New CMS Chief Donald Berwick: a Trojan Horse for Quackery?

On July 7, President Obama appointed Dr. Donald Berwick as Administrator of the Centers for Medicare and Medicaid Services (CMS). Dr. Berwick, a pediatrician, is well known as the CEO of the non-profit Institute for Healthcare Improvement (IHI), which "exists to close the enormous gap between the health care we have and the health care we should have — a gap so large in the US that the Institute of Medicine (IOM) in 2001 called it a 'quality chasm'.” Dr. Berwick was one of the authors of that IOM report. His IHI has been a major player in the patient safety movement, most notably with its "100,000 Lives Campaign" and, more recently, its "5 Million Lives Campaign."

Berwick's CMS gig is a "recess appointment": it was made during the Senate's July 4th recess period, without a formal confirmation hearing---although such a hearing must take place before the end of this Senate term, if he is to remain in the position. A recent story suggested that Obama made the recess appointment in order to avoid a reprise of "last year's divisive health care debate." The president had originally nominated Berwick for the position in April, and Republicans have opposed "Berwick's views on rationing of care," claiming that he "would deny needed care based on cost."

A "Patient-Centered Extremist"

If there is a problem with the appointment, it is likely to be roughly the opposite of what Republicans might suppose: Dr. Berwick is a self-described "Patient-Centered Extremist." He favors letting patients have the last word in decisions about their care even if that means, for example, choosing to have unnecessary and expensive hi-tech studies. In an article for Health Affairs published about a year ago, he explicitly argued against the "professionally dominant view of quality of health care":

I think it wrong for the profession of medicine—or any other health care profession, for that matter—to “reserve to itself the authority to judge the quality of its work.” I eschew compromise words like “partnership.” For better or worse, I have come to believe that we—patients, families, clinicians, and the health care system as a whole—would all be far better off if we professionals recalibrated our work such that we behaved with patients and families not as hosts in the care system, but as guests in their lives. I suggest that we should without equivocation make patient-centeredness a primary quality dimension all its own, even when it does not contribute to the technical safety and effectiveness of care.

A new definition. My proposed definition of “patient-centered care” is this: The experience (to the extent the informed, individual patient desires it) of transparency, individualization, recognition, respect, dignity, and choice in all matters, without exception, related to one’s person, circumstances, and relationships in health care.

Does this mean that Dr. Berwick would also eschew professional, i.e., expert, judgment in favor of patients' wishes? In a word, yes:

Evidence-based medicine sometimes must take a back seat. First, leaving choice ultimately up to the patient and family means that evidence-based medicine may sometimes take a back seat. One e-mail correspondent asked me, “Should patient ‘wants’ override professional judgment about whether an MRI is needed?” My answer is, basically, “Yes.” On the whole, I prefer that we take the risk of overuse along with the burden of giving real meaning to the phrase “a fully informed patient.”

Dr. Berwick is not so naive as this opinion might suggest. He envisions a "mature dialogue" in such a case, and argues that "if, over time, a pattern emerges of scientifically unwise or unsubstantiated choices...then we should seek to improve our messages..." He also admits that there might be an occasional patient whose demands are so unreasonable that "it is time to say, 'No'." That exception, he argues, should not dictate the rule.

There are situations in which most civilized people would agree with Dr. Berwick's view of 'patient-centeredness'. In both the Health Affairs article and in his recent address to the 2010 graduating class of the Yale School of Medicine, he offered real examples of petty, arbitrary hospital rules causing unnecessary sorrow for patients and their loved ones. It is in such contexts that he makes a convincing case that health professionals ought to behave "as guests in their lives." In an interview for the New York Times, he argued:

We don’t have a standard of services or processes that are comfortable for patients. We have built a technocratic castle, and when people come into it, they are intimidated.

Nothing to disagree with there. To create that standard, moreover, would not undermine settled medical practice ethics---it would celebrate them, even as it rightly embarrasses the profession for having taken so long to do so.


Enter the Woo

Eschewing the scientific basis for modern medical practice, however, is another matter. In February of 2009, Dr. Berwick gave a 'keynote' address at the IOM and Bravewell Collaborative-sponsored Summit on Integrative Medicine and the Health of the Public. He shared the podium with Mehmet Oz, Dean Ornish, Senator Tom Harkin, and other advocates of pseudoscientific health claims. I wrote about the conference at the time, mainly to call attention to its misleading use of the term "integrative medicine": literature emanating from the Summit characterized it as "preventive" and "patient-centered," whereas the only characteristic that distinguishes it from modern medicine is an inclusion of various forms of pseudomedicine.


I noticed that Dr. Berwick was on the speaker roster, which I found disappointing: I imagined that he had either gone over to the Dark Side or, perhaps, was sufficiently naive about the topic to have been duped; or, more likely, that he had cynically accepted the offer to further his ambitions. I didn't bother to listen to his speech until the CMS appointment was announced a few days ago.

It is troubling, to say the least. Dr. Berwick did not argue, as he had in the NYT piece, that "If we doctors feel a person is going to make unwise choices, we have to take on the responsibility of being teachers, educators and informers." Rather, he praised his fellow speakers, most of whom were spouting nonsense, for their "reach" and "eloquence." He praised the IOM for its "glorious record...in pursuit of better designs in health care...traditional, allopathic curative care and now migrating into this distinguished and important new arena." He mentioned homeopathy and acupuncture, not to wonder why they should be promoted as effective, but merely to warn that they will fail---presumably in some economic sense---if they try to compete with each other for reimbursement.

Such language, and Dr. Berwick's very presence at the Summit, were a far cry from advocating "patient-centeredness." What they amounted to was a generous endorsement of pseudoscientific practices and of the socio-political movement that promotes them. Even granting some naivete on his part (he called himself "an amateur at this topic"), he must have known this. Such an endorsement, unlike tearing down the "technocratic castle," has ethical implications at least as profound as those that Dr. Berwick tacitly or explicitly relies upon to support his arguments for patient-centeredness.

"Physicians have no Immunity to Moral or Ethical Constraints"

The relevant medical ethics treatises (reviewed here) are in substantial agreement that it is unethical for physicians to prescribe scientifically implausible methods or to refer patients to other practitioners for the same purpose. They are also in agreement that it is unethical to prescribe a placebo to a patient while claiming that the treatment has specific biologic activity---a point that has been vigorously argued in the UK this year, with regard to homeopathy. These ethical tenets are not mere odes to nerdy, sciency thinking; they are matters of honesty and integrity---fundamental bases for ethical interactions between physicians and patients.

In 1983, philosophers Clark Glymour and Douglas Stalker published an article in the New England Journal of Medicine titled “Engineers, cranks, physicians, magicians.” They framed modern medicine as follows, comparing it to what was then called "holistic medicine" (the article is quoted extensively here):

Medicine in industrialized nations is scientific medicine. The claim tacitly made by American or European physicians, and tacitly relied on by their patients, is that their palliatives and procedures have been shown by science to be effective. Although the physician’s medical practice is not itself science, it is based on science and on training that is supposed to teach physicians to apply scientific knowledge to people in a rational way.

The practice of medicine in the United States and in other industrialized nations is a form of consultant engineering...

That statement is just as accurate now---even more so, in this era of Evidence-Based Medicine---as it was nearly 30 years ago, even if some might find the likening of medicine to engineering displeasing. Nor is it at odds with almost any definition of "patient-centeredness," other than one that presumes that the patient's desires trump the physician's ethics:

A physician engineer can act as consoler; nothing in either logic or social psychology forbids it. But certain combinations are impossible or extraordinarily unlikely. A physician engineer cannot honestly claim powers of magic or occult knowledge. The principles governing scientific reasoning and belief are negative as well as positive, and they imply that occult doctrines are not worthy of belief. Moreover, physician engineers have no immunity to moral or ethical constraints. On the contrary, they are by training and by culture enmeshed in a tradition of rational thought about
the obligations and responsibilities of their profession.

Dr. Berwick---if he really believes what his presence and words at the "Integrative Medicine" Summit imply---is playing with ethical fire. (If, as I hope, he doesn't really believe those things, he's playing with ethics of another kind). Will we begin to see pseudomedicine "integrated" into Medicare and Medicaid? That is certainly the expectation of those who observed Dr. Berwick's performance at the Summit, and who appear intent to hold him to his word.

KA

Two other blogs that have addressed this issue are:

Dr. RW: Not only evidence based medicine but science based medicine may take a back seat in Donald Berwick's vision for patient centered care

Dr. David Gorski: Dr. Donald Berwick and “patient-centered” medicine: Letting the woo into the new health care law?

A Source of the Anechoic Effect Discovered: the Public Relations Person in the Room

A series of posts in journalism blogs last month revealed a mechanism used by health care organizational leaders to shape discussion of the issues that affect their interests, but one that is probably unfamiliar to most health care professionals and the public at large.  Let me provide the key quotes in chronological order.

First, from the Covering Health blog of the Association for Health Care Journalism (10 June, 2010):

Have you recently tried to get information from the federal government or arrange an interview with a federal official?

AHCJ’s Right-to-Know Committee is calling on journalists to report their experiences, as part of a continuing effort to pry open the doors of the federal government. We’re looking for recent anecdotes about journalists’ experiences with public information officers, especially at the Department of Health and Human Services and any of the agencies that are part of it (e.g., CDC, FDA, CMS etc.).

Please write to Felice J. Freyer, Right-to-Know Committee chair, at felice.freyer@cox.net, about problems you have encountered, including mandates to clear interviews with the press office, slow responses, refused interviews, burdensome requirements (such as written questions and answers only), extreme time limitations on interviews, PIOs listening in on your conversations, or anything else that made it hard for you to get the information and quotes that you needed in time.

The implication here, of course, is that the committee was concerned that journalists attempting to interview employees and officials of US government health agencies may encounter a variety of problems, including public information officers "listening in on your conversation."

Of course, just because the committee was concerned about a possible problem does not mean the problem exists, or is if it exists, is important.

However, a week later this post appeared in the Covering Health blog (17 June, 2010):

MedPage Today, an online breaking-news service for physicians, today instituted a rule requiring reporters to inform readers whenever a press officer has listened in on an interview.

'If a source’s comments are monitored by a press officer, then the person may not have been speaking freely,' said Peggy Peck, vice president and executive editor. 'That’s information readers should have.'

Peck instructed her staff to use phrases like 'said in a telephone interview that was monitored by a public information officer' whenever using quotes from such an interview.

Peck emphasized that a reporter’s goal should be to avoid having a press officer listening to calls or attending face-to-face interviews. 'But if that is the only way a researcher will talk, we need to let our readers know that,' said Peck’s memo to eight reporters.

Peck is a member of AHCJ’s Right-to-Know Committee, and the rule sprang from the committee’s work to end interference by public information officers in newsgathering, especially in the federal government.

'I applaud MedPage Today for taking this step and encourage reporters and editors everywhere to follow suit,' said Felice J. Freyer, chair of the Right-to-Know Committee and a member of AHCJ’s Board of Directors.

'Reporters have come to accept the presence of public relations people at interviews, but it’s really not acceptable. We all know that such eavesdropping hinders the free flow of information – and we need to let our readers know that this is happening.'

Now this is much more clear. Apparently some, maybe most of the information obtained by journalists from interviews of officials and employees of government health care agencies was monitored by public relations people, presumably to keep the interviewees "on message," and remind them not to say anything that did not fit the party line.  Furthermore, such monitoring was not often disclosed by the reports when they wrote about the interview. 

In addition, Paul Raeburn posted this on the Knight Science Journalism Tracker blog:

I’ve long been troubled by the insistence of some 'public' information officers (they are paid to work for their institutions, not the public, although the interests of the two can sometimes coincide) to listen in or sit in on interviews. Even if they don’t say a word, their presence inevitably changes the interview.

Imagine telling colleagues about the last story you wrote, and what you had to do to get it. Now imagine the same conversation with your colleagues while your editor–on whom your livelihood depends–listens in. I don’t imagine myself dissembling in either set of circumstances, but I can certainly imagine myself telling the story a little differently in each case.

The point is not that information officers are always trying to limit or shape the interview, although that clearly happens. The point is not to challenge the integrity of information officers, although, like reporters, some are better at what they do than are others. The point is that the presence of an institutional representative changes the interview. And we owe it to out readers to conduct interviews without that presence whenever possible.

Mr Raeburn seemed to make an effort to be exquisitely polite, but still managed to affirm that the public relations person in the room is a real and important phenomenon in reporting about health care.
This reinforces the notion that monitoring of interviews with journalists by public relations people is common practice, but one heretofore not discussed publicly.  It seems obvious that the point of this practice was to keep the interviewee on message, and to restrain any discussion that might not fit with the public relations persons' bosses interests.

If we did not know about the practice of keeping a public relations person in the room for interviews with people working for the government, it seems likely that we also did not know about similar practices affecting interviews with people in other kinds of health care organizations, e.g., for-profit corporations, and not-for-profit organizations.

We have frequently discussed the "anechoic effect," how important cases, stories, and data about the negative effects of concentration and abuse of power in health care, and about ill-informed, incompetent, self-interested, conflicted, or even corrupt leadership of health care organizations, and the unaccountable, unrepresentative, opaque, and often unethical governance that enables it are often just not discussed, and when discussed, produce few echoes.  Now we see another mechanism that maintains this effect.  Large health care organizations deploy substantial money and personnel to market their products and massage their messages.  These people apparently use a variety of tactics to control the flow of information to journalists.  While journalists seem to be provide much more information about the problems in health care we discuss on Health Care Renewal than professional and academic publications and meetings, we now see one more mechanism that has impeded them from doing so openly and fully.

In my humble opinion, disclosing that interviews were monitored by public relations personnel is one small, but important step in beginning free enquiry into what has gone wrong with health care.  Bravo to the people who have stood up for it. 

Aetna Government Contract Discredited

Last week, the Sacramento Business Journal reported on irregularities in how health insurance/ managed care giant Aetna obtained a contract with the US military health plan Tricare:

Aetna Inc. hired a former high-level Tricare employee with access to proprietary information about Health Net Inc.’s performance that could have given Aetna a competitive edge in its bid for a lucrative military health care contract, the U.S. Government Accountability Office has concluded.

The GAO details six flaws in the procurement process in new documents posted online Tuesday and recommends that Aetna should be excluded from the competition, leaving Health Net 'as the only viable awardee.'

The agency recommends Tricare officials perform a thorough review of what sensitive information the former Tricare employee had access to and decide what action to take to address the problem. The GAO also recommends that Health Net be reimbursed the cost of filing the protest, including attorneys fees.

The Business Journal described the details of the irregularities:

The GAO decision pointed to six flaws in the in the bid evaluation process, including:

* The agency credited Aetna with past performance of its parent and corporate affiliates but did not record which entities were involved or establish the roles they would play in the contract
* The evaluation gave Aetna the highest past performance rating without considering that its past performance was small compared with the size of the Tricare contract
* The price evaluation did not consider whether Aetna’s proposed staffing reflected a lack of understanding of the technical requirements of the contract — or showed a willingness to take a risk on the business
* The agency failed to consider the risk involved with Aetna’s proposed plan to hire large percentages of Health Net’s work force at lower pay rates
* The agency did not consider Health Net’s network provider discounts when assessing its pricing information for the program and
* The agency failed to protest Aetna’s hiring a former Tricare official with inside knowledge of Health Net’s performance on the previous contract.

'The contracting officer never considered the matter — because the awardee did not bring it to his attention— and the record shows that the individual had access to non-public proprietary information,' the decision states.

The Montgomery Advertiser added:

Though it doesn’t allege that procurement integrity law was broken, the GAO said contracting agencies like TMA have an obligation 'to avoid even the appearance of impropriety' in government procurement. This time it failed.

It's been only about nine months since we discussed legal or regulatory issues for Aetna.  In February, 2009 we discussed its settlement of accusations it underpaid claims in part through its use of a now discredited database marketed by Ingenix, a subsidiary of its supposed competitor, UnitedHealth Group.

Aetna boasts that it is

Helping to manage health care, one of the most important things in life

We believe we can help create a better health care system. This belief drives our daily decisions as one of the nation's leading health care benefits companies. We work hard to provide our members with information and resources to help them make informed decisions about their health.

Furthemore, it boasts of its mission

We help people achieve health and financial security by providing easy access to cost-effective, high-quality health care. And we continue to be a leader in building a stronger, more effective health care system by working with doctors, hospitals, employers, patients, public officials and others.

It seems one way in which Aetna works with public officials is to hire those that might have some inside knowledge of specific government contracting processes, and then take advantage of that to boost their chances of obtaining lucrative contracts, if I am reading the summary of the GAO findings correctly. 

Maybe most people have grown cynical about health care organizations', especially commercial health care insurance companies' mission statements, and may dismiss them as marketing fluff, if not complete balderdash.  However, to improve health care quality while controlling costs, facilitating access, and restoring professionalism, would be health care reformers need to make health care organizational leaders live up to their noble-sounding proclamations of corporate social responsibility. 

BLOGSCAN - More on Senate Hearings on Industry Funded CME

There has been considerable coverage of the remarkable hearings by the US Senate Special Committee on Aging on industry funded continuing medical education (CME). See reporting by Dr Daniel Carlat on the Carlat Psychiatry Blog, and by the Prescription Project on their Postscript Blog. See also the comments by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog. Some key points were that the Senators failed to see why physicians cannot afford to pay for their own CME, and therefore must depend on corporate funding to support; and the Senators failed to buy the argument that medical progress vitally depends on health care corporations paying for and influencing the education physicians get.

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?

NY State Legislator Pleads Guilty to Selling His Services to Medical Center

We have posted about cases in which hospitals or academic medical centers hired legislators to promote their political agendas. In one case in 2006, a former Rhode Island state legislator pleaded guilty to selling his influence to a local medical center, which submitted to a deferred prosecution agreement, and whose CEO was later convicted of conspiracy and fraud. (This conviction has been appealed.) In another case in 2008, a former New Jersey state legislator was convicted of fraud for selling his influence to a state health care university and academic medical center, which also had been operating under a deferred prosecution agreement.

The latest version of this type of scandal appeared towards the end of last month in the New York Times:

Saying that he knew his 'conduct was illegal and wrong,' a longtime Democratic member of the New York State Assembly, Anthony Seminerio, pleaded guilty on Wednesday to abusing his position by soliciting for himself an amount prosecutors estimated at $500,000.

Federal prosecutors said that for the last decade he traded upon his office, receiving 'corrupt payments' from people or organizations that had business before the state and sometimes threatening those who resisted his requests for money.

The payments were funneled into a company called Marc Consultants that Mr. Seminerio created to hide the income, prosecutors said.

Mr. Seminerio told Judge Naomi Reice Buchwald in Federal District Court in Manhattan that one of the organizations that paid him for wielding his political influence was Jamaica Hospital Medical Center, in Queens. It was the first public mention of Jamaica Hospital, which before the hearing had been referred to in court papers merely as 'a hospital in New York City.'

Appearing before the judge around noon on Wednesday, Mr. Seminerio, unshaven but wearing a blazer and a tie, declared in a firm voice that he was guilty of the charge of honest services fraud. In a brief statement he acknowledged that on July 10, 2008, he 'promoted the interests' of Jamaica Hospital in connection with state business and did not divulge that he had received payments from the hospital.

'My conduct had the effect of depriving others of honest services,' he said. Prosecutors stated that the hospital had paid Marc Consultants about $310,000 and that 'a separate, Medicaid-managed health care plan' affiliated with the hospital paid another $80,000. At the request of hospital officers, prosecutors said, Mr. Seminerio acted as an advocate with legislators and lobbied on their behalf with executive branch officials.

A criminal complaint states that on numerous occasions Mr. Seminerio 'took action in his capacity as a member of the Assembly to benefit the hospital at the same time that he was receiving payments from the hospital.'

The complaint also details recorded conversations in which hospital officials asked Mr. Seminerio to intervene in state budget decisions and in which Mr. Seminerio urged a Health Department official to help Jamaica Hospital take over another hospital.

There once was a time when health care was a calling, and when hospitals were considered charitable organizations which served the sick, and often the poor. Health care professionals and institutions were once held to a higher standard than, say, those who collected the garbage.

Jamaica Hospital Medical Center still proclaims its mission to be:

To serve our patients and the community in a way that is second to none

It is not clear how that squares with "corrupt payments" to a state legislator.

In my humble opinion, for health care to resolve its current crises, it will have to again be held to a higher standard. If we do not challenge the pervasive conflicts of interest within and across health care, and the outright corruption that has infected many health care institutions, none of the proposed manipulations of health care financing will make much of a dent in ever rising costs, declining access, or degrading quality.

But for this to happen, health care professionals and policy leaders will have to acknowledge how low the current standards are. As long as cases like those noted above are mentioned only in the local news media, but are not subjects for polite conversation in professional and policy venues, many will be able to cling to the illusion that things are not so bad.

Hospital Board Members with "the Juice" in New Jersey

We recently commented on the conviction of a state legislator charged with selling his influence to a powerful local medical center. NorthJersey.com has a follow-up on this story which shows how health care leaders are often members of the power elite, if not quite of the superclass, and how their machinations put this group's interests ahead of the mission of their health care organizations.


The General Overview

The trial of former state Sen. Joseph Coniglio, convicted in a bribery scandal involving Hackensack University Medical Center [affiliated with UDMNJ, which has had its own issues, e.g., here], exposed the hospital’s reach into the State House — and put a spotlight on the wealthy, influential men who serve as the hospital’s power brokers.

Hackensack’s board members have connections and political muscle that extend far beyond the hospital. At black-tie fund-raisers and dinners at board member Joseph Sanzari’s Stony Hill Inn, business — hospital and otherwise — is on the agenda.

Various board members help to underwrite Bergen County’s Democratic machine and powerful lawmakers in Trenton. They’re awarded many of the region’s public construction contracts. They have the network — and the money — to smooth over zoning issues for the hospital. Testimony at the trial this month showed they supported the hiring of Coniglio, who was convicted of steering millions in grants to Hackensack while on the hospital’s payroll.

'A political machine' is how Assistant U.S. Attorney Thomas R. Calcagni described the hospital as he told jurors about Hackensack’s relationships with former acting governor and Senate President Richard Codey, state Sen. Paul Sarlo, Coniglio and others during the trial.

Board Members' Self-Dealing

There are several results. One is that "some [board members] are also making money off the hospital." The article gave several examples of such conflicts of interest.

A few examples from the hospital’s federal tax filings for 2007, the latest available:

* Companies owned by Sanzari and Creamer are building a 975-car garage as part of the $135 million cancer center now under construction. Creamer was paid more than $475,000 by the hospital for construction services.

* The hospital paid more than $2 million to Progenitor Cell Therapy, a private stem cell research company owned in part by Ferguson; Dr. Andrew Pecora, director of the cancer center; board members Peter C. Gerhard, George T. Croonquist and Samuel Toscano Jr.; and the hospital’s chief operating officer, Robert C. Garrett.

* The hospital paid $2.5 million to lease space from Sanzari 2001, where board member David Sanzari — Joseph’s cousin — is a managing member with an ownership stake. It also spent $68,000 at the Marriott at Glenpointe hotel, which is owned by David Sanzari’s family.

* The DeCotiis law firm, one of the most influential in the state, made more than $1 million from the hospital. It is representing the hospital in the Coniglio case and guiding its campaign to reopen Pascack Valley Hospital in Westwood. During that time, Frank Huttle III, a partner, served on the board. He said Friday that he resigned recently.

* Universal Health, which operates a retail pharmacy at the hospital, received $200,000. At the time, Toscano was the company’s chief executive officer.

Political Influence Disadvantages the Competition

The membership of the hospital's leaders in the power elite could be used to advance the hospital against less-connected competitors.

The Coniglio trial served as a primer on the backroom politics of New Jersey, where certain grants, known as 'Christmas tree items,' were doled out based on who has 'the juice.' By all accounts, Hackensack mastered the game and loomed large in Trenton. From 2004 to 2006, the hospital received $17.4 million for its cancer center, an extra $9 million in charity care above the millions it was already getting and $250,000 for the Joseph M. Sanzari Children’s Hospital. A $900,000 research grant was awarded to the private stem cell firm at the hospital and $70,000 went for a seat belt study.

Those awards dwarf the grants given to Hackensack’s competitors.

Connectedness of the Hospital's Board Members

The article gave further examples of how connected were the board members, and how they used their connections.

At Hackensack, a few names — Simunovich, Ferguson, Sanzari, Creamer — keep showing up in influential roles on key boards. They serve as trustees of the Hackensack University Medical Center Foundation, the hospital’s fund-raising arm, as well as the hospital’s board of governors and Hillcrest Health Service System, the hospital’s parent corporation. Leading contractors and developers — Sanzari, Creamer and John C. Fowler — are on the building committee.

Simunovich is the former chairman of the board of governors and current chairman of the board of trustees for the Hackensack University Medical Center Foundation, the hospital’s fund-raising arm.

Governor Corzine did not reappoint Simunovich to the Turnpike Authority in 2007 after he was investigated by the State Ethics Commission; as chairman, he had voted on millions in public contracts that were awarded to Sanzari while he accepted free rides on the contractor’s private jet. Simunovich paid a $50,000 fine, which was not an admission of guilt.

'Mr. Simunovich’s actions do not reflect the standards demanded by the governor for those who serve in his administration,' Corzine’s then-spokesman Anthony Coley said.

Joseph Sanzari serves as first vice chairman, the No. 2 position on the hospital’s board of governors.

Sanzari is part owner of both the Stony Hill Inn in Hackensack and the New Bridge Inn in New Milford, popular hangouts for Bergen County’s political elite. Sanzari, his companies and employees have contributed more than $100,000 to political campaigns and political action committees in the past three years, according to data the company provided to state elections regulators.

Among his top employees is state Sen. Paul Sarlo, also the mayor of Wood-Ridge. Sarlo oversees billions in public spending as a lead member of the Senate Budget and Appropriations Committee. As chairman of the Senate Judiciary Committee, he also controls key appointments to state agencies that have awarded millions in contracts to Sanzari’s firms.

Sarlo, chief operating officer for Sanzari’s construction company, testified at the trial that he was largely responsible for getting the $900,000 grant for the hospital’s cancer center. He said he also lobbied Codey for the $9 million cancer center grant and played a role in the $900,000 grant for stem cell research at the hospital.

Conclusions

Hospitals often have sterling reputations within their communities as selfless organizations devoted to improving the health of the people. As we have noted, hospitals and other health care organizations have come to be run more often by people with managerial background than those with health care experience. Not-for-profit hospitals have boards of trustees who are supposed to exercise stewardship, making sure the organization upholds its mission. But as we have noted before, e.g., here, boards of health care and related organizations may put their own agendas ahead of the mission. Furthermore, boards of big hospitals and other health care organizations seem to be increasingly composed of the well-connected, often to the point that they can be regarded as members of the power elite, if not the superclass. There may be some short term benefits to having such people on the boards. In the long run, however, is it any surprise that their missions may give way to other interests?

Hat tip to University Diaries.

ADDENDUM (4 May, 2009) - Hackensack University Medical Center's response to the news story discussed above was apparently first to stop advertising in the offending newspaper, and ban its sales in the hospital. Another example, almost laughable, of a health care organization's leadership trying to shoot the messenger, and of how the anechoic effect may be generated. Hat tip to the Schwitzer Health News Blog.

New Jersey Legislator Found Guilty of Fraudulantly Advocating on Hospital's Behalf

Here is the latest story of health care corruption, this one involving a state legislator and a big hospital, as reported by the Newark Star-Ledger,

Former state senator Joseph Coniglio, who funneled more than $1 million in public funding to Hackensack University Medical Center after it gave him a high-paying consulting job, was convicted yesterday on six counts of fraud and extortion.

The jury of seven men and five women, who issued a split decision and were deadlocked on one of the nine counts, found Coniglio guilty on nearly all the charges involving the exchange of money.

The verdict, coming after four days of deliberations, found Coniglio guilty on five counts of defrauding the public and one count of extortion. He was acquitted on two mail fraud counts; the jury said it was unable to reach a verdict on a third mail fraud charge.

Coniglio, a retired union plumber elected to the Senate in 2001, first met in early 2004 with Hackensack University Medical Center's chief executive, John P. Ferguson -- about the time he was appointed to a seat on the influential Budget and Appropriations Committee -- and began negotiating for a $5,000-a-month consulting contract to do work that was never clearly defined. The consulting agreement was signed in May 2004 and Coniglio subsequently began lobbying to help secure a series of grants for the medical center's programs for abused children, its cancer center and children's hospital.

Prosecutors argued the consulting work was simply a guise to pay off Coniglio in exchange for his support for funding millions in special earmarks.

Assistant U.S. Attorney Rachael Honig, who agreed the case was circumstantial, told jurors corruption is secret and there is never a roadmap to detail it. 'People don't get paid to do nothing,' she said.

No hospital officials were charged, but one medical center executive had negotiated a non-prosecution agreement in exchange for testimony.

Note that this case is very similar to one in my state of Rhode Island. In that case, both a state legislator and a hospital CEO have been found guilty. (The CEO was just sentenced, as reported here in the Providence Journal.)

These cases are a reminder of the prevalence of out and out corruption in US health care. Indeed, Transparency International's 2006 Global Corruption Report argued that health care corruption is common throughout the world, in nearly all countries, regardless of their wealth, or the organization of their health care systems. Corruption misdirects health care resources, raising costs for all, and indirectly leads to restricted access to care. I submit that the corruption of people with decision making power in health care likely taints all their decisions, often to the detriment of patients and health care professionals.

Although not all health care corruption is discovered and successfully prosecuted, even those cases that result in convictions are often anechoic. If we cannot even talk about health care corruption, how are we ever going to do anything about it? But if we are not resolved to at least confront corruption, should we be whining about increasing costs, and declining access and quality?

Open letter to Sen. Baucus on Health IT

Dear Sen. Baucus,

I respectfully offer you the following information in the hope that it will improve your efforts towards healthcare reform, enabling better healthcare for all.

From the WSJ, Nov. 24, 2008:

SEN. BAUCUS: Everybody talks about health IT. We all know we need it. It hasn't happened. Why? Partly because we're America. We're not a single-payer system like the UK, which can say, you hospitals, you have to put this in because we're paying your bills.

Indeed, that was said to the UK's hospitals. It has worked out to date - to put it politely - poorly.

The UK's results to date, after the expenditure of billions of dollars ...

(and an ironic dependence on an American health IT company, Cerner; see "Big Problems Hit Royal Free's Cerner Records Roll-out" and "Milton Keynes' Care Records System Caused Near Meltdown" as examples of how that's been working out)

... are at this healthcare renewal posting and include the following results. This is recommended reading for you, Senator Baucus, and our Congress as well:

Bank bailout puts £12.7bn NHS computer project in jeopardy

John Carvel, social affairs editor
The Guardian, Wednesday October 29 2008

The future of the NHS's £12.7bn computer programme was in doubt last night after its managers acknowledged further delays in introducing a system for the electronic storage and transmission of patients' records.

Connecting for Health, the NHS agency responsible for the world's biggest civil IT project, said it was no longer possible to give a date when hospitals in England will start using the sophisticated software that is required to keep track of patients' medical files.

Christine Connelly, the Department of Health's recently appointed head of informatics, is understood to be reviewing whether the programme is a cost-effective way of improving the quality and safety of patient care.

She will have to find compelling arguments to stop the Treasury earmarking health service IT as a candidate for cuts to compensate for the billions spent on the bailout of the banks. However, the high cost of cancelling contracts with IT suppliers may be a factor saving the programme from cancellation.

In May the National Audit Office said the project was running at least four years late, but still appeared to be feasible. It has since been beset by a series of further setbacks.

The agency fired Fujitsu, the contractor responsible for building the patient record system in the south of England. It asked BT to take over the work, but has not yet agreed a price.

In London, attempts to install the system at the Royal Free hospital and Barts caused weeks of confusion and disruption. Other trusts that were next in line were so alarmed that they pleaded for postponement.

In the north, the first installation of the Lorenzo version of the software at Morecambe Bay was repeatedly delayed.

Sanator Baucus, if health IT is "easier" in the UK due to their being single payer, then heaven help the U.S. in such efforts.

You might also read my post "Should The U.S. Call A Moratorium On Ambitious National Electronic Health Records Plans?" for much more on this issue.

Back to the WSJ quoting you:

SEN. BAUCUS: But we're America. We're going to find our solution. We need to work with appropriate bodies to develop interoperable standards, then give incentives to providers so they can put the IT systems in.

I dearly wish it were that easy to "put the IT systems in." I dearly wish that standards and incentives were the sole missing links. Unfortunately, the reality is far different, as thirty-plus years of informatics research has shown.

Sen. Baucus, I invite you and your staff to increase your awareness of Biomedical Informatics. In doing so you will learn that the call for "interoperability" of health IT may be setting our sights impractically high, and that what's more needed and attainable is aggregatability of intelligently selected data elements into a national repository.

The repository can then be used as an "executive radar" and is far easier to accomplish (and already has precedents on a smaller scale) then full interoperability among a menagerie of competing HIT products from myriad strong-minded "our way is best" vendors.

As to "incentives", you will also learn from sites such as "Common Examples of Healthcare IT Difficulties" and courses such as "Organizational and Sociological Issues in Health IT" (Word file) that standards and incentives and the fact that we have a heterogeneous healthcare environment are not the major impediments to HIT diffusion.

People issues and leadership by HIT "amateurs" (those lacking formal education and credentials in the subspecialty of clinical computing) trump all other issues, as in any area of technology. You might review the article "Electronic Medical Records - Not for Amateurs" starting on page 21 of the PDF file here.

I fear, however, that Congress subscribes to the procrustean, reactionary, IT industry-enriching, Intel-Craig Barrett "if it works for my horses it will work great for people" belief that clinical computing is just another brand of business computing, and that it's fine to further burden primary care physicians in their fifteen minutes per patient with hard-to-use IT where user interaction design was an afterthought.

The very same IT that may then cause - through overly simplistic, biased or defective P4P formulas and metrics - the diversion of hard-earned money from clinicians' pockets to the payers' purse.

In which case, good luck with a national efforts at HIT.

You and the rest of Congress would need it, as physicians would rightly apply active and passive aggression and other measures to sabotage and sink ill conceived and poorly implemented HIT initiatives led by amateurs.

And if the leadership for a U.S. national health IT initiative remains typical of other flavors of IT, with its high rates of difficulty and failure, I could not condemn U.S. physicians in that regard.

Worse, Sen. Baucus, as per the European Federation for Medical Informatics (EFMI) Working Group for Assessment of Health Information Systems, you should be aware that bad informatics can kill.

Finally, everyone on your staff and in Congress should read this article from Down Under:

Pessimism, Computer Failure, and Information Systems Development in the Public Sector. (Public Administration Review 67;5:917-929, Sept/Oct. 2007, Shaun Goldfinch, University of Otago, New Zealand).

Cautionary article on IT that should be read by every healthcare executive documenting the widespread nature of IT difficulties and failure, the lack of attention to the issues responsible, and recommending much more critical attitudes towards IT. link to pdf

It tells a cautionary tale to counterbalance the irrational exuberance over IT that seems to have taken hold in our society, indeed paradoxically accelerating after the great dot-com crash of the early 2000's. (My statement on the exuberance issue is webcast at Government Health IT here.)

Senator, I hope this information is useful and enlightening to you, and helps steer a more informed approach to health IT, so that health IT can succeed in its mission to improve healthcare.

It seems self evident that a defective healthcare system cannot itself be reformed or improved via defective health IT.

-- SS

Update on the NIH “Trial to Assess Chelation Therapy”

(Some of the following is identical to a post on Science-Based Medicine dated 9/26/08.)

A few days ago, while gathering information for a post on Science-Based Medicine about intravenous hydrogen peroxide, I noticed this:

ACAM Supports NIH Decision to Suspend TACT Trial

September 3, 2008, Laguna Hills, Calif. — The American College for Advancement in Medicine, ACAM today announced its support for the National Institute for Health’s (NIH) decision to suspend patient accrual of the Trial to Assess Chelation Therapy (TACT) Trial until allegations of impropriety can be proven false. ACAM believes that the TACT trial represents a important milestone in assessing the role of chelation therapy in modern healthcare and respects the decision of the NIH.

ACAM continue to work with Dr Tony Lamas to answer the unfounded allegations of impropriety.

“We believe that the Office of Human Research Protection (OHRP) will find that the allegations are of a political nature. To serve the best interests of participants enrolled in the TACT trial and all patients and their physicians who seek answers about chelation therapy, we call for a swift end to the moratorium and resumption of the trial,” said Jeanne Drisko, MD, President of ACAM.

I alerted a few others, including Stephen Barrett of Quackwatch, who queried the news room of the National Heart, Lung and Blood Institute (NHLBI: the joint sponsor, along with the NCCAM, of the trial) and got this reply:

The investigators and institutions performing the Trial to Assess Chelation Therapy (TACT), in conjunction with their Institutional Review Boards, have temporarily and voluntarily suspended enrollment of new participants in the study. NIH has not issued any announcement or press release about this action. To contact the Office for Human Research Protections’ (OHRP) press office, call Pat El-Hinnawy, (202) 253-0458.

The “allegations of impropriety” mentioned in the ACAM press release had been made by my co-authors and me in a comprehensive article previously introduced on Health Care Renewal here. The article is available in its entirety here. In June, we made a formal complaint to the federal Office of Human Research Protections (OHRP), citing that article and additional information posted on Science-Based Medicine here. That our complaint was the instigating factor for the recent “decision to suspend patient accrual” is suggested by an email that I received last week:

I would like to know who is paying you guys off. Finally we have a chance to assess Chelation therapy and put the issue to rest and to find out whether or not it really works and you bozos screw it all up. I know that the trial was stopped and it is your fault. What are you afraid of? Why are you not decrying all of the injuries caused by medications and unnecessary surgeries? Why are we the citizens of the US deprived of a trial of EDTA so that we can judge for ourselves?

Anyone who is a thinking man, can only be disappointed in you. [sic]

Binyamin Rothstein, D.O.

Rothstein, unlike many of his fellow ACAM members, does not appear to be a TACT investigator. Like them, however, he touts chelation, intravenous hydrogen peroxide, and other baseless and dangerous treatments. He has harmed patients, his protestations nothwithstanding. His medical license was revoked in 2005, but that hasn’t hindered him from using smoke and mirrors in his relentless pursuit of profit from nonsense. He’s even managed to promote himself to the public without revealing key items from his resumé—one of the many reasons that even the most diligent regulation can’t always protect the public from scoundrels.

At least two reporters have recently covered the story (here and here). They mostly get it right. The AP report, however, states that chelation "is mainly used to treat lead poisoning." That is not technically false, but is misleading because disodium EDTA (Na2EDTA), the drug used in the TACT, has never been approved for lead poisoning and is considerably more dangerous than calcium EDTA, the drug that is so approved. Ironically, one of our objections to the TACT is that its literature---including protocols, consent forms, and subject recruitment pitches---conflates the two drugs so as to make the study drug appear safer than it is.

Indeed, the FDA has recently withdrawn its approval of Na2EDTA, citing "important safety information" and the possibility that it may be confused with the less dangerous CaEDTA:

As noted in the January 16, 2008, Public Health Advisory, there have been cases where children and adults have died when they were mistakenly given edetate disodium instead of edetate calcium disodium (calcium disodium versenate) or when edetate disodium was used for indications other than those approved by FDA.

Readers might remember that we at HCR have previously discussed the important distinction between the two EDTA salts, after a 5-year old boy was killed in Pennsylvania when a quack administered Na2EDTA to him as a treatment for autism. At the time a CDC expert was so surprised that anyone would infuse Na2EDTA that she concluded, erroneously, that it must have been a drug error: "a case of look-alike/sound-alike medications." The PA medical board's investigation subsequently confirmed that the practitioner had intended to give Na2EDTA, exactly as we had predicted.

The TACT should now be stopped altogether. Contrary to the ACAM press release, our objections to the TACT are scrupulously documented and not “of a political nature.” They are of a scientific and ethical nature. They will not be proven false, because the evidence for them is overwhelming.

BLOGSCAN - LSD and the Corruption of Medicine

On the Scientific Misconduct blog, Dr AubreyBlumsohn has a series of posts (here, here, and here) about a case he considers a major precursor to some of the problems we often discuss: research misconduct, conflicts of interest, and secrecy involving government, foundations, pharmaceutical corporations, teaching hospitals and medical schools, and doctors. The case is not one I would have thought about in this regard. It is about how the US Central Intelligence Agency (CIA) conducted clandestine testing on uninformed, often civilian subjects of psychedelic drugs such as LSD over 30 years ago, under the MK-ULTRA code-name among others. What is particularly relevant, and not widely known, is how the agency funneled funding through not-for-profit foundations, some generally well reputed; how the funds went to prestigious academic medical institutions; how large pharmaceutical corporations cooperated by providing the drugs; and how much of the research was done by well-known academic physicians and researchers.