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Showing posts with label ill-informed management. Show all posts
Showing posts with label ill-informed management. Show all posts
A new story from the UK suggests what top leaders of health care really think about health care professionals.  I realize that I risk showing my shallow understanding of UK politics when I comment on this, but I believe that the story is straightforward enough for someone from the US to understand, and has  lessons for the US and other countries.

UK Health Secretary Says Doctors Do Not Work Enough on Weekends

The story started earlier in July, 2016, when the current UK Health Secretary within the current Conservative government told National Health System (NHS) doctors they must work seven days a week, as reported by the Guardian,


The health secretary, Jeremy Hunt, has accused the main doctors’ union of walking out of NHS consultants’ [equivalent to US attending physicians] contract talks aimed at preventing 'catastrophic consequences' for patients at weekends.

Hunt said he recognised the efforts of consultants, many of whom already work on Saturdays and Sundays, but that he would impose weekend-working contracts by September if an agreement could be reached.

Also, 


The proposed contract would have at its core the controversial weekend working provision, but would include the abolition of overtime payments that Hunt has described as extortionate.

 Under the current contract, last negotiated by Labour in 2003, consultants can opt out of non-emergency work outside the hours of 7am to 7pm Monday to Friday.

Mr Hunt implied that insufficient physician presence on weekends was leading to catastrophe.

Hunt will say: 'Around 6,000 people lose their lives every year because we do not have a proper seven-day service in hospitals. No one could possibly say that this was a system built around the needs of patients and yet when I pointed this out to the BMA they told me to ‘get real.’ I simply say to the doctors’ union that I can give them 6,000 reasons why they, not I, need to ‘get real’.'

However, UK Doctors, Including Consultants, Do a Lot of Work on Weekends

Within a few days, there was an amazing response from UK physicians showing that what the Health Secretary seemed to believe about how NHS hospitals work was, not to put too fine a point on it, wrong.

From the Guardian came a piece by an anonymous trainee physician,

Last weekend, for the first time ever, I managed to make something trend on Twitter. It wasn’t a witty comment about Andy Murray triumphing in the Davis Cup, nor was it a retweet of a picture of somebody else’s cat.

I simply told a man called Jeremy that I was at work that night.

Three days later, thousands of people were telling Jeremy that they too were at work that weekend, using the hashtag #iminworkjeremy. Day and night, Friday to Monday, a large group of people felt Jeremy simply had to know what they were up to.

Because Jeremy is fairly important in the running of the country. Well, part of the country anyway – that part where the sick can just turn up and be treated without money changing hands. The part I work in, in fact, as a junior doctor.

Jeremy is concerned about how his part of the country is being run. He is upset that the ones who keep the sick alive – the doctors – aren’t there at weekends.

It’s just a pity Jeremy is wrong.

The Jeremy in question is, of course, secretary of state for health, the Rt Hon Jeremy Hunt, who last week announced he would bring in a 24-hour health service, seven days a week. To do this, he would alter consultant contracts to stop them including an 'opt-out' from weekend working – by force, if need be. To bolster his point, he told the public that there were not many consultants in at the weekends, and also that you were more likely to die if you came to hospital at a weekend.

I am not a consultant, far from it, but I do know that if and when I become a consultant, I will work weekends and I will be in at night. I accepted this when I took the role on.

So why did I, and the rest of my campaign group, tell the nation’s health workers to tell Mr Hunt that we were indeed working over the weekend?

I think, firstly, it was in answer to the claim that consultants do not work on Saturdays and Sundays. Our campaign has demonstrated that, day and night, there are doctors of all grades at work, often working unsociable hours.

The article also pointed out that having a consultant (the equivalent in the US of attending physician) available on the weekends may not lead to true seven day service if what the consultant orders is not available on weekends.

Two days later, another junior doctor's response to Mr Hunt had gone viral, as reported by the Mirror,

In an open letter, paediatric junior doctor Benjamin Carter, said health professionals felt 'upset, demoralised and feeling entirely unappreciated' after Mr Hunt painted them as 'lazy, money-grabbing, unprofessionals' who were opposed to 24-7 healthcare.

Also,


He said: 'Please allow me to paint a picture for you, as I am sure you are aware by now due to the #‎IminworkJeremy movement, a great many doctors work weekends. I for one tend to work 1 in every 3.

'This includes juniors and consultants, my consultants in particular have a rota for who is covering the weekends day and night because we need that expertise. When on call for that weekend, my consultants do ward rounds, they see sick children, they are present for the emergencies that their wealth of experience and knowledge helps resolve.

'They do not opt out, they do not complain, and they certainly do not go straight back to the golf course. They might not always be on site for the whole 72 hour weekend, but they are never more than a phonecall away.

'I look up to my consultants as pillars of excellence and professionalism. For you to say that we as a group operate with a lack of vocation and professionalism is not only false, it is gravely insulting.'

Dr Carter posted his letter to Facebook, where it has been shared more than 5,000 times in just a few hours.

In addition,

In a moving section, he explained that much of the anger aimed among doctors is because they have to deal with life and death on a daily basis, for a relatively modest wage.

He said: 'Already our pay is comparable to a high street manager [equivalent to a manager of a shop on Main St in the US], and that it pails in comparison to a city [equivalent in the US to Wall Street] worker and that neither of those professions require their workers to deal with life and death daily, to endure aggression from those we are trying to help and to be reduced to tears that result from exhaustion and the sheer emotional burden of our daily work.

'I invite you to come to my place of work and be there holding a dying child's hand and then tell me afterwards that I don't have a sense of vocation.'

A day later, a UK consultant calculated just how "extortionate" his overtime payments were, per the Independent,

A consultant angered by Health Secretary Jeremy Hunt's claims that a 'Monday to Friday' culture exists within the NHS has published an honest account of exactly how much he earns on call and at weekends.

Karan Kapoor posted the no holds barred letter to his Facebook page, describing what he takes home as a newly-appointed NHS ENT (Ear, Nose and Throat) consultant when working outside his usual hours.

His on-call supplement per month, he reveals, pays just £313.54 [currently = $532.49] - the equivalent of £2.61 [currently = $4.05] per hour and significantly less than the minimum wage. 

He concluded,

'I am genuinely offended that you have openly questioned my professionalism and vocation or that of my colleagues,' Mr Kapoor writes.

'I am no different to the thousands of Consultants, Junior Doctors, Nurses, Physios, Pharmacists, Secretaries, Speech Therapists, etc.

'We don't go on strike, we don't hold the country to ransom, we don't compromise patient care because we were meant to go home 2 hours ago, instead we go above and beyond, understanding the true meaning of professionalism and being exemplar to any health service in the world.

'Without this silent and diligent commitment, the NHS would have crumbled many years ago.'

The story also noted the groundswell of anger inspired by Mr Hunt's implication that today's NHS doctors do not work on weekends,

Last week a petition to call a debate on a vote of no confidence in the Health Secretary hit 100,000 - the required number of signatures to be considered for debate in Parliament - in less than 24 hours.

The petition, which was started by Dr Ash Sadighi, argues that Mr Hunt has 'alienated the entire workforce of the NHS' with his plans 'to impose a harsh contract and conditions on first consultants and soon the rest of the NHS staff.'

Finally, the Independent documented another online outburst generated by a consultant surgeon posting a picture of "himself moping a hospital floor" on Facebook.

What Generic Managers Really Think of Health Professionals

We have frequently discussed how US health care has been taken over by generic managers.  In 1988, Alain Enthoven advocated in Theory and Practice of Managed Competition in Health Care Finance, a book published in the Netherlands, that to decrease health care costs it would be necessary to break up the "physicians' guild" and replace leadership by clinicians with leadership by managers (see 2006 post here). Thus from 1983 to 2000, the number of managers working in the US health care system grew 726%, while the number of physicians grew 39%, so the manager/physician ratio went from roughly one to six to one to one (see 2005 post here). As we noted here, the growth continued, so there are now 10 managers for every US physician.

The managers who first took over health care may have had some health care background.  Now it seems that health care managers are decreasingly likely to have any health care background, and increasingly likely to be from the world of finance.  Meanwhile, for a long time, business schools seem to have been teaching managers that they have a God given right to manage every organization and every aspect of society, regardless how little they know about what the particular context, business, calling, etc involves.  Presumably this is based on a faith or ideology that modern management tools are universally applicable and nigh onto supernatural in their powers.  Of course, there is not much evidence to support this, especially in health care.

I have every reason to believe the idea that "professional" managers and business people should be in charge of all parts of society and all economic sectors has spread well outside the US.  UK Health Secretary Jeremy Hunt seems to be an example.  His background, according to the Gov.UK website, is that "Before his election as an MP, Jeremy ran his own educational publishing business, Hotcourses."  A Financial Times article noted that in 2014, he still had a major financial interest in the company,

Jeremy Hunt, the health secretary, has suffered a setback in his attempt to sell his education listings business after private equity group Inflexion pulled out of a proposed £35m deal.

Hotcourses, which claims to be the world’s largest database of educational courses, was set up by Mr Hunt and his business partner, Mike Elms, in 1996, before he entered parliament.

The article noted further, ironically in regard to the Mr Hunt's recent controversy,

The deal was an awkward reminder for the coalition of the large personal wealth of many cabinet ministers at a time when Labour has criticised the government for being 'out of touch' with ordinary voters.

As far as I could tell, before his political  career, Mr Hunt was a businessman with no experience or expertise in health care or biomedical science. And as of May, 2015, according to the the ThisIsMoney.uk website, Actually, he still seemed to be a businessman.  Mr Hunt still owned nearly half of the company, and was still receiving large dividend payments from it.

Nonetheless, Mr Hunt is now in charge of the whole of the British NHS.  However, his recent public pronouncement that NHS doctors do not work on weekends, and that is why the health service does not provide adequate services on weekends, reveals that he seems not to be very familiar with the organization he is supposed to be leading.  Again, we have seen many examples of leaders of big US health care organizations who seem ill-informed about their organizations, and sometimes hostile to their organization's health care mission.

However, we have not often heard a generic manager simultaneously publicly express so much hostility to health professionals  and so little knowledge about what those professionals actually do.  I suspect that is merely because many US managers are reined in better by their public relations departments and legal counsel. 

We are well into our global experiment involving handing control of virtually everything to managers, administrators, executives, and business people.  I submit it is not going well, and maybe leading us to some ultimate ruination.

As we have said again, again, again... It is way past time for health care professionals to take back health care from generic managers.  True health care reform would restore leadership by people who understand the health care context, uphold health professionals' values, are willing to be held accountable, and put patients' and the public's health ahead of self-interest. 

In the UK, doctors finally seem to be rising in protest against a particularly ill-informed businessman who is currently their boss.  It is past due for US doctors to hold to account similarly ill-informed, and sometimes also mission-hostile generic managers to whom they report.
6:42 AM
Not to bury the lede, I think it can, but it will be a lot harder than the talking heads on television predict.

I have been writing about health care dysfunction since 2003.  Lots of US politicians would have us believe we have the best health care system in the world (e.g., House of Representatives Speaker John Boehner (R-Ohio), here),   Much of the commentary on Ebola also seems based on this "best health care system in the world" notion.  For example, in an interview today (5 October, 2014) on Meet the Press, Dan Pfieffer, "senior White House adviser," said

There is no country in the world better prepared than the United States to deal with this.  We have the best public health infrastructure and the best doctors in the world.

However, at least the statistics say compared to other developed countries, US processes and outcomes are at best mediocre using the best of some admittedly flawed metrics (look here), yet our costs are much higher than those of comparable countries.  Furthermore, on Health Care Renewal we have been connecting the dots among severe problems with cost, quality and access on one hand, and huge problems with concentration and abuse of power, enabled by leadership of health care organizations that is ill-informed, incompetent, unsympathetic or hostile to health care professionals' values, self-interested, conflicted, dishonest, or even corrupt and governance that fails to foster transparency, accountability, ethics and honesty.

Thus there is reason to worry that it will be harder than many expect for the US to deal with Ebola.  There is already some evidence that some of the sorts of problems we have been discussing for years made it harder for the US to cope with even the so far limited incursion of Ebola.

Financialization of Pharmaceutical and Biotechnology Companies

George W Merck famously said,
 
We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been.

In the pharmaceutical industry, the era of George W Merck is over.  The failure to have access to an effective Ebola virus vaccine exemplifies how things have changed.

If we were to have an effective Ebola virus vaccine, we could have likely used it to vaccinate health care workers and contacts of infected patients and likely thus halt the epidemic early.


A story in Modern Healthcare suggested that now many of the big experts on Ebola and public health are concluding having a vaccine available would be very helpful,

 As West Africa's Ebola outbreak continues to rage, some experts are coming to the conclusion that it may take large amounts of vaccines and maybe even drugs — all still experimental and in short supply — to bring the outbreak under control.

Specifically,

'It is conceivable that this epidemic will not turn around even if we pour resources into it. It may just keep going and going and it might require a vaccine,' Dr. Anthony Fauci, director of the U.S. National Institute for Allergy and Infectious Diseases, told The Canadian Press in an interview.

The main reason we do not yet have such a vaccine does not appear to be scientific, but economic.

Here we posted discussion of arguments that pharmaceutical and biotechnology companies up to now have been uninterested in developing Ebola vaccines because they did not anticipate that such vaccines would produce a lot of revenue.  About one month ago, the Independent ran yet another story about an Ebola expert who believed this was the main reason for the lack of effective vaccine development up to now.

The scientist leading Britain's response to the Ebola pandemic has launched a devastating attack on 'Big Pharma', accusing drugs giants including GlaxoSmithKline (GSK), Sanofi, Merck and Pfizer of failing to manufacture a vaccine, not because it was impossible, but because there was 'no business case'.

West Africa's Ebola outbreak, which has now claimed well over 2,000 lives, could have been 'nipped in the bud', if a vaccine had been developed and stockpiled sooner – a feat that would likely have been 'do-able', said Professor Adrian Hill of Oxford University.


The US health care system is now heavily commercialized.  Health care corporations, including pharmaceutical and biotechnology companies, are often lead by generic managers who subscribe to the business school dogma of the "shareholder value theory," which seems to translate into putting short-term revenues ahead of all other goals.  Thus they have been "financialized."  At least in the pharmaceutical and biotechnology sector, such financialization appears to now be global. 

It may now be too late to contain this particular Ebola virus epidemic using a vaccine.  But unless we change how decisions are made about vaccine development, and end the dominance of financialization over drug and vaccine development, we may not be able to control the next deadly epidemic using vaccines either.

Generic Management Deluded by Business School Dogma

On 2 October, 2014, InformaticsMD posted on Health Care Renewal his speculation that the Ebola patient now hospitalized in Dallas was not identified on his first emergency department visit to Texas Health Presbyterian hospital even though a nurse apparently found out he had recently traveled from Liberia because of problems with how the hospital's electronic health record (EHR) transmitted or displayed this information.  This supposition was later apparently confirmed, but then the hospital system CEO retracted this explanation, leaving the reason he was sent home from the ED, thus risking infection of more contacts, unclear (see this post).

I now speculate that the larger reason for the problems the hospital had and is having both handling this patient, and explaining how it handled the patient is hospital leadership by generic managers who do not really understand the relevant health care issues.


Mr Barclay E Berden, the CEO of Texas Health Resources, has had a long career in hospital management.  However, his most advanced degree was "a master's degree in business administration with a specialization in hospital administration from the University of Chicago Graduate School of Business."   His official biography suggests that he has no direct experience or training in medicine, health care, or biological sciences.  Nonetheless, when he became CEO this year, according to Modern HealthCare, the chairperson of the hospital system board thought he was fully qualified,

'He brings a well-rounded perspective and unique leadership strengths to the CEO position,' board Chair Anne Bass said in a news release. 'At the same time, he represents stability and continuity that will be critical to advancing our strategy as we confront the challenges of a rapidly changing healthcare environment.'

Nonetheless, the hospital systems seems to have had trouble confronting the challenges of the change in environment due to Ebola.  Also, according to a very recent story in the Dallas Morning News, there have been performance issues at Texas Health Resource hospitals, and specifically at Texas Health Presbyterian,

Texas Health Presbyterian Hospital — under fire for releasing a Liberian man who later turned out to have the Ebola virus — has lagged behind its peers on emergency room care and lost some federal funds the past three years because it had high discharge rates of patients who later had to return for treatment.

The hospital scored significantly worse than the state and national averages in five of six emergency care indicators, with emergency room wait times twice as long as the averages, according to data from the U.S. Centers for Medicare & Medicaid Services.

The hospital also was the most penalized in Dallas under a three-year program designed to reduce the number of patients readmitted for care, according to the data.

The delays in patient treatment in the emergency room, in particular, raise important questions about Presbyterian’s emergency care, said Dr. Ashish Jha, a professor at Harvard University’s School of Public Health and a practicing general internist.

In 1988, Alain Enthoven advocated in Theory and Practice of Managed Competition in Health Care Finance, a book published in the Netherlands, that to decrease health care costs it would be necessary to break up the "physicians' guild" and replace leadership by clinicians with leadership by managers (see 2006 post here). Thus from 1983 to 2000, the number of managers working in the US health care system grew 726%, while the number of physicians grew 39%, so the manager/physician ratio went from roughly one to six to one to one (see 2005 post here). As we noted here, the growth continued, so there are now 10 managers for every US physician. 

We have frequently discussed how generic managers in charge of health care organizations may follow business-school dogma at the expense of patients' and the public's health.  In particular, they may also prioritize short-term revenue ahead of all other concerns, and hence may favor high-technology and procedural care, often performed electively, ahead of the the less glamorous and remunerative parts of health care, e.g., ED care of poor, uninsured, febrile patients.

Unfortunately, much of the country's efforts to ward off Ebola are likely to be lead by generic managers who may have little understanding of epidemiology, public health or virology, and little understanding of the state of health care at the sharp end.  So unfortunately I expect continuing "glitches," or worse.  Hopefully, the country, although not every single one of its inhabitants, will survive them.  Then we need to seriously reflect on the wisdom of handing control of health care over to generic managers, rather than health care professionals. 


Commercialization of Health Care Leading to Neglect of Routine Acute Care and Public Health 

Just as national politicians and government leaders have repeated the meme of the US health care system being "the best in the world," now that Ebola has come to Texas, state leaders have sung the same song.  For example, an editorial in the Baltimore Sun quoted the state health commissioner,

'This is not West Africa,' Texas health commissioner Dr. David Lakey said Wednesday at a news conference designed to dispel Texans' (and Americans') fear of an Ebola outbreak after a man there was diagnosed with the disease. 'This is a very sophisticated city, a very sophisticated hospital.'

The Texas Tribune ran a story produced in cooperation with Kaiser Health saying,

At a Wednesday press conference to discuss the Ebola case, Gov. Rick Perry said he was confident in the state’s preparedness. 'There are few places in the world better equipped to meet the challenge that is posed in this case,' he said. 'We have the health care professionals and the institutions that are second to none.'

However, another Dallas Morning News story recounted various problems in the public health response to the Dallas Ebola patient, including,

Delay in blood testing
After Duncan was admitted to the hospital, health officials waited nearly two days to test his blood for the Ebola virus. This may have delayed containment of people who had contact with him.
Slow containment and cleanup
Health officials left some of Duncan’s close contacts in the apartment where soiled linens and towels that he had used remained.
Failure to avoid contact with emergency workers
Ambulance workers and sheriff’s deputies are among those being monitored.

So, there is reason to suspect that the public health system in Texas may not exactly be the best in the world.  In fact, there seem to be systemic problems with public health in Texas that the Ebola scare is bringing to increased public notice.  The Texas Tribune/ Kaiser story went on to explain that in Texas, a state in which distrust of central government is great, and confidence in the private sector is high, public health is both decentralized and often poorly funded,

'We don’t really have a unifying construct for public health in Texas that’s comprehensive,' said Dr. Eduardo Sanchez, the former commissioner of the Texas Department of State Health Services (DSHS) and current chairman of the Texas Public Health Coalition. 'The system is not as connected as it could be.'

Furthermore,

But public health experts argue that the state’s response system is 'fragmented' and vulnerable to local budget cuts, which they say could hamper crisis-response efforts in the case of diseases that are more easily transmitted.

Texas’ local health departments, which provide services like immunizations and disaster response planning, operate autonomously and are funded primarily by local taxes but may be supplemented by state and federal grants. Because local health departments are not held to a single standard, their services and budgets vary tremendously around the state.

A report critical of the state’s public health system, prepared by the Sunset Advisory Commission, found that 'the roles and responsibilities of DSHS and local health departments remain undefined.' The Sunset Commission is tasked with highlighting inefficiencies at state agencies and recommending legislative action.

'A ‘local health department’ can be a few staff conducting restaurant inspections and animal control duties, or a large agency directing sophisticated disease surveillance, operating a public health laboratory and providing direct services to citizens,' according to the report.>

Some public health officials have criticized the state’s model as disjointed. Many local health departments operate independently; however, if local budget cuts to a public health department force it to discontinue a health service, DSHS is often required to step in and take responsibility for that service. The state is then left to foot the bill.

'In the event of a public health emergency ... the resources necessary to adequately respond to that are not all in the control of the health department,' Sanchez said. 'You have to have the money and the authority — whether it’s informal or formal — to actually lead a response and take care of business.'

Local entities have slashed funding for health departments in recent years, said Catherine Troisi, an epidemiologist at the University of Texas School of Public Health in Houston. Thirty-six percent of local health departments in Texas laid off staff as a result of budget cuts between 2008 and 2013, according to the National Association of County and City Health Officials.

'Public health is politics,' Troisi said.

In the US, we have pushed commercialization of health, health care and public health.  Much of our health insurance is provided by for-profit corporations.  Some of our hospitals and other organizations that provide direct patient care are for-profit.  As we noted above, most of our health care organizations are now run in a "business-like" manner by managers trained in business, but not necessarily in health care or biological science.  The thus revenue-focused health care system has emphasized procedures and high-technology, often at the expense of the basics.  So it should not be s surprise that Reuters just reported,

 Nurses, the frontline care providers in U.S. hospitals, say they are untrained and unprepared to handle patients arriving in their hospital emergency departments infected with Ebola.

Many say they have gone to hospital managers, seeking training on how to best care for patients and protect themselves and their families from contracting the deadly disease, which has so far killed at least 3,338 people in the deadliest outbreak on record.


Furthermore, using as an example Medstar Washington Hospital Center, the largest hospital in Washington, DC,

Nurses argue that inadequate preparation could increase the chances of spreading Ebola if hospital staff fail to recognize a patient coming through their doors, or if personnel are not informed about how to properly protect themselves.

At Medstar, the issue of Ebola training came up at the bargaining table during contract negotiations.

'A lot of staff feel they aren't adequately trained,' said [Emergency Department nurse Micker] Samios, whose job is to greet patients in the emergency department and do an initial assessment of their condition.

So Young Pak, a spokeswoman for the hospital, said it has been rolling out training since July 'in the Emergency Department and elsewhere, and communicating regularly with physicians, nurses and others throughout the hospital.'

Samios said she and other members of the emergency department staff were trained just last week on procedures to care for and recognize an Ebola patient, but not everyone was present for the training, and none of the other nursing or support staff were trained.

'When an Ebola patient is admitted or goes to the intensive care unit, those nurses, those tech service associates are not trained,' she said. 'The X-ray tech who comes into the room to do the portable chest X-ray is not trained. The transporter who pushes the stretcher is not trained.'

If an Ebola patient becomes sick while being transported, 'How do you clean the elevator?'

Nurses at hospitals across the country are asking similar questions.

A survey by National Nurses United of some 400 nurses in more than 200 hospitals in 25 states found that more than half (60 percent) said their hospital is not prepared to handle patients with Ebola, and more than 80 percent said their hospital has not communicated to them any policy regarding potential admission of patients infected by Ebola.

Another 30 percent said their hospital has insufficient supplies of eye protection and fluid-resistant gowns.

So up to now, it appears that in the state of Texas, and across the country, the preparedness of public health systems and of front-line hospitals to deal with Ebola is unclear.  This may be due to political cuts in funding of public agencies, a payment system that favors procedures and high-technology over basic care, and leadership by generic managers who prioritize making money short-term over less financially advantageous priorities like preparedness for epidemics.  

Summary
Thus again there is reason to fear that our commercialized health care system run by generic managers, and our neglected public health system scorned because it is not "business-like" may not be fully up to the task of containing Ebola.  Again, hopefully this too will pass, without too many casualties.  However, one, maybe the only silver lining in the dark clouds of the Ebola crisis seem to be its capacity to challenge the pompous certainty by those invested in the status quo that we have the best health care system in the world.

The Ebola crisis should, again, lead to serious reflection on true health care reform, reform that would address concentration and abuse of power, reform that would enable leadership of health care by  well-informed people who are devoted to patients' and the public's health, who are honest and ethical, who are willing to be held accountable, and would shrink the size and power of individual health care organizations to make them truly responsive to patients' health care needs and the public's health needs. 

ADDENDUM (10 October, 2014) - This post was re-posted on the Naked Capitalism blog, and on OpEdNews.com
9:37 AM
The Associated Press just published a story about another company which apparently failed to report adverse events associated with its product:

Complaints about a contact lens solution linked to a 2007 outbreak of eye infections that blinded several people went unreported by the manufacturer for more than a year, government documents show.

The documents show Advanced Medical Optics received complaints about the solution more than a year before it was recalled, and failed to promptly report nine complaints as required by law.

The company pulled its Complete MoisturePlus off the market in May 2007 after the Centers for Disease Control and Prevention linked the fluid to dozens of cases of a serious infection called Acanthamoeba keratitis.

Lawyers for customers suing AMO obtained the documents, which stem from a previously undisclosed inspection by the Food and Drug Administration, through a Freedom of Information Act request. The papers were obtained by The Associated Press.

Of roughly 70 plaintiffs suing AMO and represented by the law firm Schmidt LLP, three had eyes removed, three others suffered blindness and about two dozen had at least one corneal transplant. The others suffered permanent vision damage.

Beginning in February 2006 and continuing through November, AMO received a series of complaints about users who were diagnosed with the Acanthamoeba infections. But those reports were not disclosed until June 2007, when FDA inspectors came to investigate the company's headquarters following its product recall.


What is most striking is the company's rationale for not reporting:

When questioned by FDA inspectors, company officials said they were not obligated to report the complaints because the product's labeling does not say it protects against Acanthamoeba, according to the FDA documents.

Kelly Morrison, a spokeswoman for Abbott Laboratories, which acquired AMO in February, said the company 'believed it was reporting customer complaints in compliance with FDA regulations.' She declined to elaborate. Abbott Laboratories is based in North Chicago.


That is an original excuse. Did the "company officials" really mean to imply that in the absence of a promise to protect against a specific microbiologic organism, patients and physicians should assume that the product could be contaminated with that organism? This completely ignores the company's basic responsibility to supply a product that is uncontaminated with any harmful organisms, and unadulterated with any harmful substances, and hence to be vigilant for any events that suggest that the product could have been contaminated or adulterated.

The "company officials'" bizarre excuse suggest a fundamental lack of comprehension of their responsibilities for the health and safety of the patients using their products. This is a particularly weird example of how little many leaders of health care organizations understand about health care.
2:26 PM
A frequent theme on Health Care Renewal has been the adverse effects of health care leadership by generic managers with no background or experience in health care, and no intuitive understanding of its values. This type of leadership arose after some health care economists called for abolishing the supposed physicians' "guild," and transferring power over health care to managers as a way to control health care costs. This has not lead to control of health care costs.

The recent coverage by the New York Times of the sudden retirement of the CEO of General Motors suggests that the notion that organizations should be run by generic managers is one whose time ought to be past. Wagoner presided over a dramatic decline in the fortunes of GM.

Mr. Wagoner presided over some of the biggest losses in G.M. history. In 2002, the company had predicted that it would earn $10 a share by the middle of the decade.

Instead, G.M. lost $30.9 billion in 2008, when its per-share loss translated to more than $50 a share. G.M. stock, an economic bellwether that sold above $35 only three years ago, closed Friday at $3.62; it has fallen as low as $1.27 in the last year.

In 1994, when he took charge of G.M.’s North American operations, the company made up 33.2 percent of auto sales in the United States.

Last month, G.M. represented only 18.8 percent of American car and truck sales....


The problem may have been, in part, that Mr Wagoner was never a "car guy."

'It’s a pretty unceremonious ending,' said John Casesa, an industry analyst and managing partner of the Casesa Shapiro Group. 'G.M. lost its way in the ’70s, but the company didn’t know it until 20 years late. The hole was much deeper than he realized when he became C.E.O.'

And, Mr. Casesa said, Mr. Wagoner’s finance background might have been a poor fit: 'The most successful auto companies are run by people who came out of the revenue-generating functions — manufacturing, design, marketing — making cars and selling cars.' Mr. Wagoner, the analyst said, 'skipped the whole apprenticeship that most auto C.E.O.’s experience.'


The notion that a finance guy should run a car company makes not much more sense than the notion that a finance guy (or marketer, accountant, or lawyer) should run a hospital or a drug company. Yet now most health care organizations are run by such generic managers. Is it any wonder that while such generic managers have made a lot of money, they have been unsuccessful in controlling health care costs, much less solving any other aspect of the the health are crisis?
1:09 PM