Cart Before the Horse, Part 3: AHRQ's "Health IT Hazard Manager"

In a July 2010 post "Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?" and an Oct . 2010 post "Cart before the horse, again: IOM to study HIT patient safety for ONC; should HITECH be repealed?" I wrote about the postmodern "ready, fire, aim" approach to health IT:

In the first post, I wrote:

... These "usability" problems require long term solutions. There are no quick fix, plug and play solutions. Years of research are needed, and years of system migrations as well for existing installations.

Yet we now have an HHS Final Rule on "meaningful use" regarding experimental, unregulated medical devices the industry itself admits have major usability problems, along with a growing body of literature on the risks entailed.

For crying out loud, talk about putting the cart before the horse...

Something's very wrong here...

However, this situation is anything but humorous.

How more "cart before the horse" can government get?

In the second post, I wrote:

... So, in the midst of a National Program for Health IT in the United States (NPfIT in the U.S.), with tens of billions of dollars earmarked for health IT already (money we don't really have, but it can be printed quickly, or borrowed from China) the IOM is going to study health IT safety, prevention of health IT-related errors, etc. ... only now?

Here we go yet again.

The problem with the AHRQ (Agency for Healthcare Research and Quality, a division of HHS) announcement below of a webinar about a new tool for identifying, categorizing, and resolving health IT hazards, as I have written before, is putting the "cart before the horse" and throwing medical ethics to the wind.

If we've just developed a tool "for identifying, categorizing, and resolving health IT hazards", the magnitude of which others such as IOM admit are unknown to our detriment (e.g., Health IT and Patient Safety: Building Safer Systems for Better Care, pg. S-2), then health IT is, it follows, an experimental technology.

If it is an experimental technology, AHRQ and others in HHS should probably be raising the issue of a slow down or moratorium on widespread rollout under HITECH until risk management and remediation is better understood.  At the very least they should be calling for patient informed consent that a device that will largely regulate their care is experimental, that a competency "gap" exists among healthcare practitioners within the "health IT environment" (meaning patients are at risk), and that patients should be offered the opportunity for informed consent with opt-out provisions.  The principals should not just be announcing a webinar:

Sent: Tuesday, June 05, 2012 12:23 PM
To: OHITQUSERS@LIST.NIH.GOV
Subject: Register Now! AHRQ Health IT Webinar "Purpose and Demonstration of the Health IT Hazard Manager and Next Steps" June 11, 2:30 PM ET

Agency for Healthcare Research and Quality

Purpose and Demonstration of the Health IT Hazard Manager and Next Steps

June 11, 2012 — 2:30-4 p.m., EST

The Agency for Healthcare Research and Quality (AHRQ) has identified a gap in a health care/public health practitioner’s competency within the health IT environment. This webinar is designed to increase practitioners’ competencies in several areas: improving health care decision making; supporting patient-centered care; and enhancing the quality and safety of medication management by improving the ability to identify, categorize, and resolve health IT hazards.

The Webinar will explore the Health IT Hazard Manager—a tool for identifying, categorizing, and resolving health IT hazards. When implemented, the tool allows health care organizations and software vendors alike to learn about potential hazards and work to resolve them, including the use of data to communicate potential and actual adverse effects. The session will discuss how the Health IT Hazard Manager was tested and refined as well as strategies and implications for deploying it. The target audience includes AHRQ grantees/researchers; health care providers, including physicians and nurses; consumers/patients; and health care policymakers.

... Webinar learning objectives include:

1. Describe the rationale for developing the Health IT Hazard Manager and how it evolved through alpha and beta testing.
2. Explain the process for identifying and categorizing health IT-related hazards.
3. Demonstrate how the Health IT Hazard Manager would be used [i.e., it's not yet in use, despite mandates for HIT rollout with penalties for non-adopters - ed.] within and across care delivery organizations and health IT software vendors.
4. Discuss policy and process implications for deploying the Health IT Hazard Manager via different organizations (i.e., AHRQ; Office of the National Coordinator for Health IT; Patient Safety Organization(s); Accrediting bodies; IT entities).

In effect, HHS seems to be saying "we're working on the HIT risk problem, but roll it out anyway; if you get harmed or killed, tough luck."  This seems a form of negligence.

Have we thrown out all we know about medical research and human subjects protections in face of the magical powers and profits of computers in medicine?

-- SS

Courses and Conferences on Health Care Ethics, Corruption, Marketing

Two courses and two conferences of interest to Health Care Renewal readers are coming soon.

Short Course: Why Do Physicians Not Make Rational, Evidence Based Decisions?


A full-day course at the 14th Biennial European Meeting of the Society for Medical Decision Making on Sunday, 10 June, 2012 in Oslo, Norway. Taught by bloggers Dr Roy Poses and Dr Wally Smith, the course will address both the effects of cognitive psychological limitations and of external influences by vested interests leading to less than optimal decisions.

A full description of the course is here.
 
Online Course: Corruption in the Health Sector

A 30 hour online course given by the U4 Anti-Corruption Resource Center, offered in collaboration with the Boston University School of Public Health.  The course is "on causes and consequences of corruption in the health sector; vulnerabilities in drug supply systems, informal payments, and strategies to minimise the problems." 

A full description is here. 

Conference: Deception, Incentives and Behavior

A two-day conference given by the Rady School of Management, University of California - San Diego, on 20-21 April, 2012 in San Diego, California, USA.  This will be a multidisciplinary meeting to facilitate "research of deception and related unethical behavior in the fields of economics and psychology/judgment and decision making (JDM)."

The conference web-site is here. 

Conference: Third Annual PharmedOut Conference on How Patient Harms May Result from Industry Promotion

A two-day conference given by PharmedOut at Georgetown University in Washington, DC on
14-15 June, 2012.  The conference will focus on the how industry promotion may lead to under-use, over-use, or mis-use of drugs and devices.

The conference web-site is here.

The First State's Deadest (Deadliest?) Duck - Is This ED EHR Harming or Killing Anyone in NSW?

Nobody seems to be asking this simple question:

Is This ED EHR harming or killing anyone in NSW?

It cannot be "not compromising patient care" on first principles.

This type of practical and ethical question seems to never get asked, while what appears to be a tit-for-tat political kerfuffle goes on.

This is due in part to the baffling special accommodations afforded worldwide towards an extremely profitable but potentially extremely dangerous medical device, as well as due to the issues I described in my post about reckless technophilia and the accompanying disregard for rights of others here.

The Register

NSW government accused of dodgy software cover-up

FirstNet: the First State's deadest duck [or "deadliest duck?" - ed.]

By Richard Chirgwin

Posted in Business, 12th February 2012 22:00 GMT

The buggy FirstNet emergency department software has become the subject of a political argument in NSW. [What about a clinical and ethical argument? - ed.]

In one of those paradoxes of democracy, an opposition which, in government, was responsible for a now-despised implementation is now using the IT project as a stick to beat a government which was in opposition when the system was chosen.

Last week, the Sydney Morning Herald obtained a report into the system by Deloitte, under a freedom of information request. It says [1] the Deloitte report criticises FirstNet because it is:

- Is chronically under-funded;

- Produces inadequate records;

- Was unreliable in delivering messages, and did not provide alerts when messages failed to reach their destination; and

- Demanded excessive amounts of screen time from clinicians.

[But is it harming or killing anyone? Are those statistics being collected robustly and scientifically, or are self-serving statements by hospital executives that "care was never compromised, and nobody was injured" simply being taken at face value?

Further, the obvious increased risk of harm due to deficient IT currently in operation is being cavalierly ignored. This is alien to medicine, and could cause career termination or land people in jail in fields such as aviation if planes with known potentially-dangerous avionics software or other defects are kept flying - ed.]

In spite of its inadequacies, the Deloitte report seen by the SMH said the $AU100-plus million Cerner FirstNet system is too entrenched to abandon.

[I'm quite sure dead or injured patents would not appreciate that explanation - ed.]

Over the weekend, opposition health spokesperson Dr Andrew McDonald issued a statement accusing NSW health minister Jillian Skinner of covering up the report since August 2011.

However, other published studies into FirstNet, such as a detailed investigation by Sydney University e-health expert Professor Jon Patrick here [2], identify problems similar to those apparently cited by Deloitte. This study was undertaken to investigate issues with FirstNet outlined in November 2008 in a special commission of review, conducted by Peter Garling,

While noting that FirstNet represented an improvement on some aspects of its predecessor, Garling said the system attracted complaints that it was unfriendly to users, that the vendor and Health Department did not respond to complaints about the software, and that emergency department patients were being held in triage for excessive times, while clinical staff fought with the software.

[What sane patient would want such a system used in their care? - ed.]

Deloitte, on the other hand, was far less critical of FirstNet in 2008, when in a review [3] of triage benchmarks it managed to turn up a downtime issue, difficulty in uploading triage data to the Health Department, and the identification of the wrong doctor or nurse with a patient’s records.

Links

1. http://www.smh.com.au/it-pro/government-it/hospital-computer-system-found-lacking-20120210-1so7j.html
2. http://sydney.edu.au/engineering/it/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146
3. http://www.health.nsw.gov.au/resources/news/pdf/triage-bench-rev.pdf

Stunning.

On the argument that "the older system was worse", or the corollary argument that "paper harms and kills too", I suggest anyone who proffers that argument should realize VIOXX (refoxicib) helped far more people than it harmed in reducing pain while sparing them from GI side effects compared to "older" drugs.

Over 84 million people were prescribed rofecoxib at some time and only mere thousands, or tens of thousands, are presumed to have been injured or died.

Therefore, following their own illogic and ethical (dis)orientation, they should put all their family members on the drug - especially the elderly with cardiovascular disease - to benefit from pain relief and VIOXX's other miraculous effect, suppression of colonic polyps.

Surely those benefits outweigh the risks, and therefore it is ethical to do so, no?

Of course not.

Health IT, as I've written in many posts on this blog, has a magnitude of harms that is admittedly unknown. Health IT needs significant further study and improvement, certainly before national rollouts, and before decisions are made that particular systems are "too entrenched to abandon."

-- SS

A Critical Review of a Critical Review of e-Prescribing ... Or Is It CPOE?

In PLoS medicine, the following article was recently published by researchers at the University of New South Wales in Australia:

Westbrook JI, Reckmann M, Li L, Runciman WB, Burke R, et al. (2012) Effects of Two Commercial Electronic Prescribing Systems on Prescribing Error Rates in Hospital In-Patients: A Before and After Study. PLoS Med 9(1): e1001164. doi:10.1371/journal.pmed.1001164

The section I find most interesting is this:

We conducted a before and after study involving medication chart audit of 3,291 admissions (1,923 at baseline and 1,368 post e-prescribing system) at two Australian teaching hospitals. In Hospital A, the Cerner Millennium e-prescribing system was implemented on one ward, and three wards, which did not receive the e-prescribing system, acted as controls. In Hospital B, the iSoft MedChart system was implemented on two wards and we compared before and after error rates. Procedural (e.g., unclear and incomplete prescribing orders) and clinical (e.g., wrong dose, wrong drug) errors were identified. Prescribing error rates per admission and per 100 patient days; rates of serious errors (5-point severity scale, those ≥3 were categorised as serious) by hospital and study period; and rates and categories of postintervention “system-related” errors (where system functionality or design contributed to the error) were calculated.

Here is my major issue:

Unless I am misreading, this research took place in hospitals (i.e., "wards" in hospitals) and does not seem to focus (if even refer to) discharge prescriptions.

I think it would be reasonable to say that what are referred to as "e-Prescribing" systems are systems used at discharge, or in outpatient clinic/offices to communicate with a pharmacy selling commercially and not involved in inpatient care.

From the U.S. Centers for Medicare and Medicaid Services (CMS), for example:

E-Prescribing - a prescriber's ability to electronically send an accurate, error-free and understandable prescription [theoretically, that is - ed.] directly to a pharmacy from the point-of-care

I therefore think the terminology used in the article as to the type of system studied is not well chosen. I believe it could mislead readers not experienced with the various 'species' of health IT.

This study appears to be of an inpatient Computerized Practitioner Order Entry (CPOE) system, not e-Prescribing.

Terminology matters. For example, in the U.S. the HHS term "certification" is misleading purchasers about the quality, safety and efficacy of health IT. HIT certification as it exists today (granted via ONC-Authorized Testing and Certification Bodies) is merely a features-and-functionality "certification of presence." It is not like an Underwriter Labs (UL) safety certification of an electrical appliance that the appliance will not electrocute you.

(This is not to mention the irony that one major aspect of Medical Informatics research is to remove ambiguity from medical terminology, e.g., via the decades-old Unified Medical Language System project or UMLS. However, as I've often written, the HIT domain lacks the rigor of medical science itself.)

I note that if this were a grant proposal for studying e-Prescribing, I would return it with a low ranking and a reviewer comment that the study proposed is actually of CPOE.

That said, looking at the nature of this study:

The conclusion of this paper was as follows. I am omitting some of the actual numbers such as confidence intervals for clarity; see the full article available freely at above link for that data:

Use of an e-prescribing system was associated with a statistically significant reduction in error rates in all three intervention wards. The use of the system resulted in a decline in errors at Hospital A from 6.25 per admission to 2.12 and at Hospital B from 3.62 to 1.46. This decrease was driven by a large reduction in unclear, illegal, and incomplete orders. The Hospital A control wards experienced no significant change. There was limited change in clinical error rates, but serious errors decreased by 44% across the intervention wards compared to the control wards.

Both hospitals experienced system-related errors (0.73 and 0.51 per admission), which accounted for 35% of postsystem errors in the intervention wards; each system was associated with different types of system-related errors.

I note that "system related errors" were defined as errors "where system functionality or design contributed to the error." In other words, these were unintended adverse events as a result of the technology itself.

The authors conclude:

Implementation of these commercial e-prescribing systems resulted in statistically significant reductions in prescribing error rates. Reductions in clinical errors were limited in the absence of substantial decision support, but a statistically significant decline in serious errors was observed.

The authors do acknowledge some limitations of their (CPOE) study:

Limitations included a lack of control wards at Hospital B and an inability to randomize wards to the intervention.

Thus, this was mainly a pre-post observational study, certainly not a randomized controlled clinical trial.

Not apparently accounted for, either, were potential confounding variables related to the CPOE implementation process (as in this comment thread).

In that thread I wrote to a commenter [a heckler, actually, apparently an employee of HIT company Meditech] with a stated absolute faith in pre-post studies that:

... A common scenario in HIT implementation is to first do a process improvement analysis to improve processes prior to IT implementation, on the simple calculus that "bad processes will only run faster under automation." There are many other changes that occur pre- and during implementation, such as training, raising the awareness of medical errors, hiring of new support staff, etc.

There can easily be scenarios (I've seen them) where poorly done HIT's distracting effects on clinicians is moderated to some extent by process and other improvements. Such factors need to be analyzed quite carefully, datasets and endpoints developed, and data carefully collected; the study design and preparation needs to occur before the study even begins. Larger sample sizes will not eliminate the possible confounding effects of these factors and many more not listed here.

The belief that simple A/B pre-post test that look at error rate comparisons are adequate is seductive, but it is wrong.

Stated simply, in pre-post trials the results may be affected by changes that occur other than the intervention. HIT implementation does not involve just putting computers on desks, as I point out above.

In other words, the study was essentially anecdotal.

The lack of RCT's in health IT are, in general, one violation of traditional medical research methodologies for studying medical devices. That issue is not limited to this article, of course.

Next, on ethics:

CPOE has already been demonstrated in situ to create all sorts of new potential complications, such in at Koppel et al.'s "Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors", JAMA. 2005;293(10):1197-1203. doi: 10.1001/jama.293.10.1197 that concluded:

In this study, we found that a leading CPOE system often facilitated medication error risks, with many reported to occur frequently. As CPOE systems are implemented, clinicians and hospitals must attend to errors that these systems cause in addition to errors that they prevent.

CPOE technology, at best, should be considered experimental in 2012.

In regards to e-Prescribing proper, there's this: Errors Occur in 12% of Electronic Drug Prescriptions, Matching Handwritten and this: Upgrading e-prescribing system can bump up error risk to consider; in other words, the literature is conflicting, confirming the technology remains experimental.

This current study confirmed some (CPOE) errors that would not have occurred with paper did occur with cybernetics, amounting to "35% of postsystem errors in the intervention wards."

In other words, patient Jones was now subjected to a cybernetic error that would not have occurred with paper, in the hopes that patients Smith and Silverstein would be spared errors that might have occurred without cybernetic aid.

Even though the authors observe that "human research ethics approval was received from both hospitals and the University of Sydney", since patient Jones did not provide informed consent to the experimentation with what really are experimental medical devices as I've written often on this blog [see note 1], I'm not certain the full set of ethical issues have been well-addressed. It's not limited to this occasion, however. This phenomenon represents a pervasive, continual world-wide oversight with regard to clinical IT.

Furthermore, and finally: of considerable concern is another common limitation of all health IT studies, which I believe is often willful.

What really should be studied before justifications are given to spend tens of millions of dollars/Euros/whatever on CPOE or other clinical IT is this:

The impact of possible non-cybernetic interventions (e.g., additional humans and processes) to improve "medication ordering" (either CPOE, or ePrescribing) that might be FAR LESS EXPENSIVE, and that might have far less IT-caused unintended adverse consequences, than cybernetic "solutions."

Instead, pre-post studies are used to justify expenditures of millions (locally) and tens or hundreds of billions (nationally), with results sometimes like this affecting an entire country.

There is something very wrong with this, both scientifically and ethically.

-- SS

Note:

[1] If these devices are not experimental, why are so many studying them to see if they actually work, to see if they pose unknown dangers, and to try to understand the conflicting results in the literature? More at this query link: http://hcrenewal.blogspot.com/search/label/Healthcare%20IT%20experiment

Addendum Feb. 10, 2012:

An anonymous commenter points out an interesting issue. They wrote:

The study was flawed due to its failure to consider delays in care and medication administration as an error caused by these experimental devices.

Delays are widespread with CPOE devices. One emergency room resorted to paper file cards and vacuum tubes to communicate urgency with the pharmacy. Delays were for hours.

I agree that lack of consideration of a temporal component, i.e., delays due to technology issues, is potentially significant.

I, for example, remember a more than five-minute delay in getting sublingual nitroglycerin to a relative with apparent chest pain due to IT-related causes. The problem turned out to be gastrointestinal, not cardiac; however, in another patient, the hospital might not be so lucky.

Addendum Feb. 12, 2012:

A key issue in technology evaluation studies is to separate the effects of the technology intervention from other, potentially confounding variables which always exist in a complex sociotechnical system, especially in a domain such as medicine. This seems uncommonly done in HIT evaluation studies. Not doing so will likely inflate the apparent contribution of the technology.

A "control ward" where the same education and training, process re-engineering, procedural improvements, etc. were performed as compared to the "intervention ward" (but without actual IT use) would probably be better suited to pre-post studies such as this.

A "comparison ward" where human interventions were implemented, as opposed to cybernetic, would be a mechanism to determine how efficacious and cost-effective the IT was compared to less expensive non-cybernetic alternatives.

-- SS

Cybernetik Über Alles: Computers Have More Rights Than Patients?

[Note: this essay contains many hyperlinks. They can be right-clicked and opened in a separate tab or window.]

What medical devices are shielded from liability?

Are there other examples of legislation seeking legal protections for wide-scale use of medical devices that even the device's trade group leadership admits are not ready, and are experimental?

Here we have a proposal from a member of the U.S. Congress to shield health IT software, a medical device (per FDA's Director of CDRH - the Center for Device and Radiological Health and others), and its users from liability through an apparently unique special accommodation.

This from iHealthBeat.org:

Thursday, October 27, 2011

Bill Would Establish New Legal Protections for EHR Adopters

On Wednesday, Rep. Tom Marino (R-Penn.) introduced legislation (HR 3239) that would create certain legal protections for Medicare and Medicaid providers who have implemented electronic health record systems, the Wilkes-Barre Times Leader reports.

The bill -- called the Safeguarding Access for Every Medicare Patient Act -- would create a system for reporting potential medical errors that occur when using EHRs, but it would not allow such information to be used as legal admission of wrongdoing.

The bill would cover certain physicians and hospitals that serve Medicare and Medicaid beneficiaries. It also would cover participants and users of health information exchanges.

Marino, who is a member of the House Judiciary Committee, said that offering the new legal protections to health care providers would promote greater use of EHRs and encourage Medicare and Medicaid providers to continue serving beneficiaries. [As if they could not do so without EHR's? - ed.]

He said, "Many providers are reluctant to use [EHRs] because they believe the practice will make them more vulnerable to unnecessary legal action," [unnecessary? How about real and necessary, as per the White Paper Do EHR's Increase Liability? - ed] adding, "This [bill] protects access for seniors in the Medicare and Medicaid programs" (Riskind, Wilkes-Barre Times Leader, 10/27).

From Rep. Marino's website (my comments are in [bracketed red italics]):

Marino Introduces Safeguarding Access For Every Medicare Patient Act

FOR IMMEDIATE RELEASE
Oct. 26, 2011

WASHINGTON -- U.S. Rep. Tom Marino, PA-10, has introduced legislation that offers limited legal protection to Medicare and Medicaid providers who use electronic records. [Which, I fear, could effectively act as, or mutate into, absolute protection in the environs of the legal system - ed.]

HR3239, the Safeguarding Access For Every Medicare Patient Act, would ensure patient access to Medicare and Medicaid providers; reduce health care costs [really? That's not what Wharton and others write - ed.]; guarantee incentives to providers to remain in the Medicare and Medicaid programs; and promote participation in health information technology.

Providers will eventually be required to participate in electronic recordkeeping or face a reduction in payments.

Marino said the bill offers incentive in the form of legal protection to providers who may be reluctant to remain in the Medicare and Medicaid programs due to low reimbursement rates which are constantly being targeted for further reductions.

[I imagine the known risks of health IT such as these at "MAUDE and HIT Risks: What in God's Name is Going on Here?" are a minor consideration if you receive legal immunity - ed.]

HR3239 would create a system for reporting potential errors that occur when using electronic records without the threat of that information being used as an admission of guilt. [Even if the physician or nurse is guilty of EHR-caused or aggravated, i.e., "use error" per NIST, malpractice - ed.]

It also prevents electronic records from being used as an easy source for “fishing expeditions,’’ [like this case, this case, this case and this case where patients died? - ed.] while making sure that parties responsible for errors are held accountable [how? -ed].

The proposal allows for providers who use electronic records to take remedial measures without having those actions be used to establish guilt [even though remediation may be very relevant to malpractice, patient injury and death prior to the remediation, and the remediation is informed by the error - ed.]; places time limits on the filing of lawsuits; and offers protection against libel and slander lawsuits.

[If this provision were to allow clinicians to speak publicly about HIT flaws without legal retaliation or sham peer review, I'd be all for it - ed.]

“Many providers are reluctant to use electronic records because they believe the practice will make them more vulnerable to unnecessary legal action,” Marino said. [I think it's much more likely they are reluctant to use them due to the aforementioned hair-raising MAUDE reports and literature such as here, here and here - ed.] and “Every time a doctor or hospital chooses not to participate because of these fears, our seniors lose another provider. This protects access for seniors in the Medicare and Medicaid programs.”

Marino said HR3239 is a two-pronged attack against rising health care costs: It provides legal protection to providers while encouraging the use of health information technology which has been shown to reduce costs. [See above links on that issue - ed.]

“Best of all, passage of this bill would require no new spending,” Marino said. [Besides the hundreds of billions to be spent on the IT itself - ed.]

This sounds like a healthcare IT vendor marketing piece, with claims refuted repeatedly here at HC Renewal, usually via the biomedical literature. It's slick, purporting to "protect Medicare access" while actually promoting health IT sales.

Did Rep. Marino get snowed by the health IT lobby? (See "The Machinery Behind Healthcare Reform" in the Washington Post.)

A major question is:

What are the patients and their rights to redress for injuries that occur due to EHR's? Chopped liver?

Isn't this bill really saying that patients are experimental subjects with limited rights? In other words, that improving EHR's should be at the expense of the unfortunate patients treated under its auspices? That the computers have more rights than the patients?

That line of thinking about what in reality is unconsented medical experimentation (i.e., "First, let's experiment" as opposed to "First, do no harm") has led to some very dark places in medicine, and not just in ancient history (e.g., see "Bioethics panel blasts late U. Pittsburgh professor").

See this reading list for more on these issues. Also see the many other posts on this blog about health IT quality, usability, efficacy, risk (and that the levels of that risk are admittedly unknown), lack of informed consent, and other issues via query links such as here, here, here and here - and the hyperlinks within those lists of posts - to more fully understand this perspective.

The text of the proposed legislation is here. While not all bad, it raises a number of concerns.

Excerpts are as follows:

H. R. 3239

To provide certain legal safe harbors to Medicare and Medicaid providers who participate in the EHR meaningful use program or otherwise demonstrate use of certified health information technology.

... SEC. 4. RULES RELATING TO E-DISCOVERY.

In any health care lawsuit against a covered entity that is related to an EHR-related adverse event, with respect to certified EHR technology used or provided by the covered entity, electronic discovery shall be limited to--

[I'm not sure what "certification" has to do with litigation, since "certification" of health IT has nothing to do with safety or usability; see note below - ed.]

(1) information that is related to [what does that mean? - ed.] such EHR-related adverse event; and

(2) information from the period in which such EHR-related adverse event occurred.

[eDiscovery related to EHR-related adverse events is already difficult, e.g., obtaining complete metadata. What these provisions would do is likely to increase the complications through legal maneuvers on terms such as"related to", "period" etc. - ed.]

SEC. 5. LEGAL PROTECTIONS FOR COVERED ENTITIES.

(a) General- For a covered entity described in section 2, the following protections apply:

(1) ENCOURAGING SPEEDY RESOLUTION OF CLAIMS-

(A) GENERAL- A claimant may not commence a health care lawsuit against a covered entity on any date that is 3 years after the date of manifestation of injury or 1 year after the claimant discovers, or through the use of reasonable diligence should have discovered, the injury, whichever occurs first. This limitation shall be tolled to the extent that the claimant is able to prove--

(i) fraud;

(ii) intentional concealment; or

(iii) the presence of a foreign body, which has no therapeutic or diagnostic purpose or effect, in the person of the injured person.

... (2) EQUITABLE ASSIGNMENT OF RESPONSIBILITY- In any health care lawsuit against a covered entity--

(A) each party to the lawsuit other than the claimant that is such a covered entity shall be liable for that party's several share of any damages only and not for the share of any other person and such several share shall be in direct proportion to that party's proportion of responsibility for the injury, as determined under clause (iii);

(B) whenever a judgment of liability is rendered as to any such party, a separate judgment shall be rendered against each such party for the amount allocated to such party [does that include the IT vendor? - ed.] ; and

(C) for purposes of this paragraph, the trier of fact shall determine the proportion of responsibility of each such party for the claimant's harm.

(3) SUBSEQUENT REMEDIAL MEASURES- Evidence of subsequent remedial measures to an EHR-related adverse event with respect to certified EHR technology used or provided by the covered entity (including changes to the certified EHR system, additional training requirements, or changes to standard operating procedures) by a covered entity shall not be admissible in health care lawsuits.

[This in and of itself seems to give special accommodation to health IT, since remediation helps make the case for the presence of problems to begin with - ed.]

(4) INCREASED BURDEN OF PROOF PROTECTION FOR COVERED ENTITIES- Punitive damages may, if otherwise permitted by applicable State or Federal law, be awarded against any covered entity in a health care lawsuit only if it is proven by clear and convincing evidence that such entity acted with reckless disregard for the health or safety of the claimant. In any such health care lawsuit where no judgment for compensatory damages is rendered against such entity, no punitive damages may be awarded with respect to the claim in such lawsuit.

[Would that apply to a case such as this? Does it apply to the health IT vendors and their often cavalier software development and quality practices, if patients become injured, such as here, "A Study of an Enterprise Health Information System?" How about to this case, "A Lawsuit Over Healthcare IT Whistleblowing?" - ed.]

(5) PROTECTION FROM LIBEL OR SLANDER- Covered entities and employees, agents and representatives of covered entities are immune from civil action for libel or slander arising from information or entries made in certified EHR technology and for the transfer of such information to another eligible provider, hospital or health information exchange, if the information, transfer of information, or entries were made in good faith and without malice.

[Does that include defects reports? - ed.]

From an ethical perspective, when you know a technology can be unsafe, but you don't know the levels of risk it creates, and the literature is conflicting on the benefits (prima facie evidence the technology is still experimental), you do not promote its wide-scale use in medicine and offer special accommodations to the technology's producers and users. Period. This is especially true without explicit patient informed consent and opportunity for opt-out. To promote such technology is not ethical.

Note: I believe the misunderstanding of "certification" of health IT contributes to the problems with such proposals. "Certification" of HIT has little if anything to do with safety, reliability, usability, etc. (e.g,, see http://hcrenewal.blogspot.com/2010/03/on-oncs-proposed-establishment-of.html).

"Certification" of health IT is not validation of safety, usability, efficacy, etc., but a pre-flight checklist of features, interoperability, security and the like. The certifiers admit this explicitly. See the CCHIT web pages for example. ("CCHIT Certified®, an independently developed certification that includes a rigorous inspection of an EHR’s integrated functionality, interoperability and security.")

Health IT "certification" is not like Underwriters Laboratories (UL) certification of appliances. ("Independent, not-for-profit product safety testing and certification organization ... With more than a 116-year proven track record, UL has been defining safety from the public adoption of electricity to new breakthroughs that help protect our future. UL employees are committed to safeguarding people, places and products in new and innovative ways for today’s borderless world.")

-- SS

10/28/11 Addendum:

This Representative seems to represent districts in Pennsylvania served by the Geisinger healthcare system, including Danville, PA where their main campus is located. His legislative assistant on healthcare represented Geisinger to me in a conversation today in glowing terms. However, I suggest that Geisinger does not have a perfect track record, e.g., see the post "A 'safe' technology? Factors contributing to an increase in duplicate medication order errors after CPOE implementation" and its reader comments and links.

10/30/11 Addendum:

It occurred to me that in the post "Is Healthcare IT a Solution to the Wrong Problem?" referencing a study published in the Nov. 25, 2010 New England Journal of Medicine entitled "Temporal Trends in Rates of Patient Harm Resulting from Medical Care" [Landrigan N Engl J Med 363;22] I pointed out that the abilities of health IT to "reduce medical error" may be significantly less than imagined.

This is because most medical errors have little to do with record keeping, but instead with human factors. See the post at http://hcrenewal.blogspot.com/2010/12/is-healthcare-it-solution-to-wrong.html.

-- SS

Why 99 Percent of the Irrationally Exuberant About Health IT Need To Be Removed From Healthcare

At Roy Poses' cross post "Why 99 percent of health care should be angry" over at the KevinMD blog, I introduced a comment into the "eruption of controversy" (his term here) caused by his post.

My comment was on the topic of government and health IT:

scotsilv 3 days ago

As one of Roy Poses' co-bloggers and a Medical Informaticist, I can say with certainty that government involvement in healthcare has been disastrous. Specifically, via ONC, ARRA and the HITECH Act, prematurely pushing still-experimental healthcare information technology on an unsuspecting medical profession (for the most part) and public. See "An updated reading list on health IT" at http://tinyurl.com/emrreadingl..., .

A reply typical of the irrationally exuberant was added to the thread (emphases mine):

Brett Mello 1 day ago in reply to scotsilv

What are you basing your "certainty" on? The examples discussed in the links sound like a case of bad configuration of an EMR. It could also be a just a poor solution from a vendor. Do you know if these were even a certified applications? I would like to suggest not painting all EMR implementations and the overall value of EMR’s from a single, albeit tragic, example. [I.e., an "anecdote" - ed.] A well implemented EMR, configured in collaboration with an organization’s physicians, has been repeatedly proven to reduce medical and medication errors. Why would any educated person, including legislators and executives, support the use of a tool that would increase harm, not safety.

Education aside, we will all be patients at some point so our innate need for self preservation would seem contrarian to arbitrary investments in useless technology to manage our care. Our current health delivery method produces far more harm than the new technology being implemented to address it. We need to embrace technology and make it work for us rather than putting our heads in the sand. Take the following quote as an example:

"That it will ever come into general use, notwithstanding its value, is extremely doubtful because its beneficial application requires much time and gives a good bit of trouble, both to the patient and to the practitioner because its hue and character are foreign and opposed to all our habits and associations." - The London Times, 1834 commenting on the "stethoscope"

Note that this reply came after I presented a link to a long list of articles, more than 50, with links to each article or its abstract for ease of reference, and a personal account of healthcare IT failure.

The articles challenge the beliefs in technological determinism common about health IT, i.e., that computers + medicine 'automagically' lead to better medicine, because, well, of the addition of computers, which must improve medicine, just - because.

The reason I write that the reply was typical of the irrationally exuberant is due to the interrelationship between irrationality, logical fallacy, and absence of evidence. These characteristics are usually present in the writings proffered by those so afflicted - and, to those with vested interests in health IT, a.k.a. conflicts of interest, I should add.

I replied:

medinf 16 hours ago in reply to Brett Mello

You are lacking references supporting your arguments, which in themselves display logical fallacy.

I urge all readers to see my linked references list at the top of this thread, examine some of them (such as Jon Patrick's work on gross EHR defects, the ECRI Institute's Top Ten List of Healthcare Hazards, Romano et al.'s "Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality" and others).

There are articles from reputable sources indicating today's health IT, lacking cognitive support and other necessities for clinicians (such as per the National Research Council itself in an investigation led by health IT pioneers Octo Barnett and William Stead, see http://www8.nationalacademies.... ) does not improve quality of care, and can cause harm.

These articles should raise caution in any physician, nurse or hospital contemplating use of this technology. These reports should not be cavalierly ignored, but should be a flag for great caution. The point is, with the literature conflicting, the technology should be considered experimental and caution used when deployed on human subjects. That includes both patients and clinicians, the former who can be injured or killed, the latter whose careers can be ruined through computer-caused or computer-aggravated errors. [Note: in health IT experiments, clinicians are, in fact, also experimental subjects - ed.]

Re: "The examples discussed in the links sound like a case of bad configuration of an EMR" - you omit the existence of clinical IT defects and problems such as poor software engineering causing unreliability, mission hostile human-computer interfaces (e.g., see http://www.tinyurl.com/hostile... ), incorrect or incomplete decision support algorithms, terminological problems, and other issues. You seem to indicate the findings in the reading list may be "anecdotal." A crushing reply to that line of thought, from an expert in Australia, is here: http://hcrenewal.blogspot.com/... .

As far as "certification" of HIT, this has little if anything to do with safety, reliability, usability, etc. ( e.g,, see http://hcrenewal.blogspot.com/... ). "Certification" of health IT is not validation of safety, usability, efficacy, etc., but a pre-flight checklist of features, interoperability, security and the like. The certifiers admit this explicitly. See the CCHIT web pages for example.

You use the logical fallacy of "appeal to authority" - or show severe naivete - in asking "why would any educated person, including legislators and executives, support the use of a tool that would increase harm, not safety."

"We need to embrace technology and make it work for us rather than putting our heads in the sand" - I ask - why now, if the technology is not ready? This seems like an appeal to novelty and perhaps the bandwagon fallacy (see http://www.nizkor.org/features... ).

Regarding your 1834 London Times quote, that was in a time before the human subjects experimentation guidelines such as the Belmont Report, World Medical Association Declaration of Helsinki, Guidelines for Conduct of Research Involving Human Subjects at NIH, the Nuremberg Code, and others came into being.

That said, the use of the 1834 stethoscope analogy is a type of red herring fallacy (http://www.nizkor.org/features... ). A stethoscope and enterprise clinical IT have little in common, the latter being potentially harmful to the point of causing patient death through interference in clinical care. (I note that if the 1834 story was brought up as an allusion to doctors and nurses who dislike today's IT being "Luddites" or the like, then that's an ad hominem fallacy.)

We as a society have supposedly learned something since 1834 regarding experimental medical devices. Or have we? FDA's Jeffrey Shuren MD, JD, Director of CDRH has admitted explicitly that health IT are medical devices with definite, but unknown, levels of risk - FDA stats "may represent only the tip of the iceberg in terms of the HIT-related problems that exist" were the exact words. That is prima facie evidence the devices are experimental.

However FDA refrains from regulating them under the FD&C Act, as they do pharma IT, other medical devices, drugs, etc. because they are a political "hot potato" - as at http://hcrenewal.blogspot.com/... , http://hcrenewal.blogspot.com/..., and http://hcrenewal.blogspot.com/... ).

As is customary at Healthcare Renewal, at those three posts are links to source, quoted in full context.

I've replied to so many irrationally exuberant commenters on this very blog, that I could have authored the reply above in my sleep.

Two points:

1. My reply and its links (and the source those links lead to) can and should be used as a "template" by clinicians to educate themselves, to reply to the health IT irrationally exuberant in their organizations, and to those in government prematurely pushing this technology onto clinicians;

2. The health IT irrationally exuberant, being irrational, ill-informed, and often markedly resistant to education, need to be removed from healthcare entirely. Their cavalier attitudes about cybernetic medical experiments are dangerous, and have no place in medical affairs. Such people impede, rather then help remediate the quality, safety, usability, and efficacy of health IT. In doing so, they contribute to increased risk and to actual patient harm. The irrationally exuberant are part of the problem, not part of the solution.

-- SS

The University of Minnesota, Where Nothing Can Go Wrong, Go Wrong, Go Wrong...

As noted on the Periodic Table blog, the administration of the University of Minnesota continues to believe all is well with its clinical research activities.  A recent internal review said there was nothing more to investigate about the unfortunate death of a psychiatric patient years before. So should we all be relieved?

It will take an extensive review of the case to ultimately suggest we should not at all be relieved.  The case raised important concerns about the validity of clinical research, and whether it violates the trust of its patient-subjects.  These concerns had not been addressed before the university's most recent review, and thus seem even more pointed after its recent non-investigation.

Background: the Untimely Death of Dan Markingson

In May, 2008, the (Minnesota) Pioneer Press ran a series of articles about the untimely death of Dan Markingson which occurred while he was enrolled in a randomized trial sponsored by AstraZeneca (the CAFE study) at a site at the University of Minnesota.  The first article in the series made the following major points:

Mr Markingson had given his consent to be enrolled despite evidence that he was actively psychotic

He started having visions of killing his mother in the storm. Markingson was taken Nov. 12, 2003, to Regions Hospital in St. Paul, but it had no open psychiatric beds. He was then transferred to the University of Minnesota Medical Center, Fairview.

Weiss said discussions about research started right away at the hospital. Markingson was placed in Fairview's Station 12, a new unit at the time created to treat psychotic patients and screen them for research. Olson and Dr. Charles Schulz, head of the U's psychiatry department, helped launch the unit in part to enhance the hospital's startup schizophrenia program and meet the U's mandate to bring in more research dollars.

Olson first recommended on Nov. 14 that a Dakota County District Court commit Markingson to the state treatment center in Anoka because he was not fit to make decisions about his care. He wrote to the court that Markingson was convinced his delusions were real and that he wasn't mentally ill.

The doctor changed his opinion about the commitment in less than a week, telling the court Markingson had started to acknowledge the need for help.

Reversals by patients are common, Olson explained in an interview with the Pioneer Press last month. Schizophrenics often arrive for treatment with delusions and denial but change their outlook while hospitalized.

A judge agreed Nov. 20 with Olson's new recommendation, requiring Markingson to follow the doctor's treatment plan. The next day, Markingson signed a consent form to be part of a national anti-psychotic drug study, Comparison of Atypicals for First Episode, or CAFE.

His mother's multiple complaints that while in the study, Markingson was not getting better and not getting proper treatment were ignored

Weiss' letters to Olson and Schulz, who was a co-investigator in the study, urged them to consider different treatment options for her son, which would have disqualified him from the study. But the doctors were unconvinced by her pleas.

In particular, she wrote with strange prescience,

'Do we have to wait until he kills himself or someone else,' she asked three weeks before his suicide, 'before anyone does anything.'

There was evidence that Markingson was not getting optimal treatment

In retrospect, it was not even clear that Markingson was taking his study medications prior to his suicide:

An autopsy showed no medication in Markingson's bloodstream, and a coroner's photo showed a sealed bottle of his medication. Had he been taking his drugs?

Study officials could have been fooled. They only counted drugs left in pill bottles instead of testing blood levels in patients.

Suggestions that financial conflicts of interest influenced trial investigators' actions

The initial news article raised questions whether the study investigator had been unduly influenced to keep Markingson in the study by financial concerns:

CAFE was an early opportunity at the U for Olson to add research experience to his academic credentials. The U had recruited him in 2001 for his expertise in schizophrenia.

It was a slow start. Olson recruited one patient in 2002, and CAFE study leaders considered dropping him altogether, according to monthly recruiting summaries. Olson and the university had been dropped from a previous study because of low recruiting numbers, the doctor later said in his court deposition.

Exchanges between local and national study officials made it clear that there was pressure for results and a 'risk' that the study would be shut down if it didn't recruit enough patients.

Note that:

As Subject 13, Markingson was worth $15,000 to the U, with some of that going to Olson's salary and the psychiatry department. Switching or adding medications could have disqualified Markingson and halted payments to Olson and the department from AstraZeneca.

Overall, the study offered $327,000 to the U and an opportunity to raise the profile of its schizophrenia program.

An accompanying Pioneer Press article indicated that both Dr Olson, and the Chair of Psychiatry, Dr S Charles Schulz, were receiving considerable financial support from AstraZeneca and other pharmaceutical companies at the time of the study.

Olson received $220,000 from six companies since 2002, including $149,000 from AstraZeneca, according to the state records. Schulz received $562,000, including $112,000 as a researcher and consultant to AstraZeneca.

Olson said his AstraZeneca money went straight to the U but did support his salary. Markingson's full participation in the yearlong study meant up to $15,000 for the university.

Did the lawsuit's results indicate nothing was wrong?

Mr Markingson's mother sued the University of Minnesota and AstraZeneca, but (per the first Pioneer Press article),

The lawsuit ended this year after a judge ruled that the university had statutory immunity from such lawsuits and that AstraZeneca shouldn't stand trial because there was no convincing proof that its drug caused Markingson's death. Weiss settled with Olson, the only defendant left. She said she was granted $75,000, which went entirely toward legal bills.

Note that the results did not address the university's or its administration's role.

Dr Carl Elliott Takes Another Look

Thus the case appeared to end, with no real reconsideration of how medical schools' dependence on commercial funding of clinical studies, and how individual faculty members' financial relationships with drug, device, and biotechnology firms may affect research done on human beings.

However, in September, 2010, Mother Jones published an article by Dr Carl Elliott, a University of Minnesota bioethicist, which raised further questions about the case.

I talked to several university colleagues and administrators, trying to learn what had happened. Many of them dismissed the story as slanted and incomplete. Yet the more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Press had reported. The danger lies not just in the particular circumstances that led to Dan's death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs

Major design defects of the CAFE study:

It barred subjects from being taken off their assigned drug; it didn't allow them to be switched to another drug if their assigned drug was not working; and it restricted the number of additional drugs subjects could be given to manage side effects and symptoms such as depression, anxiety, or agitation. Like many clinical trials, the study was also randomized and double-blinded: Subjects were assigned a drug randomly by a computer, and neither the subjects nor the researchers knew which drug it was. These restrictions meant that subjects in the CAFE study had fewer therapeutic options than they would have had outside the study.

In fact, the CAFE study also contained a serious oversight that, if corrected, would have prevented patients like Dan from being enrolled. Like other patients with schizophrenia, patients experiencing their first psychotic episode are at higher risk of killing themselves or other people. For this reason, most studies of antipsychotic drugs specifically bar researchers from recruiting patients at risk of violence or suicide, for fear that they might kill themselves or someone else during the study. Conveniently, however, the CAFE study only prohibited patients at risk of suicide, not homicide. This meant that Dan—who had threatened to slit his mother's throat, but had not threatened to harm himself—was a legitimate target for recruitment.

As Dr Elliott noted, this appeared to be yet another example of manipulation of clinical research designed to make the sponsors' products look better, a topic we have frequently discussed on Health Care Renewal:

A 2006 study in The American Journal of Psychiatry, which looked at 32 head-to-head trials of atypicals, found that 90 percent of them came out positively for whichever company had designed and financed the trial. This startling result was not a matter of selective publication. The companies had simply designed the studies in a way that virtually ensured their own drugs would come out ahead—for instance, by dosing the competing drugs too low to be effective, or so high that they would produce damaging side effects. Much of this manipulation came from biased statistical analyses and rigged trial designs of such complexity that outside reviewers were unable to spot them. As Dr. Richard Smith, the former editor of the British Medical Journal, has pointed out, 'The companies seem to get the results they want not by fiddling the results, which would be far too crude and possibly detectable by peer review, but rather by asking the 'right' questions.'

This was likely what was going on with the CAFE study:

Although the documents unsealed in the Seroquel litigation do not specifically mention the CAFE study in which Dan was enrolled, they do suggest that AstraZeneca planned to establish Seroquel as the "atypical of choice in first-episode schizophrenia,' according to a 2000 'Seroquel Strate'y Summary.' A later document titled 'Seroquel PR Plan 2001' discusses the agenda for an advisory panel meeting in Hawaii. Among the potential topics were the marketing of Seroquel to first-episode patients, adolescents, and the elderly. The document refers to these populations as "vulnerable patient groups."

Even more alarming are internal documents suggesting that AstraZeneca was designing clinical trials as a covert method of marketing Seroquel. In 1997, when Dr. Andrew Goudie, a psychopharmacologist at the University of Liverpool, asked AstraZeneca to fund a research study he was planning, a company official replied that 'R&D is no longer responsible for Seroquel research—it is now the responsibility of Sales and Marketing.' The official also noted that funding decisions would depend on whether the study was likely to show a 'competitive advantage for Seroquel.'

Were study subjects protected?
So, as Dr Elliott wrote,

Many clinical studies place human subjects at risk—at a minimum, the risk of mild discomfort, and at worst, the risk of serious pain and death. Bioethicists and regulators spend a lot of time and energy debating the degree of risk that ought to be permitted in a study, how those risks should be presented to subjects, and the way those risks should be balanced against the potential benefits a subject might receive. What is simply assumed, without much consideration at all, is that the research is being conducted to produce scientific knowledge. This assumption is codified in a number of foundational ethics documents, such as the Nuremberg Code, which was instituted following Nazi experiments on concentration camp victims. The Nuremberg Code stipulates that an 'experiment should be such as to yield fruitful results for the good of society,' and 'the degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.'

But what if a research study is not really aimed at producing genuine scientific knowledge at all? The documents emerging in litigation suggest that pharmaceutical companies are designing, analyzing, and publishing trials primarily as a way of positioning their drugs in the marketplace. This raises a question unconsidered in any current code of research ethics. How much risk to human subjects is justified in a study whose principal aim is to 'generate commercially attractive messages'?

Conflicts of interest
Of course, university faculty pushed to bring in more external funds to support their careers (see this post) by university leaders with their eyes on the bottom line may not be too critical of the intricate designs of the studies they need to do to continue their academic careers, and whether such studies are really meant to promote science and improve patient care, or position products in the marketplace, especially when the same companies are paying them as consultants, speakers, etc.

In fact, Dr Elliott found reasons to make such concerns specific to the case of Mr Markingson's untimely death:

Olson had another financial reason to maintain good relations with AstraZeneca. According to a disclosure statement for a 2006 conference, he was a member of the AstraZeneca 'speaker's bureau,' giving paid talks for the company. He had similar arrangements with Eli Lilly and Janssen, the makers of the other atypicals being tested in the CAFE study, as well as Bristol-Myers Squibb and Pfizer. In addition, Olson was working as a paid consultant for Lilly, Janssen, Bristol-Myers Squibb, and Pfizer.

Bioethicists Demand an Investigation

So eight University of Minnesota bioethicists, including Dr Elliott, wrote a letter to the University administration demanding an investigation, as reported in December, 2010, by the Minneapolis- St Paul Star-Tribune,

In a letter to the board Monday, the professors questioned whether U psychiatrists lacked ethical judgment in enrolling the victim, Dan Markingson, a schizophrenic who may have lacked the wherewithal to consent to research. They also questioned whether financial incentives from AstraZeneca, the drugmaker funding the study, presented conflicts for the researchers, Dr. Stephen Olson and Dr. S. Charles Schulz.

At the time, the administration promised a serious response:

U leaders will take the letter seriously and take the protection of human research subjects seriously, said the U's general counsel, Mark Rotenberg.

But then almost immediately indicated its bias:

'The fact that this is tragic doesn't mean the treating physicians did anything wrong,' he said.

What, Us Worry?

It did not take long for Mark Rotenberg to decide that there was nothing more to worry about. As reported in February, 2011, by the Pioneer Press:

in a Monday letter to Elliott and colleagues, the chairman of the U's board of regents wrote 'we do not believe further university resources should be expended re-reviewing a matter such as this, which has already received such exhaustive analysis by independent authoritative bodies.'

'Our general counsel has provided us with the extensive reviews of this case that were performed over the years by a number of independent experts and governmental units,' chairman Clyde Allen Jr. said in the letter. 'Each and every one of these reviews resulted in the same conclusion: there was no improper or inappropriate care provided to Mr. Markingson, nor is there evidence of misconduct or violation of applicable laws or regulations.'

Of course, since Mr Rotenberg is responsible for, among other things, reducing the university's legal liability, one could see how he might not want to delve further into this case.  As we noted earlier, it is not clear that previous "exhaustive" investigations asked the questions that needed to be asked, or had access to all the relevant data.  The issues are not whether their was criminal conduct, or even civil liability, but whether the university is presiding over good science and protection of research subjects?

So we should be worried, of course, that commercial firms sponsor research on human beings mainly to serve marketing objectives, and that university faculty and administrators go along, allowing their formerly prestigious universities' names to be added to the research in exchange for the money they so much want to keep themselves living in the style to which they are accustomed. We ought to be particularly worried when these universities seem to forget about their mission to find and disseminate new knowledge in favor of defending the work that continues to bring in the money.

Thus, physicians, researchers, patients, and the public ought to be very skeptical about clinical research sponsored by commercial firms with vested interests in the research turning out a particular way, and even about research not sponsored by such firms, but done by researchers who have personal financial ties to such firms. Worse, patients ought to be extremely skeptical about the motives of researchers who want to enroll them in trials when the researchers have financial ties to commercial firms whose products could be promoted through such trials, and especially when such firms are sponsoring the trials.

As a long-time advocate for evidence-based medicine, whose advancement depends on the continuing creation of valid research evidence from clinical research, it is heart-breaking to have to make these recommendations, but they will be necessary until there is better assurance that clinical research is being done to advance science and patient care, not the commercial interests of the sponsors and the researchers.

Until academic medicine becomes more open about how and why it is doing clinical research, such skepticism is warranted.

However, I will end with a ray of hope. If the administrators and faculty do not get it, the student journalists do. Read these words in an editorial in the Minnesota Daily:

Of course, the University has maintained neither it nor anyone involved in the case did anything wrong, an odd claim to make after the Minnesota Legislature unanimously passed a law that prohibits exactly what happened and named the law after Markingson.

The University seems to think that because it was not held liable in court for Markingson’s death, it did nothing wrong. This is false; it is a cynical excuse to keep corporate drug money flowing into the University.

The regents’ decision fundamentally undermines our mission: Supposedly, the University is 'dedicated to … the search for truth.' But the letter makes it clear that corporate research cash is more important to the University than patient safety and transparency.

Refusing to set up an independent investigation is a willfully ignorant attempt to sweep the Markingson case under the rug and damages the integrity of the entire University.

Perhaps it is time for the state legislature to take another look at this issue.

True health care reform would separate clinical research, that is, research done on human beings, from the commercial interests of health care corporations and the people who work for them.

ADDENDUM (18 March, 2011) - See this post by Naomi Freundlich on the Health Beat blog.