Wednesday, 21 October 2015

"The Scourge of Managerialism" - Generic Management, the Manager's Coup D'Etat, Mission-Hostile Management Rolled Up, as Described by Some Men from Down Under

I just found an important article that in the June, 2015 issue of the Medical Journal of Australia(1) that sums up many of ways the leadership of medical (and most other organizations) have gone wrong.  It provides a clear, organized summary of "managerialism" in health care, which roughly rolls 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.  I will summarize the main points, giving relevant quotes.

Recent Developments in Business Management Dogma Have Gravely Affected Health Care

Many health practitioners will consider the theory of business management to be of obscure relevance to clinical practice. They might therefore be surprised to learn that the changes that have occurred in this discipline over recent years have driven a fundamental revolution that has already transformed their daily lives, arguably in perverse and harmful ways.

These Changes Have Been Largely Anechoic

these changes have by and large been introduced insidiously, with little public debate, under the guise of unquestioned 'best practice'.

See our previous discussions of the anechoic effect, how discussion of facts and ideas that threaten what we can now call the managerialist power structure of health care are not considered appropriate for polite conversation, or public discussion

Businesses are Now Run by Professional Managers, Not Owners

The traditional control by business owners in Europe and North America gave way during the 19th century to corporate control of companies. This led to the emergence of a new group of professionals whose job it was to perform the administrative tasks of production. Consequently, management became identified as both a skill and a profession in its own right, requiring specific training and based on numerous emergent theories of practice.

These Changes Were Enabled by Neoliberalism (or Market Fundamentalism, or Economism)

Among these many vicissitudes, a decisive new departure occurred with the advent of what became known as neoliberalism in the 1980s (sometimes called Thatcherism because of its enthusiastic adoption by the Conservative government of Margaret Thatcher in the United Kingdom). A reaction against Keynesian economic policy and the welfare state, this harshly reinstated the regulatory role of the market in all aspects of economic activity and led directly to the generalisation of the standards and practices of management from the private to the public sectors. The radical cost cutting and privatisation of social services that followed the adoption of neoliberal principles became a public policy strategy rigorously embraced by governments around the world, including successive Liberal and Labor governments in Australia.

Note that this is a global problem, at least of English speaking developed countries.  The article focuses on Australia, but we have certainly seen parallels in the US and the UK.  Further, note that we have discussed this concept, also termed market fundamentalism or economism.

Managerialism Provides a One-Size Fits All Approach to the Management of All Organizations, in Which Money Becomes the Central Consideration

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; 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.

Originally conceived as a strategy to manage large and increasingly complex organisations, in the contemporary world, no aspect of social life is now considered to be exempt from managerialist principles and practices. Policies and practices have become highly standardised, emphasising market-style incentives, devolved budgets and outsourcing, replacement of centralised budgeting with departmentalised user-pays systems, casualisation of labour, and an increasingly hierarchical approach to every aspect of institutional and social organisation.

We have frequently discussed how professional generic managers have taken over health care (sometimes referred to as the manager's coup d'etat.)  We have noted that generic managers often seem ill-informed about if not overtly hostile to the values of health care professionals and the missions of health care organizations.

Very Adverse Effects Result in Health Care and Academics

In the workplace, the authority of management is intensified, and behaviour that previously might have been regarded as bullying becomes accepted good practice. The autonomous discretion of the professional is undermined, and cuts in staff and increases in caseload occur without democratic consultation of staff.   Loyal long-term staff are dismissed and often humiliated, and rigorous monitoring of the performance of the remaining employees focuses on narrowly defined criteria relating to attainment of financial targets, efficiency and effectiveness.

The principles of managerialist theory have been applied equally to the public and the private sectors. In the health sector, it has precipitated a shift in power from clinicians to managers and a change in emphasis from a commitment to patient care to a primary concern with budgetary efficiency. Increasingly, public hospital funding is tied to reductions in bed stays and other formal criteria, and all decision making is subject to review relating to time and money. Older and chronically ill people become seen not as subjects of compassion, care and respect but as potential financial burdens. This does not mean that the system is not still staffed by skilled clinicians committed to caring for the sick and needy; it is rather that it has become increasingly harder for these professionals to do their jobs as they would like.

In the university sector, the story is much the same; all activities are assessed in relation to the prosperity of the institution as a business enterprise rather than as a social one. Education is seen as a commodity like any other, with priority given to vocational skills rather than intellectual values. Teaching and research become subordinated to administration, top-down management and obsessively applied management procedures. Researchers are required to generate external funding to support their salaries, to focus on short-term problems, with the principal purpose being to enhance the university's research ranking. The focus shifts from knowledge to grant income, from ideas to publications, from speculation to conformity, from collegiality to property, and from academic freedom to control. Rigid hierarchies are created from heads of school to deans of faculties and so on. Academic staff — once encouraged to engage in public life — are forbidden to speak publicly without permission from their managers.

Again, we have discussed these changes largely in the US context.  We have noted how modern health care leadership has threatened primary care.  We have noted how vulnerable patients become moreso in the current system, e.g., see our discussions of for-profit hospices.  We have discussed attacks on academic freedom and free speech, the plight of whistle-blowers, education that really is deceptive marketing, academic institutions mired in individual and institutional conflicts of interest, and the suppression and manipulation of clinical research.  We have noted how health care leaders have become increasingly richly rewarded, apparently despite, or perhaps because of the degradation of the health care mission over which they have presided.

The Case Study

The article provided a case study of the apparent demise of the Royal Australasian College of Physicians as a physician led organization, leading to alleged emphasis on "extreme secrecy and 'commercial in confidence," growth of conflicts of interest, risk aversion on controversial issues.  When members of the organization called for a vote to increase transparency and accountability, the hired management apparently sued their own members.

Authors' Summary

Whether the damage done to the larger institutions — the public hospitals and the universities — can be reversed, or even stemmed, is a bigger question still. The most that can be said is that even if the present, damaging phase of managerial theory and practice eventually passes, its destructive effects will linger on for many years to come.

My Summary

I now believe that the most important cause of US health care dysfunction, and likely of global health care dysfunction, are the problems in leadership and governance we have often summarized (leadership that is ill-informed, ignorant or hostile to the health care mission and professional values, incompetent, self-interested, conflicted or outright criminal or corrupt, and governance that lacks accountability, transparency, honesty, and ethics.)  In turn, it appears that these problems have been generated by the twin plagues of managerialism (generic management, the manager's coup d'etat) and neoliberalism (market fundamentalism, economism) as applied to health care.  It may be the many of the larger problems in US and global society also can be traced back to these sources.

We now see our problems in health care as part of a much larger whole, which partly explains why efforts to address specific health care problems country by country have been near futile.  We are up against something much larger than what we thought when we started Health Care Renewal in 2005.  But at least we should now be able join our efforts to those in other countries and in other sectors.   

ADDENDUM (30 October, 2015) - This post was republished on the Naked Capitalism blog.  See the comments, which are particularly interesting and important.  

Reference

1.  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.

Musical Diversion

We have to leaven this dismal post with the 1980 live version of "Down Under" by Men at Work

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Friday, 16 October 2015

Phooled Again - More Settlements Suggesting Bad Behavior by Big Pharma/ Biotech

Once again, here is a roundup of cases showing big multi-national pharmaceutical and biotechnology companies are up to their usual tricks.

Presented in alphabetical order...

Bristol-Myers Squibb Settles Charges of Bribery of Chinese Hospitals.

The best version of this I could find was in USA Today, in early October, 2015,

Pharmaceutical manufacturer Bristol-Myers Squibb has agreed to pay more than $14 million in fines to settle charges that its joint venture in China paid cash and other benefits to state-owned hospitals in exchange for prescription sales, the Securities and Exchange Commission announced Monday.

After its investigation, the SEC found that the New York-based company violated the Foreign Corrupt Practices Act in its dealings with Chinese hospitals and doctors and 'reaped more than $11 million in profits from its misconduct.'

Bristol-Myers Squibb neither admitted nor denied the findings, the SEC said.

The details, such as they were:

Chinese sales representatives at BMS China, the Chinese joint venture that is majority-owned by Bristol-Myers, paid bribes — including cash, jewelry, meals, travel, entertainment, sponsorships and other gifts — to health care providers between 2009 and 2014 to generate more sales. And Bristol-Myers Squibb 'failed to respond effectively to red flags' indicating such practices, the SEC said.

Apparently, some lower level Chinese employees were fired, although it is not clear whether they were involved in bribery, or in whistle-blowing about it, but top company management did not look too hard to see who might have authorized or directed the bad behavior,

Several BMS China employees who were fired by the company made claims that faked invoices, receipts and purchase orders were widely used to bribe health care providers. But Bristol-Myers Squibb did not investigate their claims, the SEC said.

Bristol-Myers Squibb was aware of improper payments as early as 2009, when an internal audit highlighted the problem. But the company was 'slow to remediate gaps in internal controls' over dealing with Chinese health care providers and monitor payments to them, the SEC said.

Needless to say, no one who might have authorized or directed the bad behavior, and who conceivably might have personally gotten bigger bonuses based on the revenue it brought it, suffered any negative consequences. Despite the settlement, of charges of bribery, no less, company public relations produced the usual,

We have resolved this matter with the United States Securities and Exchange Commission, and are committed to the highest standards of business integrity, vigilance and ethics across our organization.

Well then, that clears it up.

I cannot find any information about what BMS allegedly bribed the hospitals to do, and hence can draw no conclusions whether patients may have been harmed by receiving inappropriate medications.

UK Judge Found Pfizer Threatened Health Professionals

The most thorough coverage of this was, amazingly, in a medical journal, namely the British Medical Journal (Kmietowicz A. Pfizer loses UK patent for blockbuster pain drug after threats to doctors.  Brit Med J 2015; 351: h4918.  Link here.)  The background was,

The patent for the use of Lyrica for epilepsy and generalised anxiety disorder expired in July 2014, and manufacturers of generic versions already have licences for these two indications. But the manufacturer, Warner-Lambert (a subsidiary of Pfizer), holds a 'second medical use' patent for the use of pregabalin to treat peripheral and central neuropathic pain, which expires in July 2017. A second medical use patent is one that relates to a new medical use for a known compound.

Lyrica is one of Pfizer’s most successful products, with global sales in 2013 of some $4.6bn (£3bn; €4.1bn).

So apparently Pfizer set out to scare physicians away from prescribing generic pregabalin [generic Lyrica].

In his 174 page ruling Mr Justice Arnold said, 'Since late September 2014, Pfizer has taken extensive steps to try to ensure that generic pregabalin is neither prescribed nor dispensed for the treatment of pain.' This included sending a letter to the BMA and pharmacists stating that doctors and pharmacists risked infringing the patent if they supplied generic pregabalin for the pain indication and that this would be an unlawful act.

A letter sent to clinical commissioning groups in December 2014 was described by Arnold as 'calculated to have a chilling effect on the sales of Lecaent [the version of pregabalin made by Actavis].'

These letters would be seen by the recipients as a threat, said Mr Justice Arnold.

The Justice ultimately "overturned Pfizer's UK patent for pregabalin for pain control," in part because the "company made 'groundless claims' that its patent for Lyrica would be infringed if doctors did not specify Lyrica as opposed to a generic alternative when prescribing...."

This case was apparently only about the patent (and is subject to appeal), so it appears no one who apparently tried to authorize, direct or implement apparent intimidation of health care professionals with "groundless threats" will suffer any negative consequences.

This case does not seem to involve any obvious harms to patients.  However, "groundless threats" to health care professionals could have obviously demoralized them and clearly challenged their autonomy and professional values.

Sanofi Again Settles Charges of Misbranding Seprafilm

We discussed the first civil settlement the company made of this case in 2014 here.  A relatively clear summary of the new settlement was given by Reuters in September, 2015.

Genzyme Corp agreed to pay $32.59 million, admit wrongdoing and enter a deferred prosecution agreement to resolve U.S. criminal charges over its marketing of the surgical implant Seprafilm, the Department of Justice said on Thursday.

The biotechnology unit of French drug company Sanofi SA (SASY.PA) was accused of two misdemeanor counts of violating the federal Food, Drug and Cosmetic Act from 2005 to 2010 by allowing Seprafilm to be adulterated and misbranded while being sold. Sanofi bought Genzyme in 2011.

Seprafilm is a clear film used to reduce abnormal internal scarring that can cause organs and tissues to stick together following pelvic and abdominal surgeries known as laparotomies.

But the Justice Department said some sales representatives taught surgeons how to turn Seprafilm into a 'slurry' for use in increasingly popular laparoscopic surgery, even though U.S. regulators had never approved the film for that use.

According to papers filed with the federal court in Tampa, Florida, Genzyme admitted and accepted responsibility for the facts underlying the two criminal counts.

The two-year deferred prosecution agreement calls for improved oversight, and steps to halt Seprafilm sales for off-label uses. If Genzyme complies, the government will dismiss the charges.

Note that at least in this case, there was some admission by the company of the truth of the facts charged, and no protestation that "we adhere to the highest standards of integrity," or some such.

It seems possible that the use of the Seprafilm slurry in patients without clear evidence of its safety or effectiveness may have lead to patient harms, but I cannot find clear discussion of this.

Summary

So while big health care corporations, especially large drug and biotechnology companies, are always protesting how their main goal is to benefit patients, and how they support health care professionals, here are more cases in which it appears they at best set out to manipulate patients and health care professionals to maximize revenue.

Note that this is hardly the first time any of these companies have apparently misbehaved.  See our previous posts on BMS, on Genzyme (now a Sanofi subsidiary), and on Pfizer.  Note that our last discussion of the ever troubled Pfizer was only one month ago.

We have discussed endlessly how the march of legal settlements and other legal rulings affecting big health care corporations has raised questions about whether they are in it for patients and health care professionals, or just for the money.  That almost none of these legal actions has resulted in any real consequences for the individuals within the corporations who profited most from the misbehavior has allowed health care corporate managers' continued impunity, and has suggested how cozy health care corporate managers and goverment regulators and law enforcement officials have become, partially through the mechanism of the revolving door.

While these latest three cases have appeared, the mainstream media have begun to feature more discussion about how widespread managerial and corporate misbehavior is fueling the decline of the global economy, and perhaps of global society.  For example, as discussed in srticles in The Guardian, and more recently in the New York Times, Nobel Prize winners Robert Shiller and George Akerlof's new book, Phishing for Pfools: The Economics of Manipulation and Deception, suggests that widespread bad behavior in supposedly "free," and mainly unregulated markets can cause all sorts of evil.  In the Guardian, Shiller used the examples of how

 Most of us have suffered 'phishing': unwanted emails and phone calls designed to defraud us.  A 'phool' is anyone who does not fully comprehend the ubiquity of fishing.  A phool sees isolated examples of phishing, but does not appreciate the extent of professionalism devoted to it, nor how deeply this professionalism affects lives.  Sadly, a lot of us have been phools - including Akerlof and me, which is why we wrote this book

As Shiller wrote in the NYT, while he is a "free market advocate,"

we both believe that standard economic theory is typically overenthusiastic about unregulated free markets. It usually ignores the fact that, given normal human weaknesses, an unregulated competitive economy will inevitably spawn an immense amount of manipulation and deception.

Shiller and Akerlof believe that various kinds of manipulation and deception are enabled by technological advances, and that they are contagious,

When you realize that your competitor has used sophisticated and effective marketing tricks, then you will fall behind if you don’t follow suit.

This is really not a new idea,

In 1918, Irving Fisher, the Yale economist, argued that what people maximize in their actions is something that could better be described as 'wantability' rather than utility, for they are subject to temptation and mistakes in the vast array of purchases they make, leading profit-maximizing marketers to take advantage of them on a systematic basis.

In the first half of the 20th century, such critiques were of general interest. But they are little discussed today.

In the Guardian, Shiller warned that failure to address this problem in the financial sector could lead to "a new Dark Age." I fear that we are already close to a dark age for health care.

Similarly, in the Wall Street Journal, of all places, Charles Moore, the authorized biographer of Margaret Thatcher, and former editor of the conservative UK Daily Telegraph, wrote:

The relationship between money and morality, on which the middle-class order depends, has been seriously compromised over the past decade.  Which means that the mass bourgeoisie (a phrase that Marx and Engles would have thought a contradiction in terms) start to feel like the new proletariat.

Furthermore,

To the extent that people cheat in markets, they are not real markets, any more than antifreeze labeled 'wine' is real wine.  Too many advocates of markets have allowed themselves to be suborned into becoming apologists for business.  And too many businesses now operate as if their responsibilities are only to themselves and not to consumers.

See the above examples, and all we have written about bribery, kick-backs, fraud, other crime, and corruption to show how prevalent cheating is in health care.

Shiller concluded,

Marx did have an insight about the disproportionate power of the ownership of capital. The owner of capital decides where money goes, whereas the people who sell only their labor lack that power. This makes it hard for society to be shaped in their interests. In recent years, that disproportion has reached destructive levels, so if we don’t want to be a Marxist society, we need to put it right.

I would add that if we do not put these things right in health care, ending up with a Marxist system will be the least of our worries.

So as a start, to quote Shiller, we need more

heroic effortsw of campaigners for better values, both among private organizations and advocates of government regulation

Who will step up?

Our musical diversion, "Won't Get Fooled Again," the Who, 1978 live version:


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Wednesday, 7 October 2015

Fatal Fraud? - More Settlements by Commercial Hospices of Allegations They Enrolled Non-Terminal Patients

Fatal Fraud? - More Settlements by Commercial Hospices of Allegations They Enrolled Non-Terminal Patients

Introduction - Commercialized Hospices

We have occasionally written about the rise of the commercialized hospice industry, and concerns that commercialized hospices may not be providing the compassionate care they promise.  As we have discussed before, the hospice movement began with small, non-profit, community based organizations meant to provide compassionate palliative care to the terminally ill.  However, in the US, the hospice movement has been co-opted by commercial hospices, often run by large corporations, which may put profit ahead of compassion.

In the Washington Post series "Aging in America," Peter Whoriskey explored problems affecting the contemporary "industrialized" model of hospice.  He noted in August, 2014,

The hospice industry in the United States is booming and for good reason, many experts say. Hospice care can offer terminally ill patients a far better way to live out their dying days, and many vouch for its value.

In the US, hospice care is funded by Medicare, and the funding at times may seem generous. As more hospices are taken over by for-profit corporations, that money may be irresistible. Whoriskey noted,

But the boom has been accompanied by what appears to be a surge in hospices enrolling patients who aren’t close to death, and at least in some cases, this practice can expose the patients to the more powerful pain-killers that are routinely used by hospice providers.

Whoriskey presented a case in which a non-terminally ill patient was admitted to hospice, and died possibly due to aggressive use of narcotics.

Clinard 'Bud' Coffey, 77, a retired corrections officer, did the crossword in The Charlotte Observer after breakfast every morning, pursued his hobby of drawing cartoons, talked seven or eight times a day to his son Jeff and, just two weeks before his death, told a pal that he still felt 'like a teenager.'

He did, however, have some chronic back pain, and in late March he was enrolled in hospice care 'essentially for pain management,' his doctor said. Over a two week period, he received rising doses of morphine and other powerful drugs, grew sleepy and disoriented, and stopped breathing, dying peacefully at home, according to his family and medical records they provided.

While hospices tend to use very aggressive pain management strategies, they also by design do not attempt to cure patients who develop new acute problems. So if a non-terminally ill patient enters hospice, such a new acute problem could be fatal. For example, we discussed a case in which a person admitted to a commercial hospice for "debility" but apparently not defined terminal illness, died from untreated sepsis. It is possible that timely use of antibiotics could have contained her initial infection, or possibly even cured her sepsis.

Yet evidence continues to accumulate that modern industrialized hospices, especially those owned and run by large for-profit corporations, may enroll patients who are not terminally ill to increase revenue. The regulatory response to such behavior continues to be spotty, and seems focused on enrollment of non-terminal patients as a form of fraud, not as a danger to patients.

So far in 2015 two commercial hospice chains settled charges that they enrolled patients who were not terminally ill.

Good Shepherd Hospice

Early in 2015, there was very abbreviated news coverage of the settlement made by Good Shepherd Hospice. A Department of Justice press release noted,

Today, Good Shepherd Hospice Inc., Good Shepherd Hospice of Mid America Inc., Good Shepherd Hospice, Wichita, L.L.C., Good Shepherd Hospice, Springfield, L.L.C., and Good Shepherd Hospice – Dallas L.L.C. (collectively Good Shepherd) agreed to pay $4 million to resolve allegations that Good Shepherd submitted false claims for hospice patients who were not terminally ill. Good Shepherd is a for-profit hospice headquartered in Oklahoma City which provides hospice services in Oklahoma, Missouri, Kansas and Texas.

The press release specifically stated,

The government alleged that Good Shepherd knowingly submitted or caused the submission of false claims for hospice care for patients who were not terminally ill. Specifically, the United States contended that Good Shepherd engaged in certain business practices that contributed to claims being submitted for patients who did not have a terminal prognosis of six months or less, by pressuring staff to meet admissions and census targets and paying bonuses to staff, including hospice marketers, admissions nurses and executive directors, based on the number of patients enrolled. The United States further alleged that Good Shepherd hired medical directors based on their ability to refer patients, focusing particularly on medical directors with ties to nursing homes, which were seen as an easy source of patient referrals. The United States also alleged that Good Shepherd failed to properly train staff on the hospice eligibility criteria.

However, it suggested that the behavior was fraudulent, not dangerous,

'Health care fraud puts profits above patients, and steals from taxpayers,' said U.S. Attorney Tammy Dickinson of the Western District of Missouri. 'In this case, company whistleblowers alleged that patients received unnecessary hospice care while Good Shepherd engaged in illicit business practices to enrich itself at the public’s expense.'

Note that as is usual in cases of health care fraud, Good Shepherd Hospice did not admit wrongdoing, and no individual who authorized, directed or implemented the alleged bad behavior suffered any negative consequences. The minimal media coverage of this case did not discuss the possibility of any risks to patients. (For example, look here.)

Good Shepherd Hospice is part of a for-profit corporation. I could find nothing about its ownership, who its leaders are, or its financial status.  So who particularly benefited from the alleged behavior was not clear.

Guardian Hospice and AccentCare, Owned by Oak Hill Capital Partners

In early October, 2015, a brief news item in the Atlanta Journal Constitution described the settlement by Guardian Hospice.

A Georgia hospice company has agreed to pay $3 million to resolve allegations it billed taxpayers for patients who were not terminally ill,...

In particular,

Guardian Hospice set aggressive targets to recruit and enroll patients it knew were not in the last months of their lives so it could collect Medicare payments, the federal government alleged.

The article noted the settlement arose from a whistle-blower law suit, and that the whistle-blowers

alleged they routinely saw non-terminal patients being treated but were told it was necessary to keep the hospice’s 'census' up,...

The AJC article did quote their attorney as saying,

the practice was 'doubly cruel' because when unqualified patients are put on hospice, they are forced to forego regular medical care that could help cure their illness.

But it provided no further detail. The official news release only quoted an agent of the Department of Health and Human Services (DHHS) Inspector-General's office:

Hospice care is only medically appropriate – and reimbursed by Medicare – for terminally ill patients who are in the last months of their lives

Again, there were no admissions of culpabality, and no actions taken against any individuals.

The $3 million penalty seems paltry, given that we do know something about the owners of Guardian Hospice and the depth of their pockets.  One brief news article about a June, 2015, settlement made by Guardian Hospice for underpaying its nurses, did mention that Guardian Hospice is owned by AccentCare.  A little more digging found this press release from 2010 made by Oak Hill Capital Partners, a large private equity firm.

Oak Hill Capital Partners announced today that following the closing of their acquisition of AccentCare, Inc. ('AccentCare'), a premier provider of home healthcare services, including nursing and attendant care services, they intend to combine it with Guardian Home Care Holdings, Inc. ('Guardian'), a leading homecare and hospice service provider in the Tennessee, Georgia and Texas markets. The terms of the transaction were not disclosed.

The combination of AccentCare and Guardian creates one of the largest operators in the industry, with an expanded geographical footprint and highly diversified service offerings. The new company will operate over 130 branches across 10 states, serving more than 30,000 patients.

Since private equity firms have minimal reporting requirements, we do not know who owns Oak Hill Capital Partners, and hence who owns AccentCare and Guardian Hospice. We do know from the Oak Hill Capital Partners web-site that their portfolio is prodigious.

Summary and Discussion

There are more cases being reported in which hospices, particularly those owned and run by for-profit corporations, have enrolled patients who were not terminally ill.  These enrollments may be motivated by the desire for more money, but they put patients at risk.  Hospice patients may receive large doses of psychoactive drugs and narcotics, which may lead to adverse effects up to and including death.  Hospice patients may not, however, receive treatments for new acute problems, even if those problems are potentially curable.  Therefore, hospice patients may die from untreated infections that otherwise might respond to antibiotics.  Aggressive pain medication and withholding treatment of infections make sense as part of palliative care for terminally ill patients, e.g., those with terminal cancer.  But they make no sense for patients with longer life expectancy.

Nonetheless, such abuses by hospices get little press coverage, seemingly are ignored by health care regulators and law enforcement, and are almost completely anechoic in the health care, medical and health policy literature.

If a measure of society is how it cares for the most vulnerable patients, the US laissez faire approach to for-profit hospices suggests a society in decline.

To repeat what I wrote the last time for-profit hospices were (barely) in the news for enrolling the wrong patients,...

 In my humble opinion, we should return control of direct patient care, especially of the most vulnerable patients, to health care professionals and if necessary small non-profit community organizations.  We ought to give strong consideration to banning corporate hospices, and banning all forms of the corporate practice of medicine and corporate health care "delivery."

Given how many insiders make so much money from the current version of laissez faire capitalism in health care, however, I would expect strong resistance should such apparently "radical," but actually conservative proposals actually get any mainstream attention.    

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Thursday, 1 October 2015

Academic Medical Leaders as Directors of For-Profit Health Care Corporations: the Prevalence of This "New Species" of Conflict of Interest Documented in the BMJ

Academic Medical Leaders as Directors of For-Profit Health Care Corporations: the Prevalence of This "New Species" of Conflict of Interest Documented in the BMJ

The important conflicts of interest generated when academic health care leaders also serve on the boards of directors of for-profit health care corporations is suddenly less anechoic, thanks to some intrepid researchers and the British Journal of Medicine.

Background: Academic Health Care Leaders Also Serving as Directors of For-Profit Health Care Corporations

First Discovered Cases

In 2006, we first noticed that leaders of academic medicine also were serving as board members of large for-profit health care corporations.  The first example we discussed was that of Marye Anne Fox, Chancellor (equivalent to president) of the University of California - San Diego, and hence the person to whom the University of California, San Diego School of Medicine and its academic medical center report. The conflict was between this position, and her service as a member of the board of directors of Boston Scientific, a medical device manufacture, and the board of directors of Pharmaceutical Product Development Inc., a contract research organization.

Later that year, we discussed a "new species of conflict of interest."  At that time we wrote:

Medical schools and their academic medical centers and teaching hospitals must deal with all sorts of health care companies, drug and device manufacturers, information technology venders, managed care organizations and health insurers, etc, in the course of fulfilling their patient care, teaching, and research missions. Thus, it seems that service on the board of directors of a such public for-profit health care company would generate a severe conflict for an academic health care leader, because such service entails a fiduciary duty to uphold the interests of the company and its stockholders. Such a duty ought on its face to have a much more important effect on thinking and decision making than receiving a gift, or even being paid for research or consulting services. Furthermore, the financial rewards for service on a company board, which usually include directors' fees and stock options, are comparable to the most highly paid consulting positions. What supports the interests of the company, however, may not always be good for the medical school, academic medical center or teaching hospital.

Since 2006, we continued to find colorful examples of such conflicts of interest, e.g.,

- In 2006, the UnitedHealth board included multiple academic leaders, at least one of whom seemed partly responsible as a member of the board compensation committee for allowing the then UnitedHealth CEO to collect many backdated stock options (look here)
- In 2009, some attributed the problems at George Washington University's medical school that caused it to be put on probation to the conflict of interest of its provost and vice president for health affairs,  who also sat on the board of Universal Health Services, which owned the university hospital (look here)...

Through more recent years,

- In 2014, members of the AMA committee that has an outsize role in how the government fixes the pay of US doctors wer also found to be members of boards of directors of such companies as Kindred Healthcare, Hanger Inc, and Sante. (Look here.)
- In 2015, the academic physician and research unit leader nominated to be the new head of the US Food and Drug was a director of Portola Pharmaceuticals (look here)...

Look here for even more

Our Early Cross-Sectional Study

In 2007, we did a somewhat rough and ready research project based on 2005 data to determine the prevalence of such conflicts.  The results were presented in abstract form,(1) but not published as an article:

In 2005, there were 164 US health care companies in the 2005 S&P 1500, and 125 US medical schools. We identified 198 people who served on the companies' boards of directors who had faculty or leadership positions at these medical schools. Of the 125 medical schools, 65 schools had at least one faculty member and/or leader who also served on a health care corporation's board of directors. 15 schools had more than five, and 4 had more than 10 such individuals. Of the 125 schools, 7 reported to university presidents who were also directors of health care corporations, and 11 schools reported to vice-presidents for health affairs who were also such corporate directors. Four schools were lead by deans who were also health care corporate directors, and 10 schools had academic medical center CEOs who were such directors. 22 schools had at least one top leader who was also a director of a health care corporation. 36 schools reported to university boards of trustees which each included at least one director of a health care corporation, and 12 schools' own boards of trustees included at least one such director.

We concluded:

more than one-half of US medical schools had a leader or faculty member who also was a director of a major US for-profit publicly traded Bpure^ health care corporation, more than one-sixth of schools had a top leader who was also such a director, and more than one-fifth reported to boards of trustees which included such directors.

More Modern and Complete Data

Unfortunately, we never wrote a full paper about this work, although the likelihood we could have gotten it published around 2007 was very small.  It is fortunate that Anderson and colleagues did a more complete and current version of this project, which was published online this week by the British Medical Journal.(2)

Methods

Their methodology was similar to our earlier work, but more sophisticated.  They obtained data on the 2013 board members of 446 public for-profit US companies listed on New York Stock Exchange or NASDAQ and classified as in the healthcare sector, including pharmaceutical, biotechnology, medical equipment and supply companies and health care providers from the companies' 2014 proxy statements.

Results

Their results were striking, suggesting even a greater prevalence of conflicted academic leaders than our preliminary results suggested

Directors were affiliated with 85 geographically diverse non-profit academic institutions, including 19 of the top 20 National Institute of Health funded medical schools and all of the 17 US News honor roll hospitals. Overall, these 279 academically affiliated directors included 73 leaders, 121 professors, and 85 trustees. Leaders included 17 chief executive officers and 11 vice presidents or executive officers of health systems and hospitals; 15 university presidents, provosts, and chancellors; and eight medical school deans or presidents.

The new study also described the direct financial relationships among the academic leaders, professors and trustees and the corporations on whose boards they served.

The total annual compensation to academically affiliated directors for their services to companies was $54 995 786 (£35 836 000; €49 185 900) (median individual compensation $193 000) and directors beneficially owned 59 831 477 shares of company stock (median 50 699 shares).

Discussion

As we have suggested, Anderson et al stated that being on the board of directors of a for-profit health care corporation creates conflicts of interest beyond those created by simply having a financial relationship with a health care company, e.g., by participating in a commercially sponsored research project or acting as a consultant to a company.

Similar to individuals engaging in consulting relationships, directors on industry boards enter a formal contract with the company and receive financial payment for services; however, they are subject to two important differences. Firstly, unlike consultants who are compensated to provide expertise on a specific issue, directors are subject to a fiduciary responsibility to company shareholders to advance the general interests of the company and increase profits. Secondly, directors are reimbursed both through larger cash fees than typical consulting contracts and through stock options, the value of which is directly tied to the financial success of the company.

They also added the reminder that,

Though the missions of academia and for profit companies can overlap, they may also diverge, specifically when the for profit mission of industry competes with the non-profit taxpayer funded clinical and research missions of academic medical and research institutions.

So,

previous guidelines have emphasized the relationships of clinicians and researchers with industry, but institutional conflicts of interest, which arise when administrators, including executive officers, trustees, and clinical leaders have a financial relationship with industry, are increasingly recognized and pose a unique set of risks to academic missions. 

Our Summary

We have written again and again on the problem of conflicts of interest affecting health care professionals, academics, and policy makers.  The worst such conflicts may occur when individuals are simultaneously leaders of large mission-oriented health care non-profit organizations, such as teaching hospitals, medical schools, or research institutes, and board members of for-profit health care corporations.  Despite our attempts to raise such issues as important, and probably important causes of health care dysfunction, they have remained anechoic.

Now a broadly based study of this no longer so "new species" of conflict of interest has appeared in one of the biggest and most prestigious medical journals.  Let us hope it will bring this issue to the forefront, and also partially counter those who have been preaching that concerns about conflicts of interest in health care are overblown.

As we have said again and again, the web of conflicts of interest that is pervasive in medicine and health care is now threatening to strangle medicine and health care.  Furthermore, this web is now strong enough to have effectively transformed US health care into an oligarchy or plutocracy.  Health care is effectively run by a relatively small group of people, mainly professional managers plus a few (lapsed?) health care professionals, who simultaneously run or influence multiple corporations and organizations.

For patients and the public to trust health care professionals and health care organizations, they need to know that these individuals and organizations are putting patients' and the public's health ahead of private gain. Health care professionals who care for patients, those who teach about medicine and health care, clinical researchers, and those who make medical and health care policy should do so free from conflicts of interest that might inhibit their abilities to put patients and the public's health first.

Health care professionals ought to make it their highest priority to ensure that the organizations for which they work, or with which they interact also put patients' and the public's health ahead of private gain, especially the private gain of the organizations' leaders and their cronies.

ADDENDUM (16 November, 2015) - Note that an abbreviated version of this post has appeared as an electronic "rapid response" to the article by Anderson et al (link here), although the published form has on it our original submission date.   

References

1. Poses RM, Smith WR, Crausman R, Maulitz R. Selling them the rope: prevalence of for-profit health care corporate dirctors among academic medical leaders. J Gen Intern Med 2007; 22 (Suppl 1): 98.
2.  Anderson TS, Good CB, Gellad WF.  Prevalence and compensation of academic leaders, professors and trustees on publicly trade US healthcare company boards of directors: cross sectional study.  Brit Med J 2015; 351:h4826.  Link here
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Friday, 25 September 2015

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

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

Dear Queen Elizabeth,

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

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

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

In that post I observed:

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


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

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

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

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

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

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

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

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

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

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

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

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

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

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

And now this:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Among their key findings were:

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

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

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

Clearly, the CQC does not mean a positive impact.

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

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

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

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

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

Despite this patients received excellent care.

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

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

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

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

 Ditto.

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

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

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

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

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

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

That theory is likely confirmed by the following:

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

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

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

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

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

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

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

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

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

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

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

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

Sincerely,

S. Silverstein, MD
Drexel University
Philadelphia, PA

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Addendum:

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

-- SS
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