Wyeth: Ghostwritten Papers Fake, But Accurate

It looks like Wyeth has lost its battle to keep secret its practices regarding ghostwriting of scientific papers. The issue in question is whether ghostwriting contributed to excessive prescription of post-menopausal hormones and increased the incidence of breast cancer:

Posted on Sun, Jul. 26, 2009
Philadelphia Inquirer

Wyeth told to release documents on ghostwriting

Associated Press

LITTLE ROCK, Ark. - A federal judge has ordered the unsealing of thousands of pages of documents pertaining to the ghostwriting practices of Wyeth Pharmaceuticals, which is being sued over hormone-replacement drugs.

U.S. District Judge Bill Wilson ordered the papers unsealed Friday at the request of a medical journal and the New York Times. Plaintiffs' attorneys presented the papers earlier at trial to show that Wyeth routinely hired medical-writing firms to ghostwrite articles that appeared in seemingly objective medical journals but included only the name of a scientific researcher as the author.

Of course, in addition to the violation of accepted practices of authorship, such as specified by NIH and the International Committee of Medical Journal Editors, among others, such lucky authors get to "count" such papers in their academic portfolios, presumably also in violation of their own institutional policies and guidelines for fair attribution and intellectual honesty, e.g., here. Ghostwriting may also skew the tenure process, providing advantages to the unscrupulous academic over the ethical scientist or scholar. (One wonders about the true percentage of the massive number of papers claimed by some medical academics actually written by the putative first author.)

The ruling came in a case that involves about 8,000 lawsuits that have been combined before Wilson. The lawsuits focus on whether Wyeth hormone-therapy drugs Prempro and Premarin, used to treat symptoms of menopause, have caused breast cancer in some women.

The New Jersey drugmaker, which has major operations in the Philadelphia area, had already turned over the documents, which it says concern about 40 articles in medical journals and other publications, to Sen. Charles Grassley (R., Iowa).

How is evidence based medicine possible if just one drug company has sponsored ghostwritten articles in 40 medical journals and other publications? What is the "total mass" of questionable articles now infecting the literature?

Grassley sought them last year without a subpoena as part of a congressional investigation into drug-industry influence on doctors.

The documents were shown to jurors at trial but have otherwise been unavailable publicly.

Plaintiffs say ghostwriting is when a drug company conjures up the concept for an article that will counteract criticism of a drug or embellish its benefits, hires a professional writing company to draft a manuscript conveying the company's message, retains a physician to sign off as the author, and finds a publisher to unwittingly publish the work.

There are several layers of dishonesty in this activity, including foreknowledge of scientific deception through fraudulent misrepresentation of authorship by the pharma, dishonesty of the physician who "signs off" as first author, and misrepresentation by the pharma, the writing company and the physician about provenance of the article to scientific publishers.

Drug firms disseminate their ghostwritten articles to their sales representatives, who present the articles to physicians as independent proof that the companies' drugs are safe and effective.

Wyeth attorney Stephen Urbanczyk acknowledged that the articles were part of a marketing effort. But he said that they were also fair, balanced, and scientific.

What business does a lawyer have lecturing the public that the articles were a dishonest marketing effort masquerading as legitimate science, but were "fair and scientific?" How does he know? In addition, the "fake but accurate" excuse is getting quite shopworn. Hopefully, Sen. Grassley will approach ending this ghostwriting practice with vigor.

In fact, this raises another issue. I have written that management of pharma by those lacking biomedical bona fides is, by definition, mismanagement. This is a case in point. Wyeth's President, Board Chair and CEO Bernard Poussot lacks biomedical credentials. Harry Truman said "the buck stops here", but a in the case of scientific ghostwriting, CEO's such as Poussot cannot vouch firsthand for the accuracy and fairness of their company's science. He lacks the expertise. The buck does not stop at his desk; he is dependent on scientific underlings in such matters.

This affair is another instantiation of my belief that pharma is best led by those with relevant scientific expertise such as Merck under clinician-scientist Dr. Roy Vagelos. (It is perhaps not coincidental that Merck became a shadow of its former self under non-scientist Raymond Gilmartin.)

Wyeth, the world's No. 12 pharmaceutical company by sales, is being bought this fall by No. 1 drugmaker Pfizer.

How appropriate, as Pfizer is led by the former top lawyer for McDonald's and Boston Chicken, bringing to life my "If you've run McDonald's, you can run anything" metaphor. If a wise investor were to take a bearish position on a stock, this merged company would be an excellent candidate.

Finally, another ghostwriter of sorts recently died, Sandford Dody (1918-2009). Dody anonymously penned best selling autobiographies of actresses Bette Davis and Helen Hayes, among many other notables. Such ghostwriting is essentially victimless, as opposed to its counterpart in the scientific domain. However, Mr. Dody had an astute observation about the practice, even when there was no trail of diseased or dead bodies.

Per the WSJ article "A Ghostwriter Who Struggled to Accept Life in the Shadows":

... Mr. Dody, who died July 4 at the age of 90, found the work spiritually destructive. "After all," he wrote, "how does one become a ghost without dying a little?"

In the case of biomedical ghostwriting, the conspirators all "die a little" in purveying their intellectual dishonesty on a trusting public.

It's too bad some of that same public also dies, and not just a little, as wages of professorial ghostwriting sins.

The acknowledgements are where minor contributions and reviews get placed in an ethically-attributed scientific paper. Anyone who does not understand this, or rationalizes "honorary authorship" or similar workarounds to meaningful attribution does not belong in science.

Finally, scientific ghostwriting must stop. I also believe its conspirators should be excluded from receiving public money for research and excluded from the biomedical literature for a good, long period of time.

-- SS

Are the Health Plans of the Very Rich Different from Yours and Mine?

Yesterday, the New York Times published an intriguing story about "Cadillac" (that is, expensive) health insurance plans,

Goldman Sachs is one of the nation’s richest banks, and hundreds of top Goldman employees have a health care package to match — one of the 'gold-plated Cadillac' plans cited by those involved in the health care debate in Washington.

Goldman’s 400 or so managing directors and its top executive officers participate in the bank’s executive medical and dental program as part of their benefits, according to documents filed with the Securities and Exchange Commission. The program generally costs the bank $40,543 in premiums annually for each participant’s family.

Those taking part in the plan include the company’s chief executive, Lloyd C. Blankfein, and four other top officers, as well as managing directors, whose base salary is $600,000.

Goldman’s medical coverage entered the health care discussion on Sunday when David Axelrod, senior adviser to President Obama, cited the Goldman program as an example of the expensive benefits the administration might consider taxing to help pay for its health care program.

'The president actually was asked this the other day by Jim Lehrer, and what he said was that this was an intriguing idea to put an excise tax on high-end health care policies like the ones that the executives at Goldman Sachs have, the $40,000 policies,' Mr. Axelrod said.

A proposal by Senator John F. Kerry, Democrat of Massachusetts, would impose an excise tax on the insurers that issue policies like Goldman’s, with the expectation that the insurers would pass along most, if not all, of the cost to employers who buy the plans.

Leaders of the Senate Finance Committee, which is working on bipartisan version of the health care legislation in Congress, had long expressed interest in taxing some employer-provided benefits — a move many budget experts say would help slow the steep rise in health costs.

Negotiators have not yet determined the value of the plans that would set off a tax on the insurance companies; the numbers under discussion range from $20,000 to $40,000 annually, a senior administration official said.

The lower end of that range would increase the amount of money the tax would raise but would also hit some middle-class workers, whose unions in some cases negotiated robust health benefits in lieu of pay increases. Typical employer-provided plans cost $13,000 to $20,000 per family, depending on the location and the age of the plan participants.

A health care package costing $40,000 or more a year would generally have no co-payments or deductibles, according to Paul Fronstin, an analyst at the Employee Benefit Research Institute, a Washington nonprofit that studies benefits. It would also have no limits on doctors or procedures, no restrictions on pre-existing conditions and no requirements for referrals.

Few people have such policies, Mr. Fronstin said. 'It would only be top executives who run big businesses, mainly people in the C suite,' said Mr. Fronstin, referring to companies’ chief officers.

It was not clear from this article how many top corporate executives have such plans, and whether leaders of other kinds of organizations, like large not-for-profits, also have them.

My main concern about such plans is not how much they contribute to top corporate leaders' compensation packages. Such packages are generally already so outrageously huge that providing $40,000 rather than $13,000 worth of health insurance is a trivial increase. My concern is not that plan recipients' demands for health care will collectively increase health care costs, because they include only a tiny portion of the population.

My main concern, instead, is how much these plans further insulate already cocooned top executives from the vicissitudes of daily life, particularly related to coping with our current dysfunctional health care system. What benefits executive health care plans provide is not clear, but presumably they insulate executives from having to deal with the managed care/ health insurance bureaucracy which frustrates patients seeking particular services, but not necessarily the most expensive, or least beneficial services. Such executives might thus not have gut level appreciation of how dysfunctional the health care system has become for even insured patients. Since top executives often are disproportionately influential members of the "superclass," their disconnection from the realities of dysfunctional health care is likely to translate into little real support by the powers that be for meaningful health care reform. There support may be further retarded by the influence of their fellow superclass members whose personal fortunes depend on the status quo in health care.

Real improvement of health care may depend on finding leaders who have better understanding of the plight of real people.

BLOGSCAN - Reports from the ACRE Meeting

The proceedings at the first meeting of the benignly titled Association of Clinical Researchers and Educators (ACRE) was chronicled on the Carlat Psychiatry Blog here, and on Postscript, the Prescription Project blog here. ACRE, founded by Dr Thomas Stossel (see relevant post here on the sorts of arguments Dr Stossel has made), was founded to defend academics who are paid on the side by drug, biotechnology, and device companies from the complaints of the "pharmascolds." What I found most troubling was that the conference was officially opened by Dr Jeffrey Flier, the Dean of the Harvard medical school, implying a medical school endorsement of this group, and featured presentations by the presidents of the American Association of Clinical Endocrinologists, and the American Society of Hypertension, implying endorsement by these medical societies. But also see the comments by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog that there may be a silver lining to this cloud.

How "Independent" a Source of Health Care Reform Data?

This week, a Washington Post article discussed who provides the data being cited in the ongoing US debate about health care reform.

The political battle over health-care reform is waged largely with numbers, and few number-crunchers have shaped the debate as much as the Lewin Group, a consulting firm whose research has been widely cited by opponents of a public insurance option.

To Rep. Eric Cantor (Va.), the House Republican whip, it is 'the nonpartisan Lewin Group.' To Republicans on the House Ways and Means Committee, it is an 'independent research firm.' To Sen. Orrin G. Hatch (Utah), the second-ranking Republican on the pivotal Finance Committee, it is 'well known as one of the most nonpartisan groups in the country.'

But how independent is the Lewin group?

Generally left unsaid amid all the citations is that the Lewin Group is wholly owned by UnitedHealth Group, one of the nation's largest insurers.

More specifically, the Lewin Group is part of Ingenix, a UnitedHealth subsidiary that was accused by the New York attorney general and the American Medical Association of helping insurers shift medical expenses to consumers by distributing skewed data. Ingenix supplied UnitedHealth and other insurers with data that allegedly understated the 'reasonable and customary' doctor fees that insurers use to determine how much they will reimburse consumers for out-of-network care.

In January, UnitedHealth agreed to a $50 million settlement with the New York attorney general and a $350 million settlement with the AMA, covering conduct going back as far as 1994.

Ingenix's chief executive, Andrew Slavitt, said the company's data was never biased, but Ingenix nonetheless agreed to exit that particular line of business. 'The data didn't have the appearance of independence that's necessary for it to be useful,' Slavitt said.

Lewin Group Vice President John Sheils said his firm had nothing to do with the Ingenix reimbursement data. Lewin has gone through 'a terribly difficult adjustment' since it was bought by UnitedHealth in 2007, he said, because the corporate ownership 'does create the appearance of a conflict of interest.'

'It hasn't affected . . . the work we do, and I think people who know me know that I am not a good liar,' Sheils said.

Is it only an appearance of conflict, and how objective is the Lewin Group's work?

Lewin's clients include the government and groups with a variety of perspectives, including the Commonwealth Fund and the Heritage Foundation. A February report by the firm contained information that could be used to argue for a national system known as single-payer, the approach most threatening to insurers, Sheils noted.

But not all of Lewin's reports see the light of day. 'Let's just say, sometimes studies come out that don't show exactly what the client wants to see. And in those instances, they have [the] option to bury the study,' Sheils said.

So, in summary, a group providing ostensibly "independent" data and opinions about an important health care policy debate is actually a subsidiary of a commercial managed care organization/ health care insurance company which clearly has vested interests in certain policy options. While the consulting group apparently struggles to be objective, its top leader reported that is fashions its reports at the behest of its clients, and that clients can "bury" reports that offend them, possibly because they do not serve their vested interests.

It is not surprising that participants in the current, noisy debate about health care reform, like many other health policy debates, have vested interests, and that their positions are likely to promote these interests. However, what should at least be disturbing is how often those with vested interests try to appear to be disinterested and independent. Should we trust "independent" voices that actually are conflicted, or those who cite "independent" views that actually come from interested parties?

By the way, we first posted about the Lewin Group's actual status as an Ingenix, and hence UnitedHealth subsidiary here in January, 2009, and first posted about how its contribution to the current health care reform debate was being touted as independent here in April, 2009. That a news organization with the status of the Washington Post is now picking up this story suggests a little optimism that the anechoic effect might be weakening.

Physicians Down Under Get Direct About Danger of Bad HIT

Too often, physicians acquiese to demands by hospital executives that they adjust to and use health IT, even if that health IT is flawed. This is despite the fact that liability for patient care resides with the physicians, not the HIT vendor or executives.

Several physicians Down Under have had enough:

Doctors issue deadly warning
Daily Examiner, Grafton, Australia
David Bancroft | 23rd July 2009

It seems incredible that a patient record system that aims to improve treatment could kill people [not so incredible to the informed - e.g., see "Bad Informatics Can Kill" - ed.], but that is a claim being made about a new system that is almost certainly going to be introduced into the Grafton Base Hospital next week.

Earlier this month, leading health officials from the Lismore Base Hospital wrote to the North Coast Area Health Service (NCAHS) claiming a new Surginet electronic medical record system that had been operating in the hospital for several months would 'inevitably' lead to the death of patients.

But the health service said changes had been made to the Surginet electronic medical record (EMR) system since the concerns were raised by the four senior clinicians on July 2, and the system had been operating 'satisfactorily' in Sydney without patient concerns being raised. ["Without concerns raised" does not mean they do not exist - ed.]

In their letter to NCAHS chief executive officer Chris Crawford, which was copied to the Minister for Health John Della Bosca, the four medical specialists said there had been recurring problems over several months and 'these have not improved'.

“This has resulted in unnecessary compromise of patient safety,” they wrote.

“There have been repeated well demonstrated cases of near miss disasters due to these problems. [Will patients be as lucky the next time? - ed.]

“We believe that negative patient outcomes, including death, will inevitably result from the continuing use of this system.

“Surginet is fundamentally flawed.

“New technology should: improve the quality of our work; help us to be more efficient, and; make routine tasks easier.

“EMR Surginet does none of these; in fact it has had the opposite effect.

“We believe that the Surginet EMR system is unsafe and will result in patient morbidity and mortality.”

Surginet was to be implemented at the Grafton Base Hospital yesterday, but after concerns were raised with the area health service, implementation was delayed until next Wednesday.

A health service spokesman said the implementation had been delayed so the software producers, Cerner [an American company behind the HIT products that caused difficulty in the UK - see the UK House of Commons report here, esp. points 5 and 6 - ed.], could speak with Grafton surgeons and anaesthetists prior to the implementation about any concerns they may have.

“NCAHS takes any concerns raised about patient safety seriously and is addressing these,” the spokesman said.

“It should be emphasised that Surginet is operating satisfactorily in Sydney hospitals without patient safety concerns being raised. [Again, that does not mean they do not exist; clinicians may be afraid to speak out and working furiously to establish workarounds to problems - ed.]

“It is a system used worldwide that can be adapted to accommodate local work practices in NSW hospitals. ["Can be adapted" - anything "can be adapted". But has this application actually been adapted to the culture in NSW hospitals? - ed.]

“Arrangements are being made for discussions to be held with the department heads by representatives of the EMR project team and Cerner.”

The spokesman said Surginet had recently been introduced at the Maclean Hospital and there had been no complaints and the NCAHS had actually received a letter of thanks from the hospital. [A letter of thanks from whom at the hospital, exactly, and based on what substantive claims? - ed.]

Such discrepancies between one hospital and the next regarding HIT require critical evaluation - erring on the side of patient safety, not IT vendor convenience. Considering the aforementioned UK House of Commons report and the "near miss disasters" mentioned by the Australian physicians, such due diligence is mandatory in my opinion.

Further, American physicians can probably learn from these Australian counterparts in being vocal about HIT problems.

-- SS

Inquiry to Joint Commission on points I raised in my July 22, 2009 JAMA letter on HIT

As I posted here, my letter "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" was published in JAMA on July 22, 2009. A preview of the letter can be seen here, or a full version here if you subscribe to JAMA.

This JAMA letter covered some of the same points I addressed extensively at my Drexel HIT website essay "Hold Harmless and Keep Defects Secret Clauses", including the major point that hospital executives signing HIT "Hold Harmless" and "Defects Nondisclosure" contracts are in violation of Joint Commission standards for conduct related to safety, and in violation of their fiduciary responsibilities towards patient and employee safety and freedom from undue liability.

I've sent the following inquiry to Paul M. Schyve, M.D., Senior Vice President, The Joint Commission:

July 24, 2009

Paul M. Schyve, M.D.
Senior Vice President
The Joint Commission
schyve@jointcommission.org

Cc: MChassin@jointcommission.org, otrippi@jointcommission.org

Dear Dr. Schyve,

In testimony to the House Committee on Veterans' Affairs on July 22, 2009 at this link , you state:

... The Joint Commission has established standards that require the hospital to:

• Create a culture in which adverse events are reported and evaluated for underlying ("root") causes, and preventative actions are taken.
• Identify high-risk processes and prospectively determine their possible modes of failure, the effects of those failures, and the actions that will prevent the failures or mitigate their effects.
• Establish a culture of safety throughout the hospital. This accreditation standard became effective January 1, 2009, although its purpose and expectations were publicized for over a year in advance.

In my JAMA letter to the editor of July 22, 2009 entitled " Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" ( link ), I point out that the Hold Harmless and Defects Nondisclosure clauses signed by hospital executives in contracting for healthcare information technology (such as CPOE and EHR systems) are in violation of Joint Commission safety standards, as well as hospital executive fiduciary responsibilities to patients and clinicians. These clinical IT systems can and do cause medical errors and patient harm.

My letter was in response to Koppel and Kreda's March 25, 2009 article " Health Care Information Technology Vendors' "Hold Harmless" Clause: Implications for Patients and Clinicians ", JAMA. 2009;301(12):1276-1278.

I am interested in the Joint Commission's response to the issues I raise.

I await a response.

-- SS

Pseudo-Evidence Based Medicine Threatens Health Care Reform Based on "What Works"

As I posted yesterday, the increasingly noisy debate about health care reform in the US has not dealt much with the issues we often discuss on Health Care Renewal. These include problems in how health care organizations are led which threaten physicians' and other health care professionals' core values using tactics including perverse incentives, deception, and intimidation.
Last night, however, President Obama held a news conference mostly devoted to health care issues, in which he stressed the importance of changing not just how health insurance works, but how health care decisions are made. As Newsweek's "The Gaggle" blog reported,

Can I guarantee that there are going to be no changes in the health care delivery system? No. The whole point of this is to try to encourage changes that work for the American people and make them healthier. The government already is making some of these decisions. More importantly, insurance companies right now are making those decisions. And part of what we want to do is to make sure that those decisions are being made by doctors and medical experts based on evidence, based on what works, because that's not how it's working right now.

So what the President seems to be advocating is making health care more evidence-based, perhaps in the formal sense of evidence-based medicine.

As a card-carrying evidence-based medicine advocate, I certainly agree, but let me reiterate that evidence-based medicine is not just medicine based on some sort of evidence. As Dr David Sackett, and colleagues wrote [Sackett DL, Rosenberg WM, Muir Gray JA, Haynes RB, Richardson WS. Evidence-based medicine; what it is and what it isn't. BMJ 1996; 312: 71-72. Link here. ]

Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgment that individual clinicians acquire through clinical experience and clinical practice. Increased expertise is reflected in many ways, but especially in more effective and efficient diagnosis and in the more thoughtful identification and compassionate use of individual patients' predicaments, rights, and preferences in making clinical decisions about their care. By best available external clinical evidence we mean clinically relevant research, often from the basic sciences of medicine, but especially from patient centred clinical research into the accuracy and precision of diagnostic tests (including the clinical examination), the power of prognostic markers, and the efficacy and safety of therapeutic, rehabilitative, and preventive regimens.

Furthermore,

Evidence based medicine is not 'cookbook' medicine. Because it requires a bottom up approach that integrates the best external evidence with individual clinical expertise and patients' choice, it cannot result in slavish, cookbook approaches to individual patient care. External clinical evidence can inform, but can never replace, individual clinical expertise, and it is this expertise that decides whether the external evidence applies to the individual patient at all and, if so, how it should be integrated into a clinical decision.

One can find other definitions of EBM, but nearly all emphasize that the approach is designed to appropriately apply results from the best clinical research, critically reviewed, to the individual patient, taking into account that patient's clinical characteristics and personal values.

So far, so good. I believe the proper application of "real" (as described above) evidence-based medicine has the potential to improve patient outcomes while moderating health care costs. However, we have pointed out how problems arising from concentration and abuse of power in health care threaten the evidence-based medical ideal.

First, there are major problems with the development of the sort of clinical research evidence required by the EBM process. We have discussed how clinical research is frequently manipulated by those with vested interests in producing results that favor the products or services that they sell. The critical review process inherent in EBM is meant to cope with less than optimally designed and implemented research. However, the process was designed to cope with honest mistakes and inevitable trade-offs, not deliberate manipulation by vested interests.

Worse, we have discussed how vested interests may engineer the suppression of research when manipulation fails to produce the desired results. The EBM process assumes that the research on which decisions should be based is an unbiased sample of research that was done (and done to advance science, not commercial or ideological interests). When research whose results are unwanted by vested interests is suppressed, the resulting distortion of the evidence base may irretrievably bias the EBM process.

Finally, we have posted about how vested interests have distorted the discussion, dissemination, and teaching of the results of clinical research. They may develop systematic stealth marketing campaigns, often employing supposed "key opinion leaders," who are paid on the side by marketers, and using "medical education and communication companies"as marketing fronts whose publication strategies include deceptive tactics such as "ghost-writing."

Thus, a rising tide of "pseudo-evidence based medicine" threatens to overwhelm even the most conscientious physicians trying to practice evidence-based medicine.

So, while I applaud President Obama's advocacy of reforming health care to emphasize what the best evidence suggests really works, I do not think this effort will get far unless we deal with the rising tide of pseudo-evidence based medicine. As a minimum, we need full and detailed disclosure of all the relationships among vested interests and medical research and education, and a much greater role for research and education that is not subsidized by corporations bent on using research and education to market their products and services.

State, City Settle Case Alleging Medicaid Fraud

We have posted on a variety of settlements of cases alleging health care fraud, but this one has a new twist, as reported by the NY Times,

New York State and New York City officials agreed this week to repay the federal government for more than half a billion dollars in improper Medicaid claims, averting a potential court battle but adding more red ink to the state’s and city’s finances.

The settlement, which federal officials said was the largest recovery of Medicaid funds in history, ends a lengthy dispute with the federal government over whether school districts around the state improperly sought Medicaid payments for speech therapy and other services dating to the early 1990s.

Under the agreement, which was announced Tuesday, the city will repay about $100 million. The state will pay about $332 million in 10 installments over the next five and a half years and will also give up $107.9 million worth of Medicaid claims now owed by the federal government.

Though neither city nor state officials are required to admit wrongdoing under the agreement, it does require the state’s Department of Education to submit to independent monitoring of its Medicaid-financed programs.

Since the 1980s, Medicaid has helped school districts pay for the cost of services like speech therapy and psychological counseling for schoolchildren, including the cost of transportation to therapists’ offices. School districts in New York have been among the most aggressive in the country in seeking such aid: one federal study found that New York accounted for 44 percent of all student health services.

Those lawsuits, filed under the federal False Claims Act, spurred several audits by the Department of Health and Human Services of city and state programs that finance speech therapy and other programs for disabled children. Those audits found substantial potential for fraud, reporting that a vast majority of the claims submitted did not meet federal requirements, and that in many cases there was no evidence that the services had actually been provided.

This may be the first settlement of health care fraud allegations we have discussed in which all the involved parties were government agencies.

The current fervent debate in the US about health care reform has focused on ever rising health care costs. However, this debate has largely ignored the ethics of health care, and the sorts of leadership of health care organizations that has lead to rampant and costly mischief, of which this case is just the latest example. How can we control costs while so many health care leaders are seeking every angle to make more money, whatever the consequences?

What Health Care Reformers Don't Discuss

Health care reform is now the big health care story in the US. Discussion of various health care reform proposals regularly lead in print and electronic media. Yet we have been very quiet here on Health Care Renewal about health care reform.

I personally have written little, because it seems to me that hardly any of the discussion swirling around relates to the concerns we discuss on this blog. We write about the bad effects of continuing concentration and abuse of power in health care on physicians' and other health care professionals' core values. We note instances of ill-informed, incompetent, self-interested, conflicted, or even corrupt leaders of health care organizations. We discuss how problems with the governance of health care organizations allow such leadership. We comment on instances in which bad leaders use tactics such as deception, creation of perverse incentives, and intimidation. And we address how all this can lead to higher costs, decreasing access, poor patient outcomes, and demoralized professionals.

For example, just in this month, July, 2009, we posted about:

How Trusted Health Care Institutions are Lead by the Conflicted

• One of the largest and most respected medical societies gets three times as much income from the pharmaceutical, biotechnology and device industries as from membership dues, and its current generously salaried president just asks the public to "trust us, we're doctors" (link here);
• The White House health care reform czar just stepped off the board of directors of a health care corporation accused of "ruthless" behavior and making patients feel they are only equivalent to "dollars" (link here);
• An award-winning show on public television featured remarks favoring drug treatment of psychiatric illness by an academic "key opinion leader" without disclosing his multiple financial ties to the pharmaceutical industry (link here);
• A state legislator pleaded guilty to selling his services to an academic medical center (link here);
  

Health Care Leaders Do Not Share Physicians' Traditional Values

• Leaders of the university that employs the academic "key opinion leader" mentioned above intimidated another of its professors because he wrote a blog critical of the pharmaceutical industry (link here);
• A study showed that primary care doctors burn out not just because they think their pay is low, but because they work in "chaotic" environments, lead by people who do not inspire trust and whose values are not aligned with those of the physicians (link here);

And our archives, going back now to the end of 2004, include much more.

For the most part, however, these are not the issues discussed in the great health care reform debate.

There does seem to be, at the margins, some discussion of a few productive approaches, which deserve credit. These include the Sunshine bill, which would improve disclosure of conflicts of interest generated by health care corporations' payments to health care professionals and academics; the push to support some comparative effectiveness research; and some attempts to address the perverse incentives built into the system used by Medicare to pay physicians. It is not clear, however, whether these efforts are going to get very far, and in any case, they remain peripheral to fervent discussions of health care financing, which seems to be the only topic of interest to most would-be health care reformers.

I believe that the US health care reform will not produce good results if it fails to address the issues we discuss on Health Care Renewal.

But discussion of them, of course, may threaten many with vested interests, and lots of people who have been made rich and powerful by the current system.

So look forward to endless debates about whether the "public option" for health insurance is a good or bad idea, but nothing about how the insurance industry is lead, much less how pharmaceutical, biotechnology, device companies, hospitals and academic medical centers, medical not-for-profit organizations, health care information technology companies, and government agencies are lead, and how bad leadership facilitated by bad governance will continue to make things worse.

JAMA letter: "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards"

My letter "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" was published in JAMA yesterday. A preview of the letter can be seen here, or a full version here if you subscribe to JAMA.

The letter was in response to Koppel and Kreda's groundbreaking March 2009 JAMA article "Health Care Information Technology Vendors' Hold Harmless Clause: Implications for Patients and Clinicians."

The JAMA letter covered some of the same points I addressed extensively at my Drexel HIT website essay "Hold Harmless and Keep Defects Secret Clauses", including the major point that hospital executives signing such contracts are in violation of Joint Commission standards for conduct related to safety, and in violation of their fiduciary responsibilities towards patient and employee safety and freedom from undue liability. In the Drexel website essay I also noted that:

... these stipulations [hold harmless and gag clauses in contracts] further instantiate my observation that health IT lacks the rigor of medical science itself, its major Achilles heel.

Koppel and Kreda note in their JAMA reply to my JAMA letter that:

Dr Silverstein's letter adds context to our Commentary on HIT vendors' self-protective "hold harmless" clauses while introducing an important discussion about hospitals' and vendors' possible violations of Joint Commission standards. We agree with Silverstein about the misapplication of the standard business software contracting model.

Of interest, the American Medical Informatics Association (AMIA) had authored a reply to Koppel and Kreda quite different than mine, which for a time appeared on their national website (www.jamia.org) but was later withdrawn apparently due to concerns that such a letter might be viewed as an official organizational position. It was entitled "Response to Commentary in JAMA -- Ross Koppel, David Kreda" and can be read in its entirety here.

The AMIA response piece concluded:

"While we support increased transparency around error disclosure, the belief that the best approach to increase the safety and effectiveness of EHR systems is by legal regulation of system vendors is misplaced. Such an approach would stifle innovation and not achieve the desired goals. At a minimum equal attention needs to be given to the role that provider organizations bring to configuration, management and oversight of the software and related processes."

In fact, Koppel and Kreda addressed the provider side issues extensively in their article.

Of interest, JAMA did not publish the AMIA response but instead published mine. Perhaps it's because JAMA felt I had something important to say, as opposed to simply making excuses for HIT vendors and valuing prevention of "stifling of innovation" over hospital leadership's safety and fiduciary obligations to patients and staff.

"The belief that the best approach to improving HIT safety is via regulation is misplaced?" (Misplaced how, exactly?) Tell that to the airline or public transit or pharma or the medical device industries. Or to the public whose care is increasingly dependent upon these HIT systems.

It is my firm opinion that "innovation" done recklessly, in secrecy, without accountability, and via exploitation is not innovation at all.

-- SS

July 23 addendum:

Dr. Koppel has forwarded to me a letter he and Mr. Kreda submitted to AMIA in response to AMIA's aforementioned critique of his March 2009 JAMA "Hold Harmless Clause" article. Koppel and Kreda's letter, "On the AMIA Response to Commentary in JAMA by Ross Koppel and David Kreda" can be read here (MS Word .doc format).

Highlights:

... Where the AMIA authors disagree with us is the emphasis placed on errors produced in the coupling. [The coupling of healthcare organization and software, i.e., alterations and customizations beyond the control of the software vendor - ed.] We say a vast number or errors are generated in the marriage. But they say we have essentially ignored how many errors are created by doctors and hospitals seeking to consummate their relationship with HIT systems in situ ...

... A brief recap of our JAMA commentary seems in order. We wrote about: (1) the HIT vendor “non-disclosure” clauses that prevent clinicians from sharing information about errors generated from faulty software; (2) the clauses that remove all vendor responsibility for errors in their systems – and place all responsibility on clinicians and hospitals (the “hold harmless/learned intermediary” clauses); (3) the need to protect vendors from responsibilities for errors introduced when hospitals implement HIT or when untrained or incompetent clinicians use the HIT; and (4) the need for more balanced contracts that are fair to clinicians and hospitals ...

... Given that we addressed the non-software issues we are said to have ignored, we are not sure why our JAMA commentary earned the response it received on official AMIA letterhead. We hope, therefore that this letter can further a longer conversation about the many ways to make clinical IT software and its implementation better. Nonetheless, we stand by our statement that the imbalance in incentives we described in our JAMA Commentary is a structural obstacle that on balance hurts improving the clinical part of clinical IT.

Read the whole thing at the link above. (I placed Koppel and Kreda's response to AMIA on my faculty server. The response, to the best of my knowledge, was not published by AMIA itself.)

-- SS

Philadelphia VA Hospital Brachytherapy Debacle: For The Want of One Competent and Industrious IT Person

This post should perhaps be subtitled "The Theatre of the Absurd."

At Healthcare Renewal and other sites I've often commented on the remarkable accommodation given to IT personnel in hospitals, even when these personnel make capricious decisions that are contrary to the support of the mission of healthcare organizations, or contrary to the mission itself.

I wrote that many HIT problems observationally appeared due to ill-informed, capricious edicts of overempowered (relative to clinical leadership) MIS leaders, sanctioned by equally ill-informed executive leadership, for which the IT personnel were rarely held accountable.

Endangerment of ICU patients via PC's entirely inappropriate for a biohazards environment, chaos in a critical procedure area from IT complacency and incompetence, payment of millions of dollars for HIT with gross defects rendering it unusable by clinicians without consultation of in-house medical informatics expertise, and denial of access for hundreds of drug discovery scientists to the informatics tools their own leaders said were essential to new drug discovery are just a few of the situations I've personally observed due to IT department whimsy.

Remarkably, none of these situations nor others reported from numerous sources resulted in repercussions against the teflon-coated IT deities (other than, in some cases, generous promotions), thereby obstructing remediation of the attitudinal and competency problems that created the scenarios. If physicians had it this good, they'd be chopping off wrong limbs, removing the wrong organs, and failing to diagnose and treat with impunity.

At my June 2009 posting regarding an unfolding clinical debacle of national import at the Philadelphia VA hospital entitled "Bungled Brachytherapy, Computer Interfaces and Other Mysteries At The Philadelphia Veterans Administration Hospital" I wrote:

... I am uncertain how "computer interface problems" (in the Philadelphia Inquirer, they were referred to as "glitches") prevented medical personnel from determining treatment success over several years. I would be most interested in hearing more about these "interface problems."

That question has now been answered, and I am disappointed (but not surprised) at the results. Having rewritten a poor interface between a gamma scintillation camera and a PDP-11 computer in medical school during a nuclear medicine rotation at Boston City Hospital, allowing endusers to identify ROI's (regions of interest) with a light pen for automated calculation of intensities, I thought perhaps some arcane coding or driver configuration was the culprit at the VAMC Philadelphia. That was not the case:

VA radiation errors laid to offline computer

By Marie McCullough and Josh Goldstein

Philadelphia Inquirer
July 19, 2009

... It is not surprising, then, that NRC and VA investigators spent considerable time delving into why the calculations weren't done for more than a year at the Philadelphia VA.

Their investigative reports blamed a "computer interface problem" - the same terminology Kao used during his testimony last month at a congressional hearing.

The implication was that some intractable technology breakdown was behind the lapse in care [i.e., some cryptic problem requiring magical incantations and byzantine scripts that mere mortals could not understand nor remedy - ed.]

In fact, technology had little to do with the breakdown, as James Bagian discovered when he led an inquiry at the Philadelphia VA and the veterans' health system's 12 other brachytherapy programs.

Bagian, a Philadelphia-born physician and former astronaut who is now the national VA's patient-safety director, discovered that the "interface problem" was nothing more than the disconnected computer.

Here's what else his inquiry found:

The computer was initially unplugged so that another medical device could use the network port. Then, various departments dithered and ducked a request for an additional network port, which was finally installed - after a year. ["Various departments dithered and ducked?" Which departments, exactly? See below - ed.]

Some doctors, physicists, and other professionals at the VA acknowledged it was "clinically inappropriate" to omit the post-implant calculations. Some said they had informed their "chain of command."

When asked why they didn't tell the hospital's patient-safety officer, they said "it had not occurred to them to do so."

["Had not occurred to them to do so?" I've seen situations where physicians and scientists were afraid of IT leaders, due to the latter's often overinflated political influence and proficiency in playing games of political intrigue. Did this occur here, I wonder? - ed.]

So, it appears that for the want of one network connection, installed by one competent, industrious, non-complacent IT person, a national scandal has erupted that has injured many patients.

First, I ask the following questions regarding the "various departments" that "dithered and ducked" the responsibility to install an additional network connection in the brachytherapy suite:

• Was the job the responsibility of the Department of Medicine? The doctors and nurses? Could they have done so?
  
• Perhaps it was the responsibility of the Public Relations Department (who now have to pick up the pieces?)
• Was it the reponsibility of the Facilities Department?
  
• Was it the responsibility of the Housekeeping Department?
• Or, was it the responsibility of the IT Department and CIO?
  

(If you need help answering these questions, stop reading now.)

I also ask:

• Why was the IT department's failing to perform this task kept low profile through use of cryptic "interface problem" language that implied complex IT problems, as opposed to simple people problems?
  
• Who originated this language?
• Did they believe the truth could remain hidden?
  
• Why do we use the term "medical malpractice" to describe negligence in medical care, not "provider glitch?" Why the different standards?
  

I can visualize what went on behind the scenes in the IT department, refrains I have heard before - "we don't have the resources ... we need to hold more meetings to consider the issues ... it's the vendor's responsibility ... it's the network group's job, not the hardware group ... putting a new network outlet in there will cause packet storms and interfere with system XYZ ... we need to get consensus .... you [doctors] can't understand the complexities of the problem, but don't worry, we'll make it better ... hey, the docs don't need it anyway ..."

What would happen to, say, the Facilities Department if a plumbing problem led to failure of a piece of vital equipment in the OR's, and they failed to repair it for a year?

This is not to excuse the multiple layers of complacency among clinicians, safety staff, and others for toleration of this network denial situation and the lack of QC on the procedures themselves, but at the heart of this debacle is this attitude, which seems common in hospital IT departments:

"Doctors and nurses toil in hospitals so IT personnel can have comfy jobs and nifty computers."

Perhaps on this occasion, IT leaders and personnel may end up on the witness stand and be held accountable, and perhaps lose their jobs instead of being promoted. However, even this is doubtful, and it has taken a congressional investigation led by Sen. Arlen Specter to get even this far, to simply find out that the mysterious "interface glitches" were a lack of a network jack due to laziness and complacency.

Finally, I point out that it is hospital IT personnel upon whom clinicians will depend for acquisition and implementation of the HIT tools the President of the United States said are essential to changing the culture of healthcare.

As I have written, before the IT profession can change the culture of healthcare (in a positive manner, that is), its own culture must change.

IT personnel in hospitals must become part of the clinical team and support the mission of clinicians, not the other way around.

July 22 addendum:

I note again that multiple people failed here, including executives, physicians, safety officers, etc. I believe responsibility needs to be fairly assigned. However, IT needs to be included. I've witnessed or heard about too many HIT incidents where IT personnel and leadership remained scot-free when their behavior and attitudes were contributors or root causes.

As per my letter to the editor published in JAMA on July 22, "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards", IT privilege and accommodation must stop. HIT is not business IT used for widget inventory or payroll. As the VA incident shows, patient lives and well being are at stake.

July 24 addendum:

More on this from a blog on medical physics, "The Sharp End of the Photon", here:

... the errors in the placement of the radioactive seeds went undiscovered for so long because post-implant dosimetry was not performed. This involves CT scanning the patient, finding the positions of the seeds and calculating the ultimate dose the patient received. In the NRC report, the explanation was that a problem with the interface between the CT scanner and the treatment planning computer prevented transferring the CT images.

A "problem with the interface", indeed.

Also provided is a link to testimonies from witnesses at the house.gov website, which are here.

Notable is the absence of any testimony from IT leadership. The only allusion to IT is in testimony by the doctor who performed the procedures who stated:

"There should be a method of categorizing systematic problems by level of urgency so that serious problems, such as those involving failures of medical equipment or transfer of patient-related data, will receive immediate attention from the proper personnel and be quickly resolved."

Perhaps, but not in this case. A simple phone call to IT should have been adequate to resolve this particular simple problem.

-- SS

STOSSEL and ACRE: WHERE'S the BEEF?

STOSSEL and ACRE – WHERE’S the BEEF?

Thomas Stossel from Harvard is at it again. As Daniel Carlat has humorously described, Stossel is planning the inaugural meeting next week of a group to counter those he calls pharmascolds. The group is named ACRE – Association of Clinical Researchers and Educators. Here is its website: http://www.acreonline.org/ For months, Stossel has been warning of the dire negative consequences that will result from tightened conflict of interest policies, but he has not presented any persuasive examples of damage to “productive relationships between industry and physicians involved in clinical research and educational outreach.” At the same time, Dr. Stossel has conveniently overlooked the shenanigans of the bad actors whom Senator Grassley exposed. Dr. Stossel is a blowhard, as I have described here before.

But wait! ACRE has found something! A News item in the July 2009 issue of Nature Medicine (“Conflict of interest rules seen by some as too stringent”) quoted one of the participants in the upcoming ACRE conference. Avi Markowitz, chief of oncology at UT Medical Branch, Galveston, came up with this example: Patients taking a Sanofi Aventis chemotherapy product may experience peripheral neuropathy, which can cause unpleasant sensations in the hands and feet. ‘Sanofi Aventis had been providing Markowitz and his UTMB colleagues with free blankets and gloves for those patients. Last fall, however, the university adopted stricter rules banning industry freebies. Now, Markowitz can’t even accept the unbranded blankets and gloves that Sanofi Aventis has offered to provide.’ Reading between the lines, it is a good bet that these items originally were branded.

Whatever. And never mind that the patients receiving chemotherapy at UTMB are doubtless billed a hefty facility fee that must include comfort items like blankets and gloves. Since when does a chief of oncology need to beg for these basic patient care provisions from drug companies?

Is this all that ACRE can come up with? The ACRE homepage warned sternly of “restrictive conflict of interest policies that often sever productive relationships between industry and physicians involved in clinical research and educational outreach.” Does Thomas Stossel’s whining and catastrophizing through ACRE come down to piffling items like blankets and gloves for chemotherapy patients? That’s it? Where’s the beef?

At least ACRE has the good sense not to include on its program the smooth operators whom Senator Grassley outed – like Nemeroff at Emory, Schatzberg at Stanford, Kuklo at Walter Reed, Keller at Brown, Biederman at Harvard. Not even Stossel has been brazen enough to try to defend them.

The Nature Medicine News item does close on a helpful note: 'Stossel would like to see abuses involving financial conflicts of interest treated more like cases of scientific misconduct. Rather than forcing everyone to abide by prohibitive rules, he says administrators should focus on weeding out those who misbehave.' I say Amen to that, even if it is a day late and a dollar short.

We have arrived at our present state of discomfiture because the leaders of academic institutions and professional societies looked the other way for too long. They failed to do their job of reining in the ethical outliers. Grassley had to do it for them. As a result, the rest of us will be burdened with new regulations for years to come. Those who did speak up years ago were ignored or demonized. As the saying goes, every group gets the leadership it deserves. Those in academic medicine had better not count on Stossel and ACRE to lead them out of the wilderness.

Bernard Carroll.

Irish Physicians Opt Out of Vital Patient Maintenance Care, Refuse to Release Records; Court Agrees

Well, no, actually. Irish physicians did not opt out of "maintaining" the healthcare of patients and refuse to release their medical records. Even imagining such an event is absurd.

IT providers in Ireland did, however, opt out of caring for the HIT of 180+ hospitals and releasing the source code so others could do it:

HSE fails in bid to secure IT servicing for 180 hospitals

By Tim Healy

Thursday July 16 2009

The HSE [Health Service Executive - ed.] has failed to get a High Court order compelling a company to continue providing vital computer maintenance services for 180 hospital and other sites around the country.

Ms Justice Mary Laffoy also refused to grant an injunction requiring the company, Eamon Keogh, trading as Keogh Software, Harold's Cross, Dublin, to temporarily release source codes necessary for someone else to maintain and fix the computer system's software.

[In other words, traditional business computing customs of source code secrecy even in face of software orphancy shall apply - quite inappropriately - to healthcare, and providers and patients be damned. - ed.]

The system is used by A&Es, radiology departments, HSE billing services as well as in environmental health areas and "parliamentary affairs" of the HSE.

Keogh Software, which laid off all its staff providing the service on May 29, undertook to maintain the service until yesterday's judgment.

The HSE had sought an injunction requiring it to continue to provide the service pending full court proceedings.

Ms Justice Laffoy ruled that the issue of the release of the software source codes should be dealt with under an independent resolution procedure set up to deal with this eventuality.

[By that time, the hospitals will have been forced to return to manual methods and then replace the systems, or run the risk of chaos and patient harm from defective software, assuming it functions at all - ed.]

The judge also turned down a cross-application from Mr Keogh for an injunction requiring the HSE to pay for work done under a new fee agreement entered into by the parties on April 3 last.

She also dismissed his application for an injunction waiving a HSE requirement that he produce a tax clearance certificate prior to payments being made.

When the High Court heard applications from both sides last month for their respective injunctions, the judge was told the dispute was precipitated when operational problems were experienced in Naas Hospital's radiology information system [not an unimportant system - ed.]

The HSE claimed Mr Keogh failed to respond properly to these while he (Keogh) claimed they were denied access to the system by the HSE [vendor denied access to malfunctioning RIS software needing remediation? I simply find that hard to believe - ed.]

hnews@herald.ie

- Tim Healy

One wonders who will be held accountable if this unremediated, defective software results in patient harm or death. (I, however, doubt it will be the IT vendor.)

Thus are the dangers of hospitals becoming dependent on an IT industry privileged and accomodated to the point of having no accountability (as in the U.S. as detailed by Koppel and Kreda in JAMA here). Thus are also the dangers of hospitals becoming dependent on proprietary HIT, and/or not having the expertise nor the source code required to fix bugs and perform maintenance themselves.

I add that nearly our entire country is about to go that route.

But at least the software will be "certified" by the fierce watchdog group and safety advocate, the CCHIT.

Fierce to its critics and to its own organizational safety, that is (HIMSS, CCHIT's parent organization, is currently seeking to have CCHIT declared the monolithic force for HIT 'certification' in the United States).

-- SS

Turning Patients into "Dialysis Dollars"

As we have discussed in previous posts (here and here), prior to a US Supreme Court decision in 1975, physicians (and other professionals) were left free to set up and enforce their own codes of ethics. Until about 1980, the US American Medical Association (AMA) stated,

• "in the practice of medicine a physician should limit the source of his professional income to medical services actually rendered by him, or under his supervision, to his patients"
• "the practice of medicine should not be commercialized, nor treated as a commodity in trade"

The Supreme Court decision was widely construed as meaning that any promulgation by US professional organizations of ethical regulations that constrained any economic practices of their members was a violation of anti-trust laws. Thus, in 1980, the AMA dropped their prohibitions against the commercialization of medicine, and nobody, it appeared, tried to change the anti-trust law whose provisions the court interpreted.

A vivid example of how physicians and patients may be caught in the cross-fires among health care corporations in this brave new era of commercialized health care was provided by a recent report in the Denver Post:

News that Fortune 500 company DaVita Dialysis is moving its headquarters to Denver socked its competitors like a punch in the gut.

To its rivals, the kidney-care giant is a bully armed with high-powered attorneys who use lawsuits as tools to intimidate.

DaVita executives counter that they are simply strong competitors — they act as aggressors only when doctors or nurses or other dialysis companies break promises and double-cross them.

Either way, a string of DaVita-filed lawsuits around the country — with two major battles boiling in Denver and Colorado Springs — shed light on the ruthless competition over dialysis patients in an industry that costs Medicare alone more than $8 billion per year.

For years, DaVita's competition in Colorado's two largest cities was almost nonexistent.

The mud began to fly last year when the second-largest group of Denver kidney doctors, called nephrologists, ended their exclusive affiliation with DaVita and partnered with a Massachusetts dialysis company entering the Denver market. Near the same time, the largest nephrology group in Colorado Springs dumped DaVita in favor of Liberty Dialysis, which recently opened two dialysis centers in the city.

DaVita quickly sued doctors in both cities, plus a nurse battling breast cancer who quit her job at a DaVita dialysis center and took one with Liberty.

The hostility between the companies is so intense, it's seeping down to the patients.
'With everything that is going on, you feel like you are becoming sort of a dialysis dollar,' said Julie Estes, a 53-year- old Colorado Springs woman who spends three days a week, four hours at a time, hooked to a dialysis machine in order to stay alive.

DaVita says it 'paid millions' in 1998 to the doctors of Western Nephrology in Denver to retain them as medical directors of six dialysis centers in the metro area for 10 years. The doctors signed non-compete agreements, promising not to join forces with DaVita rivals or steal any of the California-based company's nurses.

Patients are free by law to choose any dialysis center they want. But dialysis companies bank on the fact that snagging the most popular kidney doctors in town to serve as medical directors of their centers will bring in the most patients — and the most dollars.

Every dialysis center is required by federal law to have a medical director to oversee the care of patients and the water purification system used to flush toxins from the blood of people with failing kidneys.

It's a side job, separate from a nephrologist's practice, that some estimate takes only a couple of hours each week. Companies and doctors declined to say what salary comes with the job, but estimates range from $20,000 to $200,000 per year depending on the competitiveness of the market.

After 10 years with DaVita, when they believed the non-compete agreement was about to expire, Western Nephrology doctors began making plans to become medical directors of shiny-new American Renal Associates dialysis centers opening in Denver with a flat-panel TV and heated, massage chair at every dialysis station.

Four of the new centers are within 3 1/2 miles of existing Da Vita centers. The non-compete agreement that Western Nephrology doctors had signed for DaVita prohibited them from having relationships with competitors within a 35-mile radius.

DaVita contends in its lawsuit that it found out about Western Nephrology's 'secret campaign' because the dialysis company they were working with applied for Medicare billing numbers for five new centers in the Denver area.

In its counterclaim, American Renal Associates accused DaVita of violating federal antitrust law — the company had controlled at least 80 percent of the Denver market. DaVita lagged in updating its dialysis centers until competition was imminent, according to court records. And the claim accused DaVita of 'filing legal actions that are objectively baseless' merely as an 'anticompetitive weapon.'

"Ruthless competition," "lawsuits as a tool to intimidate," "double crosses," flying mud, patients who feel like "dialyis dollars," non-compete agreements, medical directors paid according to "the competitiveness of the market," "secret campaigns?" - is this any way to run a health care system?

As Dr Arnold Relman pointed out (see our previous posts linked above), through the 1960s there was some consensus that health care does not function like a pure market, partially because patients cannot function like steely-eyed consumers. They do not have enough information about the benefits, harms and costs of their possible choices. They have trouble understanding the ambiguity and uncertainty of the medical context. And most important, they may not be capable of the cold cognition the free market model requires, since they may be dealing with choices whose potential outcomes prompt extreme emotions, and in many cases, they may be too frightened, sick, or cognitively impaired to make fully rational choices. In particular, patients with end-stage kidney disease, requiring dialysis to maintain life, seem very different from some ideal, coldly cognitive consumers. So what in the world are they doing caught up in these sorts of disputes?

I submit that real health care reform ought to help physicians and other health care professionals renew their professionalism, and put the provision of health care (and health education and clinical research) back in the hands of people who view these activities as callings, not purely as ways to get rich. Meanwhile, when you are a patient, be prepared to be treated merely like a source of revenue.

PS - Please note that, as we have posted before, the new US "czar" for health care reform is a former member of the board of directors of DaVita.

Again, Logical Fallacies in Defense of Conflicts of Interest: a Rebuttal to Rothman et al Appears in JACC

Earlier this year, a remarkable commentary in JAMA suggested major reconsideration of the relationships among professional medical associations (PMAs) and health care corporations.(1) Because of the influence of PMAs on clinical care, education, research, and policy, Rothman et al suggested that these organizations sever most of their financial ties to corporations such as pharmaceutical, device, and biotechnology companies. The authors suggested that the only acceptable payments to PMAs from these companies are those for advertising in publications that is clearly labeled as such, and advertising exhibits in meetings, again that is clearly labeled. Furthermore, the authors suggested that people with current or recent (within the last two years) relationships with such corporations ought not to serve as officers or trustees of PMAs, and ought not to serve on program or practice guideline committees. Rothman et al thus suggested that professional medical associations return to their roots, to be advocates for their physician members, and those members’ core values, not marketers of drugs and devices, and promoters of the interests of health care corporations.

The Journal of the American College of Cardiology (JACC) just published the first rebuttal of Rothman et al to appear in a peer-reviewed journal, written by Dr Alfred A Bove, President of the American College of Cardiology (ACC), one of the more influential PMAs.(2) Dr Bove contended that there is nothing wrong with the current relationships among corporations and PMAs, and PMAs should be free to relate to health care corporations any way they want. Dr Bove also asserted that “the assumptions that lead to ... [Rothman and colleagues’] conclusions can be challenged on many fronts.” However, in my humble opinion, Dr Bove supported these contentions with logical fallacies, rather than evidence and logic.

Appeals to Authority, Fear, and Pity

Early on, Dr Bove used a striking set of appeals to authority. (Note that his relevant quotes below appear in italics.)

“There is no comment about trust or virtue as a characteristic of the medical profession.”

“We are not to be bribed by a cheap pen or a free lunch.”

“The authors' assumptions imply that physicians as a group are not responsible people, yet physicians are among the most responsible professionals.”

These appear to be appeals to the traditional authority of the medical profession. Dr Bove simply asserts that physicians are inherently virtuous and deserving of trust, and thus no one could question the virtue of the profession.

He then compounded these appeals to authority with a veiled appeal to fear.

“The authors' assumption that the worst behavior is the average behavior of all physicians insults the profession.”

As noted below, Rothman et al did not make this assumption, so the appeal in turn rests on a straw man argument. This appears to be an appeal to fear in that an “insulted” profession might be expected to take action, legal or otherwise, to avenge the insult. It also could be a form of an appeal to pity, in that the reader might be inclined to pity the poor “insulted” physicians.

Straw Man Arguments

The bulk of the editorial consisted of a string of straw man arguments. A straw man argument propounds a distorted, exaggerated, or misrepresented version of his opponent’s argument, and then attacks it, rather than his opponent’s actual argument.

“The sole source for support of PMAs could only come from government or foundation grants....”

Actually, Rothman et al included membership dues, and by implication, meeting registration fees, journal subscription fees etc as acceptable sources of support.

“The article implies that all physicians who receive support from industry will forever be biased to support the products of the related pharmaceutical or device company.”

Actually, Rothman et al seemed to assume that conflicts of interest might affect someone for up to two years, but not forever. Thus, they suggested that board members should be “conflict free for a 2-year period before assuming the position.”

[The Rothman article] “also implies that industry does not work for the best interests of patients or the better [sic] public good, but only for profit.”

Actually, Rothman et al stated “the pharmaceutical and medical device industries make important contributions to medical progress. Their role in the development and testing of new compounds and instruments is essential for the diagnosis and treatment of disease and disability.”

“First, to assume that physicians would not be responsible for providing the best care for their patients after being associated with an industry study or consultation is inappropriate. The authors cited isolated examples of errant physicians who received large sums of money from industry and then promoted their products. They presume that all physicians are represented by these few—that we all have a price.”

Actually, Rothman et al did not discuss any particular cases of “errant physicians.” What Rothman suggested was that gifts, even of “modest value,” can bias decision making, and that the receipt itself of the gift may itself be influential. However, if even modest gifts have some influence, it is logical that large financial transactions might have major influence.

“Society understands that reward drives innovation, so expecting a financial gain from a commercial medical enterprise is not wrong. In fact, it is the only way that new ideas will move from the laboratory to the public good. Using public funds for manufacture and distribution would add an enormous burden to government costs and, based on past experience, would be unproductive.”

Rothman et al were not remotely suggesting nationalizing the drug and device industries.

“If one of us has an idea for a new device and needs industry to help refine its design, fund its development and manufacture, and establish its value by animal and clinical studies, this process should be honored, not condemned. Will the government fund the development of the next new drug? Would the government have funded the development and manufacture of an implantable pacemaker?”

At the most, Rothman et al recommended not allowing physicians who are paid by companies in conjunction with their development work to serve as top leaders, and on certain committees of PMAs. They never broadly “condemned” physicians who work with industry to develop devices.

“Governments have not shown an interest in funding the development of new drugs and devices. Industry raises the funds, takes the risks, and should reap the rewards for its role in creating a better life for our patients.”

Actually, governments have helped development considerably by funding much of the underlying basic science research. Again, Rothman et were not remotely suggesting nationalization of drug development.

Summarizing the Arguments

So Dr Bove ended up by warning that the suggestions Rothman et al made about reducing institutional conflicts of interest affecting professional medical societies, and individual conflicts of interest affecting their leaders would “destroy the best of what we have in our science and industry,” that is, destroy biomedical and clinical science, and lead to nationalization of important forms of medical production. None of that was suggested or implied by Rothman et al. After positing this dire future, Dr Bove then asserted that professional societies ought to be entitled to money from industry limited only by their “professionalism.” Thus, “industry should be able to support unbiased programs aimed at educating physicians and other health care providers about the therapies available for the care of their patients. Professional societies should be able to receive unconditional educational grants to provide up-to-date information to their members on medical therapies.” Furthermore, “the proper relationships should allow us to work with industry and allow our professional societies to receive undesignated funds from industry to foster better patient care.” So, Dr Bove wound up where he started, asserting that doctors and professional societies are inherently virtuous, and thus should be trusted to do whatever they think is right, without any external scrutiny or accountability. Yet he never demonstrated the virtue of the ACC under his leadership, or of PMAs in general, or showed why they should be trusted.

Why did the president of one of the nation’s most important medical associations publicly make such poor arguments to support his organization's current financial relationships with health care corporations? I can only speculate, but there may be some clues found by looking at what is publicly known about the current relationships of the ACC and its leaders to health care corporations.

Publicly Disclosed Relationships Among the ACC and Its Leaders and Health Care Corporations

My sources for these clues were a report on the ACC web-site on its relationships with health care corporations (through 2007), and the form 990s that the ACC is and the highly related ACC Foundation are required to file with the US Internal Revenue Service. (The form 990s are publicly available from GuideStar with a free membership. The ACC form is here, the ACCF, here.)

Perhaps unsurprisingly, it turns out that the ACC gets a large proportion of its income from industry. In 2007, it acknowledged receiving $35,882,095.15 from industry. The largest categories of industry support were "promotional/quality program support," $12,664,650; "charitable contributions," $7,603,639; and "exhibits" at meetings, $7,318,807; and "educational grants," $5,084,600. The total revenues of the ACC (which include the ACC Foundation), were $94,560,000, so that industry support accounted for 38% of total revenue. These figures should be compared to the revenue the society received from membership dues (found on its 990 form), $11,995,056, and the income it claimed from its annual scientific session, $8,400,632. So to put it another way, the ACC got about three times as much money from industry as it got from its members' dues, and almost twice as much money from industry as it got from dues and its annual meeting combined.

So were the suggestions made by Rothman et al to be implemented by the ACC, it would stand to lose at least $28 million a year (given that in 2007, about $1 million of its industry revenue was from advertising , and about $ 7.3 million was from exhibits at meetings.)

The organization's lavish revenues have allowed it to pay its full-time managers very well. In 2007, its CEO received $534,452 in total compensation; its general counsel, about $394,000; and its CFO, about $336,000. It seems obvious that were the organization to foreswear industry revenue, the organization's top full-time managers would be unable to continue to live in the style to which they are now accustomed to.

In addition, the organization's form 990 reveals that it pays its supposedly voluntary officers and some of its trustees substantial amounts as well. In 2007, it paid its president $147,750; its president-elect, $80,000; its two immediate past presidents, $79,500 and $70,000; its vice president (at that time, Dr Bove), $63,751; its treasurer, $32,500; its secretary for the board of governors, $52,500; its board of governors chair-elect, $25,000; its immediate past board of governors chair, $25,000; and some trustees amounts from $1000 to $20,520.

To my knowledge, it is unusual for a professional society to pay salaries to its voluntary officers (as opposed to full-time, hired managers.) However, given that the ACC does, it seems that were the organization to foreswear industry revenue, its officers' personal income might be threatened to some extent.

Finally, Dr Bove has his own personal financial relationships with industry. Some were disclosed because of his role on ACCs Cardiosource editorial board, including "Consultant Fees/Honoraria: Insight Telehealth Inc,""Research/Research Grants: Astella Pharma, INC," and "Royalty Income: Elsevier." In addition, in a 2008 article(3), he disclosed receiving speakers fees from Medical Seminars, Inc, and serving as a consultant to Vasocom Inc. For a 2009 conference, he also disclosed "modest" equity interests in Cardiovascular Therapeutics, and Merck.

So, in summary, it seems that the ACC gets a very substantial portion of its revenue from health care corporations, and that were it to carry out the suggestions of Rothman et al, it would lose much of that revenue. Thus, it is not surprising that ACC leadership would take exception to Rothman and colleagues' point of view. This is not the first time that an ACC president has defeneded the organization's dependence on industry funding (see post here). However, as I said in that post,

My questions are how could a society which requires such a substantial proportion, 38% of funding from commercial sponsors ignore the preferences of the sponsors for particular topics and content areas? How could such a society dare to allow criticism of the sponsors, their products, or their activities? Knowing that the society is dependent on this level of support, could society leaders really hold industry representatives at arms' length? Knowing that industry supplies more than one-third of their salaries, would society staff really keep industry outside of some bureaucratic, but not concrete 'firewall?'

In addition, it now seems the ostensibly voluntary officers of the ACC may have a personal stake in the ACCs receipt of health care corporate funding, since it is the apparent policy of the organization to pay these officers five- and six-figure salaries. Dr Bove did not disclose this apparent conflict of interest, nor did he disclose his other personal financial relationships with industry. As we have noted before, people with conflicts of interest tend to have trouble making coherent, logical and evidence-based arguments for positions related to their conflicts. As Joe Collier wrote in the BMJ, "people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult. "(4)

In any case, a previous ACC president wrote about the importance of "disclosure" and "transparency" in dealing with conflicts of interest. Whether disclosure of conflicts is sufficient to manage them, at least Dr Bove could have done the courtesy of disclosing that he is actually a salaried employee of the ACC, and disclosing his personal financial relationships with industry so that readers could try to evaluate how these financial entanglements might have affected what he wrote.

Summary

In conclusion, the first published rebuttal of Rothman and colleagues' suggestions for ensuring the independence of professional medical associations from outside vested interests was not based on evidence, but on logical fallacies rather than clear reasoning, and failed to disclose its authors' relevant financial relationships. We will see if anyone can make a better attempt.

ADDENDUM (17 July, 2009) - see additional comments by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

ADDENDUM (22 July, 2009) - see this post on the Cardiobrief blog, which alludes to the post above, but also discusses an interesting response by the CEO of the ACC to the Rothman paper, and adds original commentary on larger issues.


References

1. Rothman DJ, McDonald WJ, Berkowitz CD et al. Professional medical associations and their relationships with industry. JAMA 2009; 301: 1367-1372. (Link here.)
2. Bove AA. President's page: relations with industry: thoughts on claims of a broken system. J Am Coll Cardiol 2009; 54: 177-179. (Link here.)
3. Somers VK, White DP, Amin R et al. Sleep apnea and cardiovascular disease: an American Heart Association/ American College of Cardiology Foundation scientific statement from the American Heart Association Council for High Blood Pressure Research Professional Education Committee, Council on Clinical Cardiology, Stroke Council, and Council on Cardiovascular Nursing. Circulation 2008; 118: 1080-1111. (Link here.)
4. Collier J. The price of independence. Br Med J 2006; 332: 1447-9. (Link here.)

Computers will make this all work ... and my name is Rasputin

Only politicians could come up with something like this:

(click to enlarge)

... and, mesmerized, Rasputin style, by an IT lobby not shown in the diagram, believe computers could not only make it all work, but could save hundreds of billions of dollars over what we have in place now.

Such beliefs are madness incarnate.

-- SS

A Window on the Unworkable Settings in Which Physicians Practice

The Annals of Internal Medicine just published an important problem that helps explain why our health care crisis is so intractable. (Linzer M, Manwell LB, Williams ES, Bobula JA, Brown RL, Varkey AB et al. Working conditions in primary care: physician reactions and care quality. Ann Intern Med 2009; 151: 28-36. Link here.)

The article arose from the MEMO (Minimizing Error, Maximizing Outcome) study. The study included an initial cross-sectional survey and then longitudinal follow-up of 422 physicians, roughly equal numbers of family practitioners and general internists, in 119 different ambulatory settings in New York City, NY, Chicago, IL, Milwaukee, WI, Madison WI, and smaller towns in WI. The surveys asked physicians about their work-flow and time pressure, the pace of their practice (from calm to chaotic), their ability to control their own work activities, and five aspects of organizational culture (emphasis on quality, emphasis on information and communication, trust, cohesiveness, and alignment of values between physicians and leaders.)

The results showed how bad the practice environment in primary care/ generalist practice has become. Some important points were:

- More than half of the physicians (53.1%) said they needed more time to do physical examinations, and nearly half (47.6%) for follow-up visits.
- Almost half (48.1%) described the pace of their offices as chaotic.
- Substantial majorities of physicians thought their workplaces' organizational cultures were deficient, if not hostile.
- Only 23.7% thought there was a high emphasis on quality.
- Only 28.2% thought there was a high emphasis on communication and information.
- Only 30.6% thought there was a great amount of trust.
- Only 33.9% thought there was high work place cohesiveness
- Only 14.2% thought there was great alignment between the values of leadership and physicians.

So, to summarize, many physicians thought they did not have enough time to take care of each individual patient. Most thought their workplaces were nowhere near calm, and nearly half thought they were chaotic. Few thought that their workplaces emphasized quality or communication and information, or inspired trust or cohesiveness. Very few thought that their leaders' values were aligned with their professional values.

This blog has focused on problems with the leadership and governance of health care organizations. We have discussed leadership that is:
–Autocratic, or “imperial”
–Insulated
–Uninformed about health care context, indifferent to health care values
–Incompetent
–Self-interested
–Conflicted
–Corrupt
We have shown that the governance of health care organizations may be:
- Unrepresentative
- Unaccountable
- Opaque
- Not Subject to Ethical Standards
and that such governance facilitates and enables bad leadership.

I submit that the study by Linzer et al suggests how bad leadership can make the settings in which physicians practice unworkable. It may be that some of the time pressure that physicians face is due to the perverse incentives built into their pay schedules (e.g., see this post), and bureaucratic demands of insurers and government agencies. A fast paced and demanding environment is one thing, however, and a chaotic envirnoment is another. What else would explain chaotic work environments other than bad organizational leadership? Futhermore, how could well lead organizations ignore quality, and fail to inspire trust and cohesiveness? How could good leaders inspire four-fifths of the physicians to say the leaders of their organizations did not value what they value?

This article strongly suggests that we cannot fix the health care crisis simply by changing financing mechanisms or money flows. We can only improve health care by improving the leadership and governance of health care organizations, and by rethinking the size and scope of health care organizations. The most crucial part of health care is what goes on between individual health care professionals and individual patients. Yet our system is composed of endlessly enlarging bureaucracies run by self-interested, often clueless, and sometimes dishonest, if not criminal leaders. This must change, unless we want this crisis to get much, much worse.