Monday, November 24, 2008

upmc 99.upm.2 Louis J. Sheehan, Esquire

The University of Pittsburgh Medical Center once dominated the lucrative business of liver transplants. But as the procedure grew more common, competition from other hospitals eroded its monopoly.

Earlier this decade, UPMC made an aggressive bid to reclaim its leadership by hiring an innovative surgeon named Amadeo Marcos, who promised to double the number of liver transplants the hospital did.

Dr. Marcos delivered on his pledge. In doing so, however, he resorted to practices that some colleagues found questionable. To overcome a perennial shortage of organs, he used more livers from older donors. He transplanted some of these into relatively healthy patients for whom the risk-reward calculation was less certain. He used partial livers from living donors, and then understated complications from the controversial procedure.
[UPMC] John Carreyrou/The Wall Street Journal

UPMC relocated its headquarters into Pittsburgh's tallest skyscraper, the 62-story U.S. Steel Tower.

UPMC is a nonprofit hospital system whose income is largely exempt from taxes. Yet, it is increasingly run like a for-profit company, paying its executives high salaries, jumping into new activities and expanding abroad. Its quest to ramp up its transplant business shows how a drive for higher revenue, now common at nonprofit hospitals, could risk compromising patient care.

UPMC asked Dr. Marcos to resign in March for what it says was a code-of-conduct breach unrelated to patient care. It says it stands by his clinical work, noting that one-year survival rates for liver-transplant recipients improved in the three full years of his tenure as head of its program.

"It would be incorrect to insinuate that financial motives drove" the transplant program under Dr. Marcos, said a UPMC spokesman, though he acknowledged that stepping up transplant volume was one reason the surgeon was recruited. "Our core mission is nothing less than providing the best and most appropriate care for patients," said the spokesman, Paul Wood.
Terms of Employment

Read UPMC's employment offer letter to Dr. Marcos, plus an internal email about the plan to bring him on staff.

Dr. Marcos, 46 years old when he left UPMC, did not respond to numerous attempts to reach him, including a letter sent to his home. A lawyer who represented him in a court case last year said he hadn't been in contact with Dr. Marcos for months.

Dr. Marcos's nearly six years at UPMC coincided with rapid growth at the medical center. UPMC is one of the nation's most financially successful nonprofit hospital systems, with operations ranging from Pennsylvania to Ireland and Qatar. Even though three-quarters of its $7 billion in annual revenue is exempt from federal and local taxes, UPMC has acquired many of the trappings of large, for-profit corporations.

Its chief executive, Jeffrey Romoff, earned $4 million in the fiscal year ended June 30, 2007, and 13 other employees earned in the roughly $1 million to $2 million range. For their transportation, UPMC leases a corporate jet. Earlier this year, UPMC relocated its headquarters into Pittsburgh's tallest skyscraper, the 62-story U.S. Steel Tower.

The transplant program is a source of both profits and prestige that UPMC leverages to attract star doctors and build its other businesses, which include a health-insurance arm. Hospitals charge $400,000 to $500,000 for a liver transplant. UPMC's transplant program produced $130 million of revenue in its latest fiscal year.

UPMC became a leader in the field in 1981 by hiring Thomas Starzl, the first surgeon to successfully transplant a human liver. He turned Pittsburgh into the world's transplantation capital. At its peak in the mid-1980s, UPMC was performing about 600 liver transplants a year.
[Transplants]

It took the franchise abroad, creating, for instance, a center in Sicily. But as many other U.S. hospitals began doing the procedure, the annual total UPMC performed fell to 132 in 2001.

The next year, UPMC set out to hire a surgeon who could restore the program to its former glory. It settled on Dr. Marcos, a dashing Venezuelan with a taste for Ferraris and Porsches, who specialized in the emerging field of transplants from living donors.

He promised to double liver-transplant volume in his first year and to bring with him pairs of living donors and recipients from where he then worked, the University of Rochester (N.Y.) Medical Center, say people familiar with his recruitment. In a May 14, 2002, email to UPMC's chief executive, a top UPMC official said Dr. Marcos had boasted "he can do five liver transplantations per week."

But he carried some baggage. In March 2000, Dr. Marcos had been pressured to resign from the Virginia Commonwealth University School of Medicine after a colleague there filed a complaint with the Equal Employment Opportunity Commission alleging he sexually assaulted her, a letter the state's Board of Medicine later sent to Dr. Marcos shows. The woman, a postdoctoral fellow in the medical school's psychiatry department, also filed a federal suit against Dr. Marcos and the university that was later dismissed.

UPMC officials learned of the allegation during the vetting process, says John Fung, a surgeon who then headed the transplant program. Dr. Fung says the CEO, Mr. Romoff, played down the concerns it raised and that Mr. Romoff and Dr. Marcos "saw eye-to-eye on volume and profit."

UPMC declined to make Mr. Romoff available for an interview. Mr. Wood, the spokesman, said that Dr. Marcos denied the sexual-assault allegations and "there were no court findings to support them."

Mr. Wood acknowledged that transplant volume was a consideration in the hiring. He said "UPMC was just trying to claw back" volume it had lost.

UPMC offered Dr. Marcos $500,000 a year and "additional incentive payments," a letter dated June 21, 2002, shows. Dr. Marcos came aboard as director of clinical transplantation, reporting to Dr. Fung. http://Louis2J2Sheehan2Esquire.US
[upmc] John Carreyrou/The Wall Street Journal

UPMC's organ-transplant program is based at UPMC Montefiore.

Liver-transplant volume in Dr. Marcos's first full year there jumped to more than double the volume in the year before he came, according to data from the United Network for Organ Sharing, or UNOS. But the way he boosted it raised questions for some colleagues. http://Louis2J2Sheehan2Esquire.US

A shortage of transplantable organs from cadavers is a perennial constraint on the number of liver transplants. Dr. Marcos overcame this in part by using organs from so-called expanded-criteria donors -- deceased people who had been older or sicker than preferred liver donors.

In the 2½ years before Dr. Marcos joined UPMC, the average age of its deceased liver donors was 41, according to UNOS. By 2003, it was 47, or nine years above the national average.

And while in 2000 and 2001, UPMC used an average of only 10 livers a year from patients older than 65, it used 45 in 2003.

Dr. Marcos put some of these organs into patients who were in the early stages of liver disease, say Dr. Fung and Howard Doyle, who then worked in UPMC's transplant intensive-care unit. These were patients, they say, who sometimes didn't need a transplant.

"For the first time in years, we had people dying on the operating table or in the ICU," says Dr. Doyle, now director of surgical critical care at Montefiore Medical Center in New York. At times, according to him, patients healthy enough to walk into the hospital before being transplanted died "because they had a high-risk liver put into them."

Data from the Scientific Registry of Transplant Recipients show that during Dr. Marcos's time at UPMC, 30 liver recipients died within two days of surgery. That was a death rate of 2.4%, versus a national average of 1.6%. UPMC's Mr. Wood counters that in 2005-2007, the three complete years Dr. Marcos headed the transplant program, one-year survival rates for liver recipients improved to 84.1% from 81.2%.

Mr. Wood says UPMC used only 3% of the expanded-criteria organs that became available. "If our motivation was strictly financial, this percent would be much greater," he said.

Liver patients are ranked by how advanced their disease is. Based on a series of blood tests called MELD, scores range from 40 for the sickest to six for the healthiest. Most experts now believe the risks of a transplant generally outweigh the benefits for patients with MELD scores of 14 or lower.

During Dr. Marcos's nearly six years at UPMC, it performed 441 liver transplants on patients with scores of 14 or lower, according to UNOS. That was 35% of the liver transplants performed during his tenure, and compares with fewer than 7% in the 2½ years before he arrived.

Mr. Wood says it wasn't until 2006 that the transplant community coalesced around a score of 15 as a cutoff to allocate organs. "It would be unrealistic to expect a physician to practice according to yet-to-be-discovered criteria," he said.

Drs. Fung and Doyle say they became increasingly uncomfortable with what they considered the UPMC transplant program's relentless pursuit of volume and revenue. Both left in 2004.

Mr. Wood says Dr. Fung never raised his concerns with his superiors and gave Dr. Marcos good performance reviews. Dr. Fung says that he did raise them and that he once told Mr. Romoff that UPMC was paying a penalty with the use of bad organs.

"I couldn't square my own ethics with what was going on," said Dr. Fung, now chief of surgery at the Cleveland Clinic. "I didn't feel like the decisions that were being taken had the patient's best interest at heart."

In 2004, the New York State Department of Health fined Dr. Marcos's former employer, the University of Rochester Medical Center, for circumventing state organ-allocation rules between 2000 and 2003, during much of which time Dr. Marcos had been in charge of the program. The news didn't affect his standing at UPMC. He became head of the transplant program after Dr. Fung left that year.

Besides using more expanded-criteria livers, Dr. Marcos sharply increased the number of transplants from living donors. In these, part of the liver of a healthy person is cut off and grafted into a sick patient. If all goes well, both pieces eventually grow to normal size. The procedure is controversial because it could be risky for the otherwise healthy donor.

UPMC did 150 such surgeries while Dr. Marcos was there, according to UNOS. No donors died. However, in 69% of the cases, the recipient had a MELD score of 14 or lower -- suggesting that UPMC was putting some living donors at risk to do transplants on patients in which the risks of the operation may have outweighed the benefits.

UPMC's answer is that Dr. Marcos's use of organs from living donors saved lives, because about 50 patients on UPMC's waiting list die each year for lack of a transplantable organ.

Dr. Starzl, the pioneering surgeon for whom UPMC's transplant program is named, had long been wary of the safety of the living-donor procedure. Though long retired, the 83-year-old doctor continues to do research from an office on campus.

In early 2007, he became suspicious of the low complication rates Dr. Marcos was reporting in adult living-donor liver transplants, say people familiar with the matter. In a textbook Dr. Marcos co-wrote, he said UPMC's rate of serious complications was zero for donors and 34% among a subset of recipients.

Dr. Starzl reviewed the 121 transplants UPMC had done involving removal of the donor's right lobe, a typical procedure in adult-to-adult living-donor liver transplants. Dr. Starzl's finding, according to people with knowledge of it: Though recipients' survival rate was only slightly lower than the national average, 60% of the recipients suffered life-threatening complications, ranging from bile-duct leaks to blood-supply problems -- nearly double the rate Dr. Marcos reported.

Dr. Starzl raised his concerns with UPMC chief Mr. Romoff and other officials, including the head of the department of surgery, Timothy Billiar, say the people familiar with the situation.

A tense six-month standoff ensued. Dr. Starzl, worried that UPMC was covering the matter up, sent his findings to a medical journal, according to people familiar with the events. Dr. Billiar asked it not to publish, on the ground that Dr. Starzl hadn't obtained patient authorization to collect the data. Dr. Billiar says that Dr. Starzl's paper would have jumped the gun on a peer-reviewed internal study he had requested from another surgeon, Wallis Marsh.

UPMC and Dr. Starzl compromised: Dr. Starzl would wait for the internal study, which would be reviewed by Pierre-Alain Clavien, a Zurich surgeon who pioneered a scale to measure complications in living-donor liver transplants. UPMC's final conclusions would be published.

In January, Dr. Marsh and Dr. Clavien confirmed Dr. Starzl's finding of a 60% rate of serious complications among recipients, documents seen by The Wall Street Journal show. The review also concluded that about 10% of the living donors had suffered serious complications, belying Dr. Marcos's claim that this number was zero.

By then, Dr. Marcos was on thin ice at UPMC for another reason: He was having affairs with co-workers. A social worker who met him during an assignment at UPMC and dated him says Dr. Marcos beat her in front of her house one night in June 2007 after an argument, and police passing in a car arrested him.

A Pittsburgh Post-Gazette article described the arrest, citing court records. The records later were expunged after Dr. Marcos completed anger-management classes, according to his attorney in the case, Robert Del Greco. The woman recounted the incident in an interview.

By the fall of 2007, the married Dr. Marcos had started dating another woman, a physician's assistant on the kidney-transplant team, four people with knowledge of the relationship say. After it soured early this year, the woman filed a complaint against Dr. Marcos with a top transplant-program official. She didn't return calls seeking comment. UPMC says it won't discuss personnel issues. http://Louis2J2Sheehan2Esquire.US

UPMC asked Dr. Marcos to resign in early March for what it referred to as a violation of its code of conduct. It declines to elaborate on the nature of the violation. Mr. Wood, the spokesman, said the dismissal had "nothing to do with patient care or surgical issues." http://Louis2J2Sheehan2Esquire.US

Randy Juhl, the University of Pittsburgh's vice chancellor for research conduct and compliance, referring to Dr. Marcos's relationships and reporting of surgery complications, said the university is "very disappointed" in him. "He did give himself and us a big black mark."

UPMC says Dr. Marsh, whom it has since named interim head of the transplant program, and Dr. Starzl now are working together on a paper about complication rates in living-donor transplants and will submit it to a scientific journal. Adult living-donor liver transplants at UPMC have ground to a halt, although UPMC says it hasn't abandoned the procedure.Louis J. Sheehan, Esquire

Monday, November 17, 2008

dementia 2998.dem.111 Louis J. Sheehan, Esquire

It's plenty tough to grow old when you live alone and have no satisfying contacts with either relatives or friends. Such isolation carries an added burden, however. It sharply boosts a person's chances of developing Alzheimer's disease or related brain ailments associated with advancing age, according to a 3-year investigation of elderly Swedes. http://Louis-j-sheehan-esquire.us

In contrast, marriage and a fulfilling social life appear to protect the elderly against these brain disorders, generally categorized as dementia, concludes a team headed by epidemiologist Laura Fratiglioni of the Stockholm Gerontology Research Centre.

What's more, susceptibility to dementia rises steadily as social isolation intensifies, the researchers report in the April 15 Lancet. http://Louis-j-sheehan-esquire.us

"A poor social network may act as a precipitating factor for dementia, whereas an extensive social network can delay such an [outcome] by providing emotional and intellectual stimulation," Fratiglioni says. The biological mechanisms by which social isolation promotes dementia are unknown, she adds.

Several earlier studies conducted by other investigators showed increased death rates among elderly people with few or no regular social contacts. The frequent development of dementia in this group may partly account for those findings, Fratiglioni now proposes.

The researchers studied 1,203 people, all at least 75 years old, living at home in Stockholm. Participants scored well on a standard test of mental functioning, and none exhibited medical signs of dementia.

Nurses interviewed each volunteer about his or her social life. A total of 84 individuals cited an extensive social network, which consisted of living with a spouse, maintaining regular, satisfying contacts with children, and having rewarding relationships with other relatives or friends. Another 880 people had a moderate social network that included any two of those three factors. A limited social network, consisting of a single factor, characterized 226 participants.

Finally, the 13 people with poor social networks lived alone and weren't in contact with relatives or close friends.

During the next 3 years, 176 cases of dementia—mainly Alzheimer's disease but also some instances of dementia from damage caused by multiple strokes—developed in the Swedish sample.

The lowest incidence of dementia occurred among study participants with an extensive social network. Significantly higher rates of dementia emerged among volunteers with progressively more limited social networks.

The findings held for both men and women and for individuals who began the study with and without depression symptoms.

Marriage represented the strongest single protective factor against dementia, the scientists hold. Unless they also had other satisfying relationships, widowed or divorced participants living with an unmarried partner exhibited a higher risk of dementia than married people did.

Elderly individuals who had infrequent but satisfying contacts with children and friends still displayed a relatively low incidence of dementia. In contrast, participants citing frequent, unpleasant contacts with their children developed dementia even more often than did those who had no children. http://Louis-j-sheehan-esquire.us

The study didn't account for participation in religious or secular organizations. The researchers also can't say whether the people with poor or limited social networks had long led isolated lives or had abruptly lost many of their previous contacts at some time more than 3 years before the study began. http://Louis-j-sheehan-esquire.us

Still, the new data support the need for the elderly to interact with a variety of people in fulfilling ways, psychologist Lisa F. Berkman of the Harvard School of Public Health in Boston remarks in the same journal.

"Being alone is what is risky, not living alone," she says. Scientists should examine whether certain living arrangements, such as group homes, protect against dementia in the elderly, Berkman adds.

Thursday, November 13, 2008

heart 4.hea.111 Louis J. Sheehan, Esquire

Louis J. Sheehan, Esquire. It's been a frustrating discrepancy in health for more than a decade: Young women who suffer heart attacks and go to the hospital for treatment have been twice as likely to die as young men. Now, that gender gap is narrowing.

Louis J. Sheehan, Esquire. Women under 55 are about 30 percent more likely to die in the hospital after having a heart attack than their male peers, according to research presented yesterday at the American Heart Association conference in New Orleans.

Louis J. Sheehan, Esquire. Between 2005 and 2006, 2.4 percent of women under 55 died, a drop from the 5.1 percent who died in 1994 to 1995. Between 2004 and 2006, 1.8 percent of men younger than 55 died in the hospital after experiencing heart attacks, compared with 2.7 percent in 1994 to 1995.

"What we can see is a favorable trend," says Viola Vaccarino, a professor of medicine at Emory University School of Medicine who analyzed 916,380 heart attack patients over 12 years from the National Registry of Myocardial Infarction, a database of treatment information on some of the country's cardiac patients. "The excess mortality we noted early on is narrowing now, which is overall a good sign."

About 1.1 million people in the U.S. suffer heart attacks annually, and half of them die, according to the National Heart Lung and Blood Institute. Possible gender gaps in mortality for those who suffer heart attacks and don't go to the hospital are tougher to pin down, Vaccarino says. http://Louis-J-Sheehan.de

The reasons for the change aren't entirely clear. One possible factor may be that women's risk factors for heart attacks, such as diabetes, high cholesterol and blood pressure, aren’t worsening as much as men's are, Vaccarino says.

Still, the gap hasn’t disappeared. Studies have noted that young women whose heart attack symptoms are atypical are more likely to be misdiagnosed than are men, and that older African American women are less likely to get reperfusion therapy that restores blood flow to the heart than men are. The use of those therapies in women didn't change much between the mid-90s and 2006, Vaccarino says.

"Because there is more attention to heart disease in women, patients as well as physicians may be more aware of this and doing a better job of alerting women of their risk. Women may be willing to go to the hospital sooner," she says. "But there is still excess mortality, so it's not completely gone, but it's much better than before."