The Settlement and Conviction Round-Up: Friday Frequent Flier Edition

It's time for one of our periodic round-ups of legal settlements and convictions of health care organizations.  This time, we report on three frequent fliers, in chronologic order of the appearance of the relevant news stories.

Robert Wood Johnson University Hospital Hamilton (UMDNJ)

We have written multiple times about the woes of the University of Medicine and Dentistry of New Jersey, which lead to a deferred prosecution agreement and operation under the watchful eye of a federal monitor for several years, and resulted in criminal convictions of a former Dean and the state legislative leader he hired.  Scroll through this for far too many details. 

Now, the redoubtable Newark Star-Ledger reports:

Robert Wood Johnson University Hospital in Hamilton has agreed to pay $6.35 million to settle allegations that the facility defrauded Medicare, Justice Department officials said today.

The Mercer County hospital was accused of inflating charges to Medicare patients to obtain bigger reimbursements from the federal government.

'Taxpayer dollars should go towards quality health care, not wasted on fraud and abuse,' said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice.

The hospital denied wrongdoing in the settlement, said Skip Cimino, the facility's president and CEO. 'Robert Wood Johnson University Hospital Hamilton has resolved the outstanding Medicare Reimbursement issue with the government and looks forward to continuing its service to the community,' he said.

Note that Robert Wood Johnson Medical School is one of the two medical schools contained within UMDNJ.

Fresenius

I admit that we last discussed Fresenius Medical Care Holdings Inc, a for-profit provider of kidney dialysis services, a while ago, back in 2007. At that time, the company settled charges made by the US Federal Trade Commission that it had tried to restrain competition. Last week, the Tennessean reported:

A long-running whistleblower complaint against the once-Nashville based Renal Care Group has led to a $19.3 million federal court judgment against the acquired dialysis supplier and the German company that bought it four years ago.

The lawsuit, which focused on improper claims submitted to Medicare for home dialysis supplies, named Renal Care Group Supply Co. and Fresenius Medical Care Holdings Inc., as co-defendants. The federal government joined the whistleblower complaint more than two years ago.

Renal Care operated a shell billing company solely to submit claims on behalf of itself in violation of federal law that requires suppliers to be independent of the dialysis facilities where patients are treated, the government said. Even after employees raised concerns, Renal Care continued to operate the billing company because of the 'illicit revenues it created,' the suit said.

One employee wrote: 'I do not wish to go to jail' and felt the company's plan 'was not in the best interests of patients,' said federal Judge William J. Haynes Jr. of Nashville in his ruling.

The billings reportedly occurred over a six-year period beginning in 1999. The Fresenius-Renal Care acquisition closed in 2006 at a sales price of $3.5 billion.

Pfizer

Pfizer Inc, which proclaims itself to be the world's largest pharmaceutical company, has provided an amazing amount of material for Health Care Renewal. In September, 2009, we discussed the huge, that is, $2.3 billion dollar settlement Pfizer made of criminal and civil fraud charges. At that time, this was the fourth settlement of charges of unethical marketing made by Pfizer since 2002.

Since then, we have discussed another fraud settlement in October, 2009, and yet another in January, 2010.

Today, Bloomberg reported:

Pfizer Inc. violated U.S. racketeering law in the marketing of its epilepsy drug Neurontin and should pay $142.1 million in damages, a jury decided.

Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals claimed in a monthlong trial in federal court in Boston that Pfizer illegally promoted Neurontin for unapproved uses. The insurer said it was misled into believing migraines and bipolar disorder were among the conditions that could be treated effectively with Neurontin, approved in 1993 by the U.S. Food and Drug Administration for epilepsy.

'The jury found Pfizer engaged in a racketeering conspiracy over a 10-year period,' Tom Sobol, a lawyer for Kaiser, said after yesterday’s verdict. 'That bodes well for future cases.'

Furthermore, this was a very special kind of verdict:

The jury, which deliberated for two days, found that New York-based Pfizer violated the federal Racketeer Influenced and Corrupt Organizations Act, or RICO, and California’s Unfair Competition Law. Under RICO, the amount of actual damages found by the jury, $47.36 million, will be tripled.

The RICO statute was meant to be used against organized crime.  A jury seems to have found that Pfizer is a "Racketeer Influenced and Corrupt Organization," that is, the moral equivalent of a crime syndicate. 

Summary

So this week's settlement and conviction round-up shows the impunity that many health care organizations have exhibited thus far.  Some organizations have been charged again and again with unethical behavior.  Now one of the most frequent of the fliers has been convicted under the RICO law, certainly a new low. 

Yet none of the affected organizations in this post, and precious few we have discussed at other times, seem to have suffered any major consequences.  All have paid fines, some which seemed large at the time, but which have never been large enough to seriously threaten the organizations' financial well being.  None of the organizations seems to have lost business, or even much reputation.  Very few of the people within the organizations who approved, lead or implemented unethical behaviors have suffered any sort of negative consequences.

There seems to be something very wrong here.  In the US, we have put much of our health care system in the hands of very large organizations, for-profit and not-for-profit, without holding these organizations and their leaders accountable for their actions.  The results have been increasingly rich leaders who often behave like a new aristocracy, and repeated bad behavior by the organizations they lead. 

Our latest effort at health care "reform" has continued to rely on large private organizations, while so far not adding to their or their leaders' accountability.  In my humble opinion, if we really want to reform health care so as to improve quality, increase access, control costs, and support professionalism, we will have to make our new health care oligarchs accountable. 

Post Title → The Settlement and Conviction Round-Up: Friday Frequent Flier Edition

BLOGSCAN - At UMDNJ, Lose Your Job, Keep Your Cell Phone

We have frequently discussed the plight of the University of Medicine and Dentistry of New Jersey (UMDNJ), the largest health care university in the US. Facing indictment for federal crimes, the university operated under a deferred prosecution agreement and the supervision of a federal monitor from 2005 to 2007. We most recently blogged about UMDNJ here, and see links backward to previous posts from here. On the University Diaries blog, Prof Margaret Soltan discussed the latest aspect of mismanagement at UMDNJ to be uncovered.

Post Title → BLOGSCAN - At UMDNJ, Lose Your Job, Keep Your Cell Phone

Hospital Board Members with "the Juice" in New Jersey

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


The General Overview

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

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

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

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

Board Members' Self-Dealing

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

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

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

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

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

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

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

Political Influence Disadvantages the Competition

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

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

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

Connectedness of the Hospital's Board Members

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

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

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

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

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

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

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

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

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

Conclusions

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

Hat tip to University Diaries.

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

Post Title → Hospital Board Members with "the Juice" in New Jersey

Politician, Medical School Dean Convicted in Connection with Bribery and Fraud at UMDNJ

We have frequently discussed the plight of the University of Medicine and Dentistry of New Jersey (UMDNJ), the largest health care university in the US. Facing indictment for federal crimes, the university operated under a deferred prosecution agreement and the supervision of a federal monitor from 2005 to 2007. We most recently blogged about UMDNJ here, and see links backward to previous posts from here.

As reported by the Newark Star-Ledger, there have just been criminal convictions in two cases related to the scandals at UMDNJ:

Former senator Wayne R. Bryant was found guilty yesterday of selling his office as one of New Jersey's most influential lawmakers for a medical school job that padded his pension, in a case that also put on trial the secret political horse-trading of the state budget process.

A federal jury in Trenton convicted Bryant of bribery for soliciting a job at the School of Osteopathic Medicine in Camden County and using his influence to help the school acquire $10.5 million in state grants between 2003 and 2006.

The jury also found Bryant, 61, of Lawnside, guilty of 11 counts of mail and wire fraud stemming from the scheme to land the $35,000-a-year 'low-work' job at the school, run by the University of Medicine and Dentistry of New Jersey. Prosecutors said Bryant used the mail to apply for the job, get paid, and file a financial disclosure form for 2003 that omitted his UMDNJ job -- all in an effort to defraud the state Division of Pensions and Benefits.

'The brazen arrogance of Wayne Bryant -- to believe that he was completely beyond the reach of the law, to extort state institutions for personal profit in return for the funding of good and worthwhile programs that serve the poor, the disadvantaged and the needy of our state -- is simply the most disgusting conduct I've seen by a public official in my seven years as U.S. attorney,' [US Attorney Christopher J] Christie said.

The jurors, who deliberated 14 hours over three days, also convicted the medical school's former dean R. Michael Gallagher, formerly of Haddonfield, of bribery for hiring Bryant to perform what prosecutors say was a phony community relations job. Gallagher also was found guilty on five of the six mail and wire fraud charges involved with creating the job.

The ex-senator and the ex-dean each face more than 15 years in prison when they are sentenced March 20, according to the U.S. Attorney's Office.

The relationship between Bryant and UMDNJ was perhaps made a bit more clear by the Philadelphia Inquirer's version of the story:

In late 2002, Bryant solicited a job from Stuart Cook, then president of the public University of Medicine and Dentistry of New Jersey (UMDNJ). Prosecutors termed it a 'shakedown.'

Gallagher, the former dean of the School of Osteopathic Medicine in Stratford, then rigged a hiring process to give Bryant a job. The school is one of UMDNJ's campuses.

During the years of his employment, from 2003 to 2006, Bryant steered $10.5 million to the osteopathic school, and lobbied on its behalf in other matters.

Prosecutors noted that he had done nothing to help the school before going on its payroll.

Bryant was paid a $35,000 salary and given a $5,000 bonus one year. This, prosecutors said, despite the fact that he showed up on campus just one morning a week and spent most of his time there reading the newspaper and talking on the phone.

These were not the first findings of guilt in the UMDNJ case. Earlier this year, as we noted here, two UMDNJ cardiologists pleaded guilty of embezzlement in a scheme in which they were paid for academic work they did not do in exchange for referring patients to UMDNJ. However, by that time, nobody in a leadership position in UMDNJ had been charged, much less convicted of a crime in connection with the scandal. Now at least one former UMDNJ official has been convicted.

In a continued and striking demonstration of the anechoic effect, the UMDNJ case up to now has never graced the pages of any medical, health care research, or health care policy journal. I wonder whether the convictions of a prominent politician and a former osteopathic school dean will be enough to get this dramatic and sordid case noticed in the medical and health care literature. One would think that a large health care university forced to operate under a federal deferred prosecution agreement, under the supervision of a federal monitor, would have sufficient implications about problems in the leadership and governance of health care organizations to gain widespread attention.

However, as long as such cases are reported as merely regional aberrations, physicians, other health care professionals and patients will probably continue to believe that the ethical challenges they may witness are merely local misfortunes. Until we all recognize that the problems are widespread, if not global, we will not be moved to action. And maybe that is why there is such pressure not to discuss the wider implications of local problems, or to discuss how similar all the local problems are.

For discussion of many other cases of poor leadership and governance of health care organizations, please peruse the archives of Health Care Renewal.

Post Title → Politician, Medical School Dean Convicted in Connection with Bribery and Fraud at UMDNJ

Yet More Investigations of UMDNJ

We have frequently discussed the plight of the University of Medicine and Dentistry of New Jersey (UMDNJ), the largest health care university in the US. Facing indictment for federal crimes, the university operated under a deferred prosecution agreement and the supervision of a federal monitor from 2005 to 2007. We most recently blogged about UMDNJ here, and see links backward.

UMDNJ may no longer be under the monitor's supervision, ostensibly because of internal reforms of its management, but a recent story on NJ.com from the Newark Star-Ledger questioned the success of these reforms.

The state's medical university was overcharging the federal government by millions of dollars, even while under federal oversight for similar violations of the law, according to internal reports.

Those documents show administrators at the University of Medicine and Dentistry of New Jersey inflated medical expenditures by at least $21 million a year -- boosting Medicaid and Medicare reimbursement rates. The abuses were allowed to continue even after a consultant repeatedly warned them about the problem.

It is unclear how long the overbillings took place, but reports obtained by The Star-Ledger show they occurred as recently as last year, despite the fact the school was undergoing an administrative shake-up following earlier reports of widespread financial abuse. Those earlier abuses included the university's deliberate $4.5 million overbilling of Medicare, which was the spark that led to a 2005 federal investigation and the appointment of a federal monitor.

The new allegations raise questions about the impact and pace of reforms at UMDNJ and its University Hospital in Newark nearly a year after they emerged from the monitor's oversight.

U.S. Attorney Christopher Christie said he was troubled by the revelations. He said part of the reason his office agreed to end the federal oversight last year was the assurance by both the state and the university that there would be continuing efforts to resolve UMDNJ's long-standing internal problems.

As to the specific problems uncovered,

At issue were inflated rates paid to physicians on the UMDNJ faculty, as well as free support services -- such as office space and clerical help -- that the hospital provided to doctors in private medical practices. Those costs were submitted to federal officials to generate higher reimbursement levels than were warranted, according to the documents. The extra money was used to plug holes in the medical school's budget.

In addition, the final report by the federal monitor raised a series of issues:

Questions about the validity of the university's Medicare cost reports and possible violations of federal law -- as well as other allegations of financial abuses lodged by former medical school officials -- were also underscored by the federal monitor in a final report issued to UMDNJ administrators in December.

That confidential document, reviewed by the newspaper, raised red flags over charges of legal and ethical breaches that were to have been addressed by the university. The monitor, former federal judge Herbert J. Stern, said in the report that outside auditors were pressured to 'gloss over' findings that physicians were being paid more than market rates would dictate. As a result, the final report 'substantially understated problems which continue to exist.'

Among the monitor's other findings:

--Nurses working at the privately operated Robert Wood Johnson University Hospital in New Brunswick, another UMDNJ teaching affiliate, were on the university payroll -- and getting state benefits -- despite having no teaching responsibilities.

--On cost reports submitted to federal officials, UMDNJ improperly included the services of nurse practitioners and physician assistants who were employed in private practices.

--University Hospital was allegedly double billing for emergency room services when patients were waiting in the ER for an available hospital bed.

--UMDNJ retained and paid for legal representation of faculty members and other employees in disputes "tangentially related" to the university and "outside the scope of employment."

The allegations in the Star-Ledger article lead to announcements that a NJ State Senate Committee will investigate the university (see article here), and the US attorney opened a new inquiry, involving subpoenas served on the institution, and for its president and executive vice president to appear before a grand jury (see article here).

Of course, these latest reports involve allegations, not facts proven in a court of law. Nonetheless, they do suggest that the management of the country's largest health care university has not been reformed all that much. A corporate culture of deception and sleaze still seems to envelop the institution's executive suites. One wonders whether contributing to its entrenchment are 1) the "anechoic effect," which still has confined discussion of UMDNJ's woes to the local media and a few blogs; and 2) the lack of negative consequences so far suffered by any individual UMDNJ managers. Although UMDNJ as an institution was "punished" by a deferred prosecution agreement, individual managers, not the institution as a whole, were responsible for any misbehavior. While individual managers escape punishment, I doubt that the many honest people who work at UMDNJ can escape demoralization, and that ultimately it is the students and patients who will suffer.

Post Title → Yet More Investigations of UMDNJ

Key Opinion Leaders, Drugs for Smoking Cessation, and Transparency as a Cause of "Confusion"

A perspectives article from the April 1 issue of the Annals of Internal Medicine has provoked a slowly growing controversy. (1) Let me summarize the main points of the article before getting to the controversy.

As the title, "the case for treating tobacco dependence as a chronic disease," suggests, the authors argue "for some smokers, long-term pharmacotherapy [which] is the difference between tobacco abstinence and lifelong smoking," based on the argument that smoking is like a chronic disease.

They called for long-term use of pharmacologic treatments for tobacco addiction, including nicotine replacement therapy (NRT), buproprion, and verenicline, asserting that these drugs are safe and effective, and have "proven benefits." Such proven treatments, therefore, ought to be used long term.

Although long-term use is considered off-label, patients should be encouraged to remain smoke-free, and if extended courses of pharmacotherapy will assist them, treatment should be continued, encouraged, and reimbursed.

Rather than considering cessation medications as a short-term aid in smoking cessation, these medications should be covered in the same manner as the treatment of other long-term illnesses and conditions, such as asthma, depression, and diabetes....

However, their enthusiasm for pharmacologic treatment for smoking cessation, even in the short-term, seems to go beyond the evidence. That evidence shows that the "proven benefits" of these treatments do not accrue to the majority of patients receiving them. For example, in one widely disseminated study comparing verenicline, buproprion and placebo, the proportions of patients who were abstinent for one year (the duration of follow-up) were 21.9% for verenicline, 16.1% for bupropion, and 8.4% for placebo. Although the most effective drug, verenicline, more than doubled the continuous abstinence rate compared to placebo, the large majority of patients treated with that drug, 78.1%, did not achieve continuous abstinence, even for one year.(2) In another recent study, patients given verenicline were somewhat more likely to be abstinent at the end of a year (26.1%) than those treated with nicotine patches (20.3%), although the difference did not reach statistical significance.(3) However, again the great majority of patients treated with either medicine were not continuously abstinent, even for one year.

Thus, most smokers treated with drugs will not remain abstinent from smoking, even for one year. Furthermore, I am aware of, and Steinberg et al did not cite any data from controlled trials about the safety or effectiveness of any pharmacologic treatments of tobacco addiction for patients followed for more than one year. There is no reason to suspect that these drugs' effectiveness over the long-term would be any better than their rather marginal effectiveness when when used short-term.

In my humble opinion, Steinberg et al might have been able to make a case for controlled trials of these drugs' use that would follow patients for more than one year. But they presented no evidence to support the clinical use of these drugs, much less insurance company reimbursement for them, for time periods longer than those found in the published trials.

So why did these authors make arguments that went beyond the evidence?

Soon after the article came out, Adriane Fugh-Berman and Douglas Melnick, writing in the Bioethics Forum, noted:

The most important section of this article is the conflict of interest statement. The two authors who have advanced degrees are on the speaker’s bureau of Pfizer and are consultants to Pfizer, Novartis, GlaxoSmithKline, and Celtic Pharma. Pfizer makes varenecline (marketed under the brand name Chantix) and Nicotrol, a nicotine nasal spray. GSK makes Nicorette gum, Commit nicotine lozenges, Nicoderm nicotine patches, and Zyban (buproprion, which GSK also sells as an antidepressant under the name Wellbutrin). Novartis makes Thrive, a nicotine chewing gum ('thrive,' which means to prosper or flourish, seems a rather peculiar association for a delivery system for an addictive drug.) And Celtic Pharma is developing TA-NIC, a nicotine vaccine.

Furthermore, last week, an article in BusinessWeek provided more information about the financial ties of two authors of the Steinberg et al paper.

In 2006, Pfizer recruited Foulds to serve on its paid national advisory board for Chantix. The company also selected Foulds and Steinberg to be 'key opinion leaders,' sending them to talk to doctors about Chantix over fancy dinners and paying them each $900 per presentation. Foulds and Steinberg say that between them they have made a total of about a dozen appearances.

Steinberg received a $30,000 grant from Pfizer in April 2007 to study the effect of Chantix on patients forced to forgo cigarettes while hospitalized for other illnesses. He says this was his first research grant from a drug company. (The Robert Wood Johnson Foundation separately provided $300,000 for the hospital study.)

Steinberg, according to BusinessWeek, denied that he is influenced by his ties to Pfizer:

Adamant that his work for Pfizer and other drug companies poses no problem, he adds: 'We look at the data, and we look at our own clinical experience.'

While the authors disclosed the nature but not the effect size of their financial relationships in the Annals of Internal Medicine article, they were not so forthcoming to their patients. Per BusinessWeek,

Both doctors stress that it's not standard practice to tell patients about potential conflicts.

On the Web site for UMDNJ's smoking clinic, it's not easy for a layman to find disclosures. There is no clearly labeled list of companies that pay Foulds and Steinberg that is directly accessible from the home page. There are links to journal articles, some of which reveal industry ties. But getting the information takes effort. The online version of the Annals article requires a viewer to have a paid subscription for full access. Their twice-a-year newsletter, The Nicotine Challenger, doesn't disclose their work for Pfizer, even in articles that speak highly of Chantix.

Foulds includes a broadly worded disclosure on his blog, but doesn't name companies for which he consults.

Finally, neither author saw the need to provide more disclosures to patients.

Telling patients more about industry ties 'would just puzzle them,' Foulds says.

Steinberg sees no need to be more forthcoming. His passion for helping people quit is fueled by treating numerous cases of high blood pressure and other problems precipitated by smoking.

To add a final touch, Cathryn M Clary, vice president for external medical affairs for Pfizer, "fears too much transparency will cause confusion,"

The more information that's out there, the more difficult it will be for patients to process

There has been a good deal of discussion about drug, biotechnology and device companies paying "key opinion leaders" to help market these products (for example, see these posts here and here). And there has been a good deal of indignation that it is an affront to physicians to judge the content of medical education they provide based on who paid for it (see this link.)

Although the case of the Annals article is essentially only an anecdote, it does suggest an association between payments to key opinion leaders, and opinions that are more enthusiastic about the payers' products than the evidence seems to warrant.

Furthermore, it suggests that key key opinion leaders and the companies who sponsor them may dismiss transparency about their financial relationships as a cause of "confusion." If patients really are too naive to understand the implications of payments by drug and other commercial firms to key opinion leaders, would the KOLs and their patrons prefer that government step in to protect these poor, naive patients from such relationships they cannot understand? That is what their attitude seems to invite.

References

1. Steinberg MG, Schmelzer AC, Richardson DL, and Foulds J. The case for treating tobacco dependence as a chronic disease. Ann Intern Med 2008; 148: 554-556. Link here.
2. Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB et al. Verenicline, and alpha-4-beta-2 nicotinic acetylcholine receptor partial agonist, vs sustained release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA 2006; 296: 47-55. Link here.
3. Aubin HJ, Bobak A, Britton JR, Oncken C et al. Verenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. Thorax 2008. Link here.

Post Title → Key Opinion Leaders, Drugs for Smoking Cessation, and Transparency as a Cause of "Confusion"

Money for Nothing: More Guilty Pleas at UMDNJ, but Anechoic Effect Continues

We have done a long series of posts about the troubles at the University of Medicine and Dentistry of New Jersey (UMDNJ), the largest US health care university. The university was operating under a federal deferred prosecution agreement under the supervision of a federal monitor (see most recent posts here, here, here, here and here.) 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 posts here, and here, with links to previous posts.) More recent were some reports of amazingly wasteful decisions by UMDNJ managers leading to spending millions of dollars for real-estate that now stands vacant (see post here). There was the indictment of a powerful NJ politician for getting a no-work job in the system, and the indictment of the former dean of the university's osteopathic medicine school for giving him the job (see post here). We found out that UMDNJ had named one of its teaching hospitals for a pharmaceutical company in 2001 (see post here), that the federal monitor accused the dean of one of the UMDNJ campuses of fixing students' grades (see post here), and that the monitor found even more bizarre financial practices at the university (see post here). Although the monitoring ended this year, his most recent report found previously undisclosed problems with the university's research compliance (see post here).

Over a year ago, it was reported (see post here with links to previous posts) that UMDNJ gave paid part-time faculty positions to some community cardiologists in exchange for their referrals to the University's cardiac surgery program, but not in exchange for any major academic responsibilities. Last week, the Newark Star-Ledger provided some f0llowup,

Two cardiologists yesterday admitted signing on to high-paying, no-show jobs at the state's medical university in return for funneling patients to the school's troubled heart surgery program.

As part of the kickback scheme, the two were hired as clinical assistant professors at the University of Medicine and Dentistry of New Jersey, despite having no research credentials. They gave no lectures, taught no classes and acknowledged that they essentially did nothing more than refer patients for cardiac procedures while receiving hundreds of thousands of dollars in salary over three years.

The doctors -- Bakul Desai, 52, of Livingston and Laxmipathi Garipalli, 59, of Colts Neck -- are cooperating with the U.S. Attorney's Office and the FBI in a two-year criminal investigation that so far has implicated more than a dozen other part-time cardiologists and several top UMDNJ administrators. The scheme was hatched as part of an increasingly desperate effort to beef up a failing cardiac surgery program then on state probation, according to court records and reports by a federal monitor.

No university officials or any other physicians have been charged, although UMDNJ's chairman of medicine was forced to step down after the initial revelations became public.

In proceedings yesterday before U.S. District Judge Stanley R. Chesler in Newark, the doctors pleaded guilty to embezzling approximately $840,000 in payments from the university. The physicians stood quietly, answering questions with simple 'Yes' or 'No' answers. Both face possible jail time and suspension or revocation of their medical licenses.

U.S. Attorney Christopher Christie said others will be held accountable.

'UMDNJ has a culpable role in all of this,' Christie said. 'Don't take from these two guilty pleas today (the idea) that the institution itself is off the hook, because I will say quite clearly it is not.'

A university spokeswoman said UMDNJ and its board have 'worked aggressively' to restructure and reform the community cardiology program since concerns were first raised in 2006, including a reduction in the number of community cardiologists and changes in salaries and reporting requirements.

Desai and Garipalli should have known from the start that they were taking money for doing nothing, Christie said.

'They continued to do nothing and they continued to get paid in what is a classic New Jersey no-show government job scam,' Christie said during a news conference afterward. 'Extraordinary fraud and waste and abuse and illegality that was occurring with public money at UMDNJ.'

So here is even more documentation about the muck in which UMDNJ is mired.

We will wait and see whether there are more criminal charges in this case. In cases of health care corruption, it often seems that any penalties incurred affect those lowest on the totem pole, in this case, the two unfortunate cardiologists. Those higher up all too often get to walk away. This suggests how health care has come to be run by a power elite that do not have to follow the rules to which mere mortals are subject. I hope Mr Christie is able to buck this trend.

In the UMDNJ case, it seems obvious that someone in the management of UMDNJ had to have been involved in this scheme. It is hard to see how it could have occurred otherwise. So we wait and see if any such people are identified, much less convicted.

Another striking feature of the UMDNJ case is its manifestation of the anechoic effect. I put in a fairly long summary above at the beginning of this post emphasizing the magnitude, importance, and complexity of this case. I did so because many people, including many health care professionals and health policy makers, may be totally unfamiliar with the UMDNJ case. It has only been discussed in the news media in New Jersey (and to some extent the neighboring states of New York and Pennsylvania) and in Health Care Renewal. It has not, repeat not ever been discussed in any medical, health care, health services research, or health policy journal. It has not, repeat not appeared in any prominent medical. (I repeated the relevant searches today, of Medline, Google Scholar, and of the American Medical News, JAMA, and MedPage.)

An entire health care university admitting guilt, being subject to a deferred prosecution agreement, operating under a federal monitor, while all sorts of mismanagement and unethical behavior were uncovered, and NO ONE thinks it is worthy of discussion in any medical, health care, health services research, or health policy journal or newsletter?

The anechoic effect lives. And as long as it lives so vigorously, we make no progress in attacking the pervasive mismanagement, conflicts of interest, and outright corruption afflicting the management of health care. If we cannot even talk about these problems, how are we going to solve them?

Talking about them, however, might disturb the power elite that personally profits so much from their domination of health care. Hence, most health care professionals who are lower in status realize that to even mention such topics in public is to imperil one's career.

But as long as we cannot discuss the recent unpleasantness, things will continue to get even more unpleasant.

Fight the anechoic effect. Take back the future.

Post Title → Money for Nothing: More Guilty Pleas at UMDNJ, but Anechoic Effect Continues

UMDNJ Monitor Alleged "No Research Compliance Capability"

We have done a long series of posts about the troubles at the University of Medicine and Dentistry of New Jersey (UMDNJ), the largest US health care university. The university now is operating under a federal deferred prosecution agreement under the supervision of a federal monitor (see most recent posts here, here, here, here and here.)

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 posts here, and here, with links to previous posts.) A recent development (see post here with links to previous posts) was that UMDNJ apparently gave paid part-time faculty positions to some community cardiologists in exchange for their referrals to the University's cardiac surgery program, but not in exchange for any major academic responsibilities. Another was some amazingly wasteful decisions by UMDNJ managers leading to spending millions of dollars for real-estate that now stands vacant (see post here). Another was the indictment of a powerful NJ politician for getting a no-work job in the system, and the indictment of the former dean of the university's osteopathic medicine school for giving him the job (see post here). Most recently, we found out that UMDNJ had named one of its teaching hospitals for a pharmaceutical company in 2001 (see post here), that the federal monitor accused the dean of one of the UMDNJ campuses of fixing students' grades (see post here), and that the monitor found even more bizarre financial practices at the university (see post here).

All things must pass, so UMDNJ no longer has a federal monitor. Apparently, the publicly released version of the monitor's final report noted a number of positive changes at the university. However, a Newark Star-Ledger story revealed that even this report described contained yet another heretofore unknown problem.

Hundreds of millions in federal grants could be at risk because of lax research oversight at the state's medical university, according to a previously undisclosed portion of the federal monitor's report.

The new material, whose conclusions University of Medicine and Dentistry of New Jersey officials vigorously disputed, found the school had 'no research compliance capability' -- jeopardizing future funding, as well as the health of patients in clinical studies.

At issue is the university's problem-plagued Office of Ethics and Compliance, and UMDNJ's ability to audit research spending and report violations of clinical studies' guidelines to the federal government. The confidential portion of the report found the ethics office, whose director recently resigned and is missing other key personnel, had failed in performing critical oversight of federal research grants.

'UMDNJ admittedly has no research compliance capability at all and none is anticipated,' the monitor stated in the report.

University officials vehemently challenged the assertions.

'We have a significant amount of research compliance. We have over 20 years of history of research compliance at this university,' said Denise V. Rodgers, executive vice president of academic and clinical affairs. 'Do you think people ... would risk their reputation coming to an institution if there was no research compliance? Not a chance.'

U.S. Attorney Christopher Christie, who was briefed on the compliance findings, called it a 'serious matter' that seemed to have started long before UMDNJ came under the scrutiny of his office in 2005.

'It's always a problem when you don't have sufficient internal controls on any program. It is even a greater problem for an institution like this,' he said, citing UMDNJ's well-documented troubles with patronage, no-bid contracts and violations of Medicare and Medicaid laws.

In the public version of his final report, the monitor found UMDNJ had significantly improved since the string of scandals that nearly shut down the $1.6 billion university. However, he singled out UMDNJ's ethics and compliance office for criticism. The university's chief ethics officer, Michael R. Clarke, resigned last month after less than 18 months on the job, saying he wanted to return to the private sector. The university is now searching for a successor.

Stern's rebuke of the compliance office was far more harsh in the full report not released to the public. It alerted UMDNJ to failures that investigators only recently began looking into before the deferred prosecution agreement that led to the monitorship termination in December.

All of the monitor's reports released to the public have been edited to omit details of any ongoing investigations, and the final report cited 42 open investigative files based on 'allegations of legal and ethical breaches or conflicts of interest.'

Rodgers attributed the monitor's findings to a 'misunderstanding' over the fact that the university has not yet hired a research compliance officer. She said research at UMDNJ comes under multiple layers of oversight, including an Institutional Review Board; a Human Subjects Protection office; an office of research, as well as an institutional compliance officer and other academic officials.

'This university has over ($115 million) in grants from NIH,' she said. 'You can believe that if they had big concerns that we had no research compliance we would have not been able to get that money?'

I would note parenthetically that the rebuttals by UMDNJ officials seem to be based on logical fallacies, and therefore do not seem very convincing.

The officials first seemed to deliberately interpret the monitor's report in a very concrete way, that it alleged the university literally had not compliance efforts whatsoever. Then, they tried to rebut this straw-man argument by saying that yes, UMDNJ actually has an IRB, a human subjects protection office, etc. In fact, the report did not deny the existence of a compliance structure, it just somewhat sarcastically denied the structure was functional.

The officials then asserted that if the University had no functional non-compliance mechanism, someone ought to have already figured this out, and punished the university for it. This appears to be a version of a logical fallacy called an appeal to consequences of a belief (if X were true, there would be bad consequences. There have not been bad consequences, so X must not be true.) Why the particular problem mentioned in the report, a non-functional research compliance system, should have been more obvious than all the other problems at UMDNJ is not clear.

It's amazing how often the issues discussed on Health Care Renewal inspire health care organizational leaders to creatively use logical fallacies to defend their organizations and prior actions.

Unfortunately, this latest report reinforces the notion that the UMDNJ administration was a poster-child for poor management of an academic health care institution at multiple levels and in multiple spheres. Let's hope that things really are getting better there.

Post Title → UMDNJ Monitor Alleged "No Research Compliance Capability"

For Halloween, Reports of Spooky Finances at UMDNJ and Other Academic Institutions

We have done a long series of posts about the troubles at the University of Medicine and Dentistry of New Jersey (UMDNJ), the largest US health care university. The university now is operating under a federal deferred prosecution agreement under the supervision of a federal monitor (see most recent posts here, here, here, here and here.)



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 posts here, and here, with links to previous posts.) A recent development (see post here with links to previous posts) was that UMDNJ apparently gave paid part-time faculty positions to some community cardiologists in exchange for their referrals to the University's cardiac surgery program, but not in exchange for any major academic responsibilities. Another was some amazingly wasteful decisions by UMDNJ managers leading to spending millions of dollars for real-estate that now stands vacant (see post here). Another was the indictment of a powerful NJ politician for getting a no-work job in the system, and the indictment of the former dean of the university's osteopathic medicine school for giving him the job (see post here). Most recently, we found out that UMDNJ had named one of its teaching hospitals for a pharmaceutical company in 2001 (see post here), and that the federal monitor accused the dean of one of the UMDNJ campuses of fixing students' grades (see post here).



In response to this debacle, the New Jersey State Commission of Investigation (SCI) investigated financial practices at multiple state institutions of higher education, including UMDNJ. As compiled from articles in the (central New Jersey) Home News Tribune, and the (North Jersey) Record, the main points were

• Even after all the scrutiny given to UMDNJ, the SCI found new problems there, for example, its report alleged "a contract for janitorial and housekeeping supplies wasted $1 million over six years at UMDNJ because of overbilling. The vendor also gave liquor, meals and Yankees tickets to key UMDNJ staff." [Home News Tribune] "The company even sprang for $800 in food costs for a 60th birthday party for ... [the head of ] UMDNJ's office of supplier diversity and vendor development." [Record] Also, a construction company founded by a former UMDNJ plumber billed more than $2.8 million over seven years. The work was overseen at UMDNJ by the former plumbing partner of the construction company boss. The company built the UMDNJ official "a 400-square-foot wooden deck on his Oxford, N.J. home, free of charge. Three years later, when [he] ... decided to convert the deck into a sunroom, [the company owner] ... paid the bill."


• There were "questionable payouts to employees, including $3 million in bonuses in 2004 to UMDNJ administrators and lump-sum payments to departing officials." [Home News-Tribune]


• However, similar problems were found at other institutions. For instance, the report alleged Rutgers University paid for expensive trips, meals, and alcoholic beverages. Also, "vast amounts of money were moved through 'emergency accounts' including a $5,000 liquor bill for an anniversary celebration at the Camden campus." [Record]


• The report found instances of excessive political influence on the academic institutions, even though they had been freed from centralized state supervision in 1994. For example, "One former trustee at The College of New Jersey said he was told then-Gov. James E. McGreevey wouldn't reappoint him because 'he criticized the administration's approach to the New Jersey business community concerning taxes.' A Ramapo trustee said he resigned after state officials tried to make then-Sen. Joseph Doria Jr., D-Hudson, president of the college. [Home News-Tribune]

Although some may argue that New Jersey has uniquely bad problems, this report raises the possibility that sleazy accounting and budgeting practices may be widespread at US academic institutions, particularly but not exclusively those involved in health care. The finances of US private not-for-profit academic health care institutions are generally completely opaque. Almost never do such institutions publish detailed budget, or subject themselves to outside audits. This opacity may make it easy for such practices to flourish.

(For those who don't believe that statement, try to find a clear, detailed budget for any local health care not-for-profit. Further, try to find the results of any outside audit of any such institutions. You may need to dig much deeper than the usual glossy institutional publications and their state-of-the-art web-sites. Let me know of any success.)

Given that tuition for higher education, including health care professional education, and the costs of health care have been rising much faster than inflation for a long time now, there is reason for concern that a good chunk of the cost increases are due to questionable payments and financial practices. But until the organizations involved make their finances public and allow detailed audit, that is all conjecture.

WHAT CAN BE DONE:

Insist that your local hospitals, academic medical centers, medical schools, and universities make public detailed budgets, and subject their budgets to periodic audits. "Sunlight is the best disinfectant." But expect lots of resistance...

Post Title → For Halloween, Reports of Spooky Finances at UMDNJ and Other Academic Institutions

Fixing Students Grades at UMDNJ

Here we go again. We have done a long series of posts about the troubles at the University of Medicine and Dentistry of New Jersey (UMDNJ), the largest US health care university.

The university now is operating under a federal deferred prosecution agreement under the supervision of a federal monitor (see most recent posts here, here, here, here and here.) 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 posts here, and here, with links to previous posts.) A recent development (see post here with links to previous posts) was that UMDNJ apparently gave paid part-time faculty positions to some community cardiologists in exchange for their referrals to the University's cardiac surgery program, but not in exchange for any major academic responsibilities. Another was some amazingly wasteful decisions by UMDNJ managers leading to spending millions of dollars for real-estate that now stands vacant (see post here). Another was the indictment of a powerful NJ politician for getting a no-work job in the system, and the indictment of the former dean of the university's osteopathic medicine school for giving him the job (see post here). Most recently, we found out that UMDNJ had named one of its teaching hospitals for a pharmaceutical company in 2001 (see post here).

The very latest story comes to us courtesy of the Newark Star-Ledger,

Paul Mehne was a popular dean on the Camden campus of the state’s medical school, well-liked by the small cadre of students there who felt their satellite program in South Jersey was something special.

What troubled investigators, however, is that none of his students ever seemed to fail. A new report by a federal monitor, scheduled to be released tomorrow, concludes that Mehne doctored the grades of several medical school students, including some now practicing medicine, giving passing test scores to those who came up short on exams needed to begin specialty rotations.

Mehne, 59, associate dean for academic and student affairs who headed the University of Medicine and Dentistry of New Jersey’s Camden campus, was abruptly relieved of his duties three months ago without explanation just weeks before he was scheduled to retire.

In the report, the monitor said some students at Camden were the beneficiaries of what it called 'unethical and inappropriate' activities related to grading.

The report said all grades were first sent to Mehne before being submitted to the registrar. The monitor said Mehne also coerced the directors of medical clerkships - the special rotations taken by third- and fourth-year medical students in areas such as obstetrics or family medicine - to award passing grades to students who did not pass standardized tests.

n one case cited in the monitor’s report, the source said an unidentified student who had failed an exam upon completing a specialty rotation was never retested. The report said Mehne instructed the clerkship director to change the student’s grade on two separate occasions.

According to the sources, no Camden students were brought up before the Academic Standing Committee for grade failures while Mehne was dean, until the monitor began his investigation.

This is a different kind of unethical behavior than that found previously at UMDNJ.

The lesson seems to be that mismanagement and unethical leadership at the top allows all sorts of mischief to flourish among the middle management.

[I must disclose that my first faculty position was at the UMDNJ Camden campus, which I left in 1987.]

ADDENDUM - See also comments on Phi Beta Cons here.

Post Title → Fixing Students Grades at UMDNJ

"Bling Bling," Poltical Correctness, and the Anechoic Effect

In today's post-modern academic world, everyone is afraid of saying anything that might be the least bit offensive. (See the web-site of the Foundation for Individual Rights in Education, or FIRE, for some amazing examples.)

It seems that that even the most skeptical and iconoclastic health care bloggers may also be fearful of being too politically incorrect.

In this post on the Carlat Psychiatry Blog, David Carlat nick-named Dr Charles Nemeroff "Bling Bling" for the extent of his relationships with the pharmaceutical industry. Carlat soon had to retreat, after being taken to task by one of the editors of his own Carlat Psychiatry Report for being "too personal," apologizing, "I was trying to be humorous, but I'll admit these [writings] come across as mean."

Today, this post on the Clinical Psychology and Psychiatry Blog showed that "Bling Bling" was not an exaggeration. (Nemeroff has also come in for criticism on Health Care Renewal, here, here and here.) But even then, the anonymous Clinical Psychology and Psychiatry blogger worried, "how is a blogger to be entertaining, stick to the facts, and bring important information to readers without crossing the line into being offensive? I don't know."

Yet, in health care, in my humble opinion, the problem is not too many bullying bloggers calling people offensive names. The problem, instead, is a general fear of saying something even the least bit negative about the powers that be, even when the powers that be have done awful things.

Carlat's quick retraction of what amounted to mild sarcasm, and the Clinical Psychology and Psychiatry bloggers fear of being "offensive" are the latest demonstrations that the "anechoic effect" is alive and well in health care.

The term, first coined by Dr Russell Maulitz, describes how even the most vivid cases of mismanagement, conflicts of interest, and even corruption in health care seem to produce no echoes. Two important historical examples that have come up on Health Care Renewal include:

• Cooper Hospital - University Medical Center. In the 1990s, this case featuring briefcases filled with cash, a hospital trustee convicted of murder, and the embezzlement of over $21 million. Yet despite these lurid details, it seemed to get no notice outside of local newspapers. See post here, and details here (starting on page 3).
• Allegheny Health Education and Research Foundation (AHERF) - The CEO of this, one of the first large vertically integrated health care systems, including the US' largest health care university at the time, was called a "visionary," and gave the prestigious John D Cooper lecture at the 1996 AAMC meeting. Meanwhile, he paid himself and his top managers huge salaries (for the time), and threatened his faculty, "don't cross me or you will live to regret it." The health care system eventually went bankrupt, the then second largest bankruptcy in US history, and the CEO went to jail. Yet, excepting what I have written, this case generated only one article in the health care and medical literature. See post here with citations and links.

And there have been numerous recent cases, e.g.,

• HRDI - An organization set up by 30+ CEOs of some of the US leading hospitals, which charged a stiff fee for prospective vendors to get access to them. It was shut down in a legal settlement, which prompted the Connecticut Attorney General to call the organization, "an anticompetitive, secret society." Yet the story never appeared in most of the hospitals' home towns, much less any medical journals. (See post here.)
• Guidant - A device manufacturer which recently was accused of suppressing data about failures of its implantable cardiac defibrillators, and previously pleaded guilty to suppressing data about failures of a vascular graft product. Yet a featured interview of its CEO in a leading health policy journal avoided discussing any of this recent unpleasantness. (See post here.)
• University of Medicine and Dentistry of New Jersey (UMDNJ) - Now the largest US health care university, the university now is operating under a federal deferred prosecution agreement under the supervision of a federal monitor (see most recent posts here, here, here, here and here.) 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 posts here, and here, with links to previous posts.) A recent development (see post here with links to previous posts) was that UMDNJ apparently gave paid part-time faculty positions to some community cardiologists in exchange for their referrals to the University's cardiac surgery program, but not in exchange for any major academic responsibilities. Another was some amazingly wasteful decisions by UMDNJ managers leading to spending millions of dollars for real-estate that now stands vacant (see post here). Another was the indictment of a powerful NJ politician for getting a no-work job in the system, and the indictment of the former dean of the university's osteopathic medicine school for giving him the job (see post here). Yet none of this has appeared in the medical or health care literature.

Try a Google search for the "anechoic effect" and "hcrenewal" to see some other examples.

Yet, local media do not hesitate to report individual physicians disciplined by their state medical boards. Such discipline is on the public record (e.g., here, for my state of RI). Physicians are frequently sued for malpractice. The media run scary stories about medical errors and overpaid physicians.

But when the CEO of one of the country's biggest hospital systems goes to jail, or the biggest health care university in the country agrees to a deferred prosecution agreement, physicians don't talk or write about it.

Carlat's apology for awarding the "Bling Bling" nickname, and Clinical Psychology and Psychiatry's fear of being "offensive" suggests how fearful we are of saying anything even mildly negative about the powers that be in health care.

As Aubrey Blumsohn put it, "the desire to maintain decorum and status in medicine seems also to overwhelm all standards of decency. Our profession is inclined to fixate on the irrelevant while ignoring some very bad things. Does civility matter? In the words of David Kern: When you're in an argument with a thug, there are things much more important than civility. I do not like incivility. Yet, I like thugs even less."

If we can't even talk about mismanagement, conflicts of interest, and corruption in health care, how are we ever going to fix these problems?

Post Title → "Bling Bling," Poltical Correctness, and the Anechoic Effect

Naming a University Teaching Hospital for a Pharmaceutical Company

We recently posted (here and here) about the controversy that erupted after the leadership of the University of Iowa proposed naming their new school of public health after a local for-profit insurance company in exchange for a substantial gift from the company's associated foundation. The ensuing newspaper coverage noted that there seems to be no precedent for naming an educational instution after a corporation (as opposed to naming one for an individual donor).

One of our astute readers, however, found this amazing example. The main pediatrics teaching hospital for the University of Medicine and Dentistry of New Jersey (UMDNJ) - Robert Wood Johnson Medical School is the Bristol-Myers Squibb Children's Hospital, named, of course, for Bristol-Myers Squibb, the large pharmaceutical company.. The hospital was apparently well supported by grants from the the Bristol Myers Squibb Foundation.

The hospital opened in 2001. As best as I can tell from a Lexis-Nexis search, there was not the slightest controversy about naming a hospital for a large pharmaceutical company. Obviously, doctors and faculty at the hospital may choose to use Bristol Myers Squibb products, and to perform research, consult, or give talks for the company. Yet there was no public discussion about whether having the hospital named for the drug company produced even the appearance of an institutional conflict of interest.

The naming of the hospital occurred at a time when, in retrospect, the leadership of UMDNJ proved to be quite troubled. The university now is operating under a federal deferred prosecution agreement under the supervision of a federal monitor (see most recent posts here, here, here, here and here.) 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 posts here, and here, with links to previous posts.) A recent development (see post here with links to previous posts) was that UMDNJ apparently gave paid part-time faculty positions to some community cardiologists in exchange for their referrals to the University's cardiac surgery program, but not in exchange for any major academic responsibilities. Another was some amazingly wasteful decisions by UMDNJ managers leading to spending millions of dollars for real-estate that now stands vacant (see post here). Another was the indictment of a powerful NJ politician for getting a no-work job in the system, and the indictment of the former dean of the university's osteopathic medicine school for giving him the job (see post here).

The decision to name the hospital for the drug company was made before the federal deferred prosecution agreement was put in place. One wonders if the ongoing investigation of the previous regime at UMDNJ may cover how it ended up naming a hospital for a drug company. Since the hospital is part of a state institution, one also wonders if naming the hospital violated any conflict of interest policies or regulations.

The decision to name the hospital also took place in 2001, before the pervasive nature of conflicts of interest in health care started receiving some attention. I wonder how many other glaring examples of such conflicts we would find if we only had the time to look more into the modern history of health care.

But each one of these conflicts, no matter how financially advantageous for the parties immediately involved, has the potential to negatively affect health care for the broad population, by raising costs, impeding access, or degrading quality. It is not too late to address this member of the herd of elephants in health care's living room.

ADDENDUM (31 July, 2007) - Please see the comment below from Ed Silverman of PharmaLot, which contains the text of a 1999 Newark Star-Ledger editorial which criticizes the naming of the hospital for a drug company as "commercialism."

Post Title → Naming a University Teaching Hospital for a Pharmaceutical Company

More Indictments at UMDNJ

The pain at the University of Medicine and Dentistry of New Jersey (UMDNJ) just goes on and on. We have previously discussed, seemingly ad infinitum, the troubles there. The university now is operating under a federal deferred prosecution agreement with the supervision of a federal monitor (see most recent posts here, here, here, here and here.) 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 posts here, and here, with links to previous posts.) A recent development (see post here with links to previous posts) was that UMDNJ apparently gave paid part-time faculty positions to some community cardiologists in exchange for their referrals to the University's cardiac surgery program, but not in exchange for any major academic responsibilities. Another was some amazingly wasteful decisions by UMDNJ managers leading to spending millions of dollars for real-estate that now stands vacant (see post here).

This just in, via Bloomberg News,

New Jersey Senator Wayne Bryant, once one of the state's most powerful Democrats, was indicted today on corruption charges and accused of trading his political influence for a job at the state's medical university.

Bryant, 59, was charged in a 20-count indictment of engaging in a 'scheme and artifice to defraud the public of honest services.'

Bryant ... was accused by a federal monitor of directing millions of dollars to the University of Medicine and Dentistry of New Jersey after receiving a 'no-work' job there. R. Michael Gallagher, former dean at the medical university's school of osteopathic medicine, was also charged today in the indictment.

According to the indictment, Gallagher in 2003 gave Bryant the title of program support coordinator at the osteopathic school at a starting pay of $35,000 a year. The job helped Bryant accrue credit toward his state pension.

Bryant, according to the indictment, used his senate staff to arrange meetings for Gallagher with members of the Senate budget committee, at which Gallagher presented a 'white paper' regarding capital projects at the osteopathic school that needed funding. From 2003 to 2006, Bryant directed changes in the state budget to benefit the medical school, including an allocation of $2.325 million for the osteopathic school, the indictment said.

UMDNJ has become one of the most graphic examples of mismanagement of an academic medical institution. The case is also one of the most striking examples of the "anechoic effect." I have never found any reference to the troubles at UMDNJ in any article in a scholarly medical or health care, policy, or services research journal.

Failure to even talk about cases of bad or corrupt managment of health care institutions leaves us far from a solution to the problem.

Post Title → More Indictments at UMDNJ

UMDNJ as a Political Sand-Box

The Newark Star-Ledger just published another in its long series of stories on the troubles at the University of Medicine and Dentistry of New Jersey (UMDNJ). As we have discussed previously, the university now is operating under a federal deferred prosecution agreement with the supervision of a federal monitor (see most recent posts here, here, here, here and here.) 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 posts here, and here, with links to previous posts.) The most recent development (see post here with links to previous posts) was that UMDNJ apparently gave paid part-time faculty positions to some community cardiologists in exchange for their referrals to the University's cardiac surgery program, but not in exchange for any major academic responsibilities.

Now the Star-Ledger has come up with a story of some mind boggling decisions made by the former UMDNJ leadership that seemingly wasted millions on expensive building projects that now stand vacant. The article then concluded with another insightful analysis of what went wrong in the leadership culture of the university, an analysis that may generalize to other health care organizations.

First, let's summarize the blundering building projects. The first was a highly secure site to develop vaccines against biologic terror agents, which is years behind schedule because a UMDNJ leader wanted to relocate it to a piece of land owned by his neighbor. Per the Star-Ledger,

It was known as a Regional Biocontainment Lab.

It was announced in September 2003 by then-Health and Human Services Secretary Tommy Thomp son, who hailed it as 'a major step' toward providing effective vaccines and diagnostics for diseases caused by agents of bioterror as well as in fections such as SARS (Severe Acute Respiratory Syndrome) and West Nile virus.

The federal grant stipulated the project be built in Newark's University Heights, adjacent to an existing bioresearch lab operated by UMDNJ.

Memos and e-mails show that within four months, Robert A. Saporito -- then UMDNJ's senior vice president for academic af fairs -- was looking for another site, as university officials grew concerned they would be unable to find matching funds required to build the project.

The search for alternate sites was never disclosed to the public, to the political leaders who secured the money, or to the federal agency that awarded it.

Saporito was forced to resign in March after he was accused of abusing his expense account. In an interview before he left, he said changes in the original design, mandated by security concerns, led to discussions about relocating the lab. He said he explored moving the lab to Picatinny after receiving a call from William Marcellino, a developer who lived a few doors down from him in Brick Township.

When the National Institutes of Health learned about the Picatinny plan last year, the agency was clear: 'We explained to UMDNJ that alternate sites were not an option,' said John J. McGowan, an administrator at NIH.

In an August 2005 letter to the university, NIH officials complained that they had seen little progress on the project and warned 'if you are unable to show the project can be completed, we will need to begin to negotiate the return of funds.'

The next was a cancer center that sits mostly vacant.

The newest building on UMDNJ's Newark campus is a nine-story structure emblazoned with distinctive red signs identify ing it as the New Jersey Medical School/University Hospital Cancer Center.

It includes vast expanses of glass, state-of-the-art research labs, underground vaults for linear accelerators used in cancer treatment, and an outdoor garden for patients.

But no cancer treatment is going on. There are no doctors, no clinical services and no patients. While some researchers have moved in, more than half the building remains empty.

Christopher Paladino, a former university trustee, said there was never a real plan for the cancer center. He said millions were spent without benefit of any economic feasibility studies, or any examination of whether the center would actually bring in patients.

Paladino, named a trustee after the project began, concluded the center had been the product of jealousy between the school's Newark and New Brunswick campuses. In Newark, he said, there was a feeling that because the university has a cancer institute 'in New Brunswick, we should have it here.'

The article documented other expensive buildings that sit partially vacant in lieu of any realistic plans to use the space they provided. In particular,

Adjacent to the cancer center in Newark is a new, six-story building for ambulatory outpatient services completed this year. Walk through this structure, past the cool pastel walls, and there are few people. One level is vacant, as are large parts of the rest of the building.

Since before construction began in April 2003, UMDNJ officials knew they would have trouble down the road because the center was built with tax-free government bonds and money raised that way cannot be used for profit-making operations such as doctors' offices.

'The total confusion on that subject has been the major obstacle,' [Interim UMDNJ President] Vladeck said. 'We're starting to untie that knot.'

Vladeck said the complex was planned and built by people who put off the financial issues, figuring it would be constructed and 'by then, they would have to fix the problem.'

Finally, the Star-Ledger discussed a fascinating analysis of what has gone wrong with the leadership of UMDNJ.

Interviews with past and current officials indicate many projects were a product of a school that increasingly was divided into two worlds the past few years.
In one, nurses and doctors battled to provide health care in a poor, urban environment. But at the top were administrators who got their jobs through political patronage and whose basic job experience was not teaching or medicine, but state government and politics.

Paladino, who was an assistant counsel to Gov. Jim Florio, said political jobs seemed to be part of the lifeblood of the university.

'It's a Sharpe guy. It's a Rice guy. It's a McGreevey guy, or a DiFrancesco guy, he remarked, referring to former Newark Mayor Sharpe James, state Sen. Ronald Rice, and two former governors, James E. McGreevey and Donald DiFrancesco. Everyone has a guy. They don't hide from it.'

It wasn't always evil, he said, but it became a slippery slope as politicians sought comfortable jobs for their political supporters.

U.S. Attorney Christopher Christie, who is overseeing a criminal investigation into the university that was launched after a series of stories in The Star-Ledger last year, saw it all as less than innocuous.

"There were people in political life who were in charge of the budget process who made sure UMDNJ got taken care of, because they knew folks could go there and be employed,' said the U.S. Attorney. 'There was a very symbiotic relationship there between the political world and the university.'

He added that his parents once told him character was what you do when you think nobody's watching.

'UMDNJ,' Christie said, 'was the way politicians acted when they thought nobody was looking, and it's a pretty ugly picture.'

So there you have it. One fundamental problem with UMDNJ was that the University was run by people with no background or fundamental interest in health care, who did not share, even at an intellectual level, the values of health care. The leaders treated the country's largest health care university as there own political sand-box, completely disregarding its core mission, and thus completely disrespecting the patients and learners it was supposed to serve, and the health care professionals who tried to serve them.

After the revolution that turned health care over to business people, bureaucrats, and politicans, how many other health care organizations are run for the benefit of their leaders, rather than the missions they were supposed to support?

Post Title → UMDNJ as a Political Sand-Box