While we're at it, let's deregulate knee implants too...

-- SS

Addendum April 19, 2011:

Roy Poses observes that:

Here is a great example of regulatory capture. The health care IT industry has amassed such political clout that it now has impunity to regulation. Once again, combined economic and political power trumps patients' and the public's health and safety. We will not be able to really reform health care until we can provide for honest, independent health care regulation to uphold patients' and the public's health.

-- SS

Making a Stat Less Significant: Common Sense on "Side Effects" Lacking in Healthcare IT Sector

At my Mar. 27, 2011 post "Those Who Dismiss Healthcare (and Healthcare IT) Adverse Events Reports as Mere "Anecdotes" Have Lost - Supreme Court-Style" I wrote that the SCOTUS decided in MATRIXX INITIATIVES, INC., ET AL. v. SIRACUSANO ET AL. (link to PDF) that:

... We conclude that the materiality of adverse event reports cannot be reduced to a bright-line rule ... Because adverse reports can take many forms, assessing their materiality is a fact-specific inquiry, requiring consideration of their source, content, and context.

Wall Street Journal author and "Numbers Guy" Carl Bialik adds to that point in an article today "Making a Stat Less Significant" where he writes:

To determine whether a medical side effect is significant in an experiment requires knowing that every incidence of that side effect is being reported. Researchers can feel confident that is happening in a controlled clinical trial of a drug, but they can't be sure when a drug is being sold to the general public, as was the case with Zicam.

In other words, when one is not sure that every incident of a side effect is being reported, one should not cavalierly dismiss "anecdotal" reports of side effects, especially from reliable reporters.

The practictioners of Medical Informatics, along with the HIT Industry and its customers, appear to have failed in that regard with respect to clinical IT (electronic medical records, CPOE etc.) For years they have argued that these medical devices should not be regulated because that would "stifle innovation" and that reports of device adverse events were "anecdotal." Many in the field still make these arguments.

This view extends all the way up to the Director of the Office of the National Coordinator for Health IT, who glibly stated per the Aug. 2010 Huffington Post Investigative Fund article FDA, Obama Digital Medical Records Team at Odds over Safety Oversight that FDA's own reports of health IT related injuries and deaths were “anecdotal":

ONC director Blumenthal, the point man for the administration, has called the FDA’s injury findings “anecdotal and fragmentary.” He told the Investigative Fund that he believed nothing in the report indicated a need for regulation.

Those "injury findings" appear in an FDA Internal Memo made available by the aforementioned Huffington Post Investigative Fund and archived at the following link:

Internal FDA memorandum on HIT risks (PDF) to Jeffrey Shuren MD JD (Director, Center for Devices and Radiological Health). Health Information Technology (H-IT) Safety Issues. "This is an Internal Document Not Intended for Public Use." Feb. 23, 2010.

(My description/summary of the memorandum is at my Aug. 2010 post "Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun?")

That memorandum itself emphasizes how FDA's own knowledge of these events is partial due to reporting impediments and lack of knowledge of resources such as FDA's MAUDE database.

The known reports were likely "the tip of the iceberg" according to the Director of FDA’s Center for Devices and Radiological Health (CDRH) Jeffrey Shuren, MD, who also happens to be a lawyer.

As at the aforementioned "tip of the iceberg" link, at an HHS meeting of the HIT Policy Committee's Adoption/Certification Workgroup on February 25, 2010, Shuren testified:

... In the past two years, we have received 260 reports of HIT-related malfunctions with the potential for patient harm – including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist.

Even within this limited sample, several serious safety concerns have come to light. The reported adverse events have largely fallen into four major categories: (1) errors of commission, such as accessing the wrong patient’s record or overwriting one patient’s information with another’s; (2) errors of omission or transmission, such as the loss or corruption of vital patient data; (3) errors in data analysis, including medication dosing errors of several orders of magnitude; and (4) incompatibility between multi-vendor software applications and systems, which can lead to any of the above.

The problem with ignoring testimony and reports of health IT-related difficulties and dismissing them as "anecdotal" goes back to the issue of "knowing that every incidence of that side effect is being reported."

While FDA itself admits significant doubt about completeness of reporting in its memo, what's worse is that Koppel and Kreda at University of Pennsylvania wrote a paper from which one might conclude that the healthcare and health IT industries are themselves aligned to conceal health IT adverse events reports.

In their remarkable article Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians, Journal of the American Medical Association, 2009;301(12):1276-1278, we learn that there is little motivation for device safety in the health IT industry:

Healthcare information technology (HIT) vendors enjoy a contractual and legal structure that renders them virtually liability-free—“held harmless” is the term-of-art—even when their proprietary products may be implicated in adverse events involving patients. This contractual and legal device shifts liability and remedial burdens to physicians, nurses, hospitals, and clinics, even when these HIT users are strictly following vendor instructions...HIT vendors are not responsible for errors their systems introduce in patient treatment because physicians, nurses, pharmacists, and healthcare technicians should be able to identify—and correct—any errors generated by software faults. [In other words, they are expected to be clairvoyant when presented with erroneous or missing data - ed.]

We additionally learn that:

The significant disparity between buyers and sellers in knowledge and resources [about healthcare IT problems] is profound and consequential. Vendors retain company confidential knowledge about designs, faults, software-operations, and glitches. Their counsel have crafted contractual terms that absolve them of liability and other punitive strictures while compelling users’ non-disclosure of their systems’ problematic, or even disastrous, software faults.

In other words, health IT customers and users have a gag order imposed on them regarding software faults and defects.

I think any reasonable person would conclude there is great doubt as to whether "every incidence of [HIT side effects] is being reported."

I also pointed out in JAMA (link) and on my Drexel website (link) how agreeing to these terms caused hospital executives to violate both their fiduciary duties to their organization's workers as well as Joint Commission safety standards obligations.

(I've personally reported health IT defects I'd observed in hospitals where my relatives were patients to FDA's MAUDE database, discovering that the institution itself, whose officials I alerted to the problems, did not. An example is here.)

The above is all common sense.

Thus, the dismissal of reports of health IT-related patient injury, deaths, and "near misses" represents a failure of common sense, as well as a massive abrogation of fiduciary responsibilities and legal and ethical obligations among the Medical Informatics, health IT vendor, healthcare delivery, and healthcare regulatory sectors.

One end result is that it permits software like this to be mandated by state governments on hundreds of hospitals. One can only imagine the public, press and legal reactions if mission-critical software issues of this magnitude were brought forth after an aviation or nuclear power plant disaster.

The cavalier dismissals of HIT mishap reports clearly fall into the "knew, or should have known" category of negligence.

Plaintiff attorneys for patients injured or killed via HIT-related mishaps should take note.

-- SS

Note: my WSJ comment on this issue appears here.

How Academic and Government "Anecdotes Are Not Data" Ideologues Kill People

I'm already receiving comments that, regarding Prof. Jon Patrick's detailed exposé of the dangers of ill-suited-for-purpose ED EHR's, Patrick's observations are:

... not really valid because they're not peer reviewed; they're just anecdotal.

Only an egghead could pen such words.

I always get hives immediately after eating strawberries. But without a scientifically controlled experiment with all the right peer review, it's not reliable data. So I continue to eat strawberries every day, since I can't tell if they cause hives.

I'd already written about anecdotalist refrains at my Mar. 7, 2011 post "Australian ED EHR Study: Putting the Lie to the Line "Your Evidence Is Anecdotal, Thus Worthless" Used by Eggheads, Fools and Gonifs." In that essay I cite Dr. Patrick himself on "anecdotal evidence", regarding which he hit the ball out of the Southern Hemisphere in an editorial in "Applied Clinical Informatics" entitled "The Validity of Personal Experiences in Evaluating HIT."

Aside from the fact that eggheads also don't seem to care about the issues of faulty peer review, especially in profitable biomedical sectors, such as at "The Lancet Emphasizes the Threats to the Academic Medical Mission" with its embedded links, and "Has Ghostwriting Infected The Experts With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?", there's this simple fact:

Public health catastrophe warnings from responsible sources don't need peer review, they need investigation.

Yes, there were those pesky, off-narrative journalistic reports that the Japanese nuclear reactors were not entirely safe, that Bernie Madoff was a fraud, that mortgages for everyone was not a good idea, that the O-rings couldn't stand sub-freezing temperatures, that the the foam that broke off the Columbia launch tank caused a danger, and that the Titanic didn't have enough lifeboats, but they weren't peer reviewed...so we ignored them. Saved us a lot of money, too.

-- SS

Addendum:

At my post "Real" Medical Informatics: What Does a Problem List of Typical Health IT Look Like, Part 2", I opined:

If the purpose of Medical Informatics is the improvement of healthcare (as opposed to career advancement of a small number of academics through publishing obscure articles about HIT benefits while ignoring downsides in rarified, echo-chamber peer reviewed journals), then:

• Who are the "real" medical informatics specialists, and;
  

• Who are the poseurs?

... researchers like Jon Patrick who address real-world issues of great import to patients on HIT risks, and further go public on the web with their work without the full blessings of some dusty journal (and those like Ross Koppel who also directly address the downsides, and others who make available to the public material such as on blogs like this and this, papers like this and sites like this) are the former.

Those who deem only "peer reviewed" articles worthy of daylight, and everything else - especially and particularly reports of downsides - "anecdotal" (the anecdotalists) are the latter.

I stand by this assertion.

Finally, I ask: at what point does ignoring work such as Prof. Patrick's, if patient harm is caused by the system he reviewed, constitute reckless endangerment and perhaps criminal negligence by hospital and government officials?

-- SS

Addendum Mar. 23:

As if on cue, this story appeared in the WSJ:

March 23, 2011

Japan Ignored Warning of Nuclear Vulnerability

TOKYO—Japanese regulators discussed in recent months the use of new cooling technologies at nuclear plants that could have lessened or prevented the disaster that struck this month when a tsunami wiped out the electricity at the stricken Fukushima Daiichi power facility.

However, they chose to ignore the vulnerability at existing reactors and instead focused on fixing the issue in future ones, government and corporate documents show. There was no serious discussion of retrofitting older plants with the alternative technology

I guess the "vulnerability reports" just weren't peer reviewed, therefore meaningless - or not reviewed by the "right" peers.

This sounds like our own FDA, ONC office and Institute of Medicine (via the Committee on Patient Safety and Health Information Technology), "choosing to ignore" health IT "vulnerabilities" (such as the aforementioned) and focusing on future issues such as comparative effectiveness research, "the common good", etc. instead.

I call this attitude "reckless endangerment" and hope plaintiff attorneys are paying close attention.

-- SS

Former NIH Director Spins Through Revolving Door, Ends Up at Sanofi-Aventis

A bit of news that got little attention this month was a new job for the former head of the US National Institutes of Health (NIH).  Dr Elias Zerhouni had left the NIH in October, 2008.  Here is the Reuters version of the story of his hew career:

French drugmaker Sanofi-Aventis (SASY.PA) replaced its head of research and development with a leading academic and former top U.S. health official on Tuesday to raise its game in medical innovations.

The company said Elias Zerhouni would lead R&D of drugs and bring R&D for vaccines under his control too as Sanofi reshapes its portfolio and looks to vaccines as one area for growth to offset sales losses from mounting generic competition.

The appointment of Zerhouni, a professor of radiology and biomedical engineering, comes as Sanofi battles to buy U.S. rare disease specialist Genzyme.

Chief executive Chris Viehbacher brought in Zerhouni in February 2009 as his scientific adviser, shortly after taking charge of the group which he has been transforming to include the development of drugs based on biotechnology.

Zerhouni's Embrace of Corporate Health Care

Although Zerhouni ostensibly left the NIH to return to academia at Johns Hopkins University, note that by February, 2009, four months after his resignation was announced, Zerhouni was already advising the Sanofi CEO. 

Soon after he joined the corporate health care world in earnest.  In April, 2009, he was proposed for membership on the board of directors of Actelion Ltd, a Swiss biotechnology company.  On December 8, 2009, he was elected to the board of Danaher Corp, a diversified technology corporation which makes medical devices.  At some time he had become President of the Zerhouni Group, which advertised itself as a resource to "pharmaceutical and biotechnology companies, trade organizations, sovereign wealth funds, government agencies, and research entities around the globe."

Zerhouni at the NIH: His Response to the Conflict of Interest Scandal

There is more than a little irony inspired by Zerhouni's quick circuit through the revolving door.

Zerhouni became director of the NIH in 2002, and announced his departure in October, 2008. In December, 2003, David Willman published his landmark article in the Los Angeles Times on severe conflicts of interest affecting NIH scientists and leaders.  It revealed that formerly stringent conflict of interest policies at the Institutes were rescinded by then director Dr Harold Varmus in 1995, during the Clinton administration, and increasingly since 1998, disclosure of NIH personnel's conflicts of interest had been reduced.  Thus, in 2002, Zerhouni had taken charge of an agency already deeply affected by conflicts of interest affecting many of its leaders, even though that was not yet public.  He initially did nothing about the situation. 

Willman published another series of articles revealing even more breathtaking conflicts of interest in December, 2004.  (See our post here.)   By then, a Los Angeles Times editorial said there was the "appearance of corruption" at the NIH, and called for Dr Zerhouni's resignation. 

Only after the second series of articles did Dr Zerhouni swing into action (see post here).  In February, 2005, he announced that he would now hold the NIH to a "higher standard."  Yet new conflict of interest stories kept surfacing and their handling kept provoking concern (e.g., see this post from 2007, and this post from 2008), and concerns about how NIH deals with conflicts of interest affecting the extramural researchers it funds persist to this day (e.g., see this post). 

By the late 1990s, the NIH, like many other government agencies, seemed to have become extremely cozy with the world of big corporations.  Dr Zerhouni did nothing to obvious to reduce the local version of this coziness until it had become a public scandal.  His actions let questions about the relationships of the NIH, once a pristine example of a government run biomedical research agency, with big health care business persist to this day. 

So it should perhaps be no surprise that he so quickly transitioned from the government that is supposed to be"of the people, by the people, for the people" to top leadership positions in corporate health care.

Other US Government Health Care Agency Leaders Transit the Revolving Door

Meanwhile, the previous commissioner of the US Food and Drug Administration, Dr Andrew von Eschenbach, is Senior Director for Strategic Initiatives at the Center for Health Transformation, a group whose membership includes some of the biggest health care organizations, many of which have had their own moments in the sun on Health Care Renewal.  For example, see Charter Members, AstraZeneca, Sutter Health, and Wellpoint; and Platinum Members, GlaxoSmithKline and Merck.  Dr Eschenbach is also on the board of directors of Histosonics Inc. 

Also, the previous director of the Centers for Disease Control, Dr Julie Geberding, became President of Merck Vaccines in late 2009. 

Conclusions

So the revolving door just keeps spinning, its revolutions suggesting how closely tied together big government and big corporations have become in what is now the health care business.  Whatever the motivations of Doctors Zerhouni, von Eschenbach, and Geberding were, the message to every person in a leadership position in health care in the US government has to still be: you too can earn big corporate compensation soon after you leave here.  Who knows how much that siren song will lead current government leaders to avoid antagonizing the leaders of big health care corporations during their government "service."  That is, of course, not what we want them to be thinking about if government agencies ae to serve the people, not the CEOs of big corporations. 

I am sure that the career transitions of Doctors Zerhouni, von Eschenbach, and Geberding were perfectly legal.  If we want government health care agencies to put the peoples' interests ahead of those of the CEOs of big health care corporations, should not, however, the law be changed to at least slow down the revolving door?

"Unreasonably Dangerous" Heparin

It is time for an update on the case of the deadly contaminated heparin sold by Baxter International, which has received much less attention than seems warranted given its human costs (81 lives).  How the heparin was contaminated, and how the contaminated heparin ended up being sold as a US Food and Drug Administration approved American product are still unknown.  Despite the fact that the outcome of this case were so bad, it received disproportionately little attention when it was first made public, and now seems to have become nearly anechoic.

Case Summary 

Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China. That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label. The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small "workshops" operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA. The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many patients who received got seriously ill or died. While there have been investigations of how the adulteration adversely affected patients, to date, there have been no publicly reported investigations of how the OSCS got into the heparin, and who should have been responsible for overseeing the purity and safety of the product. Despite the facts that clearly patients died from receiving this adulterated drug, no individual has yet suffered any negative consequence for what amounted to poisoning of patients with a brand-name but adulterated pharmaceutical product.  (For a more detailed summary of the case, look here, and for all our posts on this topic, look here.)

Civil Cases Plod Forward
If there is any ongoing official investigation of this case, it has not been made public.  Civil cases filed by patients allegedly injured by the heparin, or by relatives of patients who died allegedly from the heparin, seem to be proceeding at a glacial pace.  However, there is one development in one set of civil cases worthy of note.  As reported two weeks ago by Alicia Mundy in the Wall Street Journal:

A state court in Illinois has granted a partial summary judgment to two plaintiffs suing Baxter International Inc. over contaminated blood thinner, saying that some of the company's heparin was 'unreasonably dangerous.'

The suit involves tainted imported heparin ingredients from China that caused a public health crisis in 2008, and were linked to more than 80 deaths in the U.S. and many other serious allergic reactions.

Some 300 cases nationwide against Baxter and its main ingredient supplier, Wisconsin-based Scientific Protein Laboratories LLC, were consolidated in Chicago in Cook County Circuit Court.

Both companies have said that they weren't negligent and weren't responsible for the deadly reactions among patients.

The Illinois judge's ruling, dated Wednesday, involved a motion for partial summary judgment that named only Baxter. The motion was filed on behalf of two plaintiffs in the consolidated cases, one of whom died.

The ruling cites statements by Baxter's corporate quality vice president and the president of the company's medication delivery division that the heparin was defective.

Baxter argued in its defense that a jury should address the question of whether a product is 'unreasonably dangerous.' The company noted that the two Baxter executives who agreed in depositions that the heparin was defective aren't doctors or scientists. However, Judge Jennifer Duncan-Brice wrote that the issue before her wasn't whether heparin actually caused the death or injury to the plaintiffs, but just whether the product was, as a matter of fact, contaminated.

The most basic responsibility of a pharmaceutical company is to produce pure, unadulterated product.  As the current director of the US Food and Drug Administration wrote in this week's New England Journal of Medicine, the agency's "modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law, more than a quarter of a century in the making, that prohibited interstate commerce in adulterated and misbranded food and drugs."  However, in the 21st century, drug companies are increasingly failing to produce unadulterated products, and the FDA is having increasing difficulty assuring patients that the drugs they take meet even the most basic safety standards. 

I submit that corporate cultures increasingly influenced by the arrogant, greedy, amoral leadership of the financial services industry that lead us to the brink of another depression are also leading us to the brink of a poisonous era in health care.  Corporate leaders intent on cutting costs, and paying themselves as much of the resulting proceeds as possible, may see quality and safety as just another cost cutting target.  Corporate leaders brought up in the culture of finance, but untrained and inexperienced in engineering, science, and medicine find it all too easy to ignore quality and safety and focus on the bottom line.  (It is ironic that in the quote above, Baxter International's attorneys made light of the judgments of the company's own executives because they are not physicians or scientists.)

Meanwhile, society seems to have been so mesmerized by the mantra that laissez faire capitalism will lead to miraculous "innovation" that we do not even attend to instances in which it lead instead to death.

As we have said until being blue in the face, as long as the leaders of health care organizations are not held accountable for the results of their decisions on health care quality, cost, and access (even in such extreme quality violations as those resulting in multiple patient deaths), we can expect continuing decisions that sacrifice quality, increase costs, and worsen access, but that are in the self-interest of the people making them.


To really reform health care, we must hold health care organizations and their leaders accountable (and not blame all the problems on doctors, other health care professionals, patients, and society at large).

EHRevent.org CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error?

Additional detailed answers to the questions I raised here and here about a new site EHRevent.org, for reporting of healthcare IT-related medical errors, can now be found at a HIStalk interview entitled "HIStalk Interviews Edward Fotsch MD, CEO, PDR Network (EHR Event)" at this link.

It is an interesting interview. I certainly find the recognition of need for an EHR/clinical IT problems reporting service a major cultural advancement in healthcare.

It's still unclear to me how -- and why -- this organization originated with little to no public knowledge and involvement, especially considering the organization types mentioned below that participated, and how it will function in interactions with myriad healthcare IT stakeholders.

Here's an explanation by Dr. Fotsch:

... We work with a not-for-profit board called the iHealth Alliance. They Alliance is made up of medical society executives, professional liability carriers, and liaison representatives from the FDA. They govern some of the networks that we run, and in exchange for that, help us recruit physicians. Professional liability carriers, for example, promote our services that send drug alerts to doctors because that’s good and protective from a liability standpoint.

In the course of our conversations with them roughly a year ago, when we were talking about adding some drug safety information into electronic health records, we came across the fact that there were concerns from the liability carriers that there was no central place for reporting adverse EHR events or near misses or potential problems or issues with electronic health records.

[Translation: the carriers saw their losses potentially increasing as a result of litigation arising from EHR-related lawsuits, and decided to do something proactive- ed.]

They were interested in creating a single place where they could promote to their insured physicians that they could report adverse EHR events. Then it turned out that medical societies had similar concerns.

[That must have been one of the best-kept secrets on Earth considering the promotion EHR's have received as a miracle-working technology, and the lack of expression of concerns from those societies - ed.]

Rather than have each of them create a system, the Alliance took on a role of orchestrating all of the interests, including some interest from the FDA and ONC in creating an electronic health record problem reporting system. That’s how it came into play.

Our role in it, in addition to having a seat on the iHealth Alliance board, was really in network operations — in running the servers, if you will, which didn’t seem like a very complicated task. Since business partners we rely on for our core business were interested in it, it was easy to say yes. It frankly turned out to be somewhat more complicated than we originally thought [I predict they haven't seen anything yet; wait until they get knee deep into real world EHR issues - ed.], but now it’s up and available.

While I find the recognition of need for an EHR/clinical IT reporting service a major advancement, I am nonetheless troubled by certain statements made by Dr. Fotsch. They seem at odds with the theoretic and empirical findings of medical informatics, social informatics, human-computer interaction and other fields relevant for health IT evaluation, and/or seem to demonstrate biases about HIT. My comments are in red italics:

Fotsch:

… Probably what we’re seeing more often than not, the real challenge with EHRs like any technology, turns out to be some form of user error.

[What about contributory or causative designer error? – ed.]

“I didn’t know it would do that"

[Why did the user not know? Lack of training, poor manuals, or overly complex information systems lacking informative messages and consistency of control-action relationships, as an example? -ed]

... or “I didn’t know that it pre-populated that"

[Why did it pre-populate? Was that inappropriate for the clinical context, such as in this example?]

... or “I didn’t know I shouldn’t cut and paste"

[Then why did the software designers enable cut and paste, without some informative message on overuse, such as length of text cut and pasted?– ed.]

... or “I wasn’t paying attention to this"

[Perhaps due to distractions from mission hostile user interfaces? -ed]

... or maybe the user interface was a little confusing

[What is "a little confusing?" (Is that like "A little pregnant?) And why was it confusing? User intellectual inadequacy, or software design issues leading to cognitive overload? - ed.]

Actual software errors appear to be the exception rather than the rule as it relates to EHR events.

["Actual software errors" are defined as, what, exactly--? Loss of database relational integrity as a result of a programming error, as apparently recently happened at Trinity Health, a large Catholic hospital chain as reported in HIStalk? Memory leaks from poor code? Buffer overflows? What?]

That’s at least as I understand it.

[Understand it from whom? Hopefully not from me or my extensive website on the issues, the site whose header sadly now appears as below - ed.]

A new, unfortunate header for my website on health IT failures. Click to enlarge the shaded area, or click here to go to the site.

In summary, a "blame the user" attitude seems apparent. There appears to be little acknowledgment of the concept of IT "errorgenicity" - the capacity of a badly designed or poorly implemented information system to facilitate error, and of the systemic nature of errors in complex organizations to which ill-done IT can contribute.

These are concepts understood long ago in mission critical settings, as in this mid 1980's piece from the Air Force cited in my previously-linked eight part series on mission hostile health IT:

From "GUIDELINES FOR DESIGNING USER INTERFACE SOFTWARE"
ESD-TR-86-278
August 1986
Sidney L. Smith and Jane N. Mosier
The MITRE Corporation
Prepared for Deputy Commander for Development Plans and Support Systems, Electronic Systems Division, AFSC, United States Air Force, Hanscom Air Force Base, Massachusetts.

... SIGNIFICANCE OF THE USER INTERFACE

The design of user interface software is not only expensive and time-consuming, but it is also critical for effective system performance. To be sure, users can sometimes compensate for poor design with extra effort. Probably no single user interface design flaw, in itself, will cause system failure. But there is a limit to how well users can adapt to a poorly designed interface. As one deficiency is added to another, the cumulative negative effects may eventually result in system failure, poor performance, and/or user complaints.

Outright system failure can be seen in systems that are underused, where use is optional, or are abandoned entirely. There may be retention of (or reversion to) manual data handling procedures, with little use of automated capabilities. When a system fails in this way, the result is disrupted operation, wasted time, effort and money, and failure to achieve the potential benefits of automated information handling.

In a constrained environment, such as that of many military and commercial information systems, users may have little choice but to make do with whatever interface design is provided. There the symptoms of poor user interface design may appear in degraded performance. Frequent and/or serious errors in data handling may result from confusing user interface design [in medicine, this often translates to reduced safety and reduced care quality - ed.] Tedious user procedures may slow data processing, resulting in longer queues at the checkout counter, the teller's window, the visa office, the truck dock, [the hospital floor or doctor's office - ed.] or any other workplace where the potential benefits of computer support are outweighed by an unintended increase in human effort.

In situations where degradation in system performance is not so easily measured, symptoms of poor user interface design may appear as user complaints. The system may be described as hard to learn, or clumsy, tiring and slow to use [often heard in medicine, but too often blamed on "physician resistance" - ed.] The users' view of a system is conditioned chiefly by experience with its interface. If the user interface is unsatisfactory, the users' view of the system will be negative regardless of any niceties of internal computer processing.

I am not entirely happy when the CEO of an organization taking on the responsibility of being a central focus for EHR error reporting makes statements that are consistent with unfamiliarity with important HIT-relevant domains, as well as a possible pro-IT, anti-user biases.

For that reason as well as the other questions raised at my prior posts (such as the onerous legal contract and apparent lack of ability of the public to easily view the actual report texts themselves), I cannot recommend use of their site for EHR problems reporting.

I recommend the continued use of the FDA facilities until such time as a compelling argument exists to do otherwise.

-- SS

Addendum 11/28/10:

This passage ends the main essay at my site "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" and is quite relevant here:

... An article worth reviewing is "Human error: models and management", James Reason (a fitting name!), BMJ 2000;320:768-770 (18 March), http://www.bmj.com/cgi/content/full/320/7237/768:

Summary points:

• Two approaches to the problem of human fallibility exist: the person and the system approaches
  

• The person approach focuses on the errors of individuals, blaming them for forgetfulness, inattention, or moral weakness

• The system approach concentrates on the conditions under which individuals work and tries to build defenses to avert errors or mitigate their effects

• High reliability organizations---which have less than their fair share of accidents---recognize that human variability is a force to harness in averting errors, but they work hard to focus that variability and are constantly preoccupied with the possibility of failure.

-- SS

There You Go Again: Richard Epstein Says "Conflict-of-Interest Rules Thwart Medical Progress"

Richard Epstein, a professor at the New York University and University of Chicago law schools, just authored a report on the perils of conflict of interest rules.  In his blog, "The Libertarian," he summarized his beliefs that strict conflict of interest (COI) rules and restrictions on pharmaceutical marketing "spell lower rates of innovation and slower dissemination of new products." 

Prof Epstein is extremely prominent.  The Manhattan Institute, of which he is a fellow, claimed, "Professor Epstein's influence is profound: he is one of the three most cited law professors in the United States and the most cited professor writing largely in private law." Thus, it is disturbing that it appears that his objections are based on a series of logical fallacies.  (Note that we critiqued a defense of certain conflicts of interest he made in 2007 here on similar grounds.)

Ad Hominem: Enemies of Capitalism

Prof Epstein implied that the people who advocate strong conflict of interest rules are enemies of capitalism and free markets.  For example, he wrote, "most of the modern critics of the drug and medical device industries start with the assumption that the profit-motive alone is sufficient to distort the behavior of all scientists and researchers."  Later, "the people who line up most strongly against drug and device companies often treat the phrase 'market forces' as though it embodies the worst things in life."  How he was able to read the minds of those who disagree with him is unclear.  Attacking proponents of strict COI regulation as anti-capitalists (and by implication, socialists or communists) appears to be an ad hominem fallacy.

Burden of Proof: Ignoring Evidence of Harms of COI, Asserting Evidence of Benefits

Prof Epstein argued that COIs rarely if ever leads to bad effects: "the number of instances of serious abuses of power in the drug and device industry, like in medical research itself, is small, relative to the huge number of interactions that have taken place." Thus, he ignored evidence that commercially funded research may be biased in favor of the sponsors' products.(1-4) On the other hand, he implied that financial relationships  among physicians and researchers and commercial firms that sell health care products and services are necessary for "rapid development and deployment of new pharmaceuticals and medical devices," and for "innovation" in the field, but provided no evidence for these points.  Thus, while ignoring evidence of the possible harms of COIs, he failed to provide evidence for their benefits.  By placing the burden of proof on those who disagree with him, while avoiding it himself, he invoked the burden of proof (or appeal to ignorance) fallacy.

Appeal to Common Practice: Scientists Wearing Multiple Hats

Prof Epstein asserted that strict COI rules would disturb what is now common practice.  They would threaten how "the best research scientists in universities ... wear multiple hats.  In addition to researching within the academy, they also offer consulting services to drug companies, or start businesses of  their own."  Academics may currently behave in this way, but that does not mean this behavior is optimal in any sense.  Thus, Epstein employed the fallacy of the appeal to common practice. 

Slippery Slope: Silencing Communication and Collaboration

Prof Epstein asserted that strict rules on COI would "prohibit the collaborative efforts that have long characterized standard practices [in research]."  Specifically, he asserted the rules could stipulate that "no scientist who sits on any Food and Drug Administration (“FDA”) review committee, or any hospital conflict of interest committee, should be allowed to have connections with the pharmaceutical industry."  Also, "collaborations between government and industry scientists on research projects of common interests should either be totally eliminated or heavily regulated."  Finally, he asserted, "free interchange of information within and across firm boundaries is best calculated to allow the sharing and coordination of vital information," but "strong conflict of interest regulation poses real threats to these dynamic interactions."

Yet rules about conflicts of interest generally refer to those generated by financial relationships, most often payments by commercial firms to academics, researchers or physicians.  Payments are not necessary for collaboration.  Researchers can communicate, share information, even work together without one party paying the other.  Warning of such dire consequences of regulations that have nothing directly to do with communication or collaboration amount to the slippery slope fallacy.

Appeal to Authority: the "Most Gifted Members of the Academy"


Prof Epstein noted above that it was the best researchers who consult for commercial firms or start their own firms.  Later, he stated, "the ablest scientists often have the most extensive outside practices."  In complaining about rules that limit the pay of faculty members for services on boards of directors of for-profit health care companies, he asked, "why crimp the behavior of the most gifted members of the academy who can also make major contributions to industry?"  Thus he seemed to agree with the arguments made by representatives of pharmaceutical and device companies that the doctors who they pay to speak, consult, or do research are the best and the brightest.  However, there is considerable evidence (e.g., see posts here and here), that such "key opinion leaders" or "thought leaders" are chosen because of their sympathy to the companies and their products, and their malleability.  In addition, there is evidence that medical schools now put more emphasis on ability to attract external funding than any other faculty characteristic in decisions about payment, promotion, and retention (see post here).  Prof Epstein's invocation of the need to honor the best and the brightest appears to be a variant on the appeal to authority fallacy. 

Summary

So here we have another example, by " one of the nation's most prolific legal thinkers, (according to the Manhattan Institute) of a defense of the prevalent conflicts of interest that affect academic physicians and clinical researchers.  Like many previous such defenses, it seemed to be mainly based on logical fallacies. 

Also, like many previous such defenses, it was made by someone with a history of his own financial relationships with health care corporations.  To his credit, Prof Epstein did disclose, "over the years, I have worked extensively with various groups in the pharmaceutical industry, but have done no such work in the past few years."  On the other hand, he did not disclose his previous relationships with eSapience, a company which once claimed it "shapes the debate on issues that intersect law, economics, and policy."  (See post here.)

The currently prevalent relationships with health care corporations among academic physicians, researchers, and other decision makers and influencers in health care have been lucrative for them.  I have yet to see a coherent, logical argument that these relationships are good for patients, medical education, biomedical or clinical science, or public health made by anyone who does not have such relationships.

By the way, Prof Epstein also complained about overly rigorous regulation of pharmaceutical marketing in the same blog post, but since this really seems to be a distinct topic, I will not discuss his arguments here. 

References

1.  Bekelman JE et al. Scope and impact of financial conflicts of interest in biomedical research: a systematic review.  JAMA 2003; 289: 454-465.  Link here.
2.  Lexchin J et al.  Pharmaceutical industry sponsorship and research outcome and quality: systematic review.  Brit Med J 2003; 326:  1167.  Link here.
3.  Jorgenson AW et al. Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: systematic review. Brit Med J 2006; 333: 782.  Link here.
4.  McGauran N et al. Reporting bias in medical research - a narrative review.  Trials 2010; 11: 37.  Link here. 

Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun? I report, you decide.

From the aforementioned Huffington Post Investigative Fund article "FDA, Obama Digital Medical Records Team at Odds over Safety Oversight" and timeline of industry resistance to government oversight of health IT (link), one document stands out in my mind.

The internal FDA memorandum of Feb. 23, 2010 ("not intended for public use") to Jeffrey Shuren on HIT risks. which I have now re-hosted at this link (PDF) is quite fascinating.

Internal FDA Memo ("not intended for public use") on potential dangers of health IT. Download the PDF here.

The memo begins:

This report serves to characterize medical device reports (MDRs) in the Manufacturer and User Facility Experience (MAUDE) database, inclusive of MedSun reports, pertaining to Health Information Technology (H-IT) safety issues as requested by the Office of the Center Director, Center for Devices and Radiological Health (CDRH), in contrast to the previously submitted MedSun and Office of Compliance information.

(I've mentioned MAUDE here and here, including a report of an HIT-related patient death at the latter link.)

To those "anecdotalists" in the healthcare information technology community who believe reports of HIT-related harm are "anecdotal, and anecdotes don't make data" (as opposed to the "Markopolists"):

When an internal FDA review of their own data concludes the following, I invite you to think about the point of view that maintains that reports of HIT-related patient injury and death are so 'fragmentary' as to not merit (actually, demand) significant resources be diverted to rigorously addressing the issue of HIT risk:

In summary, the results of this data review suggest significant clinical implications and public safety issues surrounding Health Information Technology. The most commonly reported H-IT safety issues included wrong patient/wrong data, medication administration issues, clinical data loss/miscalculation, and unforeseen software design issues; all of which have varying impact on the patient’s clinical care and outcome, which included 6 death and 43 injuries. The absence of mandatory reporting enforcement of H-IT safety issues limits the number of relevant MDRs and impedes a more comprehensive understanding of the actual problems and implications.

This is especially true considering the FDA's own noted limitations of their information sources:

Limitations of the MAUDE search and final subset of MDRs include the following:

1. Not all H-IT safety issue MDRs can be captured due to limitations of reporting practices including

... (a) Vast number of H-IT systems that interface with multiple medical devices currently assigned to multiple procodes making it difficult to identify specific procodes for H-IT safety issues;
... (b) Procode assignments are also affected by the ability of the reporter/contractor to correctly identify the event as a H-IT safety issue;
... (c) Correct identification by the reporter of the suspect device brand name is challenged by difficulties discerning the actual H-IT system versus the device it supports.
2. Due to incomplete information in the MDRs, it is difficult to unduplicate similar reports, potentially resulting in a higher number of reports than actual events.
3. Reported death and injury events may only be associated with the reported device but not necessarily attributed to the device.
Memo: H-IT Safety Issues
4 Correct identification by the reporter of the manufacturer name is convoluted by the inability to discern the manufacturer of the actual H-IT system versus the device it supports.
5 The volume of MDR reporting to MAUDE may be impacted by a lack of understanding the reportability of H-IT safety issues and enforcement of such reporting.

If HIT were VIOXX or Phen-Fen, the class action lawsuits would likely be starting already.

(Note: for more on why there is a scarcity of data on HIT related adverse events, see my paper "Remediating an Unintended Consequence of Healthcare IT: A Dearth of Data on Unintended Consequences of Healthcare IT" at this Scribd link. This paper was not accepted on first draft by the medical informatics peer review process. I received anonymous review comments such as one that paradoxically stated that the paper "did not contain anything that could not be read in any big city newspaper", an odd comment indeed considering the topic. On that basis I decided not to attempt a revision but to post the paper publicly. -- SS)

One has to ask why this internal FDA report has not been made public until the Huffington Post article, nor been acted upon vigorously. The term of art is "double standard" compared to pharmaceuticals and other medical devices.

When the NEJM starts publishing unreferenced statements of absolute certainty like this from ONC Chair Blumenthal:

The widespread use of electronic health records (EHRs) in the United States is inevitable. EHRs will improve caregivers’ decisions and patients’ outcomes. Once patients experience the benefits of this technology, they will demand nothing less from their providers. Hundreds of thousands of physicians have already seen these benefits in their clinical practice.

and the HuffPo Investigative Fund quotes him as follows:

“We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system,” Blumenthal said when unveiling new regulations in Washington on July 13.

... a statement easily demonstrable to be without merit, in fact, then one has to wonder where science has gone.

One also has to wonder if someone is short-circuiting the FDA's role in regulating this technology.

Could Blumenthal (in essence a family doctor), Sibelius (a trial lawyer), DeParle, or others, or the White House itself be telling FDA how to conduct its business? Are they impeding FDA's regulatory role in the irrationally exuberant multi-billion $$$ race to HIT utopia?

Finally, it is my belief that numerous health IT/medical informatics academics and talking heads who've steadfastly avoided the issue of health IT-related patient harm, or scoffed at it in legally-discoverable forums, might find themselves as defendants in upcoming plaintiff lawsuits. "Knew, or should have known" is the phrase that might apply.

As I learned from my pre-informatics Transit Authority medical management experience, juries will likely not take kindly to academic and marketing arguments akin to Scott Adam's sarcastic example of the logical fallacy of "ignoring all anecdotal evidence":

"I always get hives immediately after eating strawberries. But without a scientifically controlled experiment, it's not reliable data. So I continue to eat strawberries every day, since I can't tell if they cause hives."

-- SS

More About What We Don't Know About the Contaminated Heparin from China

We last blogged about the case of Baxter International's adulterated heparin here.  (For a more detailed summary of the case, look here.)

In summary, Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China. That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label. The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small "workshops" operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA. The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many patients who received got seriously ill or died. While there have been investigations of how the adulteration adversely affected patients, to date, there have been no publicly reported investigations of how the OSCS got into the heparin, and who should have been responsible for overseeing the purity and safety of the product. Despite the facts that clearly patients died from receiving this adulterated drug, no individual has yet suffered any negative consequence for what amounted to poisoning of patients with a brand-name but adulterated pharmaceutical product.

Now, an article in the Wall Street Journal by Alicia Mundy tells us more about what we don't know,

The Chinese government didn't pursue an investigation into contaminated heparin sent to the U.S. in 2007 and 2008, despite repeated requests from the U.S. for help, according to a congressional probe.

Two House Republicans said Food and Drug Administration officials recently told them that the agency has been "severely hampered" by the lack of cooperation from China in finding those responsible.

Furthermore,

'It is shocking to find out two years after Chinese-made heparin was killing Americans, the Chinese government still has done no investigating to find out why,' said Mr. Barton, the top Republican on the House Energy and Commerce Committee. He called on ... [FDA Commissioner Margaret] Hamburg to air the issue with Chinese officials.

Chinese officials denied there is a problem,

Yan Jiangying, spokeswoman for China's State Food and Drug Administration, said the congressmen's accusations are 'not true.'

Ms. Yan said her agency 'did a very thorough investigation, including very detailed inspection and testing, and surveys of enterprises as well. We signed an agreement with the FDA on drug safety in the end of 2007, and strengthened the monitoring of heparin.'

Note that their investigation, such as it was, did not appear to identify any misconduct or wrong-doing by anyone.

So now we know more about what we do not know about the deadly adulterated heparin from China.

But remember this is a case about heparin sold in the USA by Baxter International, an American company as an American product, resulting in the death of Americans.  Also, remember that the American company obtained the heparin from another American company, Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. 

Since Baxter International sold the heparin under its own label, should not its leaders be responsible for the safety and purity of the product?  Since Scientific Protein Laboratories LLC furnished the active pharmaceutical agreement to Baxter, and obtained it from a factory it partially owned in China, should not its leaders also be responsible for the safety and purity of the product?

It would be important to find out ultimately where in China the adulterated heparin entered the supply chain, but the current uncertainty about the initial origin of the contamination does not absolve those in the US who sold the active pharmaceutical ingredient, and then sold that ingredient in bottles with a US company label of responsibility for the safety and purity of the drug.

Why have we heard nothing more from Baxter International's and Scientific Protein Laboratories' leaders about the deadly heparin which they had sold?  Why have we heard nothing more about any investigation of these US based participants in this case? 

Both US companies doubtless saved money by buying the heparin from the cheapest Chinese sources they could find, by not directly inspecting and supervising its production, and by at best ignoring the lack of regulation of producers of active pharmaceutical ingredients in China.  They and their leaders benefited from this out-sourced, off-shore production.  (Note that Baxter CEO Robert L Parkinson Jr received total compensation of $14,361,305 according to the company's proxy statement, and six named officers all received more than $2,200,000.) Why aren't they being held accountable for its bad results?

As we have said until being blue in the face, as long as the leaders of health care organizations are not held accountable for the results of their decisions on health care quality, cost, and access (even in such extreme quality violations as those resulting in multiple patient deaths), we can expect continuing decisions that sacrifice quality, increase costs, and worsen access, but that are in the self-interest of the people making them.

To really reform health care, we must hold health care organizations and their leaders accountable (and not blame all the problems on doctors, other health care professionals, patients, and society at large).

Hat tip to Ed Silverman on the PharmaLot blog.

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

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

The Unapproved IUDs

Here are the main points. The issue that caused so much local controversy was the use of unapproved IUDs:

Ten Rhode Island medical groups with 28 doctors told the Health Department that they bought IUDs, a form of birth control, from a foreign source, at prices about half what they had to pay for IUDs approved for use in the United States. Many had stopped using the unapproved devices long before the Health Department began its investigation in June.

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

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

Unapproved IUDs Made by an American Company in Finland and Sold in Canada

Most of the "unapproved devices" the doctors were using were apparently made in Finland by an American company.

In most cases, the doctors were using Mirena, which is made at a factory in Finland by an American company, Bayer Healthcare Pharmaceuticals. Only when it comes through approved channels can doctors and patients be assured that a product meets FDA standards. But it is unclear whether Bayer –– or anyone –– makes a version of Mirena that does not meet those standards.

The doctors imported the devices from far-away, exotic Canada.

Most of the devices apparently came from Canada, where the government negotiates with drug and device makers to keep prices low.

There is no reason to suspect the devices were counterfeit, or defective.

'If they’re really from Canada and from a reputable pharmacy, it should be exactly the same thing [as the FDA-approved version],' said Sheryl Ruzek, a retired public health professor at Temple University and vice chair of the board of the ECRI Institute, a nonprofit organization that evaluates medical procedures and products. 'My hunch is the patients were not harmed,' she said.

Potential Negative Consequences for the Physicians

However, the RI physicians are in big trouble for importing them:

In Rhode Island, the state boards that regulate physicians, nurses and nurse-midwives are investigating all those involved. If any are found guilty of unprofessional conduct, they could face disciplinary action such as a reprimand or license suspension. The state attorney general’s office has a Medicaid fraud unit, but declined to comment. The U.S. Attorney also had no comment.

US doctors in other states have also been importing IUDs, and also are in big trouble:

So many doctors were importing IUDs or considering doing so that the American College of Obstetricians and Gynecologists recently took an official stand, issuing an advisory opposing the use of imported devices.

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

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

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

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

We last blogged about the case of Baxter International's adulterated heparin here.  In summary, Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China.  That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label.  The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small "workshops" operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA.  The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many patients who received got seriously ill or died.  While there have been investigations of how the adulteration adversely affected patients, to date, there have been no publicly reported investigations of how the OSCS got into the heparin, and who should have been responsible for overseeing the purity and safety of the product.  Despite the facts that clearly patients died from receiving this adulterated drug, no individual has yet suffered any negative consequence for what amounted to poisoning of patients with a brand-name but adulterated pharmaceutical product.

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

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

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

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

An Attempt to Hold Health Care Leaders Accountable for Their Organizations' Bad Behavior?

We have frequently noted how health care organizations accused of kickbacks, fraud, and other unethical and sometimes illegal behavior involving how they produce or market health care products or services often are allowed to settle the charges only with a fines to the companies, and sometimes with corporate integrity agreements.  Almost never are the people who authorized, directed, or implemented the unethical behavior required to pay any sort of penalty.  We recently commented on a case in which an executive of a medical device company accused of exaggerating the performance of a diagnostic test in development was charged, not with misleading doctors or patients by the US Food and Drug Administration (FDA), but with misleading investors by the US Securities and Exchange Commission (SEC).  That executive lost her job, and will be barred from leading any public company.

So up to now, a corporate executive responsible for misleading doctors or patients about issues that could affect clinical decisions or outcomes likely would never pay a penalty, but one responsible for misleading  investors about similar issues could lose his or her job and livelihood.

Now, per an article in Fortune, it appear the situation may be changing,

The federal government is fed up with the amount of fraud, especially recurring fraud from the same companies, happening in the pharmaceutical industry. So regulators have decided that when it comes to punishments, it's time to get personal.

From now on, individual executives risk being ejected from their jobs -- and perhaps even barred from the industry -- for fraud their companies commit, even if they did not participate or even know about the crimes.

Furthermore,

The new approach, emerging from the unusually powerful Inspector General's office in the Department of Health and Human Services, reflects frustration with corporate recidivism even in the face of ramped-up fines, penalties and disgorgements.

'We are going to start to use that authority in the appropriate circumstances to get high level executives out of companies, so that the company has a better shot at changing its behavior, so that it does not become a recidivist,' explains Lewis Morris, chief counsel to the Inspector General.

The article noted some cases in which even large fines and corporate integrity agreements seemingly failed to deter future bad behavior by the companies which paid these penalties. For example,

In the government's most recent major settlement -- in which AstraZeneca agreed to pay $520 million -- the fine represented 16.5% of the $8.6 billion income (between 2001-2006) from U.S. sales of Seroquel, a powerful anti-psychotic. AstraZeneca (AZN) turned this narrowly approved drug into a cash cow by marketing it for much wider use, including by the elderly and children, even though they are particularly vulnerable to 'serious and debilitating side effects.'

All the while, AstraZeneca was operating under a corporate integrity agreement (CIA) with the Inspector General, imposed after a 2003 off-label marketing case.

We discussed the AZ settlement here in October, 2009. We asked then, "Does anyone really still believe that integrity agreements, and settlements assessed against huge corporations deter such profitable bad behavior?"

Another example:

Drug company Pfizer (PFE, Fortune 500), which was fined $2.3 billion just last September, is now on its third CIA. Steeper fines and harsh individual penalties should help put more teeth into these agreements and keep companies from flouting them.

We discussed the repeated lack of effect of settlements by Pfizer here in September, 2009. We concluded, "So will even a $2,300,000,000 settlement and yet another corporate integrity agreement make Pfizer or any other health care corporation act more ethically? I doubt it."

The Fortune article quoted Peter Rost, former Pfizer executive turned whistle-blower and ethics advocate (and to whose blog I offer a hat tip for first mentioning the Fortune article), on aspects of corporate culture and corporate incentives that foster repeated unethical behavior by management,

'Usually by the time someone becomes a senior executive they are very aware of the pitfalls in the organization, and they have become masters at not doing something wrong or not getting caught doing something wrong,' explains Peter Rost, a former senior Pfizer executive turned industry gadfly.

Incentive-based compensation systems -- typically 40% to 50% of salespeople's income comes from hitting their numbers -- are one weak point. 'They are going to work real hard to increase those numbers and do whatever it takes, and if they think somebody gave them a wink about doing this or that, they are going to run with it.' says Rost.

Booting senior executives out for any fraud under their watch might end the wink-and-nod system, giving hope to critics.

In my humble opinion, the government's new approach looks like real progress. Giving corporate executives personal impunity was a recipe for increasing unethical, and sometimes criminal behavior. The sorts of marketing fraud they authorized or directed certainly lead to increasing costs, and overuse of unnecessary and sometimes harmful tests and treatments. While there have years of complaints about health care's increasing costs and decreasing quality in health policy circles, it is just amazing that until now, there has been so little action against the bad behavior that was undoubtedly responsible for much of these problems.

So three cheers for making health care organizations' leaders accountable for the bad behavior of their organizations.

After cheering, however, there ought to be some serious inquiry about why they were not held accountable much sooner.  It turns out that there has been legal justification for holding leaders so accountable available for a long time:

All that's required for the government to flex this remarkably broad authority -- embedded in the Responsible Corporate Officers Doctrine -- is that the executives were in a position to have stopped the fraud that resulted in a criminal conviction or plea.

Note that the Responsible Corporate Officers Doctrine apparently derives from a US Supreme Court case about the selling of misbranded or adulterated drugs into interstate commerce under the US Food and Drug Act, decided in 1943.

However, it looks like in the hyper laissez faire climate of the last 20 or more years, no one wanted to bother to invoke it. After all, the formerly highly regarded leader of the US Federal Reserve believed there was no need for regulators to punish fraud, because the magic of the market would take care of it. US health care has paid a heavy price for such breathtaking naivete (see the PBS Frontline show, "The Warning." )