Princess Health and A SLAPP Against Clinical Research?. Princessiccia

Princess Health and A SLAPP Against Clinical Research?. Princessiccia

free speech intimidation medical devices

Gusty 14:11 Add Comment

Posts on the Wall Street Journal Health Blog, the Clinical Psychology and Psychiatry Blog, and by Dr Aubrey Blumsohn on the Scientific Misconduct Blog all picked up on a brief story in the Harvard Crimson about a lawsuit apparently claiming that a clinical research article, and a randomized controlled trial no less, was defamatory. Here is the gist from that news article,

Harvard Medical School professor Douglas P. Kiel is facing a lawsuit because of an article he published in the July 2007 issue of the Journal of American Medicine (JAMA).

In the study, Kiel, a gerontologist, said that hip protectors are not effective in preventing injuries among elderly patients, a claim challenged by HipSaver, a popular hip protector manufacturer, in a suit filed in Norfolk Superior Court on Feb. 15.

HipSaver�s president, Edward L. Goodwin, said in an interview that it was scientifically inaccurate for the conclusions of Kiel�s study to be applied to hip protectors in general.

Robert L. Hernandez, who is representing HipSaver, described Kiel�s article as 'disparaging' and 'grandiose.'

Actually, as quoted by Dr Blumsohn, the JAMA article's conclusions were framed in the typically measured terms of clinical research reports.

In summary, this large multicenter clinical trial failed to demonstrate a protective effect of a hip protector on hip fracture incidence in nursing home residents despite high adherence, confirming the growing body of evidence that hip protectors are not effective in nursing home populations.

These results add to the increasing body of evidence that hip protectors, as currently designed, are not effective for preventing hip fracture among nursing home residents.

[See Kiel DP, Magaziner J, Zimmerman S et al. Efficacy of a hip protector to prevent hip fracture in nursing home residents: the HIP PRO randomized controlled trial. JAMA. 2007; 298: 413-422. Link here.]

Of course, if these conclusions were libelous, than practically any scientific article could be considered libelous.

Equally obviously, HipSaver leadership have a perfect right to criticize the Kiel article. But to sue the authors because the company disagrees with their conclusions could have a chilling effect on science. This lawsuit seems to be a deliberate effort to intimidate clinical scientists who dared to collect and publish data which suggesting that commercial products may not be as wonderful as their marketers claim.

If clinical scientists start fearing to publish such conclusions, then we can throw the whole of science based medicine out. This, of course, would be a catastrophe.

Furthermore, this lawsuit can be construed as an attack on basic human rights in the US context. In this context, it appears to be a SLAPP, that is, Selective Litigation Against Public Participation. This term was coined to describe lawsuits designed to intimidate people from speaking out about issues of public interest (but in a way that might threaten vested interests.) For more information about SLAPPs, see the SLAPP Resource Center. Also see this article from the First Amendment Center.

Most US states, including Massachusetts, have laws that allow SLAPPs to be countered. For example, in Massachusetts, the law provides (see the SLAPP Resource Center), ]

Any written or oral statement made to, or in connection with, a governmental proceeding is protected under the statute. In addition, any statement that is reasonably likely to encourage review of an issue by the government or enlist public participation is protected under the statute. Other important provisions of the statute include: (1) a special motion to dismiss; (2) an expedited review of the special motion to dismiss; (3) the government may defend or support the defendant in the special motion to dismiss; (4) all discovery is stayed upon the filing of the special motion to dismiss; (5) the burden shifts to the plaintiff to prove the statements were not protected by the statute; and (6) costs and reasonable attorneys� fees shall be awarded to a victim prevailing on the motion to dismiss.

I don't think it is too much of a stretch to apply the SLAPP concept to a lawsuit aimed at the free discussion of the effectiveness of treatments in health care, given that the government indirectly or directly pays for many of these treatments, and that determining the effectiveness of treatments is clearly a public health policy issue.

I fervently hope HipSavers withdraws this ill-conceived lawsuit. If the company persists, I fervently hoped its attempted SLAPP gets slapped down.

Here is another sorry example of how health care, particularly clinical research, is under seige by those with vested interests and private agendas.

Princess Health and Stories About Device Manufacturers' Payments to Orthopedic Surgeons Resurface. Princessiccia

Princess Health and Stories About Device Manufacturers' Payments to Orthopedic Surgeons Resurface. Princessiccia

conflicts of interest medical devices orthopedic surgeons

Gusty 13:48 Add Comment

Late last year, we posted (here, here, and here) about the payments, often huge, that five manufacturers of prosthetic joints (Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew) revealed they made to orthopedic surgeons and various academic and other organizations. The lists are here: Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer. We also noted that some of the leadership of the major orthopedic societies have received substantial amounts from these companies, as have the societies themselves.

Despite the obvious potential for these payments to influence practice, teaching, and research, the issue received almost no attention after the initial media reports. Last week, however, it created a few more ripples. As reported by Bloomberg News, via the Washington Post,

Four makers of artificial hips and knees paid doctors more than $800 million in royalties and fees in four years to influence their choice of implants, a U.S. investigator told Congress.

The unidentified companies control about three-quarters of the $9.4 billion worldwide market for hips and knees, said Gregory E. Demske, an assistant inspector general at the Health and Human Services Department, at a hearing yesterday of the Senate Special Committee on Aging.

'Illegitimate' payments, the extent of which is unknown, influence orthopedic surgeons' medical judgment and are so common that it will be difficult to eliminate the practice, Demske and other witnesses said. The fees have enriched doctors and distorted the market by bolstering sales of lower-quality devices, they said.

'Industry and physicians are equally culpable,' said Sen. Herb Kohl (D-Wis.), chairman of the panel. 'Some physicians make it known to the companies that they will be loyal to the highest bidder. Where does the patient's well-being fit into the equation?'

Even an executive at one of the device companies admitted problems with the payments.

It's clear the device companies went too far, said Chad Phipps, Zimmer's general counsel.

'In hindsight it now appears that as the industry expanded to meet patient needs, the use of consultants may have been excessive at times,' Phipps told the committee.

In addition, a Minneapolis Star-Tribune story referred to

Wine-tasting outings to California's Napa Valley. Ski trips to Colorado. Tickets to sporting events. Gourmet meals at swanky restaurants. Forays to 'adult entertainment' clubs. Fat checks for what some see as questionable work.

And a Wall Street Journal story gave this example

In some cases, a company sales representative would spend one or two hours in an operating room watching a surgeon implant his company's device. The company would then pay the doctor for eight to 10 hours of 'training' services, according to findings that government investigators shared with the committee.

Maybe I shouldn't be amazed that this story has provoked so little response, much less outrage. Even though some academic orthopedists were getting literally millions of dollars a year (see this post), very few seem worried that such fabulous payments might have had some influence on their clinical decisions, on what they taught their students or colleagues, or on their research.

As noted before, some people are concerned by how physicians may be influenced by gifts of pens, coffee mugs, and pizza lunches. If we should be concerned about coffee mugs, how much more should we be concerned by multi-million dollar royalties or consulting payments?

But of course, it's easier to forbid coffee mugs and pizzas for medical students and house-staff than making the chair of orthopedics choose between his job and his multi-million dollar royalties.

Princess Health and The Spooky Stability of U.S. Health Care. Princessiccia

Princess Health and The Spooky Stability of U.S. Health Care. Princessiccia

Gusty 15:16 Add Comment

I only read last week a terrific commentary by Lawrence Brown in the New England Journal of Medicine�s January 24, 2008 issue on reform of the U.S. healthcare system and its chances. It�s titled The Amazing Noncollapsing U.S. Health Care System � Is Reform Finally at Hand?, and full text is available free to everyone.

Like Brown, I remember in 1993 when the punditry was pronouncing that health care reform was inevitable (it wasn't). I don�t remember (I was a kid) but have read health care panel discussions on policy from the 60�s amazingly reminiscent of today�s discussions about what an ever-increasing share of the GDP healthcare costs had become and how this was unsustainable. Brown�s article discusses the strong forces that make for stability in our very problematic healthcare system.

DemfromCT at DailyKos noticed the article promptly and commented.

Jeff Goldsmith at the Health Care Blog also comments, but I think takes the discussion in a completely wrong-headed direction by suggesting that this stability is benign. As Brown points out, it is far from that. This stability allows the continuance of the false complacency Americans so frequently have about �everybody getting healthcare� (despite poor kids and adults without asthma medication, cancer patients who can't get treated, lack of dental care and its toll in both physical and mental pain and infection, unavailability of rehab care and needed medical equipment, etc., etc.). It allows the continuance of an expensive idolatry of technology and of rampant, unnecessary, and harmful overtreatment [see Shannon Brownlee's excellent book on the topic of overtreatment]. It allows the continuance of a dangerous and patchy �non-system of care,� as Brown so rightly points out.

But as Brown also points out, the forces making for stability and non-collapse are powerful indeed. If you missed the article too, it�s well worth reading.

Princess Health and Pharma arguments and hogwash. Princessiccia

Princess Health and Pharma arguments and hogwash. Princessiccia

Gusty 14:35 Add Comment

The heparin manufacturing scandal sheds light on the typically rampant cynicism of U.S. Pharma arguments. When before the Medicare drug benefit there was a lot of pressure to allow importation of Canadian drugs, both sides were rather disingenuous in their arguments.

The pro-import side typically just presented it as an issue of competition and of not letting U.S. companies rip off U.S. citizens. What went unsaid is that what we were importing (and I thought it was in many ways an excellent idea) was not really Canadian drugs, but Canadian price controls. Since �price controls� is a four-letter word in the American lexicon, this was rarely stated.]

On their side and much more cynically, Pharma companies (with FDA complicity) stirred up fears about FDA approval and importation of allegedly dangerous �foreign drugs�. Unsaid was how many "American" drugs were really manufactured in whole or in part abroad (something I noticed at the time because I had run into shortages of prescribed asthma pharmaceuticals from time to time and had heard it was on account of problems at foreign factories).

The heparin scandal really points up big-time just how intellectually dishonest and cynical pro-Pharma arguments often are.

Princess Health and Heparin in an Era of Hogwash. Princessiccia

Princess Health and Heparin in an Era of Hogwash. Princessiccia

Baxter biotechnology FDA heparin Mismanagement mission-hostile management outsourcing pharmaceuticals

Gusty 14:21 Add Comment

Two weeks ago we first posted about an emerging scandal about the production of the drug heparin, a biologic that has been in use for over 70 years. First, we posted about the sudden increase in the frequency and severity of adverse effects due to heparin that carried the Baxter International label. However, its "active ingredient," that is, the heparin itself, was purchased from Scientific Protein Laboratories LLC, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Furthermore, it turns out that the factory was never inspected by either the US Food and Drug Administration (FDA) or its Chinese counterpart.

Last week, we posted about how the CEOs of Baxter International and Scientific Protein Laboratories did not seem aware of the origin of the heparin for which they were ostensibly responsible. Furthermore, it turns out its origin was not just Changzhou SPL, but a series of small, unregulated Chinese factories.

Since then, the plot has continued to thicken.

A congressional investigation is starting. Per the Wall Street Journal,

congressmen asked whether Baxter had known the Chinese plant hadn't been inspected and suggested the company might therefore be distributing an unapproved drug.

In a separate letter to HHS Secretary Michael O. Leavitt, the lawmakers asked for records relating to the FDA's preapproval inspection policy. They also sought an explanation of the agency's interpretation of the legal status of drugs shipped into 'United States commerce by a drug company that knew or should have known that FDA had not performed a preapproval inspection, as is alleged in the Heparin case.'

Chinese regulators dodged any responsibility. Again, per the Wall Street Journal,

China's drug-safety agency, responding to questions about oversight of an exported blood-thinning compound, said checks of pharmaceutical ingredients made in China are ultimately the responsibility of countries that buy them.

The State Food and Drug Administration said it works with foreign counterparts to monitor drug-ingredient production. But it said that based on international practice, 'safeguarding the legality, quality and safety of active pharmaceutical ingredients' is up to importing countries.

The supply chain of heparin in China appears to be even more difficult to trace than previously reported. An investigative report published in the NY Times, first quoted the CEO of Scientific Protein Laboratories, Mr David Stunce, "we have a collection chain in place, and we stick with that." However,

But interviews with dozens of heparin producers and traders in several Chinese provinces, as well as a visit to a village near here dominated by tiny family workshops that process crude heparin from pig intestines, show the difficulties confronting investigators as they seek to trace the supply chain. The picture that emerges is of a chain more complex, and less orderly, than the one Mr. Strunce laid out.

The Chinese heparin market has become increasingly unsettled over the last year, as pig disease has swept through the country, depleting stocks, leading some farmers to sell sick pigs into the market and forcing heparin producers to scramble for new sources of raw material. Traders and industry experts say even big companies have been turning more often to the small village workshops, which are unregulated and often unsanitary.

One of the wholesalers named by Scientific Protein Laboratories, Ruihua Biochemical in Hangzhou, said it provided a mix of crude heparin that it manufactured and some that it bought 'from small factories nearby in several villages.' The owner, Hua Ruihua, said he never inspected the small factories. 'We are not the government,' he said in a telephone interview. 'We have no right to inspect their pigs or intestines or facilities.'

The owner of one of those workshops, Fan Yinan, said, I sold to Ruihua several times before, but since last September I have had no intestines.' He confirmed that 'no one from Ruihua inspected my pigs or intestines.'

Strunce's response was this non-denial denial, "we have no information to suggest your information is true."

Some heparin is produced in primitive and unsanitary conditions. The Times reporters also visited some small factories, whose operations do not exactly inspire confidence in the safety and purity of their products.

Some experts say as much as 70 percent of China�s crude heparin � for domestic use and for export � comes from small factories in poor villages. One of the biggest areas for these workshops is here in coastal Jiangsu Province, north of Shanghai, where entire villages have become heparin production centers.

In a village called Xinwangzhuang, nearly every house along a narrow street doubles as a tiny heparin operation, where teams of four to eight women wearing aprons and white boots wash, splice, separate and process pig intestines into sausage casings and crude heparin.

The floors had large puddles and drainage channels; the workshops were dilapidated and unheated; and steam from the production process fogged up the windows and soaked the walls. There were large ovens to cook ingredients and halls lined with barrels to store enzymes, resins, intestines and wastewater.

'This is our family-style workshop,' said Zhu Jinlan, the owner of one heparin operation, who stopped sorting pig intestines and invited visitors to a back room, where she lives with her husband and child. 'We�ve been doing this about 10 years.'

Experts say the small, unregulated factories could pose dangers because they do not have the same controls and rules as large slaughterhouses, which also produce crude heparin.

'If you don�t control the incoming source, it�s very hard to get rid of the contaminants,' says Liu Jian, a heparin expert at the University of North Carolina.

Mr. Strunce of S.P.L. says his company never buys directly from the crude-heparin producers, only through its wholesalers, which he called 'consolidators' � Changzhou Techpool, its Chinese joint venture partner, and Ruihua. His company, he said, has records documenting all the transactions.

But here in Rugao, producers of crude heparin tell a somewhat different story. A sales manager for a major supplier, Nantong Koulong, said he sells directly to S.P.L. without going through either of the two wholesalers. 'We provided crude heparin to Changzhou SPL,' said the sales manager, Chen Jianjun. Some of Koulong�s stock comes from the unregulated workshops, he said.

The owner of one such workshop, Ms. Zhu in Xinwangzhuang, said she sold to S.P.L. two years ago. She also sells to Koulong. 'We are really a traditional family-style plant,' she said. 'We have no certificate.'

S.P.L. said it never bought directly or indirectly from Koulong.

The large companies cared more about getting heparin cheap than about where it came from. Again, according to the NY Times,

After an outbreak of blue ear pig disease swept through 25 of China�s 31 provinces and regions last year, prices soared, and many drug suppliers had to look to the small workshops. The epidemic, said Cui Huifei, a heparin expert at the Shandong University School of Medicine, 'made those biotech companies inevitably purchase from the family-style plants, for cheaper prices'

A sales manager for another large slaughterhouse in Shandong Province, north of Jiangsu, said he was approached late last year by a buyer for S.P.L. offering what he described as rock-bottom prices for crude heparin.

'It was impossible,' said the sales manager, Wang Shengfu, who works for Shandong Jinluo Group, a major producer of crude heparin. 'Only small factory-style farms could accept that low price.'

The deal was never consummated.

Wherever it gets its heparin, there were problems in the Changzhou SPL Plant. US Food and Drug Administration (FDA) inspectors finally got to the Changzhou SPL plant, and here is what they found, according to the Wall Street Journal,

Food and Drug Administration inspectors found problems at a Chinese plant that made most of the active ingredient for Baxter International Inc.'s blood thinner heparin, but the agency still hasn't pinpointed a cause for hundreds of bad reactions in people who took the drug.

Among other findings, the FDA said investigators found lapses in the Changzhou, China, manufacturer's quality-control procedures and the way it assessed its own efforts to remove impurities from raw materials.

The FDA also said yesterday it was seeking to examine upstream consolidators and small workshops that supplied raw material to the Changzhou factory. FDA inspectors found in its inspection report that some heparin sold in the U.S. included 'material from an unacceptable workshop vendor.'

Baxter International has recalled nearly all its extant heparin products, as reported in the WSJ article above.

Finally, the toll of serious adverse events linked to heparin has increased to 448, possibly including as many as 21 deaths. (See the same article.)

Health Care Renewal has documented numerous cases of financial mismanagement by leaders of health care organizations. We have discussed misleading marketing by drug, biotechnology and device companies, and by hospitals, academic medical centers, and health insurance companies. We have noted how medical education has been twisted into marketing, and clinical science has been manipulated, aided by pervasive conflicts of interest affecting physicians, academics, and various not-for-profit organizations.

But through all that, even I thought that the purity of the drug supply remained sacrosanct. Even I thought that no US or major multinational pharmaceutical or biotechnology company would sacrifice the purity and quality of the drugs they sold to cut their costs.

I may have thought that over-the-top marketing and shoddy research had inflated the benefit/ harm ratio of many drugs and devices. Up to now, however, I never doubted the purity of an FDA approved drug sold in the US with the logo of a reputable drug or biotechnology company.

In my previous academic life in which I spent a fair chunk of my time as an academic hospitalist, I often oversaw the use of parenteral heparin. I never would have suspected that the raw material in a vial of Baxter heparin came from some primitive, unsanitary, uninspected "family style" workshop in China.

We have reached a new low in US health care. The system is now mired in muck. We need a new generation of muck-rakers to clean it out. We need a total overhaul of the management of US health care organizations. We need managers who once again put patients before profits, and before lining their own pockets. Until things change, more people will die, and we will all eventually drown in the hogwash.

Princess Health and The American Diabetes Association and Its Pharmaceutical Donors. Princessiccia

Princess Health and The American Diabetes Association and Its Pharmaceutical Donors. Princessiccia

American Diabetes Association institutional conflicts of interest

Gusty 19:03 Add Comment

The New York Times reported last week about potential institutional conflicts of interest affecting the American Diabetes Association. The Times' article's main focus was on the organization's ties to the food industry, especially to makers of highly caloric food:

SnackWell�s Sugar-Free Lemon Creme cookies have nearly as many calories as some sugar-rich cookies. Yet until recently the box featured an American Diabetes Association logo, advertising the cookie as a 'proud sponsor' of the charity�s efforts on behalf of the nation�s 21 million diabetics.

Foods like the Sugar-Freedom Eskimo Pie and Frosted Shredded Wheat have also sported the American Diabetes Association logo over the years. The companies paid the A.D.A. to be associated with a respected voice for healthful eating. The association wanted the money to finance its uphill battle against a widening epidemic of Type 2 diabetes, which is associated with obesity.

To its credit, the ADA has started to rethink its relationship with the food industry.

But in the last year the A.D.A. began rethinking how it raises money from companies, especially from those whose primary business is selling foods and beverages that are high in calories, even if they have created some sugar-free items.

The group has allowed some food company deals to expire and has turned down millions of dollars in new sponsorships.

However, although it received less attention in the article, what may be a more important issue is the ADA's relationships with pharmaceutical companies (quotes below somewhat re-ordered.)

Though they often present the most difficult choices, food companies represent a small segment of the A.D.A.�s corporate support. Pharmaceutical companies remain the largest corporate contributors, but the guidelines have not affected them as much because the A.D.A. has never allowed its logo to be put on specific medicines.

Others remain concerned about the A.D.A.�s relationships with pharmaceutical companies. Their presence is evident throughout the charity, from its annual convention, which is largely underwritten by drug makers, to its board meetings, where pharmaceutical executives have served on the volunteer committees that set policy.

The A.D.A. says its independence is evident because it has often acted against the interests of the pharmaceutical industry. Last month, for example, a panel it appointed to study how to treat people at heightened risk of developing diabetes decided against recommending the use of higher-priced brand-name drugs.

But critics say the drug industry�s influence can be seen in the A.D.A.�s emphasis on the treatment of diabetics, which often involves drug therapy, over efforts to persuade people to change the way they live so that the disease can be prevented in the first place.

Dr. Peter Lurie, deputy director of the Health Research Group of Public Citizen, the government watchdog group, said the influence of pharmaceutical money can be very subtle.

'The question is what happens in the close calls,' he said. 'If you are at more cocktail parties, if you have more mugs from the company in your kitchen, you are just going to be more receptive.'

A.D.A. officials cited an event from several years ago to illustrate their resistance to such influence. An A.D.A. panel found that antipsychotic drugs could help fuel diabetes. The announcement angered a drug manufacturer, Eli Lilly and Company, a longstanding A.D.A. benefactor that stood to lose hundreds of millions of dollars in lawsuits.

Some A.D.A. officials said they believed the company became so angry it sought to have Dr. Kahn fired, a charge the company denies.

Either way, nothing happened. Dr. Kahn, the association�s chief scientific officer, kept his job.

'Show me one instance where money has caused us to do something that is wrong,' Dr. Kahn said in an interview. 'You can�t.'

One starts to wonder whether there is any large US health care non-profit corporation that does not receive a significant amount of funding from the for-proft health care sector.

It may be very hard to prove such relationships have caused not-for-profit organizations like the ADA to do "something wrong," especially if one demands a scientific level of proof of causation.

On the other hand, a not-for-profit that gets a large amount of money from, say, the pharmaceutical industry might be hesitant to be critical of the industry or its products, or prone to give the industry the benefit of a doubt.

But even such relatively subtle biases could put the industrial benefactor's interests ahead of the not-for-profit organization's own mission.

Large, stable funding streams from commercial firms may be tempting, but not-for-profit leaders must ask themselves if they are worth the doubts they ought to raise.

Princess Health and More Fall-Out from Allegations of Faculty Positions Traded for Referrals at UMDNJ. Princessiccia

Princess Health and More Fall-Out from Allegations of Faculty Positions Traded for Referrals at UMDNJ. Princessiccia

anechoic effect deferred prosecution agreement UMDNJ

Gusty 14:29 Add Comment

The latest development in the mess at the University of Medicine and Dentistry of New Jersey (UMDNJ) produced some interesting analysis in the media. 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 latest 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.

First, the indefatigable Newark Star-Ledger reported that Dr Jerrold Ellner, the chair of medicine at the UMDNJ Newark campus, was put on administrative leave because he and Ronald Pittore, of the school's legal department, "were identified by the university's federal monitor as key figures in UMDNJ's plan to hire at least 18 local cardiologists as part-time clinical assistant professors."

That event inspired a news analysis article in the New York Times. The points it made included,

As New Jersey�s state medical school has been shaken in the past year by disclosures of widespread financial mismanagement, administrators there have repeatedly defended the institution, the University of Medicine and Dentistry of New Jersey, by insisting that the scandals have affected its treasury but not the quality of care for the more than two million patients it treats each year.

But a federal monitor�s recent accusations that the cardiology unit at the university�s main hospital has been paying kickbacks to doctors for referring heart patients have undercut that argument at a time when the school�s future remains in doubt.

The fact that some of the university�s most prominent doctors now stand accused of taking part in an illegal scheme that involved life-or-death medical decisions is likely to further tarnish the school�s image at a time when state officials are deciding whether to merge the institution with Rutgers University and Robert Wood Johnson University Hospital.

Governor Corzine said on Wednesday that charges about the quality of care being affected by the scandal were deeply troubling � 'It�s really disgusting that the culture allowed for this kind of practice' � but added that he had not decided whether to restructure or disband the school.
But other state officials said the latest round of disclosures would only heighten pressure for a merger.

'This just highlights the disaster of trying to salvage what�s left,' said State Senator Raymond J. Lesniak, a Democrat from Union County who is chairman of a panel examining the future of the school. 'Before, the focus was on enhancing the ability to provide education. But now we�re also talking about direct impact on health care and people�s lives.'

On one hand, it is too bad that this analysis appeared in the Times' regional section. Although one would think that a scandal of this magnitude involving the biggest health care university in the US would attract national attention, as an example of the anechoic effect, it has been treated largely as a regional matter.

On the other hand, the analysis recounts some curious ideas about this case.

The first is that a scandal involving top leaders of the health care university had only financial significance, at least until a top physician leader was involved. Underlying this might be an asumption that the managerial and financial sphere of the university is entirely separate from the clinical and academic sphere. But the mismanagement in the former sphere must have sapped resources from the latter. Furthermore, it is hard to believe that clinical and academic personnel did not sense something wrong in the top management, and at least that the focus was more on the personal interests of the top management than the mission of the university. Such a sense would likely at least have dispirited these personnel, and certainly would not have enhanced their performance.

The second curious notion was that the involvement of a top physician-leader somehow signifies that the institution is now irredeemable, and the only remaining choices are to merge it into another institution, or shut it down entirely. This seems to discount, again, all the hard-working clinical and academic personnel who have been laboring to keep things together at UMDNJ together despite the bad behavior by top management. Maybe somebody should talk to this long-suffering group before any irrevocable decisions are made about the structure of the institution. And again, for better or worse, all should remember that health care institutions are made up of many dedicated hard-working people, besides the top managers. Perhaps again the underlying assumption is that somehow imperial top management is indistinguisable from the institution, the notion that "l'hospital c'est moi."

This notion must be discarded in favor of health care governance that is more representative of the relevant stake-holders, as well as more accountable, transparent, and ethical.