Cambridge University Hospitals Trust IT Failures: An Open Letter to Queen Elizabeth II on Repeated EHR Failures, Even After £12.7bn Wasted in Failed NHS National IT Programme

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Cambridge University Hospitals Trust IT Failures: An Open Letter to Queen Elizabeth II on Repeated EHR Failures, Even After £12.7bn Wasted in Failed NHS National IT Programme

Unknown 9/25/2015 Komentar

Dear Queen Elizabeth,

I am an American citizen who has written for years about healthcare information technology mismanagement (IT malpractice), dangers to patients of this technology when faulty in healthcare, and the huge mania or bubble that has surrounded this technology in a layer of fairy tales that has cost your Kingdom's treasury, as well as that of the U.S., dearly.

Your subjects seem unable to learn from their mistakes, or learn even from free material at sites such as this, or at my academic site at Drexel University at http://cci.drexel.edu/faculty/ssilverstein/cases/.

Instead of being appropriately skeptical, they spend your citizen's money extravagantly and with abandon on grossly faulty computing.  This results in serious health care meltdowns such as I observed at my September 22, 2011 post on your now-defunct National Programme for IT in the National Health Service (NPfIT).  That post was entitled "NPfIT Programme goes 'PfffT'" and is at http://hcrenewal.blogspot.com/2011/09/npfit-programme-going-pffft.html.

In that post I observed:

... [NPfIT] also failed because of collective ignorance of these domains [e.g., healthcare informatics, social informatics, etc. - ed.] among its leaders, and among those who chose the leaders. For instance, as I wrote here:

The Department of Health has announced the two long-awaited senior management appointments for the National Programme for IT ... The Department announced in February that it was recruiting the two positions as part of a revised governance structure for handling informatics in the Department of Health.

Christine Connelly will be the first Chief Information Officer for Health and will focus on developing and delivering the Department's overall information strategy and integrating leadership across the NHS and associated bodies including NHS Connecting for Health and the NHS Information Centre for Health and Social Care.Christine Connelly was previously Chief Information Officer at Cadbury Schweppes with direct control of all IT operations and projects. She also spent over 20 years at BP where her roles included Chief of Staff for Gas, Power and Renewables, and Head of IT for both the upstream and downstream business.

Martin Bellamy will be the Director of Programme and System Delivery. He will lead NHS Connecting for Health and focus on enhancing partnerships with and within the NHS. Martin Bellamy has worked for the Department for Work and Pensions since 2003. His main role has been as CIO of the Pension Service.

Excuse me. Cadbury Schweppes (candy and drink?) The Pension Service? As national leaders for healthcare IT?

Also see my August 2010 post "Cerner's Blitzkrieg on London: Where's the RAF?" at http://hcrenewal.blogspot.com/2010/08/cerners-blitzkrieg-on-london-wheres-raf.html.

It's clear medical leaders in the UK learned little from the £12.7bn NPfIT debacle.  Now we have this:

Addenbrooke's Hospital consultants concerned over online records
BBC News
31 July 2015
http://www.bbc.com/news/uk-england-cambridgeshire-30393575

A £200m online patient-record system has been "fraught with problems" and medics' concerns "seemingly overlooked", senior hospital consultants have claimed.

A letter seen by the BBC reveals management at Addenbrooke's and Rosie hospitals in Cambridge were told of "serious" issues last month.  It came after the hospitals transferred 2.1 million records in October.

The trust said "unanticipated" issues led to "more than teething problems". 

The hospital is the first in the UK to use Epic's eHospital system, which is used in hospitals in the US.

To the CEO, these problems are just "hiccups":

... Chief executive Dr Keith McNeil admitted there had been "more than teething problems" and "some of it was anticipated and some of it was unanticipated". The "unanticipated" problems included problems with blood tests and "one of the busiest periods in the hospital's history", he said. He added: "We're profoundly sorry about that... people will understand that you can't do an information technology implementation of this size without some hiccups.

"Hiccups" are a euphemism for incompetence in system design, implementation and testing before it is used on live patients, Your Majesty.  I also note that a close relative of mine, and numerous other patients I know of are severely injured or dead due to these "hiccups."  

And now this:

Addenbrooke's and Rosie hospitals' patients 'put at risk'
BBC News
22 September 2015
http://www.bbc.com/news/uk-england-cambridgeshire-34317265

One of the UK's biggest NHS trusts has been placed in special measures after inspectors found it was "inadequate".

Cambridge University Hospitals Trust, which runs Addenbrooke's and the Rosie Birth Centre, was inspected by the Care Quality Commission in April and May.

Inspectors expressed concerns about staffing levels, delays in outpatient treatment and governance failings.

... Prof Sir Mike Richards, the Care Quality Commission's (CQC) chief inspector of hospitals, said while hospital staff were "extremely caring and extremely skilled", senior management had "lost their grip on some of the basics".

"[Patients] are being put at risk," he said. "It is not that we necessarily saw actual unsafe practice but we did see they would be put at risk if you don't, for example, have sufficient numbers of midwives for women in labour."

The trust, which is said to be predicting a £64m deficit this year, has apologised to patients.

I note that these hospitals had been the beta site for the first implementation of U.S. EHR maker EPIC company's product of the same name.  That £64m deficit looks a bit suspicious for IT overspend; for example see this U.S. hospital's experience of going in the red over fixing 10,000 "issues" (problems) with EPIC, in my post of June 2, 2014:  "In Fixing Those 9,553 EHR "Issues", Southern Arizona’s Largest Health Network is $28.5 Million In The Red" at http://hcrenewal.blogspot.com/2014/06/in-fixing-those-9553-ehr-issues.html.

... Perhaps the most worrying aspect of the Addenbrooke's story is not that such a world-renowned hospital has ended up in a predicament like this, but rather that it happened so quickly.

A year ago the trust which runs the hospital - Cambridge University Hospitals NHS Foundation Trust - wasn't even on the Care Quality Commission's radar in terms of being a failing centre.

I suggest a deep connection between this rapid fall, and the rapid rise of an EHR - an antiquated term for what is now an enterprise command-and-control system for hospitals.

... In fact, two years ago - as the regulator was embarking on its new inspection regime - it was among the band of hospitals considered to be the safest, according to the risk-rating system at the time.

But now a hospital which can boast to being a centre of excellence for major trauma, transplants, cancer, neurosurgery, genetics and paediatrics, has been judged to be a basket case and will join the 12 other failing hospitals already placed in special measures.

In my view, a major disruptive technology such as a new EHR is the Number One suspect in such a fall.

... Certainly it seems to have made mistakes - as the troubles with its £200m computerised patient records programme illustrates - but it's hard to escape the feeling that this is just the tip of the iceberg.

The "troubles with its £200m computerised patient records programme" is likely the iceberg, not just its tip.

The Care Quality Commission ("The independent regulator of health and social care in England", http://www.cqc.org.uk/) investigated these hospitals and issued a report, located at http://www.cqc.org.uk/location/RGT01/reports.

Among their key findings were:

Introducing the new EPIC IT system for clinical records had affected the trust’s ability to report, highlight and take action on data collected on the system. 

Excuse me?   Spend £200m on a computer system, and the result is impaired ability to report, highlight and take action on data collected?  Something is very wrong here.

 ... Although it was beginning to be embedded into practice, it was still having an impact on patient care and relationships with external professionals.

Clearly, the CQC does not mean a positive impact.

... Medicines were not always prescribed correctly due to limitations of EPIC, although we were assured this was being remedied.

Spend £200m on a computer system and the result is medicine prescription impairment (with the risks to patients that entails)?  Excuse me?

If those "limitations" affect these British hospitals, what "limitations" on getting prescriptions correct exist in all the U.S.-based hospitals that use this EHR, I ask?

... There was a significant shortfall of staff in a number of areas, including critical care services and those caring for unwell patients. This often resulted in staff being moved from one area of a service to another to make up staff numbers. Although gaps left by staff moving were back-filled with bank or agency staff, this meant that services often had staff with an inappropriate skills mix and patients were being cared for by staff without training relating to their health needs.

I suspect many staff were so unhappy with the EHR that they left, and recommended others not come.

Despite this patients received excellent care.

Odd how patient care and safety is never affected by bad health IT, as in the myriad stories at this site under the indexing key "patient care has not been compromised" (http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised).

... Clinical staff were not always able to access the information they required – for example, diagnostic tests such as electrocardiographs (ECGs) to assess and provide care for patients. This was because ECGs had to be sent to a central scanning service to be scanned into the electronic recording system [a.k.a. EHR] once the patient had been discharged. This meant their ECGs would not be available for comparison purposes if a patient was re-admitted soon after discharge.

Very, very bad IT planning, potentially putting unstable patients at risk.  Cybernetic miracles always have "fine print" that needs be read by skeptical managers BEFORE implementation.

Where agency staff were used, they were not always able to access information about patients they were supporting. 

 Ditto.

... Some staff told us there were no care plans on the new IT system.  Some staff told us the doctors’ orders had replaced care plans on the new EPIC IT system. These orders were task-orientated and did not always reflect the holistic needs of the patients.

This defective arrangement sounds like it was designed by non-clinicians.   The hubris and arrogance of non-clinicians sticking their heads into clinical issues - especially those of an IT-management background - must be witnessed to be fully comprehended.  It is my belief that such individuals should be subject to the liability as are the clinicians whose work increasingly depends on these IT systems.   If you dare to stick your neck into clinical affairs regarding systems upon which clinicians depend, you should be subject to the same liabilities as a clinician.  Unfortunately, this rarely if ever occurs.

 ... Whilst there were up-to-date evidence-based guidelines in place, we were concerned that these were not always being followed in maternity. This included FHR monitoring, VTE and early warning score guidelines. Staff were competent and understood the guidelines they were required to follow, however, lack of staffing and familiarity with the computer system (EPIC) made this difficult.

The point being missed here is that paper records required no massive multi-hundred page training manual in order to to perform basic functions such as the above.  The complexity of EHRs is costly, unnecessary, impairs clinicians and the solution is a massive scale back and simplification of these systems' complexity and scope.  Unfortunately, that, too is unlike to happen until the negative impacts become increasingly visible and intolerable - a meltdown I predict will occur, eventually.

... Since the introduction of EPIC, outcomes of people’s care and treatment was not robustly collected or monitored. For example, there was no maternity dashboard available since December 2014.

Again, spend £200m and have this result?  Something is seriously wrong here.  I suspect it is that personnel no longer had the time to perform monitoring, as they were likely distracted and struggling to keep afloat with more fundamental medical issues (like keeping major mishaps from occurring) using a complex and buggy EHR system.

That theory is likely confirmed by the following:

... At unit level we observed examples of excellent leadership principles; however, leadership of the directorate overall required improvement. This was because senior managers had not responded appropriately or in a timely way to known and serious safety risks, there was a general lack of service planning, and because key performance data was not being collected robustly and therefore not being analysed. We recognised that EPIC was the root cause of the problems with data collection, and that prior to its introduction in October 2014 many of the data collection issues were not apparent, however, improving this issue was not seen as a priority.

Management, I suspect, became complacent due to their infatuation with cybernetics and a belief that with a big-name EHR in place, operational ills were accounted for and they could relax.  (I've written of this phenomenon as the "syndrome of inappropriate overconfidence in computing.")  Management complacency, bad health IT and struggling clinicians is a very, very bad combination.

... Staff understood their responsibilities for safeguarding children, and acted to protect them from the risk of avoidable harm or abuse. There were enough medical staff but there were nursing shortages in some areas, such as in the day unit and in the neonatal unit. The new ‘EPIC’ (a records management system) computer system added to pressures on staff but effective temporary solutions helped to protect patients.

In other words, workarounds were used to get around the work-impeding EHR.  Workarounds introduce yet more risk.

... the electronic records system (EPIC) created significant numbers of delayed discharges that impacted on patients receiving end-of-life care.  ... Many staff said they had struggled with EPIC and it was time consuming. The specialist palliative care team found patients dropped off the system, so kept two lists to avoid losing patients.

One does not struggle with paper records.  (My current colleagues tell me the EHR struggle is non-ending.)  I further note that a computer system's rights, it appears, took precedence over patients' dying with dignity.

... While introducing EPIC, processes to deal with remaining paper records were unclear. For example, staff documented follow-up appointment requests on notepads. Paper records which were not stored in EPIC were inconsistently stored within the outpatients department. Inaccurate discharge summaries led to a risk that patients would not receive appropriate follow up care.

A fetish to totally eliminate paper, even where paper is the best medium for a purpose (e.g., as here:  http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story), creates major chaos and increases risk.

In conclusion, Your Highness, it might benefit your citizens (and those of the U.S.) if a national re-education programme were instituted to de-condition your leaders from unfettered belief in cybernetic miracles in medicine, a mental state they attain in large part due to mass EHR vendor and pundit propaganda.

A more sober mindset is recommended by your subject Shaun Goldfinch in "Pessimism, Computer Failure, and Information Systems Development in the Public Sector" (Public Administration Review 67;5:917-929, Sept/Oct. 2007, then at the University of Otago, New Zealand): 

The majority of information systems developments are unsuccessful. The larger the development, the more likely it will be unsuccessful. Despite the persistence of this problem for decades and the expenditure of vast sums of money, computer failure has received surprisingly little attention in the public administration literature. This article outlines the problems of enthusiasm and the problems of control, as well as the overwhelming complexity, that make the failure of large developments almost inevitable. Rather than the positive view found in much of the public administration literature, the author suggests a pessimism when it comes to information systems development. Aims for information technology should be modest ones, and in many cases, the risks, uncertainties, and probability of failure mean that new investments in technology are not justified. The author argues for a public official as a recalcitrant, suspicious, and skeptical adopter of IT.

Such a mindset would be helpful in preventing massive wastes of healthcare Pounds, Euros and Dollars better spent on patient care than on cybernetic pipe dreams.

Sincerely,

S. Silverstein, MD
Drexel University
Philadelphia, PA

------------------

Addendum:

I would like to hear from those in the know if my suspicions are correct.  Please leave comments.

-- SS

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Turn That Door Around - A Physician Substantially Tied to the Pharmaceutical Industry Nominated to Run the FDA

boards of directors CME conflicts of interest FDA key opinion leaders logical fallacies revolving doors

Turn That Door Around - A Physician Substantially Tied to the Pharmaceutical Industry Nominated to Run the FDA

Unknown 9/24/2015 Komentar

It seems to be the season of the revolving door in health care.  The latest version got some media attention, because it involves one of the most important health care leadership positions in the US government, the Director of the Food and Drug Administration (FDA).  However, the case actually seems much more serious than what the media has recently reported.

The Basics

For an introduction, we turn to the Wall Street Journal from September 15, 2015:

President Barack Obama plans to nominate the prominent cardiologist and medical researcher Robert Califf as the next commissioner of the Food and Drug Administration, the White House said Tuesday.

Dr. Califf had been named the FDA’s deputy commissioner for medical products and tobacco—effectively the No. 2 post—in February. He joined the FDA from Duke University, where he had served as a professor of medicine, a leading pharmaceutical researcher and the vice chancellor for clinical and translational research.

The new nomination got some rave reviews. For example, from the WSJ article,

Francis Collins, director of the National Institutes of Health and a scientist who has worked with Dr. Califf for years, called this 'a fantastic nomination.'

Then this in the NY Times (Sept 15, 2015):

'He’s never forgotten that at his core he’s a doctor, and he cares deeply about providing evidence to help people take better care of patients,' said Dr. Robert Harrington, professor and chairman of the department of medicine at the Stanford University School of Medicine, who worked with Dr. Califf at Duke.

Also, a MedPage Today article was entitled, "Califf Nomination for FDA Chief Gets Most High Marks," and included such testimonials as,

'He has a very good understanding of industry and academia, and think that will serve him well,' Caleb Alexander, MD, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness in Baltimore, told MedPage Today....

Also, this from Dr Harlan Krumholz,

He's a broad thinker and a very creative and visionary individual. He will be an outstanding choice.

And this from Dr Sanjay Kaul,

I can't think of a more qualified person than Dr. Califf to lead the FDA at the present time. He is an accomplished leader in cardiovascular disease research whose work has resulted in therapies that save lives and improve the quality of life for millions of patients.

Is it time to break out the confetti yet?

Conflicts of Interest a Fly in the Ointment?

The only fly in the ointment was the matter of Dr Califf's ties to industry. The WSJ article included,

Diana Zuckerman, president of the National Center for Health Research, a Washington-based group focusing on medical-product safety, questioned his ties to the drug industry.

'Dr. Califf’s expertise and his close ties to the pharmaceutical industry are both well-known,' she said. 'His ties to industry have been a source of great concern to public-health experts when he was previously considered for FDA commissioner, and those ties raise important questions about this nomination.'

The MedPage Today article noted that Public Citizen's Health Research Group stated,

'During his tenure at Duke University, Califf racked up a long history of extensive financial ties to multiple drug and device companies, including Amgen, Astra-Zeneca, Eli Lilly, Johnson & Johnson, Merck Sharpe & Dohme and Sanofi-Aventis, to name a few,' Michael Carome, MD, the group's director, said in a statement. 'Strikingly, no FDA commissioner has had such close financial relationships with industries regulated by the agency prior to being appointed.'

The MedPage Today article, however, then went on to undermine those concerns, implying that only fringe people like those at Public Citizen were really worried. 

Most experts contacted by MedPage Today seemed to think Califf would not have a problem getting Senate confirmation. 'I expect him to be confirmed," said [Dr. Steven] Nissen. 'He is very well liked by people ... in both parties, and I would expect the nomination to go well.'

'All signals suggest that Dr. Califf is well-respected on both sides of the political aisle,' Jay Wolfson, DrPH, JD, senior associate dean at the University of South Florida's Morsani College of Medicine, in Tampa, said in an email.

'There are some who believe his relationship with [the drug industry] may be a problem, but most see it as a value-added factor in building a functional, more streamlined relationship with the industry in order to improve the speed with which truly effective and quality drugs and devices are made available, mitigate the excessive costs associated with pharmaceuticals, and influence policies and practices intended to improve health status.'

Note that the experts were not all named, or their expertise described, the first two paragraphs were really about Dr Califf's political support, and the third paragraph clearly reflected the views of someone who thought that the FDA needs to have a lighter regulatory touch. 

There was additional reporting about Dr Califf's conflicts of interest, but again with the effect of minimizing their importance.  The Wall Street Journal published a second article on September 18, 2015 which first reported,

From 2009 through early 2015, Dr. Califf received consulting fees of roughly $205,000 from companies including Johnson & Johnson, Merck & Co., GlaxoSmithKline PLC and one medical-device maker, records show. The payments are documented by the federal Open Payments database, and PharmaShine, a database of pharmaceutical disclosures operated by Obsidian Healthcare Disclosure Services LLC. Drug makers spent an additional $21,000 on travel, meals and other expenses for Dr. Califf, data show.

But the article provided this counterpoint,

Kevin Griffis, a spokesman for the Department of Health and Human Services, said Dr. Califf had ceased all work with drug makers once he was hired by the FDA and that he has gone through a rigorous screening process for potential conflicts of interest. Mr. Griffis said Dr. Califf had donated all the consulting fees he has received since the mid-2000s to nonprofit groups.

'Dr. Robert Califf’s professional career has been dedicated to advancing biomedical research, including the rigorous evaluation of the safety, efficacy and appropriate use of both new medical products and those already on the market,' said Mr. Griffis, assistant secretary for public affairs at HHS.

Note that Dr Califf already is at the FDA, in a position that I do not believe required Senate confirmation.  It is striking, however, how the agency's own public relations people have jumped to his defense now as a nominee who has to be confirmed by the Senate.  However, I suppose that had Dr Califf donated all this fees to a local soup kitchen, they could not be called much of a conflict of interest.  But Mr Griffis said "nonprofit groups," without specification, not "soup kitchens." And continue reading to find out more. 

A simultaneous NY Times article enlarged a bit on Dr Califf's industry relationships,

He has written scientific papers with pharmaceutical company researchers, and his financial disclosure form last year listed seven drug companies and a device maker that paid him for consulting and six others that partly supported his university salary, including Merck, Novartis and Eli Lilly. A conflict-of-interest section at the end of an article he wrote in the European Heart Journal last year declared financial support from more than 20 companies.

However the NYT article also quoted Mr Griffis about the donations to "nonprofits," and added,

A résumé studded with industry funding is not unusual in academic medicine, Dr. Califf’s supporters note. Doctors are paid consulting fees all the time, and universities routinely conduct clinical trials on behalf of companies. Those contracts help support university researchers’ salaries, a standard practice. Many emphasize that it does not imply an inherent conflict.

His supporters contend that Dr. Califf’s vast experience in the clinical science world could be a major asset in his new post.

Furthermore,

Supporters and former colleagues say Dr. Califf’s background makes him perfectly suited to the job of commissioner. He has spent years improving the way clinical trials are conducted, coming up with groundbreaking trial designs for medicines against blood clots.

'His integrity in scientific matters is impeccable, and his innovation in clinical trial design is legendary,' said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, who has been an outspoken critic of both the F.D.A. and drug companies.

Even better,

Dr. Califf is often in the gym on the StairMaster before 6 a.m., said a former colleague at Duke, Dr. Adrian Hernandez. He often invites younger doctors to join him in golf and has a passion for Duke basketball that he expresses by wearing the team colors on game days.

How could anyone criticize a man who is at the gym at 6 AM?

More seriously, note that while the recent reporting may bring up questions about Dr Califf's conflicts of interest in terms of financial relationships with drug, device and biotechnology companies when he was on the Duke faculty, all the reporting also included passages minimizing the importance of these conflicts.  To minimize the issue of conflicts of interest, articles cited unnamed experts, suggesting the logical fallacy of an appeal to authority; noted that the financial ties that were criticized are standard practice in academic health care, suggesting the logical fallacy of an appeal to common practice.  The articles also cited Dr Califf's positive attributes which may have been relevant to his work at the FDA, like knowledge of research, but were not related to the question of conflicts of interest. This suggests another appeal to authority, or something of a reverse ad hominem (pro hominem?) fallacy.  It seems odd that what appear to be straightforward journalistic reports of a presidential nomination included such attempts to defend the candidate.  Note further that many of these logical fallacies appeared not in quotes from Dr Califf's supporters, but in text apparently written by journalists (e.g., "industry funding is not unusual," "in the gym on the Stairmaster," etc.)

Nonetheless, this is the state of play as of this moment.  The thrust of the media coverage suggested that Dr Califf is a brilliant physician and researcher, and while he as some ties to industry, they do not amount to much of a problem, except in the eyes of the likes of Public Citizen.


If one digs deeper, however, there is more. When Dr Califf was appointed to his current FDA position in February, 2015, and years earlier when his name was first mentioned as a possible candidate to run the FDA, evidence appeared that his ties to pharmaceutical, biotechnology and device companies were much more serious than what the recent accounts suggested.  

Where Does the Money from Industry Sponsored Research Grants Go? 

The recent coverage of Dr Califf's nomination in the NY Times dismissed his multiple corporate research grants as common practice.  Yet in the TIME coverage of  his original appointment to the FDA in February, 2015, this reminder of the significance of corporate sponsored research grants appeared.

Califf says his salary is contractually underwritten in part by several large pharmaceutical companies, including Merck, Bristol-Myers Squibb, Eli Lilly and Novartis.

Note that apologists for physician and academician interaction with industry often claim that industry funding of research grants that does not go directly to individuals does not cause important conflicts of interest. In one sentence, however, this article underlined how these grants support academic salaries, and hence lead to the dependency that is at the heart of conflicted relationships.

As we posted in 2007, academic medical institutions now depend on "external," including corporate research funding to support their research faculty's salaries, and via "overhead," their overall budgets.  Dr Lee Goldman, then Dean and Executive Vice President at Columbia University, called faculty who bring in a lot of grant money "tax payers," who earn gratitude, and likely bonuses and perks.  Thus Dr Califf's multiple large corporate research grants cannot be completely dismissed as conflicts of interest. 


A More Extensive List of Industry Relationships

Furthermore, a relatively obscure February, 2015, report from MDDIOnline noted that Dr Califf had more industry relationships than were reported this month,

Conflict of interest disclosures dating back to 2007 made public by the DCRI show that Califf has been paid for consulting or other services provided to a number of medical device pharmaceutical, and biotech companies, including Medtronic, Acumed, Bayer Healthcare, Merck, Novartis, Roche, GlaxoSmithKline, Bristol-Myers Squibb, Sanofi-Aventis, and Eli Lilly & Co. Califf also disclosed that he held equity in two pharmaceutical companies—Boulder-based N30 Pharmaceuticals and South San Francisco, CA-based Portola Pharmaceuticals—as recently as 2014. Califf retired from Portola’s board of directors January 26, according to a press release from the company.

A somewhat more obscure commentary by Martha Rosenberg in OpEdNews provided even more extensive listings of Dr Califf's industry relationships. And it suggested having a look at the disclosures he has made in the past in medical journal articles. A statement in a 2013 JAMA commentary was particularly telling,

Dr Califf receives research grants that partially support his salary from Amylin, Johnson & Johnson, Scios, Merck/Schering-Plough, Schering-Plough Research Institute, Novartis Pharma, Bristol-Myers Squibb Foundation, Aterovax, Bayer, Roche, and Lilly; all grants are paid to Duke University. Dr Califf also consults for TheHeart.org, Johnson & Johnson, Scios, Kowa Research Institute, Nile, Parkview, Orexigen Therapeutics, Pozen, WebMD, Bristol-Myers Squibb Foundation, AstraZeneca, Bayer/Ortho-McNeil, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Gilead, GlaxoSmithKline, Li Ka Shing Knowledge Institute, Medtronic, Merck, Novartis, sanofi-aventis, XOMA, University of Florida, Pfizer, Roche, Servier International, DSI-Lilly, Janssen R&D, CV Sight, Regeneron, and Gambro; all income from these consultancies is donated to nonprofit organizations, with most going to the clinical research fellowship fund of the Duke Clinical Research Institute. Dr Califf holds equity in Nitrox LLC, N30 Pharma, and Portola.

These lists of corporations from which Dr Califf got salary support and consulting fees are much longer than previous lists.  He acknowledged 13 commercial research sponsors, and consulted for 32 organizations, most of which were pharmaceutical companies.  Again, given that the salary support and overhead likely supplied by corporate research grants do suggest conflicts of interest, Dr Califf may have had many more of these sorts of conflicts than current reports implied  

A Seat on a Pharmaceutical Company Board of Directors

Note that the MDDIOnline article mentioned that Dr Califf was a member of the board of directors of Portola Pharmaceuticals. That was a significant source of income.  According to the Portola Pharmaceuticals 2015 proxy statement, Dr Califf received $259,623 in cash and stock options from the company in 2014.  I cannot find anything to suggest that this payment did not go directly to him.  This position, and the money it paid were not mentioned in the recent coverage. That payment alone seems to represent a major conflict of interest.

However, being on the board of directors of a health care corporation presents a deeper conflict than that produced by a simple payment of money or stock options, no matter how large. In 2006, we discussed corporate directorships as a new and important species of conflict of interest for medical academics.  As we have previously posted, corporate directors have fiduciary responsibilities to the company and its shareholders to support its financial success.  They are supposed to "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.]   Thus corporate directors have a much more significant commitment to the corporation than do corporate consultants, or researchers supported by corporate grants. 

Where Did Those Donated Consulting Payments Go?

Also note that the disclosure statement in the JAMA article mentioned that most of the consulting payments Dr Califf received went to the clinical research fellowship of the Duke Clinical Research Institute (DCRI).  Dr Califf was the first director of DCRI, 

So, while Dr Califf apparently did donate the consulting fees to a non-profit organization, that organization actually was part of Duke, and an organization that Dr Califf once led. It appears likely that Dr Califf benefited at least indirectly in terms of institutional gratitude and reputation from these consulting fees that he donated to his own institution.  So it appears that Dr Califf's donations of his consulting fees did not reduce the conflicts of interest generated by these fees to the extent suggested by the current FDA spokesperson and current media reports. 

Payments for "Educational Activities" 

Finally, perusal of disclosures of Dr Califf's commercial relationships made by the Duke Clinical Research Institute for the years 2010-2015 showed that he received payments for "educational activities" in 2011 from Amylin.  Information about earlier years is not available on this site, but in 2009, Dr Daniel Carlat wrote this about Dr Califf's then rumored candidacy for leadership of the FDA in the Carlat Psychiatry Blog,

look at these industry disclosures. He took money—lots of money--from 18 different pharmaceutical or device firms. Most of this was not for research, but for consulting and speaking, including CME. If Dr. Califf believes that it is ethical for physicians to help drug companies market their products, that’s his own business. But to elevate him to a position in which he is the country’s chief watchdog over unsafe medications and foods seems a dangerous move. With money from 18 drug companies padding his bank account, he will presumably spend most of his FDA career recusing himself from crucial decisions. Not a good idea.

There has been no mention of Dr Califf being a paid speaker for pharmaceutical companies in any of the recent reporting.  Dr Carlat implied that Dr Califf was paid to speak to further marketing objectives of pharmaceutical companies, that is, was giving "drug talks."  Since the publication of "Dr Drug Rep" in the New York Times in 2007, authored by Dr Carlat, the public has learned that such talks mainly include content provided by the pharmaceutical companies, and are meant by the companies as marketing exercises.  From that case we also learned that physicians who deviate from the marketing message do not last long on speakers' bureaus.  (See posts here and here.)

Paid speakers may be regarded by pharmaceutical companies as paid "key opinion leaders," KOLs, who serve a marketing function in the guise of academics. As noted here and here, the companies buying their services may believe they have bought the services of sales people.    Evidence about key opinion leaders actually performing like marketers has come from documents revealed during litigation (e.g., see this recent example of a huge monetary settlement made of charges that GlaxoSmithKline, a major multinational drug company committed fraud among other things, and in the course of its unethical activities used key opinion leaders as marketers).   Also, see the Neurontin marketing plan (see post here), and the Lexapro marketing plan (see post here) for examples of how company keaders view key opinion leaders as marketers.

So the revelation that Dr Califf received corporate payments for "education" suggests a bigger commitment to corporate marketing objectives than has previously been revealed.  

Summary

So, looking at not only current media reports, but media reports from earlier this year, and also proxy statements, the fine print of journal articles, and old blog posts, it appears that Dr Robert Califf really did have very substantial financial interactions with the drug, device and biotechnology industry.  These interactions likely underwrote his salary and his standing with the leaders of his former employer, Duke University.  Dr Califf seemed to be a paid speaker for drug companies on at least two occasions, suggesting that the companies may have put him in a covert marketing role, or viewed him as a paid key opinion leader.  Finally,  Dr Califf served on the board of directors of one drug company, a much deeper commitment than being a sponsored researcher or consultant.

Thus Dr Califf really appears to be one of the most, if not the most drug, device and biotechnology industry connected individual ever nominated to lead the agency that is the most important regulator of the US drug, device and biotechnology industry.  Some of his connections, particularly his previous membership on a pharmaceutical company board, and his previous roles as a paid pharmaceutical speaker, suggested not only financial relationships, but commitments to companies' financial and marketing goals.  These appear to be major conflicts of interest vis a vis Dr Califf's current leadership position at the FDA, and his nomination to be the ultimate leader of this regulatory agency.  This is the revolving door writ large.

As we have said very recently,  the revolving door can be veiwed as a species of conflict of interest.  Government officials who can look forward to extremely lucrative employment in health care industry may be much more inclined to seem friendly to the industry while in office.  Government officials who just came from industry are likely to maintain their industry mindset and be mindful of their industry friends.

Worse, some experts have suggested that the revolving door is in fact corruption.  As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.

Furthermore, the ongoing and increasing revolving door phenomenon clearly suggests excess coziness between industry and government, now to the extent that industry and government leaders of health care are becoming interchangeable.  This suggests that health care is increasingly run by this cozy ingroup, who very likely put their own interests ahead of those of patients and the public.

The continuing egregiousness of the revolving door in health care shows how health care leadership can play mutually beneficial games, regardless of the their effects on patients' and the public's health.  Once again, true health care reform would cut the ties between government and corporate leaders and their cronies that have lead to government of, for and by corporate executives rather than the people at large.

ADDENDUM (28 September, 2015) - This post has been republished on the Naked Capitalism blog,  and OpEdNews.

ADDENDUM (28 September, 2015) - See also more detail on Dr Califf's activities on the Portola board on the PEU Report blog. 

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A Quiet Turn of the Revolving Door - Director of NIMH to Go Directly to Google Life Sciences

NIH NIMH revolving doors Thomas Insel

A Quiet Turn of the Revolving Door - Director of NIMH to Go Directly to Google Life Sciences

Unknown 9/18/2015 Komentar

Amidst a lot of health care news, the job plans of Dr Thomas Insel, currently the director of the National Institute of Mental Health (part of the US National Institute of Health) made a very small splash.  The most comprehensive account was in the New York Times.

Dr. Thomas R. Insel, the director of the National Institute of Mental Health, announced on Tuesday that he planned to step down in November, ending his 13-year tenure at the helm of the world’s leading funder of behavioral-health research to join Google Life Sciences, which seeks to develop technologies for early detection and treatment of health problems.

As noted in the NYT article, Dr Insel had great influence over the direction of mental health research and policy,

Dr. Insel took over the N.I.M.H. in 2002 and steered funding toward the most severe mental disorders, like schizophrenia, and into basic biological studies, at the expense of psychosocial research, like new talk therapies. His critics — and there were plenty — often noted that biological psychiatry had contributed nothing useful yet to diagnosis or treatment, and that Dr. Insel’s commitment to basic science was a costly bet, with uncertain payoffs.

A Modern Healthcare article documented Dr Insel's specific organizational roles beyond his directorship that could have influenced research and policy,

Insel chaired the Interagency Autism Coordinating Committee, which is a federal advisory committee that coordinates autism research and services and was established by Congress.

Insel also co-chaired the Blueprint for Neuroscience Research, which supported the pioneering Human Connectome Project, a project to map the human brain, and the NIH Brain Research through Advancing Innovative Neurotechnologies program, which aims to accelerate the development and application of innovative technologies to map brain circuits.

Insel also headed up the Common Fund efforts in Molecular Libraries, Single Cell Biology, and Genotype-Tissue Expression.

Comment

So Dr Insel clearly helped steer current US government mental health care research and policy towards its current course.  Now he is going directly, not with any sort of delay or waiting period, to a commercial firm poised to take advantage of the current direction of US mental health care research and policy.

Although more subtle than, say, a leader of a government regulatory agency departing for a position at a company regulated by that agency, this, in my humble opinion, appears to be an example of the revolving door.  Certainly it fits the broad 2011 Transparency International definition,

The term ‘revolving door’ refers to the movement of individuals between positions of public office and jobs in the private sector, in either direction.

Despite this, as far as I can tell, no one else so far has referred to this job transfer as an example of the revolving door.

Furthermore, as we noted here, the revolving door can be veiwed as a species of conflict of interest.  Government officials who can look forward to extremely lucrative employment in health care industry may be much more inclined to seem friendly to the industry while in office.  Government officials who just came from industry are likely to maintain their industry mindset and be mindful of their industry friends.

Worse, some experts have suggested that the revolving door is in fact corruption.  As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.

We have discussed Dr Insel's approach to conflicts of interest before.  Note that Dr Bernard Carroll, posting on this blog, has written extensively about Dr Insel's apparently rather lax approach to conflict of interest issues while he was at NIH raised by the case of Dr Charles Nemeroff.  Look here,  here, here, and here.  Recapping these, I noted that Dr Insel later confessed that his statements about these issues "may be viewed as misleading."

Nonetheless, as far as I can tell, no one else so far has used the term conflict of interest in discussing Dr Insel's new job.  The anechoic effect continues.

As we have said endlessly, most recently here, the ongoing and increasing revolving door phenomenon clearly suggests excess coziness between industry and government, now to the extent that industry and government leaders of health care are becoming interchangeable.  This suggests that health care is increasingly run by this cozy ingroup, who very likely put their own interests ahead of those of patients and the public.

The continuing egregiousness of the revolving door in health care shows how health care leadership can play mutually beneficial games, regardless of the their effects on patients' and the public's health.  Once again, true health care reform would cut the ties between government and corporate leaders that have lead to government of, for and by corporate executives rather than the people at large

ADDENDUM (24 October, 2015) - This post was republished in OpEdNews.

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Politico 2015: EHR sellers using “gag clauses” (despite Koppel/Kreda's 2009 JAMA article on EHR nondisclosure clauses, and my 2009 JAMA Letter to the Editor on how these clauses violate Joint Commission safety standards)

Darius Tahir david kreda defects nondisclosure clause gag clause healthcare IT risks hold harmless clause Politico ross koppel

Politico 2015: EHR sellers using “gag clauses” (despite Koppel/Kreda's 2009 JAMA article on EHR nondisclosure clauses, and my 2009 JAMA Letter to the Editor on how these clauses violate Joint Commission safety standards)

Unknown 9/15/2015 Komentar

I have not blogged on EHR issues in some time, despite some interesting source material such as:

• "Evidence Summary: Electronic Health Records (EHRs)" at http://www.ohri.ca/kta/docs/KTA-EHR-Evidence-Review.pdf ; 
• "Electronic Health Records Software Often Written without Doctors' Input" at http://www.scientificamerican.com/article/electronic-health-records-software-often-written-without-doctors-input/ ; and
• "Avoiding Expensive And Consequential Health Care Decisions Based On Weak Research Designs" [e.g., EHR expansion - ed.] at http://healthaffairs.org/blog/2015/08/31/avoiding-expensive-and-consequential-health-care-decisions-based-on-weak-research-designs/.

These can be read at the links above, and are self-explanatory.

A new Politico investigation and article, however, is worth writing about:
  

Politico
Doctors barred from discussing safety glitches in U.S.-funded software
Darius Tahir
09/11/15
http://www.politico.com/story/2015/09/doctors-barred-from-discussing-safety-glitches-in-us-funded-software-213553

President Barack Obama’s stimulus put taxpayers on the hook for $30 billion in electronic medical records, many of which have turned out to be technological disasters.

But don’t expect to hear about the problems from doctors or hospitals. Most of them are under gag orders not to discuss the specific failings of their systems — even though poor technology in hospitals can have lethal consequences. 

[Change the "can" to "does", e.g., ECRI Deep Dive, http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html - ed.]

A POLITICO investigation found that some of the biggest firms marketing electronic record systems inserted “gag clauses” in their taxpayer-subsidized contracts, effectively forbidding health care providers from talking about glitches that slow their work and potentially jeopardize patients.

[E.g., see http://hcrenewal.blogspot.com/search/label/glitch - ed.]

POLITICO obtained 11 contracts through public record requests from hospitals and health systems in New York City, California, and Florida that use six of the biggest vendors of digital record systems. With one exception, each of the contracts contains a clause protecting potentially large swaths of information from public exposure. This is the first time the existence of the gag clauses has been conclusively documented.

I note this Politico article appears six years after the seminal JAMA article on hold harmless and defects nondisclosure clauses:

• "Health Care Information Technology Vendors' "Hold Harmless" Clause - Implications for Patients and Clinicians" by Koppel and Kreda, JAMA 2009;301(12):1276-1278), http://medecon.pbworks.com/f/IT%20Accountability%20JAMA09.pdf,

as well as:

• this author's followup JAMA Letter to the Editor "Healthcare IT, Hospital Responsibilities, and Joint Commission Standards" (can be seen in its entirety at http://jama.jamanetwork.com/article.aspx?articleid=184302) pointing out that such clauses and those who signed them were in violation of Joint Commission safety standards. 
• (I published a longer version at http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda.  Also see my 2009 post at http://hcrenewal.blogspot.com/2009/03/health-care-information-technology.html).

In that 2009 JAMA Letter to the Editor I observed:

... In their Commentary, Dr Koppel and Mr Kreda made clear the problems associated with applying the customs and traditions of business software contracting and sales (where “hold harmless” and “keep defects secret” clauses are commonplace) to health care information technology (HIT) as if they are the same. I believe that ignoring their differences has likely created an epidemic of violations of hospital governing body responsibilities and Joint Commission standards for health care organization leadership.

In 2015 I stand by these assertions.  Computer and business personnel - through arrogance, selfishness, narrow-mindedness and other issues - have made a mess assuming that business software practices apply to clinical medicine and healthcare IT.  In the latter domain, however, increased clinical stress and hypervigilance due to bugs clinicians have to work around (that might have been fixed sooner), lessening their performance and increasing risk, and patient injury and death has been the result of a belief that clinical computing is just a niche area of business computing.  (I've been making this point for at least 15 years, I might add.)

Such contractual practices endanger patients, and in 2015 are reckless, negligent and inexcusable.

http://injury.findlaw.com/accident-injury-law/recklessness.html
Recklessness means the person knew (or should have known) that his or her action were likely to cause harm. Negligence means that the person acted in violation of a duty to someone else, with the breach of that duty causing harm to someone else.

More from the Politico article:

Vendors say such restrictions target only breaches of intellectual property and are invoked rarely.

IP breaches?  While I understand the business issues at hand, in reality this is farcical.  There is little unique and valuable IP in these systems...as if one EHR vendor would really copy off another EHR vendor's screens.  I've seen many EHRs and their instruction manuals and in my opinion there's little worth stealing from any of these look-alike systems.

But doctors, researchers and members of Congress contend they stifle important discussions, including disclosures that problems exist. In some cases, they say, the software’s faults can have lethal results, misleading doctors and nurses who rely upon it for critical information in life-or-death situations.

Change the "can" to "do."  See ECRI link above, posts such as at http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html, and as readers here know, I have one less living relative thanks to EHR faults.  (I know of others that I cannot discuss.)

Critics say the clauses – which POLITICO documented in contracts with Epic Systems, Cerner, Siemens (now part of Cerner), Allscripts, eClinicalWorks and Meditech – have kept researchers from understanding the scope of the failures.

I actually refute that.  I believe many researchers (in the field of Medical Informatics, at least) were blinded by their own wishful thinking about health IT and their own misplaced overconfidence in computing.  My writings for a decade and that of many other "iconoclasts", based on experience and insight from other fields in which we worked, clearly raising huge red flags, were derided or summarily ignored.  For instance, see my post "The Dangers of Critical Thinking in A Politicized, Irrational Culture" from almost exactly five years ago at http://hcrenewal.blogspot.com/2010/09/dangers-of-critical-thinking-in.html.  There was enough data to ascertain that major problems were extant.

Even the ECRI Deep Dive EHR safety study referenced above, now at least three years old, finding 171 IT mishaps in 9 weeks in just 36 hospitals voluntarily reported, causing 8 significant harms and 3 possible deaths, is rarely cited by the "researchers."  See http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html.

... Sheldon Whitehouse (D-RI) asked a panel of witnesses [during a HELP committee hearing earlier this summer], including Allscripts CEO Paul Black: “Can anyone on this panel see a single reason why these contracts should have gag clauses in them?”  No one ventured a reason.

Perhaps, I ask, because it would be hard to say something like "Senator, our computers have more rights than patients, and we don't give a damn about patient harm as long as the $$$ keep rolling in, and payouts for screw-ups that do make it to court are manageable", Ford Pinto-style, in such a setting?

After POLITICO disclosed its findings, an aide to HELP Chairman Lamar Alexander (R-Tenn.) said the committee would look at the issue, “exploring potentially harmful effects of these clauses – including how they could inhibit interoperability.”

The interoperability issue is a diversion if not a non-sequitur.  Dreamers still believe billions will be magically saved, and lives saved, via "interoperability", ironically at a time when basic operability is poorly achieved.

Let me state this clearly:  health IT will always be a major cost center and will never result in the mass cost savings attributed by the pundits to it.  From experience, I state that is a pipe dream, a fantasy, a risible statement consistent with a mania over the technology.  The issues in medicine that cost dear money are complex, and are not amenable to solution via cybernetic miracles.

See http://hcrenewal.blogspot.com/2012/09/wsj-koppel-and-soumerai-major-glitch.html for more on this issue:

... a comprehensive evaluation of the scientific literature has confirmed what many researchers suspected: The savings claimed by government agencies and vendors of health IT are little more than hype.

To conduct the study, faculty at McMaster University in Hamilton, Ontario, and its programs for assessment of technology in health—and other research centers, including in the U.S.—sifted through almost 36,000 studies of health IT. The studies included information about highly valued computerized alerts—when drugs are prescribed, for instance—to prevent drug interactions and dosage errors. From among those studies the researchers identified 31 that specifically examined the outcomes in light of the technology's cost-savings claims.

With a few isolated exceptions, the preponderance of evidence shows that the systems had not improved health or saved money.

Rather than saving money, the industry is sucking in some of that $17 or so trillion the United States just doesn't have (http://www.usdebtclock.org/).  See for instance "The Machinery Behind Health-Care Reform: How an Industry Lobby Scored a Swift, Unexpected Victory by Channeling Billions to Electronic Records", Washington Post, by Robert O'Harrow Jr., May 16, 2009.

Back to Politico:

... Take Cerner’s agreement with LA County’s Department of Health Services, signed in November 2012 and worth up to $370 million. It defines the vendor’s confidential information as “source code, prices, trade secrets, mask works, databases, designs and techniques, models, displays and manuals.” Such information can only be revealed with “prior written consent.” The protections cover the provider company, and its employees.

Such agreements, which are typical of the contracts examined by POLITICO, “contain broad protections for intellectual property and related confidentiality and non-disclosure language which can inhibit or discourage reporting of EHR adverse events,” said Elisabeth Belmont, corporate counsel at MaineHealth.

Belmont said she had also seen non-disparagement wordings that prohibit providers from disseminating negative information about the vendor or its software. POLITICO found no direct evidence of such clauses.

"Non-disparagement wording?"

How about good old-fashioned Orwellian thought control?  See my Oct,. 2013 post 'Words that Work: Singing Only Positive - And Often Unsubstantiated - EHR Praise As "Advised" At The University Of Arizona Health Network' at http://hcrenewal.blogspot.com/2013/10/words-that-work-singing-only-positive.html.

... The executive branch—the Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare and Medicaid Services are responsible for the subsidy program— has done little about the clauses, though providers and researchers have been grumbling about them since the 2011 Institute of Medicine report warning that “[t]hese types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks.”

...Agency officials say they deplore the clauses but lack the capacity to directly address the problem. “We strongly oppose ‘gag clauses’ and other practices that prevent providers and other health IT customers and users from freely discussing problems and other aspects of their health IT,” an ONC spokesman said.

But, he continued, ONC cannot police them. The clauses take a variety of forms, and the extent to which vendors invoke them varies, making enforcement difficult – particularly for a small agency that doesn’t have investigative or police powers.

A small agency that doesn’t have investigative or police powers?  Really?  Yet - ONC is a promoter of the non-regulatory "Safety Center" concept as a solution to health IT safety risks.  See for instance http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html.  Their response above to Politico seems disingenuous.

What follows in the Politico article is vendor excuses and soothing reassurances, like this one:

... Epic executives said they encourage open discussion. “With permission, we very frequently allow folks to share information around the software,” said Epic’s vice president for client success, Eric Helsher.

I'll surmise I would not be able to easily get detailed information on the ten thousand EPIC "issues" I highlighted at my Nov. 2013 post "We’ve resolved 6,036 issues and have 3,517 open issues": extolling EPIC EHR Virtues at University of Arizona Health System", http://hcrenewal.blogspot.com/2013/11/weve-resolved-6036-issues-and-have-3517.html, for publication on this blog.

... a lot of problems may go under-reported. That offends [Dr. Bob] Wachter, who says the patient safety world “takes it as religion” that information be shared as widely as possible.

“These are worlds colliding. You can understand why a technology business would put restrictions on screenshots. But we’re not making widgets here, we’re taking care of sick people,” he said.

“At some level, I’d say, ‘How dare they?’”

"At some level?"  What level, exactly?

How about the life-and-death level?

Worlds colliding, indeed; the aforementioned business-IT world and the clinical world.  I would drop the "at some level" phrase, though, and also go back to my 2009 JAMA letter observation that I repeat once again: 

... In their Commentary, Dr Koppel and Mr Kreda made clear the problems associated with applying the customs and traditions of business software contracting and sales (where “hold harmless” and “keep defects secret” clauses are commonplace) to health care information technology (HIT) as if they are the same. I believe that ignoring their differences has likely created an epidemic of violations of hospital governing body responsibilities and Joint Commission standards for health care organization leadership.

Health IT companies are simply not team players in medicine.  Their heavy-handedness and narrow thinking has harmed and killed patients.   How many in total? 

Last year I spoke to a half dozen US House members and a dozen or so aides of House members who could not attend.   I was accompanied by two Plaintiff's lawyers (yes, Plaintiff's lawyers) who told their own tales of EHR-mediated catastrophes whose survivors they had represented.  They were there for that purpose, to inform the US Reps that health IT was killing people.

Extrapolating the ECRI Deep Dive study figures and adding in other known cases, the true level of harms is anything but pretty.

It would be a very useful exercise to measure it explicitly rather than using the Ostrich approach (see for instance my post "FDA on health IT risk:  "We don't know the magnitude of the risk, and what we do know is the tip of the iceberg, but health IT is of 'sufficiently low risk' that we don't need to regulate it" (http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html). 

However, obtaining the data in a robust matter could result in those reporting the data violating EHR gag and non-disparagement clauses.

We must respect the rights of the computers...

-- SS

Addendum:  the Politico article, unfortunately, while a major piece, did not cite Koppel/Kreda or their pioneering 2009 JAMA article.  I surmise this was an oversight.

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Pfizer's Latest International Pfiascos - Charges of Anti-Competitive Practices, Inflated Prices, Deception and Secrecy

adverse effects antitrust deception executive compensation health care prices legal settlements marketing Pfizer suppression of medical research vaccines

Pfizer's Latest International Pfiascos - Charges of Anti-Competitive Practices, Inflated Prices, Deception and Secrecy

Unknown 9/14/2015 Komentar

Many big health care organizations seem to just be unable to keep out of trouble, and the bigger they are, the more kinds of trouble.  Pfizer Inc, considered to be one of the world's largest pharmaceutical companies, has supplied us with plenty of stories.  Enough new stories about Pfizer have accumulated since last year to do a roundup.   

Presented in chronological order....

Italy Demands Damages from Pfizer for Anti-Trust Violations

This story came out in May, 2014, via Reuters,

Italy said on Wednesday it was seeking more than a billion euros in damages from multinational drug companies following a ruling by the country's antitrust authority that their policies had been detrimental to Italy's national health service.

The health ministry said in a statement it was requesting a total 1.2 billion euros ($1.6 billion) from Novartis and Roche for the damages incurred in 2012-2014, and was requesting 14 million euros from Pfizer.

It cited several recent antitrust rulings that the companies' repeated anti-competitive actions had caused the national health service 'considerable damage'.

The specific charges against Pfizer were:

Italy's state council, the highest administrative court, in February ruled that Pfizer had abused its dominant position relating to the glaucoma drug Xalatan 'with a clear and persistent intention to suppress competition'.

At least in English language news sources, I have not seen how this turned out, but note that this was apparently an administrative court finding, not just a prosecutor's allegation.

Pfizer Accused of Overcharging for Pediatric Vaccines

This appeared in January, 2015, here via Ed Silverman's PharmaLot blog (when it was affiliated with the Wall Street Journal),

In a bid to widen access to vaccines, Doctors Without Borders is calling on Pfizer and GlaxoSmithKline to lower the prices for their pneumococcal vaccines to $5 per child in developing countries. The non-profit claims the drug makers are 'overcharging' donors and developing countries for vaccines that 'already earn them billions of dollars in wealthy countries.'

The non-profit, which regularly advocates for lower prices for medicines, maintains that, in general, the price to vaccinate a child against several diseases is now a 'colossal' 68 times more expensive than in 2001. In a new report, Doctors Without Borders attributes 45% of that increased cost to the price tags for pneumococcal vaccines sold by the drug makers. Pneumococcal disease, by the way, kills about 1 million children per year, mostly in poor and developing nations.

Think about the children.

The non-profit maintains that the current price tag makes it difficult to supply the vaccine to large numbers of children, and the drug makers have already received $1 billion in incentives to manufacturer the vaccine for developing countries. 'We think it’s time for Glaxo and Pfizer to do their part to make vaccines more affordable for countries in the long term, because the discounts the companies are offering today are just not good enough,' says Malpani in a statement.

Moreover, Doctors Without Borders warns that pricing may eventually make it harder for a growing number of middle-income countries to afford vaccines. Over time, some of these countries will eventually ‘graduate’ from the subsidized vaccine pricing established by Gavi and, when that happens, Doctors Without Borders estimates costs may rise up to six times what is the countries pay today.

The post included a statement from Pfizer about how hard it is to manufacture the vaccine, and an update to the post included a statement from Pfizer that it was already selling its pneumococcal vaccine, Prevenar 13, below cost to GAVI, which buys up vaccines and provides them to poor countries. A week later, again via (the old version of) PharmaLot, Pfizer announced an additional 6% price cut. Furthermore, Bill Gates, whose foundation supports GAVI, insisted that cutting vaccine prices would discourage pharmaceutical companies from investing in vaccine research and supplying products to poor countries, according to the Guardian.

However, neither Pfizer nor Mr Gates acknowledged how much money Pfizer already is making from Prevenar in developed countries, amounts which likely do far more than offset any losses in poorer countries. Specifically, in July, 2015 FierceVaccines reported that

The world's biggest vaccine by sales--Prevnar 13--just keeps getting bigger. And in doing so, the shot helped Pfizer notch 44% vaccines growth for the second quarter as the unit saw sales grow from $1.09 billion in last year's Q2 to $1.58 billion during the period this year.

For the quarter, the superstar pneumococcal disease-blocker notched a U.S. sales increase of 87% versus the same period last year, a jump Pfizer CEO Ian Read attributed to 'continued strong uptake' in U.S. adults.

Also,

Prevnar 13, which reeled in $4.29 billion in sales last year, is expected to grow to $5.83 billion in 2020 and remain atop the vaccines sales charts.

And,

The company is also working 'country by country' to broaden the vaccine's reach in G7 countries....

So there seems to be some evidence in support of the Doctors Without Borders claim that Pfizer could easily afford some small losses selling vaccines for use by poor children in less developed countries while it makes billions of dollars from vaccine sales in developed countries.  


Pfizer Settles Shareholder Suit for $400M

This settlement was just the latest that has resulted from allegations of illegal drug marketing by Pfizer.  As reported again by the redoubtable Ed Silverman in the old version of PharmaLot,

Pfizer has reached an agreement in principle to pay $400 million to settle a class-action securities lawsuit that alleged the drug maker illegally marketed several medicines and, subsequently, caused investors to lose money, according to a filing with the U.S. Securities and Exchange Commission.

The lawsuit alleged that, between January 2006 and January 2009, Pfizer marketed several drugs on an off-label basis. The medicines included the Bextra painkiller that was withdrawn from the market in 2005; the Geodon antipsychotic; the Zyvox antibiotic and the Lyrica epilepsy treatment.

The lawsuit, which was filed in federal court in 2010, alleged that the sales boost the drug maker received from the marketing prompted Pfizer executives to make 'false and misleading statements about Pfizer’s financial performance and sales practices [that] caused Pfizer stock to trade at artificially inflated prices.'

This settlement followed an even larger one back in 2009 when,

the drug maker revealed plans to pay $2.3 billion to resolve criminal and civil allegations that these drugs were marketed illegally.

We discussed that settlement in 2009 here, here, and here.  Note that the 2009 settlement included a guilty plea to a criminal charge (albeit to a misdemeanor), and was of allegations including paying kickbacks to doctors for use of Pfizer drugs.  So this additional settlement of deceiving investors just ices that cake. 

UK Competition and Markets Authority Stated Pfizer Abused Market Dominance

This story appeared in August, 2015, via the Telegraph,

The Competition and Markets Authority (CMA) has issued a statement of objections alleging the companies breached UK and EU law by raising the prices they charged for phenytoin sodium sold to the NHS.

In particular,

The CMA says that for years industry giant Pfizer, which is listed in the US, and Flynn, a Stevenage-based company, between them sold the drug at a price up to 27 times higher than it had been previously priced.

Before September 2012, Pfizer manufactured and sold phenytoin sodium capsules to UK wholesalers and pharmacies under the brand name Epanutin.

Pfizer then sold the UK distribution rights for Epanutin to Flynn, which 'de-branded' the drug and started selling its version in September 2012. Pfizer continued to manufacture the drug, which it sold to Flynn at prices the CMA says were 'significantly higher' than those at which it had previously sold Epanutin.

The CMA claims Pfizer sold the drug at between 8 and 17 times its historic prices to Flynn, which then sold on phenytoin sodium at between 25 to 27 times more than the prices previously charged by Pfizer.

Before Flynn bought the rights for Epanutin, the NHS spent about £2.3m on phenytoin sodium capsules a year, according to the CMA. After the deal this spend rose to just over £50m in 2013 and more than £40m in 2014.

While the CMA findings were apparently "provisional," but the agency has the power to find that the law has been breached and "has the power to fine then up to 10pc of their global annual turnover - last year Pfizer had revenue of almost $50bn."  So this is the second government finding of anti-competitive behavior by Pfizer in a little over one year.

Pfizer Resists AllTrials Calls for Transparency

Late in August, 2014, per the Guardian,

Pfizer, one of the world’s largest pharmaceutical groups, has said it will resist demands from investors and transparency campaigners that it disclose results from all historical drug trials.

We have been discussing how pharmaceutical, biotechnology, and device companies have manipulated the clinical trials they sponsor to increase the likelihood that the results make their products look good, and may suppress trials whose results cannot be made to look good enough. This clinical research suppression and manipulation can lead to poor clinical decisions, may harm patients, and abuses the trust of patients who volunteer to participate in clinical research. This situation has led to the AllTrials campaign to make clinical research transparent (look here). However,

Pfizer said it had a 'longstanding commitment to clinical trial transparency' and it already published data for trials from 2007. Requests for earlier data are considered on an individual basis. But it added: 'We don’t believe that further investment beyond this would offer value to patients, health services or to our shareholders.'

This despite arguments above about the harms of research suppression.  Given how much money Pfizer has spent on lawsuits, including one above about allegations of its management's deception of shareholders, one might think it would be worth it for management to make a little investment in transparency.

Pfizer Found to Have Withheld Reports of Adverse Drug Events in Japan

Finally, reported in September, 2015 by in-PharmaTechnologist.com,

Pfizer failed to report hundreds of serious adverse drug reactions (ADRs) in the required timeframes according to Japan’s Ministry of Health, Labor and Welfare (MHLW) which has issued the US firm with a business improvement order. 

That website has copy protection so I cannot quote further, but the order involved 11 drugs, including Enbrel and Lyrica.  So here is yet another example of a government agency finding that Pfizer was less than transparent, if not overtly deceptive.

Summary

So in a little more than a year, Pfizer has been accused of anti-competitive practices raising drug costs in Italy, excess pricing of vaccines for use by poor children in undeveloped countries, deceiving its own investors about illegal marketing activities in the US, abuse of market dominance leading to excessive drug costs in the UK, stonewalling clinical trial transparency measures globally, and failing to disclose adverse drug effects in a timely manner in Japan.  This is on top of an already impressive record of misbehavior (See our summary of Pfizer mischief at the end of the post.)

However, as seems usual these days, no one at Pfizer who might have authorized, directed or implemented any of this bad behavior has ever seemingly paid any sort of penalty for it.  Instead, while this was going on, the top leadership of Pfizer just gets richer faster and faster.  In fact, in March, 2015, the Wall Street Journal reported the current Pfizer CEO's total compensation in 2014,

Pfizer Inc. said Thursday that Chief Executive Ian Read’s total compensation rose 23% last year, lifted by an increase in pension value that offset a reduced annual bonus and equity award.

Furthermore,

Mr. Read’s 2014 pay package totaled $23.3 million. The board raised the CEO’s salary to $1.83 million from $1.79 million but decreased his annual bonus by $400,000 and his equity award by nearly $1 million despite concluding that Mr. Read’s leadership during the year was 'outstanding.'

[Even though] Over the course of 2014, shares in the New York-based pharmaceutical company gained about 2% amid a 4% decrease in revenue.

It is not obvious that the rise in CEO pay is even remotely correlated to any rise in share-holder value.  Moreover, there seems to be a total disconnect between the rewards given the CEO and the ethical record of the company he leads, especially since Pfizer, which calls itself "one of the world's premier pharmaceutical" corporations, announces its aspirations thus,

we at Pfizer are committed to applying science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them.

Never mind all those pesky allegations of overpricing, anti-competitive practices, deception and opaqueness, and never mind that current executives are becoming exceedingly risk in part from the continuation of such practices.  So it seems the board of Pfizer will just continue handing its executives piles of money, despite, or for all I know, because of the company's continuing bad behavior.  Given these incentives, is it any wonder that the bad behavior continues?  Pfizer seems to be just another example - albeit a big one - of how health care is dominated by an oligarchy of unaccountable leaders who continue to demonstrate their impunity hidden by aspirational but hollow public relations and marketing.

Of course, it is doubtful such bad behavior would continue if there risks of external penalties, e.g., from law enforcement.  But there never seem to be any.

In the past, US law enforcement authorities have announced they would use the responsible corporate officer doctrine, a legally tested rationale for prosecuting corporate managers for bad behavior by those who report to them (e.g., in 2010, look here),  But it seems they have never done so, at least in cases involving large health care organizations.  Last week, the US Department of Justice announced it would start going after executives of companies that misbehave, and would press the companies to give up the name of responsible executives in exchange for more lenient treatment of the companies themselves (e.g., see this report in the NY Times).  Meanwhile, however, the march of legal settlements for bad behavior in health care continues, absent any penalties for organizational leaders who might have authorized or directed it, much less for those who simply put incentives in place to foster bad behavior while looking away from what those incentives inspired.    

I hope these current promises by law enforcement officials are not as hollow as earlier ones, because continuing our society's continuing failure to rein in corrupt business practices via law enforcement and regulation may lead a desperate populace to more radical approaches. The UK Labor Party just elected a Marxist leader (see this Reuters report.)  One wonders how long it will be before anger at the larger oligarchy, of which health care leadership is merely a part, boils over in other countries, and in more radical ways.

Instead, we continue to advocate for true health care reform with the immediate priority of changing how health care organizations are led, and ensuring leadership that upholds health care values, is willing to be accountable, and is open, honest, transparent and ethical.  We still may have time to reform.  But the reform will have to be big and true.  If not, moderate voices may be drowned out, and the results may be worse than anyone could imagine.

Appendix - Pfizer's Previous Settlements


For all our posts on Pfizer, look here.

In the beginning of the 21st century, according to the Philadelphia Inquirer, Pfizer made three major settlements,
- In 2002, Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor.
- In 2004, Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000.
- In 2007, Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug.

Thereafter,
- Pfizer paid a $2.3 billion settlement in 2009 of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post here).
- Pfizer was involved in two other major cases from then to early 2010, including one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post here).
- The company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post here).
- Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York in early 2011 (see post here). 
- In March, 2011, a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see this story in Bloomberg).
- In October, 2011, Pfizer settled allegations that it illegally marketed bladder control drug Detrol (see this post).
- In August, 2012, Pfizer settled allegations that its subsidiaries bribed foreign (that is, with respect to the US) government officials, including government-employed doctors (see this post).
- In December, 2012, Pfizer settled federal charges that its Wyeth subsidiary deceptively marketed the proton pump inhibitor drug Protonix, using systematic efforts to deceive approved by top management, and settled charges by multiple states' Attorneys' General that it deceptively marketed Zyvox and Lyrica (see this post).
- In January, 2013, Pfizer settled Texas charges that it had misreported information to and over-billed Medicaid (see this post).
- In July, 2013, Pfizer settled charges of illegal marketing of Rapamune (see this post.)
- In April, 2014, Pfizer settled allegations of anti-trust law violations for delaying generic versions of Neurontin( see this post).
- In June, 2014, Pfizer settled another lawsuit alleging illegal marketing of Neurontin (see this post).

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