Sabtu, 30 Januari 2016

Testing the Insulin Model: A Response to Dr. Ludwig healthpolicyandmarket

Dr. David Ludwig, MD, recently published a response to my critique of the carbohydrate-insulin-obesity hypothesis.  This is good because he defends the idea in more detail than I've encountered in other written works.  In fact, his piece is the most scientifically persuasive defense of the idea I can recall.

Before we dig in, I want to emphasize that this is science, not tribal warfare.  The goal is to arrive at the best answer, rather than to win an argument.  I'm proceeding in good faith, based on my belief that Ludwig and I are both serious people who care about science and human health, and I hope my audience will do the same.  That said, let's get to it.

Read more »

from Whole Health Source http://ift.tt/1QNzWnl Testing the Insulin Model: A Response to Dr. Ludwig healthpolicyandmarket

Jumat, 29 Januari 2016

Whom Can You Trust? - FTC Charges DeVry University, Sister School of American University of the Caribbean and Ross University Medical Schools, with Deceptive Marketing Health Service Home

Now there is another reason for Americans who aspire to medical careers to be concerned about applying to offshore medical schools.

Introduction

Admission to US medical schools is increasingly difficult.  So many who seek medical careers may be tempted to apply to schools outside the US.  In the last 30 years, American entrepreneurs have opened offshore medical schools, mostly in the Caribbean, that cater to US students.  They teach in English, and do not require immersion in an unfamiliar culture, so may be more attractive than medical schools in other countries whose mission is to educate physicians to practice in those countries. In 2010, Eckhert documented that the number of offshore medical schools, "for-profit institutions whose purpose is to train U.S. and Canadian students who intend to return home to practice," but not to train physicians to practice in the countries in which these schools are located, was rapidly growing.(1)  By 2010, there were 33 such schools, 20 of which were new since 2000.

Such offshore medical schools exist in a grey area.  The small countries or colonies in which they are located usually do not seek to regulate them, since the physicians they produce are going to practice elsewhere. There is no requirement that these offshore medical schools be accredited in the US.  Such  accreditation is currently not required for individual graduates of such schools to be admitted to US house-staff programs or for US licensure.  So perhaps it is not surprising that little is known about these schools.

How they choose students, the qualifications or even names of their faculty, their curriculum, how they supervise clinical training (which is mostly done by affiliated North American hospitals), and what happens to their graduates are obscure.  Eckhert attempted to describe what is known, but noted "variability exists in the availability of information on faculty; where data exists, it is noted that most of the permanent on-site basic science faculty are internationally trained, many have no documented medical education experience in the United States, and it is not uncommon for them to be OMS [offshore medical school] alumni."

Such information as is available about these schools comes from the schools themselves.


DeVry Accused of Deception


Yet now there is reason to be more suspicious about the information the schools choose to reveal.  This week, media reports documented that the US Federal Trade Commission (FTC) is suing DeVry University for allegedly "deceptive" recruiting practices.  DeVry University is a subsidiary of DeVry Education Group.  DeVry has two offshore medical schools as subsidiaries, the American University of the Caribbean School of Medicine, and Ross University School of Medicine.

Here is a summary from the Miami Herald,

On Wednesday, the Federal Trade Commission sued DeVry, which operates three Florida campuses, including one in Miramar, for 'deceptive' recruiting practices. The company is one of the nation’s largest for-profit colleges, with 50-plus U.S. campuses, and more than 41,000 students. In addition to the disputed 90 percent number [of graduates who found work in their chosen field], the FTC alleges DeVry also falsely advertised that its graduates 'earn 15% more than graduates from other colleges and universities.'

The allegations were that DeVry rigged the statistics:

The FTC suit alleges that DeVry fudged the numbers on its 90 percent job placement rate by leaving out some out students who weren’t finding jobs. This was done by classifying the students as not actively seeking employment, even though that wasn’t the case, the FTC says.

According to the FTC, DeVry also boosted its job placement numbers by counting students as placed in their field even when that clearly wasn’t accurate. Examples of DeVry’s 'in field' placements cited in the lawsuit include:

▪ A graduate from the technical management degree program working as a mail carrier.
▪ A business administration graduate working as a waiter at the Cheesecake factory.
▪ A business administration graduate working as a secretary at a prison.
▪ A technical management graduate working as a sales associate at Macy’s.

The Miami Herald reporter found at least one more example,

One former student at DeVry’s Miramar campus told the Herald that the school’s recruiter made it seem like his project management degree would lead to guaranteed employment. But after graduating in 2011, the student, who asked to be identified only by his first name, Luis, said he never got a callback from the more than 50 job postings he applied for.

Luis said he has $30,000 in student loans, and is working the same type of job he had before enrolling at DeVry, as a medical device technician.

A blog post on the Republic Report included two more examples,

graduates who majored in technical management working as unpaid volunteer positions at medical centers;

a business administration graduate with a health care management specialization working as a car salesman.

Not surprising, the corporate leadership of DeVry University denied the claims, and dismissed the evidence as "anecdotal examples that exaggerate the allegations but do not prove them."  They focused on the overall numbers, claiming that "there is no national standard for calculating employment statistics...."

 Yet they did not challenge the particular anecdoes, all of which seemed to be examples of unsuccessful placements claimed by the University to be the opposite.

Adding to Previous Concerns about DeVry Owned Offshore Medical Schools

In 2013, we posted about a Bloomberg investigative article about the two DeVry owned medical schools, at the American University of the Caribbean and Ross University.  The article focused on multiple issues:
-  high attrition rates of students compared to those in US based schools
-  inability of many students to complete clinical training in the customary two years
-  low rates of students matching to US residencies compared to US graduates
-  high costs for students, presumably a cause of their high levels of debt

Keep in mind that some of these concerns were based on statistics supplied by DeVry.  Yet now there is a new reason to be doubtful about their statistics.  Furthermore, while Eckhert wrote in 2010 that the increasing presence of offshore medical graduates in the US "obligates U.S. medicine to take a closer look at these educational programs," no such scrutiny has occurred since then. 


Summary

Outsourcing US medical education to offshore schools that largely escape regulation in the US, and in the countries in which they are located is another outstanding example of how the US has applied hyper market based solutions to health care. While more US students are attending such schools, and often paying a high price and incurring high indebtedness for the privileges of doing so, there are many reasons to be doubtful about the quality of the education they may receive, and the likelihood of their long-term success as physicians.

Yet health care, and particularly the quality of education received by those who practice medicine in the US, could be viewed as a public good.  Dubious training of US doctors affect not only the doctors themselves, but their patients' and the public's health.  Outsourcing this education could put a lot of people at risk.

However, it does provide an attractice opportunity for the managers of the outsourced system to make money.  Per the DeVry Education Group 2015 proxy statement, CEO received $5,343,407 in total compensation that year, and owned over one million shares of stock (currently valued at just under $20 million).  Four other named officers each received at least $1 million.

So, we see another aspect of the US health care system in which money seems to trump mission, facilitated by an unseemly alliance between wealthy corporate executives and bad US government policy.  We need to reexamine our fascination for "market based" approaches to health care, when almost nothing about any part of health care resembles, or could resemble a free market.  We need to make health care more transparent, and shine more sunshine on the nooks and crannies, like off-shore but US corporate owned medical schools.  We need to facilitate health care leadership and governance that puts patients' and the public's health first, way ahead of the personal enrichment of the participants.  

As long as the US continues its light touch regulation of the outsourced offshore system which now educates increasing numbers of US doctors(2), Americans who want to become doctors ought to be very skeptical about the futures they may face if they choose to go to such offshore schools. 

References

 1.  Eckhert NL.  Private schools of the Caribbean: outsourcing medical education.  Acad Med 1010; 85: 622-630.  Link here.
2.  Eckhert NL, van Zanten M.  U.S.-citizen international medical graduates - a boon for the workforce? N Engl J Med 2015; 372: 1686-7.  Link here.

from Health Care Renewal http://ift.tt/1Vw14GH Whom Can You Trust? - FTC Charges DeVry University, Sister School of American University of the Caribbean and Ross University Medical Schools, with Deceptive Marketing Health Service Home

Kamis, 21 Januari 2016

Health Care Managers as Ever More Effective Value Extractors - Following Up on Novant Health and Cape Cod Healthcare Health Service Home

The ever increasing compensation of top managers of health care organizations provides incentives to continue business as usual.  We have frequently discussed executive compensation for top health care leaders that seems wildly disproportionate to their contribution to their organizations' health care mission.

Furthermore, not only does executive compensation seem to have anti-gravity properties, rising even at institutions facing financial challenges, or while other employees face salary cuts and job loss, but it continues even after the lack of justification for it has been called out.

Herein we discuss two examples of continuing anti-gravity compensation that occurred at institutions we have previously cited for similar problems.  These are discussed in the order of their appearance in the media.  


Novant Health
 
In 2011, we first noted that executives of Novant Health, headquarted in Winston-Salem, NC, were getting raises while they were laying off  more lowly employees.  Then in 2014, we posted about more raises going to Novant executives, again while more lowly employees had their pay cut.

Recently, in December, 2015, Richard Craver, writing for the Winston-Salem Journal, discussed the latest (2014) compensation figures from Novant Health.

Carl Armato, chief executive and president of Novant Health Inc., received a 14.4 percent jump in salary during fiscal 2014 to $1.19 million.

In addition,

Armato is in his fourth year as the system’s top executive. His salary has risen 70.9 percent since he took over as the top executive Jan. 1, 2012, following the retirement of Paul Wiles.

Armato’s incentive compensation increased less than 1 percent to $919,738. Altogether, Armato’s core compensation was $2.59 million.

Other top executives also did very well,

Jeff Lindsay, chief operating officer, received $709,856 in salary, $382,813 in bonus and incentive pay and overall core compensation of $1.23 million. Lindsay, former president of Forsyth Medical Center, was not listed among Novant’s top executives in fiscal 2013.

For the 27 listed current executives, as of Dec. 31, 2014, on Novant’s Form 990 filing with the Internal Revenue Service, the system spent $12.17 million on salaries and $8.73 million on bonuses and incentive pay.

Specifically,

Seven other listed Novant Health Inc. executives received at least $442,000 in salary and core compensation of at least $517,000 for fiscal 2014.

* Fred Hargett, chief financial officer, received a 15.9 percent raise in salary to $708,924, bonus and incentive pay of $565,120 and overall core compensation of $1.54 million.

* Jesse Cureton, chief consumer officer, received a 14.2 percent raise in salary to $573,683, bonus and incentive pay of $472,173 and overall core compensation of $1.07 million.

* Jacqueline Daniels, chief administrative officer, received a 3.9 percent raise in salary to $565,283, bonus and incentive pay of $518,631 and overall core compensation of $1.13 million.

* Sallye Liner, former chief clinical officer, received a 2.9 percent raise in salary to $516,171, bonus and incentive pay of $474,991 and overall core compensation of $1.05 million.

* Dr. Thomas Zweng, chief medical officer, received $470,217 in salary, bonus and incentive pay of $282,014 and overall core compensation of $790,191.

* John Phipps, president of Novant Medical Group, received $459,024 in salary, bonus and incentive pay of $377,219 and overall core compensation of $873,015.

* Peter Brunstetter, chief legal officer, received $442,116 in salary, bonus and incentive pay of $45,000 and overall core compensation of $517,765.

The hospital system trotted out some of the usual talking points used to justify very high pay for top executives.

Novant, like most health care systmes serving North Caroling, says high compensation levels are necessary to recruit and retain executives to run 'a very complex organization.'

That was nearly identical to what they said last year,

Novant, as do most not-for-profit health-care systems serving North Carolina, stresses high compensation levels are necessary to attract executives to run 'a very complex organization.'

Furthermore, the system's board of trustees say

bonuses and incentives are based on annual and three-year goals that 'focus on the quality and safety of health care, improving the patient experience, transforming to an electronic health record, financial stewardship and providing community benefit.'

To put that in perspective, the 27 top executives are about 0.1% of the system's total workforce of "about 25,000."  The $20.9 million used for their salaries, bonuses, and incentive pay (but apparently not retirement benefits and other perks) amounted to 0.55% of the system's total revenue (of about $3.79 billion) and approximately 1% of the approximately $2 billion the system spent on all employee salaries and benefits (according to the Novant 2014 financial statement).

However, just a month before, the Triad Business Journal and Mr Craver again in the Winston-Salem Journal covered a case that certainly questioned the "financial stewardship" of Novant top management, but did seem like some sort of parody of the "community benefit" they provided. Per the former,

Novant Health has reached a preliminary settlement with a group of current and former employees over handling of their retirement plans, with the health system agreeing to pay $32 million and make changes going forward.

The proposed settlement has been agreed to by Novant and the seven plaintiffs, which include a variety of doctors, nurses and other health care workers,...

The point of the litigation was

what plaintiffs claim are excessive fees associated with the system's retirement plan along with 'kick-backs' to a Triad businessman with a long-standing relationship with the health system.

The complaint alleged that during a three-year period starting in 2009, the plan paid excessive compensation of close to $18 million to Colorado-based Great-West Life & Annuity Insurance Co. and brokerage firm D.L. Davis & Co., based in Winston-Salem and operated by CEO and President Derrick Davis.

Along with the allegations of excessive fees, the plaintiffs claimed that entities owned or controlled by Davis benefited from real estate and development deals with Novant Health.

Also,

The agreement would also bar Davis and his companies from being involved in the management of Novant Health retirement plans and would prohibit Novant from entering into any new real estate deals or business relationships with Davis and his companies for at least four years.

As is customary in such cases, a Novant statement said its leadership "do not agree with the claims in the lawsuit," but agreed to the large settlement and other stipulations apparently to avoid "a long and costly legal battle."  But if the complaint was unfounded, how would it be good stewardship not to contest it?  Of course, were it to be true, then there would be even more evidence of poor stewardship.

In fact, for full disclosure, I got to add my skepticism about how Novant recompenses its managers in the text of Mr Craver's December, 2015, article,

'Each organization seems to have their own set of metrics, often frequently adjusted, and that somehow always make their own executives seem good,' Poses said.

'Every organization thinks their executives are above average,' Poses said. 'There are no overseers willing to question executive pay, since boards are mainly executives of other organizations; and executives are always compared only with other executives.' 

Somehow, I doubt that any Novant executives or board members would care about what I said, or that Novant executive pay will not continue to climb, unless push comes to shove.

Cape Cod Healthcare

In January, 2015, we blogged about how the former CEO of Cape Cod Healthcare had been collecting severance pay for 3 years, totaling more than $3 million, after he abruptly left his  and after being sanctioned by the state medical board for faulty prescribing abusable psychoactive drugs (which he allegedly took himself) ; and it was revealed that there were concerns about financial mismanagement at the health care system which he formerly ran.  While CEO of Cape Cod he also presided over multiple layoffs, some of which were of clinical personnel.  At that time, of course, the system board of trustees defended his leadership because they said it improving system finances.

No, on January 14, 2016 the Cape Cod Times reported,

For the fourth year since abruptly leaving Cape Cod Healthcare, former CEO Dr. Richard Salluzzo pulled in a hefty paycheck, according to new financial reports filed with the state attorney general’s office.

Since parting ways with the nonprofit corporation in November 2010, Salluzzo has taken in about $3.5 million, including $407,371 for the most recent year on file, fiscal 2014.

In many ways, this report doubled down on the previous 2015 version. Dr Salluzzo did not merely preside over layoffs, but

During his tenure Salluzzo presided over what he called the largest job cut in Cape Cod Healthcare’s history, a layoff of about 200 employees, in addition to bringing about improvements such as better billing.

The chairman of the system's board of trustees did not merely defend Salluzzo's financial results, but

'The actual performance was just phenomenal,' [Chairman William] Zammer said. 'We have a healthy, vibrant health care system.'

The Cape Cod Times suggested that observers outside the hospital system begged to differ,

But a professor of business ethics at Bentley University in Waltham questioned the extent of Salluzzo’s 'golden parachute,' while the spokesman for a nurses union called it 'outrageous.'

'These post-employment payouts must have been in his initial contract,' said W. Michael Hoffman, executive director of the center for business ethics at Bentley.

'It does sound crazy and wrong given the amount of his golden parachute,' Hoffman said in an email.

'It’s unconscionable we’re still paying someone who left under questionable circumstances,' said David Schildmeier, spokesman for the Massachusetts Nurses Association.

Schildmeier said the money would be better spent on patient care, especially since Cape Cod Healthcare draws a large percentage of its patient revenue from taxpayer-funded Medicare and MassHealth programs.

Dr Salluzzo is gone, but I doubt that the board of trustees is listening to these critics, and again unless push comes to shove, I suspect the new CEO will find his position to be very remunerative.

Summary

As I said in 2015,...

 As health care organizations have become increasingly big and influential, their leadership has been increasingly in the hands of generic professional managers, not health care professionals.  These hired managers have commanded generous and ever increasing pay, which has been justified by the common talking points: managers have extremely hard jobs and are brilliant, and high pay is necessary in a competitive market to attract and maintain top leaders.

Yet none of the boosters of high pay for health care managers, who mainly seem to consist of the legal, marketing, and public relations personnel who answer to them, and occasionally the board members who also are hired manager, answer the obvious questions:
What is the evidence that managers are brilliant and their jobs are so hard, especially when compared to the highly-trained health care professionals at their own institutions?
Is their really a free market in hired managers, and why is it so isolated from the market for health care professionals and other people employed by health care organizations?

These justifications seem particularly ridiculous when managers whose results are obviously not brilliant, e.g., marked by deficits, losses, and lay-offs, are getting huge and increasing pay.  They also seem ridiculous when the "market" apparently dictates salary cuts and lay-offs for all employees other than the managers of a particular organization.

 Instead, it seems likely that hired health care managers make more and more because of the influence they have on their own pay.  This influence is partially generated by their control over their institutions' marketers, public relations flacks, and lawyers.  It is partially generated by their control over the make up of the boards of trustees who are supposed to exert governance, especially when these boards are subject to conflicts of interest and  are stacked with hired managers of other organizations.  Furthermore, per the dogma of pay for performance, their pay may be heavily tied to short-term financial results, rather than fulfillment of the patient care or academic mission.

Thus, as in the larger economy, non-profit hospital managers have become "value extractors."  The opportunity to extract value has become a major driver of managerial decision making.  And this decision making is probably the major reason our health care system is so expensive and inaccessible, and why it provides such mediocre care for so much money.

So to repeat, true health care reform would put in place leadership that understands the health care context, upholds health care professionals' values, and puts patients' and the public's health ahead of extraneous, particularly short-term financial concerns. We need health care governance that holds health care leaders accountable, and ensures their transparency, integrity and honesty.


So push needs to come to shove.  I just posted that generic management/ "managerialism" just drove physicians who are corporate employees of one big health care system to unionize and contest their working conditions and other outcomes of generic management.  I submit that to get true health care reform, physicians, health care professionals, and members of the public concerned about our ever more expensive, yet constantly declining health care system need to do more than just read angry blog posts.

But until they do, I guess I will have an infinite number of follow-up posts, like this one, to write.  

from Health Care Renewal http://ift.tt/1RWFk9i Health Care Managers as Ever More Effective Value Extractors - Following Up on Novant Health and Cape Cod Healthcare Health Service Home

Rabu, 13 Januari 2016

Death of EHR "Meaningul Use" imminent. (Hopefully the death of the 'National Programme for Health IT in the HHS' is imminent, too.) Health Service Home

I've written a number of posts on the Orwellian-named "Meaningful Use" experiment with electronic health records systems, imposed upon United States physicians by the Department of Health and Human Services through its Office of the National Coordinator for Health Information Technology (ONC).

See these posts and others retrieved by query link http://ift.tt/1TVwYfd:

Meaningful Use Final Rule: Have the Administration and ONC Put the Cart Before the Horse on Health IT?

Meaningfully Experimental Protocols and Interfaces to Nowhere? Nagging Questions On Healthcare IT Remain

Science or Politics? The New England Journal and "The 'Meaningful Use' Regulation for Electronic Health Records"

"Meaningful Use" not so meaningul: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing

EHRs and "Meaningful Use": Begging the Question in the New England Journal of Medicine

The Scientific Justification for Meaningul Use, Stage 2: The NWB Methodology

Meaningful Use and the Devil in the Details: A Reader's View

  
In these posts and others I expressed significant skepticism about the 'Meaningful Use' scheme.

But what did I know?  Our betters in government and academia knew far better how to seriously annoy physicians, make more burdensome (and hence more dangerous) the already onerous task of EHR use, and waste the tax money we hard-working Americans pay to an increasingly bloated bureaucracy that acts as if money grows on trees (the U.S. debt has doubled in recent years to almost $19 billion, see http://ift.tt/s7OFL1).

From the horse's mouth (or perhaps the animal's other end) at http://ift.tt/1P5lFAJ:

Meaningful Use Defined

Meaningful use is using certified electronic health record (EHR) technology to:
  • Improve quality, safety, efficiency, and reduce health disparities
  • Engage patients and family
  • Improve care coordination, and population and public health
  • Maintain privacy and security of patient health information

I note that none of this was backed by science at the time of its formulation.

The end result of the MU experiment is this:

CMS’s Slavitt: End of meaningful use imminent in 2016
Internal Medicine News
WHITNEY MCKNIGHT
January 12, 2016
http://ift.tt/1niVGfm

Meaningful use is on its way out.

Andy Slavitt, acting administrator of the Centers for Medicare & Medicaid Services, told investors attending the annual J.P. Morgan Healthcare Conference that CMS is pulling back from the health care IT incentive program in the coming months.

“The meaningful use program as it has existed will now be effectively over and replaced with something better,” Mr. Slavitt said. Without providing full details, he said that March 25 would be an important date as concerns the rollout of the new health IT initiatives.

The waste of resources and time, and the alienation of physicians by this grand(-ly foolish) experiment is significant:

“We have to get the hearts and minds of physicians back. I think we’ve lost them,” Mr. Slavitt said.

No foolin'.  Ya think?

This was predictable by anyone with half a brain about healthcare information technology reality.  (It's a real loss that hyper-enthusiast health IT geniuses responsible can't be fired and banned from the domain of healthcare - for life.)

Perhaps the officials at HHS got their first clue about clinician unhappiness via a long January 2015 letter from about 40 medical societies, including the AMA, American College of Physicians, American College of Surgeons, and numerous others that they did not exactly love these systems and the MU experiment.  See my January 28, 2015 post "Meaningful Use not so meaningful: Multiple medical specialty societies now go on record about hazards of EHR misdirection, mismanagement and sloppy hospital computing" at http://ift.tt/1BoAqEj and the letter itself at http://ift.tt/1xDWBoW.

He noted that, when the meaningful use incentive program began, few physicians and practices used electronic health records and concerns were that many would not willingly embrace information technology. Now that “virtually everywhere care is delivered has a computer,” it’s time to make health care technology serve beneficiaries and the physicians who serve them, Mr. Slavitt said.

The revealing nature of this candid statement is breathtaking.  He's admitting that 1) many physicians, rightfully reluctant to not "willingly embrace" IT, had the technology imposed upon them by government (due to its "concerns") via penalties for non-adopters and 2) with the systems in the physicians' faces at the cost of hundreds of billions of dollars that could have been better spent on healthcare itself (e.g., for those subject to 'disparities", i.e., the poor), now it's time to make the systems serve patients and physicians.

Brilliant.

The cost, however, was too high, Mr. Slavitt said. “As any physician will tell you, physician burden and frustration levels are real. Programs that are designed to improve often distract. Done poorly, measures are divorced from how physicians practice and add to the cynicism that the people who build these programs just don’t get it.”

The 'cynicism' (def: inclination to believe that people are motivated purely by self-interest; skepticism) that the builders of these programs don't "get it?"  It's not cynicism.  It's a rational conclusion arrived at via empirical observation.

I also recall in the not-so-distant past that physician complaints were dismissed as the complaints of "Luddites."  I've heard this at Informatics meetings, at medical meetings, at commercial health IT meetings (e.g., Microsoft's Health Users Group, and at HIMSS), at government meetings (e.g., GS1 healthcare), and others.

It's rewarding to finally have government officials admit those charges were, to be blunt about it, lies or delusions.

Soon, CMS will no longer reward health care providers for using technology, but will instead focus on patient outcomes through the merit-based incentive pay systems created by last year’s Medicare Access and CHIP Reauthorization Act (MACRA) legislation. 

Perhaps that's a move in the right direction; time will tell.  However, I'm sure physicians have GREAT confidence in how well that will work out, yet another government experimental project.

In addition to asking physicians to work with health care IT innovators to create systems that work best according to their practice’s respective needs, CMS is calling on the private sector to create apps and analytic tools that will keep data secure while fostering true and widespread interoperability.

This is in the realm of delusion.  Physicians "asked" to "work with" (for free?) the same "innovators" (i.e, health IT companies) whose "innovation" led to the massive disaffection for today's health IT, and the burdens that technology has placed on the medical profession, nurses and other clinicians as well?   Further, it's actually believed that the companies will listen, when they've failed to do so for several decades running?  My head spins.

Anyone seeking to block data transfer will find CMS is not their friend. Mr. Slavitt said. “We’re deadly serious about interoperability. Technology companies that look for ways to practice data blocking in opposition to new regulations will find that it will not be tolerated.”

And who, exactly, is going to enforce that edict on proprietary systems, which health IT companies view (correctly, from the business perspective) as giving them a competitive edge?  I'm sure the health IT companies, who now hold medicine captive, are shaking in their boots.

Dr. James L. Madara, CEO of the American Medical Association, echoed Mr. Slavitt’s comments on the current, negative impact of EHRs on physicians’ practices. He noted that many physicians are spending at least 2 hours each workday using their EHR and may click up to 4,000 times per 8-hour shift.

I should open a clinic for health IT-caused carpal tunnel syndrome and repetitive motion injuries.  Oh wait!  There's no ICD-10 code for that to bill (see http://ift.tt/1O9jfQi).

Dr. Madara outlined three AMA goals to help restore the physician-patient relationship. The first is to restructure the medical school curriculum, which he said essentially is the same as it has been for 100 years. New generations of physicians should be taught how to deliver collaborative care that includes telemedicine, more ambulatory care, and home care. Community-based partnerships, he said, would become key to treating chronic diseases like diabetes and would have to be factored into reimbursement models. The AMA also seeks to improve health outcomes and ensure thriving physician practices.

Central to the AMA’s plan for the future: Helping physicians restructure practice via technology. He announced that the AMA is a founding partner in the Silicon Valley (Calif.) based Health2047, a company focused on supporting health IT and other entrepreneurs in their efforts to provide physicians with digital tools that improve patient outcomes, among other innovations.

As to "helping physicians restructure practice via [information] technology", this seems an example of what I termed "Heath IT hyper-enthusiasm" writ large.  See My March 11, 2012 post "Doctors and EHRs: Reframing the 'Modernists v. Luddites' Canard to The Accurate 'Ardent Technophiles vs. Pragmatists' Reality" at http://ift.tt/1mtvl94.

What is needed, as I have repeatedly written, is not to have physicians "restructure" practice to adopt to IT, rather to restructure IT (the systems themselves, the developmental methodologies, the backgrounds of the industry leadership, the industry itself) to match the needs of physicians and patients.

The AMA holds a minority of the nation's physicians as members; a 2011 article "American Medical Association membership woes continue" (CMAJ. 2011 Aug 9; 183(11): E713–E714, http://ift.tt/KDGUfn) indicated this:

In the early 1950s, about 75% of US physicians were AMA members. That percentage has steadily decreased over the years. In June, at the annual meeting of its policy-making body, the House of Delegates, the AMA announced that it lost another 12 000 members last year. That brings total membership below 216 000. Up to a third of those members don’t pay the full $420 annual dues, including medical students and residents. Not counting those members, somewhere in the neighbourhood of 15% of practising US doctors now belong to the AMA.

Hair-brained schemes to "restructure practice via technology" will likely drop those numbers further.

The National Programme for IT in the NHS (NPfIT) died several years ago (http://ift.tt/1BoAqEk).

It is my hope the death of "meaningful use" heralds the death of the equally wasteful and ill-thought-out National Program for health IT in the HHS, a.k.a. HITECH, and a return to recognition of the truth: that health IT is experimental, that it (and its subjects) must be treated with that in mind, that its progress cannot be mandated, and that the technology, as any other IT, needs to be approached with great skepticism e.g. per 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

-- SS



from Health Care Renewal http://ift.tt/1SOPs2M Death of EHR "Meaningul Use" imminent. (Hopefully the death of the 'National Programme for Health IT in the HHS' is imminent, too.) Health Service Home

Sabtu, 09 Januari 2016

Always Hungry? It's Probably Not Your Insulin. healthpolicyandmarket

David Ludwig, MD, recently published a new book titled Always Hungry? Conquer cravings, retrain your fat cells, and lose weight permanently.  The book is getting widespread media coverage.  Ludwig is a professor of pediatrics at the Harvard Medical School and a professor of nutrition at the Harvard School of Public Health.  He's a pediatric endocrinologist, but his primary focus is research, particularly the impact of nutrition on hunger, calorie expenditure, and body weight.  Although I sometimes disagree with how he interprets evidence, he has made significant and useful contributions to the scientific literature in these areas, and I also support his efforts to find policy solutions to curb the intake of sweetened beverages and other junk foods.  In the grand scheme of things, he's an ally in the fight to improve the American diet.

Ludwig has written several high-profile op-ed pieces in recent years, both in the popular press and in scientific journals (1, 2).  He argues that our understanding of eating behavior and obesity may be all wrong, and that our focus on calories may be leading us away from the true cause of obesity: hormonal imbalance.  And the primary culprit is insulin.  You might recognize this idea, because it's similar to the one that science journalist Gary Taubes developed in his book Good Calories, Bad Calories.

According to this view, overeating is irrelevant.  We gain fat because our insulin levels are too high, leading our fat tissue to take up too much fat, and other tissues to take up too much glucose, causing our blood energy levels to drop and resulting in fat gain, hunger, and fatigue.  The ultimate cause of the problem is the rapidly-digesting carbohydrate and sugar we eat.  This idea is encapsulated by Ludwig's quote, "Overeating doesn't make you fat.  The process of getting fat makes you overeat" (3).

Here are eleven facts that may make you question this line of reasoning:
Read more »

from Whole Health Source http://ift.tt/1IWgenE Always Hungry? It's Probably Not Your Insulin. healthpolicyandmarket

Health Care Corruption Workshop Slildes Now Online Health Service Home

Slides from the workshop entitled Defense Against the Dark Arts - Understanding and Challenging Health Care Corruption given by Dr Roy Poses and Dr Wally Smith at the Physicians for a National Health Plan (PNHP) meeting, October, 2015, in Chicago, IL, US, are now online here. There also is a link to the slides on our Past Meetings and Events page.

from Health Care Renewal http://ift.tt/1ZiZf6e Health Care Corruption Workshop Slildes Now Online Health Service Home

Jumat, 08 Januari 2016

Yet another observation that known health IT injuries and deaths are "the tip of the iceberg" Health Service Home

I've noted a new observation of the limited data available on health IT harms being the (quote) "tip of the iceberg."

This statement appears in "Electronic Health Record–Related Events in Medical Malpractice Claims", Gruber et al., J. Patient Saf 2015, http://ift.tt/1kTnh4Y (PDF available free from link on right side of page.)

From the abstract:

Background: There is widespread agreement that the full potential of health information technology (health IT) has not yet been realized and of particular concern are the examples of unintended consequences of health IT that detract from the safety of health care or from the use of health IT itself. The goal of this project was to obtain additional information on these health IT-related problems, using a mixed methods (qualitative and quantitative) analysis of electronic health record-related harm in cases submitted to a large database of malpractice suits and claims.

Methods: Cases submitted to the CRICO claims database and coded during 2012 and 2013 were analyzed. A total of 248 cases ( less than 1%) involving health IT were identified and coded using a proprietary taxonomy that identifies user- and system-related sociotechnical factors. Ambulatory care accounted for most of the cases (146 cases). Cases were most typically filed as a result of an error involving medications (31%), diagnosis (28%), or a complication of treatment (31%). More than 80% of cases involved moderate or severe harm, although lethal cases were less likely in cases from ambulatory settings. Etiologic factors spanned all of the sociotechnical dimensions, and many recurring patterns of error were identified.

Conclusions: Adverse events associated with health IT vulnerabilities can cause extensive harm and are encountered across the continuum of health care settings and sociotechnical factors. The recurring patterns provide valuable lessons that both practicing clinicians and health IT developers could use to reduce the risk of harm in the future.

Note the statement at pg. 5:

... The actual incidence of harm cannot be reliably estimated from this data; nonetheless, it is generally agreed that safety events represented in malpractice claims are the ‘tip of the iceberg', insofar as the vast majority of cases, even cases that involve harm, do not result in suits.

I've heard claims that up to 95% of potential meritorious medical malpractice suits never make it to the lawsuit stage due to difficulties in, and costs of, prosecution.  Anecdotally, the latter observation corresponds to my own family's experience; several attorneys would not take my mother's EHR-related medical malpractice case initially, due to her age and concerns about expenses.

I note at my post today "Repeated crushing by alligators and crocodiles: ICD-10 has you covered. Harmed by bad health IT? No codes for that" at http://ift.tt/1O9jfQi that repeated attacks and crushings by creatures of Order Crocodilia are well-covered by ICD-10, but health IT harms do not appear to be covered by the same mandatory coding system.  My view is that this is likely by design, not due to lack of knowledge of these events by ICD-10 experts involved in creating this coding system.

  • Other use of that same "tip of the iceberg" phrase of which I have written:

FDA CDRH Director Jeff Shuren MD, JD's statement that the known risks are "the tip of an iceberg" at the HIT Policy Committee, Adoption/Certification Workgroup on February 25, 2010, where the topic was "HIT safety" (The text is available at http://ift.tt/1OSEQjC):

... In the past two years, we [FDA] have received 260 reports of HIT-related malfunctions with the potential for patient harm – including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist.

ECRI Institute:  http://ift.tt/1kTngxS.com/print/TEC-290834/HIT-Errors-Tip-of-the-Iceberg-Says-ECRI:

HIT Errors 'Tip of the Iceberg,' Says ECRI
Cheryl Clark, for HealthLeaders Media , April 5, 2013

Healthcare systems' transitions from paper records to electronic ones are causing harm and in so many serious ways, providers are only now beginning to understand the scope.

... Karen Zimmer, MD, medical director of the institute, says the reports of so many types of errors and harm got the staff's attention in part because the program captured so many serious errors within just a nine-week project last spring.  The volume of errors in the voluntary reports was she says, "an awareness raiser."

"If we're seeing this much under a voluntary reporting program, we know this is just the tip of the iceberg; we know these events are very much underreported."

Tip of the iceberg:  ignore it at your peril

 -- SS

from Health Care Renewal http://ift.tt/1S945OR Yet another observation that known health IT injuries and deaths are "the tip of the iceberg" Health Service Home

Repeated crushing by alligators and crocodiles: ICD-10 has you covered. Harmed by bad health IT? No codes for that. Health Service Home

Your government at work, spending your tax dollars and making your doctors want to retire early due to increasing bureaucratic busywork. The new ICD-10 coding system they must now use has codes like these, in case you get attacked by a crocodile or alligator.

It even has codes for repeat crushing by the critters...

Notably missing: there are no codes for harms caused by defective, mis-designed or badly implemented electronic medical records/ordering/lab review systems...

From the CMS ICD-10 search page at http://ift.tt/1N9EmnO:

ICD-10 Code    ICD-10 Code Description
W58.11XA    Bitten by crocodile, initial encounter
W58.11XD    Bitten by crocodile, subsequent encounter
W58.11XS    Bitten by crocodile, sequela
W58.12XA    Struck by crocodile, initial encounter
W58.12XD    Struck by crocodile, subsequent encounter
W58.12XS    Struck by crocodile, sequela
W58.13XA    Crushed by crocodile, initial encounter
W58.13XD    Crushed by crocodile, subsequent encounter
W58.13XS    Crushed by crocodile, sequela
W58.19XA    Other contact with crocodile, initial encounter
W58.19XD    Other contact with crocodile, subsequent encounter
W58.19XS    Other contact with crocodile, sequela

Of course, species of Crocodilia matters (http://ift.tt/1gi21Cz):

W58.01XA    Bitten by alligator, initial encounter
W58.01XD    Bitten by alligator, subsequent encounter
W58.01XS    Bitten by alligator, sequela
W58.02XA    Struck by alligator, initial encounter
W58.02XD    Struck by alligator, subsequent encounter
W58.02XS    Struck by alligator, sequela
W58.03XA    Crushed by alligator, initial encounter
W58.03XD    Crushed by alligator, subsequent encounter
W58.03XS    Crushed by alligator, sequela
W58.09XA    Other contact with alligator, initial encounter
W58.09XD    Other contact with alligator, subsequent encounter
W58.09XS    Other contact with alligator, sequela

Haven't searched ICD-10 for "abduction and experimentation by Roswell Greys" yet.


What's the ICD-10 code for this?

-- SS

from Health Care Renewal http://ift.tt/1O9jfQi Repeated crushing by alligators and crocodiles: ICD-10 has you covered. Harmed by bad health IT? No codes for that. Health Service Home

Kamis, 07 Januari 2016

Generic Management of Health Care Non-Profits, Brought to You by Leaders of (Sometimes Failed, or Bailed Out) Finance on the Board? Health Service Home

Introduction - Managerialism

 We have frequently posted about what we have called generic management, the manager's coup d'etat, and mission-hostile management. Managerialism wraps these concepts up into a single package.  The idea is that all organizations, including health care organizations, ought to be run people with generic management training and background, not necessarily by people with specific backgrounds or training in the organizations' areas of operation.  Thus, for example, hospitals ought to be run by MBAs, not doctors, nurses, or public health experts.  Furthermore, all organizations ought to be run according to the same basic principles of business management.  These principles in turn ought to be based on current neoliberal dogma, with the prime directive that short-term revenue is the primary goal.

One Explanation - Finance Leaders Ascendant on the Boards of Health Care Non-Profits

I just found a useful article that provides one explanation for the rise of managerialism in health care non-profit organizations.  It postulated that the increasing prevalence of leaders of finance firms on the baords of trustees of such organizations led to increasingly managerialistic leadership.

Thanks to a link from Naked Capitalism to a post on ShadowProof that led to an article in the Stanford Social Innovation Review by Garry W Jenkins, entitled, "The Wall Street Takeover of Nonprofit Boards."  It described a study of the membership of the boards of 23 of "the nation's leading private research universities," most of which have medical schools and academic medical centers, and all of which have major biomedical and/ or health care research operations, as well as leading liberal arts colleges and large New York City non-profit organizations, including a few hospitals.  (We will restrict our discussion of the quantitative results to the former group of leading universities.)

The most important result was that 40% of trustees of the universities in 2014 "had a substantial professional career in finance," up from 19% in 1989.  Futhermore, in 2014, 56% of university board leadership positions were held by people from finance, up from 26% in 1989.   The author noted that the prevalence of people from the finance sector on university boards was far bigger than their prevalence in the population.  Only 6% of the private non-farm workforce in the US was in finance in 2012.

The author summarized his findings:

Over the past twenty-five years the compostion of the boards at some of America's most important nonprofit organizaI I has dramatically changed. Without much notice, a legion of Wall Street executives (investment bankers, hedge fund managers, and others) has taken a growing number of seats in nonprofit boardrooms. Not only that, they hold a disproportionate share of the leadership positions on these boards.

He then linked the increasing dominance of non-profit governance to the increasing tendency of these organizations to be run like for-profit businesses, that is, the rise of "managerialism."

Scholars and practitioners have documented various pressures placed on nonprofit organizations by donors and private foundations to adopt business approaches.

Although some of the pressure to adopt business approaches has come from external forces, it may also be true that the concepts and norms of philanthrocapitalism are also now carried into nonprofit organizations by the directors of public charities themselves.

He then provided a much more detailed discussion:

As financiers come to dominate the boards of leading nonprofits, it is not surprising that their approaches and priorities have made their way, very explicitly and fundamentally, into the governance of the nonprofit sector. Practices such as data-driven decision-making, an emphasis on metrics, prioritizing impact and competition, managing with three- to five-year horizons and plans, and advocating executive-style leadership and compensation have all become an essential part of the nonprofit lexicon.

Nonprofit leaders regularly hear about these finance practices from board members and donors whose native habitat is the financial services world. Moreover, nonprofit managers have come to accept them as reasonable principles upon which donors base their giving. More often than not, organizations are also expected to incorporate these principles in the management of the not-for-profit enterprises for which managers and boards share responsibility.

Although many of these business approaches may strengthen nonprofit capacity, we should also be mindful of the ways in which these same tools can morph into pathologies, ignore the costs or trade-offs associated with extending business thinking to the charitable sector, or distort organizational priorities. Numerous critics have written thoughtfully about the ways in which market-based thinking and approaches applied to the nonprofit sector provide false promise, with the potential to dilute charitable values, undermine long-term mission focus, incentivize small, incremental goals, and threaten shared governance and other forms of participatory problem-solving.

Beyond leading to the borrowing of financial concepts and tools in the boardroom, the rise in the number of nonprofit directors with ties to finance may also contribute to deeper changes in the underlying institutional values and motivations, a trend that economic sociologists refer to as the financialization of the nonprofit sector.

Financialization describes a spread of financial logics, influence, and strategies into new fields and organizations in ways that transform the culture, policies, and values of institutions.  Indeed, wealthy nonprofits-like colleges, universities, and museums-have long engaged with financial markets as endowment investors, but the scope and scale of today's nonprofit borrowing, aggressive debt financing, securitization transactions, and complex real estate transactions is unprecedented. Such shifts may affect the organization's strategic direction and orientation in a number of ways, including directing board and management attention to debt service, incentivizing organizations to invest resources on activities that return higher profit margins to cover debt service, elevating the centrality and importance of financial managers in strategic planning and decision-making, and increasing the need for and power of senior staff well versed in complex financial instruments.

The list of practices above and the description of financialization sound very much like standard operating procedures of generic management which we have previously described.  The discussion of pathologies above sounds similar to our discussions of how managerialism distracts from or undermines the mission.


The one quibble I have with Jenkins' discussion is that it puts almost the entire onus on the financial leaders on the boards of trustees, rather than the top managers of the organizations.  It may be that increasingly financialized boards hire increasingly generic managers, but there may be a symbiosis between the two groups.

So Jenkins' conclusion seems reasonable:

if boards are to operate as designed, and if they are to be maximally effective, then the composition of nonprofit boards must be more diverse and not dominated by financiers. 

But the problem of financial sector domination of health care non-profit boards may be even worse than that Jenkins describes.

The Dark Side of Finance

Even though Mr Jenkins is concerned about excess of influence of too many financially oriented people on the boards of non-profits, he is quite respectful of those in the finance field. "Individual finance professionals do bring skills, wisdom, and other positive attributes to nonprofit boards."  He also wrote, "This is not to say that finance professionals care less (or more) about a nonprofit organization or its mission.  Nor do I believe that all finance professionals think alike."  Many finance professionals may be very well-intentioned, of course.  But Jenkins seems to thus ignore the dark side of finance's recent history.

Finance firms are certainly known for the use of "financial logics, influence and strategies," and the employment of specific practices.  However, after 2008, they were also known for dangerously slipshod, if not unethical, sometimes corrupt management.  


In 2008, the global financial collapse/ great recession reshaped the global economy, and has been linked to the stagnation of the middle class and growth of plutocracy.  There have been numerous discussions of the role of the leadership of financial organizations in these events.  The blog Naked Capitalism has been covering these issues from the global financial collapse to the current day.  Some of the very many excellent sources on this era include the movie Inside Job,



and books such as Predator Nation by Charles Ferguson, 13 Bankers by Simon Johnson and James Kwak, and Bailout Nation by Barry Ritholtz.

A chapter in Predator Nation was entitled "Crime and Punishment: Banking and the Bubble as Criminal Enterprises.  In it, Mr Ferguson noted the following list of

prosecutable crimes committed during the bubble, the crisis, and the aftermath period by financial services firms ...

Securities fraud (many forms)
Accounting fraud (many forms)
Honest services violations (mail fraud statute)
Bribery
Perjury and making false statements to federal investigators
Sarbanes-Oxley violations (certifying false accounting statements)
RICO offences and criminal antitrust violations
Federal aid disclosure regulations (related to Federal Reserve loans)
Personal conduct offenses (many forms: drug use, tax evasion, etc)

Most of these never led to prosecution in an era of the revolving door and exceedingly lax law enforcement of actions by big corporations ("too big to jail")  Yet Ferguson argued for investigation of possible illegal acts by many large companies, and specifically named Citigroup, AIG, Lehman Brothers, Goldman Sachs, JP Morgan Chase as worthy of investigation.

Many of these organizations' leaders also were on the boards of health care organizations. Since 2008, we began noting that the governance of prominent health care non-profits was often dominated by finance firms, including those implicated in the 2008 collapse, although our observations were case-based, not quantitative.  The concern was not simply that health care organizations were being led into generic management and "managerialism," but that that the incompetence, unethical behavior, and corruption in the finance sector could cause equally bad problems in health care.  We have no systematic proof of that, but consider some of our more colorful cases, which include leaders of the financial firms named by Mr Ferguson...


2008

What Linked the Parallel Declines of Citigroup and the Harvard University Endowment? - In 2008, the collapse of the value of the Harvard endowment occurred on the watch of Harvard Corporation (board of trustees) members half of whom were leaders of big finance firms.

The Leadership of an Elite American University - Brought to You by the People Who Brought You the Global Financial Collapse - Six of the seven "charter trustee" members of the board of Dartmouth College who led a crusade, facilitated by packing the board with self-appointed as opposed to alumni elected members, to discredit elected board dissidents were leaders of big finance firms. Of the six new people whom they packed on as "charter trustees," half were also leaders of such firms.

2009

Hedge Fund U - Bernie Madoff, the supposed finance wizard who went to jail for a huge Ponzi scheme was on the board of Yeshiva University. The chairman of the board's finance committee was Ezra Merkin, a hedge fund operator who ran a "feeder" operation for Madoff's Ponzi scheme.

A Board of Trustees, or a Social Club for the Superclass? - Of the 29 non-physician board members of the Hospital for Special Surgery, 23 had major relationships with, and many of these had leadership roles in finance firms, including such bailed out, too big to fail firms as AIG, Bank of America, Citigroup, Goldman Sachs, JP Morgan Chase, and Wachovia.

2010

Members of the Board of Now Bankrupt Lehman Brothers as Leaders of Health Care? - Members of the board of Lehman Brothers, whose failure was related to the onset of the financial crisis, also served on the boards of Vanderbilt University, the American Red Cross (as CEO), New York - Presbyterian Hospital, New York University, and Tel Aviv University.

A "Very Well Paid Boob" on the Harvard Corporation? - the university's governing board included one of the architects of the overgrowth of Citigroup, which had to be bailed out, and also of the deregulation of finance which allowed the company to be too big to fail.

Failed Leaders of Citigroup as Leaders of Health Care - The bailed out Citigroup board of directors also served on the boards of trustees of Johns Hopkins Medicine, Health System and Hospital, Brown University, Tufts University, Columbia University, Howard University, the Rockefeller Foundation, Harvard (as mentioned above), and Cornell University. 

2012

New York - Presbyterian Hospital Trustee Advocated Novel Cardiac Procedure - "Reach In, Rip Out Their Heart, and Eat It Before They Die" - Richard Fuld, the former CEO of Lehman Brothers, whose failure was related to the onset of the crisis, and who once advocated, presumably only symbolically, eating the hearts of his financial competitors, was on the board of the prestigious hospital.

2014

The Medical School as Hereditary Plutocracy - Retiring Board Chair Sanford Weill of Cornell Weill Medical School Names His Own Daughter as New Chair - the board chairmanship of the medical school went from the former CEO and chairman of the bailed out, too big to fail Citigroup (see above) to his daughter, who runs her own finance firm.

Yet outside of a few grumpy bloggers, the continuing presence of leaders of too big to fail, too big to jail, often bailed out financial firms on the boards of some of our most notable health care organizations and universities has attracted almost no comment, and less concern.


Summary

The continuing dysfunction of US health care, with ever rising costs, stagnant quality, and still inadequate access, is well known.  There is constant loud argumentation over "Obamacare."  (Congress just passed a repeal of it, which the president has threatened to veto.)  Yet there is little in depth discussion or inquiry about what is really going wrong.  The really unpleasant issues rarely surface in polite discussion.  We have called this aversion to direct discussion of big problems the anechoic effect.

So I hope that there is more discusison of who gets to lead health care organizations, and who gets to sit on the boards that exercise stewarship over them.  We need far more light shined on who runs the health care system, using what practices, to what ends, for the benefits of whom.

True health care reform would enable transparent, honest, accountable governance and leadership that puts patients' and the public's health over ideology, self-interest, and self-enrichment.



from Health Care Renewal http://ift.tt/1ITo0i5 Generic Management of Health Care Non-Profits, Brought to You by Leaders of (Sometimes Failed, or Bailed Out) Finance on the Board? Health Service Home

Selasa, 05 Januari 2016

How Much do You Know About Your Own Brain? healthpolicyandmarket

We tend to believe we're aware of what's happening in our own brains, and also in conscious control of our behavior.  But a growing body of neuroscience and psychology research demonstrates that most of what happens inside the brain-- including the processes that cause us to select and execute behaviors-- is beyond our conscious awareness.  This has important implications for our eating behavior, body weight, and health, as I explore in my upcoming book The Hungry Brain.

Let me give you a straightforward example that illustrates how little of our brain's activity we're aware of.  It focuses on information processing by the visual system, which is one of the best-understood systems of the brain.  I drew the basic facts of this example from a recent talk by the accomplished neuroscience researcher Marcus Raichle, who studies patterns of activity in the human brain.

Read more »

from Whole Health Source http://ift.tt/1UuD5r4 How Much do You Know About Your Own Brain? healthpolicyandmarket

2016 Obamacare Outlook wholehealthsource



from Health Care Policy and Marketplace Review http://ift.tt/1O3QYuE 2016 Obamacare Outlook wholehealthsource

Minggu, 03 Januari 2016

Stealth Public Relations and Health Advocacy, Special Pleadings and the Opposition to Guidelines Discouraging Overuse of Narcotics Health Service Home

As I have written before as a physician who saw too many dire results of intravenous drug abuse, I was amazed how narcotics were pushed as the treatment of choice for chronic pain in the 1990s, with the result that the US was once again engulfed in an epidemic of narcotic abuse and its effects.  In mid-December, 2015, as reported in the Washington Post,

The nation continues to suffer through a widespread epidemic to prescription opioids and their illegal cousin, heroin. The CDC estimated that 20 percent of patients who complain about acute or chronic pain that is not from cancer are prescribed opioids. Health-care providers wrote 259 million prescriptions for the medications in 2012, 'enough for every adult in the United States to have a bottle of pills,' the CDC wrote.

Last week, the National Center for Health Statistics reported that the number of overdose deaths from legal opioid drugs surged by 16.3 percent in 2014, to 18,893, while overdose fatalities from heroin climbed by 28 percent, to 10,574. Authorities have said that previous efforts to restrict prescription drug abuse have forced some people with addictions to the medications onto heroin, which is cheaper and widely available.

This rising tide of death and morbidity seems to have been fueled by reckless, sometimes deceptive, sometimes illegal marketing by the pharmaceutical companies that produced narcotics other than heroin.

Background - Legal Drug Pushing

As I wrote in 2013,

the realization began to dawn that patients, doctors and society were being victimized by a new type of pusher man, this time dressed in a suit and working for an 'ethical' drug company.  In the earlier days of Health Care Renewal, we first posted (in 2006) about allegations of deceptive and unethical promotion of fentanyl by Cephalon that lead to its overuse by patients beyond those with cancer who were its ostensible target population.  Then in 2007 came the spectacular case of guilty pleas by a subsidiary of Purdue Pharma and several of its executives for 'misbranding' Oxycontin,  that is, promoting it far beyond any medically legitimate use in severe chronic pain.  Following that various investigations, well chronicled in the Milwaukee Journal Sentinel, showed how pharmaceutical companies employed deceptive marketing techniques, subverting medical education and research, and creating conflicted key opinion leaders and institutionally conflicted disease advocacy groups, to push more 'legal' narcotics  For example, see the Journal Sentinel reports the subversion of :  medical schools and their faculty; .medical societies, disease advocacy groups, and foundations; and guideline writing panels.  In 2012, we posted about how a drug company paid key opinion leader admitted to second thoughts about his role promoting narcotics.

As I described in that 2012 post, the new narcotic pushers relied on only the most sketchy evidence about the safety of prescription narcotics.  In the 1990s, they taught that the rate of addiction caused by prescribing legal narcotics was only 1%, but this was based on a tiny flawed case series of a mere 38 patients.  In 1996, a consensus statement from the American Academy of Pain Medicine and the American Pain Society, entitled "The Use of Opioids for the Treatment of Chronic Pain," included the following statements,

Pain is often managed inadequately, despite the ready availability of safe and effective treatments.

Studies indicate that the de novo development of addiction when opioids are used for the relief of pain is low.

Yet one of the primary proponents of profligate use of narcotics to treat chronic pain later admitted he

erred by overstating the drugs' benefits and glossing over risks. 'Did I teach about pain management, specifically about opioid therapy, in a way that reflects misinformation? Well, against the standards of 2012, I guess I did,' Dr. Portenoy said in an interview with The Wall Street Journal. 'We didn't know then what we know now.'

Also,

'I gave innumerable lectures in the late 1980s and '90s about addiction that weren't true,' Dr. Portenoy said in a 2010 videotaped interview with a fellow doctor. The Journal reviewed the conversation, much of which is previously unpublished.

In it, Dr. Portenoy said it was 'quite scary' to think how the growth in opioid prescribing driven by people like him had contributed to soaring rates of addiction and overdose deaths. 'Clearly, if I had an inkling of what I know now then, I wouldn't have spoken in the way that I spoke. It was clearly the wrong thing to do,' Dr. Portenoy said in the recording.


The CDC Attempts to Moderate the Use of Opioids for Chronic Pain

So to me it seems quite reasonable the US Center for Disease Control and Prevention (CDC), being cognizant of the rising toll of narcotic addiction, would attempt to do something about it.  As reported by the Washington Post,

The government on Monday urged primary-care physicians who prescribe opioids for pain relief to rein in their use of the drugs, proposing new guidelines that call for a more conservative approach than the one that has led to a crippling epidemic of addiction to the powerful narcotics.

Just a few days after a new report showed a surge of drug-related overdoses in 2014, the Centers for Disease Control and Prevention suggested in draft recommendations that physicians tackle chronic pain with other methods, such as physical therapy and non-opioid analgesics, before turning to the powerful medications. If opioids, such as OxyContin and Percocet, are necessary, the agency recommended short-acting versions over extended release formulations, the lowest possible dose and short-term prescriptions.

It also suggested that doctors ask patients to take urine tests before prescribing opioids and additional urine tests at least once a year if they continue on the drugs, to ensure that they aren't secretly taking other opioids or illegal drugs.

'What we want to just make sure is that doctors understand that starting a patient on an opiate is a momentous decision,' said CDC director Tom Frieden. 'The risks are addiction and death, and the benefits are unproven.'

Based on the events since they 1990s, the lack of clear data from well performed randomized controlled trials of the effectiveness of opioids in chronic pain, and their obvious, known risks, that seems like common sense to me.

The Strong but Obscure Opposition to the CDC Guidelines

However,others disagreed.  The guidelines attracted immediate opposition, for reasons that were not immediately obvious.  Four days after the Post article, the Associated Press reported that the guidelines were in big trouble,

A bold federal effort to curb prescribing of painkillers may be faltering amid stiff resistance from drugmakers, industry-funded groups and, now, even other public health officials.

Also,

Critics complained the CDC guidelines went too far and had mostly been written behind closed doors. One group threatened to sue. Then earlier this month, officials from the FDA and other health agencies at a meeting of pain experts bashed the guidelines as 'shortsighted,' relying on 'low-quality evidence.' They said they planned to file a formal complaint.

The CDC a week later abandoned its January target date, instead opening the guidelines to public comment for 30 days and additional changes.

Anti-addiction activists worry the delay could scuttle the guidelines entirely.

This, however, did not make much sense.  I repeat, the evidence that narcotics are effective for chronic pain other than that due to terminal cancer is very weak.  The evidence that opioids have multiple side effects, some fatal, and can cause addiction, which has more side effects, and bad societal consequences, is strong.  So the evidence that narcotics have benefits that are worth their harms, both to individuals and society, in this setting is essentially non-existent.  So why did these guidelines go too far?  Why invoke low quality evidence, when the evidence that is low quality is about the benefits of the drugs?  Who should be sued?  Furthermore, why did the CDC cave in so readily to these critics?

The AP noted,

But industry-funded groups like the U.S. Pain Foundation and the American Academy of Pain Management warn that the CDC guidelines could block patient access to medications if adopted by state health systems, insurers and hospitals.

Of course they could reduce access.  The whole point of the guidelines is to reduce access.  But who would want more access to medicines that do more harm than good?

Then there was the issue of just who it was who opposed the guidelines. Much of the opposition seemed to come from rather obscure organizations with authoritative names.  Some of the opposition was chronicled by equally obscure, apparently journalistic organizations. (From now on, I will highlight these mysterious organizations by using bold, italic text in this color.)  For example, according to the Washington Post,

Many of the patient and physician groups opposing the CDC guidelines are part of a larger coalition called the Pain Care Forum, which meets monthly in Washington to strategize on pain issues. Officials from the White House, the FDA, NIH and other agencies have met with the group over the years, according to documents obtained by The Associated Press under the Freedom of Information Act.

The Pain Care Forum presents itself as a leaderless collective that does not take formal positions. But most members receive funding from drugmakers, including OxyContin-maker Purdue, whose chief lobbyist helped found the group and remains at its center.

The mission of the Pain Care Forum, its organizational nature (informal group, membership society, non-profit advocacy group, etc), its leadership, and its sources of funding were not entirely obvious from this article.  But certainly the drift of the article was that the organization maybe represents pharmaceutical manufacturers, particularly the previously discredited Purdue Pharma (see above) more than others.  So why not take what it says with many grains of salt.

But who threatened to sue?  Which FDA officials chimed in, and why, given that the FDA does not have a mission that includes writing guidelines?   That was not clear from the AP story.

My attempts to gain further clarity produced more mystification.  A Medscape article also claimed that the opposition to the CDC guidelines included Dr James Madara, the Executive Vice-President and CEO of the American Medical Association, and "some members of the Interagency Pain Research Coordinating Committee [who] criticized the process, according to the Pain News Network."  It was not clear whether Dr Madara's viewpoint had broad support in the AMA, which members of the Interagency Pain Research Coordinating Committee opposed the CDC guidelines, and whether this opposition was personal, or reflected the considered viewpoint of the committee.  Furthermore, that committee's purview does not obviously include clinical guideline development or public health, so why it was commenting on this issue was also unclear.  

The Pain News Network story which apparently was the source used by the Medscape in turn referred to a Politico story, but one which is only available to subscribers.  The Pain News Network also credited a survey by "the Pain News Network and the Power of Pain Foundation."

The Medscape article said nothing more about the Pain News Network.which is not exactly a household word in health care journalism.  The Pain News Network story did not give more detail about the Power of Pain Foundation, whose mission, nature, leadership, funding etc was not obvious.   

The Pain News Network story also quoted the Washington Legal Foundation's chief counsel.

The overly secretive manner in which CDC has been developing the Guideline serves the interests of neither the healthcare community nor consumers.

Similarly, the Washington Post article also credited the Washington Legal Foundation's opposition to the CDC guidelines,

The Washington Legal Foundation, a public interest law firm dedicated to protecting the free enterprise system, accused the CDC of trying to formulate them secretly by failing to make public the work of its original advisory committee, the Core Expert Group. The CDC disputes that accusation, but issued the recommendations in draft form Monday and will have them reviewed by another advisory panel after receiving more comment over the next 30 days, Frieden said.

Yet, neither the Pain News Network nor the Post explained why a group supporting "free enterprise" was so concerned about this issue, or what expertise it might have in this area.  It is ironic that a group that proclaims opposition to secrecy seems less than transparent about its involvement in this issue.

Finally, the nature of the Pain News Network, which claims to be a "non-profit, independent news source," is also obscure.  It appears to be one of those non-profits that has no physical address per its web page of contact information, does not disclose its sources of funding, and if it files US Internal Revenue Service 990 forms, I cannot find them.

The most detailed article I could find about the substance of the complaints about the CDC guidelines was in another obscure source, the Legal News Line.  The article mostly described the concerns of

Peter Pitts, a former associate commissioner of external affairs at the U.S. Food and Drug Administration and now president and co-founder of the Center for Medicine in the Public Interest, can be counted among those critical of how the panel was put together.

Pitts' main issue was that a member of the group that developed the CDC guidelines was biased. He said,

'So you have to have as open of a mind as possible.'

And that’s exactly where the CDC went wrong, Pitts said, pointing to Jane Ballantyne. Ballantyne served as a member of the CDC’s “Core Expert Group,” which played a key role in developing the agency’s opioid guidelines.

Ballantyne, a retired professor of anesthesiology and pain medicine at the University of Washington, is a member of the International Association for the Study of Pain, or IASP, and last year was named president of the Physicians for Responsible Opioid Prescribing, or PROP.

PROP’s mission, according to its website, is to 'reduce opioid-related morbidity and mortality by promoting cautious and responsible prescribing practices.'

'Not only does she have strong opinions, but extra strong opinions -- almost on the lunatic fringe -- on pain medicine issues,' Pitts said.

'For the CDC to say, we’re going to put someone who comes to the discussion with such preconceived notions on such a committee, you have to ask yourself, why? And then why was it hidden from the public?'

The Legal New Line's example of supposed journalism did not apparently ask Pitts what was "lunatic" about wanting to promote cautious and responsible prescribing of opioids.  That seems to me like common clinical sense, the opposite of insanity.  

Also, Pitts complained that beyond this alleged bias, Dr Ballantyne had a conflict of interest,

Pitts noted Ballantyne’s connection to law firm Cohen Milstein Sellers & Toll PLLC -- a plaintiffs law firm that is known for its class action lawsuits and has been hired by a number of state attorneys general in recent years, including some of those to whom it donated.

Ballantyne reportedly disclosed her services as a paid consultant for Cohen Milstein to the CDC. The firm currently is helping to represent the City of Chicago in a lawsuit filed against a group of pharmaceutical companies over the marketing of opioid painkillers.

Note that in the first paragraph above, the writer apparently meant that the law firm donated to the campaigns of the attorney generals.

More importantly, why the apparent conflict of interest affecting a single member of a large group - the core expert group of which Dr Ballantyne sat included 17 people - was so important was not apparent from Mr Pitts' argument.  Mr Pitts did not explain how any sort of advisory group that included experts in the field could avoid people who already had strong opinions about that field.  The Legal News Line article did not discuss Mr Pitts' own background, or provide any information about the Center for Medicine in the Public Interest, which he leads.  

I could not find reporting in major news outlets or medical/ health care scholarly publications about the opposition to the CDC guidelines beyond the stories in the Washington Post, AP, and Medscape, and a brief report in Modern Healthcare.  I did find numerous articles on yet another little known website called the National Pain Report, (e.g. see this one).

So to summarize so far, the opposition to the new CDC opioid guidelines was apparently strong enough to delay, if not derail them.  Yet who was in the opposition, their funding, and their interests remains obscure.  The arguments of the opposition remain unclear.  Even some of the purported journalists reporting on the opposition remain mysterious.  There seems to be a tremendous amount of fog surrounding the opposition to more conservative prescribing of narcotics for non-cancerous chronic pain.

The Common Thread - Stealth Health Policy Advocacy


It was striking that much of the opposition seemed to come from rather mysterious organizations, the Pain Care Forum, Power of Pain Foundation, Washington Legal Foundation, and Center for Medicine in the Public Interest.  However, the reporting on these organizations was minimal.  Furthermore, some of the news sources reporting on the opposition to the CDC guidelines also were rather mysterious, such as the Pain News Network, National Pain Report, and Legal News Line.

One recent media article, and some of our previous blogging, though suggest that the opposition organizations all have ties to the pharmaceutical industry, and in several cases, directly to one of the major producers of legal opioids.  On December 23, 2015, Lee Fang wrote in the Intercept by way of an introduction,

The pharmaceutical companies that manufacture and market OxyContin, Vicodin, and other highly addictive opioid painkillers — drugs that have fueled the epidemic of overdoses and heroin addiction — are funding nonprofit groups fighting furiously against efforts to reform how these drugs are prescribed.

In particular,

An investigation by The Intercept has found that the pharmaceutical companies that dominate the $9 billion a year opioid painkiller market have funded organizations attacking reform of the prescribing guidelines:
  • The Washington Legal Foundation, a nonprofit that litigates to defend 'free-market principles,' threatened the CDC with legal action if the agency moved forward with the proposed opioid guidelines. The WLG claimed the CDC’s advisory panel for the guidelines lacked 'fair ideological balance,' because it included a doctor who is part of an advocacy effort against opioid addiction. The WLF does not disclose donor information, but has filed friend-of-the-court briefs on behalf of Purdue Pharma, the makers of OxyContin. In a recent article with Pain News Network, a spokesperson for Purdue Pharma conceded: 'We’re long-standing supporters of WLF, in addition to several other business and legal organizations. We’ve provided them with unrestricted grants.'
  • The Pain Care Forum organized opposition to the CDC prescribing guidelines, mobilizing regular meetings among stakeholders opposed to the idea, according to an investigation by AP reporter Matthew Perrone. A recently re-filed complaint by the City of Chicago found that Burt Rosen, the chief in-house lobbyist for Purdue Pharma, controls the Pain Care Forum. A former drug company employee allegedly told investigators that Rosen tells the Pain Care Forum 'what to do and how we do it.' The Pain Care Forum is funded through contributions by Purdue Pharma, as well as major opioid manufacturers Cephalon, Endo, and Janssen, a subsidiary of Johnson & Johnson.
  •  The Power of Pain Foundation, a group funded by Purdue Pharma, asked supporters to contact the CDC in opposition to the guidelines, claiming that 'taking away pain medication and making providers afraid to prescribe due to your guidelines is only going to make more abusers, increase suicides, and tear apart the lives of millions.'
Fang also noted that the Legal News Line, the source of the story documenting Peter Pitts' problems with the CDC guidelines, also is tied to the pharmaceutical industry:

The U.S. Chamber of Commerce, a corporate lobbying group that represents opioid manufacturers, including Johnson & Johnson, issued a press release masquerading as a news story [published by the Legal News Line] criticizing the CDC guidelines. (The U.S. Chamber operates a public relations effort dressed up as a bona fide media outlet called Legal Newsline, which it uses to disseminate stories that support the political priorities of its member companies.)

In addition, on Health Care Renewal we have previously discussed the Center for Medicine in the Public Interest.  Back in 2008, we noted that when writing for the New York Times, Mr Pitts had to disclose that the Center for Medicine in the Public Interest receives pharmaceutical industry funding, including from Pfizer and the PhRMA.  At that time, Mr Pitts' day job was  Senior Vice President for Global Health Affairs at the big public relations firm Manning, Selvage and Lee. Manning, Selvege and Lee had many big pharmaceutical accounts  Since then, he moved on to become director for global healthcare at Porter Novelli, also a public relations/ communications company with many health care corporate clients, including pharmaceutical companies, and now appears to be a consultant in the life sciences area for YourEncore.  I cannot find any updated information on current Center for Medicine in the Public Interest funding, but there is no reason to think that it is not still funded by the pharmaceutical industry.

Mr Pitts' published objections to the CDC guidelines had to do with the supposed bias and conflicts of interests of a single member of the guideline expert panel, and the alleged lack of transparency of the guideline project.  Yet Mr Pitts was not very transparent about his own background, and his and his organizations' financial interests.  For Mr Pitts to condemn the guideline panel member's conflict while hiding his own conflict amounts to a garish example of the logical fallacy of special pleading.  Similarly, the Washington Legal Foundation's objections to the alleged biases of the guideline panel, given that  foundation is apparently funded by Purdue Pharma, is another garish example of the same logical fallacy.

On the other hand, the Pain News Network and the National Pain Report remain obscure.   The former claims to be a non-profit organization, but I cannot find its federal 990 filing, identify its board of trustees, or even determine its physical address. It does claim an affiliation with the Power of Pain Foundation.  The National Pain Report at least has a physical address, which it shares with the equally obscure American News Report. Other details, like its ownership, remain obscure.  The failure of supposedly journalistic organizations to publicly reveal basic information about their nature and operations does raise suspicions that they are not really so journalistic.

Summary

In summary, the organizations most widely mentioned as opposing the new CDC guidelines that recommend more conservative use of opioids for chronic pain seem to be heavily involved with the pharmaceutical companies that make such opioids.  Thus, the opposition to the guidelines seems to be arising from a stealth public relations campaign leading to stealth health policy advocacy.  Furthermore, at least so far, the objections to the guidelines do not seem clearly based on logic and good evidence from clinical research, again suggesting they are more about financial interests than improving patient outcomes and reducing risks.

Overuse and misuse of opioids, which may lead to all the individual and social consequences of opioid addiction, are clearly major, worsening medical and public health issues.  We need earnest effort to address these problems, which should be informed by a logical, evidence-based discussion of the clinical and social realities.  Such a discussion is only hindered by the growing fog of objections launched by mysterious organizations funded by the companies who have made the most money selling narcotics.  So we also need some societal response to the growing domination of the public debate by marketing and public relations, often based on emotional manipulation, logical fallacies, and outright deception.

We cannot address our worsening health care dysfunction when public discussion and policy making blunders about in the fog of stealth health policy advocacy, stealth lobbying, and stealth marketing.  If the leaders of big health care corporations really believe they are making good products and providing good services that add value and improve patients' and the public's health, they ought to be able to rely on honest and open communications.  If they cannot disavow stealth public relations and stealth marketing, we ought to disavow the companies that practice them.

Not So Cheerful Musical Interlude

Unfortunately, given the topic of this post, here is Lou Reed singing Heroin




from Health Care Renewal http://ift.tt/1ODOqjO Stealth Public Relations and Health Advocacy, Special Pleadings and the Opposition to Guidelines Discouraging Overuse of Narcotics Health Service Home