Physicians go flatline on EHR enthusiasm

In a new study, physicians' enthusiasm levels for EHR's seem to resemble this EKG:

Do physicians really experience a satisfaction 'J-curve' with EHRs?
Max Green 
July 6, 2016 
http://www.beckershospitalreview.com/healthcare-information-technology/do-physicians-really-experience-a-satisfaction-j-curve-with-ehrs.html 

There's a school of thought about EHR adoption that suggests physicians experience an initial decrease in their positive perceptions of the technology, but over time those levels creep back up and ultimately surpass their pre-implementation perceptions. But does that J-curve actually exists for EHRs? A new study in the Journal of the American Medical Informatics Association says no. 

That "school of thought" must be from U.B.H. (Univ. of Blind Hyperenthusiasts) and O.U. (Ostrich University).

"[W]e did not find evidence for a J-curve pattern with respect to positive perceptions eventually exceeding baseline measures," the authors concluded. "Some measures followed a U-curve (returned to baseline), or flatlined, while most followed an L-curve (fell and remained below baseline)."

Translation: doctors hate the technology in its present form.

The study is based on a prospective longitudinal survey of Ann Arbor-based University of Michigan Health System physicians over the course of two years, from when they dropped their homegrown CareWeb EHR, for Epic's. Although all physicians received training on the new system and the system "invested substantial resources developing customized content," according to the paper, the only significant increase over baseline perception after two years of the new EHR was for documenting while in the exam room with patients. 

Surely, that accomplishment is worth the investment of hundreds of millions of dollars ...

"Future research is warranted to determine if positive perceptions eventually surpass baseline, and what interventions can help physicians use EHRs more effectively," the authors concluded.

The answer is "likely not."

In fact, the results of the new study are not surprising considering the not-so-glowing reviews of EHRs forwarded on to HHS in Jan. 2015 by the list of medical societies below (see link to the letter at my Jan. 28, 2015 post "Meaningful Use Not So Meaningful: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing" at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html):

American Medical Association
AMDA – The Society for Post-Acute and Long-Term Care Medicine
American Academy of Allergy, Asthma and Immunology
American Academy of Dermatology Association
American Academy of Facial Plastic
American Academy of Family Physicians
American Academy of Home Care Medicine American Academy of Neurology
American Academy of Ophthalmology
American Academy of Otolaryngology—Head and Neck Surgery
American Academy of Physical Medicine and Rehabilitation
American Association of Clinical Endocrinologists
American Association of Neurological Surgeons
American Association of Orthopaedic Surgeons
American College of Allergy, Asthma and Immunology
American College of Emergency Physicians
American College of Osteopathic Surgeons
American College of Physicians
American College of Surgeons
American Congress of Obstetricians and Gynecologists
American Osteopathic Association
American Society for Radiology and Oncology
American Society of Anesthesiologists
American Society of Cataract and Refractive Surgery and Reconstructive Surgery
American Society of Clinical Oncology
American Society of Nephrology
College of Healthcare Information Management Executives
Congress of Neurological Surgeons
Heart Rhythm Society
Joint Council on Allergy, Asthma and Immunology
Medical Group Management Association
National Association of Spine Specialists
Renal Physicians Association
Society for Cardiovascular Angiography and Interventions
Society for Vascular Surgery

But, as the EHR pollyannas say, it'll all be better in ver. 2.0.

-- SS

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Bad Apple or Bad Orchard? - A Narrative of Alleged Individual Research Misconduct that Sidestepped the Pharmaceutical Corporate Context

Tales of medical research misconduct seem increasingly prevalent in the media, and are getting increasing attention.    They often may present a simple narrative, like this recent story in the New York Times, "An NYU Study Gone Wrong, and a Top Researcher Dismissed."

The Narrative Arc

A Renowned Researcher

The researcher in question was one Dr Alexander Neumeister.  Oddly enough, the article provided very little information about his background, but made it clear he was at New York University, and was a "top researcher."

The Potentially Ground-Breaking Studies

The NY Times article noted that the studies were of "an experimental, mind-altering drug."  In particular,

In one of the shuttered studies, people with a diagnosis of post-traumatic stress caused by childhood abuse took a relatively untested drug intended to mimic the effects of marijuana, to see if it relieved symptoms.

The study was ground-breaking, in that

It’s a critical time for two important but still controversial areas of psychiatry: the search for a blood test or other biological sign of post-traumatic stress disorder, which has so far come up empty, and the use of recreational drugs like ecstasy and marijuana to treat it.

The drug was not identified, but the article noted that it was

a drug intended to produce some of marijuana's effects, made by Pfizer

and was thus like the drug in "a French trial," that caused six patients to be "hospitalized with severe neurologic problems."

The study was apparently a small short-term randomized controlled trial

Some participants took the drug over a seven-day period; others took a placebo pill. The N.Y.U. team performed scans on each person to see whether brain activation patterns correlated with symptom relief.

The study called for recruiting 50 people with a PTSD diagnosis, according to study documents.

Research Misconduct Discovered

Initially, apparently,

Dr. Charles Marmar, the chairman of the psychiatry department at N.Y.U., said that people working with Dr. Neumeister had reported concerns about the lab’s compliance with research standards.

This led to

The federal inspection, from July 16 to Aug. 5 last year, found that the research team had failed to assess at least three subjects 24 hours after they had taken the experimental drug, contrary to study protocol, according to the F.D.A. letter. In several instances, the agency found, Dr. Neumeister had falsified documents by signing a fellow investigator’s name on reports. 'However, in fact, you or another study employee actually conducted these study procedures,' not the colleague, the F.D.A. concluded.

In summary

The violations 'jeopardize subject safety and welfare, and raise concerns about the validity and integrity of the data collected at your site,' the F.D.A. said in a letter

Note that the article did not explain why the FDA was called upon to investigate this problem.



Aggrieved Research Subjects

The article focused on one Ms Diane Ruffcorn, who "writes a popular Facebook blog on trauma,"

'I think their intent was good, and they were considerate to me,' said one of those subjects, Diane Ruffcorn, 40, of Seattle, who said she was sexually abused as a child. 'But what concerned me, I was given this drug, and all these tests, and then it was goodbye, I was on my own. There was no follow-up.'

After the trial, she was concerned because

Ms. Ruffcorn said she had several odd symptoms after the trial, including a hyper, wired sensation that occurred without the usual memories of abuse.  For months, she tried to find out whether those reactions were tied to the experimental drug, but because the study was shut down and the data belonged to Pfizer, the N.Y.U. doctors could not tell her whether she had taken the drug or placebo.

However,

Earlier this month, after much persistence, she found out that she’d taken the placebo. 'It was a big relief,' she said.

Note that the article did not explain why Pfizer owned the data, and would not reveal it. 

The Researcher Punished

The researcher did not agree that things were so bad,

Georges Lederman, a lawyer for Dr. Neumeister, said there may have been protocol violations, 'but N.Y.U. has taken the position that those violations were more egregious than we believe they actually were.' The issues could have been easily remedied, he said, and noted that they did not cause the sponsor of the research, the pharmaceutical giant Pfizer, to shut it down.

Note that the article did not explain why Pfizer was empowered to shut such a study down.

In any case,

Dr. Neumeister and N.Y.U. continue to disagree over the seriousness of the research violations, both sides said. But the university has tossed out all of the data as unreliable, and tracked down the study participants to check on their health, Dr. Marmar said.

And apparently Dr Neumeister quit, or was fired, although the article only said NYU "parted ways with a top researcher."

Summary

So, in summary, the story was that a prominent researcher was doing cutting edge research at a big university, but people onsite noted some problems, the government was called in to investigate, the investigation found problems, the research was stopped, and the researcher lost his job.  However, while the article mentioned that Pfizer sponsored the study, Pfizer had control of the study's data, and Pfizer had the power to shut the study down, the article did not comment on whether the involvement of Pfizer could have had any relationship to the narrative of alleged individual researcher misconduct.

Research Misconduct as a Problem with Bad Apples

Thus, in my humble opinion, this story followed the usual narrative arc of research misconduct stories: an individual scientist over-reaches, possibly in pursuit of fame and money, is discovered and punished, and things get back to normal.  The implication is that research misconduct is a bad-apple problem, although fueled by a hyper competitive research environment.  For example, last week the (UK) Times Higher Education Suppplement published an article entitled, "Is There a Problem with Research Integrity," that opened,

For many academics today, research is not about pushing intellectual boundaries. It is not about investigating a fascinating issue so much as it is about churning out publications, demonstrating impact and generating revenue in order to meet the performance targets upon which institutional reputation and individual careers depend.

The temptation to cut corners is immense. Tricks include getting your name on a paper that you contributed little towards, or “salami-slicing” the same research across several publications. More seriously, some researchers falsify – misrepresent – their data, or even fabricate them entirely. Some universities tacitly encourage such behaviour and the boundary between academic integrity and malpractice is becoming blurred.

The current case seems to be on of attempted falsification, misrepresentation of research data.

Notice the use of the pronoun "you," emphasizing that research misconduct is about individual misconduct.  Similarly, tha THE article included commentaries by various individuals.  One was by a "research integrity expert," who began,

Having positive and preferably spectacular research findings is wonderful. It helps you to get a publication in a journal with a high impact factor, which will be cited often and may attract a lot of media attention. This is not only a pleasant ego boost but may also be instrumental in getting your next grant or strengthening your academic position. So, in an ever more competitive and metrics-driven scientific environment, it is tempting to make such results occur by any means necessary.

All this is true as far as it goes.  But in my humble opinion, the usual research misconduct narrative is vastly oversimplified, as is the case reported by the New York Times.

We have been writing for years about massive problems with manipulation of clinical research to increase the likelihood that the results would satisfy vested interests, and suppression of research whose results remain unsatisfactory after such manipulation.  The vested interests are most commonly pharmaceutical, biotechnology or device companies and those working with them.  Such suppression and manipulation may make treatments that do not work look efficacious, and treatments that are dangerous look safe, and may lead to excess costs, and worse, harms to patients.  This kind of research misconduct may be facilitated by individual researchers seeking fame and fortune, but is hardly an individual sport.

Focusing on individual research misconduct thus leaves the larger problem of vested interests dominating clinical research anechoic.

Looking carefully at the NYU/ Neumeister case as reported, and a little research on the web suggests that there may be more involved than just the conduct of one researcher.  But that could only be confirmed, or refuted, by investigation beyond what this humble blogger can do.

A Pharmaceutical Company Sponsored, Likely Pharmaceutical Company Designed, Phase II Drug Study Gone Wrong

The NY Times article acknowledged, almost parenthetically, that the study on which the article was focused was sponsored by Pfizer, although it first did so in the context of Dr Neumeister's lawyer arguing that the problems with the study were not that serious:

[he] noted that they did not cause the sponsor of the research, the pharmaceutical giant Pfizer, to shut it down.

Later, the article stated,

Pfizer said that N.Y.U. was responsible for conducting the trial,

but noted

the company had previously tested the same drug, known as an F.A.A.H. inhibitor, for osteoarthritic pain, without significant side effects. 'The safety profile we observed does not preclude future development of our compound,' a Pfizer spokesman said by email.

So this was not a case of a company funding a study merely to advance medical science.  The implication was that the company was testing its own compound in hopes of seeking approval from the US Food and Drug Administration. That must be why it was the FDA that investigated the research misconduct, particularly to the extent that the conduct of the research violated a "protocol" to which the FDA was apprently privy.

More evidence that the study was under the control of Pfizer, rather than of Dr Neumeister, could be inferred from the problems Ms Ruffcorn had in determining whether she had taken the drug or placebo.

For months, she tried to find out whether those reactions were tied to the experimental drug, but because the study was shut down and the data belonged to Pfizer, the N.Y.U. doctors could not tell her whether she’d taken the drug or a placebo.

Note that the "data belonged to Pfizer," not to NYU or Dr Neumeister.

In fact, in perhaps the only critical look given to this story, in a post on Neuroskeptic, 

I believe the compound in question is PF-04457845.

I believe this because ClinicalTrials.gov lists a trial of PF-04457845 for PTSD, a trial which was recently terminated. NYU was one of the research sites. I also think that this trial is the fateful one, as it matches the NYT’s description of that study. Interestingly, ClinicalTrials.gov says that the trial was stopped 'based on Pfizer portfolio prioritization and not due to safety and/or efficacy concern or change in benefit:risk assessment of PF-04457845'.

So given that the study was a small randomized controlled trials of patients, not of healthy volunteers, it appeared to be a Pfizer sponsored, Pfizer designed, Pfizer controlled Phase II study being done in the hope of eventually marketing PF-04457845.

As noted in an article about agreements between academia and industry on the conduct of randomized controlled trials(1),

Many randomized clinical trials (RCTs) are designed and sponsored by for-profit companies. Companies typically contract academic investigators to identify, recruit, and manage patients. Clinical research under these circumstances is a business transaction that bears the potential for conflicts of interest, including those regarding the publication of trial results

It also appears that Pfizer was spending a more than tiny sum on this work.   A Politico article from 2014 revealed that Dr Neumeister at that time had a $1.7 million grant from Pfizer, presumably for this particular study.  Thus this drug trial was likely providing NYU with more than negligible monetary support, most likely including salary support for Dr Neumeister.

Dr Neumeister apparently has had some previous involvement with pharmaceutical companies, and with Pfizer specifically.  A search of the ProPublica Dollars for Docs 2009-13 database revealed that Dr Neumeister received consulting, travel funds and a more than $227,000 grant from Eli Lilly.  Dr Neumeister apparently is currently on the advisory board for Fiorello Pharmaceuticals.  In a 2015 article in the Journal of Clinical Psychiatry(2), Dr Neumeister acknowledged that he "has received consulting fees from Pfizer."

Conclusion

So it seems that in this case a study which may not have been conducted according to research standards was likely a pharmaceutical sponsored, designed, and controlled Phase II trial done as part of an effort to seek approval for a new drug.  Hence this case was not only about allegations of individual research misconduct, but about yet more problems with the implementation of commercially controlled human experiments designed to ultimately further marketing as well as science.  Yet none of the public discussion so far of this case was about whether Pfizer had any responsibilities to assure the quality of the research in which it was so involved, much less whether interactions between the company, the university which was being funded by the company, and the researcher employed by the university but whose salary was probably partially underwritten by the company might have affected how the study was implemented.

There may be many problems with individual misconduct affecting clinical research.  But failure to consider how this research is now mainly conducted within a commercial milieu seems to be missing the elephant in the room.  If we cannot plainly discuss research misconduct as part of the larger picture of health care dysfunction, we will not be able to do much about it.  True health care reform would help end the taboo on discussion about how powerful organizations and their wealthy and powerful leaders distort health care.  

ADDENDUM (11 July, 2016) - This post was re-published on the Naked Capitalism blog. 

References

1. Kasenda B, von Elm E, You JJ, Blumie A et al. Agreements between Industry and Academia on Publication Rights: A Retrospective Study of Protocols and Publications of Randomized Clinical Trials. PLoS Med 13(6): e1002046. doi:10.1371/journal.pmed.1002046. Link here.

2.  Mota N, Sumner JA, Lowe SR, Neumeister A et al. The rs1049353 Polymorphism in the CNR1 Gene Interacts With Childhood Abuse to Predict Posttraumatic Threat Symptoms. J Clin Psychiatr 2015; 76(12):e1622–e1623. Link here.

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Still No Questions Asked - Journalists Fail to Challenge Talking Points Used to Justify Million Dollar Plus Executive Compensation at New York Non-Profit Hospitals

It's deja vu all over again. I even get to reuse the introduction of a post from one month ago.  As I wrote in May, 2016,...

 The problem of ever rising, amazingly generous pay for top health care managers is a frequent topic for Health Care Renewal.  We have suggested that the ability of top managers to command ever increasing pay uncorrelated with their organizations' contributions to patients' or the public's health, and often despite major organizational shortcomings indicates fundamental structural problems with US health, and provides perverse incentives for these managers to defend the current system, no matter how bad its dysfunction.

In particular, we have written a series of posts about the lack of logical justification for huge executive  compensation by non-profit hospitals and hospital systems.  When journalists inquire why the pay of a particular leader is so high, the leader, his or her public relations spokespeople, or hospital trustees can be relied on to cite the same now hackneyed talking points.

As I wrote last year,  and last month,

It seems nearly every attempt made to defend the outsize compensation given hospital and health system executives involves the same arguments, thus suggesting they are talking points, possibly crafted as a public relations ploy. We first listed the talking points here, and then provided additional examples of their use. here, here here, here, here, and here, here and here. 

They are:
- 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 (and have to be to do such a difficult job).

Yet as we discussed recently, these talking points are easily debunked.  Additionally, rarely do those who mouth the talking points in support of a particular leader provide any evidence to support their applicability to that leader.

Bit at least most journalists who inquire into hospital executive compensation used to make an attempt to be "fair and balanced" by also quoting experts who question the talking points.

But not so much lately,...

Million Dollar Plus Hospital CEOs in New York

The Journal News, based in the northern New York City suburbs, ran a series of articles about executive pay and perks at NY hospitals and hospital systems.  The main aricle in the series is here.  A listing of the five highest paid hospital officials is here.  A listing of executive perks, and conflicts of interests affecting the hospitals' and hospital systems' board members is here.  The main article began,

New York's nonprofit hospitals paid millions in bonuses to executives and doctors despite a high-stakes battle to reduce health care spending.

As patients struggled to afford rising medical bills, incentive packages for top hospital executives reached seven figures and approached payouts at Wall Street banks, The Journal News/lohud has found.

Perks at the nonprofit hospitals included first-class plane tickets, chauffeurs and country club memberships. Severance and retirement payments mirrored golden parachutes awarded to for-profit corporate executives.

The article noted that 112 people who worked for non-profit hospitals in the Lower Hudson valley earned more than $1 million.  The biggest pay went to the top executives of the biggest systems:

Bonuses and payments spiked the highest among executives at the helm of major hospital consolidations, data show.

North Shore University Hospital’s President/Chief Executive Officer Michael Dowling topped the list in 2014. He was paid $10.1 million in salary, bonuses and other pay. That is compared to $3 million in 2010.

Dowling’s payments came as the Long Island hospital and its affiliated organization, then North Shore-LIJ, began its ongoing expansion.

The health system, now Northwell Health, has pushed into the Lower Hudson Valley, partnering with Northern Westchester Hospital in Mount Kisco and other regional providers.

Also,

Dr. Steven Safyer, president and CEO of Montefiore Medical Center in the Bronx, was paid nearly $4.9 million in 2014, including a bonus of $1.3 million.

That's an $800,000 increase from the $4.1 million he was paid in 2010. It came as Montefiore bought bankrupt hospitals in Mount Vernon and New Rochelle, and pushed its expansion northward into Westchester County, which now includes a partnership with White Plains Hospital.

Note that Dr Sayfer also was given a hospital-paid car and driver.  

An accompanying article noted the three other highly paid CEOs in New York state, Warren Hern, CEO of Unity Health Systems in Rochester, $7,490,213;  Mark Clement, CEO of Rochester General Hospital, $5,323,856; and Dr Steven Crowin, CEO, New York Presbyterian Hospital, $4,591,728 [who also benefited from a policy allowing first-class or business airfare for flights over 6 hours, and some form of housing allowance.)

Other million dollar plus CEOs in the Lower Hudson valley included John Federspeil, president, Hudson Valley Hospital Center, $2,055,377; Joel Seligman, CEO, Northern Westchester Hospital, $2,043,289; Dr Cary Hirsch, CEO, Bon Secours Charity Health System (Good Samaritan Hospital in Suffern), $1,170,575; Keith Safian,  CEO, Phelps Memorial Hospital Center, Sleepy Hollow, $1,494,760; Lawrence Levine, CEO, Blythedale Children's Hospital, $1,701,471, Edward Dinan, CEO, Lawrence Hospital Center, $1,707,780; Dr Craig Thompson, CEO, Memorial Sloan-Kettering Cancer Center, $2,944,926 (who also got first-class or coach airfare for flights over 6 hours, and some form of housing allowance); and Jon Schandler, CEO, White Plains Hospital, $1.799,952.

The Usual Talking Points to Justify Executive Compensation

The Journal News article also included justifications for this munificent pay by hospital officials that used the usual talking points. 

We have to pay competitive rates

We have to pay enough to retain at least competitive executives


The spokesman for Northwell Health asserted,

The fact that we're located in the New York market ... only increases the competitive pressures on compensation.

Then,

Julius Green, a partner at Baker Tilly, a New Jersey-based accounting firm advising 100 hospitals in the Northwest, attributed expansions and higher pay to growing competition nationwide.

Also, from Blythedale Children's Hospital,

As the [Affordable Care Act] mandates take effect, and the number of insured individuals rise, the need for skilled healthcare workers will surely increase as will the competition for that talent.

Our executives are brilliant

Said Michael West, senior attorney for the New York Council of Nonprofits,

If you're running an organization that has a $500 million budget, you have to have someone with the wherewithal to run it and you have to pay for that.

Said Rachael McCallen, a Montefiore spokeswoman,

Our executives navigate a complex healthcare environment making appropriate investments to ensure a forward-thinking, innovative and responsive care model that provides higher value, lower cost integrated care services.

Furthermore, the next week the Journal News publised an op-ed by William Mooney, CEO of the Westchester County Association, which was devoted to defending the pay of his fellow CEOs.  It started with indignation against anyone who would question the pay of our fearless leaders,

While it is fashionable to cast aspersions on high-income earners, the arguments set forth about the compensation levels of area health-care CEOs are misguided and erroneous.

Then Mr Mooney again hit the talking points.

We have to pay competitive rates

We have to pay enough to retain at least competitive executives

Given that a hospital is a community organization, the compensation of their executives is decided by boards made up of community members who base their decisions on research, competitive market analyses and responsible financial projections.

Our executives are brilliant

Running a hospital is a business unlike any other. First and foremost, hospitals are complex organizations that are about protecting and promoting health, and saving lives.

Also,

A hospital CEO is responsible for overseeing and guiding his or her staff through a maze of financial and regulatory challenges while making sure safety and performance standards are at the highest possible levels.

Third, the technology and infrastructure enhancements that today’s hospital CEO must manage are vast and rapidly changing. The staffing required to support all of these disparate functions encompasses a wide range of skill sets and education. A hospital CEO must understand and manage all of those roles, and must keep an eye on the demands and responsibilities of maintaining new technology.

In addition, the op-ed concluded with the argument:

your readers would be better served by reporting on the qualitative and quantitative benefits our community derives from having the best health-care leaders in the nation at the helm of our local hospitals.

And these leaders to more than manage finances. The op-ed implied that hospital CEOs are personally responsible for savings lives. This can be seen in the quote above under the brilliance argument, and later:

Non-profit status is conferred upon an organization that does something for the public good. Saving lives clearly is in the public’s best interests!

This despite the fact that the majority of CEOs in the article above, and indeed the majority of top managers of hospitals and hospital systems are not health care professionals, and cannot take any direct responsibility for patient care.  This also despite the assertion by Mr West, the senior attorney for the New York Council of Nonprofits, that "hospitals are run like a business,..."suggesting that the people running them might put money, not "doing something for the public good," first.

Also, note that while Mr Mooney extolled the community based boards whose members made such discerning decisions about executive pay, he did not address these members' numerous conflicts of interests.  For example, re some of hospitals and hospital systems with the most highly paid CEOs,

Stephen Friedman was a board member of Memorial Sloan-Kettering in 2014 when the cancer center paid $10.5 million for architectural services from Perkins/Eastman. Friedman’s brother-in-law, identified as Mr. Perkins, is affiliated with the firm, tax filing show. Bradford Perkins is listed as the co-founder and chairman of Perkins/Eastman, according to its website.

Jamie Nicholls was a Memorial Sloan-Kettering board member in 2014. Her spouse was a co-founder of King Street Capital Management, which the hospital paid nearly $700,000 for management fees, tax filings show.

And,

White Plains Hospital disclosed one business transaction involving an interested person. The filing has few details. It reported the name of the interested person as 'Donor #24' and the relationship with the hospital as a 'substantial contributor.' The amount of the transaction was $15,350,345, and the description is 'BUS TRANS.'

And,

New York-Presbyterian paid $440,225 for investment management fees to Coatue Management, which listed its founder and chief executive officer as Philippe Laffont, a hospital trustee, tax filings show.

And,

Kaleida Health in Buffalo paid $121,660 to the Greater New York Hospital Association for participation dues in 2014. James Kaskie, former president and chief executive officer at Kaleida, was also a board member at the association, tax filings show.

Finally, note that neither the main article nor Mr Mooney's op-ed cited any evidence, even anecdotal, that these particular leaders are so brilliant, or that their hospitals are better than average, even in terms of finance, much less actual care of patients.   

No Challenges to the Talking Points

The main article did not include any dissenters who questioned expansive executive pay.  An accompanying editorial in the Journal News could only muster some anemic concern.  It called multi-million dollar compensation for local non-profit hospital system executives "unsettling."  It did contrast ever rising executive pay with the difficulty patients have paying their bills.  But it could only muster conclusions that mirror the talking points:

Hospitals are quick to defend their executives' rising compensation, and their arguments are good ones. Chief among them is that hospitals must compete for the best top officials, including with for-profit hospitals across the U.S. They say they need to attract and keep leaders who can competently oversee growing health-care systems, meet ever-changing government regulations and improve patient care and satisfaction.

So, all they called for was disclosure of compensation:

Hospital executives deserve fair pay for hard work; taxpayers deserve to know that resources are being used to attain quality care for all.

Although Mr Mooney seemed to see "aspersions" in the article,  and thought "the article implies that hospital CEO compensation is somehow responsible for the continued rise in healthcare costs," and argued that "hospitals do not deserve to have nonprofit status," I could find no such challenges in the Journal News series to the notion that top non-profit hospital managers deserved every penny they got.

Conclusion

Sadly, the ever rising compensation of top health care managers seems to inspiring less, rather than more skepticism in the media.  No more is it true that  nearly all articles that try to delve into executive compensation at all at least quote some experts who are skeptical of current practices.

The Journal News series included no such attempts at balance.  In my humble opinion, while it reported on useful facts, the opinions it contained leaned towards propaganda for managers' current privileged position in health care. 

Despite all the blather about how top hospital executives deserve millions of dallars, there are real reasons to be skeptical.  As we discussed here, there is a strong argument that huge executive compensation is more a function of executives' political influence within the organization than their brilliance or the likelihood they are likely to be fickle and jump ship for even bigger pay.  This influence is partially generated by their control over their institutions' marketers, public relations flacks, and lawyers.  It is partially generated by their control over the make up of the boards of trustees who are supposed to exert governance, especially when these boards are subject to conflicts of interest and  are stacked with hired managers of other organizations. 

While Mr Mooney was indignant that high executive pay may be considered a reason that hospital charges and health care costs are rising, he did not even discuss the argument that the current method of determining such pay may provide perverse incentives to grow hospital systems to achieve market domination, raise charges, and increase administrative bloat.  As an op-ed in US News and World Report put it about executive pay in general,

But the executive pay decisions made inside corporate boardrooms have an enormous impact in the outside world. Outrageous pay gives top executives an incentive to behave outrageously. To hit the pay jackpot, they'll do most anything. They'll outsource and downsize and make all sorts of reckless decisions that pump up the short-term corporate bottom line at the expense of long-term prosperity and stability.

So I get to recycle my conclusions from my last post in this series....

We will not make any progress reducing current health care dysfunction if we cannot have an honest conversation about what causes it and who profits from it.  In a democracy, we depend on journalists and the news media to provide the information needed to inform such a discussion.  When the news media becomes an outlet for  propaganda in support of the status quo, the anechoic effect is magnified, honest discussion is inhibited, and out democracy is further damaged.

True health care reform requires ending the anechoic effect, exposing the web of conflicts of interest that entangle health care, publicizing who benefits most from the current dysfunction, and how and why.  But it is painfully obvious that the people who have gotten so rich from the current status quo will use every tool at their disposal, paying for them with the money they have extracted from patients and taxpayers, to defend their position.  It will take grit, persistence, and courage to persevere in the cause of better health for patients and the public. 

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New AMA President Andy Gurman, MD on EHRs: " I don't have one, and no one can make me use one."

The love-fest with EHRs continues, to the great chagrin of the believers in fairies, unicorns and cybernetic utopia.

Andy Gurman, MD, Takes Reins as AMA President
Jun 17, 2016
Gale Scott, HCPLive
http://www.hcplive.com/medical-news/andy-gurman-md-takes-reins-as-ama-president

The American Medical Association’s new president, Andrew W. Gurman, MD, known for his affability and quick wit, is not one to seek out controversy.

In an interview before being sworn in this week as the AMA’s annual meeting in Chicago, IL, Gurman said he has no agenda for his tenure at the top of the organization.

Considering the mass hatred of EHRs by physicians (and nurses), the issue of EHR-related harms, compromised patient data security, physician scorecards, and other noxious issues, maybe he should have an agenda.  E.g., see my Jan. 28, 2015 post "Meaningful use not so meaningful: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing" at http://hcrenewal.blogspot.com/2015/01/meaningful-use-not-so-meaningul.html.

... Though physicians’ anger over the frustration of using existing electronic health records was a major topic of conversation at the [annual AMA] meeting, Gurman said he had little to add other than no one could make him use one.

 “I don’t have an EHR,” he said. Due to the fact that he runs his own practice he found it easier and cheaper just to forgo the enhanced payments he would get under the federal “meaningful use” regulations for converting to electronic records. “I just take the penalties,” he said.

Not every physician can afford the time sink most EHRs represent, and the increasing penalties for non-users, unfortunately.

Perhaps on the AMA agenda should be a return to sense regarding physician and nurse documentation, with significant reduction in their clerical burden for starters.

-- SS

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Reckless indifference to nurse's concerns about bad health IT results in showing her the door?

At numerous past posts I referred to hospital executives' reckless indifference to the concern of seasoned clinicians about bad health IT, such as at  http://hcrenewal.blogspot.com/2013/07/rns-say-sutters-new-electronic-system.html and  http://hcrenewal.blogspot.com/2013/11/another-survey-on-ehrs-affinity-medical.html and other posts.

I now see a stunning story of the results of EHR iconoclasty and patient advocacy:

CNO claims hospital forced her out after she raised concerns about EMR
Becker's Hospital Review
Written by Akanksha Jayanthi  
June 14, 2016 
http://www.beckershospitalreview.com/legal-regulatory-issues/cno-claims-hospital-forced-her-out-after-she-raised-concerns-about-emr.html

 A former nursing executive at Sonoma West Medical Center in Sebastopol, Calif., has filed a lawsuit against the hospital, alleging she was fired after raising concerns the EMR was a threat to patient safety, reports The Press Democrat.

Autumn AndRa, RN, was serving as CNO of the hospital when she approached CEO Ray Hino and said the EMR, called Harmoni, was unsafe, according to the report.

Ms. AndRa was reportedly terminated from her CNO position April 14 and was offered a position in the intensive care unit, which her attorney Daniel Bartley told The Press Democrat would have been a demotion. Ms. AndRa left the hospital due to alleged harassment, according to Mr. Bartley.

If these allegations are true, a clinician, the Chief Nursing Officer, was shown the door in an act of recklessness for her complaining about bad health IT.

Some definitions: 

Bad health IT:

Bad Health IT is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, is difficult and/or prohibitively expensive to customize to the needs of different medical specialists and subspecialists, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, lacks evidentiary soundness, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation.   

Reckless indifference:

Deliberate indifference is the conscious or reckless disregard of the consequences of one's acts or omissions. It entails something more than negligence, but is satisfied by something less than acts or omissions for the very purpose of causing harm or with knowledge that harm will result.

A wrongful termination lawsuit was apparently filed:

... The lawsuit alleges the EMR system mixes patients' records, so information in one patient's chart moves to another patient's chart. It also alleges the EMR has issues tracking and updating patient medications and does not display patient code status information, which informs providers of patients' desired medical interventions, according to the report.

These types of gross defects, if true, represent an on its face menace to patient safety.

Further, these issues (and the harm that may result) are well known.  In fact ONC's contractor RIT just released a comprehensive review article on health IT problems (see "Report of the Evidence on Health IT Safety and Interventions", May 2016, at https://www.healthit.gov/sites/default/files/task_8_1_final_508.pdf).

CEO Ray Hino had the usual refrain seen in so many postings here (under the blog query "Patient care has not been compromised" - http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised):

Mr. Hino told The Press Democrat the EMR did not pose any danger to patients, and no patients have been harmed because of software defects.

Like most others uttering that line, as I've documented, Mr. Hino apparently lacks expertise (e.g., in clinical, IT or Medical Informatics domains) to render such a judgment about patient danger if the EHR did or does exhibit such problems.  His bio is at https://www.linkedin.com/in/raymondhino.

As to whether patients were harmed, that is irrelevant if the EHR has such defects.  Sooner or later, they will be.  The issue is risk, not body counts (yet).

There's also this.  The EHR in question is not the product of the major EHR vendors but the work of apparent insider.  See http://about.harmonimd.com/usa/ referencing just two implementations, one at Somona West Medical Center, California, the subject of this post, and one at the Kilimanjaro Christian Medical Centre, Tanzania, Africa:

... The lawsuit also names Dan Smith, the developer of the EMR software in question, as a defendant. According to the lawsuit, Mr. Smith "has engaged in retaliation against [Ms. AndRa] and other employees who have voiced concerns that Mr. Smith's electronic medical records system, his self-dealing, and his management of medical and financial decisions are not in the best interests of SWMC and pose life-threatening risks to patient care," reports The Press Democrat.

Not only did Mr. Smith develop the software in question, but he is a significant financial backer and influencer at SWMC. According to a 2015 report from The Press Democrat, Mr. Smith and his wife have contributed nearly $9 million to the hospital in donations and forgivable loans, and he plays a role in "ever major decision" regarding the hospital. Mr. Smith is on SWMC's board of directors. 

I really don't think injured or dead patients (or juries) will find those relationships an excuse for bad health IT, what seems like a clinical trial of new IT by a private company and owner without informed consent (including divulging to patients and users a possible COI), and the discharge of someone complaining about it.

Mr. Smith and hospital officials declined to comment on the lawsuit, citing pending litigation, according to the report.

My expertise is available should the parties so desire.

-- SS

6/21/2016 Addendum:

https://en.wikipedia.org/wiki/Human_subject_research 

Human subjects

The United States Department of Health and Human Services (HHS) defines a human research subject as a living individual about whom a research investigator (whether a professional or a student) obtains data through 1) intervention or interaction with the individual, or 2) identifiable private information (32 C.F.R. 219.102(f)). (Lim, 1990)^[2]

As defined by HHS regulations:

"Intervention"- physical procedures by which data is gathered and the manipulation of the subject and/or their environment for research purposes [45 C.F.R. 46.102(f)]^[2]

"Interaction"- communication or interpersonal contact between investigator and subject [45 C.F.R. 46.102(f)])^[2]

"Private Information"- information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public [45 C.F.R. 46.102(f)] )]^[2]

"Identifiable information"- specific information that can be used to identify an individual^[2]

Human subject rights

In 2010, the National Institute of Justice in the United States published recommended rights of human subjects:

• Voluntary, informed consent
• Respect for persons: treated as autonomous agents
• The right to end participation in research at any time^[3]
• Right to safeguard integrity^[3]
• Benefits should outweigh cost
• Protection from physical, mental and emotional harm
• Access to information regarding research^[3]
• Protection of privacy and well-being^[4]

-- SS

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CORRUPTION OF CLINICAL TRIALS REPORTS: A PROPOSAL

CORRUPTION OF CLINICAL TRIALS REPORTS:

A PROPOSAL

There is a disconnection between the FDA’s drug approval process and the reports we see in medical journals. Pharmaceutical corporations exploit this gap through adulterated, self-serving analyses, and the FDA sits on its hands. I suggest we need a new mechanism to fix the problem – by independent analyses of clinical trials data.

When they analyze and publish their clinical trials in medical journals, pharmaceutical corporations have free rein to shape the analyses. The FDA conducts independent analyses of the data submitted by the corporations, and it may deny or delay approval. But the FDA does not challenge the reports that flood our medical journals, both before and after FDA approval. It is no secret that these publications are routinely biased for marketing effect, but the FDA averts its gaze. That failure of the FDA – a posture known as enforcement discretion – has been well documented. The question is why? At the same time, exposing the biases has been difficult for outsiders because the data are considered proprietary secrets.

A Case Study

Now, a detailed example of deliberate corporate bias has finally been documented, through materials released in litigation. This exposé was reported by Drs. Jon Jureidini, Jay Amsterdam, and Leemon McHenry. Their findings were recently published, and their article is freely available on-line. This example concerned a clinical trial of an antidepressant drug in children and adolescents. The drug, citalopram, was already approved for use in adults, and its off-label use in children would spread if there was published supportive evidence. An Investigational New Drug (IND) protocol and plan of analysis were filed by Forest Laboratories with the FDA in 1999. The trial was completed in 2002, and the results were publishedin American Journal of Psychiatry in 2004 – but the FDA did not accept the results as sufficient to approve this drug for use in children or adolescent patients. By that time the patent on citalopram had expired and Forest Laboratories introduced a virtual twin drug, escitalopram (single active enantiomer). That more expensive version of citalopram was heavily promoted, and it was approved in 2009 for use in children, but even then the FDA specifically noted that safety and efficacy were not established in children under age 12. Since then, new analyses suggest that most antidepressant drugs have little evidence of efficacy even in older children.

Tricks of the Trade

In service of a positive report, the statistical analyses performed by Forest Laboratories deviated from the IND plan of analysis, and negative results were edited out. The biases now documented by Dr. Jureidini and his colleagues for that 2004 sponsored reportin American Journal of Psychiatry included:

·       Inflating the main measure of the drug's effect by reporting an incorrect and clearly exaggerated effect size. On being challenged, the authors later explained their misinformed computation without actually acknowledging the error.

·    Failure to report secondary measures of response because they were negative. Those measures had been stipulated in the IND protocol to serve as cross-checks on the main result. These negative findings were airbrushed out of the publication by corporate marketing.

·    Unplanned, new secondary measures of response were inserted ex post facto because they were positive (that is a real no-no).

·    Violations of the IND protocol were not reported and were then fudged (patients who had properly been excluded per protocol were put back in for analysis, which made a nonsignificant primary outcome analysis turn positive).

·    Adverse events were analyzed and summarized in a misleading way.

·    The finding that the drug had no effect on depression in children under age 12 was not reported, even though an age-effect interaction analysis had been specifically projected in the IND protocol. This strategic omission left the impression that off label use of citalopram in younger children could be clinically reasonable.

·    The corporation knew that another, unpublished, trial in children, conducted by their European partner Lundbeck was negative, and that it raised concerns about suicide risk, but that information was withheld. The authors later were challengedin the journal about this concealment. Their responsewas utterly disingenuous.

·    The published article failed to acknowledge that it was authored by a non-medical ghostwriter, who took direction from marketing executives – the 2004 publication was a marketing product purporting to be an objective scientific report.

·    Academic authors were recruited only after the manuscript was written, reviewed, and approved in-house – these nominal academic authors were signed on to front for the corporate narrative.

·    The perfunctory role of the academic (ahem) authors is clear from the fact that they failed to recognize the wildly inflated effect size claimed for the drug – something that was instantly obvious to several groups of competent readers.

The Payoff

These changes created the appearance of a positive result, and the publication drew wide attention. According to Thomson Reuters Web of Science, it has been cited over 160 times, placing it in the top 5% of cited articles in clinical medicine from 2004. This early publication gave plausible justification for off-label use of citalopram/escitalopram in children, even with FDA approval having been denied, and even though the trial was actually negative. The FDA has reported that between 2005 and 2010 well over 750,000 patients up to age 17 received escitalopram, including almost 160,000 under age 12. Thus, the sleight of hand about failure to show even fudged efficacy in younger children is especially deplorable. Internal memoranda reproduced in the exposé by Dr. Jureidini and his colleagues give a clear picture of the corporate manipulation of the scientific publication process. Now we know – in black and white – just how bad the bias can be. This kind of data manipulation, with ad hoc cherry picking and moving of goalposts, is unacceptable, but it is entrenched. Indeed, it is business as usual – and the FDA looks away.

A Specific Proposal

Our primary defense against such perversions of scientific reporting is fidelity to the registered IND protocol and plan of statistical analysis. The solution is not hard to see: We need independent analyses of clinical trials because we cannot trust the corporate analyses. In effect, we need something like the Underwriters Laboratory to verify the statistical analyses of clinical trials. Nobody takes the manufacturing corporation’s word for it concerning the safety and performance of X-ray machines or cardiac defibrillators. Why treat the statistical analysis of drug trials any differently? It’s highly technical work.

Who should assume that responsibility? Why not the FDA? After all, they alone see all the data. My specific proposal is for Congress to mandate that the FDA analyze all clinical trials data strictly according to the registered protocols and analysis plans. That requirement should apply to new drugs or to approved drugs being tested for new indications. It should apply also to publications reporting new trials of approved drugs. Corporations and investigators should be prohibited from publishing their own in-house statistical analyses unless verified by FDA oversight.

Why Bother?

There are three good reasons for prohibiting in-house corporate analyses of clinical trials data. First, as the present example illustrates, the inherent conflict of interest is simply too great to be ignored. Second, when corporate statisticians who answer to marketing executives get “creative” in the ways exposed here, then the conditions for valid statistical analyses no longer apply – the statisticians are then on a fishing expedition and they are no longer testing the defined study question with fidelity to the methods specified in the IND protocol. In that case, any nominally significant statistical findings are just exploratory, not actionable – not good enough to justify off-label use of the drug, especially when properly evaluated alternatives are available.

Third, there can be no justification for treating the production of influential publications in medical journals any differently than we treat the production of potent drugs. Our FDA continuously inspects production facilities for evidence of physical adulteration, even as far away as China. They now need to monitor the adulteration of clinical trials reports in medical journals. The harms of adulterated analyses can be just as serious as the harms of adulterated products.

Push Back from Pharma?

We can expect the pharmaceutical industry to mount a First Amendment challenge to this proposal. It will fail, because the public health is too important. Just as there is no First Amendment right to shout fire in a crowded theater, so also corporations have no First Amendment right to say a drug is safe and effective when they know it isn’t. That is a betrayal of patients.

The corporations will also claim piously that their publications undergo peer review. Sadly, that is no barrier to this pervasive corporate bias because the peer reviewers for medical journals don’t see all the real data – they see only the data the corporation wants them to see. Only the FDA sees all the data. We can no longer cling to the myth of informed and unbiased peer review of clinical trials reports. The corporations rely on that myth as a fig leaf to support their First Amendment claims and to defend their practice of in-house statistical analyses. Moreover, medical journals also are subject to bias and conflict of interest. We could note that the Associate Editor of American Journal of Psychiatry in 2004 was also a major U.S. key opinion leader for Forest Laboratories. According to one of the released depositions, he was instrumental in securing acceptance of the report by the journal.

Business as Usual?

The present example is not an isolated case. Dr. Jureidini and his co-authors described several similar, recent examples. One of those was the reanalysis by Jureidini and others of an infamous trial of paroxetine for pediatric depression. And still, fresh exposés keep appearing. The latest is from Lisa Cosgrove at the University of Massachusetts in Boston and her colleagues, involving “ghost management of the information delivery process” for another new antidepressant drug, vortioxetine – available on-line here. (What is it with the antidepressants, anyway?) On this Health Care Renewal blog, Roy Poses has called attention to these issues. As recently as June 8, 2016 he discussedthe Transparency International report on corruption in the pharmaceutical sector.

Eric Topol, who helped to expose the Vioxx scandal, made similar points recently in a BMJ commentary: “The bad science in clinical trials has been well documented and includes selective publication of positive results, data dredging, P hacking, HARKing, and changing the outcomes that were prespecified at the beginning of the study…. Furthermore, the disparity between what appears in peer reviewed journals and what has been filed with regulatory agencies is long standing and unacceptable.”

It’s No Time for Old Solutions 

As the eye-popping numbers of children treated with escitalopram show, even off-label use of an undistinguished drug in a niche population can be highly profitable. That is why I am proposing that the statistical analysis of clinical trials data can no longer be entrusted to pharmaceutical corporations, on account of their massive inherent conflict of interest. Open access to patient level data, as well as pre-registration of protocols and of data analysis plans, have been actively promoted for some years now to clean up the corporate bias in clinical trials. These are positive developments, but they will not close the disconnection highlighted just above by Dr. Topol. The once idealistic world of clinical trials has changed irreversibly in the past 30 years. As one observer has noted, “… in the course of time the coordinated actions of industry, government, and the biomedical research community have degraded the basic rules of empirical science…” We would do well to acknowledge this fact, and to recognize with Abramson and Starfield that “The first step is to give up the illusion that the primary purpose of modern medical research is to improve Americans’ health most effectively and efficiently. In our opinion, the primary purpose of commercially funded clinical research is to maximize financial return on investment, not health.”

When corporations are involved, there is no point in prolonging the myth of noble and dispassionate clinical scientists searching for truth in clinical trials. It’s over. We would do better to stop pretending that corporate articles in medical journals are anything but marketing messages disguised with the fig leafs of coöpted academic authors and of so-called peer review. The case study reported out by Drs. John Jureidini, Jay Amsterdam, and Leemon McHenry shows us the real face of business as usual in commercial clinical trials. That being the case, it makes no sense to expect corporations and academic key opinion leaders suddenly to reform their biased and conflicted behavior. Only a structural change from the outside like I propose here has any chance of succeeding. The statistical analysis of clinical trials is too important to be entrusted to the sponsoring corporations.

It is time for Congress to grasp this nettle. The time for enforcement discretion is past, and we need Congress either to direct the FDA to act or to create a new mechanism of oversight. To do nothing would be unthinkable.

Bernard J. Carroll

Professor and Chairman Emeritus,

Department of Psychiatry, 

Duke University Medical Center.

E-mail: bcarroll40@comcast.net

The writer is a former chairman of the Psychopharmacologic Drugs Advisory Committee, Food and Drug Administration, U.S Public Health Service.

Acknowledgment: Several colleagues commented and made suggestions on drafts of this post – in particular John M. Nardo, MD, Donald F. Klein, M.D., and Patrick Skerrett from STAT News.

Update 06-23-2016:  This post was cross-posted on Naked Capitalism, where some interesting comments can be found.

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A Plea from a Traveling Blogger

A thousand apologies - since the Society for Medical Decision Making meeting in London, we have been traveling in the UK, and I have been unable to find the time to post on the blog.  But in exchange we have caught up with good old friends, met lovely people, and seen fabulous sights and beautiful country.  I plan to return very soon, and then after much catching up, will then resume normal activity.

But a reminder - a comment on our latest post suggested that Health Care Renewal does good work, but requires more effort. 

Yet, all our blog posts are written by volunteers who have day jobs or are retired.  At the moment, we have no real budget, no paid staff, no investigators, no researchers, no paid legal counsel, much less communications and public relations specialists.  If more effort is required, it may have to come from YOU, dear readers.  If you think that casting light on the issues we discuss is important, and taking action to improve health care dysfunction is more important, YOU also need to do something.

Of course, we would greatly appreciate contributions to FIRM -  the Foundation for Integrity and Responsibility in Medicine, the tiny non-profit organization which we formed to provide support to the blog and similar dissemination, education and advocacy efforts to address health care dysfunction.  FIRM is a US 501(c)3 non-profit and so contributions are deductible in the US to the extent provided by law.  You can send contributions to FIRM at 16 Cutler St, Suite 104, Warren, RI, 02885, USA.  Or email me (info at firmfound dot org) with questions.

If FIRM had real money, maybe we could develop a staff and do a lot more to shine light on the dark side.  However, what is really required is effort by more than one organization and a few volunteer bloggers.   Consider doing something yourself.  Write a guest blog post for us, start your own blog, write a letter to the editor, an op-ed, or a journal article.  Write your legislator.  Meet with your legislator's staff.  Organize a group of like minded people and do something organized.  If you are a health professional, try to do your work in a way that will address health care dysfunction.

Howwever, do not expect it to be easy.  There are many people personally enriching themselves through the current system.  They will do all they can to preserve the status quo.  They may command vast marketing, public relations, lobbying, and legal resources (all ultimately paid using other peoples' - often your - money) to maintain the status quo.

Saying something to combat the anechoic effect is hard.  Doing something is harder.  But if we don't do something, it will all get worse.

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