Is the Patient Centered Outcomes Research Institute Really More Industry-Centered?

One of the biggest reasons our health care system seems so dysfunctional is that clinicians and patients have great difficulty determining what might be the appropriate management of particular clinical problems.  Due to endless and sometimes deceptive marketing, conflicts of interest affecting health care professionals and academics, and manipulation and suppression of clinical research, making truly evidence based decisions that put individual patients interests first has become very difficult.  Instead, we may end up using excessively expensive, relatively ineffective, and more dangerous than anticipated drugs, devices, and diagnostic and therapeutic strategies, thus leading to poor patient outcomes and high costs.

Background - the Patient-Centered Outcomes Research Institute (PCORI)

One lingering hope has been that better clinical research, particularly focusing on the outcomes that are most important to patients (patient-centered outcomes), and comparing clinical strategies that may be widely used but poorly evaluated (comparative effectiveness research) would help dissipate the fog.  An attempt to promote such research in the US appeared in our recent health reform legislation, the Affordable Care Act.  It authorized the creation of the Patient Centered Outcomes Research Institute (PCORI).

However, as we observed, how good a solution this would be would depend on the details.  Our concerns were that PCORI, which is an independent although government sponsored institute, not a government agency, might be too beholden to "stake-holders" including the large organizations, device and pharmaceutical companies, insurance companies, hospital systems, etc, that already dominate health care and may promote their and particularly their executives' interests ahead of patients.

Recently, Merrill Goozner, the editor of Modern Healthcare, raised similar concerns,

there is the law's requirement for stakeholder boards to set PCORI research priorities. They must include representatives of researchers, clinicians, patients, providers, insurers, employers and industry. The interests of those groups are not the same. Priority-setting by stakeholder boards could turn into a prescription for steering clear of the most controversial, and therefore most significant, questions.

So,

There is no shortage of drug and device firms, specialty hospitals and medical specialty societies with a vested interest in leaving certain questions unasked or muddying the waters with methodological quibbles. They shouldn't be allowed to hijack or soften the agenda.

PCORI is now in operation, but has seemingly not gotten a lot of scrutiny. What scrutiny it has received as not allayed these concerns.

The PCORI Advisory Panels

Recently, the publication of the membership of four key advisory panels for PCORI got the attention of  Michael Millenson, blogging on the Health Care Blog.  He noted that initially the members of the panels were identified only by name and city of residence, without any information on their other affiliations or characteristics.  He suggested,

PCORI isn’t a church, where all are created equal in the eyes of God, but a politically created, politically governed, controversial dispenser of a very large amount of money that a host of interest groups would like to control. PCORI staff chose the panel members in part by looking at their affiliations, and those connections (or lack of them) should be an immediate part of the public record when the appointments are announced. By being vague, PCORI obfuscates political and power relationships and makes it more difficult for the public and industry stakeholders to either approve of or criticize those choices.

Eventually, PCORI did release somewhat more information on membership of these panels, on Addressing Disparities, Assessment of Prevention, Diagnosis, and Treatment Options, Improving Healthcare Systems, and Patient Engagement.  Mr Millenson was able to review the membership of one panel, and noted some strange anomalies in a comment to his original blog post. 

One panel member who supposedly represents "patients, caregivers, and patient advocates" had a full time position with a pharmaceutical company.  Another worked for a big consumer organization which is heavily funded by the pharmaceutical industry.

This raised concerns that PCORI may get guidance from people whose interests are actually different from those they are supposed to represent.

Therefore, I attempted to review the stated affiliations of all PCORI advisory panels.

Review of the what was made public about the membership of the advisory panels revealed several additional important anomalies.  Members said to be representing "patients, caregivers, and patient advocates" appeared to have positions working for organizations who might have their own, and different interests from the group they were supposed to be representing. 

Let me summarize the apparent anomalies by advisory panel.  In each case, in alphabetical order by panel,  I will list the panelists name, supposed representation, and affiliation, with my comments. 

Addressing Disparities

Monique Carter MS - Dallas, TX
representing: patients, caregivers, and patient advocates
affiliation: Senior Research Scientist, AROG Pharmaceuticals Inc

So this person would appear to be more of an industry (pharmaceuticals) representative.

Venus Gines, MA, P/CHWI - Manvel, TX
representing: patients, caregiver, and patient advocates
affiliation: Instructor, Chronic Disease Prevention and Control Research Center, Department of Medicine, Baylor College of Medicine

So this person appears to be more of a clinician, or health system representative

Doriane C Miller MD - Chicago, IL
representing: patients, caregivers, and patient advocates
affiliation: Director, Center for Community Health and Vitality, University of Chicago Medical Center

So this person also appears to be more of a clinician, or health system representative.

Carmen E Reyes, MA - Whittier, CA
representing: patients, caregivers, and patient advocates
affiliation: Center and Community Relations Manager, Los Angeles Community Academic Partnership in Research in Again, UCLA

So this person appears to be more of a health system representative.

Mary Ann Sander, MHA, MBA, NHA - Pittsuburgh, PA
representing: patients, caregivers, and patient advocates
affiliation: Vice President, Aging  and Disability Services, UPMC Community Provider Services

So this person appears to be more of a health system representative

Deborah Steward, MD, MBA - Jacksonville, FL
representing: clinicians
affiliation: Florida Blue

So in summary, this panel included five people who ostensibly represent patients, caregivers, and patient advocates but who actually work for large academic medical centers or health systems, and one who was there to ostensibly represent patients, caregivers, and patient advocates who works for a pharmaceutical firm.  (In addition, one person supposedly representing clinicians apparently works full time for a health insurance company.)

Assessment of Prevention, Diagnosis, and Treatment Options

Karen Chesbrough, MPH - Annandale, VA
representing: patients, caregivers, and patient advocates
affiliation: Scientific Program Administrator, Foundation for Physical Therapy.

Note that the stated mission of the Foundation for Physical Therapy is that it "supports the physical therapy profession’s research needs," and the foundation is funded in part by companies that make physical therapy devices and supplies  (look here).  Therefore, this person appears to be more of a representative of clinicians, or perhaps industry (devices).

Bettye Green RN - South Bend, IN
representing: patients, caregivers, and patient advocates
affiliation: Community Outreach Nurse and Associate Director of Advocacy, Alliance for Clinical Trials in Oncology, Saint Joseph Regional Medical Center

So this person appears to be more of a health system representative.

Debra Madden - Newtown, CT
representing: patients, caregivers, and patient advocates
affiliation: Clinical Applications Systems Analyst, Associated Neurologists

So this person appears to be more of a clinician representative.

Daniel Wall - Spencer, WI
representing: patients, caregivers, and patient advocates
affiliation: Analyst, Biomedical Informatics Research Center, Marshfield Clinic Foundation

So this person appears to be more of a clinician or health system representative

So in summary, this panel included four people who ostensibly represent patients, caregivers, and patient advocates but who actually work for health systems or clinician organizations, and one of the latter organizations appears to be heavily funded by the medical device and supplies industry.

Improving Healthcare Systems

Susan Diaz MPAS, PA-C - Jacksonville, FL
representing patients, caregivers, and patient advocates
affiliation: Physician Assistant in Liver Transplant, Mayo Clinic in Florida

So this person appears to be more of a clinician, or health system representative.

Anne Sales PhD-  Ann Arbor, MI
representing: patients, caregivers, and patient advocates
affiliation: Professor, School of Nursing, University of Michigan

So this person appears to be more of a clinician, or health system representative.

Jamie Sullivan MPH - Silver Spring, MD
representing: patients, caregivers, and patient advocates
affiliation: Director of Public Policy, COPD Foundation.

Note that the COPD Foundation receives support at least from "Boehringer-Ingelheim/Pfizer Inc. and Grifols" (look here).  .

So this person appears to be at least somewhat an industry (pharmaceutical) representative.

So in summary, this panel includes three people who ostensibly represent patients, caregivers, and patient advocates, two of whom actually work for large health system, and one who works for a foundation with significant pharmaceutical industry support.  

Patient Engagement

Stephen Arcona MA PhD - East Hanover, NJ
representing patients, caregivers, and patient advocates
affiliation: Executive Director, Outcomes Research Methods & Analytics, Department of Health Economics and Outcomes Research, Novartis Pharmaceuticals Corporation

So this person appears to be more of a researcher, and industry (pharmaceutical) representative.

Marc Boutin JD - Washington, DC
representing patients, caregivers, and patient advocates
affiliation: Executive Vice President and Chief Operating Officer, National Health Council 

Note that while the National Health Council claims to be an advocate for people with chronic disease and disability, its core membership includes "major pharmaceutical, medical device, health insurance, and biotechnology companies." and it receives considerable industry support.  For example, it disclosed contributions in the $100,000 - $300,000 range from Amgen, Astra-Zeneca, Eli Lilly, Novartis, Pfizer, and the Pharmaceutical Research and Manufacturers of America (PhRMA), and smaller but still significant contributions from other pharmaceutical companies and other industry associations.  So this person appears to be at least somewhat of an industry (pharmaceutical) representative.

Charlotte W Collins JD - Elkridge, MD
representing patients, caregivers, and patient adovcates
affiliation: Vice President of Policy and Programs, Asthma and Allergy Foundation of America

Note that while the Asthma and Allergy Foundation of America claims to be a patient advocacy organization, it disclosed financial support from many pharmaceutical, device, and health insurance companies, and from major health care systems

So this person appears to be at least somewhat an industry, health insurance, and/or health system representative.

Amy Gibson, RN MS - Washington, DC
representing patients, caregivers, and patient advocates
affiliation: Chief Operating Officer, Patient-Centered Primary Care Collaborative (PCPCC)

Note that the PCPCC has an executive committee that includes multiple pharmaceutical, device, and health insurance companies, and health systems.  So this person appears to be at least somewhat an industry, health insurance, and/or health system representative.

Julie Ginn Moretz - Augusta, GA
representing patients, caregivers, and patient advocates
affiliation: Associate Vice Chancellor, Patient- and Family-Centered Care, University of Arkansas for Medical Sciences

So this person appears to be more of health system representative.

Sara Triagle van Geertruyden - Washington, DC
representing patients, caregivers, and patient advocates
affiliation: Executive Director, Partnership to Improve Patient Care (PIPC)
(Note: this affiliation appears incomplete.  Sara van Geertruyden is listed as a current partner of Thorn Run Partners, a lobbying firm, with a major practice area in health care, boasting, "Thorn Run Partners offers one of Washington, DC’s most comprehensive, competent and effective health policy practices."


Note also that PIPC has membership that includes many specialty physician societies, and a steering committee that includes the Biotechnology Industry Organization, and PhRMA. 

So this person appears to be more of an industry (pharmaceutical and biotechnology) representative.

So in summary this panel includes six members who ostensibly represent patients, caregivers, and patient advocates, but who work for either patient advocacy organizations that get considerable industry support, or a health system, or a pharmaceutical company.  One person whose affiliation was listed as a patient advocacy organization also somehow appears to be a full-time lobbyist.  

Summary

While PCORI has set up advisory panels that seem to strongly emphasize representation of patients, caregivers, and patient advocates, a substantial fraction of the people who are supposed to provide this representation seem to work for patient advocacy groups with considerable industry support, or directly for industry or health care systems.  Some of them may work as clinicians or researchers, but many appear to have high level executive positions with these organizations.  One appears to be a full-time lobbyist at a firm that has a strong health care practice. 

Thus it appears that PCORI advisory panels actually may be as much about the interests of big health care organizations, including pharmaceutical and device companies, health insurance companies, and large hospital systems, as they are about patients, caregivers, or patient advocates.  

I am afraid my and Merrill Goozner's original fears that PCORI may end up being more about industry-centered interests than patient-centered outcomes may not be paranoid.  I do hope that PCORI leadership manages to put improving patients' and the public's health ahead of making industry executives happy. 

by Roy M. Poses MD, for Health Care Renewal

Marin General Hospital's Nurses are Afraid a Defective EMR Implementation Will Harm or Kill Patients .. CEO Cites Defective HHS Paper and Red Herrings As Excuse Why He Knowingly Allows This To Continue

- Posted at the Healthcare Renewal Blog on May 30, 2013 -

The following appeared in the Marin County Independent Journal about an EHR system so bad the nurses at Marin General Hospital were publicly complaining, putting their careers at risk (see my May 17, 2013 post "Marin General Hospital nurses warn that new computer system is causing errors, call for time out"):

National critic of health care information technology says Marin General should heed nurses' advice

By Richard Halstead
Marin Independent Journal

Posted:   05/27/2013 04:03:00 PM PDT

The critic is me.   I spoke to the reporter but did not know he would publish:

A nationally known critic of electronic health records has harshly criticized managers at Marin General Hospital for their response to a plea by nurses to hold off on a new computer system to prevent potentially dangerous errors.

"The executives at the hospital should be taking out extra insurance policies because they're setting themselves up for a massive corporate negligence lawsuit," said Dr. Scot Silverstein, an adjunct professor of health care informatics at Drexel University in Philadelphia.

Silverstein, who contacted the Independent Journal after reading about the Marin General situation, doesn't dispute the potential of digital records; but he believes implementation has been rushed. He thinks electronic health records should be regulated by the federal Food and Drug Administration, much like medical hardware or pharmaceuticals.

Or regulated by someone with experience in similar mission critical software, and with regulatory teeth.  Paper tigers and bad health IT are a very poor mix where patients' rights are concerned IMO.

At issue is a new computerized physician order entry system, known as CPOE; doctors place medication orders for patients directly into the system.

At a meeting of the Marin Healthcare District board on May 14, a group of Marin General nurses told the board problems with the new computer system were diverting them from their patients and causing errors, such as sending orders to the wrong patients. One nurse reported that a patient had received a medication to which he was allergic.

That is a very direct calling out of the potential for harm and death by front line clinical personnel.  To ignore it is grossly if not criminally negligent.

Lee Domanico, who serves as the CEO of both Marin General and the Marin Healthcare District, assured the board that the hospital was safe, despite "glitches" in the new system. Domanico said he was working to fix the problem.

Glitches = safe?  The Board must be highly gullible if they believe this  See http://hcrenewal.blogspot.com/search/label/glitch for more on "safe" glitches.

Silverstein said, "Glitches are a euphemism for life-threatening electronic health record malfunctions and defects."


"What they need to do is exactly what the nurses are asking for," Silverstein said. "They need to turn the system off and put it through rigorous testing and confirm the thing is going to work properly with no glitches before they use it on patients."

That's not rocket science - its common sense - unless they think their own nurses are lying.

Of course, as computers have more rights than patients, and bonuses might be affected, the system will likely continue in full operation, with patients as guinea pigs, and the nurses punished for informing the public that perhaps they should consider other hospitals while the "glitches" in this enterprise clinician command-and-control system are worked out.

Two days after the Marin Healthcare District meeting, Domanico issued a press release stating, "We have not received any medication error incident reports resulting from the implementation of computerized physician order entry."

On Friday, however, Barbara Ryan, a Marin General registered nurse who serves as the California Nurses Association/National Nurses United representative, said, "I can't understand why that statement was made."

Ryan said nurses have told her of errors, and information about errors appears in "Assignment Despite Objection" forms that nurses have filed since implementation of the computerized order system began on May 7. Nurses file the forms to document formal objections to an unsafe, or potentially unsafe, patient care assignment.

The statement's reason and purpose seems fairly obvious. 

Ryan said Marin General nurses have filed close to 50 such forms so far this month; she said typically 10 to 20 such forms are filed per month at the hospital.

"There are still problems with the system," she said. "There are still mistakes being made." Ryan said the hospital needs to boost nurse staffing ratios during the implementation.

That would increase costs (and probably decrease the pool of money for bonuses).

Jon Friedenberg, Marin General's chief fund and business development officer, said the hospital is in the process of upgrading computer servers and adding memory to work stations to increase the speed of the new computerized order system.

"We completed an upgrade of memory to 200 of the work stations, and 120 of the work stations have been replaced," Friedenberg said.

This reminds me of a similar IT fiasco I faced some years ago, when the brilliance of IT personnel really shone through regarding an ICU monitoring system that crashed regularly.  Their solution?  Add more RAM.  (See "Serious clinical computing problems in the worst of places: an ICU" at http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU).

... Silverstein earned a medical degree from Boston University and subsequently completed a two-year fellowship in medical informatics at Yale University School of Medicine. He served as Merck Research Laboratories' director of scientific information in the early 2000s before serving for a time as a full-time professor at Drexel University. Today, in addition to teaching part-time, Silverstein works on [EHR-related - ed.] medical liability cases for plaintiff attorneys. [And the defense too, when asked; I'd rather advise on how to prevent mistakes, in fact, than get involved after the fact when someone's been injured or killed - ed.]

What was not mentioned was that I was a CMIO in a major hospital in the mid to late 1990s.

But of course, I - and similarly trained Medical Informatics experts - "don't have enough experience" to lead (as opposed to being an 'internal consultant') health IT projects, a refrain I've often heard from hospital executives.

Silverstein said he started assisting on the liability cases after his mother died as the result of an electronic health care record error that resulted in her not being given the proper heart medicine. Silverstein said his mother's case was not an anomaly.

For example, he pointed to the results of a recent Emergency Care Research Institute study of 36 hospitals conducted over a nine-week period. Asked to report electronic record problems on a volunteer basis, Silverstein said the hospitals reported 170 malfunctions, including eight incidents that resulted in patient harm, three of which may have contributed to patients' deaths.  Although the federal Food and Drug Administration does not regulate health care information technology, some manufacturers have voluntarily supplied data to the FDA. In February 2010, the FDA reported it had been notified of 260 problem events involving health care information technology in the previous two years that were linked with 44 injuries and six deaths.

See my Feb. 28, 2013 post "Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI Deep Dive Study of Health IT Events" at http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html.  Also see my Aug. 5, 2010 post "Internal FDA memorandum of Feb. 23, 2010 to Jeffrey Shuren on HIT risks. Smoking gun? I report, you decide" at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html. I merely report what ECRI, AMA and FDA have reported.

Finally:

In his press release, however, [CEO] Domanico stated that "more than 150 studies conducted since 2007 have confirmed that organizations using health information technology, like CPOE, have seen positive outcomes."

I believe he's referring to a highly biased and scientifically defective ONC paper of 154 selected studies: "The Benefits Of Health Information Technology: A Review Of The Recent Literature Shows Predominantly Positive Results."

What an unbelievably cavalier attitude.

My colleagues and I refuted (dare I say trashed) that paper pretty thoroughly here:
http://hcrenewal.blogspot.com/2011/03/benefits-of-health-information.html.

Even worse, the mention of that paper, or EHR benefits in general, is a diversion, an in-your-face red herring (at best; an inability to reason logically at worst), steering away from the real issue:  an EHR implementation about which nurses are complaining ... in the now.

http://www.nizkor.org/features/fallacies/red-herring.html:  A Red Herring is a fallacy in which an irrelevant topic is presented in order to divert attention from the original issue.

That a CEO of a major hospital relies on one defective paper - one that he most likely lacks the experience and expertise to understand, let alone critically evaluate - and red herrings is a poster example of why medical and medical informatics amateurs should not be running hospitals or clinical IT projects.

-- SS

Ghosts in the Criminal Machine - How a Drug Company Can Plead Guilty to Federal Fraud, Yet No One is Held Responsible

We have often discussed how leaders of health care organizations have become increasingly unaccountable for their actions.  A recent, slightly obscure story shows how a corporate admission of guilt to a felony can be used to prevent anyone, including anyone in corporate management, from being held responsible for that fraud.

Basics of the Settlement

The case was that of ISTA Pharmaceuticals.  The basics appeared in brief wire service articles, like this one from Rueters (via Fox News):

Ista Pharmaceuticals pleaded guilty on Friday to charges it used kickbacks and improper marketing to boost sales of a drug meant to treat eye pain and agreed to pay $33.5 million to settle criminal and civil liability, the U.S. Department of Justice said.

The unit of eye care company Bausch & Lomb pleaded guilty to conspiracy to offer kickbacks to induce physicians to prescribe Xibrom, a drug meant to treat pain after cataract surgery, and conspiracy to promote that drug for unapproved uses, including after Lasik and glaucoma surgeries.

Ista agreed as part of a criminal settlement to a $16.63 million fine and an $1.85 million asset forfeiture. It also agreed to a $15 million civil settlement to resolve allegations that its marketing of Xibrom caused false claims to be submitted to government health care programs.

Kickbacks Disguised as Honoraria and Consulting Fees

Note that unlike many such legal settlements involving large health care organizations, this one involved admissions of guilt to felonious criminal offenses.  The severity of the charges apparently arose out of the egregious conduct of company executives.  Colorful details were supplied by the Buffalo (NY) News:

ISTA, which is based in California, admitted using kickbacks to doctors and an illegal marketing campaign as part of an elaborate scheme to increase its sales of Xibrom.

The scheme, outlined in detail in newly released court papers, ranged from company-provided instruction sheets for doctors to continuing medical education programs to promote the drug.

In many cases, ISTA employees were told not to leave printed materials behind in doctors’ offices or to keep records of their meetings with doctors in order to avoid detection by others.

The company went so far as to offer speaking engagements and consulting appearances to doctors in hopes that they might use Xibrom for non-authorized treatments.

Doctors can legally prescribe drugs for non-FDA approved treatments, but drugmakers are prohibited from promoting their products for those uses.

'Essentially they entered into consulting arrangements to induce physicians to prescribe their drug,' said Jeffrey I. Steger, a lawyer in the Consumer Protection Branch of the U.S. Department of Justice.

When [US District Judge Richard J] Arcara asked if money was the doctors’ motivation, Steger said yes.

'Thousands of dollars,' he told the judge.

So here we have a company admitting that it bribed doctors to prescribe its drug, and its techniques of administering bribes included paying the doctors honoraria to give talks, and paying the doctors as consultants.  As an aside, note that many defenders of "collaboration" among doctors and industry sign the praises of doctors "consulting" for industry, and often see nothing wrong with industry paying doctors for "educational" speeches.  Yet here is more evidence that such paid talks and consulting assignments may be nothing more than marketing, and at times are merely disguised bribery.

An Apparently Tough Penalty

An unusual feature of this settlement was that (per Reuters):

As part of the settlement, Ista will be barred from participating in Medicare and Medicaid,...

That would appear to be the death knell for the company, as reported by Reuters,

Bausch & Lomb, which is based in Rochester, New York, said it was pleased to settle the matter, which involved conduct between January 2006 and March 2011, and that it knew of the government probe well before it purchased Ista.

That purchase closed in June 2012 and Bausch and Lomb plans to wind down the Ista corporate entity by year end.

So Bausch and Lomb bought a company that turned out to be valueless?  But wait,...  there's a trick. 

As detailed in FiercePharma,

 ISTA will be barred from doing business with Medicare, Medicaid, et al, for 15 years. Luckily for Bausch + Lomb, however, it bought ISTA in June 2012,  late enough in the game to actually escape the ramifications of exclusion. The exclusion won't begin until 6 months after the settlement date, giving Bausch + Lomb time to transfer ISTA's products out of that subsidiary and shift the drugs over to the Bausch + Lomb label.

A Crime Committed by... No One?

So Bausch and Lomb gets ISTA's drugs, and essentially can resolve the company's felony convictions by relatively small fines, and through management sleight of hand, can finesse ISTA's disbarment from federal programs..  This will occur despite admissions that someone within ISTA, presumably within ISTA management, perhaps high up in ISTA management, per FiercePharma,

instructed reps to avoid leaving a paper trail of their off-label discussions with doctors. Prosecutors had enough evidence of this to persuade ISTA to plead guilty to a felony fraud charge. 'These instructions were given in order to avoid having their conduct relating to unapproved new uses being detected by others, the Justice Department said. 'ISTA agreed that this conduct represented an intent to defraud under the law.'

So felony fraud was committed, but no person apparently committed it.  It was as if a ghost committed the crime.

 

Not only was a crime committed, but apparently by nobody, the corporation within which the crime was committed also becomes obscure.  ISTA became responsible, but by being bought out by Bausch and Lomb, the more severe penalty directed against ISTA will be meaningless.  

 

Should Bausch and Lomb be responsible?  Of course, they claim they should not.  As reported by Bloomberg, 

 

 Rochester, New York-based Bausch & Lomb said the actions occurred 'well before' it acquired Ista in 2012. 

'Bausch & Lomb is committed to earning trust in everything that we do and is pleased to have resolved this pre-acquisition issue,' Bob Bailey, a Bausch & Lomb spokesman, said in a statement. 

In fact, The Hill reported that the bad behavior took place from 2005 to 2010: 

But consider that while ISTA recently became part of Bausch and Lomb, since 2007, Bausch and Lomb has been wholly owned by private equity firm Warburg Pincus.  In fact, as we discussed in in 2009, some people suspected that this maneuver would have allowed Baush and Lomb to settle multiple suits alleging that its products were faulty and dangerous out of the public eye.  So while ISTA is now really Bausch and Lomb is now really Warburg Pincus, no one in the management of ISTA, Bausch and Lomb, or Warburg Pincus apparently will be held responsible for criminal fraud and kickbacks to doctors, even though guilty pleas for these felonies have been made.  So somehow we have admissions that crimes were committed, crimes that compromised the integrity of doctors, and exposed patients to needless side effects, yet these crimes were apparently committed by ... nobody, by a ghost, and even the machine that ghost was in - was it ISTA, Bausch and Lomb, or Warburg Pincus? - becomes a mystery.  Where is Sherlock Holmes when we need him most?.

Summary

This case thus becomes a really striking example of the impunity of health care corporate managers.  They can commit crimes, even felonies, yet the company, but no human beings, is held responsible.  But the company being a company, it cannot go to jail.  And through the magic of obfuscatory corporate take-overs, which company is guilty is not even apparent. 

As we have said ad infinitum,

 We will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.

The Best Governance for Medicines ... is in Thailand

The Best Health Care System in the World? 

Here in the US, a lot of people have been convinced that we have the best health care system in the world.  For example, during the 2012 US presidential campaign, Politi-Fact reported,

House Speaker John Boehner, R-Ohio, says the health care law signed by President Barack Obama -- and upheld by the U.S. Supreme Court -- imperiled the nation’s health care system.

'Gov. Romney understands that Obamacare will bankrupt our country and ruin the best health care delivery system in the world,' Boehner said, during the July 1, 2012, edition of CBS’ Face the Nation.

Boehner wasn’t the only one making that claim on the Sunday talk-show circuit. On Fox News Sunday, Senate Minority Leader Mitch McConnell, R-Ky., added that the U.S. has 'the finest health care system in the world.'

More recently, as the Huffington Post reported,

Sen. Jeff Sessions (R-Ala.) charged Thursday that Obamacare is destroying the 'greatest health care system the world has ever known' and that it was 'horrible' for anyone to suggest Americans receive anything less than the best care, even though they die younger on average than people in many other countries.

'This is just one example of what happens in this country when people in Washington take on the arrogant view that they know how to fix the health care system -- one of the most massive, complex, marvelous systems the world has ever known,' Sessions said on the Senate floor.

One would expect that the greatest health care system in the world would have the greatest pharmaceutical industry in the world too.  In fact, as noted by Politi-Fact,  that is pretty much what Congressman Boehner asserted,

 Boehner’s office also noted that wealthy foreigners flock to the U.S. to receive care because of its cutting-edge facilities, and that the U.S. is among the leaders, if not No. 1, in medical research and pharmaceutical development.

Not the Best Governance for Medicines in the World

A recent article from the National News Agency of Malaysia will probably not get a lot of attention in the US, or other developed countries, but it does suggest another reason to be very skeptical about shouts of "USA Number 1" at least applied to health care.  The article's main point was:

The World Health Organisation (WHO) has praised Thailand for the world's best governance for medicine, Thai News Agency (TNA) reported.

Public Health Minister Dr. Pradit Sintawanarong, who is attending the 66th World Health Assembly in Geneva, Switzerland, from May 20-28, told journalists on Wednesday that the WHO has asked Thailand to co-organise a meeting on good governance for medicine, as the Thai Kingdom is considered the world's most advance in governance for medicine and should be a good example for other countries.

Dr. Pradit, who was invited by the WHO to open a meeting on Thailand's governance for medicine and health systems, held as part of the 66th World Health Assembly, acknowledged that the WHO has also asked Thailand to share experiences in another side meeting on 'Good Governance in the Pharmaceutical Sector:The Case of Thailand and Malawi'.

Again, a lot of people think of the US health care system as a model of the rest of the world.  Here is one little bit of data that maybe it should not be the model for "governance for medicine."  Of course, that phrase itself is almost never used here.  Its definition, however, should be instructive.

The World Health Organization has had a small "Good Governance for Medicines" program since 2004.  We first discussed it here in 2008  On the program web-site, its goal is defined:

contributing to health systems strengthening and preventing corruption by promoting good governance in the pharmaceutical sector.

Specifically the programme aims:
-To raise awareness on the impact of corruption in the pharmaceutical sector and bring this to the national health policy agenda
- To increase transparency and accountability in medicine regulatory and supply management systems - To promote individual and institutional integrity in the pharmaceutical sector
- To institutionalize good governance in pharmaceutical systems by building national capacity and leadership.

So if Thailand received recognition for having the best governance for medicines, the implication is that the US does not.

In fact, we and other dissidents have documented a host of problems with individual and institutional integrity in the pharmaceutical sector, lack of transparency and accountability in medicine regulatory and supply management systems, and actual corruption in the pharmaceutical sector.  Some of the most recent big examples on Health Care Renewal since December, 2012, include:
-  the CEO of drug and biotechnology company Amgen collected tens of millions of dollars while his company settled lawsuits alleging it gave kickbacks to doctors, pharmacists and others to use potentially dangerous medicines (post here)
-  Pfizer's 14 legal settlements since 2000, including settlements of allegations of fraud, illegal promotion of hazardous drugs, kickbacks given to physicians, bribery of foreign officials, etc.  The biggest was for $2.3 billion.  In one case, the company was convicted of being a racketeering influenced corrupt organization (RICO) (post here).
- Three settlements in the US by GlaxoSmithKline in 2012, of allegations including deceptive marketing to hide drugs' adverse effects, improperly preventing generic competition, and a $3 billion settlement for deceptive marketing and improper promotion of multiple drugs (post here).
- Eli Lilly settled allegations that it bribed foreign officials.  (In 2009 it pleaded guilty to criminal charges arising from deceptive marketing of Zyprexa) (post here)
- After making two settlements of overcharging the US government in 2007 and 2009, Sanofi settled US allegations of giving kickbacks to doctors (post here)..
-  The pharmaceutical paid "key opinion leader" who was most influential in promoting widespread use, and probably overuse of opiates, admitted it was all "misinformation" (post here).

See also our posts on bribery, kickbacks, fraud, crime, and corruption, not to mention deception, stealth marketing, conflicts of interest, institutional conflicts of interest, etc.

Participatory Democracy in Health Care


So good for the Thais for apparently doing much better with far fewer resources.  One reason seems to be that the government has made good governance for medicines, defined as above, a big priority:

According to the public health minister, the Thai government and his ministry have adhered great importance to good governance for medicine (GGM) and health systems and Thailand has also joined the WHO's campaigns on the GGM from the first stage, concerning the assessment of the situation and the installation of relevant systems.

I can also speculate that one reason they have done better is their conscious effort to enlist the public at large in discussing and setting the direction of their health care system.  For example, as we discussed in 2009,  Thailand has set up by law a National Health Assembly, with its stated goal to be:

an instrument as well as a learning process to develop participatory public polices on health and pushing for practicability.

Assemblies have been held yearly since 2008.  A detailed report on the 2008 assembly is here. [Rasanathan K, Posayanonda T, Birminghan M et al.  Innovation and participation in the first National Health Assembly in Thailand. Health Expectations 2012; 15: 87-96].  The most recent was in December, 2012 (look here.)  

Such a mechanism for broad public input into health care does not obviously occur in the US.  Instead, we have corporations spending billions on lobbying, public relations, stealth advocacy, and campaign contributions.  We have the constant interchange of top government and corporate health care leaders via the revolving door.

We do not have any significant public discussion of good governance for medicines, or anything like it.  (The few, rare exceptions about which I know are the recent Healthy Skepticism meeting on Selling Sickness, and the now yearly meetings organized by PharmedOut.org)  Discussion of deception, conflicts of interest, crime and corruption affecting large health care organizations is muted and anechoic.  I know of precisely one course on health care corruption in any US medical, public health, or health administration school (look here, and its focus is on developing countries.)

Time to head to Bangkok?....  But if we all cannot... 

In the US, we will not have a chance of meaningfully improving our health care system until we start listening to unbiased health care professionals and academics (in particular, who have not been paid off by vested interests),  civil society organizations, and people and patients at large, and stop getting all our insight from corporate executives, their cronies, and their paid experts.  We will not have a chance until we allow discussion of all the problems, including bad leadership and governance, dishonest and deceptive practices, conflicts of interests, and outright crime and corruption.  We will not have a chance until we put our priority on patients' and the public's health, not the vested interests of those who have gotten rich off the current dysfunctional system. 


.

Executive Compensation as "Legal Corruption" - and the Continuing Example of the Troubles of Wake Forest Baptist

"Legal corruption" was the description of current executive compensation practices appearing, of all places, in the Wall Street Journal.  The arguments, by Henry Mintzer of the Desautels Faculty of Management at McGill University, apply to health care, and provide a counterpoint to the usual talking points that are trotted out whenever a top health care manager, or his cronies, feels the need to justify his or her compensation. 

A Rigged Game with Other Peoples' Money

Prof Mintzer's arguments start with the assertion that executive bonuses are hopelessly rigged in favor of the managers who receive them.  In particular:

•  They represent gambling with "other people's money," in this case, "the stockholders [of large public corporations] not to mention the livelihoods of their employees and the sustainability of their institutions"

• Bonuses are given just based on the appearance of winning, for example, when a company's stock goes up short term, regardless of long-term results.

• Bonuses are given even when the company may lose, for example, the "golden parachute," or severance package that even executives forced to resign or retire may receive.

• Bonuses are given for actions that at best only provide potential gains for the company, for example prior to a merger, but before it is known that the merger will be successful

• Bonuses are given just for showing up, that is, "retention bonuses."

Thus he contended that bonuses inspire executives to be gamblers in a game rigged in their favor.

Based on False Assumptions

Furthermore, he argued that the current system of executive compensation is based on false assumptions.  These include:

"A company's health is represented by its financial measures alone - even better, the price of its stock." 

However, as Prof Mintzer noted:

Companies are a lot more complicated than that. Their health is significantly represented by what accountants call goodwill, which in its basic sense means a company's intrinsic value beyond its tangible assets: the quality of its brands, its overall reputation in the marketplace, the depth of its culture, the commitment of its people, and so on.  

I would note that this applies especially in health care, and more especially to organizations that provide direct patient care.  No hospital system, for example, could function at all without a corps of dedicated health professionals, physicians, nurses, therapists, etc. 

Furthermore, Prof Mintzer wrote,

All too often, financial measures are a convenient substitute used by disconnected executives who don't know what else to do—including how to manage more deeply.  Or worse, such measures encourage abuse from impatient CEOs, who can have a field day cashing in that goodwill by cutting back on maintenance and customer service, 'downsizing' experienced employees while others are left to 'burn out,' trashing valued brands, and so on. Quickly the measured costs are reduced while slowly the institution deteriorates 

This is obviously particularly pernicious in health care, a field in which institutions are complicated, and dependent on the efforts of some very highly trained and specialized people well beyond the management suite. 

"Performance measures, whether short or long term, represent the true strength of the company." 

Prof Mintzer pointed out the lack of accurate measures of the overall performance of a company or organization. 


"The CEO, with a few other senior executives, is primarily responsible for the company's performance."  

Prof Mintzer asked,

In something as complex as the contemporary large corporation, how can success over three or even 10 years possibly be attributed to a single individual? Where is teamwork and all that talk about people being 'our most important asset?'

More important, should any company even try to attribute success to one person? A robust enterprise is not a collection of 'human resources'; it's a community of human beings. All kinds of people are responsible for its performance. Focusing on a few—indeed, only one, who may have parachuted into the most senior post from the outside—just discourages everyone else in the company.

Again, this is obviously particularly the case in health care organizations, especially those that provide direct patient care.

Leading to the Worst Possible Leaders and Leadership

Finally, Prof Mintzer argued that the current system is designed to promote the worst possible leadership, leading likely to the worst possible outcomes.  He opened with

 Executive bonuses—especially in the form of stock and option grants—represent the most prominent form of legal corruption that has been undermining our large corporations and bringing down the global economy. 

Our argument has been that the current leadership of health care is similarly bringing down our health care system.

He later noted that current compensation practices mainly function to select out the worst possible leaders:

 executive compensation these days reinforces a class structure within the enterprise that is antithetical to its effective functioning. Because of its symbolic nature, executive compensation as currently practiced sends out the worst possible signal to everyone in the enterprise.

Furthermore,

bonuses can serve one purpose. It has been claimed that if you don't pay them, you don't get the right person in the CEO chair. I believe that if you do pay bonuses, you get the wrong person in that chair. At the worst, you get a self-centered narcissist. [Or even a full-fledged, if non-violent, psychopath, as noted here - Ed] At the best, you get someone who is willing to be singled out from everyone else by virtue of the compensation plan. Is this any way to build community within an enterprise, even to foster the very sense of enterprise that is so fundamental to economic strength?

Accordingly, executive bonuses provide the perfect tool to screen candidates for the CEO job. Anyone who insists on them should be dismissed out of hand, because he or she has demonstrated an absence of the leadership attitude required for a sustainable enterprise.

Of course, this might thin the roster of candidates. Good. Most need to be thinned, in order to be refilled with people who don't allow their own needs to take precedence over those of the community they wish to lead.

It will be interesting to see if anyone attempts a logical refutation of Prof Mintzer's arguments.  My guess is that we will see little response, based on the usual public relations dictum that it is best not to acknowledge one's detractors, even if they are right.  Furthermore, I predict that what responses there are will partake heavily of logical fallacies.

Finally, it is worthwhile to think about Prof Mintzer's points when assessing the arguments made in favor of particular executives' outsized remuneration. 

An Example - Continued Riches for Wake Forest Baptist Executives

Outsize Executive Compensation Continues

A few weeks ago, we noted that the leaders of this large medical center, while previously proclaimed as visionaries, and enjoying enlarging compensation, seemed to have lead the institution to a financial crisis due to difficulties with a poorly chosen or implemented electronic health record system. 

One follow up story updated compensation information and provided the official management rationale for the ongoing largess.  The redoubtable Richard Craver wrote in the Winston-Salem Journal,

Wake Forest Baptist Medical Center provided its top executive, Dr. John McConnell, an 11.9 percent raise in salary during 2011 to $983,777, although his total compensation dropped 18 percent, the center reported Wednesday as part of an annual regulatory filing.

McConnell was paid $2.04 million in total compensation, compared with almost $2.5 million for 2010. Although Wake Forest Baptist operates on fiscal years that end on June 30, the pay for its top executives is required to be listed on a calendar-year basis.

The main difference between the 2010 and 2011 compensation totals for McConnell was $461,575 he received as a one-time payment that replaced the retirement benefits he forfeited upon leaving the University of Texas Southwestern Medical Center in Dallas. McConnell was required to work at Wake Forest Baptist for two years to receive the one-time payment.

Keep in mind that in 2008-9x, Dr McConnell made a total of just over $700,000, so his compensation in 2011 was about three times that.

The benevolent board of the medical center saw to it that Dr McConnell got money for all sorts of reasons:

McConnell received $384,203 in bonus and incentives in fiscal 2010-11. The center said the amount reflects the achievement of clinical quality, academic and financial goals set by the board of directors. The bonus was down $115,797 from fiscal 2009-10 primarily because the center reduced the potential percentage of the incentive compensation from 75 percent of his base salary to 53 percent.

McConnell received $38,511 in other reportable compensation, which the center listed: as $8,797 in annual dues for Forsyth Country Club and Rotary Club membership, defined as for business purposes; $16,500 qualified deferred compensation; $3,612 in after-tax life-insurance deduction; and $9,602 in an automobile allowance.

 He also received $619,002 in contributions to retirement plans, including a supplemental executive retirement plan solely for McConnell’s benefit.

One wonders why, given his salary and bonus, Dr McConnell could not afford to pay dues to the country club and rotary on his own, or for his own car expenses, or to provide for his own retirement, for that matter?

Other executives also continued to do very well:

Donny Lambeth, former president of N.C. Baptist Hospital, received $2.47 million in total compensation. Lambeth served as president of Davie County Hospital and Lexington Medical Center before retiring last year. He is now serving as an N.C. House representative.

Lambeth’s $495,595 in base salary represented an 8 percent decrease related to his reduced job responsibilities. His bonus and incentive compensation was down 2 percent to $181,988. The bulk of Lambeth’s compensation was $1.62 million related to a fully vested deferred compensation upon his retirement.

Dr. Thomas Sibert, president of Wake Forest Baptist Health and chief operating officer, received a 14 percent increase in total compensation to $1.13 million, including $631,297 in salary (up 15.7 percent) and $234,540 in bonus and incentive compensation (up 41.3 percent). Sibert took over his role in September 2010.

Edward Chadwick, chief financial officer, received a less than 1 percent increase in total compensation to $979,420. His salary rose 4.6 percent to $527,216, while his bonus and incentive compensation fell 5 percent to $189,929.

Russell Howerton, chief medical officer, was paid $295,714 in salary, $300,786 in bonus and incentive compensation and $657,025 in total compensation. Doug Edgeton, former president of Piedmont Triad Research Park (recently renamed as Wake Forest Innovation Quarter), received $490,485 in salary, $162,367 in bonus and incentive compensation and $710,729 in total compensation.

The Chief Information Quietly Departs, with Some More Money

Meanwhile, Mr Craver also reported the quiet departure of the executive who presided over the troubled implementation of the EHR,

The chief information officer for Wake Forest Baptist Medical Center is stepping down, effective May 31, the center confirmed Friday.

Sheila Sanders has served in that role, as well as vice president of information technology, since being hired in 2009 to direct the center’s overhaul of its IT system.

She is leaving at a time when the center is struggling financially and operationally with implementing the Epic electronic health records system — one of the largest overall projects Wake Forest Baptist and most health care systems have undertaken in recent years.

Note that Ms Sanders was well rewarded for her questionable efforts,

Sanders was paid $333,961 in salary, $89,145 in bonus and incentive compensation and $464,543 in total compensation in 2011, according to a regulatory filing that Wake Forest Baptist made public Wednesday. The center’s executive-compensation data typically is about 18 months old when released.

In terms of salary, Sanders ranked sixth among the center’s 27 listed management officials. 

It was clear that Ms Sanders ought to have been directly responsible for the EHR implementation,

 The center said Sanders’ duties included clinical information, administrative, business, academic and research support systems, as well as core IT functions that include a central IT help desk, email, computer desktop support, IT security and telecommunications.

Nonetheless, the extremely well-paid top leadership did not seem to have hard feelings.

Dr. John McConnell, the center’s chief executive, said in a statement that Sanders decided in January to take 'a brief career break' after completing major portions of the overhaul. He said Sanders is relocating to Florida to spend more time with her family.

Wake Forest Baptist spokesman Chad Campbell stressed it was Sanders’ decision to leave her positions, and it was not related to Epic, which went live in September on the center’s main campus.

Also,

'We are deeply grateful to Sheila for her numerous contributions that will serve the medical center for years to come,' McConnell said. McConnell said senior IT officials will manage day-to-day IT operations with his oversight while the center conducts a national search for her replacement.

But to reiterate,

 The center said May 2 it had launched another round of 'multi-million dollar' cost-cutting measures that will last through at least June 30, the end of its 2012-13 fiscal year, related to fixing Epic revenue issues.

 Perhaps any attempt to saddle the chief information officer with responsibility would point out the lack of responsibility imposed on even higher level and better paid executives for apparently approving and authorizing her previous work.

The Usual Talking Points

Instead, the official statement from hospital system management about top executives' compensation trotted out the usual talking points in defense of all this lavish pay,

Wake Forest Baptist said in a statement explaining its executive compensation packages that as an academic medical center, it requires management with 'a special set of skills and experience to manage relationships with physicians and researchers, the university, its patients and community. … It takes proven talents possessed by a small group of health care executives.'

'Compensating executives, as we do all of our employees, competitively and appropriately, is crucial to the success of Wake Forest Baptist and to Northwest North Carolina.'

In addition,

 Baptist said its executive compensation is based primarily on comparisons with 32 academic medical centers, including Duke University Hospital and UNC Hospitals. 

With regard to Dr McConnell's special retirement plan,

'This is a common benefit for executives at academic medical centers and health systems to encourage retention and provide competitive retirement benefits,' the center said in its statement.

We first listed the talking points here, and then provided additional examples of their use here, here and here.   The official administration discussion above does seem to include: 
- We have to pay competitive rates
-  We have to pay enough to retain at least competent executives, given how hard it is to be an executive
-  Our executives are not merely competitive, but brilliant.

Left out was any evidence about the executives' performance, much less their degree of responsibility for their institution's performance.  Why the few top paid executives should continue to get credit for the institutions' supposed, but unspecified successes, while escaping any accountability for its failures (including the looming problems with its commercial health care information technology) was of course not mentioned. 

So here is a great, current example of how top health care executives are gambling with other peoples' money, in a game rigged so that they always win.  As long as we continue such perverse incentives in health care, they will continue to inspire leaders to line their own pockets at the expense of our health care institutions, and ultimately to the detriment of patients' and the public's health. 

Conclusion

So let me conclude with Prof Mintzer's conclusion,

All this compensation madness is not about markets or talents or incentives, but rather about insiders hijacking established institutions for their personal benefit.

Too many large corporations today are starved for leadership—true leadership, meaning engaged leadership embedded in concerned management. And the global economy desperately needs renewed enterprise, embedded in the belief that companies are communities. Getting rid of executive bonuses, and the gambling games that accompany them, is the place to start.

Marin General Hospital nurses warn that new computer system is causing errors, call for time out

- Posted on the Healthcare Renewal Blog May 17, 2013 -

Of course, the ever-present euphemism for life-threatening EHR malfunctions and defects, i.e., "glitches" are the cause (http://hcrenewal.blogspot.com/search/label/glitch):

Marin General Hospital nurses warn that new computer system is causing errors, call for time out

By Richard Halstead
Marin Independent Journal
Posted:   05/15/2013 04:07:49 PM PDT

Nurses at Marin General Hospital have asked administrators to put implementation of a new computerized physician order entry system on hold until glitches can be worked out and more training provided to nurses and doctors who use it.

Nearly a dozen nurses attended the regularly scheduled meeting of the Marin Healthcare District board Tuesday night at Marin General to voice their concerns. The district board oversees Marin General, but it does not involve itself in the hospital's day-to-day operations.

"Orders are being inadvertently passed to the wrong patients. People have gotten meds when they've been allergic to them. This is dangerous," said Barbara Ryan, a Marin General registered nurse, who works in pediatrics and the intensive care nursery. "We're not asking you to get rid of it. We're asking you to place it on hold."

Orders passed to wrong patients?  No problem, just a glitch!  Meds people are allergic to?  Just a glitch.  Dangerous?  No way.  It's just a glitch!

But Lee Domanico, who serves as the CEO of both Marin General and the Marin Healthcare District, said, "I'm confident that in spite of the implementation issues, we have a system today that is safer for patients than our old paper system, and it will get even safer as we gain experience with it and work to fix some of the glitches we've experienced."

Where's the data backing up that assertion, I ask?  The actual risks of paper records don't seem to be robustly documented anywhere.

Ryan, who serves as the California Nurses Association/National Nurses United representative, was one of four Marin General nurses who spoke during the public comment portion of the meeting. Ryan said the nurses warned in advance of the system's roll-out on May 7 that nurses and doctors had insufficient knowledge of the system. Ryan said due to problems with the software nurses had been unable to open the program at home to practice using it.

And yet the rollout happened anyway?  That seems to me to be reckless indifference to the concerns of clinicians.

"Lo and behold the problems that we were worried about have happened," Ryan said. "We're looking at two-hour preps for surgery and two- to three-hour discharges; skilled nursing facilities calling back saying, this really doesn't make sense; the wrong meds ordered on the wrong patients and then given to the wrong patients; the inability for nurses to be able to see what the doctor ordered and double-check it."

Of course, I might add, patient safety was not compromised, the other common refrain of EHR glitch-excusers ... see below.

Ryan said nurses have and will continue to file "assignment despite objection" forms due to the system. Nurses file the forms to document formal objections to what they consider an unsafe, or potentially unsafe, patient care assignment.

"We will take patients but we will object to the assignment because it is unsafe," Ryan said. "This system is making it unsafe."

These will be exceptionally helpful in court to any patients injured or killed as a result of these "glitches" and EHR rollout that occurred despite direct warnings from clinical experts.

Marin General nurse Susan Degan said, "This is not about resistance to change. It's about accountability. My most important role is that of patient advocate. I am held accountable when errors are made."

Domanico acknowledged there have been some technical problems with the Paragon system, including making it possible for nurses to open from home. And he said the software is not faster than the old paper system.  [Considering it's acknowledged all the way up to the highest levels of HHS that current EHR's slow physicians down, one wonders if anyone in this organization thought an EHR would actually increase speed? - ed.]

About the "resistance to change" canard, see my essay "Doctors and EHRs: Reframing the 'Modernists v. Luddites' Canard to The Accurate 'Ardent Technophiles vs. Pragmatists' Reality" at http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html .

"So yes," Domanico said, "it is causing stress for nurses who have heavy workloads, who are learning how to use it, particularly in areas where we need to speed up the computer."

What?  "Speed up the computer?"  They've spent tens if not hundreds of millions for an EHR, and the computer's too slow?

Actually, I think what this CEO in an obvious display of health IT ignorance is trying to say is that we have to do something about the system's poor usability, which sort of mimics what the Board Chair of the American Medical Assocation just said (http://hcrenewal.blogspot.com/2013/05/ama-finally-on-board-with-ehr-views.html).

Also - clinician stress promotes error.

But Domanico challenged the suggestion that patient safety at Marin General had been compromised.

In fact, there is no way the issues described above cannot be compromising patient safety, on its face. (http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised).

"I would have no hesitation about entering this hospital tonight," he said.

As a VIP, of course, this CEO would get special treatment.  Thanks a lot.

I would NOT want to be a patient there under these conditions, unless perhaps I had a 24x7 medically-skilled advocate/bodyguard.

Board member Ann Sparkman, who previously served as in-house counsel at Kaiser Permanente, said nurses at Kaiser struggled at first when a new computer system was introduced there.

Sparkman said, "It's just to be expected."

This seems a rather bizarre appeal to common practice (http://www.nizkor.org/features/fallacies/appeal-to-common-practice.html).

The stunning ignorance of this board member about proper mission-critical IT safety testing and implementation, such as performed in pharma, aerospace, etc. is, quite frankly, shocking.

Further, an attitude that life-threatening "glitches" are "just to be expected" by a member of the Board of Directors, with fiduciary responsibilities regarding hospital operations, is grossly negligent in my opinion, and completely ignores patient's rights.

Unbelievable.

One wonders if any formally-trained medical informatics experts were in leadership roles in this project.

-- SS

American Medical Association finally on board with EHR views expressed on this blog since 2004

- Posted on the Healthcare Renewal Blog May 17, 2013 -

It seems to have taken awhile, but organized medicine seems to finally be recognizing that today's commercial health IT is not quite the revolutionizing, transformative, plug-and-play panacea to healthcare's ills it is often touted as:

AMA Wire
May 15, 2013
AMA board chair: HHS should address EHR usability issues immediately

The government needs to act quickly to remedy the impaired usability of electronic health records (EHR) if the technology's touted benefits are to be realized, AMA Board of Trustees Chair Steven J. Stack, MD (left), told officials during a federal hearing last week.

"The AMA and most physicians believe that, done well, EHRs have the potential to improve patient care," Dr. Stack, an emergency physician in Lexington, Ky., said during his 30-minute testimony. "At present, however, these EHRs present substantial challenges to the physicians and other clinicians now required to use them."

He emphasized that many of today's EHR systems require significant changes before they can deliver the promised outcomes. Referring to Medicare's meaningful use program, he pointed to undesired consequences of pushing EHR systems on physicians before the technology was completely ready for prime time.

"Immediately" is strong language.

I note that the phrase "health IT done well" is a term I've been using since 1998 at my now-Drexel-based health IT teaching website at http://www.ischool.drexel.edu/faculty/ssilverstein/cases, as well as at this blog.

Penned by me at my aforementioned Drexel graduate teaching site, originally housed on AOL, in 1998 and still appearing in its main essay:

... While clinical IT is now potentially capable of achieving many of the benefits long claimed for it such as improved medical quality and efficiency, reduced costs, better medical research and drugs, earlier disease detection, and so forth, there is a major caveat and essential precondition:  the benefits will be realized only if clinical IT is done well.  For if clinical IT is not done well, as often occurs in today’s environment of medical quick fixes and seemingly unquestioning exuberance about IT, the technology can be injurious to medical practice and biomedical R&D, and highly wasteful of scarce healthcare capital and resources. 

Those two short words “done well” mask an underlying, profound, and, as yet, largely unrecognized (or ignored) complexity.  This website is about the meaning of "done well" in the context of clinical computing, a computing subspecialty with issues and required expertise quite distinct from traditional MIS (management information systems, or business-related) computing.

(I have more recently switched to the easier-to-parse terminology of "good health IT" vs. "bad health IT" after discussions with Dr Jon Patrick at U. Sydney during my visit Down Under last summer, http://hcrenewal.blogspot.com/2012/08/my-presentation-to-health-informatics.html.)

I've also heard "not ready for prime time" before.  It is a phrase I used in speaking with a New York Times reporter that then appeared in the Oct. 8, 2012 NYT article "The Ups and Downs of Electronic Medical Records" (http://www.nytimes.com/2012/10/09/health/the-ups-and-downs-of-electronic-medical-records-the-digital-doctor.html?pagewanted=2) by Milt Freudenheim, October 8, 2012, where I am quoted and this blog cited:

... Critics are deeply skeptical that electronic records are ready for prime time. “The technology is being pushed, with no good scientific basis,” said Dr. Scot M. Silverstein, a health I.T. expert at Drexel University who reports on medical records problems on the blog Health Care Renewal. He says testing these systems on patients without their consent “raises ethical questions.”

The AMA Board chair went on to opine:

"Attempting to transform the entire health system in such a rapid and proscriptive manner has compelled providers to purchase tools not yet optimized to the end-user's needs and that often impeded, rather than enable, efficient clinical care," he said.

He noted that physicians are "prolific technology adopters" but that adoption of EHR systems has required federal incentives because the technology still is "at an immature stage of development."

My near-exact terminology has been that the technology is still experimental.

"EHRs have been and largely remain clunky, confusing and complex," he said.

Perhaps he read my ten-part series on the health IT mission hostile user experience at this blog, at http://www.tinyurl.com/hostileuserexper.

According to a recent survey by AmericanEHR Partners, physician dissatisfaction with EHR systems has increased. Nearly one-third of those surveyed in 2012 said they were "very dissatisfied" with their system, and 39 percent said they would not recommend their EHR system to a colleague—up from 24 percent in 2010.

A survey I posted about in Jan. 2010 is here:  "An Honest Physician Survey on EHR's", http://hcrenewal.blogspot.com/2010/01/honest-physician-survey-on-ehrs.html

Dr. Stack spoke at a "listening session" hosted by the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), a division of the U.S. Department of Health and Human Services (HHS). The agencies coordinated the session to examine how a marked increase in code levels billed for some Medicare services might be tied to the increased use of EHRs.

Dr. Stack noted that some Medicare carriers have begun denying payment for charts that are too similar to other records.

"In this instance, even when clinicians are appropriately using the EHR, a tool with which they are frustrated and the use of which the federal government has mandated under threat of financial penalty, they are now being accused of inappropriate behavior, being economically penalized, and being instructed ‘de facto' to re‐engineer non‐value‐added variation into their clinical notes," he said. "This is an appalling Catch‐22 for physicians."

"Mandated under threat of financial penalty" has been one of my stated "cart before the horse" issues with HITECH (e.g., http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html).

Dr. Stack advised officials that three key actions are necessary to rectify these issues with EHR systems:

• The ONC promptly should address EHR usability concerns raised by physicians and add usability criteria to the EHR certification process.
• CMS should provide clear and direct guidance to physicians concerning use of EHRs for documentation, coding and billing.
• Stage 2 of the meaningful use program should allow more flexibility for physicians to meet requirements as EHR systems are improved.

The AMA will continue to work with federal agencies to improve EHR systems and the Medicare meaningful use program.

I've been calling for usability evaluation to be added to the certification process, including in comments during public comment periods to HHS, for some time.

What the AMA Board Chair is apparently missing, though, is health IT safety.  They should perhaps read my post on the recent ECRI Institute Deep Dive Study on health IT risk - itself based on a report in their own AMNews (amednews.com) publication ("Peering Underneath the Iceberg's Water Level: AMNews on the New ECRI Deep Dive Study of Health IT Events", http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html).

I don't think any prudent person would consider a 9-week study of 36 hospitals with volunteered reports of 171 health information technology-related problems, where eight of the incidents reported involved patient harm and three may have contributed to patient deaths, information to ignore.

-- SS