Pfizer May No Longer be Able to Delay Paying Its Asbestos Claims of Nearly $1 Billion

Pfizer, which claims to be the "world's largest research-based pharmaceutical company," is one step closer to paying a nearly one billion dollar settlement of legal claims of harms due to the asbestos products it used to manufacture.

Pfizer Settles - More or Less - Some of its Asbestos Liability

Most people would not think of Pfizer as a producer of asbestos.  However, the back-story, as reported in the Philadelphia Inquirer, and as we discussed here in 2011, is that

Pfizer used to have a minerals, pigments and metals division and, in 1968, it bought Quigley Company Inc., which made insulation for heavy industry.

Quigley's Insulag contained asbestos.

So,

Quigley stopped production at its facility in Old Bridge, N.J., in 1992.  When it filed for bankruptcy in 2004, Quigley faced more than 160,000 lawsuits, most related to asbestos product liability.

By apparently holding out the legal fiction that Quigley was an independent entity, Pfizer seemed to use to use the bankruptcy filing to delay making any payment of these claims, most of which likely involved illnesses due to asbestos exposure.  As the Inquirer article said,

Pfizer has spent the nine years since arguing that bankruptcy law protects it from such lawsuits.

notwithstanding the fact that Pfizer itself is hardly bankrupt.

But now, as Bloomberg reported (via the New London [CT] Day),

 Pfizer Inc.'s non-operating Quigley Co. won permission to end almost nine years in bankruptcy under a plan that resolves most asbestos claims against the former insulation maker and its parent, the world's largest drugmaker.

U.S. Bankruptcy Judge Stuart Bernstein in Manhattan Wednesday approved a Chapter 11 plan under which Pfizer will contribute assets worth $964 million. He rejected a prior plan almost three years ago, saying Pfizer was improperly using Quigley's bankruptcy to shield itself from asbestos claims.

Note that Pfizer has consistently argued that it should bear no responsibility for the effects of the asbestos made by its subsidiary:

'Pfizer has never been found derivatively or directly liable for injuries allegedly caused by Quigley's asbestos- containing products,' [Pfizer spokesman Christopher] Loder said.

Pfizer used to have a minerals, pigments and metals division and, in 1968, it bought Quigley Company Inc., which made insulation for heavy industry. Quigley's Insulag contained asbestos.
Read more at http://www.philly.com/philly/business/20130627_Drug-maker_Pfizer_fails_to_escape_costly_asbestos_case.html#AltGBB8oXa8YPkAC.99

Furthermore,

Pfizer has said throughout the case that it never made or sold Quigley's products and it doesn't have liability for them. Asbestos, once widely used as an insulator, was later shown to cause cancer.

Convenient Fictions

This case received little notice in 2011 and is receiving little notice now, and mainly for its business implications.  Yet the reporting does suggest  dots to connect to reveal some larger hypocrisies.

Dedicated to improving health and well being?

Pfizer asserts on its website that it

has remained dedicated to discovering and developing new, and better, ways to prevent and treat disease and improve health and well being for people around the world.[italics added]

Yet despite this supposed dedication to health and well-being, it has long delayed any possible compensation to people who may have acquired severe, if not fatal disease from contact with one of its products.

As per Bloomberg, note the examples of

people like Brenda Hagerich, 62, of Hot Springs, Ark., may get payments on their claims. Hagerich, whose father died in 1999 of mesothelioma, said she has been waiting for a second distribution of a $125,000 payment.

Ownership without responsibility

According to current media reports,  Pfizer attorneys repeatedly contended that because Quigley was a subsidiary of Pfizer, Pfizer could not be held accountable for its actions.  Yet Pfizer owned, and presumably thus gained all revenue from and chose the leadership of Quigley.  At best, maintaining this fiction seems heartless given Pfizer's stated interest in peoples' "health and well being."

Who knew asbestos was dangerous?

The current reports seem to imply that Pfizer's accountability should be mitigated because at the time it acquired Quigley, no one knew that asbestos was hazardous.  The Bloomberg report stated,

Quigley made asbestos-containing products from the 1940s to the 1970s, including Insulag, a powdered insulation. Pfizer, based in New York, bought the company in 1968.

But,

Pfizer has said throughout the case that it never made or sold Quigley's products and it doesn't have liability for them. Asbestos, once widely used as an insulator, was later shown to cause cancer.

The last sentence implies that asbestos was only shown to cause cancer after Pfizer acquired Quigley in 1968.  However, this suggests a lack of knowledge of medical history.

In fact, evidence that asbestos was dangerous would have been readily available in 1968. Pulmonary asbestosis was recognized in 1927.(1, noted in 2).  Furthermore, by 1952, as per Dr Richard Doll(3),

The majority of workers (cited by Hueper, 1952) consider that a causal relationship between asbestosis and lung cancer is either proved or is highly probable and the reality of the relationship was agreed at the recent International Symposium on the Epidemiology of Lung Cancer.

Doll reported further data in 1954 and concluded,

lung cancer was a specific industrial hazard of certain asbestos workers....

Summary

So while Pfizer officials ought to have known that in 1968 it was acquiring a company that made products that likely caused lung cancer, for more than 40 years, they have managed to stall payments to now mainly the heirs of people who acquired severe disease due to those products.  This clearly suggests that in this matter the company leadership has consistently put its revenue ahead of its ostensible dedication to peoples' health and well being.  Then again, this is hardly the first example of dubious ethical conduct by Pfizer.  See this post for a list of the 14 legal settlements of allegations of misconduct made by Pfizer since 2000, only one of which was related to the current case.

Furthermore, dedication to short-term revenue over everything else has resulted in huge wealth for Pfizer's hired managers.  Per the Wall Street Journal, only the latest example is,

The total 2012 compensation for Pfizer Inc. (PFE) Chief Executive Ian C. Read was valued at $25.6 million, up 2.5% from 2011, as the drug maker hit two out of three key financial objectives last year. 

Mr. Read's compensation was based partly on the company exceeding targets for total revenue and adjusted earnings-per-share, while missing its target for cash flow in 2012, Pfizer said in a proxy statement filed Thursday with the U.S. Securities and Exchange Commission.

Presumably, the total revenue target would have been a bit lower if Pfizer had managed to set aside assets to pay the asbestos related claims discussed above in 2012 rather than in 2013.

This relatively anechoic example shows how hollow ring most of the claims by leaders of big health care organizations that they value patients' and the public's health.  That may be convenient public relations puffery, but again and again the bottom line seems to matter more to them.  We have shown numerous examples of mission-hostile management, and of leaders compensated outrageously out of proportion to their contributions to patients' and the public's health.  Thus, why should health care professionals, or patients believe that anything they do puts patients ahead of money?

As we have said so often, health care professionals and society at large needs to hold large health care organizations' leadership accountable for their missions, and push out leaders who put their own pocketbooks and their organizations' revenue ahead of patients' and the public's health. 



References

1.  Cooke WE.  Pulmonary asbestosis.  Br Med J 1972; 2: 1024.
2.  Hasan FM, Nash G, Kazemi H. Asbestos exposure and related neoplasia: the 28 year experience of a major urban hospital.  Am J Med 1978, 65: 649-654. Link here.
3.  Doll R. Mortality from lung cancer in asbestos workers.  Br J Indust Med 1955; 12: 81-86.  Link here. 

Shut Up and Sell - the Corporate Physician's New Motto?

Evidence has been seeping into public view about the extent physicians who sign up to take care of patients as corporate employees give up their professionalism.

Shut Up...

In April, 2013, Medscape published an article whose striking title was "Can You Speak Out Without Getting Fired or Being Labeled a Troublemaker?"  The answer was basically "no."

Physicians often see problems at their workplaces relating to patient quality of care, financial practices, mistreatment of staff, and other issues. But as more doctors take jobs as employees of hospitals, medical groups, and other large organizations, they increasingly face the same dilemmas as millions of other working stiffs. When they come across actions or policies that they don't think are right, they have to decide whether it's worth it to speak out and get labeled as a troublemaker -- or perhaps even get fired.

 Across the country, a growing number of physicians are indeed losing their jobs -- and often their hospital staff privileges -- after protesting employment conditions. Such complaints may involve patient quality-of-care problems, short staffing, misallocation of funds, improper financial incentives, fraud and abuse, discrimination, overuse or withholding of medical services, or other misconduct, say organized medical groups, employment attorneys, and physician recruiters.

Of course, physicians swear oaths to put the needs of their individual patients first, and doing so within a large organization might well involve protesting conditions and practices that may affect the quality of care or even endanger patients.  But woe unto physicians who try to fulfill their professional responsibility when doing so goes up against the top executives to whom the physicians must now report.

'We were naive when we went into this,' says Maria Rivero, MD, who with her professional colleague and significant other Derek Kerr, MD, filed administrative complaints against their long-time hospital employer in 2010. 'We thought if we just brought it to people's attention, they would fix the problem and leave us alone. But if you blow the whistle on high-level executives, you need to prepare to be harassed and lose your job.'

Even working within the system to fix problems can lead to big trouble,

Still, the formal professional approach doesn't always work either. Cloyd Gatrell, MD, an emergency physician who was employed by EmCare, says that he and his wife Kathryn, a nurse, voiced concerns and presented data to executives at Carlisle Regional Medical Center in Pennsylvania in 2008 and 2009 on what they saw as inadequate nurse staffing levels that endangered patients.

After getting no results, Dr. Gatrell contacted the state health department, prompting a state inspection that found insufficient staffing. In 2010, he was fired by EmCare at the request of the hospital, according to his 2011 lawsuit against the hospital and EmCare claiming violation of whistleblower protection laws. His wife was fired earlier, and she sued separately. The hospital issued a statement declining comment on the litigation.

'We're supposed to be advocates for patients, but being employed puts us in a precarious position in taking a position on patient interests that's against what the hospital administration favors,' says Dr. Gatrell, whose suit is in the discovery stage. 'I think a physician still has that responsibility.'

Physicians who sign contracts with corporate employers, perhaps thinking that they will have less bureaucracy with which to contend and a more certain salary than they did in private practice, seem blissfully, or willfully unaware that those contracts may take away their ability to control their practices and stand up for their patients.

Still, federal and state whistleblower laws only provide protection from retaliation for physicians in certain situations, such as those employed by public entities or those who complain about civil rights violations or Medicare and Medicaid fraud and abuse. Otherwise doctors may have to rely on contract provisions or on state employment law, which may not offer much protection.

[An anesthesiologist on the AMA Board of Trustees and his hospital system's board,] Dr. Annis says that the AMA's new statement of principles for physician employment -- which asserts that physicians should not be retaliated against by their employers for speaking out on patient care issues -- provides support for doctors when they raise legitimate professional concerns with their employers. He says it's best for physicians to work through their medical staff organization.

But Dr. Gatrell points out that the AMA statement explicitly accepts that physician employment contracts may allow hospitals to strip doctors of their medical staff membership and clinical privileges at the same time they are terminated, known as a 'clean sweep' clause. 'If that's accepted by the AMA, the rest of the principles protecting physicians are meaningless," he argues. "If physicians can be fired without cause and then automatically lose their medical staff membership and its due process protection, how many will dare be a patient advocate?'

Some experts advise physicians not to sign employment agreements with such onerous provisions. But others say that physicians often have little leverage to remove them. 'It's not an equal negotiating table,' says Dr. Gatrell, who's now working for a small urgent care practice.

A May, 2013 article again in Medscape about the "4 Top Complaints of Employed Doctors," explained why physicians often see a lot they could or should protest to assure the quality of their patients' care,

 Some doctors report that hospital administrators treat them with a lack of respect. One female doctor said, also on condition of anonymity, that her biggest challenge on her job was 'how to handle nonphysician high school grads bossing you around when they function as your 'superiors' in your employer's organization. They manage their insecurities by bullying physicians and through passive aggressiveness, but always seem to gain the upper hand with those at the top.'

These are the sorts of brilliant administrators often hired by brilliant top executives, maybe at a cheap price to keep the bottom line and executive compensation healthy..  Furthermore, given that as we have discussed, "financialization" of hospital management often puts a bigger priority on short-term revenue than on quality care, as per one senior physician,

 'physicians are being increasingly targeted when they get in the way' of hospitals' agendas

To make more money faster, many hospital systems now seem to want physicians to only make referrals for lucrative tests and treatments within the system, even if some patients might be better served elsewhere,

The AMA recently issued guidelines for physician employment stating that 'a physician's paramount responsibility is to his or her patients.' Employers should not retaliate against physicians for asserting their patients' interests, according to these guidelines. 'In any situation where the economic or other interests of the employer are in conflict with patient welfare, patient welfare must take priority,' the AMA says.

The guidelines also call for employers and employed physicians to disclose to patients any agreements or understandings they have that restrict, discourage, or encourage particular treatment or referral options.

Nevertheless, employed physicians are often expected to refer patients within their own groups and send tests to a hospital laboratory or imaging center. Hospitals may tell employed surgeons which kinds of joint implants to use, and according to a New York Times article even whether to implant defibrillators in Medicaid patients. It's unclear how often any of this is disclosed to patients.

'What we doctors say is that we're ethically bound to our patients because we took an oath, and that's what our license is based on,' says Linda Brodsky. 'But many hospitals say, 'No, you're employed here, and what we say goes.'

Note that so far there seems to be little evidence that the AMA guidelines about physician employment are being honored other than in the breach.  It is also disappointing that the leadership of the medical society that represents internists seems so unworried,

 David L. Bronson, MD, President of the American College of Physicians, disputes Brodsky's assertion that hospitals tend to squelch doctors who criticize leadership for policies that they believe harm patient care. In fact, he says, healthcare organizations may identify outspoken physicians as potential leaders, 'as long as they're collaborative and trying to solve problems, and not just be a thorn in the side of everyone they know. Organizations are looking for physician leaders, and physicians who can collaborate and not just be adversarial can go far inside organizations.'

I would guess, having seen so many examples of generic management, mission-hostile management, management that seems more focused on the money than patient care, and management that seems to be able to make itself rich without evidence that it has done anything noteworthy to uphold hospitals' clinical missions, that hospital systems that promote physicians who are willing to speak out against hired executives are vanishingly rare.

And Sell

In June, 2013, Beckers Hospital Review published an article suggesting that now hospitals are going beyond just pressuring employed physicians to refer potentially profitable patients within the system, and now are pressuring physicians to act as salespeople to their colleagues,

 A few hospitals are beginning to train their employed physicians to "sell" the hospital, which involves asking referring doctors in the community to send patients their way....  the pressure to bring doctors into sales is mounting.

The author, the former publisher of Modern Healthcare, made a remarkable argument based on a definition that seems wildly optimistic,

 Customer service lies at the core of salesmanship. The Business Dictionary defines salesmanship as satisfying customer needs through a sincere and mutually beneficial process aimed at a long-term relationship.

Of course, skeptical physicians used to exposure to the sales tactics pharmaceutical and device companies use (look here, here, and here,  for example) might wonder why the author did not discuss such marketing tactics as the employment of half-truths and biased information, and the use of emotional appeals to trump reason and logic.

That the author was serious was shown by his list of seven pointers for hospitals seeking to transform its employed physicians into marketers.

Of course, physicians who are already "key opinion leaders" employed by drug and device companies, whose marketing executives may think. that "key opinion leaders were sales people for us," (see this post), might not be fazed by now being asked to market their own hospital.  Never mind about Principle II of the AMA Code of Ethics

II. A physician shall uphold the standards of professionalism, be honest in all professional interactions, and strive to report physicians deficient in character or competence, or engaging in fraud or deception, to appropriate entities.

The Moral of the Story

We have previously discussed various aspects of the travails of the brave new world of the corporate physician.  Physicians and other health professionals who sign on as full-time employees of large corporate entities have to realize that they are now beholden to managers and executives who may be hostile to their professional values, and who are subject to perverse incentives that support such hostility, including the potential for huge executive compensation.  Physicians seem to be willing to sign contracts that underline their new subservience to their corporate overlords, and likely trap them within confidentiality clauses that make blowing the whistle likely to lead to extreme unpleasantness.

It is disappointing that even medical societies that ostensibly support physicians' professional values have been afraid to warn against such employment, or do much to help physicians trapped within it.

Physicians who go to work for big corporations have to realize that they may be forced to put corporate executives' vested interests ahead of their patients.  Patients whose physicians work for big corporations must realize that their health care will now be corporate, with all that entails.

  As I have said before, we need to challenge the notion that direct health care should ever be provided, or that medicine ought to be practiced by for-profit corporations. I submit that we will not be able to have good quality, accessible health care at an affordable price until we restore physicians as independent, ethical health care professionals, and until we restore small, independent, community responsible, non-profit hospitals as the locus for inpatient care.

Monetary losses and layoffs from EHR expenses and EHR mismanagement

More on monetary losses and layoffs from EHR expenses and EHR mismanagement:

1.  Layoffs to balance the budget...

http://www.news-record.com/news/local_news/article_da765340-d912-11e2-9eac-001a4bcf6878.html

... Wake Forest University Baptist Medical Center [Winston-Salem, NC] said in November 2012, that it would cut 950 jobs — 6 percent of its total staff.

Electronic records programs continue to push costs higher. The Winston-Salem Journal reported that Wake Forest’s Epic [EHR] program caused $8 million in work interruptions during the 2012-2013 year alone. Wake Forest is cutting costs at least through June 30 to make up for some of Epic’s expense. Its efforts include furloughs, wage reductions and other cuts.

2.  Cerner EHR Project Loses U.K. Hospital 18 Million Pounds

http://www.informationweek.com/healthcare/electronic-medical-records/ehr-project-loses-uk-hospital-18-million/240157036

... Royal Berkshire Foundation Trust's implementation of Cerner Millennium electronic health record system is costly to maintain and hard to use, causing patient backlogs ... British hospital's attempt to implement an electronic health record (EHR) system has been so disastrous that it has had to write off £18 million ($28 million).


... "Unfortunately, implementing the [EHR] system has at times been a difficult process and we acknowledge that we did not fully appreciate the challenges and resources required in a number of areas," said the hospital's chief executive, Ed Donald. 

In 2013, I find the statement "we did not fully appreciate the challenges and resources required in a number of areas" remarkable.

Dear Mr. Donald, please allow me to introduce you to a novel concept:

A Google search.  (Free, no less.)

Try this, for example:  https://www.google.com/search?q=healthcare%20IT%20failure

(I note that competent experts in my field, Medical Informatics, given appropriate executive presence - including hiring and firing authority, instead of the usual 'internal consultant' roles - could have prevented your organization's mistakes, and for a mere fraction of the £18 million.)

A campaign against public sector waste in Britain, The Taxpayer's Alliance, has seized on the hobbled project as an especially egregious example of bad procurement. "[NHS] trusts must work a lot harder to get a good deal for the taxpayers footing the bill," it warned.  [I guess money doesn't grow on trees in the UK as it seems to in the US -ed.]

The row comes in the same week British Parliament members expressed frustration that the funding scheme that supported other British hospitals' investment in EHRs, the controversial £9.8 billion ($15.2 billion) National Program for IT cancelled in 2011, continues to cost the country millions, with contracts in some cases not set to expire for 12 more years. [NPfIT in the NHS - see query link http://hcrenewal.blogspot.com/search/label/NPfIT - ed.]

Berkshire, however, opted out of that program in 2008 and had instead linked with the University of Pittsburgh Medical Center to help it implement Millennium.

I am merely the messenger here...

-- SS

No Blues, but Lots of Green for St Louis Hospital System CEOs

A recent article in the St Louis Post Dispatch provided the latest examples of how hospital executive compensation continues to defy gravity.  In summary,

In recent years, executives at St. Louis-area nonprofit health organizations have seen annual double-digit increases of as much as 40 percent in their total compensation packages, which typically include salaries, bonuses, pensions and health benefits.

Such pay hikes occurred as these nonprofit organizations enjoyed their largest operating margins in years,...

The examples include...

BJC Healthcare

Steven Lipstein, president and chief executive of St. Louis-based BJC Healthcare, received a total compensation package of about $3.3 million in 2011, the latest year currently available per BJC’s tax filings. That’s a 40 percent hike over his compensation of $2.3 million in 2010. A year earlier, he received a 4 percent increase.

In particular,

 According to BJC’s 990 tax filing, Lipstein’s 2011 compensation of $3,279,956 included a base salary of $920,576; bonuses and incentive pay of $2,213,555; other compensation of $15,733; deferred compensation of $99,651; and $30,441 in 'nontaxable benefits.'

Also,

Five BJC executives received total compensation packages in 2011 exceeding $1 million.

For comparison, note that

The health system paid about $1.7 billion in salaries and benefits in 2011 to its 28,559 employees — an overall increase of nearly 5 percent over its labor costs in 2010, when it had about 250 fewer employees.

So Mr Lipstein's compensation rose much faster than the system's total labor costs.  Also,

 BJC employees — which include a spectrum of jobs from administrators, physicians and nurses to medical technicians, office workers and supply clerks — earn annual salaries and benefits on average totaling about $58,343. Lipstein’s pay package of $3.3 million for 2011 was 56 times greater than the average BJC employee’s compensation.

So the CEOs compensation was much larger than that of the average employee, and seems to have risen much faster.

SSM Health Care

William Thompson... [is] chief executive of Creve Coeur-based SSM Health Care, which operates 18 hospitals in four states. He received total compensation of $2.3 million in 2011 — a 26 percent increase over 2010.

Some of that pay hike was attributable to a change in jobs. Thompson, SSM’s former chief operating officer, assumed the role of chief executive in August 2011. In 2010, his pay increased 95 percent from $918,229 to $1.8 million.

Ascension Health Alliance

 Anthony Tersigni, chief executive of Ascension Health Alliance, received total compensation in fiscal year 2012 of $4 million — a 12 percent increase over the previous year. A year earlier, he received a 6.5 percent increase over the previous year in his former role as chief executive of Ascension Health. 

In addition,

 Nine executives at Ascension’s headquarters received total compensation in fiscal year 2012 exceeding $1 million.

Mercy Health

Lynn Britton, chief executive of Mercy, received $2.2 million in total compensation in fiscal year 2012 — a 15 percent increase over 2011. A year earlier, he received an 18 percent increase.  

And,

Five current and former Mercy executives received total compensation in fiscal year 2012 exceeding $1 million.

Myra Aubuchon, a former Mercy senior vice president who left the health system in 2010, received a payout in fiscal year 2011 of $3.4 million for retirement benefits, severance and other compensation. In fiscal year 2012, she received an additional $405,339 in compensation.

Mercy executives are provided additional perquisites, including first class and charter travel on Mercy’s aircraft and the opportunity at times for their spouses to accompany them to business and other events. Executives and staff fly to and from some business meetings in Mercy’s midsize corporate jet, a Rockwell Sabreliner. 

The Usual Talking Points

So all CEOs of the St Louis area's bigger non-profit health care systems made more than $1 million, often several  times that.  Most of the systems had multiple other hired executives who made at least $1 million.  Often executives received other perks far beyond anything received by other employees, such as travel on corporate jet aircraft.  

We have noted that nearly every attempt made to defend the outsize compensation given hospital and health system executives involves the same talking points.   We first listed the talking points here, and then provided additional examples of their use here, here here, and here.   They are:
- We have to pay competitive rates
-  We have to pay enough to retain at least competent executives, given how hard it is to be an executive
-  Our executives are not merely competitive, but brilliant.

The Post-Dispatch article provided more examples of these stereotypical justifications.

Competitive Rates

 The SSM CEO actually seemed to make such an argument to justify his own pay,

'I’ve been (at SSM) for 33 years, and for a lot of those years I wasn’t paid nearly the salary I’m paid now,' Thompson said. 'If you look at the revenue, I don’t think I’m over- or underpaid.'

He provided no data to support is argument.

And again,

Salaries and benefits for nonprofit health executives 'need to be competitive if we are going to be able to attract the talent needed to run these very complex organizations,' he said.

How that talent was defined was not apparent.

The chief of  public relations of Ascension Health Alliance added,

 [Chief advocacy and communications officer Jon] Glaudemans said that Ascension is seeking “to remain competitive in a market that is increasingly complex and characterized by challenging regulatory circumstances, including implementation of the Affordable Care Act.”

From the senior vice president for human resources for Mercy Health, Cynthia Mercer, we had this contribution,

'We’re competing for the same pool for talent,' Mercer said. 'It’s difficult to secure talent. ...'

She did not provide a definition of talent either.  Note that she also said,

We feel that it’s very important as a ministry to be just in our approach, respecting the dignity of each of our co-workers regardless of their position.  

She did not explain the justice provided by the top executives' use of private corporate aircraft and the free travel provided to their spouses.

Retention

An example came from the chief PR flack from Ascension,

'We are required to be competitive, but we also have a mission to care for those who are poor and vulnerable. Candidly, many of our executives could do better for themselves working in other environments.'

He did not give evidence that his or any other local executives were in great demand in such other environments.  He certainly did not try to reconcile how an organization with a mission to care for "the poor and vulnerable" was making a multimillionaire out of its CEO.

Brilliance

The chief public relations flack at Ascension Health Alliance provided this example,

'When we look for leadership of our ministry, we need to draw from the best and brightest to serve those who are poor and vulnerable,' said Jon Glaudemans,...

Whether his use of the term "best and brightest" was meant to be an ironic allusion to the leaders who lead the US into the controversial and bloody Viet-Nam War was not clear.

In response to the first Post Dispatch article, a physician, self-described as " a 40-year veteran of Washington University Medical School and BJC hospitals," wrote a letter in Mr Lipstein's defense.  To prove the CEO's brilliance, Dr Robert G Levitt gave him personal credit for a number of accomplishments, such as addressing readmissions for congestive heart failure patients, and avoiding outbreaks of multidrug resistant bacteria in intensive care units, that seem to be more likely to have resulted from diligent work by health professionals.  He praised Lipstein for actually "respond[ing] to emails from physicians and staff," which hardly seems brilliant.  Finally, he noted "BJC has not laid off workers as other St. Louis hospital systems have done to save costs."

It only took three days for that point to be proven wrong, as the St Louis Post-Dispatch then reported, "BJC Healthcare began on Wednesday laying off 160 employees, the first layoffs in the company’s 20-year history."  Per the St Louis Business Journal, these layoffs may include at least some "direct patient care staff," that is, e.g., nurses, and were due to declining revenue. 

Summary

The St Louis Post Dispatch main article on CEO pay opened thus,

Trimming medical costs is the latest mantra among hospital executives, government bureaucrats, insurers and benefit managers as they grapple for ways to contain U.S. health care spending.But executive compensation in the health care industry shows few signs of hitting a ceiling. 

It included comments by Professor Harold Miller of the Center for Healthcare Quality Payment and Reform and Carnegie-Mellon University,

'But if a health care executive’s pay is based on the amount of revenue they generate, the problem is in the incentive,” he said. “Basically, hospitals get rewarded by putting more heads in beds. It works against the goal of affordable health care. We need to start paying these executives to keep people healthy.'

And he noted the danger is,

when executives start chasing their own compensation rather than the good of the company. We’ve seen that in banking, and that can happen in health care

I would argue that this is already what is going on. Non-profit organizations whose missions include taking care of poor people pay their top executives millions of dollars. We have yet to see any logical, evidence-based justifications for such generous and ever rising compensation.  This compensation is increasingly out of proportion to what other employees are paid   Their compensation may rise even when their organizations' finances are challenged (see the example of the BJC layoffs above).  Nearly all rationalizations of their compensation are made by people whose jobs depend on the executives they are defending (as above), or by other hired executives who may be eager to defend their brethren. 

As long as hired executives chase compensation rather than uphold the health care mission, expect their personal fortunes to increase, and the mission to wither.

We await  true health care reform which would ensure health care organizational leadership that puts upholding the health care mission ahead of lining their pockets.  . 

Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday

At my May 30, 2013 post "Marin General Hospital's Nurses are Afraid a Defective EMR Implementation Will Harm or Kill Patients ... CEO Cites Defective HHS Paper and Red Herrings As Excuse Why He Knowingly Allows This To Continue" at http://hcrenewal.blogspot.com/2013/05/marin-general-hospitals-nurses-are.html, I lamented that hospital management felt they could ignore clinicians calling for implementation postponement of what they viewed as bad health IT, dangerous to patients, with impunity.

Finally, medical professionals stand up to imperial hospital management that, in a perhaps criminally negligent fashion (e.g., see my post on the ECRI Deep Dive Study on Health IT harm at this link), ignores its clinicians over too-rapid deployment of health IT.

Also see newspaper article at http://www.cantonrep.com/news/x393137745/Affinity-nurses-seek-delay-on-electronic-records#axzz2WcOMZpvF.

(The hospital management is extolling the safety of the new Cerner system.  What could possibly go wrong?  -- I'd bet the executives, despite their fiduciary duties towards maintaining a safe hospital environment, have no idea about Cerner defects such as at the FDA MAUDE database; see "MAUDE and HIT Risks: What in God's Name is Going on Here?" at http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html or are familiar with "Medical center has more than 6000 'issues' with Cerner CPOE system in four months" at http://hcrenewal.blogspot.com/2010/10/medical-center-has-more-than-6000.html.  Instead, unpaid bloggers do their work for them to protect patients....)

See this:

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

For Immediate Release - June 18, 2013

For more information: Michelle Mahon, RN, 234-207-6706 or Liz Jacobs, RN, 510-273-2232

Affinity RNs Call for Halt to Flawed Electronic Medical Records System Scheduled to Go Live Friday

Affinity Medical Center RNs in Massillon, Ohio are calling on hospital officials to delay the planned June 21 implementation of the Cerner electronic medical records (EMR) system, until the hospital bargains with the nurses and proceeds in a safe manner.

The direct-care RNs, represented by the National Nurses Organizing Committee (NNOC) in Ohio, an affiliate of National Nurses United (NNU), say that nurses, the primary users of the complex system, have had insufficient training, which will put patients at risk. The implementation, which has been done without bargaining with NNOC, reflects yet another violation of federal labor law by Affinity, nurses say.

Nurses have documented their concerns in a detailed letter to hospital officials. Those concerns include woefully inadequate training, short staffing in the first days of the roll out, and the subsequent risk of harm to their patients.  The system, they say, has the potential of violating the Ohio Nursing Practice Act because it doesn’t permit RNs to communicate individualized, potentially life-saving information about their patients.

The letter, which RNs attempted to deliver to hospital officials on Friday, cites nationally recognized experts in health information technology who reinforce the RNs’ concerns. Most notably, the Institute of Medicine (IOM) has concluded that the failure to include RNs in all steps of this transition is one of the most significant barriers to successful, safe implementation of electronic health records systems.

Hospital officials have continued to refuse to meet with nurses, and would not accept the letter.  [Willful ignorance? - ed.] Without bargaining with the union or acknowledging the nurses’ concerns, the hospital added a few more trainings late Friday, but the RNs say that remains far from adequate.

Over the last few years, American healthcare corporations have invested heavily in information technology (IT) systems, which make up a multi-billion dollar market.

“RNs who actually use these systems day in and day out have found that the kind of care they can provide with this new technology is limited,” said NNOC Co-president Cokie Giles, RN. “The programs are often counterintuitive, cumbersome to use, and sometimes simply malfunction. Nurses are finding that the technology is taking time away from patients and fundamentally changing the nature of nursing.”

NNOC/NNU has successfully negotiated clauses in its contracts that allow RNs to play a greater role in reviewing and approving new technologies before they are introduced, and that the new technologies will not supersede RN professional judgment. 

“I have been chosen as a ‘super-user,’ said Amy Pulley, an RN who works in the endoscopy unit of the hospital. “I’m not sure what makes me ‘super’ with the limited training for this complex system that I’ve received. I’m concerned that the manner in which this technology is being implemented may pose serious disruptions in patient care.”

Highlights of RN Concerns on the Implementation of the Cerner Electronic Medical Records System at Affinity Medical Center

Inadequate Staffing

·        Several units will be severely short staffed for the transition, despite the fact that the hospital has been planning on the “go live” date for several months.

·        The entire hospital and all portions of the system will go live at once, referred to as the “big bang” approach, which has a very low rate of success, rather than implementing it in trial, pilot stages.

·        They are utilizing the ‘super-user’ model which will pull nurses from direct-care so they can be available to teach, leaving several units without enough nurses to care for patients.

·        The hospital refuses to decrease the number of elective procedures or provide additional staff during the transition time.

Lack of training

·        Some nurses have received only one day of training.

·        Super-users have received no education or training in the system beyond what is provided to the other users.

Design flaws

·        Placement of the workstations are ill conceived—RNs must turn their back to patients while documenting.

·        During one education session, the system crashed because 17 users at one time overloaded it.

Failure to consult nurses

·        Several concerns were brought to management’s attention which they were unable to answer. One example— how will RNs override the system in the event of an emergency?

Affinity is one of five hospitals in California, Ohio, and West Virginia that are part of one of the nation’s largest for-profit hospital chains, Tennessee-based Community Health Systems where affiliates of NNU are pursuing federal action for significant violations of RN rights.

The National Labor Relations Board held a five-day hearing in May in a complaint filed by the nurses and NNOC over Affinity’s refusal to bargain a first contract and retaliation against RNs for advocating for their patients and their colleagues. A decision by an NLRB administrative law judge is pending. CHS affiliated hospitals in West Virginia and California are facing similar sanction from federal officials. At one of the California hospitals last week, a U.S. District Court judge issued an injunction ordering the hospital to return to negotiations with the RNs.

CHS is the second largest for-profit hospital chain in the United States, and one of the wealthiest. Over the past five years, CHS reported over $1.5 billion in profits to the Securies Exchange Commission.

Michelle Mahon, RN

National Representative

National Nurses United

mmahon@nationalnursesunited.org

234-207-6706

I believe the nurses should strike if their concerns are not heeded.

I once worked in a highly-unionized city Transit Authority; I believe the unions would have shut the Authority down in the face of even a fraction of concerns like this that could impact pubic safety - and their own memberships' careers and lives.

-- SS

6/20/13 addendum:

I note that this EHR medical device (per FDA) is non-FDA approved, nor vetted by any regulatory agency.  Apparently the hospital believes it has the prerequisite skills and expertise to vet this device for safety.  Who, exactly, will take responsibility for bad outcomes?

FDA's Chair of the Center for Device and Radiological Health, Jeffrey Shuren, MD JD, stated explicitly that EHRs were medical devices on Feb. 25, 2010 (see testimony to the HHS Health Information Technology HIT Policy Committee at this PDF) that:

... Under the Federal, Food, Drug, and Cosmetic Act, [that regulates all drug, medical devices, etc. in the United States - ed.] HIT software is a medical device. Currently, the FDA mandates that manufacturers of other types of software devices comply with the laws and regulations that apply to more traditional medical device firms. These products include devices that contain one or more software components, parts, or accessories (such as electrocardiographic (ECG) systems used to monitor patient activity), as well as devices that are composed solely of software (such as laboratory information management systems)... To date, FDA has largely refrained from enforcing our regulatory requirements with respect to HIT devices.

I also note that patient informed consent to its use in their care is likely not being sought.  Should it?  If not, why not?

-- SS

9/2/2013 addendum

The comment by "Anonymous August 20, 2013 at 11:24:00" has many characteristics of a sockpuppet (see http://hcrenewal.blogspot.com/2010/01/more-on-perversity-in-hit-world.html) - ignoring everything written in the post and expressing perverse and deranged views.  See it, and my response, in the comment section.  A post about an anti-health IT union dispute such as this is a strong potential sockpuppet magnet.

-- SS

"Computer problems" force docs back to paper charts at Memorial Hospital - From June 11 until at least June 24?

More on the wonders and dependability of commercial health IT, as implemented in hospitals, which are generally an IT backwaters:

Computer problems force docs back to paper charts at Memorial Hospital

Published: June 17, 2013 

BELLEVILLE (Illinois) — Computer problems have caused Memorial Hospital (http://www.memhosp.com/Pages/Home.aspx) staff back to the old days of using paper to chart patients' treatments.

The hospital's computer system, Meditech, went down late on Tuesday, June 11 and is not expected to be fully restored until at least Monday, June 24, according to the hospital. In the meantime, staff will be recording patients' medical records unto traditional paper charts.

"While the duration of this down time is unfortunate, all hospital services continue utilizing the backup process we have in place for occasions such as this," Memorial President Mark Turner said in a prepared statement. "I am extremely proud of the way our employees and medical staff have pulled together to maintain quality care and patient safety."

Once the system is up and running again, the information from the paper charts will be transferred into each patient's electronic medical record. The same standards for patient confidentiality and safety are being met, according to the hospital.

The computer problems are believed to result from upgrades added to the system in preparation for a major upgrade in July.

"The duration of this down time is unfortunate?"  This mission-critical system went down June 11 and won't be fully restored until June 24?  How is this even possible?  What, exactly, were their maximal-uptime, redundancy, disaster recovery and business continuity strategies?  Was there a natural disaster in that area I don't know about?

Regarding the hospital President's statement that:

"I am extremely proud of the way our employees and medical staff have pulled together to maintain quality care and patient safety."

I would translate that to read:

"Our IT incompetence is all on you, clinicians.  You're liable for any patient harm that results in the messy transitions from IT to paper, and back from paper to IT."

-- SS

Addendum - a question I've asked before - if everything is just fine, business as usual, with no safety impediments after reverting to paper due to emergency ... then why spend $100 million+ on EHRs?

Read more here: http://www.bnd.com/2013/06/17/2660472/computer-problems-force-docs-back.html#storylink=cpyA

A Call to Restore the Integrity of Clinical Research - but Will Anyone Heed it?

Concerns about suppression and manipulation of clinical research to serve vested interests have finally gotten a little more mainstream.

Background: Suppression and Manipulation of Clinical Research

For a long time, we have decried and discussed examples of manipulation of clinical research done to increase the likelihood that its results would please vested interests, often drug, device or other corporations that sponsored the research and often exerted considerable control over its design, implementation, analysis, and dissemination.  We have also decried and discussed examples of suppression of research whose results offended such vested interest, sometimes done when manipulation did not succeed in producing such pleasing results.


I wrote about suppression of research in my 2003 paper on health care dysfunction,(1)

The integrity of medical research has been violated by the deliberate suppression of its results.

That assertion was based on several important, although understandably largely anechoic cases.

I first wrote about systematic attempts to manipulate clinical research in 2005, based on Richard Smith's PLoS Medicine commentary which listed specific tactics that vested interests could use to make it more likely that research studies would provide them with favorable results.

Although striking cases of manipulation and suppression appeared more frequently starting in the 1990s, in the last few years it has become more apparent that these are widespread problems.

A Call to Restore Integrity

This week, the British Medical Journal published a special article calling for restoration of suppressed or manipulated clinical trials(2), accompanied by an editorial entitled, "restoring the integrity of the clinical trial evidence base."(3)

The article used slightly different terminology than we do, replacing suppression with invisibility, and manipulation with distortion, thus,

Two basic problems of representation are driving growing concerns about relying on published research to reflect the truth. The first is no representation (invisibility), which occurs when a trial remains unpublished years after completion. The second is distorted representation (distortion), which occurs when publications in medical journals present a biased or misleading description of the design, conduct, or results of a trial.

The article boldly asserted

Both go against the fundamental scientific and ethical responsibility that all research on humans be used to advance knowledge and are symptomatic of a general culture of data secrecy. The end result is that the healthcare, biomedical research, and policy communities may, despite best intentions and best practices, end up drawing scientifically invalid conclusions based on only those parts of the evidence base they can see.

The editorial went further, asserting that

This crisis of hidden or misreported information from clinical trials—and the resulting distortion of the clinical evidence base—is widely recognized and commonly decried. It is one of the leading scientific problems of our time, but few solutions have been put forward.

Furthermore, it concluded with a warning about the immorality of continuing on the current course,

The results of clinical trials are a public, not a private, good. The public interest requires that we have a complete view of previously conducted trials and a mechanism to correct the record for inaccurately or unreported trials. If we do not act on this opportunity to refurbish and restore abandoned trials, the medical research community will be failing its moral pact with research participants, patients, and the public. It is time to move from whether to how, and from words to action.

Thus the notion that suppression and manipulation of clinical research is a systemic, severe problem that confounds health professionals and hurts patients is no longer a concern of only a few fringe dissidents, but a matter for discussion in the foremost mainstream medical journals.

Will Anyone Heed the Call?

Furthermore, this dire problem formulation suggests the need for a strong solution, as proposed by the article, and seconded by the editorial.  Using the term "abandoned trials" for " unpublished trials for which sponsors are no longer actively working to publish or published trials that are documented as misreported but for which authors do not correct the record using established means such as a correction or retraction (which is an abandonment of responsibility)," Doshi and colleagues wrote,

We call on institutions that funded and investigators who conducted abandoned trials to publish (in the case of unpublished trials) or formally correct or republish (in the case of misreported trials) their studies within the next year.

Starting in 2005, we have repeatedly called for protection of " researchers' rights to speak truth to power," but then noted that "right now, it is more often power that speaks to truth."  The question is whether without some bigger allies, individual clinical researchers will stand up on their own to restore the integrity of clinical research.

The big reason to worry is that most of these researchers work within a context which strongly favors vested interests, rather than scientific truth, or the rights of research subjects.  The researchers who would be most likely to be able to heed the call by Doshi et al are those within academic medicine. Yet clinical research in the academic medical world now functions within a strong and deep web of individual and institutional conflicts of interests, subjects that we also have written about incessantly.

There is evidence suggesting that the majority of medical faculty,(4) and the majority of their academic departmental leaders(5) have important financial ties to the health care corporations most likely to have reason to want to suppress or manipulate research.  Furthermore, most academic medical institutions have stated their interest in increasing "collaboration" with industry, usually giving the rationale that this will lead to "innovations" that will bring better tests or treatment to patients. (See posts here,  here and here for some examples.)  Such collaboration also tends to bring a lot of money to institutional budgets.  Further collaboration with industry is likely favored by academic leaders' own financial ties to the same sorts of corporations discussed above.  Thus it should be no surprise that a study by Mello et al in 2005 suggested that most of the managers of academic medical institutions who control research contracts are willing to give significant control of of research design, implementation, analysis, and dissemination to the sponsors, not the researchers.  (See this post.) (6)


Thus, a researcher who volunteers to restore suppressed or manipulated clinical studies might become suddenly very unpopular with his or her colleagues or supervisors, and perhaps with people who are already paying him or her.

So as long as health care professionals, policy makers, and the public at large are willing to go along with the notion that academic medical institutions' "collaboration" with "industry" is absolutely necessary to foster "innovation" and hence medical progress, it is very unlikely that academic medical researchers will be willing to help restore the integrity of clinical research.  In fact, while we continue on our present course, the integrity of clinical research will probably get even worse.
 
Since questioning the integrity of contemporary clinical research might make those with vested interests who have been willing to suppress or manipulate research very uncomfortable, perhaps it should be no surprise that the paired articles in the British Medical Journal have been relatively anechoic.  For example, while one might think the publication of these simultaneous articles might get at least a little coverage in the "main-stream media," I can find not a single mention of them there.  (So far, only the Chronicle of Higher Education, MedScape the Science Insider blog and The Scientist blog have provided news coverage.)


So I hope the brave people who wrote the article and editorial are also willing to join us in decrying the web of individual and institutional conflicts of interest that have entangled health care professionals and academic medicine.  Individuals and institutions who make medical or health care decisions, or who are involved in medical and health care education and research should reveal all their conflicts of interest, at least in the interests of honesty.  Furthermore, in the interest of patients' and the public's health, clinical research meant to assess medical tests, treatments, and programs should be done completely independently from the corporations that sell them.  


References

1.  Poses RM.  A cautionary tale: the dysfunction of American health care.  Eur J Int Med 2003; 14: 123-130.  Link here..
2.  Doshi P, Dickersin K, Healy D et al.  Restoring invisible and abandoned trials: a call for people to publish the findings.  Br Med J 2003;  BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f2865  Link here.
3.  Loder E, Godlee F, Barbour V et al.  Restoring the integrity of the clinical trial evidence base.  Br Med J 2003;  BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f3601  Link here.
4. Campbell EG, Gruen RL, Mountford J et al.  A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. Link here.
5. Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786.  Link here.
6.  Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352:2202-2210. Link here.

PROFESSOR NEMEROFF GOES TO LONDON

THREE STRIKES AND …

Professor Charles Nemeroff is being honored today in London. He will deliver a high profile lecture at the Institute of Psychiatry, King’s College London, a component of The University of London. IoP and its associated Maudsley Hospital have long been at the forefront of psychiatric research in Britain. The occasion today is the establishment of a new program on mood disorders, and Professor Nemeroff’s topic will be “The Neurobiology of Child Abuse: Treatment Implications.” He will be introduced by Professor Allan Young and the vote of thanks will be proposed by Professor Sir Robin Murray, a former dean of IoP-Maudsley. In the chair will be Professor Carmine Pariante, a onetime colleague of Professor Nemeroff. The current dean, Professor Shitij Kapur, seems to be staying in the background.

On this side of the pond we are depressingly familiar with Professor Nemeroff. He is the poster boy for conflict of interest in academic psychiatry. I will not rehearse here all the ethics issues in which he has been compromised over the past 15 years. Suffice it to say that as a result of those issues he was dismissed from his departmental chairmanship at Emory University; he was required to resign as editor of the journal Neuropsychopharmacology; he was banned from involvement in NIH grants at Emory University for 2 years; he received an unprecedented sanction from the Ethics Committee and Council of The American College of Neuropsychopharmacology (ACNP), which included a 2-year ban on participating in ACNP meetings and committees; the Accreditation Council on Continuing Medical Education (ACCME) issued a punitive sanction on a program that he directed, finding commercial bias and requiring the program to be withdrawn; and he was referred by Senator Charles Grassley of the US Senate Finance Committee to the Inspector General of the US Department of Health and Human Services for investigation of grounds for criminal charges.

The administrators of IoP-Maudsley apparently ignored these warning signals when they announced over a month ago that they had tapped Professor Nemeroff for today’s honorific lectureship. Many other professionals were shocked, however, and they voiced their disapproval widely – directly to the IoP, in the mainline press, in the British Medical Journal, in on-line comments, and even in a video critique. University Diaries ran a critical commentary, as did the respected weblogs Pharmalot and 1Boringoldman. Significantly, the letter to British Medical Journal came from a psychiatrist affiliated with IoP itself.

The IoP responded with typical academic stonewalling. Professor Carmine Pariante and Professor Allan Young wrote to the Critical Psychiatry Network, defending the decision to engage Professor Nemeroff. Unfortunately for them, their letter contained 2 fatal mistakes. First, they highlighted the perceived academic distinction of Professor Nemeroff as justification for his selection, thereby confusing an ethics issue with a competency issue. Who cares about Professor Nemeroff’s supposed expertise? When such a compromised individual is given honorific status it sends the wrong message to junior faculty members and to trainees. It also sends the wrong message about the institution's values, as I have discussed before. The IoP will be tainted by this episode for years to come, and the responsible administrators deserve all the frowns and brickbats that will come their way.

The second fatal error in the IoP response was to cast the issue in terms of academic freedom. That claim is rank hypocrisy. The protests are ethics complaints, not disagreements about content or professional turf. Professor Nemeroff was impeached by his peers for ethical lapses, as the record of sanctions clearly shows. That is what sparked the protests. The IoP administrators are displaying glass eyes and tin ears.

We should also question the scientific judgment of the IoP administrators. Treatment implications of child abuse is a featured focus of Professor Nemeroff’s lecture. How much do the IoP administrators really know about Professor Nemeroff’s work in this area? Do they know how little he has published in this area? Do they know that he is on the public record with at least 2 instances of misrepresenting his work in this area?

Professor Nemeroff’s sole publication of original data in this area appeared in 2003 (PubMed ID 14615578). It was a secondary analysis of a large clinical trial, first reported in 2000, that originally did not consider child abuse as a moderating variable in the response of chronically depressed patients to an antidepressant (nefazodone) or to cognitive behavior therapy (CBASP). The 2003 report claimed that, in patients with a history of childhood trauma, response to CBASP was superior to response to nefazodone. At the same time there was no significant difference in response rates to drug or to CBASP between patients with or without childhood trauma histories. A portion of this report was later retracted (see PNAS 2005 November 8;102(45):16530) because the data concerning reduction of Hamilton depression scores had been misrepresented.

Notwithstanding the retraction, Professor Nemeroff discussed the retracted data without the necessary qualification in a 2008 Continuing Medical Education program – the same one that was sanctioned by ACCME. Use of retracted material in this way is inconsistent with ethically grounded teaching. It also is inconsistent with FDA standards for scientific reference publications. Among other requirements, the FDA standards state that scientific reference publications may not “be false or misleading, such as a journal article or reference text… that has been withdrawn by the journal or disclaimed by the author, or…” Professor Nemeroff then went further, stating in the video record that a history of childhood abuse or neglect “predicts poor outcome… particularly to pharmacotherapy.” That claim is outright false. The data simply do not support that claim.

Professor Nemeroff repeated these same misrepresentations on the video record a second time in January 2012 when he presented Psychiatry Grand Rounds at New York University. Once again Professor Nemeroff displayed sleight of hand in palming off a nonsignificant difference as both statistically and clinically significant. To reiterate, Professor Nemeroff’s own data do not show a statistically or clinically significant difference between chronically depressed patients with and without a history of child abuse in their responses to drug or to CBASP.

The question for today is, will Professor Nemeroff repeat these misrepresentations in his lecture at the IoP-Maudsley? Should he do that, then the 3-strike rule needs to be invoked. I nominate the administrators at IoP-Maudsley for the job of lowering the boom finally on Professor Nemeroff. That would be one way they might redeem themselves in this fiasco.

Oh, and by the way, Professor Nemeroff has apparently done nothing more in this area since the 2003 partially retracted secondary analysis of an earlier study. But others have been looking at his claims and have not confirmed them – see, for instance the Canadian study that found no difference in response rates to pharmacotherapy or cognitive behavior therapy in patients with and without histories of severe childhood maltreatment (PubMed ID 22428942). Will Professor Nemeroff acknowledge this non-confirmation of his narrative when he speaks today at the IoP-Maudsley? We are agog.

If the administrators of IoP-Maudsley wish to continue defending their selection of Professor Nemeroff as a world expert on the treatment implications of child abuse, then who am I to argue? I don’t need to argue… the record speaks for itself.

One final point: the IoP response to the Critical Psychiatry Network stated that Professor Nemeroff “will not be presenting any research that was funded by commercial companies or affected by commercial implications. Obviously, he will be declaring any relevant conflicts of interest prior to his lecture.” The administrators at IoP should be aware that Professor Nemeroff’s data on treatment implications of child abuse (such as they are) do, in fact, come from a commercially sponsored clinical trial. I would also bet dollars to donuts that Professor Nemeroff declares no relationship to Bristol Myers Squibb, the sponsor of that trial.

What are the larger lessons of this new affaire Nemeroff? Academic institutions like IoP-Maudsley need spine and due diligence to maintain decent standards and to put the hand wavers where they belong – not on center stage. Raise the bar, chaps!

BERNARD CARROLL

UPDATE 06-18-2013

We are waiting for a response from the Institute of Psychiatry… it could be a long wait. We have learned that Professor Nemeroff was unwilling to make publicly available the slides he used in his lecture yesterday. Hmmm.

Meanwhile, I should clear up some potential confusion about the data in Professor Nemeroff’s 2003 publication that I discussed yesterday. When I said the data showed no significant difference in response to cognitive behavior therapy (CBASP) between patients with and without early life trauma, I said that because Professor Nemeroff had made no claim that there was a difference. He made a variety of other claims, but not this one. I took this to mean that he had looked for a significant difference but didn’t find one. It is not possible for anyone to make an independent determination of what he found because he did not report the data transparently – there was no positive statement of sample sizes for different treatments, for example, and the remission rates were not consistently reported: some were stated numerically while others were only displayed graphically. For what it is worth, there might actually be a significant difference in response to CBASP between patients with and without early life trauma. We just cannot be sure. Let the record stand corrected. Maybe Professor Nemeroff can clear that up?

None of this alters the fact that Professor Nemeroff’s data show no significant difference in response to nefazodone between patients with and without early life trauma. And, none of this alters the misrepresentations by Professor Nemeroff that I discussed yesterday. In the sanctioned CME presentation in 2008 he positively stated on the video record that a history of childhood abuse or neglect “predicts poor outcome… particularly to pharmacotherapy.” That claim is outright false. The data simply do not support that claim, and, once again, he made no such claim in the 2003 publication.

Likewise, in the 2012 Grand Rounds presentation at NYU, Professor Nemeroff positively stated that patients with chronic depression but without a history of childhood trauma “did better with drug than with CBASP.” That also is a false statement (see Figure 1B of the 2003 publication). There is no significant difference and none was claimed in the paper.

Meanwhile, in both these misleading presentations that are on the video record Professor Nemeroff used the retracted material that I mentioned yesterday. He used it in classic hand waving fashion to embellish his narrative, but he used it without the required qualification that was given in his retraction notice!

Aren’t we all justified in asking the Institute of Psychiatry to release Professor Nemeroff’s slides from yesterday’s much publicized lecture?

BERNARD CARROLL

IT Specialist and the job he wouldn't take: hospital management's health IT "plan" is a checklist for failure

Received unsolicited on June 14, 2013 from a computer professional whose identity I am redacting.  Posted with his permission:

Dr. Silverstein,

Thank you very much for the many insights and helpful references provided on your "Contemporary Issues in Medical Informatics" (http://www.ischool.drexel.edu/faculty/ssilverstein/cases/) web site! In performing my due diligence for a position as an IT Director at a small rural hospital, I have come across your writings. 

I originally applied for this position in the hopes of leveraging my IT, project management, compliance and security experience to gain new expertise in healthcare IT. After my initial phone interview with the "CIO" and HR Director, at which I discovered that I would have the responsibility to implement a poorly conceived new EMR project, without the authority or resources to make it successful, additional red flags were raised which required further research. This led me to you.  

I cannot help but chuckle at the organizational, social and project management dysfunctions in medical IT, as described in your "Ten Critical Rules for Applied Informatics..."  (http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=tenrules).   I have encountered similar dysfunctions in the world of military and commercial IT.  With a little tweaking, your lessons learned are applicable across a wide range of IT disciplines and a good reminder of how to avoid IT project and career failures and achieve successes.

Yet, I understand and have come to appreciate your thesis that medical IT is fundamentally different from business IT. Even though I am convinced that I could do better than most, I have concluded that it is probably wiser for a competent healthcare informaticist to lead HIT implementation projects. I wonder how many such competent informaticists there can be! Unfortunately, since I have no background in medicine, it is probably a little late for me to become one. 

I certainly will not engage in this particular opportunity. What I know of the hospital management's "plan" at this point is a checklist for failure. The reality of this rural hospital, and apparently thousands of similar situations, is unnecessarily and depressingly tragic for patients and clinical professionals. I appreciate your crusade to raise the bar for healthcare IT, and therefore IT in general. Thank you for saving me from jumping in to an untenable situation.

Ironically, and sadly, this letter is similar to others I have received dating to 1999.  Little has changed in nearly 15 years, except that with the rush to implement this unregulated, experimental technology thanks to the HITECH Act, there's likely going to be a lot more patient harm, especially at smaller hospitals new to this endeavor.

-- SS