Tuesday, December 22, 2015

How Managerialists Turned Housestaff Training into a Zero-Sum Game: the Continuing Saga of the FIRST and iCompare Studies

A ongoing controversy about two controlled trials (FIRST and iCompare) meant to test the bizarre hypothesis that sleep depriving medical housestaff (that is, physicians in training) would improve health care provided new evidence that academic medicine has been captured by managerialists.  

Background: the Controversy about the FIRST and iCompare Housestaff Sleep Deprivation Trials

In early December, 2015 we posted about two clinical trials, FIRST and iCompare, designed to test the hypothesis that  increasing housestaff sleep deprivation would improve care continuity, and thus somehow improve housestaff their performance and their patients' outcomes.  Not only did the studies' hypothesis seem strange, but the studies seemed to violate fundamental rules of research ethics.  Study investigators proceeded without obtaining formal informed consent from their house staff or patient research subjects, and did not allow any research subjects to opt out without penalty (e.g., house staff would have to quit their programs and find new ones to opt out).  Finally, after Public Citizen and the American Medical Student Association (AMSA) complained about the studies, study defenders based their arguments on logical fallacies.

Why would distinguished medical educators behave so strangely?  I hypothesized that medical educators could not imagine a way to improve care continuity without worsening trainees' sleep deprivation because all logical methods to do so would cost money.  However, the managerialist executives to whom medical educators are now beholden shrink from increasing costs, other than their and their cronies' own compensation.

Two Psychiatric Residents Write about the Zero-Sum Game of Housestaff Training

Of course, the controversy, and particularly the complaints from AMSA and Public Citizen have been largely anechoic.  But recently, the Washington Post published a commentary by two psychiatric residents on these issues.  The authors, Jeffrey Clark and David Harari, confirmed many of my concerns about the sleep deprivation trials.  They personally verified that the studies were done without informed consent from the research subjects.

The two of us and our patients were not provided informed consent before being enrolled in the iCompare trial.

The also confirmed that the trial investigators assumed they were working in a zero-sum framework.

We already know that extended shifts are dangerous. While many people rightfully suspect that current duty-hour limits aren’t improving outcomes, these studies err in assuming that the dangers of sleep deprivation must be traded for the dangers of shared patient care. Such a zero-sum framework won’t help us improve patient care or ensure the well-being of resident physicians.

To elaborate, the big problem with the duty hour restrictions is that while limiting the consecutive hours interns were supposed to work, this was not accompanied by any diminution of the total workload of housestaff at any one institution.

The standards published in 2011 by the Accreditation Council for Graduate Medical Education still allow hospitals to put residents through blistering 80-hour work weeks, while setting maximum shift lengths of only 16 hours for interns and 24 hours for more senior residents. Interns simply work shorter but more-frequent shifts. Doctors hand off patients to each other more regularly but without the training needed to manage these transitions effectively. And, by and large, hospitals have not responded to the changes with larger workforces, leaving residents no choice but to compress their daily work into shorter time periods.

It appears that housestaff were formerly sleep deprived not by their own choice, but because they were required to accomplish enormous amounts of work.  The new duty-hour limits rearrangde their work into shorter shifts, without diminishing their total responsibilities.  This does not seem like much of an improvement.  The FIRST and iCompare trials were designed to test whether removing the new duty-hour limits, and thus increase sleep deprivation, would somehow help, which ignores the reason  the new duty-hour restrictions were enacted.  But simply shortening shifts accomplishes little as long as total workload remains the same.

Stimulants, An Even Worse Solution

So Clark and Harari confirmed my concerns about the FIRST and iCompare trials.  But they added a new and in some ways even more dire concern.  They uncovered an even more troubling response by medical academics to the zero-sum game which the managerialists ensure they are playing.

Adequate sleep is a fundamental physiological need. No amount of caffeine, prescription stimulants (as some physician leaders have advocated for) or 'alertness management strategies' can adequately compensate for acute and chronic sleep deprivation.

In an aside, Clark and Harari suggested the medical educators were advocating that housestaff use prescription stimulants to counteract the effects of sleep deprivation.  This seems astonishing.

Yet a brief search revealed many informal accounts of medical students and housestaff using psychoactive prescription drugs to increase wakefulness.  For example, see an account of a medical student using Focalin (dexmethylphenidate) here.  Surveys, for example by Shy et al of emergency residents, suggest that use of stimulants by housetaff is rare,(1), but survey respondents may be unwilling to admit to such behavior, and emergency medicine residents may work shorter shifts than medicine and surgery residents.

Also, there is some other evidence that medical educators may encourage use of stimulants.  At least one 2014 guest poster on the KevinMD blog stated

at one medical university, it is common knowledge among the student body that struggling individuals are encouraged to see a physician about their 'possible ADD,' or attention deficit disorder.

Furthermore, in 2009, Rose and Curry writing in the Mayo Clinic Proceedings (2) noted that 

extending the use of drug therapy to include resident with no identified sleep disorder to improve concentration and learning, improve wakefulness, enhance performance, and promote high-quality patient care (especially at night) raises a variety of concerns

without explaining who came up with that idea in the first place.  However, in a response to a letter challenging their commentary, they denied (3) that they were advocating for such drug use, but never made clear who else was.

As we have noted, stimulants used for attention deficit and hyperactivity disorder (ADHD) are  amphetamines or relatives of amphetamines, and have dangerous adverse effects.  Encouraging, even subliminally, medical trainees to use such dangerous drugs to try to compensate for underfunding of training programs seems unethical, as the above letter writer pointed out.(3)  That medical educators would resort to such an extreme solution suggests how they are now boxed in. 

Conclusion: the Problem is Managerialism   

While the ongoing trials of housestaff sleep deprivation have been largely anechoic, the recent Washington Post commentary by Clark and Harari make questions about why in the world medical academics would have set up such trials and continue to defend them even more stark.

But it seems that medical academics are boxed in, playing a zero-sum game.  They may know that there housestaff are overworked and sleep deprived, a situation that endangers the housestaff and their patients.  Yet every reasonable way one could imagined improving the situation would require spending more money, most likely to hire more people to spread the workload.  Yet spending more money may be an anathema to the generic managers to whom medical academics report.  Spending more money would decrease revenue, and for many managerialist managers, increasing revenue, not patient outcomes or physician performance, is the prime directive.    


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.

To conclude, as I did on my first post on the sleep deprivation studies....  I hope that the two studies create the degree of controversy they deserve, and that the federal government promptly starts investigating honestly and thoroughly.  I further hope that this unseemly episode causes medical educators to rethink the cozy or at least conflict averse relationships they have with their managerialist leaders.

True health care reform would restore health care leadership that understands health care and medicine, upholds the health care mission, is accountable for its actions, and is transparent, ethical and honest.



References

1.  Shy BD, Portelli I, Nelson LS. Emergency medicine residents' use of psychostimulants and sedatives to aid in shift work. Am J Emerg Med 2011; 29: 1034-36. Link here.

2.  Rose SH, Curry TB.  Fatigue, countermeasures and performance enhancement in resident physicians.  Mayo Clin Proc 2009; 84:  955-57.  Link here.


3.  Paparodis R. Fatigue, countermeasures and performance enhancement in resident physicians.  Mayo Clin Proc 2010; 85: 300 - 303.  Link here.

Wednesday, December 16, 2015

How Managerialsm/ Generic Management Damaged the American Red Cross

The American Red Cross is a storied non-profit organization.  It provides disaster relief, provides a major part of the US blood supply, and has important public health teaching functions, such as teaching cardio-pulmonary resuscitation (look here).  Nonetheless, its operations have become increasingly controversial.  ProPublica has been investigating them for years.  The latest ProPublica report, entitled "The Corporate Takeover of the Red Cross," showed how this renowned organization has suffered under generic management/ managerialism, providing another case study showing how bad generic management and mangerialism are for health care and public health.

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 (sometimes in the for-profit sphere called the shareholder value principle, look here.)

The ProPublica article showed how the leadership of the American Red Cross was given over to generic managers; how they ran the organization based on generic business management principles; and how the results were bad for the organization's mission.  I will address each point with quotes from the article, and add the commentary that was lacking in a straight investigative journalistic report.

The New Leaders were Generic Managers

The New CEO is a Generic Manager who Specialized in Marketing

Gail McGovern became Red Cross CEO in 2008.  Her academic background was in the "quantitative sciences."  Her first job was as a computer programmer. Then,

McGovern climbed steadily through the ranks at AT&T. By the mid-1990s, she was head of the company’s consumer markets division....

Next,

McGovern left AT&T in 1998, then spent four years at Fidelity Investments, where she was promoted to be the head of the retail mutual fund and brokerage business. Then came six years as a marketing professor at Harvard Business School....

On the other hand, she apparently had no specific experience, training or expertise relating to the mission of the Red Cross, and specifically no experience, training or expertise in public health, health care, blood banking, or disaster relief.

She Believes in the Primacy of Marketing

Her academic writings spell out her theory of corporate leadership. 'In many organizations, marketing exists far from the executive suite and boardroom,' she and her coauthors wrote in an article for the Harvard Business Review. Companies that make this mistake are doomed to 'low growth and declining margins.'

One could argue that perhaps in the long run, a good product that sells itself might be better for a manufacturing firm than a temporarily persuasive marketing campaign.  Even so, the mission of the Red Cross is not first to grow and make more money, or even to sell products, but instead it is

The American Red Cross prevents and alleviates human suffering in the face of emergencies by mobilizing the power of volunteers and the generosity of donors.
She was Hired by the Red Cross to Promote Generic Management with Emphasis on Marketing

Ms McGovern was hired at a time when the dogma that business managers ought to run everything was becoming very prominent.

McGovern, selected after a global search by a headhunting firm, was seen as a candidate who would bring private-sector methods to the nonprofit. 'Isn’t it great that we have someone that really has had that business expertise in developing and working with a brand and recognizing the power of it?' [Red Cross Board Chairwoman Bonnie] McElveen-Hunter told the Washington Post at the time.

Note that the Chairwoman of the Board of Governors herself was

a wealthy Republican donor appointed by President George W. Bush in 2004

According to Wikipedia, she is a businesswoman whose undergraduate degree was in business, who worked for Bank of America and then founded Pace Communications, and who also has no discernable experience or expertise in health care, public health, or disaster relief.

The ProPublica article did not suggest that Ms McElveen-Hunter or anyone else really thought through how a generica manager practicing managerialism would actually benefit the mission of the Red Cross.

The CEO Recruited Other Generic Managers

Soon after she joined the Red Cross, McGovern recruited executives who had worked with her at AT&T and Fidelity....

Furthermore, 

As part of her effort to run the Red Cross more like a business, McGovern recruited more than 10 former AT&T executives to top positions. The move stirred resentment inside the organization, with some longtime Red Cross hands referring to the charity as the 'AT&T retirement program.'

Again, one would expert a generic manager to feel most comfortable amongst others of her ilk.  Again, any consideration of whether running the Red Cross "more like a business" would improve its success as a charity was not evident.

The New Generic Managers Relied on Generic Management Dogma

The new generic managers conceived of their job as "a corporate turnaround that would touch every aspect of the charity's finances and operations."

They Established Centralized Control

The work of the Red Cross was traditionally done by local chapters. The new generic managers sought to decrease their independence from "corporate."  So,

Each of the Red Cross’ more than 700 chapters had its own bank account, tracked its own volunteers, and ran its own computer system. McGovern hoped to realize considerable savings by consolidating these back-office functions, creating what she dubbed 'One Red Cross.'

The notions that different chapters might face different challenges, and hence that flexible local control might do better addressing these challenges than would centralized top-down command were not apparently considered.

They Cut Costs, Particularly Through Cutting Employee Benefits and Laying Them Off

and hence tried to enhance short-term revenue:

She also got to work cutting costs: there was a round of layoffs; she killed the charity’s generous pension program and suspended matching contributions to employees’ retirement accounts.

Also,

When McGovern was hired as CEO, there were over 700 Red Cross chapters across the country. Today, there around 250, though some former chapter offices stayed open even as they were folded into other chapters. The Red Cross declined to say how many offices it closed.

Over the course of McGovern’s tenure, the number of paid employees fell from around 36,000 to around 23,000 and the Red Cross today spends several hundred million dollars less a year than it did in 2008. (Most of the staff cuts were from local chapters, not the blood business, though the Red Cross declined to provide a breakdown.)

Cost-cutting, especially by cutting compensation to and benefits of line employees, is a central mantra of current business management.  The effects these cuts have on the morale and performance of the remaining employees, and the downstream effects on the organization are generally ignored.  The specific implications for a charity meant to uphold a mission were not discussed.  

They Focused on Marketing and Public Relations

Early on,

McGovern laid out a vision to increase revenue through 'consolidated, powerful, breathtaking marketing.'

'This is a brand to die for,' she often said.

In addition,

The Red Cross’ chief of fundraising, a former colleague of McGovern’s from Fidelity, told the assembled officials that the organization should attract far more than the $520 million in donations it was bringing in annually. 'Strength of brand,' his PowerPoint said, 'justify results in $1-2 billion range.'

Also, CEO McGovern chose Jack McMaster to run the public health training operation,

 praising McMaster to Red Cross staff as a master marketer and a trusted former colleague [at AT&T].

As an aside, actually,

After leaving AT&T, he took a job in 1999 as CEO of a Dutch telecom company called KPNQwest. In just a few years, he had run it into what Reuters called a 'spectacular collapse,' prompting a bankruptcy, a storm of lawsuits, and comparisons to Enron. Just months before the company went under, McMaster publicly boasted that it was poised for dramatic growth.

This suggests that McGovern placed far more priority on hiring "master marketers" than finding trustworthy leaders.   Of course, a CEO who is mainly a professional marketer may see marketing as central to whatever organization she is running.  The notion that the Red Cross had such a wonderful brand because it used to do wonderful things did not apparently occur to the new generic marketers.  Furthermore, the notion that even "master marketing" may not hide the undermining of the organization's mission also did not occur.   

They Suppressed Opinions They Did Not Want to Here

As discontent among staff rose (see below), leading to anguish expressed on social media,

critical posts later disappeared from the Facebook page. Moderator Ryan Kaltenbaugh reminded participants that the group was intended to be 'a POSITIVE forum sharing ideas, stories, pictures, links, videos and more across our great country.'

'[P]lease (please) refrain from posting your negative personal views,' he continued.
To a leadership obsessed with marketing, appearance may have seemed to be everything.  Yet again, suppressing the bad news does not make what generated it disappear.

They Paid Themselves Very Well 

We have often discussed how executive compensation in health care now seems to rise beyond any level that could be justified by the executives' actions and performance.  A central problem with managerialism seems to be that now top managers can virtually set their own pay.  Thus, they have become value extractors, more focused on their own enrichment than their organizations' ultimate success.  The ProPublica article did not explicitly discuss executive compensation except after the failure of the expansion plans by the "master marketer" McMaster,

Amid layoffs in the division last year, bonuses given to McMaster and his team raised eyebrows within the Red Cross, a former headquarters official said.

In a statement, the Red Cross said the bonuses were appropriate because the division hit 'strategic milestones' including establishing 'a national tele-service platform and national sales and service delivery models.'


Regardless, the division failed to reach its real goal, expansion of its business.

Furthermore, there is evidence that during the reign of McGovern, the top managers as a group have been very well paid, especially given that they were running a charity whose good works are largely supported by contribuations and the taxpayers.  We noted in a 2011 post that

In 2009, then CEO Gail McGovern received over a million in total compensation, $1,032,022 to be exact. Its President for Biomedical Services got $850,489. Its Executive VP for Biomedical Services got $596,309. Twelve other executives got more than $250,000. Of those, ten got more than $350,000.

Since then, while Ms McGovern's compensation has actually declined, the number of very well paid managers has actually grown.  According to the organization's latest available IRS Form 990 filing, for 2013, Ms McGovern had total compensation of over $597,000, and 15 managers had total compensation over $250,000, of these, 10 were over $400,000.

So despite all the problems afflicting the Red Cross (see below, and the larger ProPublica series), the top managers still managed to pay themselves very well.

The Results were Bad

The Marketers' Best Laid Plans Led to Declining Contributions

The "master marketer" did not do so well.

McMaster laid out how the CPR unit would attract more customers while at the same time hiking prices for classes and training materials in CPR, swimming, and babysitting. He believed the Red Cross brand justified higher prices than were being charged around the country.

Customers voted with their wallets. When prices rose, many simply switched to lower-cost providers.

'We thought if we raised prices, American Heart [Association] would probably raise prices, and life would be good,' McGovern said at a 2013 employee town hall meeting, referring to the Red Cross’ competitor in the CPR class business. 'Didn’t happen.'

Also,

 'A halfway competent market analysis would have told you that the bulk of our business was in selling to small businesses who viewed us as a business expense,' recalled one former chapter executive director. 'When the massive price increases arrived, it was too much and customers bailed.'

This illustrates that the generic managers did not even achieve their business goal, increasing sales and increasing revenue.  What did they care, though, if the bonuses still rolled in? 

Centralized Control, Benefit Cuts, Layoffs, and the Marketing Focus Wounded Employee Morale and Discouraged Volunteers

Those who push generic management practices often seem blind to their adverse effects.  So,   

 Many of those who taught classes — including volunteers who did the work for free — quit after being turned off by headquarters’ poor communication and insistence on centralized control.

Also,

But much like the organization’s paid staff, many of its volunteers appear deeply disillusioned. An internal survey obtained by ProPublica found volunteers around the country had a satisfaction rate of 32 percent this year — down 20 points from last year.

Furthermore,

Driving the alienation, longtime employees and volunteers say, is a gulf that has opened up between McGovern’s executive suite and the rank and file who have spent decades in the mission-focused nonprofit world.

She has surrounded herself with a tight-knit group of former telecom colleagues, they say. 'They’re all people from the period when AT&T imploded,' said one former senior official. 'The priorities seem to be a reflection of what that team is comfortable with: sales and marketing.'

An internal assessment previously reported by ProPublica and NPR said national headquarters’ focus on image slowed the delivery of relief aid during Hurricane Isaac and Superstorm Sandy. Officials engaged in 'diverting assets for public relation purposes,' according to the assessment. 
The Red Cross depends on its staff and volunteers to do the work.  What did the brilliant generic managers and master marketers think would happen if they fired lots of staff, drove volunteers to quit, and disillusioned those who remained?

Layoffs and Cutback Reduced Capacity to Respond to Disasters

One example was the response in West Virginia
 
In West Virginia, where several chapters have been shuttered, emergency management officials said the group’s response to recent disasters has been anemic. After a recent water shortage caused by a chemical leak, the charity declined to provide any help to residents, the Register-Herald of Beckley reported. Local officials described that as business as usual for the charity. When a tornado hit in the southern part of the state, the Red Cross’ inadequate response left scores of victims without enough food, according to the newspaper.

Another was the response in northern California,

In Northern California last year, the Red Cross shuttered the Napa County chapter and laid off disaster relief staff, according to an internal PowerPoint presentation. Then, in September, a drought-fueled fire swept through the area, consuming more than 75,000 acres and 1,200 homes.

Because of the issues with the Red Cross’ shelter, nearly all of 1,000 displaced people at the Napa County Fairgrounds — including the elderly, new mothers and children, and anyone with a pet — ended up sleeping outside in tents, cars or RVs. The problems were first reported by the Press Democrat newspaper.

Also,

Local officials were furious. They say the Red Cross showed up lacking basic supplies such as Band-Aids, portable toilets, and tarps to protect against the rain. Instead the group’s volunteers handed out Red Cross-branded bags of items that weren’t urgently needed like lip balm and tissues.

The Red Cross responders were inexperienced and, according to residents, not enough of them spoke Spanish, the language of many of the fire victims.


In general, as told by former Red Cross volunteer Becky Maxwell, a self-described "die-hard Red Cross person for 25 years," who quit after becoming increasingly frustrated,

'McGovern has fired almost all of the trained and experienced volunteers and staff,' Maxwell told ProPublica, replacing them 'with people who have absolutely no knowledge of what the Red Cross is or does in a disaster. Not only is she setting these people up to fail but she is compromising the service delivery that is so important to the clients.'


Summary

The Red Cross Board of Governors, largely composed of well paid business managers (e.g., a former Vice Chairman of Goldman Sachs, a senior vice president of Eli Lilly, the chief financial officer of Home Depot, the executive vice president of Target), decided that a generic manager using a managerialist approach could cure the organization's perceived ills.  The new CEO, who lacked any obvious experience or training relevant to the Red Cross mission, hired her former cronies at AT&T and Fidelity as managers.  The new team cut costs, laid off employees, centralized management, and focused on marketing.  The apparent results were fewer, less experienced, upset staff; fewer volunteers; declining interest in public health training products; and worsening disaster response.

Thus, once again, generic managers and managerialism have laid low a formerly proud charity.  Unfortunately, this one also happens to have vital public health and disaster relief roles that have now been severely compromised.

Based on previous experience, it should come as no surprise that generic managers who do not know much or care much about public health and health care, and who rely on a one-size fits all management dogma uninformed by the public health or health care context or public health or health care values will end up undermining patients' and the public's health.

The real surprise is that the generic managers have up to now had no problem maintaining the managers' coup d'etat, that is, their iron grip on the leadership of most public health and health care organizations.

To prevent our ongoing downward spiral, we need to reverse the managers' coup d'etat, and return leadership to those who understand health and health care, support their values, and are willing to be accountable for doing so. 

ADDENDUM (17 December, 2015) - This post was republished on the Naked Capitalism blog

Thursday, December 10, 2015

A Small Challenge to Impunity - Lawsuit Against Former Synthes CEO Proceeds

Numerous allegations of bad behavior by big health care organizations, some apparently causing patient harm, have resulted in legal settlements, sometimes of criminal charges.  Yet rarely do the individuals who apparently authorized, directed, or implemented the bad beahvior suffer any negative consequences.  In particular, the top executives on whose watch the bad behavior occured seem to have impunity.

Suing the Former Synthes CEO

So it is news that a lawsuit will proceed against the former CEO of medical device company Synthes,  alleging actions that led to the death of a patient.  The basics were reported by the Daily Caller,

Hansjorg Wyss ... will face charges of running a 'criminal profiteering enterprise' through the illegal use of a drug and in violation of federal patient safety rules that resulted in the death of a 67-year old woman....

Washington State Superior Court Judge Dean Lum agreed Oct. 30 that Wyss, a Swiss billionaire ... can stand trial under the state’s racketeering laws for leading a criminal enterprise that caused the death of Reba Golden. She died during an illegal drug test conducted by Wyss’s company in 2007.

The Washington suit charges Wyss, the former CEO of a Pennsylvania-based medical device company called Synthes and his co-defendants with murder in the second degree as a class A felony, second degree assault and criminal profiteering under the Washington Criminal Profiteering Act.

Wyss faces a statutory civil penalty of $250,000 for each violation, amounting to $9.2 million for 'personal injury to and death of Mrs. Golden.' He is charged in 37 violations.

The plaintiff is Reba Golden’s daughter, Cynthia Wilson, whose mother died in 2007 on the operating table after Synthes organized illegal 'market tests' for at least 50 persons across the country of an untested bone cement substance that the Food & Drug Administration banned for use in the spine.

Ultimately, five patients died during the illicit drug testing. Synthes failed to report the deaths to the FDA, as required by law, until the third fatality occurred.

Furthermore, 

Wyss 'entered into a criminal enterprise to perfo'rm illegal and experimental surgeries on patients,' Daniel Hannula, Golden’s attorney, told The DCNF.

Also,

'Mr. Hansjorg Wyss was the controlling stockholder and ranking executive of Synthes and Norian Corporation and the leader of a criminal enterprise,' the complaint states. 'The criminal enterprise engaged, for profit, in a pattern of criminal profiteering activity,' enticed by the prospect of a company forecast of $3 million in after-tax profit for the first year of sales.

Judge Davis agreed case was about profits, saying their behavior was 'generated by a desire to realize the immense profits.'

Hannula told the DCNF, 'they completely ignored what was required of them in order to get their product to the market as quickly as possible because they recognized that this was a market of huge financial potential.'

These are only allegations, of course. However, again, it is very rare for any top executive of a health care organization to personally face a lawsuit for his or her organization's conduct, no matter how bad that conduct may be. 

The Synthes Case Up to Now

We already knew that Synthes' conduct was particularly bad. We last discussed the Synthes case in 2011.  The case was already extraordinary in that it resulted in criminal convictions of several high-ranking Synthes executives.  At that time we wrote:

Synthes USA, the American branch of a Swiss based device company, first settled charges that it had been paying surgeons with company stock to use its products in its clinical trials in 2009 (see this post).  Then prosecutors alleged that these were not really rigorous trials. Instead, for marketing purposes, executives of Synthes subsidiary Norian persuaded surgeons to use its Norian XR product in a case series of spine surgery patients and then publish the results.  Three patients who received the product for this "off-label" use died.  This scheme was alleged to have been directed by 'person no. 7,' whom journalists identified as the company CEO, Hansjorg Wyss (see post here.)   In an unusual move, the prosecutors indicted four company executives, who then pleaded guilty.  They did not take any further action against Wyss, who turns out to be one of the world's richest men (see post here).

In 2011, Wyss agreed to sell Synthes to Johnson and Johnson, itself a company with a very chequered past (look here), thus making himself into a multi-billionaire, and one of the world's richest men.  (Currently, Forbes lists Wyss as number 240 on its list of the world's richest, estimating his fortune at $6.1 billion.)

The case then slipped into relative obscurity, although Fortune ran a long-form article on it in 2012, which called it a "medical horror story."

An Almost Anechoic Lawsuit

Because of the unusual nature of the ongoing lawsuit, one might expect that it would generate some public discussion.  One would be wrong.  The litigation against Mr Wyss so far has received almost no media coverage, demonstrating the ongoing anechoic effect.  We previous defined  the anechoic effect, as the phenomenon that information or discussion that could challenge or discomfit the powers that be in the US health care often generates no echoes.  

To date, I could only find coverage of the ongoing lawsuit against Mr Wyss in the Daily Caller.  And ironically the Daily Caller did not appear to cover this case because it specializes in malfeasance in health care.  It seemed to cover it because it may have indirectly reflected negatively on prominent members of the US Democratic Party.

Actually, the main focus of the article I quoted above was not health care.  It was that Mr Wyss appears to be a supporter of Hilary Clinton, the currently leading Democratic candidate for the US presidential nomination, and of ostensibly left-wing causes.  I put an ellipsis in the first sentence of the article to allow me to focus on its health care aspects.  What I removed was not a description of Mr Wyss not as an extremely rich former CEO of a medical device company, but as

Hansjorg Wyss, a prominent Clinton foundation donor and wealthy bankrolled of liberal activist groups, will face charges of running a 'criminal profiteering enterprise'....

And the article's title similarly did not mention health care at all: 

Major Clinton Donor Faces 'Criminal Profiteering' Charges

The Daily Caller actually specializes not in health care malfeasance, but in issues of interest to the right wing.  As Politico reported in 2014, Tucker Carlson, described as a "conservative pundit, who founded the Daily Caller, has said

What I despise most about the legacy media isn’t just that they’re mindlessly liberal, though they are.

The Columbia Journalism Review described the Daily Caller as having

carved out a cozy corner of the web in its short life. It’s a place for conservatives to read about the latest liberal scandal and the latest movements in the GOP presidential field.
So presumably if Mr Wyss was uninterested in politics, and did not donate to any remotely left wing causes, the Daily Caller would not have covered the ongoing lawsuit, leaving it totally anechoic.

But whether of not the Daily Caller had an axe to grind when making its choice to report on the ongoing litigation against Mr Wyss, why did every other media outlet to ignore the story?  Perhaps again the rule is in general it is simply not done to publicly discuss what might excessively embarass the people who have gotten very rich from the currently dysfunctional health care system?

Conclusions

The just revealed story of the lawsuit against the extremely rich former CEO of Synthes does suggest that perhaps individuals injured by our curent dysfunctional health care system could use the legal system to try to challenge those who get rich from enabling such injuries.  Or not, because the outcome of this lawsuit is uncertain.

Furthermore, the initiation of this lawsuit again reminds us that those who lead large health care organizations, and may profit mightily from them, regardless of the effects on patients' and the public's health, remain beyond the law.  It is not clear why the US Department of Justice chose not to even attempt to prosecute Mr Wyss, although they apparently believed he was responsible for directing the actions that led to patient deeaths.  But his impunity mirrors that granted to just about every top health care manager who authorized or directed corporate bad behavior that endangered patients. 

This impunity is further enabled by how anechoic stories of bad leadership of health care organizations, even of apparently criminal or corrupt leadership, are.  As long as most health care professionals and the public at large remain unaware of the dark side of health care, they are unlikely to seek light to shed upon it.

True health care reform would encourage open, widespread discussion of all aspects of health care dysfunction, particularly bad behavior by those who profit most from it, and would encourage health care leadership that puts patients' and the public health first, is willing to be accountable for its actions, is transparent, honest and ethical. 

Thursday, December 03, 2015

Drinking the Managerialists' Kool-Aid? - Why Did Medical Educators Launch Trials of Increased Sleep Deprivation of Physician Trainees Apparently in Violation of the Nuremberg Code?

It all seemed so bizarre.  In 2014, with little fanfare, two large trials that imposed longer work hours and sleep deprivation on physician-trainees (interns and residents), ostensibly to combat the problem of excess hand-offs of patients among physicians.  Both trials involved multiple academic medical centers, including some of the most prestigious in the US.  Within a year, the American Medical Student Association (AMSA) and Public Citizen called for a federal investigation of the trials, calling them "highly unethical."

This unprecented conflict between prestigious academic medical institutions and the largest organization of medical students and a respected watchdog group suggests either the former have serious ethical problems, or the latter have gone a little crazy.  The minimal media attention to the dispute did not explain what is going on.  My suspicion is that these events open a window on how respected medical academics are now in the thrall of the managerialist leaders of health care.

Background of the Studies

My Personal Experience on the Medical Housestaff

Let me start by disclosing the axe I am grinding.  I was an internal medicine intern from 1978-79 in a program known to be very arduous.  For much of the year, I worked up to 36 consecutive hours every fourth night, often without more than a few hours of sleep.  My on call shifts were extremely busy, involving admission of usually 4-5 complex and acutely ill patients, handling exacerbations and emergencies affecting my own patients already in the hospital, and three other interns' patients for about 12-15 hours of the shift.  The workload was augmented by a hefty amount of "scut," that is, tasks that either did not involve direct patient care, or could easily have been done by someone who was not a physician, e.g., paperwork and phone calls, other bureaucratic tasks, drawing blood, starting IVs, and even transporting patients.  As the shift dragged on into the evening, I knew my mind was getting fuzzier and my coordination was getting clumsier.

The notion that working 36 hours straight was educational, was good for my patients, or was good for me seemed nonsensical.  One reason I went into medical education was to improve the experience for future trainees.

Addressing Housestaff Sleep Deprivation

I was hardly the only person who thought the work requirements imposed on medical housestaff were nonsensical.  The first notable improvement was the advent of night float systems that allowed on-call housestaff to get at least some sleep.  Eventually, in part after the infamous "Libby Zion case," (see NY Times retrospective here,)  teaching hospitals were required to limit work hours.  In 2003, Accreditation Council for Graduate Medical Education limited the total work week to 80 hours, required one day off a week, and required call schedules no more frequent than every third night.  (Note that my old program fulfilled all but the first.)  In 2011, the rules were tightened further, limiting interns to shifts no longer than 16 hours.

Pushback Against Duty Hour Restrictions

Yet soon after the pushback began.  A 2014 MedPage today article that described the two studies noted,

The rule change elicited mixed reactions from residents and program directors of residency programs, who worried that increased hand-offs led to worse patient care and shorter hours reduced education opportunities. 


I agree that the increasing number of hand-offs could be problematic, and discuss that below.  On the other hand, the notion that sleep deprived housestaff could learn anything useful while in that condition seems bizarre.  There is plenty of evidence about the adverse cognitive effects of sleep deprivation, including affects on learning.  (See, for example, Durmer et al.)(1)

A brief discussion of one of the two trials, the iCOMPARE trial, put it this way:

Policy limiting duty hours in graduate medical education training programs has become a central point of debate amongst stakeholders. Evidence from human chronobiology and sleep science argues for shorter shifts, because fatigue leads to errors. Evidence from operations research argues for more continuity because patient handoffs also lead to errors, and may reduce the effectiveness of education necessary to produce independent clinicians for the nation’s future.


Poorly Conceived Study Question

The two controversial trials were thus designed to answer the question of whether allowing increased consecutive duty hours would lead to better hand-offs and better outcomes.   This question seems poorly conceived, and was not clearly justified.

The trials were apparently based on the idea that housestaff training programs can exist in only two possible states: allowing longer duty hours with fewer and better done hand-offs, or allowing shorter duty hours with more and badly done hand-offs.  Therefore, the only choice seems to be to maintain the current system (tighter duty hour restrictions) or go back to the old system (more relaxed restrictions).

However, these are not the only possible alternatives.  One can easily think of other choices.

Oddly, the spotty materials about the iCOMPARE trial available online did not include any consideration of why the more restrictive duty hour regulations may have led to bad handoffs.  Perhaps the current problem with hand-offs, while it may be real, may have not come about only due to a decrease in the consecutive hours housestaff were allowed to work.  Perhaps it came about because the consecutive hours regulation was imposed on the closed systems of housestaff training programs in which the clinical and non-clinical responsibilities of the housestaff were fixed.  So, cutting consecutive work hours without decreasing the number of patients that need to be managed, or the housestaff's total workload, including "scut," may have pushed individual residents to try to do more work in less time.  This could have had various detrimental effects, including increased numbers of hand-offs occurring under too much time pressure. 

That hypothesis suggests that measures other than allowing more consecutive work hours could address any unintended effects on hand-offs of the mandated consecutive work hour reduction.  It seems plausible that shorter duty hours combined with measures to decrease total housestaff workload, starting with offloading "scut" work, could produce as good or better results than simply going back to the old system.  

Nonetheless, the two trails were set up as if the only alternative to the current situation is to return to the old situation (longer work hours allowed).  Thus it seems that the reasoning underlying the trials was based on a false dilemma.     

Summary of the Studies' Methods

This apparently badly conceived study question led to trials whose design and implementation raised further concerns.  Per the 2014 Medpage article:

The Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) will compare the current duty-hour regimen (16-hour maximum continuous work period for interns) to what the trial calls a 'more flexible regimen' that eliminates the 16-hour cap.

A total of 59 residency programs are enrolled, including academic and community-based programs.

The 12-month study, led by investigators from the University of Pennsylvania, Johns Hopkins University, and Brigham and Women's Hospital, states that its goal is 'to provide evidence to help policymakers evaluate whether the current duty-hour standards should be changed.'

Measured outcomes will include 'patient safety and trainee education,' with data from Medicare claims, exam scores, and participant surveys.

The study comes on the heels of a similar year-long, randomized trial for surgical interns (Flexibility In duty hour Requirements for Surgical Trainees, or FIRST), which began in July 2014 and is currently underway.


Also

The programs in iCOMPARE's intervention arm will adhere to three rules, which are consistent with the ACGME's July 2003 duty hour regulations:
An 80-hour weekly limit
1 day off in 7
In-house call no more frequent than every 3 nights, averaged over 4 weeks


The Protest

In November, 2015, the complaints about the two trials were announced by AMSA and Public Citizen.  The main issues were summarized in a Huffington Post article by Dr Michael Carome of Public Citizen.   First he stated that on its face, making house staff work long hours, as they are in the intervention group, is dangerous.

The iCOMPARE and FIRST trials have allowed first-year medical residents to work shifts lasting 28 consecutive hours or more -- nearly twice the current maximum number of hours allowed by the Accreditation Council for Graduate Medical Education (ACGME) for such residents. The ACGME's awareness of the known harms to both residents and patients caused by excessively long work hours led the organization in 2011 to tighten restrictions on resident physicians' work hours, including limiting shifts for first-year residents to a maximum of 16 hours.

Substantial evidence shows that sleep deprivation due to excessively long work shifts increases the risk of motor vehicle accidents, needle-stick injuries and exposure to blood-borne pathogens, , and depression in medical residents. It also exposes their patients to an increased risk of medical errors, sometimes leading to patient injuries and deaths


The last statement cited seven references. I should note here that I could not find in the current media reports, or in the spotty documentation of the ICompare trial avaiable online any engagement with the evidence that sleep deprivation is bad for trainee physicians (and everyone else).

The next important point is that the housestaff who were research subjects of the trial, and their patients who also were at least indirectly research subjects did not give their informed consent for participation in the trial.

Among the many disturbing aspects of the trials is the researchers' failure to seek the voluntary informed consent of either the resident doctors or their patients who are forced to be part of these experiments.

According to a recent media report, the University of Pennsylvania's IRB -- the designated lead IRB that reviewed and approved the iCOMPARE trial -- incorrectly found that the trial involves only 'minimal' risk and therefore waived the requirements for obtaining informed consent for all subjects.

For the FIRST trial, the administrator of the IRB at Northwestern University, the lead institution for that trial, shockingly determined that the trial was not even 'research with human subjects' and, therefore, that IRB review and approval were not required. As a result, there was no opportunity for the IRB to discuss the risks of the research and the need for obtaining the voluntary informed consent of both the general surgery residents and their patients. This determination represents a colossal failure of Northwestern University's human subjects protection system. This same failure presumably occurred at many of the other institutions that participated in the FIRST trial.


An article in the business section of the Chicago Tribune added that Public Citizen claimed the failure to obtain informed consent was all the more serious because the house staff and patients were exposed to danger contingent on their trial participation.

It claimed the 'highly unethical' experiments, including the other led by the University of Pennsylvania and Johns Hopkins University, exposed doctors to an increased risk of making serious medical errors and suffering personal injury.

'Substantial evidence shows that sleep deprivation due to excessively long work shifts increases the risk of motor vehicle accidents, needle-stick injuries and exposure to blood-borne pathogens and depression in medical students,' according to the complaint. For patients, the long hours could lead to increased medical errors and death, the complaint said.


Furthermore, the trials apparently did not include mechanisms for house staff to refuse participation, or to stop participating.  An article in Medscape quoted Dr Karl Bilimoria, a professor of surgery at Northwestern who led the surgical trial,

Dr Bilimoria said that for first-year general surgery residents assigned extended hours at intervention-arm hospitals, the trial was no secret. 'They were told, because they had to monitor their hours,' he said. 'Residents knew which arm of the trial they were in.'

'This has been very public.'

Asked whether this process amounted to informed consent, he replied that if residents strongly disagreed with the prospect of longer hours, 'they could choose to work elsewhere.'


The news coverage of the controversy included several statements that the trials were particularly and severely unethical.  For example, a BMJ news article quoted

Charles Czeisler, professor of medicine and director of sleep medicine at Harvard Medical School [who] told the BMJ, 'I was shocked when I heard about this study assigning resident physicians to work marathon shifts.'  Czeisler said that even as little as one week of sleep deprivation was knwon to cause serious harms.


In Modern Healthcare,

Other ethics researchers found it difficult to understand how such a trial could be approved by an institutional review board.

'Because you're looking at deaths of patients as the major outcome, that makes it much more difficult ethically to support because patients may be harmed,' said Dr. Robert Klitzman, director of the master of bioethics program at Columbia University. 'If you find that twice as many patients died under anything but the current system, you could say they died unnecessarily.'


Apparent Violations of the Nuremberg Code



 [Photograph: Defendants in the dock at Nuremberg trials.  Link here.]

In fact, in my humble opinion, the two trials appeared to violate several major components of the Nuremberg Code, the set of principles for ethical research that was developed after Nazi atrocities visited in the course of supposed medical experiments were revealed during the Nuremberg Trials.  These principles include,

1. The voluntary consent of the human subject is absolutely essential.

This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision. This latter element requires that, before the acceptance of an affirmative decision by the experimental subject, there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person, which may possibly come from his participation in the experiment.


The two trials did not get true informed consent from the housestaff subjects. As trainees required to complete housestaff training to become surgeons or internists, informing housestaff that their program would be participating in the trial, and their only option if they did not want to participate would be to seek another program surely seems like any consent they provided was given under duress.  Furthermore, it is not clear that they were ever informed of "all the inconveniences and hazards reasonably to be expected; and the effects upon" their "health or person[s]."

2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methds or means of study, and not random and unncessary in nature.


Again, if the major rationale for doing the trials was to mitigate the postulated effects of increasing hand-offs, there are many other ways one could try to do this which do not involve increasing duty hours and sleep deprivation.

3.  The experiment should be designed based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study, that the anticipated results will justify the performance of the experiment.


Again, there is a considerable body of research that sleep deprivation is harmful to patient and humans in general.  Thus, the science suggests that increasing sleep deprivation will have unfavorable results, and thus the performance of a trial of increasing sleep deprivation  seems unjustified.

9. During the course of the experiment, the human subject should be at liberty to bring the experiment to an end, if he has reached the physical or mental state, where continuation of the experiment seemed to him to be impossible.


Again, the housestaff could not easily opt out of further participation. At best, to do so, as one of the investigators said, they would have to quit their training programs, which could jeopardize their careers and entail major financial costs.

The Rebuttal

The main arguments of the trial proponents in response to the complaints seemed weak, and often appeared to be based on logical fallacies.

The ACGME and the IRBs Approved the Trials - Appeals to Authority

In the Chicago Tribune article:

But Northwestern said the council [ACGME] granted a waiver for the longer hours and helped fund the study.

'It was done with their approval,' Dr Karl Bilimoria, principal investigator for the trial ... said.


An article from the Milwaukee Journal Sentinel and MedPage Today  quoted Dr Thomas Nasca, CEO of the ACGME,

He said institutional review boards at all the participating hospital reviewed the trial protocols and determined the patients did not need to be informed.


These arguments amount to assertions that the trials must have been ethical because external authorities said they were.  Thus they appear to be based on logical fallacies, appeals to authority

The Arguments and Evidence Supporting Duty Hour Restrictions are Weak - Burden of Proof

In an unfortunately misnamed ModernHealthcare article (it refers to medical students rather than housestaff) , Dr Bilimoria was again quoted,

The key piece is that we just have never had prospective, randomized high-level evidence to inform our decisionmaking....


Similarly, in a Medscape article  Dr Nasca, the ACGME CEO,

calls resident scheduling rules a work in progress, especially because only very small, single-institution studies have examined the effect of long hours on residents and patients.


On the other hand, there are no big randomized trials to suggest that longer duty hours or increased sleep deprivation is advantageous.  However, there are huge numbers of studies that show that sleep deprivation is bad for patients and people in non-medical settings, as well as medical trainees.

In any case, the supporters of the trials seem to be arguing that the burden of proof should be on those who want to limit duty hours, while it seems more reasonable that to justify a trial of increased sleep deprivation, the burden of proof was on those who proposed the trial.  Thus, this appears to be a version of the burden of proof logical fallacy.

Increased Hand-Offs are Bad, and the Only Alternative to Having Them is to Increase Duty Hours - False Dilemma

In trying to defend their work the advocates for these trials further corroborated my concerns above that the trials were conceived without any consideration that measures other than increasing duty hours (and consequent sleep deprivation) was the only possible alternative to the current situation.   For example, in the Modern Healthcare article.

'There's always a trade-off,' [senior RAND natural scientist Dr Mark] Friedberg said, noting the increased number of patient hand-offs that occur with shorter hours. These hand-offs reduce consistency of care and open patients up to more mistakes and miscommunication among providers. 'It's not clear-cut. That's why you have to do the science,' he said.


However, he did not argue that increased hand-offs are so bad that a trial of increasing duty hours and sleep deprivation to achieve fewer hand-offs could be justified.  He also did not consider whether there might be some way to mitigate the effect of increased hand-offs without causing sleep deprivation.

Similarly a New Haven Register article quoted Dr Thomas Balcezak, chief medical officer for Yale-New Haven, saying

one issue is that there are 'more handoffs between caregivers' when residents work shorter hours. 'There’s always a risk that important information could fall through the cracks' because of 'a lack of consistency or continuity.'

Again, that seems to be at best a theory, but not evidence based argument. Besides, the article quoted Dr Carome of Public Citizen on just one of many other possible approaches to mitigate the effects of increased hand-offs,

hospitals could overcome that problem by hiring doctors to work overlapping shifts.


There is no evidence that the people who were so concerned about hand-offs thought of any alternative ways to mitigate any problems the duty hour restrictions could have created.  This corroborates my concerns that the trials were fundamentally based on a logical fallacy, the false dilemma.

Managerialism and Tunnel Vision

So why would medical educators at some of the most prestigious US teaching hospitals launch trials to see if increasing housestaff sleep deprivation might benefit them and their patients, mandate partcipation of housestaff and patients in these trials without obtaining informed consent or allowing these subjects to opt out of the trials, thus seemingly violating the Nuremberg Code, and then defend their actions with logical fallacies?

I do not think they have gone mad.  I do suspect they are in the thrall of their managerialist hospital executives.

Recently we discussed the rise of managerialism in the leadership of health care organizations. Managerialism, which wraps up what we have called generic management, the manager's coup d'etat, and aspects of mission-hostile management into a very troubling but coherent package, was first  described for a medical audience in 2015 by Komesaroff in an article in the Medical Journal of Australia(2):

The particular system of beliefs and practices defining the roles and powers of managers in our present context is what is referred to as managerialism. This is defined by two basic tenets: (i) that all social organisations must conform to a single structure [defined by management theory and dogma]; and (ii) that the sole regulatory principle is the market. Both ideas have far-reaching implications. The claim that every organisation — whether it is a mining company, a hospital, a school, a professional association or a charity — must be structured according to a single model, conforming to a single set of legislative requirements, not so long ago would have seemed bizarre, but is now largely taken for granted. The principle of the market has become the solitary, or dominant, criterion for decision making, and other criteria, such as loyalty, trust, care and a commitment to critical reflection, have become displaced and devalued. Indeed, the latter are viewed as quaint anachronisms with less importance and meaning than formal procedures or standards that can be readily linked to key performance indicators, budget end points, efficiency markers and externally imposed targets.


Many of the prestigious teaching hospitals/ acacemic medical centers/ hospital systems participating in the two controversial trials may be led in the managerialist tradition.  We have shown numerous examples of such leadership that may put short term revenue and the continuing enrichment of top managers ahead of all other concerns, including good patient care and the integrity of academics, has been frankly mission hostile, and jump on the latest management bandwagons as solutions all problems.

I postulate that housestaff directors at such institutions tremble at the idea of challenging such leaders.  Yet to improve the handoff problem, teaching programs might have to do things that cost money.  Spending money that does not lead to immediate increases in revenue, and boosts in management pay, could be an anathema to managerialists.  Also, to improve the hand-off problem, programs might have to challenge management dogma, such as the worship of badly designed, time wasting electronic health records.  So I suspect the leaders of the two studies consciously or unconsciously eschewed trial designs that could assess any educational alternative that might have made management uncomfortable.  Thus boxed in, they wound up with an apparently indefensibly unethical research project.

I hope that the two studies create the degree of controversy they deserve, and that the federal government promptly starts investigating honestly and thoroughly.  I further hope that this unseemly episode causes medical educators to rethink the cozy or at least conflict averse relationships they have with their managerialist leaders.

True health care reform would restore health care leadership that understands health care and medicine, upholds the health care mission, is accountable for its actions, and is transparent, ethical and honest.

ADDENDUM (5 December, 2015) - This post was republished on the Naked Capitalism blog

References

1.  Durmer JS, Dinges DF.  Neurocognitive consequences of sleep deprivation.  Sem Neurology 2005.  25. 117-129.  Link here.

 2.  Komesaroff PA, Kerridge IH, Isaacs D, Brooks PM.  The scourge of managerialism and the Royal Australasian College of Physicians.  Med J Aust 2015; 202: 519- 521.  Link here.

Friday, November 27, 2015

Ross Koppel challenges feckless academics on poor health IT design

The academic health IT community has spent the past decade (at least) burying their collective ostrich heads in the sand about the crappy software that is called health IT.

A few, though, have taken on the health IT industry at the heart of bad health IT design (including yours truly, which sadly was not enough to save my own mother from health IT design defects).

Probably the bravest soul on these issues, however, is Penn sociologist Ross Koppel.  In a critique of the latest from the medical informatics academic community on reigning in the hazards of this technology, an article by Sittig and Singh at U. Texas, he wrote the following piece in the BMJ:

The health information technology safety framework: building great structures on vast voids
http://m.qualitysafety.bmj.com/content/early/2015/11/19/bmjqs-2015-004746.full.pdf

Download it and read it in its entirety.  It makes the point that the solutions to these problems (which I increasingly believe just might be an insoluble, wicked problem without major scope and ambition reductions regarding the use of health IT) must be based on reality.

The reality must start from a firm response not to end users being flummoxed by bad rollouts or by carelessness (user error), but to the issue of products poorly designed from the get-go by their sellers whose primary interest is to make money come hell or high water.

Koppel makes the point that one will not get good results driving a car if that car is designed poorly, with hidden and confusing controls, defective brakes and an engine that overheats and explodes without warning, no matter what post-design interventions take place.

The issues of design flaws and fundamental fitness for purpose need to be blown open in a manner similar to the manner in which drugs and other medical devices are evaluated and regulated.  Academia needs to lead the charge, not suggest band aids, however well intentioned those band aids might be.

Koppel writes:

 ... In essence, I suggest that these two eminent colleagues tell us to look under the lamppost even though, as the old saying goes, the keys were dropped 70 feet away from the lamppost in the dark. Both Singh and Sittig, of course, are fully aware of the errors listed above,3 4 but (1) they expect that we can detect and understand these problems with error reporting, although many potentially serious errors go undetected (thus, unreported), and when detected, the poor design features that contributed to the error may not be readily apparent. (2) Singh and Sittig tend to attribute those sorts of problems to poor implementation, user errors or lack of access to the technology. They do not seriously question if the software is fit for its purpose.

And this:

 ... In fact, their assumption that HIT software is well designed runs throughout their work. They write about: misused software, unavailable software, poorly
implemented software and malfunctioning software (emphasis added), but what of badly designed software—neither user friendly nor interoperable with systems holding needed patient data? That failure is
not in their purview. They don’t challenge HIT vendors who design the software, or the regulators, who so often serve primarily as HIT industry promoters. Here’s what they write we need to address (my
italics): ‘1) concerns that are unique and specific to technology (e.g., to address unsafe health IT related to unavailable or malfunctioning hardware or software);
2) concerns created by the failure to use health IT appropriately or by misuse of health IT.

I add that such articles tend to confuse policy makers about what truly is needed to solve problems with HIT.

I've had the guts to take on these issues via the legal route after the death of my mother, something that led a number of academic zealots to intone that the incident, in 2010, a decade after my writings on bad health IT began, caused me to lose my objectivity.  That puerile, perverse reasoning passes for wisdom in certain academic informatics circles.  Yet it appears their objectivity about health IT never existed.

I lack respect for paper writers who in effect become apologists for products birthed as dangerous right out of the gate by opportunistic health IT companies.  Perhaps the health IT-mediated death of one of their loved ones would wake them up, but I sometimes doubt even that.

This is no mere academic spat. In this case, patient risk and harm worldwide is at issue.

The root of any software problem in healthcare, as I've written before, is at the design level.  Trying to work around bad design without facing reality leads to and perpetuates risk, patient harm, clinician disillusionment (e.g., the Medical Societies letter to ONC) and impairment of clinicians trying to take care of patients.

Kudos to Koppel. I hope the repercussions of his challenge to the usual academic fecklessness and special accommodations afforded this unregulated industry are not too severe.

Academics can be feckless towards possible sources of funding, but quite mean to internecine challenges, as Sittig, one of the authors of the challenged piece, was with me in an incident I found out about only because he did not know one of the people to whom he badmouthed me had been a former student I'd mentored.

-- SS

Tuesday, November 24, 2015

Their Cheating Hearts - Latest Allergan Settlement Is a Reminder of Merger Participants' Sketchy Pasts

A Huge, but Sketchy Merger

The announced merger and "tax inversion" of Pfizer and Allergan would be one of the largest corporate marriages in US history.  It has drawn more than its share of criticism.  For example, per the Los Angeles Times, former US Senator and Secretary of State, and current presidential candidate Hilary Clinton said "this proposed merger, and so-called inversions by other companies, will leave U.S. taxpayers holding the bag."

By creating the world's largest drug company, it could certainly further consolidate the US and global pharmaceutical market and raise already high drug prices.  While Pfizer in particular has benefited from US funding of biomedical research, including training of researchers and development of research infrastructure, (see this New Yorker article by John Cassidy) making the company pseudo-Irish may be "unpatriotic," as President Obama said with regard to tax inversions in general (per the Washington Post).

The nature of the merger, creating a company that would be Irish for tax purposes, but effectively run out of the US seems at least intellectually dishonest.  (Note that the CEO of its supposedly Irish component, Allergan, works out of Parsippany, NJ (per Bloomberg, here.)

The main beneficiaries of the merger appear not to be patients, or health care providers, or US taxpayers, but top company executives.  As John Cassidy wrote,

It's hard to avoid seeing the merger as a cynical move designed to boost Pfizer's stock price and generate a windfall for the company's senior managers....

But the latest settlement by Allergan, which I was just about to write about before the merger was officially announced, is a reminder that the companies are a good fit in one sense.  Both have long histories of shady behavior as marked by many legal settlements, and in some cases corporate guilty pleas and convictions.

The Latest Allergan Settlement

The beginnings of the latest Allergan settlement were noted back in July, 2015, but first not even connected to Allergan.  According to the US Federal Bureau of Investigation (FBI),

A former district manager of Warner Chilcott Sales U.S., LLC (Warner Chilcott), a pharmaceutical company based in Rockaway, N.J., pleaded guilty today in U.S. District Court in Boston in connection with a scheme to deceive insurance companies and Medicare so that they would cover the costs of Warner Chilcott’s osteoporosis medications, Actonel and Atelvia.

The idea was to promote two of Warner-Chilcott's products, osteoporosis medicines Actonel and Atelvia, by evading insurance company requirements for physicians to justify their use, given questions about their benefits versus harms, and availability of generic treatments for osteoporosis.

Beginning in 2010 and throughout 2011, Podolsky directed the sales representatives in his district to fill out prior authorizations for physicians who prescribed Actonel and Atelvia using false clinical justifications as to why the patient needed Warner Chilcott drugs and submit them to health insurance companies. In some instances, Podolsky’s sales representatives reviewed patients’ medical charts to get the information necessary to fill out the prior authorizations, in violation of the Health Insurance Portability and Accountability Act (HIPAA). Podolsky also directed sales representatives to utilize a website to submit prior authorizations to insurance companies to disguise their identity as pharmaceutical sales representatives. Podolsky and the sales representatives that he supervised knew that they should not be involved in the preparation or submission of prior authorizations.

But Podolsky was not a lone wolf. At the end of October, 2015, the Boston Globe reported more fully on the scheme, and the large settlement made by Allergan, of which Warner-Chilcott was merely a subsidiary. US Department of Justice allegations involved top leaders of Allergan.

The drug reps bought the doctors lunches, dinners, drinks. They paid for speeches the doctors never made. And in exchange, the doctors prescribed drugs that boosted their sales.

Warner Chilcott, a unit of pharmaceutical giant Allergan PLC, will pay $125 million to settle these and other charges in an agreement announced Thursday by US Attorney Carmen M. Ortiz in Boston.

Ortiz said the company ran an elaborate scheme to prod doctors — including in Massachusetts — to prescribe its drugs in exchange for kickbacks.

Warner Chilcott’s former president, W. Carl Reichel, was charged in federal court for allegedly conspiring to pay kickbacks to physicians, and a Massachusetts physician, Dr. Rita Luthra of Longmeadow, was indicted for allegedly accepting payments.

Warner Chilcott illegally promoted at least seven drugs, including the osteoporosis treatments Actonel and Atelvia.

Court documents show that Warner Chilcott representatives promoted their drugs by wining and dining physicians and giving them money and gifts for participating in medical education events. These events often were held at 'upscale restaurants' and contained 'minimal or no educational component.'

The company made fraudulent requests to the federal government and to insurance companies to boost sales of their drugs, the US attorney’s office said, and employees also made unsubstantiated claims about the drugs’ benefits.

Note that the charges were of actions that went well beyond financial fraud. They included dishonest marketing and kickbacks to physicians. The alleged actions could have harmed patients, by inducing physicians to prescribe unneeded drugs with known adverse effects.

Note further that unlike many other legal settlements about which we have written in the past, this one did not allow the company to escape by just paying some money and then claim that it did not confirm or deny the charges.  In this case, the company pleaded guilty.

Warner Chilcott has agreed to plead guilty to health care fraud. It will pay a $23 million criminal fine and $102 million to resolve false claims with state and federal governments. The case was brought by two whistle-blowers.

And as noted above, unlike many other legal settlements which did not entail any negative consequences for those who authorized, directed, or implemented the bad behavior, in this case a top executive (although not the highest executive in the overall corporate structure, and not a current executve) was charged with a crime and apparently actually physically arrested (although he has not been convicted of it, yet.)

Meanwhile, Reichel, the former Warner Chilcott president, was arrested in Boston on Thursday.

Prosecutors say in their indictment that Reichel designed a sales and marketing strategy to entice doctors to prescribe his company’s drugs with free dinners and bogus speaking fees. The physicians paid to give speeches often did not speak at all, and instead enjoyed expensive dinners with sales representatives, the indictment says.

Reichel left Warner Chilcott in 2011, according to a news release.

Furthermore, per a Forbes column, Mr Reichel was allegedly involved up to his proverbial eyeballs.

The Reichel indictment says that, while president of Warner Chilcott’s pharmaceuticals divisions from 2009 to 2011, he directed company sales staff to push physicians’ to prescribe its drugs by throwing money at doctors’ in various ways, such as expensive dinners for doctors and their spouses and 'speaker' fees to attend informal dinners without educational content.

Reichel also allegedly provided sales reps with a separate expense account to buy food and drinks for employees of physicians who prepared prior authorization forms certain insurers required to pay for patients’ drugs.

Reichel hired 'Type A crazy' sales representatives, as he called them, who were provided with 'limited training concerning compliance with health care laws and otherwise de-emphasized the importance of compliance to the sales force,' the indictment says.

Of course, the top executive in the overall corporate structure said the usual, as likely written by his public relations spin doctors,

Brent Saunders, the chief executive of Dublin-based Allergan, said in a statement: 'We take seriously our responsibility and commitment to abide by all US and international laws that govern the sales, marketing, education, and promotion of our products, and recognize the tremendous impact that this responsibility has on the customers and patients we serve.'

Finally, two other middle managers involved in the case entered guilty pleas, according to the Department of Justice.

Thus this settlement may be regarded as much tougher than many previous legal settlements involving big health care organizations.

However, its bearing on the huge Prizer-Allergan merger has apparently not so far been publicly discussed.

Allergan's Previous Track Record

It is not that the new Allergan settlement is a one-off.   It needs to be viewed in the context of Allergan's previous history of misbehavior.

That history may be a bit obscure, especially because of Allergan's complex corporate structure.  However, a Wall Street Journal article on the merger provided a bit of Allergan's corporate back story,

Allergan itself is the result of a number of mergers in quick succession. It started off as a generic-drug company called Watson Pharmaceuticals Inc. In 2012, Watson acquired Swiss rival Actavis Group and adopted that name. It also absorbed Warner Chilcott PLC and Forest Laboratories Inc. in multibillion-dollar deals.

Mr. Saunders was CEO of Forest Labs, and became CEO of Actavis after that deal. Shortly after, Allergan’s predecessor was put into play when Valeant Pharmaceuticals International Inc. made an unsolicited offer to buy the California company.

Actavis then stepped in as a white knight and bought Allergan, taking the company’s name.

Allergan and its predecessor companies have an interesting record of misbehavior.  Just perusing Health Care Renewal one can find:

-  Actavis was convicted and fined more than $170 million in 2011 by a Texas jury of misrepresenting prices to the state's Medicaid program (see this post.)

-  In 2010, in case which included allegations that it paid kickbacks to physicians to promote its product, Allergan pleaded guilty to to federal charges of misbranding of Botox and agreed to penalties of about $600 million (see this post).

-  In 2010, Forest Laboratories settled allegations that it deceptively promoted drugs, particularly that it promoted anti-depressant Celexa for children by partially by covering up negative trial results about it.  This likely hurt patients, since anti-depressants like Celexa have been shown to have severe adverse effects, including suicidal ideation, for children.  The company also was charged with giving kickbacks to physicians to promote drugs.  The company pleaded guilty to a felony charge of obstructing justice, and two misdemeanors, including misbranding Celexa and illegal distribution of Synthroid.  The company paid over $300 million in penalties and submitted to a corporate integrity agreement.  (See this post)  The Department of Justice threatened to disbar the CEO of Forest Laboratories, but then inexplicably backed off (see this post). 

So the latest settlement by Allergan subsidiary Warner Chilcott is the fourth major settlement since 2010.  The company and its predecessors have pleaded guilty to crimes, at least once to a felony, and settled cases involving allegations of kickbacks and deceptive marketing practices. 

Pfizer's Previous Track Record

And things really get interesting when one considers Pfizer's track record, which seems much sorrier than Allergan's.  Our latest post, about Pfizer misbehavior was only one month ago (October, 2015).  A  UK judge found that the company threatened health care professionals for using a generic competitor.

Many posts on Pfizer can be found here.   The latest update of Pfizer's troubles since 2000 follows.

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).
- In 2015, a settlement by Pfizer of a shareholders' lawsuit stemming from charges of illegal marketing was announced (see this post).

Summary

So the proposed merger of Pfizer and Allergan would truly create a behemouth of bad behavior.  The combined company would have a staggering record of legal settlements, guilty pleas and convictions involving deceptive marketing, fraud, kickbacks, bribes and anti-trust violations, and even an obstruction of justice plea and a RICO conviction.  Yet the managers in charge of the two companies when the bad behavior occurred never had to suffer any negative consequences (although in one current case there is the possibility one executive might be convicted).  Many of these managers have become amazingly rich during the course of their leadership.  Is there any reason to think, absent any unexpected increase in the courage and resolve of government law enforcement, or any unexpected public protest, that the new company will not continue to misbehave as long as its executives are making money from the process?

The Pfizer Allergan merger is the true poster child for the amorality, and consequent dysfunction and decline of modern US and now global health care. As long as top managers of big health care organizations can act with impunity, can avoid all responsibility for their organizations' bad behaviors, and can personally profit wildly from their companies actions, the health care death spiral will continue.  Will we continue to cry out in the wilderness, or will anyone else see the writing on the wall?

A musical moment to partially alleviate the gloom. "Your Cheatin Heart" sung by Hank Williams Jr.