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. 

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.

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.

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.

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.

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.

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.

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.