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Tuesday, 31 March 2015

Times: American boards are exceptional--and not necessarily in a good way

Times: American boards are exceptional--and not necessarily in a good way

Komentar
The recent New York Times piece on the behavior of (mainly for-profit, but by extension...) US organizations' boards of directors, goes some way toward explaining the anechoic effect.

The redoubtable Gretchen Morgenson reports on the gulf between company directors' approach to transparency in the United States when compared, say, with a lot of boards in the UK, Holland, and the Scandinavian countries.

The novel idea of taking shareholders' views into account seems to be far more common on the other side of the pond. When it comes to for-profit entities, of course, investors' expectations come into play--you'd think this would be an easier case.

One would think that directors would take their fiduciary responsibilities seriously, and at least listen. In the US, however, there seems to be a systematic process of hiving off the directors in a sort of anechoic chamber. Two-thirds of board members in one survey didn't communicate at all with the outside world. Over half hadn't even had a discussion about their organizational communications policies!

Non-profits--and health care spans both types--don't have investors per se. But they have lots of stake-holders. Health Care Renewal's editor and lead blogger, Dr. Poses, has reported in these pages early and often about the lack of transparency on both sides of this rather artificial divide. It's a bit surprising, then, to hear that accountability is more highly valued in Europe than in these democratic United States.

My own experience with boards has been highly consonant with this insular approach. Directors seem mostly there to prop up management. Rubber stamps are the most important tools. Fat wallets also help. Circling the wagons is the most important skill set. Board members in health care organizations, including those that are not-for-profit, either don't talk about what they see lacking, or, scarier still, it's nicely hidden from them. Probably both. I've heard chairpersons publicly excoriate directors, in front of their peers, for "free-lancing" when they engaged in responsible outside communication.

These boards, and especially their chars, almost invariably defer to management. Non-profits wait until their top management do something not merely execrable but illegal and humiliating before they remove them. Is this laziness or selling-out? Unclear. Maybe both.

If this is the kind of American Exceptionalism our organizations subscribe to, they might want to try being a bit more unexceptional!
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Saturday, 28 March 2015

Opinion, CIO Magazine: "The medical profession needs to get over its fear of information technology"- their complaints bogus

Komentar
There comes a time when the pundits defending the status quo in the healthcare information technology sector and health IT utopianism simply need to be thoroughly and definitively refuted.

This is such a time.  CIO magazine reaches the country's information technology leadership, including those in heathcare.   Hence, canards and meritless defamation of physicians can (and in my experience does) impact the attitudes and decisions of the leaders of the very technology physicians are increasingly dependent upon to deliver safe care.

Ultimately, such misinformation can and does result in patient harm through bad health IT.

Let's start with the title and subtitle alone of an opinion piece in CIO magazine:

March 26, 2015 
Paddy Padmanabhan - Opinion
http://www.cio.com/article/2886751/healthcare/the-medical-profession-needs-to-get-over-its-fear-of-information-technology.html 

The medical profession needs to get over its fear of information technology
Continued objections to Electronic Health Records ( EHR) by sections of the physician community are bogus. They arise from past entitlements and a lack of accountability.

The term "bogus" has clear meaning:

Merriam-Webster dictionary
http://www.merriam-webster.com/dictionary/bogus
Bogus
:  not genuine :  counterfeit, sham

This is a laughable yet alarming, cavalier defamation and attempted character assassination of the medical profession.

Mr. Padmanabhan is described as a business leader & entrepreneur with over 25 years of experience in Technology and Analytics in the Healthcare sector as well as being a consultant in that domain.  I can openly aver that, with an apparent significant bias as seen below towards the medical profession, I would not want him involved in any way in my own care...

There is nothing "bogus" about, for instance,

The author risibly dismisses them all with the word "bogus."  It might be opined that he was too indolent to conduct research, but I'll just opine he doesn't know what he doesn't know and that the opinion piece was based on simple ignorant arrogance.

I am uncertain what "entitlements" he refers to, but using paper records was not a physician "entitlement" - in fact, they are still used when the lousy hospital IT decides to go on vacation as it recently did, for example, at Children's Hospital Boston ("Boston Children’s emerges from electronic records shutdown", Boston Globe, March 25, 2015,  http://www.bostonglobe.com/metro/2015/03/25/boston-children-emerges-from-day-shutdown-electronic-medical-records/Q6sE7hRM4CxFeMEDYWP8IK/story.html#). 

(Of course, patient safety was not compromised - it never is when the IT goes out - right.  See the many posts at the query link http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised.)

Further, the true "lack of accountability" lies with the healthcare IT industry itself and the hospital leadership who agree to their terms of contractual indemnification (Health care information technology vendors' "hold harmless" clause: implications for patients and clinicians. Koppel & Kreda, JAMA. 2009 Mar 25;301(12):1276-8. doi: 10.1001/jama.2009.398, http://medecon.pbworks.com/f/IT%20Accountability%20JAMA09.pdf. 

Also see my commentary in a JAMA letter to the editor of July 2009 at http://jama.jamanetwork.com/article.aspx?articleid=184302 emphasizing how these arrangements violate Joint Commission safety standards, and my posting my health IT academic site at http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda).

And that was just responding to the title and subtitle.  Now to the body of the piece:

... In a recent article in a national publication, a member of our physician community raked up a debate by declaring the Electronic Health Records (EHR ) mandate to be a debacle and argued that EHR’s actually harm patients.  These are bogus objections.


Congratulations for disrespecting my mother's grave, Mr. Padmanabhan (http://hcrenewal.blogspot.com/2013/09/on-ehr-warnings-sure-experts-think-you.html)  and that of many other people harmed by Information Technology Malpractice as for example in the above links

Also see "The Malpractice Risk of Electronic Health Records", Legal Intelligencer - a Pennsylvania Legal newspaper, March 17, 2015, http://www.thelegalintelligencer.com/most-read-articles/id=1202720405290/The-Malpractice-Risk-of-Electronic-Health-Records.

Thanks for being an expert on the issues you so glibly dismiss, Mr. Padmanabhan.  I guess you forgot to check out the AHRQ hazards taxonomy (http://healthit.ahrq.gov/sites/default/files/docs/citation/HealthITHazardManagerFinalReport.pdf) and similar resources on health IT risk:




A "bogus" checklist of known EHR risks from the U.S. government.  Click to enlarge.

Back to the opinion piece:

... According to a Rand Corporation study, the three key objections against the implementation of EHR’s:

--It costs too much to implement an EHR system: Yes, it costs money to implement any new software. Given a choice, physicians would prefer not to use email or even the telephone because all of these things cost money and have no direct relation to the treatment of patients. What these same physicians also fail to mention is that large hospital systems have been extending significant subsidies to small physician practices in order to help them address the costs.

"Given a choice, physicians would prefer not to use email or even the telephone because all of these things cost money and have no direct relation to the treatment of patients." (?)


Really?

This is an example of a profound anti-physician bias, although one could argue that the term mentioned by Yves Smith on Naked Capitalism, "lunatic triumphalism", comes into play with that statement.

What these same physicians also fail to mention is that large hospital systems have been extending significant subsidies to small physician practices in order to help them address the costs.

And just what % of the total costs of ownership are covered, Mr. Padmanabhan?   The financial analyses I see show significant clinician unreimbursed expense for the office.

Inpatient settings - that's another matter entirely - we're talking hundreds of millions of dollars or more per organization.

Perhaps my math is wrong, but hundreds of millions of dollars hospitals dish out on corporate health IT can pay for entire new hospitals, or pay for the medical care of countless disadvantaged people.  (e.g., http://hcrenewal.blogspot.com/2014/06/100-million-epic-install-dampens.html, as well as http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html and http://hcrenewal.blogspot.com/2013/06/want-to-help-hospital-go-bankrupt-get.html)

--It takes time away from patient care: Physicians love to talk about how much they care about being with their patients. However, they also routinely overbook their schedules with the sole intention of increasing patient visits and claiming additional reimbursement.

That's a very serious and, to my knowledge, completely unfounded accusation.  Many physicians are burned out from being compelled to see too many patients by administrators, especially if they are employed which is becoming very common. You in my opinion need to be taught how not to hate physicians and other clinicians, Mr. Padmanabhan:

Physician Burnout: It Just Keeps Getting Worse
Medscape, Jan, 26, 2015
http://www.medscape.com/viewarticle/838437

A national survey published in the Archives of Internal Medicine in 2012 reported that US physicians suffer more burnout than other American workers.[1] This year, in the Medscape Physician Lifestyle Report, 46% of all physicians responded that they had burnout, which is a substantial increase since the Medscape 2013 Lifestyle Report, in which burnout was reported in slightly under 40% of respondents. Burnout is commonly defined as loss of enthusiasm for work, feelings of cynicism, and a low sense of personal accomplishment

Back to the opinion piece:

EHR’s can actually aid their productivity by reducing the time it takes to pull up medical history, so that they have more time to spend on actually talking to their patients.

An expert with far more experience than you, Mr. Padmanabhan, says you are flat wrong (not counting me).  His name is Dr. Clement McDonald, and he is an EHR pioneer ("The Tragedy Of Electronic Medical Records", http://hcrenewal.blogspot.com/2014/10/the-tragedy-of-electronic-medical.html):

... McDonald now has a nationally influential post to promote electronic medical records, as the director of the Lister Hill Center for Biomedical Communications, a part of the National Library of Medicine, which is one of the National Institutes of Health.

During his talk, McDonald released his latest research survey, which found that electronic medical records “steal” 48 minutes per day in free time from primary care physicians.

Back to the opinion of Mr P.:

--EHR systems are hard to use and are not secure: There may be some merit to this. No one is making claims that EHR systems are perfect.


"May be some merit?"

"May?"


There is perhaps merit to saying Mr. Padmanabhan is either ill-informed, or delivering deliberate misinformation  (e.g., "NIST on the EHR Mission Hostile User Experience", http://hcrenewal.blogspot.com/2011/10/nist-on-ehr-mission-hostile-user.html, and multiple posts on breach issues retrievable via query link http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy).

However, there are a few key aspects that these physicians prefer to not acknowledge when making these arguments:

--Shared electronic medical records can reduce expenses: Physicians routinely bill for duplicate medical expenses, such as tests, that would be avoided if the test results can simply be pulled up electronically. This should logically reduce healthcare costs at a system level.

Great in theory, but the real world is just not that simple.  Mr. Padmanabhan like many other IT hyper-enthusiasts apparently see IT as a silver bullet.  Just put it in and .... presto!  All complex multi-factorial social problems are solved, with no ill effects. Perhaps he and other hyper-enthusiastic health IT pundits need to read this article:


Pessimism, Computer Failure, and Information Systems Development in the Public Sector.  (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand).  Cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT.  linkto pdf

And this:

"Doctors and EHRs: Reframing the "Modernists v. Luddites" Canard to The Accurate "Ardent Technophiles vs. Pragmatists" Reality", http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html

More opinion:

--Quality of treatment can improve significantly: When a complete medical record is available about a patient, including details of visits to multiple healthcare professionals, the quality of diagnosis and hence treatment decisions should improve greatly. This improves patient safety and reduces medical errors, since everyone has access to the same set of data.

 That may be the only accurate statement in the opinion piece.  Yet, even this is not proven in the real world, and with today's highly experimental health IT.

--EHR’s can enable preventive diagnosis and early intervention that reduces costs and improves patient health: Enter healthcare analytics. Having patient medical records in an electronic system enables this data to be analyzed for preventive and early action, improved disease management, and reduced hospitalizations. The whole notion of population health management rests on this premise and is hard to argue with.

It's actually easy to argue with, as are most grandiose pronouncements about computational alchemy (i.e., in the world of data, turning lead into gold).

Again in theory, yes, but Mr. Padmanabhan is seemingly unaware of issues I raised in my article "The Syndrome of Inappropriate Overconfidence in Computing: An Invasion of Medicine by the Information Technology Industry?" at http://www.jpands.org/vol14no2/silverstein.pdf.  The uncontrolled nature of aggregated EHR data, and social factors that skew and bias it, never seem to enter into the minds of the computational alchemists.

The truth is:

  • Physicians, nurses and other clinicians are rightfully afraid of having bad health IT forced upon them due to the constraints of their time, their concentration, and their obligations and legal liabilities; 
  • Physicians are rightfully unwilling to be the experimental subjects of IT hyper-enthusiasts who are so hooked on theory, they ignore the actual downsides of an immature, experimental technology in the real world, including patient injury and death; and

I note that I feel dirtied even having to write this post.

-- SS

Addendum 3/27/15:  

A colleague observed:

.. And I suppose all those current med students and residents who grew up with information technology and have known nothing but  EHR’s are “afraid” of information technology?  I’m hearing complaints from the younger generation about the problems with using them. 

-- SS
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Thursday, 26 March 2015

Two New Independent Reports on the Death of Dan Markingson, But Now What Will Happen?

Two New Independent Reports on the Death of Dan Markingson, But Now What Will Happen?

Komentar
Years after his death, there is now a little more clarity about the clinical trial in which Dan Markingson was enrolled when he died.  Whether this clarity will have any impact remains to be seen.

We most recently posted about the aftermath of Mr Markingson's death here, (and see posts in 2013 here, and in 2011 here.)  Very briefly, Mr Markingson was an acutely psychotic patient enrolled in a drug trial sponsored by Astra Zeneca at the University of Minnesota.  His enrollment was said to be voluntary although at the time he enrolled he had been under a stayed order that could have involuntarily committed him to care.  Despite his mother's ongoing and vocal concerns that he was not doing well on the study drug and under the care of trial investigators, he continued in the trial until he died violently by his own hand.  After his death, his mother Mary Weiss, friend Mike Howard, and University of Minnesota bioethics professor Carl Elliott campaigned for a fair review of what actually happened.  University managers not only rebuffed their concerns, but harshly criticized Professor Elliott, and ended up reprimanding him for "unprofessional conduct."

Two New Reports

In the last few weeks, two new independent reports on the case appeared.  Both vindicated the concerns and questions raised by Mary Weiss, Mike Howard, and Prof Elliott.

Association for Accreditation of Human Research Protection

One, called for by the University of Minnesota faculty senate, was by the Association for Accreditation of Human Research Protection,  and said that the university left research subjects "susceptible to risks that otherwise would be avoidable" (see this Minneapolis Star-Tribune article.)  Furthermore, according to a post in the Science Insider blog from the American Association for the Advancement of Science, it said,

[T]he external review team believes the University has not taken an appropriately aggressive and informed approach to protecting subjects and regaining lost trust,

Also, it said the university has been

assuming a defensive posture. In other words, in the context of nearly continuous negative attention, the University has not persuaded its critics (from within and outside the University) that it is interested in more than protecting its reputation and that it is instead open to feedback, able to acknowledge its errors, and will take responsibility for deficiencies and their consequences.

Finally, it noted a "climate of fear" in the Department of Psychiatry.

Office of the Legislative Auditor for the State of Minnesota

The second report, available in full here,was from the Office of the Legislative Auditor for Minnesota.  If anything, it was more damning. Its summary included,

the Markingson case raises serious ethical issues and numerous conflicts of interest, which University leaders have been consistently unwilling to acknowledge. They have repeatedly claimed that clinical research at the University meets the highest ethical standards and dismissed the need for further consideration of the Markingson case by making misleading statements about past reviews. This insular and inaccurate response has seriously harmed the University of Minnesota’s credibility and reputation.

It seemed to affirm in detail nearly all of Weiss', Howard's and Elliott's concerns.  It recommended that the University should suspend new psychiatric drug trials until the problems it identified were remedied (see Star-Tribune article here.)

Vindication, but Will It Lead to Progress?  

Taken together, these reports vindicate the work of Mr Markingson's mother, friend, and academic watchdog Professor Elliott and their supporters.  As the Star-Tribune reported,

'Over the past eleven years the University of Minnesota has made us feel as if we have no voice, no rights and absolutely nothing remotely called justice,' wrote Mike Howard, a close friend to Markingson’s mother, in a letter in the audit. 'This report is the first step toward accountability.'

The Minnesota Post added the response of Professor Elliott and a colleague,

'It’s nice to have an independent confirmation of what we’ve been telling the university for five years, but which they have refused to listen to,' he told MinnPost on Thursday.

Elliott said he is not convinced, however, that Kaler and other university leaders are going to take responsibility for what happened in the Markingson case — or take the necessary steps to fix the problem going forward.

'One of the most worrying findings in the report was the widespread belief on campus that the university leadership doesn’t care about human study subjects,' he said.

Leigh Turner, another U bioethicist who has also been outspoken about the issues raised by the Markingson case, expressed similar concerns. 'Can we expect reform from the very people who have done nothing for the past several years?' he said in a phone interview.

'I hope there’s some change,' he added. 'But the fact that [Markingson died in 2004] and it’s now 2015, I think hope has to be tempered with a dose of realism. There are some very powerful forces interested in minimizing the findings and suggesting that there are only minor things that need to be done.'

It appears there a several major remaining questions.

What Were the Underlying Causes?

Although both reports went into some detail about what happened to Mr Markingson, they seemed not to dwell on why it happened.  They did not seem to address relevant contextual factors, policies, and decisions.  For example, the report by the Office of the Legislative Auditor included,

We understand that the University of Minnesota has been and should continue to be an institution that delivers not only high quality medical care but also engages in cutting edge medical research— research that does pose risks to human subjects. In addition, we do not question the appropriateness of the University obtaining money from pharmaceutical and other medical companies to support that research. However, in every medical research study—whether supported with public or private money—the University must always make the protection of human subjects its paramount responsibility.

However, as we and many others more erudite have discussed frequently, clinical research that evaluates products or services made by the commercial sponsors of the research has proven to be highly susceptible to manipulation by these sponsors to increase the likelihood that the results will serve marketing purposes, and suppression if the manipulation fails to produce the wanted results.  Commercial sponsors often strongly influence the design, implementation, analysis and dissemination of clinical research.  Often their influence is mediated by financial relationships with individual researchers and with academic institutions who seem more and more beholden to outside sponsors, that is, by conflicts of interest.  The report by the Auditor noted pressures, including financial pressures on the physician who ran the study in which Mr Markingson was a subject to enroll more patients and keep them enrolled.  To protect patients better in the future, in my humble opinion the relationships among commercial sponsors, academic medical institutions, and individual researchers need further consideration.  Is the easy money supporting research coming from commercial firms with vested interests in the outcome of that research really worth the risks of biased results, hidden results, and to research subjects?   

Will Anything Change and Will Anyone be Held Accountable?

Once these two reports were delivered, it now seems to be up to university managers to make needed changes.  In general, these are the same managers who are described above as so "defensive," who not only ignored complaints, but appeared to try to silence those who complained.  If they are left in charge, why should we expect them to make any meaningful changes?  Instead, should they  not be held accountable for their actions?  

Will the University Cease Hostilities Against Dr Elliott?

Again, as noted above, university managers did not merely disagree with Professor Elliott.  They disparaged him, appeared to try to intimidate him, and reprimanded him.  It seems at the very least he is owed an apology.  So far, nothing in the news coverage suggests he has or will receive one.

Will Anyone Notice? 

So far, this case has gotten good coverage in Minnesota media.  However, it has largely been ignored in the national media.  Beyond Minnesota, I could only find mention in some blogs, e.g., in PharmaLot by Ed Silverman, and in Forbes by Judy Stone.  I have seen nothing in any US medical or health care journal, although the British Medical Journal did cover it in a news feature.  This case clearly has global implications, and ought to be considered one of the most important cases illustrating the perils of commercially sponsored human research, but it remains proportionately anechoic.

Summary

The latest reports seem only to confirm that clinical research at major academic institutions has gone way off track.  It now seems that in their haste to bring in external funding, university administrators and the academic researchers who are beholden to them have sadly neglected the protection of their own patients.  As we have said ad infinitum, true health care reform would turn leadership of health care organizations over the people who understand and are willing to uphold the mission of health care, and particularly willing to put patients' and the public's health, and the integrity of medical education and research when applicable, ahead of the leaders' personal interests and financial gain.

ADDENDUM (25 March, 2015) - See also numerous posts by Professor Elliott on the Fear and Loathing in Bioethics blog,  by Bill Gleason in the Periodic Table blog,  and by Mickey Nardo on the 1BoringOldMan blog. 

ADDENDUM (30 March, 2015) - Note that after receiving offline comments, I changed the first paragraph to emphasize the clarity is about the trial, rather than the patient's death, and second paragraph to clarify that the order to commit was stayed.
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Saturday, 21 March 2015

A $6.6 Million CEO Dreams of a "Doctor-Less" Future

A $6.6 Million CEO Dreams of a "Doctor-Less" Future

Komentar
The CEO of giant hospital system UPMC, Mr Jeffrey Romoff, has been one of the best compensated CEOs of ostensibly non-profit hospital systems.  As we noted here, his 2013-14 compensation was $6.6 million.  UPMC has become so big and its top managers so rich that a former Mayor of the city of Pittsburgh sued the organization claiming it was not really not-for-profit (look here and here).  The leadership of UPMC has previously supplied us with some interesting examples of conflicts of interest (look here and here). 

The announcement of a new alliance of Pittsburgh organizations provided an interesting insight into the thinking for which such a CEO is paid the big bucks.  Leaders of three big organizations, UPMC, the University of Pittsburgh (with which UPMC is affiliated), and Carnegie-Mellon University announced an alliance to use "big data" in health care (see this article in the Pittsburgh Post-Gazette).


UPMC, the University of Pittsburgh and Carnegie Mellon University on Monday announced the formation of the Pittsburgh Health Data Alliance to 'revolutionize health care and wellness' by using data to detect potential outbreaks as well as create health care innovations that will spawn spinoff companies.

The clinical goal, the leaders of the three institutions said, is to remake health care so that it is at once more computerized, yet more personalized, using millions of gigabytes of accumulated health records to predict and treat patients’ health issues in a manner far more specific than is possible today.


Big data now seems to be the latest rage in business schools and among the high-tech crowd, never mind the failures of fancy statistical modeling based on big data that helped lead to the global financial collapse of 2008.  Similarly, despite at least 30 years of research, multivariate prediction and diagnostic modeling in medicine has never lived up to its expectations.  Few models have been demonstrated to be better than mediocre predictors when tested in real-life clinical settings.  Finally, there are numerous concerns about privacy and data security when patients' data is being avidly traded back and forth.

The most striking talk in this meeting, however, was by UPMC CEO Jeffrey Romoff.  The Pittsburgh Post-Gazette noted,

Mr. Romoff said he envisioned 'doctor-less health care,' which is not to say there will be no doctors in the future, but they will be greatly aided by computerized diagnoses, by biometric data gathered on smartphones and transmitted in real time, and by a patient’s own genome. It could result in a new form of  'artificial intelligence,' he said.

The reporter, however, seemed to have edited Mr Romoff to take the edge off what he said.  A video of that part of the conference can be found, for the moment, here.  I transcribed, I believe accurately, Mr Romoff's three most relevant sentences.

The majority of healthcare that everybody receives will be accessible on their handheld device.

We will be thinking about 'doctor-less' healthcare.

We will in fact create an artificial intelligence better than the superb level of intelligence we now have among our physicians and our healthcare professionals.

So, in my humble opinion, it did not sound like Mr Romoff was just envisioning that physicians someday may actually have access to diagnostic or predictive models that are highly accurate for real patients.  He was envisioning replacing physicians with machines, with artificial intelligence. 

Again, never mind that despite years of work and billions of dollars, artificial intelligence so far has proved remarkably dumb.

So furthermore, in my humble opinion, this provided a glimpse into how health care managers now think.  Mr Romoff appears to be a generic manager.  He is not a health care professional, and has no apparent experience taking care of patients (see his official bio, listing his most advanced degree as a Masters in Philosophy).  Generic managers now often seem to think of themselves as some sort of new aristocracy, far removed from the peasants who work for them.  Would not it be easier for such aristocracy to avoid working with such peasants at all?  Machines would be so much neater and cleaner, would not ask for raises or think of unionizing or rebelling (at least outside of the world of Terminator movies).

Leaving aside such fantasies for the moment, the most concerning problem with Mr Romoff's dream of robotic doctors is that anyone who has ever had any direct involvement in health care knows that doctors need to do much more than crunch data and make predictions and diagnoses.  Doctors and other health care professionals have sworn to put patients' interests first.  That implies that doctors must talk to, endeavor to understand, and be empathetic towards their patients.  Many times we doctors may not do this anywhere near perfectly.  But we are human, so can at least try.  Artificial intelligence may be getting closer to making better health care predictions and diagnoses, but does anyone seriously think we are close to making an understanding, empathetic machine?

I believe that Mr Romoff has unwittingly made another argument why he and his fellow generic managers should not be leading health care.  Health care should be lead by people who understand the actual care of patients, uphold health care professionals' values, and are willing to be accountable for putting patients' and the public's health first. 

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Thursday, 19 March 2015

Same Old, Same Old - Johnson and Johnson Settles Charges it Concealed Adverse Effects of Risperdal, Vaginal Mesh Device, Pleads Guilty to Selling Adulterated Tylenol, Announces CEO Got 48% Raise to $25 Million

Same Old, Same Old - Johnson and Johnson Settles Charges it Concealed Adverse Effects of Risperdal, Vaginal Mesh Device, Pleads Guilty to Selling Adulterated Tylenol, Announces CEO Got 48% Raise to $25 Million

Komentar
We have devoted a lot of bytes over the years to the stream of allegations and ethical questions about Johnson and Johnson, the giant pharmaceutical/ biotechnology/ device company, and resulting legal actions.  Meanwhile, the company has bestowed a gushing stream of money on its top executives.  Its almost spring, 2015, and it seems nothing has changed.

Johnson and Johnson's Latest Legal Misadventures

Jury Verdict that Company Concealed Harms of Risperdal

Let us start with the latest legal news about J&J.  In late February, 2015, as reported on the PharmaLot blog by Ed Silverman,

In a setback to Johnson & Johnson , a Philadelphia jury decided the health care giant must pay $2.5 million in damages for failing to warn that its Risperdal antipsychotic could cause gynecomastia, which is abnormal development of breasts in males. The lawsuit was brought by the family of an autistic boy who took the drug in 2002 and later developed size 46 DD breasts, according to a lawyer for the family.

The case has drawn attention for a few reasons. For one, this was the first lawsuit claiming J&J hid the risks of gynecomastia to go to trial after a handful of cases were settled in recent years. The trial also served as a reminder that J&J paid $2.2 billion two years ago to resolve criminal and civil allegations of illegally marketing Risperdal to children and the elderly.

Moreover, former FDA commissioner David Kessler served as a paid expert witness for the family and testified that J&J knew about the risks associated with Risperdal, but failed to disclose the data showing the extent to which youngsters may develop gynecomastia. In a report prepared for a 2012 case that was settled, Kessler wrote that J&J’s Janssen unit, which marketed the drug, had violated the law.

Note that the central allegation in this case was not simply that the drug had adverse effects, but that the company knew about these effects, and hid them.  In my humble opinion, since we entrust pharmaceutical companies to provide safe and effective products, withholding information about adverse effects is a fundamental violation of this trust. 

As noted above, this follows on another case with a much bigger financial settlement about questionable marketing of Risperdal. In addition, as the PharmaLot post noted, there are many more individual cases like this one waiting in the wings, "J&J says there are about 1,200 such lawsuits filed in courts around the country,..."

Jury Verdict that Company Concealed Harms of  Vaginal Mesh Device

Similarly, as reported by Reuters in early March, 2015,

A California jury on Thursday ordered Johnson & Johnson's Ethicon Inc unit to pay $5.7 million in the first trial over injuries blamed on the TVT Abbrevo, one of numerous transvaginal mesh products that are the subject of thousands of lawsuits.

Following more than three days of deliberations in Kern County, California, jurors found Ethicon liable for problems with the TVT Abbrevo's design and for failing to warn about its risks, according to a lawyer for plaintiff Coleen Perry.

Perry was awarded $700,000 in compensatory damages and an additional $5 million in punitive damages after jurors in the Bakersfield court found Ethicon's conduct amounted to 'malice,' her lawyer said.

Again, note that this lawsuit was not merely about the adverse effects of, in this case, a device, but about allegations that the company knew about these effects, but hid them.  My comments about violation of a fundamental trust above apply. 

Again, this is but one of the earlier cases of a cohort that may number 36,000.

Company Pleads Guilty to Selling Adulterated Tylenol

Finally, as reported in mid-March, 2015, by Reuters,

A Johnson & Johnson subsidiary pleaded guilty on Tuesday to selling liquid medicine contaminated with metal and agreed to pay $25 million to resolve the case, the U.S. Department of Justice said on Tuesday.

The subsidiary, McNeil Consumer Healthcare, pleaded guilty to one federal criminal charge in the case.

In 2010, the company launched mass recalls of certain children's over-the-counter-medicines, including Infants' Tylenol and Children's Motrin, made at its Fort Washington, Pennsylvania plant.

It was the latest in a series of recalls at the time. There were far-reaching multiple recalls from 2008 to 2010 involving hundreds of millions of bottles and packages of consumer brands such as Tylenol, Motrin, Rolaids, Benadryl and other products due to faulty manufacturing. The recalls kept widely used products such as Children's Tylenol off pharmacy shelves and seriously tarnished J&J's once-sterling reputation.

In addition to metal particles getting into liquid medicines, there were moldy odors and labeling problems.

Furthermore, as emphasized in a report in the Philadelphia Business Journal, this case also involved allegations that the company seemed to conceal the problem.

McNeil, after receiving the consumer complaint, did not initiate or complete a 'corrective action preventive action' plan as required by the federal government.

The federal government also alleged other instances in which McNeil found metal particles in bottles of infants' Tylenol at its Fort Washington facility, but failed to initiate or complete a corrective action plan.

Note that in this case, the company pleaded guilty and so could not claim it was merely settling to put the case behind it.  Furthermore, note that this was not the first case arising from charges that the company sold adulterated products made in the Pennsylvania and other factories (for example, see this post.)   We posted frequently about a long string of recalls of presumed defective or adulterated Johnson and Johnson products (here, here, here and here).  Again, in my humble opinion, we we trust drug companies to sell pure, unadulterated products.  Selling adulterated products again fundamentally violates this trust.

Unfortunately, these three cases, like many of the legal settlements we discuss, involved relatively small penalties that only accrued to the company as a whole.  The monetary penalties, while they may seem large to regular citizens, could appear as relatively trivial costs of doing business to company management.  Furthermore, no individual who authorized, directed, or implemented the behavior identified in these cases suffered any kind of penalty.  So these cases added to the many examples of the impunity of managers of large corporations who almost never seem to bear any legal responsibility for their actions.  In the case of Johnson and Johnson managers, this is all the more striking, since the current cases are just the latest in a very long string.  (See Appendix below for a list of Johnson and Johnson legal misadventures we have discussed since 2010.)


Johnson and Johnson CEO's Latest Raise


Finally, a day later, the Wall Street Journal reported on the continuing good fortune of the Johnson and Johnson CEO, to be contrasted with the company's poor fortunes in the courts of law.

Johnson & Johnson said Chairman and Chief Executive Alex Gorsky’s total compensation jumped 48% to $25 million last year, lifted by an increase in stock and option awards. Mr. Gorsky’s stock and option awards rose to a total value of $13.6 million from $8.7 million a year earlier. The board also raised Mr. Gorsky’s base salary to $1.5 million from $1.45 million in 2013, and the CEO also benefited from a jump in pension value.

In a filing Wednesday, the pharmaceutical giant said Mr. Gorsky’s compensation increase was based on the board’s conclusion that J&J successfully executed near-term priorities, exceeded financial goals and built on momentum in its pharmaceutical business.

As a result, J&J awarded Mr. Gorsky an annual performance bonus of 135% of target and long-term incentives at 130% of target. Awards at J&J are capped at 200% of target.

The article noted that at least one other top Johnson and Johnson manager also was raking it in.

Paulus Stoffels, world-wide chairman of Pharmaceuticals, made $18.3 million last year, more than double his 2013 total compensation, boosted by a stock award of $10.7 million.
Funny, the board's rosy view of Mr Gorsky's performance seemed totally uninformed by the company's latest legal misadventures.

(By the way, to anyone who would argue that many of these misadventures were the results of behavior that occurred before Mr Gorsky became CEO, note that his official company biography stated that he joined the company's Executive Committee in 2009, implying some shared responsibility for overall company management since then.)

Same Old, Same Old

A few weeks back, one of our commentators complained that our posts have a certain sameness.  Unfortunately, we agree.  We keep seeing variants of the same sorts of outrageous stories in the news media that we began to post about in 2004.   The problems are not getting better.  Perhaps they are getting worse.

In particular, we have previously contrasted this particular company's recurrent legal and ethical problems with its top managers' accumulating wealth.  In 2011 we posted about the contrast between previous Johnson and Johnson CEO William Weldon's enlarging fortune and political influence with some of the earlier legal cases that raised questions about the trustworthiness of the company.

But the point of this blog is not to come up with titillating stories to make people chuckle.  The point is to challenge the continuing, severe problems afflicting the leadership and governance of health care, the resulting incompetent, unethical, and sometimes criminal behavior, and the downstream effects on patients' and the public's health.  Do not blame the messenger for the sameness of the problem.  Blame those who are getting wealthy and powerful from the ongoing decline in health care. 

If we truly want to see more accessible, more effective, less costly health care in our life times, we need to first call out the bad leadership that has kept such aspirations at bay for so long, and second start to hold current leadership accountable for the mess they have made.


Appendix - Johnson and Johnson Legal Record since 2010-
2010
- Convictions in two different states for misleading marketing of Risperdal
- A guilty plea for misbranding Topamax
2011
- Guilty pleas to bribery in Europe  by Johnson and Johnson's DePuy subsidiary
- A guilty plea for marketing Risperdal for unapproved uses  (see this link for all of the above)
- A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post here)
2012 
 - Testimony in a trial of allegations of unethical marketing of the drug Risperdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers. After these revelations, the company abruptly settled the case (see post here).
-  Johnson & Johnson was fined $1.1 billion by a judge in Arkansas for deceiving patients and physicians again about Risperdal (look here).
-  Johnson & Johnson announced it would pay $181 million to resolve claims of deceptive advertising again about Risperdal (see this post).
2013
-  Johnson & Johnson settled case by shareholders alleging that management made misleading statements and withheld material information about manufacturing problems (see this post)
-  Johnson & Johnson Janssen subsidiary pleaded guilty to a charge of misbranding Risperdal, and settled for a total of $2.2 billion allegations that it promoted the drug for elderly demented patients and adolescents without an indication, and despite evidence of its harms (see this post).
 -  Johnson & Johnson DePuy subsidiary agreed to settle with multiple plaintiffs for $2.5 billion allegations that it sold defective mental-on-metal artificial hip, and hid evidence of its harms .
- Johnson & Johnsonn Janssen subsidiary was found by two juries to have concealed harms of its drug Topamax (see this post for this and above case).
- Johnson & Johnson Ethicon subsidiary's Advanced Surgical Products and two of its executives agreed to settle charges by US FDA that is sold mislabeled products used to sterilize equipment such as endoscopes (see this post).
- Johnson & Johnson fined by European Commission for anticompetitive practices, that is, collusion with Novartis to delay marketing generic version of Fentanyl (see this post).
2014 
- Johnson & Johnson DePuy subsidiary settled Oregan state charges that it marketed the ASR XL metal-on-metal hip joint prosthesis without disclosing its high failure rate (see this post). 
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