More Trouble in the OC: Golden Parachutes for UC Leaders, and "Malfeasance" at UCI

Last month, we posted about two inter-related stories from the University of California (UC) system.

The first was about lavish pay and other compensation given to many top UC administrators, while state support of the system shrunk, and fees paid by students grew. But UC leadership argued that high pay was needed to attract top quality executives.

This rationale was challenged by the second story, about the collapse of the University of California - Irvine (UCI) liver transplant program, amid charges of mismanagement. That campus, of course, was lead by highly paid executives at the time.

In the last month, local newspapers have followed up on both stories, providing yet more details about just how well UC leaders were recompensed, with as little public notification as possible; and about just how badly UCI was mismanaged, despite the excellent compensation of its leaders.

UC Pay and Perks

More stories surfaced about favorable treatment of particular UC managers.

• Former UC - Davis Vice Chancellor Celeste Rose was asked to resign. When she threatened to sue for race and gender discrimination, the university quickly agreed to a settlement entitling her to two years of salary ($205 K per year), and other payments totalling nearly $500 K. Yet despite policies that the UC Regents must approve settlements worth more than $250 K, or salaries over $200 K, the Regents were never told of these arrangements (per the San Francisco Chronicle).
• Former UC Provost MRC Greenwood was charged with violating conflict of interest policies by hiring Lynda Goff, a friend and business partner, first as an executive assistant, then in academic affairs at a salary of $192 K. In addition, Winston Doby, UC Vice President for Student Affairs, who reported to Greenwood, hired Greenwood's son into a specially created internship position. When these events came to light, the university launched an investigation, but permitted Greenwood to resign her administrative position before it was completed, agreeing to give Greenwood 15 months of leave at her $ 301 K salary (per the San Francisco Chronicle).
• In 1993, UC policy required the Regents to approve paid leaves for more than three months granted to top administrators after they left their jobs. In 1994, then UC President Jack Peltason promised to completely stop awarding year long paid vacations to departing administrators. Yet UC again began awarding paid leaves upon departure in 2003. In the past 13 months, in addition to the cases above, former UC - Berkeley Chancellor Robert Bardahl and former Lawrence Berkeley National Laboratory Director Charles Shank were awarded prolonged leaves at more than $300 K each per month. Former state Senator Quentin Koop, who tried to put an end to paid leaves, responded, "It's a betrayal. You can't depend on the probity of university leaders." State Senator Abel Maldonado (R - Santa Maria) said, "This perpetual lack of transparency needs to end." (per the San Francisco Chronicle).

The Los Angeles Times wrote,

UC is far too inclined to use public money as a slush fund - and ... it will take more than a legislative committee or even the outside audit that UC is finally launching to fix matters.
When revelations first arose this fall about millions of dollars in perquesites given to UC administrators, this page cautioned that though they should be thoroughly investigated by an outside body, running a prestige university is costly and most of the expenses might be justified. That's still true. But these early examples show that UC administrators have a disquieting tendency to run a loose ship, and run it by their own, rather than state or university rules. Such shenanigans hardly enhance the universities' prestige. Furthermore, UC President Robert C. Dynan has strenuously resisted closer oversight or public transparency.
It will take sustained, outside scrutiny of UC - by auditors hired by the Legislature, rather than the regents - to remind UC executives that they are accountable to the public for each costly decision.

The Mess at University of California - Irvine

Meanwhile, the problems at UCI continued to demonstrate that lavish compensation of UC executives has not bought superlative performance.

A Los Angeles Times investigation revealed how hospital leadership permitted the UCI liver transplant service to dwindle to one run by a single, and increasingly embattled surgeon, Dr Sean Cao. Liver transplant services are rated by their outcomes, particularly their overall survival rate. The unit's survival rate was considered to be under the norm. So, "improving the statistics became the mission of the program.... But with so few surgeries, a single death in the operating room could drastically skew the survival rate - a mathematical misfortune of small transplant programs." Therefore, "with so much riding on each operation and so few people to bear the responsiblity, the program was driven to dysfunction by a paralyzing fear of failure, and an obsession for keeping up appearances."

Hospital administrators had been warned by the United Network for Organ Sharing (UNOS) that the program needed to expand, and "both the Dean's office and hospital management appear[ed] to understand." But the program was never enlarged. Similarly, despite recommendations made in 2003 to develop a computerized data base for the program, in 2005 the hospital was still writing a request for proposals to develop the database (per the Orange County Register).

After Dr Cao left, the Los Angeles Times reported that the hospital was only able to secure a part-time liver transplant surgeon. Dr Marquis Hart, based at UC San Diego, 90 miles away, agreed to help. But UCI Medical Center CEO Dr Ralph Cygan "provided false information to keep the unit running." He assured federal regulators "that UCI had recruited a full-time transplant surgeon to revive the program." Government regulators met Cygan and left "with the clear impression that Dr. Hart would be leaving UC San Diego and moving full time to UCI." UCI administrators also told their staff that Hart was key to reviving their program. On their web-site, they said "Dr. Hart is an experienced transplant surgeon who comes to us from UC San Diego Medical Center," without noting that he came to them only about one and a half days a week.

Furthermore, as federal inspectors scrutizined UCI Medical Center, other problems appeared. The center's dermatology program is on academic probation (per the Orange County Register).

And the Register also reported that the leaders of the Center's cardiology division, Dr Jagat Narula and Dr Mani Vannan, lack US board certification in cardiology and even in internal medicine. Narula and Vannan also failed to get California medical licenses. The former head of the division, Dr Michael Brodsky, charged, "It's because UCI can't attract good doctors to come and work here." Narula had briefly run the cardiology program at Hahnemann University Hospital, but "left amid accusations that the program was floundering." Narula's successor there said, "There were financial problems in the division and concerns about the way it was being run administratively." Nonetheless, "Narula has gone on to be among the five highest-paid UCI employees. In the 2004-05 fiscal year, he earned $400,000, more than the dean...." Brodsky concluded,

The whole thing is embarassing. It shows that this liver business is not one isolated phenomenon. It's just another example of continuing malfeasance.

Conclusions
One of the UC Regents had argued that if a university can't offer lavish pay, "you don't get to look at the best people in the market." (See our post here.) If the UCI leadership are "the best people in the market," I hate to think what the other people in the market look like.
Instead, the UC cases suggest that lavish executive pay and perks at health care organizations, rather than being necessary to attact good leaders, actually correlates with bad leadership. Perhaps executives who are most concerned about their personal financial advancement are less likely to be devoted to the academic and health care mission.

External Threats to Evidence-Based Practice

Tooting my own horn a bit, I am happy to announce that my article, "External Threats to Evidence-Based Practice," has appeared in the latest issue of the Rhode Island American College of Physicians (ACP) chapter newsletter. It's on the web here.

In the article, I review the evidence-based practice process, summarized in four steps, and then threats that can occur at each step.

Please take a look. Comments and questions are always welcome, of course.

[I should note that that the opening column from the RI ACP Governor, Dr Yul Ejnes, deals with some aspects of the dysfunctional US health care system that are no doubt familiar to readers of Health Care Renewal. And anyone who spots some content elsewhere in the newsletter that is rather ironic when juxtaposed to my column gets two points.]

A Cover-Up at UMDNJ?

The pot continues to boil at the University of Medicine and Dentistry of New Jersey[UMDNJ]. (See our last post here, with links to prevous ones.)

The University, the largests health sciences university in the US, is currently operating under a federal deferred prosecution agreement. The University has agreed to have its financial affairs run by a federal monitor in exchange for the deferral of criminal indictment of the institution itself. This is the only example known of a university (health sciences or other) subject to such an agreement.

Now, the Newark Star-Ledger, which has doggedly pursued this story, has published allegations that UMDNJ officials have attempted to impede the federal investigation of the University. Specifically,

• "The university deleted e-mail files on a regular basis - despite orders to retain all documents."
• "'Veiled threats of retaliation' were made against University Hospital finance official Kathryn Gibbons, a key witness whof irst discovered that UMDNJ and its faculty physicians group were billing for the same services - now the focus of the federal investigation."
• "UMDNJ's attorneys failed to heed specific instructions from federal prosecutors not to conduct an internal investigation of their own."

NJ Acting Governor Richard Codey said, "There were people that were below the level of the board and the president that were impeding the investigation and may have been engaged in what would be called a 'clear cover-up.'"
State Senator Loretta Weinberg noted, "This place needs to be shaken up, and it is a shame because I really believe there are a lot of good people there, starting with the students and medical staff." This just underlines the horribly demoralizing effect the sort of mismanagement that went on at UMDNJ has on health care professionals and students.
What effect the mess at UMDNJ has had on patients is unknown.
And I am still waiting for this story to break through to the national media, much less the medical and health care literature. An echo? Do I hear an echo? Not yet.

The Karasik Conspiracy: "the Novel the Pharmaceuticals Industry Tried to Commission, Then Control, and Finally Kill"

We have previously posted (also here and here) on the abortive efforts of the Pharmaceutical Research Manufacturers of America (PhRMA) to covertly sponsor the writing of a thriller about terrorists poisoning drugs imported from Canada to inflame the public about the dangers of importing drugs from overseas. At some point, elements of the PhRMA leadership realized their folly, and sought to cancel the project. But the spurned authors refused to accepted an additional payment to close out the project, but never to talk about it. Instead, they rewrote their tome, making a pharmaceutical company one of the villains.

The new version, now entitled "The Karasik Conspiracy," has been published, and, of course, has its own web-site. It announces, "the novel the pharmaceuticals industry tried to commission, then control, and finally kill."

The site is remarkable because it includes transcripts of many emails among the authors, the consultant for PhRMA who arranged the project, and PhRMA executives. Some choice bits:

• On the purpose of the book - "This memo will confirms [sic] our conversation that I would like to commission the authoring and publication of a gripping fiction novel aimed at realistically depicting the potential terrorist threat to the pharmaceutical supply of our nation." "Confidentiality with respect to the origins of this project is paramount." [Mark Barondess, consultant to PhRMA, to Michael Viner, owner of Pheonix Books, the publisher] (See link here.)
• Barondess' second thoughts seemed to be more related to his literary criticisms than concerns about the ethics of the project - "I want you to know that I finished reading the book and while improved, it is still a very difficult read. It does not matter to me that books in the spy genre are usually hard to read—all I care about is whether someone will pick up this book and either never buy it or worse yet, stop reading it. I thought that we requested that the fundamental premise of the book was to change. While the Muslim component was added in the beginning, it completely fizzles out in the rest of the book. I still do not accept the premise that Spivak is going to attempt to blackmail the US over Serbia—it is just silly. It would be better if he was just a sociopath that wants to harm Americans because we are infidels." [Barondess to Viner, July 7, 2005] (Link for this quote and all others below is here.)
  "We do not want anyone to get hurt and we will not let that happen to you or the company. The bottom line is that we still do not have a book that is satisfactory to us. Maybe with the steps we discussed today, we can get there."[Barondess to Viner, July 9, 2005]
• On the involvement of Valerie Volpe, Director of Professional and Patient Relations for PhRMA - " I have just finished my review of the manuscript. While the book is significantly improved, in my view, it still requires more editing. Valerie is reading it tonight and has promised to give me her comments by the close of business tomorrow. A couple of things will help make a decision of whether to continue forward with the book. Is there an objection if we take over the editing? It seems that it would simplify the process." [Barondess to Viner, July 11, 2005]
  "I provided the writer with literally volumes of data to guide the storyline. I spent considerable time in person with the writer clearly outlining the premise of the book and the goals we expected to achieve." [Volpe to Barondess, July 19, 2005]
• PhRMAs attempted cancellation of the book was again based on concerns with the book's literary quality, not the ethics of the project - "The book that was sent was unsuitable in every respect, especially given the fact that the book was written by an author with no experience whatsoever in this genre. That lack of experience was apparent not only in the first draft (and pointed out to you), but in all subsequent drafts." [Barondess to Viner, Aug 2, 2005]
• PhRMA attempted to keep the whole thing quiet, and not to have any new book derived from the project say anything derogatory about the pharmaceutical industry - "I will pay you $100K in consideration of a full and complete release of claims from all parties, agents and employees. I need a confidentiality agreement regarding the work you were performing and confidentiality of the settlement agreement. I also need an agreement that there will be nothing written in the book which is adverse to the pharmaceutical industry, and that I will have the right to approve any manuscript, consent not to be unreasonably withheld." [Barondess to Viner, Aug 2, 2005]

You just can't make this stuff up.
Assuming that this web-site is closer to the truth than the novel is, this is a vivid illustration of how leaders of big health care organizations have substituted propaganda, disinformation, and intimidation for reasoned debate and discussion about health care issues.

"For Guidant, These People Are Just Numbers"

We have also posted frequently about the troubles of Guidant, a manufacturer of medical devices, particularly implantable cardiovascular devices. Recently, we posted that New York State Attorney General Elliot Spitzer has sued Guidant for fraud, charging it concealed defects in its implantable cardiac defibrillators (ICDs, devices that use electric shocks to the heart to attempt to restore normal rhythm). In summary:

• Guidant has admitted that it did not disclose information about defects in ICDs to doctors and patients.
• These ICDs are very expensive, costing about $25,000.
• Had the physicians and patients known prospectively that the ICDs were not as reliable as previously thought, they might have chosen not to implant them, and implanting such flawed defibrillators provided less benefit to the population of patients receiving them than they thought they would receive.
• Thus, by concealing the information, Guidant likely made more money and increased costs to the health care system, but decreased the benefits to patients.

Last week, the New York Times reported that documents released in connection with another law-suit against Guidant showed that the company was aware by 2002 of flaws, some potentially serious, in the company's ICDs. The company estimated that the failure rate of the devices was about 15 per 10,000, and that about 12% of patients whose ICDs failed would die or suffer a life-threatening event. Yet, perhaps because the company thought that the risks of replacing an ICD would outweigh the risks of device failure, the company did not reveal these estimates.
Dr. William H. Maisel, a cardiologist at the Beth Israel - Deaconess Medical Center, charged, "For Guidant, these people are just numbers.... But for me, these patients are people."
Today, the Boston Globe and the Washington Post reported that the US Food and Drug Administration (FDA) had found "significant violations" at Guidant's Minnesota factory where it makes ICDs. The FDA banned export of the devices or any new uses of the devices until the problems at the factory are resolved. Guidant replied that it had done a "broad, thorough, and systematic review" of quality control and "made substantial steps" in responding to the FDAs findings.
Again, although the failure rate of Guidant's ICDs was low, keeping information about this rate secret prevented doctors and patients from making fully-informed decisions about not only whether to replace already implanted ICDs, but whether to implant such a device in the first place, and if so, whether to implant one made by Guidant.
The principles of evidence-based medicine suggest that doctors and patients need access to the best evidence to make informed decisions about tests and treatments. Suppression of such evidence ultimately will harm patients. We need to make the consequences of such suppression severe enough to deter self-interested leaders of health care organizations from even thinking about hiding or manipulating clinical research.

Some Consequences for SFBC International

We have posted frequently about the troubles of SFBC International, a for-profit clinical research firm.

Last month, we posted about allegations that private, for-profit clinical research firms, including SFBC International, supervised by for-profit institutional review boards (IRBs), were doing sloppy and shoddy work. We then noted allegations that SFBC International had tried to threaten or intimidate research subjects who talked to reporters about such poor research practices. Furthermore, we discussed how a review commissioned by the company found that a top executive, Jerry Seifer, SFBC International's Vice President for Legal Affairs, threatened participants in clinical studies who had talked to the press with deportation. Seifer, it turns out, had been the subject of past regulatory sanctions by federal regulators. In addition, study participants in a trial of an immunosuppressant drug carried out by the firm's Canadian subsidiary, SFBC Anapharm, acquired tuberculosis after exposure to another participant with active disease, despite their complaints to Anapharm staff.

There have been some consequences for all this. The South Florida Business Journal reported that Seifer has resigned, although SFBC International gave no reason for his departure. Also, the Miami Herald reported that the company has hired investment banks "to explore strategic alternatives," which the newspaper suggested meant looking for buyers for the firm, whose stock price has dropped from $41 to $15.

Commercial research firms are carrying out an increasing proportion of clinical research. Doctors and patients depend on such research when making decisions about which tests and treatments to employ. Thus, the troubles of SFBC International, a major player in the commercial clinical research world, raise yet another set of worries about the integrity of clinical research.

However, although these troubles have attracted the attention of legislators and investors, they have caused few ripples in health care circles. The anechoic effect lives.

More on UMDNJ: "New Jersey - It's Worse Than You Can Imagine"

It's getting hard to keep up with the bad news coming out of the University of Medicine and Dentistry of New Jersey (UMDNJ), now operating under a federal deferred prosecution agreement. (See most recent post here, with links chaining back to a now voluminous set of posts.)

More Resignations

To start with the ironic - in an email sent last week, Marykate Noonan, Director of the Office of Business Conduct at UMDNJ, reminded all employees of newly introduced mandatory ethics training:

Recipients: All Employees
Delivery Priority: Standard
M E M O R A N D U M
DATE: December 15, 2005
TO: All Employees of UMDNJ
Cc: Dr. John Petillo, President, UMDNJ
FROM: Marykate Noonan, DPM - Director, Office of Business Conduct
RE: Mandatory Ethics Training for ALL New Jersey State Employees
____________________________________________________________________
Executive Order 41, issued by Acting Governor Codey, requires ethics training for ALL employees of New Jersey State Authorities, of which UMDNJ is one. There are two ways in which to take this training. The Executive Commission on Ethical Standards will conduct on-site ethics training at all our campuses during the month of January. The dates and times of this training will be announced shortly. The alternative way to take this ethics training is to use the State of New Jersey's on-line training modules. This on-line training MUST be completed by December 31, 2005.

The irony is that Noonan just resigned, along with two other top managers at UMDNJ who had allegedly in involved in questionable activities there, according to the Newark Star-Ledger.
Vivian Sanks-King, vice president for legal affairs, formerly recipient of $280,000 a year in salary, a $36,500 performance bonus, and the use of a 2002 Buick Park Avenue, resigned. The Star-Ledger reported that US Attorney Christopher Christie alleged Sanks-King "conspired" to cover up overbilling of Medicare and Medicaid.
Noonan earned $119,600 a year, received a $11,381 bonus last year, and drove a 2000 Dodge Intrepid supplied by UMDNJ.
Deidre Henry-Taylor, head of compliance at University Hospital in Newark, resigned, giving up her salary of $117,488 a year. Her bonus last year was $10,263.
Golden Parachutes Revealed
Another Star-Ledger article revealed that other top managers who had resigned recently received previously undisclosed "golden parachutes." It took the threat of a law-suit for UMDNJ to reveal this information to the newspaper.
James Archibald, former senior vice president for administration and finance, received two years worth of salary, at $285,312 a year, health and pension benefits, secretarial services, and the use of a Chevrolet Suburban SUV with an option to buy, plus a gas card and cell phone. "Federal investigators have subpoenaed a series of records tied to Archibald, whose name figures prominently in memos and other documents related to questions internally about the legality of UMDNJ's Medicare and Medicaid filings." Archibald now works at Drexel University College of Medicine, where he is Senior Vice President for Health Sciences.
John Ekanius, former vice president for government and public affairs, received one year of his $180,525 salary, health benefits, secretarial services, a laptop computer, and use of a car. Ekanius was named in a federal subpoena seeking documents. Ekanius also now works at Drexel, as Associate Dean for External Relationships and Strategic Development.
Sidney Mitchell, president of University Hospital, will receive two years of his $418,470 salary. Mitchell was also the target of a subpeona. He is still on the UMDNJ payroll, and is also currently president of Pascack Valley Hospital in Westwood.
The newspaper also noted that the severance packages included clauses that "the recipients make no comments or statements that might disparage UMDNJ, and with other confidentiality clauses." Such clauses may not be legal given UMDNJ's status as a state institution. And to add more irony -- the initiator of the policy on severance packages was apparently James Archibald, himself.
More Local Comments

The mess at UMDNJ continues to incite local commentary (although I have yet to find any reaction from farther than New York state.)

According to the Glocester County Times, NJ state legislator warned that UMDNJ may face a crack-down by the legislature. "They have to do the right thing and bring people in to clean this thing up. If they don't get their house in order, I think you're going to see the Legislature take some action."

And Jeffrey Page, a columnist for the Bergen County Record had plenty of choice words.

The feds are looking into a stinking little mess in which the University of Medicine and Dentistry of New Jersey may have double-billed the federal and state governments....
You can do nothing to avoid the stink when reading the UMDNJ story. Nor, of course, could you be accused of extreme cynicism if, after reading about the mischief at UMDNJ, you had sent [Acting Governor] Codey an urgent e-mail suggesting the five finalists [for new NJ state slogan] be scrapped and that the slogan be 'New Jersey: It's Worse Than You Can Imagine.'

But more seriously, Page suggested one small remedy.

When physicians take the Hippocratic Oath they swear to conduct their medical lives honorably. A pure life will bring doctors the blessing of God and the respect of their peers and the public. 'But should I trespass and violate this oath, may be reverse be my lot,' they conclude grimly.
Clearly, UMDNJ administrators should have to swear a similar oath - and suffer a similar reversal of their lots should they falter.

Getting the leaders of health care organizations to openly, publicly embrace a clear code of ethics would be one small step in the right direction, and not just for UMDNJ.

More Summary, and Much Documentation of the Blumsohn Case: "Rent-a-Researcher?"

A new article about the case of Dr Aubrey Blumsohn has just appeared in Slate, written by Jennifer Washburn. The title says it all.

It does a good job summarizing events in the case so far. What is most remarkable is that it links to a series of documents and recorded conversations that back up what has been reported previously. (See our last post here, with links to previous posts.)

The key points of the case are as follows, (with relevant links to documents and recordings):

• Dr Aubrey Blumsohn, a senior lecturer at Sheffield University, and Professor Richard Eastell performed a research project on the effects of the drug risedronate (Actonel, made by Procter & Gamble Pharmaceuticals [P&G]) under a contract between P&G and the University.
• Although the research contract designated Blumsohn and Eastell as "Investigators" under whose direction the project would be carried out, Blumsohn was not given access to the original data collected by the project.
• Despite numerous requests, (like this one), P&G refused access to this data repeatedly.
• Blumsohn was concerned that he and Eastell could be accused of scientific fraud if they continued to make presentations and write articles and abstracts without access to the data which they were supposedly writing about.
• Blumsohn became suspicious that some of the analyses done by P&G could be misleading, especially related to a graph shown to him that omitted 40% of patient data.
• Blumsohn objected to P&G arranging for papers and abstracts to be written by a professional writer, but with Blumsohn listed as first author. Blumsohn was concerned that such ghost-written documents were mainly meant to convey "key messages" in support of P&G's commercial interests.
• Eastell warned Blumsohn not to aggravate P&G, because the company was providing a grant to the University which "is a good source of income."
• After repeated failed attempt to get the data, Blumsohn complained to numerous officials at Sheffield University, including Eastell, medical school Dean Tony Weetman, University Vice-Chancellor Robert Boucher, and the Head of the University's Department of Human Resources, Ms R Valerio.
• Still unable to get the data, he spoke with news reporters about his case. At this point, Sheffield suspended him, but then offered him a severance agreement if he signed a contract binding him not to make any detrimental or derogatory statements about the University and its leaders.

A good summary of the case written by Blumsohn (in the letter to Valerio):

I performed a large-scale research project involving samples collected as part of FDA trials used to register the drug Risedronate (RJ102356). Measurements were performed in my laboratory, and Professor Eastell was coinvestigator. The aim of the study was to address an important and controversial question relating to this class of drugs. The company failed to allow investigators access to randomisation and event codes from the study. They continued to refuse access to this information to authors even after ghost-authoring work in the names of myself and Professor Eastell, and after substantial and increasing information emerged to suggest that the company data analysis could not be trusted. This breached their contract with the university, although restrictive contracts are widely held to be unenforceable in any event. The procedure was in conflict with all of the norms of usual legitimate scientific conduct. It is not necessary for me to demonstrate exactly how data analysis was perverted. Nor is it necessary to elaborate the effect that this may have on patient care. The principle at stake is clear, and such a process involving a sponsor is not ever appropriate in clinical medicine, or in any other branch of science.

Washburn drew some important conclusions:

Why did Sheffield, a top-flight research university, try to silence and get rid of Blumsohn?
The answer appears to lie in the complex and increasingly compromised relationship that have grown up between some research universities and the pharmaceutical industry.
Universities with medical schools have become dependent on drug companies for an ever-larger share of their research budgets - roughly 80 percent of clinical research is now privately funded. And drug companies, in turn, have pressed for greater control over the research process, making it easier for them to obscure or delete negative results from published academic papers.
Universities have long accepted funding from pharmaceutical companies to conduct clinical trials. But in the past, their professors insisted on running those trials independent of the sponsor. As the Blumsohn case makes clear, this arm's-length relationship appears to be breaking down.
Whatever the solution, something needs to be done soon. Scholarly independence has taken too many hits.

Hear, hear.

More on the Deferred Prosecution of UMDNJ

Local newspapers continue to aggressively pursue the deferred prosecution agreement offered to UMDNJ. (Our most recent post on this topic was here.)

Telling were comments made by US Attorney Christopher Christie to the UMDNJ Board of Trustees, according to the Newark Star-Ledger,

It is my policy to inform targets of a federal investigation that they are targets. Now I'm here to tell you that the University of Medicine and Dentistry of New Jersey is a target of a federal investigation. I have enough evidence to indict the university.
We no longer have any faith in your ability to fix any of the problems that have led to the conduct in the case.
But let there be no mistake about it and I want to tell each one of you face to face - if we cannot reach an agreement, I will do my job and prosecute this entity.

The North Jersey Media Group reported that a number of current and former members of the leadership of UMDNJ are targets of continuing investigation. "Other sources in the Codey administration and at UMDNJ confirmed that investigators are looking at the role played by Vivian Sanks-King, the university's vice president for legal management." "Others of interest, these and other knowledgeable sources confirmed, include Christy Davis-Jackson, the vice president for government affairs who has announced her resignation; former University Hospital President Sidney E. Mitchell, who became president of Pascack Valley Hospital in Westwood after leaving UMDNJ in 2004; former UMDNJ Medical School Dean Russell Joffe; University Hospital's former Chief Financial Officer James Lawler; and Marykate Noonan of the university's Office of Business Conduct."
One aspect of this case that has not received much attention is the demoralizing effect it must have had and be having on the many honest, hard-working employees and students of UMDNJ. The Star-Ledger quoted Mary Mathis-Ford, head of UMDNJ's Board of Concerned Citizens, as saying the climate at the school was the "worst" it has been in 24 years.
I only hope that this case, tragic as it has been, will start people thinking about how conflicted, unethical, and corrupt management of health care organizations has become a systemic problem, and what we in health care need to do about it.
But first, people outside of New Jersey will have to hear about this case. At least the New York Times just reported on it as regional news. Let's see if the case will further break free from the anechoic effect.

Conflicted Bioethicists

Carl Elliott also recently wrote an article in Dissent on bioethicists with conflicts of interest.

His main points were:

• Contemporary bioethicists often get funding from commercial sources, particularly pharmaceutical companies.
• Bioethicists have discounted the effects of commercial support on their own writing and behavior. For example, two American bioethics societies commissioned a task force to examine for-profit bioethics consultation. The task force did not find such consultation problematic, but eight of its ten members had previously performed such for-profit consultations themselves.
• Bioeticists own conflicts of interest may explain why "at a time when the pharmaceutical industry is coming under heavy public criticism for unethical practices - illegal marketing, Medicare fraud, research abuse, ghostwritten journal articles, unexplained deaths in research studies - it is striking how little of the criticism has come from bioethicists."

He concluded:

Bioethicists who accept money from the pharmaceutical and biotechnology industry are not impartial arbiters on the question of whether industry funding constitutes a conflict of interest for academic researchers.
At a bare minimum, bioethicists writing on conflicts of interest need to disclose their industry ties in their scholarly publications on the topic
More important, however, industry-funded bioethicists should not be writing the guidelines under which their own financial activities will be regulated, or serving on the conflict of interest committees that enforce these guidelines.

Again, read the whole thing. I have wondered for a while why professional bioethicists seem so uninterested in the unethical practices that now afflict many parts of health care, beyond even the list of practices Elliott attributed to the pharmaceutical industry above. Bioethicists' own conflicts of interest may be one explanation. Thus, yet another defensive line against unethical and corrupt health care leadership has been breached.

Commercial For-Profit Institutional Review Boards: "Ethics for Sale"

Carl Elliott and Trudo Lemmens took on for-profit institutional review boards in an article in Slate. Some key points were:

The primary means of protecting research subjects are ethics committees known as institutional review boards.
The idea was that to protect the welfare of research subjects, all studies would be reviewed in advance by an ethics committee independent of the researchers conducting the study, whose scientific zeal might lead them to shortcomings safety. Traditionally, IRBs have been volunteer committees made up of scientists and clinicians working in the hospitals and medical schools where the studies they review are being carried out.
Today, however, the ethics review of more than half of all new drug submissions to the Food and Drug Administration is handled by a single for-profit IRB, Western Institutional Review Board in Olympia, Wash.
How did we get here? When IRBs were established a generation ago, medical research was conducted mainly by individual investigators working in medical schools who were funded by the federal government and who had little financial stake in their studies. These days, medical research is a massive, multinational corporate enterprise. Rather than contracting with academic researchers to test new drugs, the pharmaceutical industry has found it cheaper and more efficient to conduct studies in physicians' offices, industry laboratories, and private testing sites like SFBC's in Miami. As recently as 1994, 63 percent of clinical trials were taking place in academic settings. Ten years later, that figure had shrunk to 26 percent. Along with private-sector clinical research has come private IRBs, which market themselves by promising fast and industry-friendly service.
But the private IRBSshave a direct financial interest in keeping their drug-company clients happy. If one for-profit IRB rejects a study as unethical, the pharmaceutical company sponsoring the study can simply send it somewhere else. Free-marketeers argue that there's a countervailing pressure that should make drug companies welcome strict policing from the IRBs - the possibility that a strict ethics review on the front end could head off a lawsuit on the back end. But in reality, the incentives don't pan out that way. Lawsuits, while on the rise, are still relatively rare. For the companies bankrolling the clinical trials, litigation is a quite-manageable cost of doing business.
Surprisingly, for-profit IRBs have drawn little criticism from bioethicists. Instead, some university and government scientists are increasing their influence.
IRBs were never intended to be formal regulatory bodies. They were supposed to provide a kind of professional self-regulation, in which scientists were advised by their colleagues.
That mission might have made sense 30 years ago. Today, however, the prevalence of private-sector drug research and the push to commercialize every facet of medical research makes the original model hopelessly outdated. Research subjects need a watchdog to protect them, and not one that is owned by the pharmaceutical industry. If IRBs cannot do the job, then we need to replace them with something that can.

As the saying goes, read the whole thing.

"A Public Embarrassment": UMDNJ Offered Deferred Prosecution

The story of the University of Medicine and Dentistry of New Jersey (UMDNJ) just gets ever more dismal. We had previously discussed allegations that UMDNJ had offered no-bid contracts, at times requiring no work, to the politically connected; had paid for lobbyists and made political contributions, even though UMDNJ is a state institution; and seemed to be run by political bosses rather than health care professionals. (See most recent post here, with links to previous posts.)

In the last week, allegations that UMDNJ had overbilled Medicare and Medicaid emerged. The Newark Star-Ledger reported:

• In 1999, a memo to Catherine Marino, then Medical Director of University Hospital, suggested that the University's "computer system inexplicably was configured to charge the maximum possible daily reimbursement rate for all Medicare patients admitted to UMDNJ's University Hospital in Newark, regardless of the actual care provided - essentially overcharging the federal government millions of dollars." Marino instituted "procedures to correct the problem," and assumed it had been fixed.
• In 2001, a "confidential report by an outside consultant... again concluded the hospital and its physicians were billing Medicare for the same services in many clinics. Records show that report about double-billing went to Vivian Sanks King, an attorney who was the university's vice president for legal management."
• In 2002, a University official conducted a routine internal review of billings for acute hospital care. The review discovered both double-billing and "configuring the hospital's billing system to the highest level of care, or acute care," apparently regardless of the services rendered. The official said, "When we started to look at that, we realized it hadn't been changed [from 1999]. I absolutely believe it was intentional. They actually went in there and made everything appear it was covered (at the full rate), and it wasn't. You can't look at that as being accidental." The amount of overcharging appeared to "be in the millions of dollars."
• "Separately, ... [the officer] said an audit conducted by the accounting firm of PricewaterhouseCoopers also found significant coding errors that indicated significant overpayments by Medicare: Basically, the hospital was charging for services not provided, or charging at the wrong rate."
• The official brought the issues to Vivian Sanks King.  The official "said she was instructed to take back all memos and make it appear that the review was only in draft form." Sanks Kings did not respond to the Star-Ledger's reporters.  The official "said she was forced to resign in July, 2003."
• The issue came up again next summer. Adam Henick, UMDNJ vice president for ambulatory care, and James Lawler, University Hospital's Chief Financial Officer (CFO), "also sent a memo to Sanks King reporting the improper billing." "Hennick said that after he threatened to report the problem to federal regulators, he was taken off the task force. He then went to the Office of the Inspector General for the Centers for Medicare & Medicaid Services and to the state Department of Criminal Justice. A month later, his employment was terminated."

The next day, the Star-Ledger reported:

• James Lawler, before he resigned as hospital CFO, refused to sign off on the hospitals Annual Report on Medicare. His lawyer said Lawler "did not feel he could vouch for the hospital's report. The attorney said no one else in the finance department was willing to sign it either."

The day after, the Star-Ledger reported that two members of the UDMNJ Board of Trustees resigned because of conflicts of interest. Yesterday, a third resigned. They had not been accused of any wrongdoing, and were complying with a new order from the Interim State Governor that no one with a potential conflict could serve on the board. In fact, NJ state senator "Loretta Weinberg, the most vocal critic of UMDNJ's administration in the state Legislature, said she was sorry to see the three members resign because they were among 'the good guys.'"

Then came the coup de grace. Today the Star-Ledger reported that US Attorney Christopher Christie gave UMDNJ the choice of accepting a deferred prosecution agreement, which included the placement of a federal monitor to supervise all of the University's finances, or face indictment for federal fraud charges. Such an indictment "would result in the cutoff of all Medicaid and Medicare reimbursement to the UMDNJ's University Hospital in Newark, closing it down." While talking to the Board, Christie announced,

This place is a public embarrassment.

According to an accompanying article in the Star-Ledger, during Christie's meeting with the Board, "Only Christie spoke. He went on for about an hour, laying out the criminal case his office was prepared to pursue, one that could cripple the university. He cited statutes and potential crimes that date back to 1999. He reminded board members the agreements wouldn't spare individuals. Some remain 'subjects' of an investigation, he said." Another article noted that similar deferred prosecution agreements had been used against large corporations, including Bristol Myers Squibb this year. However, no one could recall a University submitting to one.

The problems at UMDNJ have received considerable attention in the local media, but still not in the national media, nor in medical and health care publications. Although the actions of UMDNJ leadership have been assailed by local editorialists, state politicians, and one US Attorney, so far, we have yet to hear any criticism from any national physician, hospital, academic, or accrediting organization, or the like. Thus, the anechoic effect persists.

Yet, when the now obviously egregious case of bad leadership at UMDNJ is added to the numerous other cases that have appeared on Health Care Renewal, we see problems not just local to the state of New Jersey, but national, and probably global.

Clearly, health care leaders who are more concerned about their personal business and political interests than the mission of their health care institutiosn are unlikely to be effective in pursuing that mission. Letting such leaders persist in power risks wrecking whole health care institutions, as seen in the case of UMDNJ.
Once again, until we ensure that health care organizations' governance is representative, accountable, transparent, and ethical, we will continue to get inaccessible, over-priced, shoddy health care.

We need the sort of dogged law enforcement that has been directed against UMDNJ's publicly embarrassing leadership. But a revolution in health care leadership will only be achieved by grass-roots action, by physicians and other health care professionals, and ultimately by the public. Bad leaders will not reform themselves.

Diabetic? New York City wants to know . . .

New York City will require laboratories to report all HbA1c results above normal, along with patient and physician information. Plans are to compile a registry of an estimated half-million diabetics (stories at Bloomberg.com, NY Times, and Newsday, with more details in a Health Department presentation pdf). The Department of Health enthusiastically wants to track increased incidence of Type II diabetes in children, map physical areas within the City where blood sugar control is better or worse, etc. It also wants to target interventions at both patients and physicians, starting a pilot treatment program in the Bronx in 2007. For instance, alerts would be sent to patient and doctor if 90 days passed without a new HbA1c test, and patients with poor HbA1c control would receive letters and educational materials. Clinicians would get a quarterly roster of their patients stratified by glycemic control and best practice recommendations. New York will be the first city to make diabetes a reportable disease.

Although the city says that patients can opt out of the program, procedures are not yet developed for them to do so, even though the program is to begin right away, with current laboratory electronic reporting developed for other required health reporting likely to be easily adapted to add the new value. The health department presentation talks about giving patients the opt-out option when they receive their first letter from the department, which really does not touch the issue of whether they are in the patient database.

Thomas Frieden, the city health commissioner, pooh-poohs privacy concerns, saying that security protections will prevent patient information from being passed along to insurers or others.

I think this goes way too far for a non-infectious disease and an agency that does not actually have any responsibility for the patient’s care, in a country where negative health information can be extremely damaging to an individual wanting insurance or employment. Dr. Frieden, though, compares it to cancer registries or communicable disease reporting.

Quite an empire-builder, is Dr. Frieden. He would also like to track treatment status and lab test results of HIV patients city-wide.

Were I a NYC physician or patient, I'd be furious that the city was sticking its oar in in this fashion, and I’d think my rights violated. Yes, surveillance information can be of value, but given possible ramifications I absolutely wouldn’t be willing to throw information into the bucket, nor have the city contacting me about what to do.

But then, were I in NYC, I wouldn’t be asked.

If NYC were to hire negotiators, take bids, and make a deal with a test strip provider to buy large quantities of strips for residents at low cost and resell them to all NYC residents for less than diabetics could normally buy them for, I’ll wager they could save a lot more lives and the program could pay for itself, without violating anyone’s privacy.

The Topol - Merck - Cleveland Clinic Case Gets More Complex, and Gets More Attention

The Cleveland Plain Dealer and the New York Times are continuing to uncover new complications in the story of how Dr Eric Topol lost his academic leadership position at the Cleveland Clinic. We most recently discussed the story here.

The Times suggested that what is going on at the Clinic "goes far beyond a simple power struggle between strong-willed men," but has "focused attention on the many longstanding corporate ties at the clinic." It suggested that Topol first made himself unpopular with the rest of the Clinic leadership when be publicly criticized Merck and its handling of Vioxx in 2004. Soon, "Dr Topol soon found himself under attack. He was the subject of the Fortune magazine article, which contended he had a conflict of interest." Furthermore, "Dr Topol soon found himself under fire at the clinic.... The Clinic investigated Dr Topol's business dealings, according to people briefed on the inquiry." Dr Topol's response was to "cut all ties to industry." That made him even less popular. "When his contract came up for renewal at the clinic at the end of last year, the clinic put Dr Topol on a form of probation, giving him a six-month contract rather than the usual yearlong agreement...." Thus, the Times implies that Dr Topol lost his academic leadership positions because he renounced the sort of industry ties that other Clinic leaders cultivated.

These ties were even more complex than previously reported. The Times reported these new examples:

• Malachi Mixon, the Chairman of the Clinic's Board of Trustees, is the CEO of Invacare, a major home health care supply company. Invacare does about $200,000 worth of business with the Clinic yearly, although Mixon dismissed this as "peanuts."
• Dr Bernadine Healy, the first women to head the US National Institutes of Health (NIH), the former President of the American Heart Association, the former head of the Red Cross and wife of the former CEO of the Clinic, Dr Floyd Loop, is a Trustee of Invacare, and owns 41,570 of its stock options.

The Cleveland Plain Dealer also disclosed more possible conflicts of interest affecting the leadership of the Clinic:

• Via a report in the Wall Street Journal, Clinic CEO Dr Toby Cosgrove publicly praised a heart lung machine made by a company called CardioVention without revealing his or the Clinic's financial interests in it. CardioVention was sued in 2002 after a patient on whom its machine was used at the Clinic died, and the company ceased operations in 2003.
• Harry Rein, founder of Canaan Partners, who helped the Clinic set up and run its own venture capital fund, Foundation Medical Partners, was revealed to be a member of the Clinic's Board of Trustees.

The Times quoted Dr Jerrome Kassirer, former Editor of the New England Journal of Medicine, saying that the potential conflicts of interest at the Cleveland Clinic are "extremely serious," but that in having such conflicts, the Clinic "is not unique at all." Thus, the case of Dr Topol's dispute with the Cleveland Clinic is becoming emblematic of how leaders of large health care organizations are increasingly affected by more and more severe conflicts of interests. Such conflicts may undermine their organizations' missions and the core values of their physicians and other health professionals.
There is one bit of good news here. The national attention this case has received is a sign that the anechoic effect is ending.
The anechoic effect is our term for how cases of ill-informed, incompetent, conflicted, or even corrupt management of health care organizations, and how they threaten health care's core values seem to vanish without any wider echoes. For example, some of the biggest whistle-blower cases of the 1990s, those of Dr David Kern and Dr Nancy Olivieri, were hardly noticed in the national media (US and Canadian, respectively) despite aggressive reporting in regional news outlets.
But, now the New York Times and the Wall Street Journal seem to be sticking with the case of Dr Eric Topol, not just leaving it to the Cleveland Plain Dealer. And it has attracted the attention of Paul Krugman, one of the Times' national columnists, who is now warning of a "medical-industrial complex," and corruption as a systemic problem in health care.
Maybe this will make physicians, policy makers, and the public at large recognize conflicted health care leadership, and the larger issues of concentration and abuse of power in health care as fundamental threats.

More Shoddy Work by Commercial Research Firm

Last month, we posted about allegations that private, for-profit clinical research firms, supervised by for-profit institutional review boards (IRBs), were doing sloppy and shoddy work. We then noted allegations that one such firm, SFBC International, had tried to threaten or intimidate research subjects who talked to reporters about such poor research practices.

SFBC International is now back in the spotlight.

On one hand, the Miami Herald reported that "outside counsels" hired by SFBC International to review its operations had partially exonerated their clients. Some of the "outside counsels'" arguments were:

• That the apparent conflict of interest raised because the wife of a Vice President of SFBC worked for one of its IRBs, was less serious because she did not vote on panels that reviewed SFBC studies. Replied Ken Goodman, of the bioethics program at the University of Miami, "this doesn't clear the arm's length test."
• Responding to allegations that SFBC International is a "recruiting mill" using "poor desparate people," the counsels said "our review revealed that SFBC requires valid Social Security or tax identification numbers, in order to ensure that its participants are legal United States residents."
• Responding to allegations that SFBC International's CEO threatened research participants who talked to the press with deportation, the counsels noted that it was really Jerry Seifer, SFBC International's Vice President for Legal Affairs, who said "Well, if you don't have your immigration, don't you know you can get deported?" "If you're illegal, immigration is down the street on 79th street." Also, "I have a friend in the INS and I can ask my friend and I can deport you guys." [The Miami Herald just reported that Seifer, who just bought a $15 million dollar house and a Rolls-Royce jointly with SFBC International chair Lisa Krinsky, settled charges by the US Federal Trade Commission that he misrepresented wireless cable TV licenses he was selling to consumers. He also was fined and subject to a cease and desist order by the Commodities Futures Trading Commission.]

Although SFBC International Lead Director Jack Levine said that this reporte exonerated the company, per Bloomberg news, it sounds to me like the counsels were just quibbling about the prior allegations.
Furthermore, Bloomberg News has just reported more evidence of shoddy, sloppy work done by SFBC International.
SFBC International's Canadian subsidiary, SFBC Anapharm Inc, was running a trial of an immunosuppressant drug, ISA 247, for Isotechnika Inc. At their Montreal test center, patients were to be confined to the center 24 hours a day for a total of 31 days, for which they would earn Canadian $6800, most to be paid after the full 31 days.
One patient, identified only as Moshen, was confined in a double room with a man from Haiti, whom Moshen described as "lethargic," and coughing up blood. Despite Moshen's multiple complaints to SFBC Anapharm Inc. staff, the patient remained in the room for eight days. Moshen was assured that he was "okay."
He wasn't okay. He later turned out to have active tuberculosis (TB). Moshen and eight other study participants have now tested positive for latent TB. SFBC Anapharm staff did not initially test Moshen's room-mate for TB. Even though the study protocol involved an immunosuppressant drug that could activate latent TB, the study protocol did not require prospective subjects to be screened for TB by skin PPD testing or chest x-rays.
On learning that he had latent TB presumably acquired from his room-mate during the study, Moshen said "I was shocked." "They never apologized. They don't care. They don't give a damn."
The study was ostensibly supervised by a for-profit IRB, Aurora. Its argument for not requiring TB testing of study participants was since Montreal has a large Haitian population, "many potential participants would likely tested positive and have been excluded from the trial. 'It's clear the test has not utility,' said [Aurora President Jack] Corman." Responded Professor Steven Miles of the University of Minnesota, "That statement doesn't make any sense."
SFBC International's lawyer reacted to Moshen's anger by saying, "Anapharm very much regrets that the subject feels this way. They hope he recalls that Dr. Larouche apologized to him and to his fellow volunteers." SFBC International, however, has also asked study participants to sign a waiver releasing the company from any claims. Trudo Lemmons, a Professor of Law and Bioethics at the University of Toronto, described the requests for a waiver, "outrageous," and "unethical."
Have we fallen so far? Clinical research is the only way to tell what tests and treatments really do for patients. Clinical research was once an honorable undertaking, done mainly at teaching hospitals and academic medical centers. As a physician, I have taught about the importance of clinical research and how best to use its results to make better health care decisions. I have urged patients to enter clinical trials. Putting my money where my mouth was, I was the proud participant in one major trial (and just had my five-year follow-up visits for it.)
But we have noted again and again how commercial research sponsors may manipulate how clinical research is designed, carried out, analyzed, and disseminated. Now I would be very cautious about suggesting anyone should enroll in a clinical trial, especially if it has commercial sponsorship.
And hearing about these outrageous practices perpetrated by commercial research firms with the acquiescence of commercial IRBs, I sadly would not suggest that anyone enroll in a trial run by a for-profit research firm. We have fallen so far.

UPI picks up on pitfalls of bad clinical computing

A recent CPOE article in Journal of Pediatrics ("Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System", PEDIATRICS Vol. 116 No. 6 December 2005, pp. 1506-1512) has been picked up by United Press International (UPI).

Note these comments by AMIA official Paul Tang at the end of the UPI piece:

Paul Tang, incoming chair of the American Medical Informatics Association, said he thought there would be less risk with computerized healthcare systems in the future if the software were implemented by specialists.

"Anywhere along the line, from designing the system to its implementation, the process needs to be handled by medical informatics specialists . After all, you don't let general practitioners dispense powerful chemotherapy drugs," Tang told UPI.

A good analogy. I and others in healthcare informatics have been writing about this for a number of years (e.g. my website on informatics leadership of clinical IT). It's interesting to see what was originally thought of as a provocative assertion about the need for cross-disciplinary specialists to lead clinical IT is now becoming mainstream.

Of course, the Journal of Pediatrics article received pushback. It was critiqued on its methodology and its inferences in the medical informatics community itself and by the vendor, a part of which is presented in the UPI piece below:

IT-related deaths highlight tech needs

By ASTARA MARCH (covers healthcare technology for UPI)

WASHINGTON, Dec. 12 (UPI) -- Patient deaths at the University of Pittsburgh Children's Hospital blamed on a computerized physician order entry (CPOE) system point to the troubling possibility that electronic healthcare systems designed to save lives are, in some cases, having the opposite effect.

A key to correcting the problem might be to better tailor software systems to existing hospital networks and to assure that the systems are designed and implemented by specialists, experts say.

According to an article published in the December issue of the Journal of Pediatrics, after the Pittsburgh hospital installed a CPOE system the mortality rate of children
admitted to the hospital after being transported from another facility increased from 2.80 to 6.57 percent.

The CPOE system installed in the hospital at the time was Cerner Corporation's PowerOrder.

The deaths -- all linked to delays in obtaining medication -- were blamed on CPOE's software-design problems and faulty implementation.

Yong Han, of the University of Michigan Medical School in Ann Arbor and lead author of the journal article, told United Press International he was especially concerned about the software aspect of the problem.

"Medical software directly impacts patient care, for better or worse, and there are no checks and balances for it right now," said Han, who formerly worked at the Pittsburgh hospital.

"I could get together with my friends at MIT, whip up a program, put it on the market and no one could stop me," he said. [I wrote about this issue here in 1998 or so. - ed.]

"Drugs or medical devices must go through some degree of inspection and evaluation to determine whether the manufacturer's claims are substantiated. There's no such process for medical-software programs at the current time, and I think there needs to be," Han argued.

Although she declined to comment on Han's assessment of the system, Terri Steinberg, clinical applications manager for the Alfred I. duPont Hospital for Children in Wilmington, Del., told UPI that her facility's own experience with the software system at issue and with similar programs, has been problem-free.

"We have used the same software program as (that used at) Han's hospital since 1999 with no difficulty," she said.

Steinberg also stressed the importance of the human element when using the complex computer systems. "When you implement software in a medical environment, you must address your institution's workflow process and support the people who are using the system. Human beings are the primary determinants of failure or success of any kind of software implementation," she said.

For its part, the software's maker pointed to what it called flaws in Han's study. James Fackler, Cerner's director of critical care, charged that the data was unreliable because it compared 13 months of mortality data before the CPOE system was installed with only five months of data afterwards.

"Pediatric critical care is very seasonal. In pediatric ICUs, a mortality rate of 7 percent over six months is often followed by a mortality figure of 1 to 2 percent during the next six months. I would like to see figures for the full 13 months after our system was installed to be sure the effects were due to IT problems and not the normal fluctuations hospital pediatrics units experience," he said.

Paul Tang, incoming chair of the American Medical Informatics Association, said he thought there would be less risk with computerized healthcare systems in the future if the software were implemented by specialists.

"Anywhere along the line, from designing the system to its implementation, the process needs to be handled by medical informatics specialists. After all, you don't let general practitioners dispense powerful chemotherapy drugs," Tang told UPI.

Tang said serious problems can occur at three places in a software system.

"If the software needs too many clicks or takes too long to accomplish a task, that has to be corrected. Then there's software configuration. The vendor and the customer have to integrate the software with the hospital's system so they work well together," he said.

"The third place problems can occur is training staff and physicians to use the system. That's the customer's responsibility and it's often neglected," Tang said

I reproduce some of my comment to the informatics community below:

... This study is dealing with children, of course, and is perhaps a flag that much more detailed study of these systems, especially in socially-sensitive environments such as pediatrics, need to be performed.

For if this study's findings are not just due to serendipity and do reflect some underlying causation, the medical, ethical and legal issues could be enormous.

The health IT industry needs to realize this, and that some of their executives might end up on the witness stand during litigation as defendants. They (and we) need to do as much as possible to both sponsor such studies, and encourage others to do them, rather than discourage or disparage them - as was done in the example of Univ. of PA sociologist Ross Koppel [who wrote the JAMA article "Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors"], where Ross was accused in print of being "disingenuous", I believe. In medicine, there is no legitimate excuse for protecting a company at patients' expense.

... Quite seriously, I think the question of why systems that do not fit the clinical environment well are still designed and sold, and why systems that might be OK from a design perspective are implemented without clinician and patient needs front and foremost, needs to be asked.

As per Joan Ash's research and " Most hospitals don't use latest ordering technology " in late 2003:

Computers programmed to screen out errors and standardize physicians' orders for prescriptions, tests and other care have been a source of hope in reducing medical errors and improving patient safety. The problem is that most hospitals aren't using this technology, known as computerized physician order entry (CPOE) ... Reducing medical errors gained a sense of urgency in 2000 when the Institute of Medicine reported on the issue. The institute found that medical errors may be responsible for up to 98,000 deaths in hospitals and cost the U.S. health care system approximately $38 billion per year.

Despite a wide array of quality, policy and financial incentives to use CPOE, fewer than 10 percent of American hospitals make it completely available to their physicians. This was among the findings of a study conducted by researchers in the Oregon Health & Science University School of Medicine and recently published in online edition of the Journal of the American Medical Information Association (JAMIA).

[Use of CPOE] is not yet widespread because it has a reputation for being difficult to implement successfully. Patient care information systems like CPOE ... can create unintended or "silent" errors, according to a separate study conducted by the same author in the Netherlands and Australia.

The study's authors divide these silent errors into two main types: errors during data entry and retrieval, and errors in the communication and coordination process. Both types of errors occur because the systems simply don't take into account the work atmosphere most health care professionals experience, according to Ash, also lead author of this study.

"Many information systems simply don't reflect the health care professional's hectic work environment with its all too frequent interruptions from phone calls, pages, colleagues and patients," Ash said. "Instead these are designed for people who work in calm and solitary environments. This design disconnect is the source of both types of silent errors."

The screen itself can cause errors. Choices that appear too close together result in ordering the wrong tests or sending orders for the wrong person. If a system is rigidly structured, it causes users to focus closely on entering details and switching from screen to screen to enter information.

"Some patient care information systems require data entry that is so elaborate that time spent recording patient data is significantly greater than it was with its paper predecessors," the authors wrote. "What is worse, on several occasions during our studies, overly structured data entry led to a loss of cognitive focus by the clinician. "

Calm and solitary environments, indeed.

How are systems that ignore the healthcare workplace's realities finding their way into real products? How is this possible? While the workflow of the National Security Agency might be secretive, the realities of the medical work environment are certainly not. Who are the CPOE designers, exactly, and what are their backgrounds? How could investor dollars have been spent in such a fashion as to ignore the fundamental realities of clinical settings? How could IT companies have designed and implemented systems that "led to a loss of cognitive focus by the clinician" and created error?

Again, the question is: why does this occur, and what factors permit it to happen?

-- SS

The "Whiff of Corruption": Update on the Topol - Merck - Cleveland Clinic Case

There are a number of developments in the Topol - Merck - Clevleand Clinic case.

We have previously discussed, most recently here and here, the complex story of how Dr Eric Topol abruptly lost his academic leadership positions at the prestigious Cleveland Clinic shortly after he testified about Merck, its handling of research about and marketing of Vioxx, and its attempts to intimidate him; and just before a report came out alleging serious conflicts of interests affecting the Clinic's leadership, conflicts which Topol had been investigating.

First, excerpts of an interview with Topol appeared in an article in theheart.org, (here, subscription required), a web-site edited by Topol, and were picked up in an article in the Cleveland Plain Dealer. On the timing of his dismissal, Topol said:

It's a little hard to believe it was a coincidence. I'm not trying to say that the Vioxx/Merck thing was the only reason this occurred; I'm just saying it contributed and certainly the timing of it had to play a role, unquestionably.

Furthermore,

All I can say is, if you have a table of organization changed, it doesn't need to be done on an immediate basis like this. My appointment naturally would have run out at the end of the calendar year, so ti could have been set up that, in January, we'd start off with this different configuration .... The emergency action is very peculiar, and the fact that it was not even approved first by the board of trustees - you'd have thought that this would have been approved before they told me. So this is what's troubling about this whole thing: why did this have to be such a rush?"

Meanwhile, the Plain Dealer also reported that the Cleveland Clinic was going to do an "independent review" of the conflicts of interest issue. The newspaper quoted James Unland, who consults for hospitals about compliance, "This is a house that needs to be cleaned." Furthermore, he stated that the review should be conducted by "someone with no hidden agenda or prejudice one way or another." We'll see how it actually is done.

Finally, New York Times columnist Paul Krugman took note of this case. He wrote,

The real story is bigger than either the company or the the clinic. It's the story of how growing conflicts of interest may be distorting both medical research and health care in general.
The essence is simple: crucial scientific research and crucial medical decisions have to be considered suspect because of the financial ties among medical companies, medical researchers, and health care providers.
The past quarter-century has seen the emergence of a vast medical-industrial complex, in which doctors, hospitals and research institutions have deep financial links with drug companies and equipment makers. Conflicts of interest aren't the exception -they're the norm.
The whiff of corruption in our medical system isn't emanating from a few bad apples. The whole system of incentives encourages doctors and researchers to serve the interests of the medical industry.

Krugman will be suggesting how to change the bad policies that lead to all this. I'm not sure I'll end up agreeing with all his suggestions. And readers of Health Care Renewal will note that the problems goes beyond research, and beyond the organizations he mentioned. But I do believe that in general, he gets it.

Paying for Silence: Updating the Blumsohn - Procter & Gamble - Sheffield University Case

The Times (UK) Higher Education Supplement (THES) has reported more about the case of Dr Aubrey Blumsohn at Sheffield University.

We have posted before (here most recently) about how how Dr. Blumsohn had attempted, in vain, to get access to the data from a research project on the drug risedronate (Actonel, made by Procter & Gamble Pharmaceuticals [P&G]) that he was ostensibly leading, and to control the writing of research abstracts that was done supposedly in his name. His attempts were opposed by P&G. Sheffield University failed to support his efforts, and after he talked to the media about his problems, suspended him from his duties.

THES reported that the University had offered Blumsohn 120,000 pounds sterling "compensation" and another 25,000 "for injury to feelings." However, to get the money, Blumsohn would have had to agree not to make any "detrimental or derogatory statements" about Sheffield, or its staff, including the Dean, Tony Weetman, and its Vice-Chancellor, Robert Boucher.

Blumsohn rejected the offer, stating "Effectively, I would be accepting 145,000 [pounds] in exchange for allowing part of the jigsaw of clinical and scientific debate to remain uncorrected, and this would be unconscionable."

Its remarkable how many health care leaders seem focussed on secrecy.

We have posted a few times about this (here most recently). Each of those posts was in response to sets of cases in which health care leaders tried to suppress facts or opinions they didn't want aired in public.

So I get to quote myself again - Posts on Health Care Renewal recently "demonstrated the continuing threats against transparency and openness in health care. They also demonstrate that many threats come from leaders of large health care organizations who don't like information that puts them in a bad light made public. Yet how will we improve health care without access to information about what is going wrong, and opinions about what do to improve things?"

Sunlight is the best disinfectant.

Former Bio-Tech Leader Busted for Failing to Pay Child Support

A while back we posted about the curious case of Protocol 126 at the Fred Hutchinson Cancer Center in Seattle. Much of it was based on a series of investigative reports in the Seattle Times (see this web-site.)

In summary, a series of trials, called Protocol 126, at the Hutchinson Cancer Research Center were run by researchers who had extensive, major financial relationships with Genetic Systems, the company that developed the treatment used in the protocol. The investigators failed to divulge these relationships, despite institutional rules to the contrary. They are alleged to have intimidated other physicians and IRB members who tried to review questionable elements of their protocol. The patients enrolled in the protocol did very badly, probably worse than had they had conventional treatment. Efforts by Hutchinson physicians to have an on-site local or federal investigation of the conduct of the protocol did not succeed. Even though Protocol 126 ran from 1981 to 1993, the controversy surrounding it was not revealed until the Seattle Times series in 2001, and it has received little attention in the medical and health care literature since.

We also noted that the founder of Genetic Systems, David Blech, was found guilty of two counts of fraud.

The Seattle Times just provided some follow-up about another of the principle figures in Genetic Systems, Dr. Robert Nowinski, whom Blech hired to run the company. After he sold his shares in Genetic Systems, Nowinski went on to found three more bio-technology companies, Icos, PathoGenesis, and VaxGen, and he helped to found Primal. In 1990, he said, "if you took the 15 largest biotechnology companies of the 1980s, we founded three of them." After getting out of bio-tech, he went on to set up a high-tech art gallery in Seattle. However, this year he was reported again to be trying to "broker a billion-dollar deal with a local biotech company on behalf of some major investors."

The Times reported he has just been arrested on two federal criminal counts of failing to pay child support. Prosecutors say he is about $125,000 in arrears. He has also been subject to civil suits that claim he hid assets during his divorce proceedings, and that he withdrew a "loan," never paid back, from a trust fund meant to benefit his children from the failed marriage.

What a motley crew we have had running health care organizations!

Perhaps it's time to think about setting some standards for who gets to do that.

Dental Student Suspended for Blogging

At Marquette University, dental student Theodore Schrubbe has been suspended, required to repeat a semester (costing $14,000 in tuition), and threatened with expulsion. (See reports in the Milwaukee Journal-Sentinel, the Badger Herald, and the Marquette Tribune.)

His offense? - He posted uncomplimentary comments about an unidentified professor and some unidentified class-mates on his blog.

A University committee found him "guilty of professional misconduct in violation of the dental school's Code of Ethics and Professional Conduct," and supposedly of violating a university rule against "stalking, hazing, or harassments." The Code includes provisions requiring students "to conduct interactions with each other, with patients and with others in a manner that promotes understanding and trust." It condemned "actions, which in any way discriminate against or favor any group or are harassing in nature."

These actions have already come under fire from defenders of free speech. Another student blogger at Marquette said the action would have "a chilling effect on free speech and free expression." Mark Goodman of the Student Press Law Center said, "This decision raises serious questions about the school's commitment to free expression. If the university has the ability to punish students for expression that occurs outside of class and school-sponsored events, they are really controlling students' lives." Daniel D'Angelo, an adjunct faculty member at Marquette, and a c0-director of its Ethics and Professionalism curriculum, wrote, "what he [the student] wrote was imprudent, immature, and oftentimes distasteful. But ... it doesn't make these entries unethical or immoral."

Schrubbe has appealed the matter within the Marquette system.

This case illustrates how at academic health care institutions, codes of "professionalism" can be twisted into a speech code, a means to to control free speech and free expression, and how health care professional students may be taught that whatever they do, they can't criticize the powers that be without paying a steep price.

Such enforcement of a speech code seems to be completely in conflict with Marquette's own stated mission, "Our mission, therefore, is the search for truth, the discovery and sharing of knowledge, the fostering of personal and professional excellence, the promotion of a life of faith, and the development of leadership expressed in service to others." One cannot search for truth, or share knowledge, while fearing that saying something displeasing to the powers that be will result in punishment.

FIRE has documented numerous cases of attacks on free speech, free expression, and academic freedom at American colleges and universities.

Health Care Renewal has noted more and more cases suggesting such threats exist in teaching hospitals and medical schools, and may affect even senior faculty. For instance, see the recent cases of Dr Aubrey Blumsohn, and Dr Eric Topol, just to start.

But I'm sure there will be those who will say that these cases just involved trouble-makers. After all, even Schrubbe's defenders allowed that he was "imprudent, immature, and distasteful." And they may be believe all will be fine and dandy in the health care academy, at least once we get rid of difficult people like Schrubbe. What a Brave New World we will have then.

More Things That Go Bump in the Night

From ghoulies and ghosties
And long-leggedy beasties
And things that go bump in the night,
Good Lord, deliver us!

The Wall Street Journal just published an investigative report updating our knowledge about the ghost writing of medical articles. It includes some important new examples of the genre.

• The manuscript of an article in the American Journal of Kidney Diseases, whose first author was ostensibly Alex J Brown was posted on the web-site of medical writer Michael Anello as an example of his work. He had been commissioned by a medical communications company to write the paper on behalf of Abbott Laboratories, which makes Zemplar (paricalcitol), a Vitamin D analog. Anello was not listed as an author of the published article. (Brown AJ. Therapeutic uses of vitamin D analogues. Am J Kidney Dis. 2001 Nov;38(5 Suppl 5):S3-S19.) Brown claims he partially re-wrote Anello's draft, and was responsible for the final version of the article. Anello has since removed the article from his web-site.
• A medical writer paid by GlaxoSmithKline helped draft a manuscript on the safety of acetaminophen versus aspirin and other analgesics for patients with asthma. GSK makes a version of acetaminophen (Panadol) outside the US. The published article stated that the first author "performed the analysis and drafted the paper." (Jenkins C, Costello J, Hodge L. Systematic review of prevalence of aspirin induced asthma and its implications for clinical practice. BMJ 2004;328:434) The lead author said that the "structure of her work was 'suggested' by the company version but she and the other authors did their own analysis." She also denied knowing that the company paid the writer. GSK said the failure to disclose the role of the medical writer was "a lapse on the part of GSK." A rapid response was just (December 13, 2005) appended to the electronic version of the article, stating, "A medical writer assisted in sourcing the papers, summarising their content and reviewing drafts for this review of the literature, but declined to be included as an author. The authors reviewed all papers considered for the analyses. The scientific evaluation of the data and the clinical commentary contained in the review was provided by the authors. The authors have recently been made aware that, without their knowledge, the medical writer's costs had been met by GlaxoSmithKline, but are confident that the information presented in the review was accurate and reflected the authors' personal scientific opinions."

The Wall Street Journal article also recounts some cases that may be familiar to the readers of Health Care Renewal.

• There was the omission by someone at Merck, unbeknownst to the lead author, of pertinent data about adverse events afflicting patients treated with Vioxx from the manuscript of the VIGOR study sent to the New England Journal of Medicine. (See our post here.)
• How the manuscript of the Advantage trial of Vioxx was written in-house by Merck, not by its first author. (See our post here.)
• The "stealth marketing" campaign that included the authoring of multiple articles about Zoloft (sertaline) by a medical education company at Pfizer's behest. (See our post here.)
• The finished draft of a manuscript on the adverse effects of warfarin sent to Dr. Adriane Fugh-Berman by a medical communications company hired by AstraZeneca, which was starting to market a new competing drug, Exanta (ximelagatran). (See our posts here, here and here.)

Kudos to the Wall Street Journal and reporter Anna Wilde Matthews for reminding us that ghost-writing is an ongoing, unsolved problem. It would be fitting to conclude with a quote from the editorial in the Journal of General Internal Medicine that accompanied Dr Fugh-Berman's article noted just above.

Publishing biased literature is not simply "getting the message out" for the pharmaceutical client of the medical education company. It injects bias and untruth into the scientific dialogue in order to enhance corporate profits.
How much is sullying the medical literature worth in market share?

Protect us, indeed!

Was Topol Fired for Investigating Conflicts of Interest at the Cleveland Clinic?

The story of the firing of Dr Eric Topol from his leadership positions at the Cleveland Clinic Lerner College of Medicine has just gotten murkier.

The Wall Street Journal published an investigative report on the Cleveland Clinic's complex financial dealings, involving the Clinic's own venture capital fund, and a company called AtriCure. It suggests the possibility of multiple conflicts of interest affecting the top leadership of the Clinic, which were under internal investigation by a conflict of interest committee which included Dr Topol, that is, until he was fired.

In summary,

• Searching for "new ways to make money," the Cleveland Clinic sent up its own venture capital fund, Foundation Medical Partners (FMP).
• The Clinic became the biggest single investor, or limited partner, in FMP, putting in $25 million, which entitles the clinic to 38% of FMP's profits.
• Dr Delos (Toby) Cosgrove was one of the original general partners who managed the fund, and he invested in it personally. At the time, Dr Cosgrove was Chairman of the Department of Thoracic and Cardiovascular Surgery at the Clinic. "The fund's general partners were entitled to share an annual management fee of 2.75% of the money raised from investors that totals about $1.7 million a year. There were three general partners." Furthermore, "the fund's profits are known as 'the carry.'" "Dr Cosgrove was 'compensated with carry,' but didn't receive any of the management fees.."
• "Dr Cosgrove said he was required to invest in the fund by virtue of his role as general partner." Dr Cosgrove invested about $200,000 in the fund. "The fund lent ... the money to invest."
• In 2002, FMP invested $3 million in AtriCure, a private start-up company making medical devices. AtriCure makes a device that it advertises as allowing "you to make linear, transmural lesions that you can trust every time in a matter of seconds." Furthermore, "Using discreet field bi-polar radiofrequency, the AtriCure ASU delivers targeted ablative energy while simultaneously measuring the change in conductive properties of the lesion as it is created." The AtriCure web-site is very vague about what one might use such a device to do.
• Dr Cosgrove became a member of AtriCure's board of directors.
• "Dr Cosgrove also has developed a device for AtriCure ... which the company says it plans to begin marketing in the second half of next year. Dr Cosgrove would receive royalties for the device, known as the Cosgrove Clip."
• "Dr Cosgrove confirmed he also has a financial interest in companies doing research at the Clinic through his personal investment in Canaan partners," another venture fund run by Harry Rein, a friend of Cosgrove's who helped set up FMP.
• Physicians at the Cleveland Clinic have actually used to AtriCure device to treat atrial fibrillation (an irregular heart rhythm that predisposes patients to strokes) by ablating (destroying) electrically conductive heart fibers. For example, a group of Clinic physicians, including Dr. Cosgrove, published an article describing the results of this procedure on 513 patients. (Gillinov AM, McCarthy PM, Blackstone EH et al. Surgical ablation of atrial fibrillation with bipolar radiofrequency as the primary modality. J Thorac Cardiovasc Surg 2005; 129: 1321-8.) Cleveland Clinic physicians, specifically including Dr. Cosgrove, have promoted this procedure, using the AtriCure device, at national meetings.
• These physicians, again specifically including Dr Cosgrove, have not revealed their direct or indirect financial ties to AtriCure to the patients on whom they use this device, in their talks, and in their publications. For example, the article above lists Dr Gillinov and Dr McCarthy as consultants to AtriCure, but did not mention any ties that Dr Cosgrove had to the company. The article also did not mention that at the time it was written, Dr Gillinov and McCarthy had both been offered options to buy 25,000 shares of AtriCure stock.
• The US Food and Drug Administration (FDA) "has three times rejected AtriCure's application to have the system approved for cardiac use...." "Four patients are know to have died shortly after having the AtriCure procedure, at hospitals other than the Cleveland Clinic. AtriCure didn't notify the FDA...."
• "FMP has also invested in two other companies conducting trials at the Clinic: Immunicon Corp. and CardioMems Inc." The amounts it invested were $5 million and $3 million respectively. The Clinic also directly invested $2.75 million in Immunicon.
• "Last winter the Cleveland Clinic's conflict-of-interest committe learned that the FMP venture fund was an investor in companies doing research at the Clinic...." One of the members of the committee was Dr Eric Topol. "Some committee members worried that the Clinic's ties to AtriCure could color what patients were told when weighing treatment options. They also worried that their CEO's roles at AtriCure and the venture fund that invested in the company created a conflict...." "The Institutional Review Board in February directed Clinic researchers conducting clinical trials of the three companies' products to put a 'voluntary' hold on their work...." "The hold was lifted in May after the Clinic reworded consent forms."
• "The conflicts committee began to look into the role of Dr Cosgrove at FMP and AtriCure.... Not long afterward, Dr Cosgrove stepped down from AtriCure's board and said he would give up his position as a general partner at FMP."
• "Dr Cosgrove last week told Dr Topol he was losing his top post at the Clinic's medical school, a change that will take Dr Topol off the conflict-of-interests committee and the Clinic's board of governors."

The Cleveland Plain Dealer reported today that the Cleveland Clinic's board of directors has confirmed the removal of Dr Eric Topol as chief academic officer and provost of the Lerner Medical School. This action also definitively removed Dr Topol from the conflict of interest committee that had been investigating the ties among Dr Delos Cosgrove, Cleveland Clinic CEO, other Clinic physicians, FMP, AtriCure, and other companies doing research at the Clinic. Dr Cosgrove reiterated that this was part of a "streamlining move, nothing more." He said, "there are a lot of people trying to put a lot of spin on what the facts are." However, "students at the medical college sent a letter to the Clinic's board of trustees in support of Topol...." The Plain Dealer article suggested "the exposure also opens the door to questions from the Senate Finance Committee Chairman Charles Grassley, who has launched an investigation into the practices of nonprofit hospitals.
So was Dr Topol fired from his academic leadership positions to streamline the administration? This explanation seems unlikely, given Topol's prominence, and his role in creating the very medical school from whose leadership he was fired.
Was Dr Topol fired because he criticized Merck's Vioxx drug and its marketing, and revealed how Merck executives tried to intimidate him? Or was it because he helped investigate some conflicts of interest and other strange financial goings on involving top Clinic physicians and leaders, including its current CEO?
It seems more credible to suggest that Topol was punished by his own institution for blowing a whistle, regardless of which whistle proved most offensive.
Again, if such a prominent physician and academic leader can be published for whistle blowing, who in health care is safe? And if no physician or medical academic can feel safe speaking truths that offend the powerful, should any patient or student feel safe?
[Update: the MedPundit take on this story is here, the Schwitzer Health Care News take is here. Retired Doc is a bit ambivalent. Medical Rants doesn't agree, though.]