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Intensive Care: One Patient, 34 Days In the Hospital, a Bill For $5.2 Million --- He Had Internal Bleeding; Doctors at Duke Spared No Effort to Control It --- A Missing $7,000 Syringe By Ron Winslow. Wall Street Journal, Eastern edition; New York, N.Y. [New York, N.Y] 02 Aug 2001: A.1.

DURHAM, N.C. -- Stephen Dedrick, chief of pharmacy at Duke University Medical Center, returned an

urgent beeper message from his office one Friday morning to hear a startling report: His

department had just ordered $250,000 worth of one drug, for delivery overnight from California. It

was for a single patient. And it would last only through the weekend.

Even by the standards of the country's high-tech, high-cost health-care system, what followed was

an extraordinary episode in American medicine. Over 34 days of treatment, the patient ran up a bill

of $5.2 million. More than 95% of it was for drugs.

The patient, 69-year-old retired prison guard Slim Watson, had developed a rare disorder much like

hemophilia. The only remedy was a complex regimen of blood proteins and other drugs that

doctors hoped would halt his internal bleeding and restore his blood's ability to clot. Within days of

his admission to Duke's 16-bed intensive-care unit, Mr. Watson was going through IV bags of

clotting factor at a rate of $30,000 every four hours. The staff started calling him the million-dollar

man.

Just getting the drugs to his bedside became a huge logistical challenge, involving pig farms in

England, a biotech plant in Denmark and midnight trips to the local airport, where Duke staffers met

planes flying in fresh shipments of medicine. Doctors, pharmacists and nurses went to great

lengths coordinating Mr. Watson's care to make sure the highly perishable drugs were used with

maximum effect and minimal waste. "This was like a transfer of gold from Fort Knox," says Peter

Kussin, one of the intensive-care doctors.

Their treatment decisions had implications well beyond the fate of their patient. His extreme use of

blood factors exacerbated a global shortage of one medicine, posing a risk that others needing it

would be denied. And the case wreaked budgetary havoc as Duke Medical Center was in the midst

of a cost-saving initiative.

There was little likelihood that reimbursement from Medicare and a private plan would cover all of

the hospital's costs. "It was clear this was going to have an impact on our profitability," says

William J. Fulkerson Jr., Duke's chief medical officer, who kept senior administrators abreast of the

case as it progressed. "At the same time," he adds, "it was clear we were going to do what was best

for the patient."

Mr. Watson, after a 31-year career in the Pennsylvania prison system, had retired and returned with

his wife to their home state of North Carolina. They settled in a modest single-story brick home,

where Mr. Watson started a garden growing Swiss chard and other vegetables. An Army veteran,

he joined his local American Legion unit, serving for a time as its commander. Though bothered by

diabetes, heart problems and psoriasis, he had no reason to foresee a medical crisis late last

summer when he noticed some curious dark circles on his skin.

After a local hospital's tests showed he was anemic and bleeding internally, Mr. Watson was

admitted to Duke Medical Center on Oct. 10. There, doctors diagnosed a condition called acquired

factor VIII inhibitor. Antibodies produced by his immune system had begun attacking his factor VIII,

a protein critical to blood clotting. Most hemophiliacs lack this blood factor congenitally. But each

year, about 250 Americans with no previous clotting problems suddenly develop a factor VIII

disorder, for reasons that are mostly a mystery.

Sometimes it is associated with cancer, but doctors found no sign of that in Mr. Watson. They

couldn't figure out what caused his condition. But they determined he was bleeding somewhere in

his gastrointestinal tract. And they told him early on that if they couldn't stop it, he wouldn't

survive.

Still, the doctors were optimistic. Medicines developed over the past two decades have

transformed treatment of bleeding disorders. About 75% of people with acquired factor VIII

inhibitors are treated successfully, in most cases within a few days. "Usually you can get the

bleeding stopped," says Thomas Ortel, a Duke hematologist. "Then you can treat the underlying

cause of the antibody and the patient will frequently do fine."

One medicine is Hyate:C, a form of factor VIII derived from the blood of pigs. Made in Britain by

Ipsen Biopharm Ltd., a unit of Paris-based Beaufour Ipsen Group, it has been available in the U.S.

since 1986. But supplies have been crimped in the past five years by a virus infecting pigs

throughout the world.

To avoid viral contamination, the company says it discards up to 90% of harvested pig blood in the

initial stage of manufacturing. As a result, the blood of more than 20 pigs is needed to make one

small vial of powder-like crystals. That is one reason Hyate:C's wholesale price is about $1,000 a

vial.

A typical patient needs 15 to 24 vials just for the initial dose, Ipsen Biopharm says, with full

treatment usually taking about 100 vials. "Whenever we get a [Hyate:C] patient, we know we're in

for some big bucks," says John Kessler, Duke's deputy director of pharmacy.

Duke has had several patients with Mr. Watson's diagnosis in the past year. They all responded

more quickly than Mr. Watson, one leaving the hospital in just 72 hours. Charges for these patients

ran between $50,000 and $200,000.

Mr. Watson's case called for a second drug, a genetically engineered version of another blood

factor, VIIa. Novo Nordisk of Denmark sells it under the name NovoSeven. In part because of the

biotech drug's complex manufacturing requirements, NovoSeven costs $6,800 wholesale for one

small vial.

Doctors also gave Mr. Watson steroids and a cancer drug. They frequently put him through a

dialysis-like procedure called plasma pheresis, to try to filter out the culprit antibodies and allow his

own factor VIII to revive. He needed repeated blood transfusions. And throughout his stay, he

underwent numerous other tests and procedures aimed at finding out precisely where he was

bleeding, in hopes that doctors could cauterize the area and stop it.

These tests were unavailing. When doctors inspected his colon, they found pooled blood but no

lesions. High-tech X-ray and nuclear-scanning searches were inconclusive.

The doctors, nurses and pharmacists delivered all this care at a frenetic pace, and coordinating it

became a daunting challenge. Once, a pheresis team gave Mr. Watson his blood-filtering treatment

right after a nurse had given him a new IV bag of Hyate:C. Thousands of dollars worth of medicine

was cleansed from his system and wasted.

Pharmacy officials, growing concerned about the intense use of expensive blood factors, brought

the case to the attention of Duke's senior administrators. Like most nonprofit academic hospitals,

Duke constantly wrestles with how to make ends meet while handling its various missions: care for

both paying and indigent patients, plus ambitious programs of teaching and research. Squeezed by

managed care and tight Medicare reimbursement, Duke's health system would have been in the red

in fiscal 2000 but for investment income. On an operating basis, it lost $11 million on revenue of

$1.11 billion in the year ended June 30, 2000.

Duke had just launched an initiative that sought to cut its projected fiscal 2001 drug spending by

$4 million. As the Watson case grew more complex, one effect was quickly apparent: "It would take

that initiative and throw it out the window," says Michael Burke, chief financial officer of the Duke

health system.

Although Duke's top administrators rarely get involved in individual cases, this time they

intervened. Mr. Burke asked for a special effort to document all decisions about care and account

for every drop of blood factor, to put Duke in the best position for insurance reimbursement. Dr.

Fulkerson asked his top specialist on blood disorders, Dr. Ortel, to oversee the use of blood factors.

Staff members say none of the senior officials questioned the decision to treat Mr. Watson

aggressively.

Despite the Hyate:C and his other treatments, Mr. Watson's bleeding continued after his first week

at Duke. Doctors grew increasingly concerned that if they didn't stop it soon, he would turn

irretrievably for the worse. Even though surgery could be fatal to a patient with bleeding problems,

the doctors decided their best option was to remove the portion of his colon considered the most

likely source of the bleeding.

Dr. Ortel's first major task was to order mega-doses of Hyate:C for Mr. Watson's postsurgical

treatment. For several days after surgery, he went through it at a retail rate of more than $250,000

a day.

In the mixing room, where pharmacists and technicians prepare 2,000 custom doses of drugs a

day, pressure was intense. Just 15 of the daily doses were for Mr. Watson. But each Hyate:C dose

required as many as 30 vials, and fresh doses were needed every four hours.

As pharmacists reconstituted the powdered Hyate:C with sterile water, they had to take special

care to prevent the mixture from frothing, which would reduce its potency. Just preparing Mr.

Watson's medicines took up to four hours of staff time a day.

The pharmacy storeroom was busy, too. Duke keeps little Hyate:C and NovoSeven on hand. They

are too costly and needed too seldom, and unused vials usually can't be returned. So throughout

Mr. Watson's stay, the pharmacy had to get new shipments of at least one of the blood factors

several times a week.

Hyate:C, which must be kept frozen until shortly before it is used, posed special problems: It had to

be flown to Durham from Ipsen's distribution center in California packed in dry ice. Hospital

staffers regularly made the 20-minute drive to meet planes at Raleigh-Durham airport, often in the

middle of the night.

The task of coordinating much of this effort fell to Joanne "Bo" Latour, a clinical pharmacist who

has spent her entire 15 year-career at Duke working with patients in the ICU. She attended the

morning rounds at Mr. Watson's bedside, where Dr. Ortel and intensive-care-unit doctors reviewed

his status and determined what tests, procedures and transfusions he needed that day. Dr. Ortel

mapped out the blood-factor dosing plan, and then Ms. Latour worked with ICU nurses on timing of

blood tests to make sure the results would be valid. She scheduled the pheresis team's procedures

to avoid a repeat of the factor-cleansing mixup. She checked with the storeroom to make sure

enough blood factor was on hand.

"This case tested our limits of being able to devote so much for one patient, without doing it at the

expense of 700 other patients," says Mr. Dedrick, the pharmacy chief.

It was also a test for Mrs. Watson, 67, a tall, reserved woman who had worked as a clerical

supervisor in a clinic. She visited her husband on the unit every day, often spending nights in the

ICU waiting room. "It seemed like they were always doing something to him," she says. She was

grateful for the care and particularly comforted that nurses were always attending to him.

She gave little thought to how much it all cost. "I was just hoping it would save his life," she says.

Shortly after Mr. Watson emerged from surgery, on his ninth day at Duke, the effort started to pay

off. His blood count stabilized. His internal bleeding finally seemed to have stopped. For the first

time since his admission, doctors, nurses and pharmacists began to think their patient had turned

the corner.

To the staff on the 8200 unit, as Duke's ICU is known, Mr. Watson's progress was welcome news.

The unit's 16 high-tech beds are nearly always full, mostly with desperately ill patients who have

tubes in their throats and are unconscious or sedated. Doctors and nurses have few opportunities

to get to know them.

Mr. Watson was different. Though seriously ill, "he was sitting up in bed talking to all of his health-

care team," says Mr. Kessler, the deputy director of pharmacy. "He was not moribund with tubes

and ventilators and at Death's door."

Despite all the procedures and discomfort, Mr. Watson rarely complained. When staffers passed

near his room, he waved hello. He called one doctor "Smiley." He nicknamed a nurse "Sarge" after

she took away a cracker he wanted to eat. He told Dr. Ortel he shouldn't have to come to work on a

Saturday.

Though never told how expensive his care was, he knew of his "million-dollar man" nickname. More

than once, he told his doctors he thought they should be spending the money on someone

younger.

"He was very charming," says Loretta Que, the attending physician in the ICU during the early part

of the case. "He appreciated what you were doing and he told you so." On weekends, Mr. Watson

had a steady stream of guests, friends from his church and the American Legion in addition to

family members, many in from out of state.

Staying comfortable was difficult. He used a trapeze-like bar attached to his bed to pull himself up

and adjust his long frame. He was frustrated that he couldn't get out of bed. "That didn't suit him,"

Mrs. Watson says. "But he always stayed in a good frame of mind."

After the surgery, Mr. Watson's condition held steady for about five days. But on the sixth day, the

beginning of his third week at Duke, he suffered a setback. His stomach hurt and his blood count

dropped. The internal bleeding resumed.

Dr. Ortel determined that Mr. Watson was becoming resistant to the factor VIII from pigs, a

common occurrence with extended use of the drug. He switched Mr. Watson to NovoSeven, the

bioengineered blood factor from Denmark.

This one didn't pose the same delivery problems, but it had to be prepared more frequently. Mr.

Watson continued to need transfusions, tests and procedures aimed at finding the bleeding source,

all requiring intricate coordination. Once, Ms. Latour saw a technician from the mixing room deliver

a $7,000 syringe of NovoSeven to the unit, but when a nurse went to use it, it was nowhere to be

seen. After a nerve-racking search, Ms. Latour was about to order a remake when the syringe

turned up, folded in the pages of the medical chart.

As costs mounted far beyond anything encountered before, even in other cases of acquired factor

VIII inhibitor, Duke's pharmacists consulted colleagues at other institutions and scoured medical

studies to see how any similar case might have been handled. "We found nothing that we could

look to and say, at this level of cost, here are the guidelines," says Mr. Kessler.

On Nov. 1, Mr. Watson's 21st day at Duke, Dr. Kussin took charge of the ICU as part of a regular

rotation among intensive-care specialists. Like others, he was immediately impressed with Mr.

Watson's good-natured stoicism.

But within a couple of days, Dr. Kussin began to lose the enthusiasm shared by other members of

the team for their patient's prospects. Mr. Watson hadn't regained bowel function after the surgery

and he was being fed intravenously because he couldn't eat or drink through his mouth -- two

critical indicators that he wasn't getting better. Doctors ruled out a second surgical effort to stop

the bleeding. Even if surgeons could find the source, there was little confidence now that they

could keep him from bleeding to death in the operating room.

With a fresh perspective on a case that others had been living with for three weeks, Dr. Kussin

began asking the medical team during morning rounds how they felt about continuing the regimen

of costly blood factors for Mr. Watson. Such questions are routine at the ICU, where 20% of

patients die and many others are discharged to nursing homes where they won't recover from their

illnesses. ICU staffers are often confronted with terminally ill patients hooked up to high-tech

medical gear that isn't likely to do much good.

"There's a lot of waste," Ms. Latour says. "We talk about it a lot."

There are successes, too. During Mr. Watson's stay, Yvonne Spurney, nurse manager of the ICU,

was herself a patient there, after aggressive treatment for cancer. She recovered and is back on the

job. "We're not a glamorous unit," she says, "but we are people's hope."

When Dr. Kussin first posed his question about Mr. Watson, no one raised any doubts about

continuing treatment. Though Mr. Watson wasn't getting better, he wasn't getting much worse,

either. Kay Wellemeyer, a nurse on the unit, says she struggles with the ethics of high-cost care

provided to comatose patients whose prospects appear dim. "I never felt that about him," she says.

Dr. Ortel also favored staying the course. Mr. Watson's heart, kidneys and other organs seemed to

be holding up. Unlike some patients with coagulation problems, he wasn't bleeding from his nose

or gums or even from the skin punctures for IV lines and blood draws. If they could just stop the

internal source, Dr. Ortel reasoned, Mr. Watson would be in the clear.

Dr. Kussin deferred to Dr. Ortel and the others. As the attending physician, he says, he finds it's

important "to let the rest of the team get comfortable that they've done everything they can."

NovoSeven, like the other blood factor, seemed to help, but not fully take hold for Mr. Watson.

"There were times when he seemed to stabilize, and then he would start oozing again," Dr. Ortel

says. "Just when we thought, `OK, we've turned a bend here,' the next lab result would be lower."

Then, on Nov. 9, Mr. Watson's 30th day at Duke, his condition suddenly worsened. His stomach and

lower body swelled with blood. He became short of breath. His kidneys began to fail. After one last

attempt to find a bleeding site, the medical team discussed the situation among themselves and

with Mr. Watson's family.

"At that point, I think everybody agreed that we had tried everything we could," Dr. Ortel says.

Mr. Watson seemed to have had enough as well. "He said he got his spiritual side together and got

his soul right with God," recalls Mrs. Watson, his wife of 46 years, tears welling. Over the next

couple of days, his two daughters, his son, his two brothers and Mrs. Watson spent time with him

one by one. "We told him if he wanted to go, he could," Mrs. Watson says.

The blood-factor treatment was stopped, and Mr. Watson was put on sedatives to ease his

discomfort. On the afternoon of Nov. 13, with several of his family members at his side, he smiled

and blinked. "Finally, he just closed his eyes," Mrs. Watson says.

In the end, what made the case so costly was the persistent uncertainty of its outcome. If Mr.

Watson had been dying of another disease, use of blood factors probably would have been much

more limited, his doctors say. If he had responded quickly, as often happens, he wouldn't have

needed so much of them. For most of his stay, he was neither dying nor getting better. "Fifty-fifty

cases are the toughest and most expensive to be in," Dr. Kussin says.

"As a business decision," treating Mr. Watson "wasn't a great one," Dr. Kussin concedes. He notes

that "our hospital has always told us to spend what we need to take care of people." But as a

physician who has also served as a senior administrator, he says, "This amount of money has

never been put on the table before for one patient. When does a hospital have the right to say,

`Time out'?"

Duke's insurance reimbursement from Medicare, plus a private plan, was $2.5 million. Hospitals

have to accept this as payment in full. The family wasn't billed. In the end, owing to the complex

way Duke bills for overhead and other expenses, it says it took a loss of $800,000 on the case.

The charges on the bill included $1.9 million for NovoSeven and $2.9 million for Hyate:C, the factor

made from pigs' blood. Ipsen says it sold U.S. hospitals 10 million units of Hyate:C last year for 163

patients. More than 980,000 of those units, nearly 10%, were given to Mr. Watson alone.

Duke's final bill ran to 45 pages. The column where the charge for each item appeared wasn't wide

enough for numbers higher than five figures and two decimal points. Daily six-figure charges for

blood factors ran over into an adjacent column.

On the last page, the total reads: $214,333.50. The "5," as in $5 million, doesn't appear. The format

couldn't handle a number that large.