Zyprexa: Mother Wonders if Psychosis Drug Helped Kill Son

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January 4, 2007

Mother Wonders if Psychosis Drug Helped Kill Son

By ALEX BERENSON

 

http://www.nytimes.com/2007/01/04/business/04drug.html?ex=1325566800 & en=f68391e7\

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At first, the psychiatric drug Zyprexa may have saved Kauffman’s

life, rescuing him from his hallucinations and other symptoms of acute

psychosis.

But while taking Zyprexa for five years, Mr. Kauffman, who had been a soccer

player in high school and had maintained a normal weight into his mid-30s,

gained about 80 pounds. He was found dead on March 27 at his apartment in

Decatur, Ga., just outside Atlanta.

An autopsy showed that the 41-year-old Mr. Kauffman, who was 5 feet 10

inches, weighed 259 pounds when he died. His mother believes that the weight

he gained while on Zyprexa contributed to the heart disease that killed him.

Eli Lilly, which makes Zyprexa, said in a statement that Mr. Kauffman had

other medical conditions that could have led to his death and that “Zyprexa

is a lifesaving drug.” The company said it was saddened by Mr. Kauffman’s

death.

No one would say Mr. Kauffman had an easy life. Like millions of other

Americans, he suffered from bipolar disorder, a mental illness characterized

by periods of depression and mania that can end with psychotic

hallucinations and delusions.

After his final breakdown, in 2000, a hospital in Georgia put Mr. Kauffman

on Zyprexa, a powerful antipsychotic drug. Like other medicines Mr. Kauffman

had taken, the Zyprexa stabilized his moods. For the next five and a half

years, his illness remained relatively controlled. But his weight ballooned

— a common side effect of Zyprexa.

His mother, Millie Beik, provided information about Mr. Kauffman, including

medical records, to The New York Times.

For many patients, the side effects of Zyprexa are severe. Connecting them

to specific deaths can be difficult, because people with mental illness

develop diabetes and heart disease more frequently than other adults. But in

2002, a statistical analysis conducted for Eli Lilly found that compared

with an older antipsychotic drug, Haldol, patients taking Zyprexa would be

significantly more likely to develop heart disease, based on the results of

a clinical trial comparing the two drugs. Exactly how many people have died

as a result of Zyprexa’s side effects, and whether Lilly adequately

disclosed those risks, are central issues in the thousands of

product-liability lawsuits pending against the company, and in state and

federal investigations.

Because Mr. Kauffman also smoked heavily for much of his life, and led a

sedentary existence in his last years, no one can be sure that the weight he

gained while on Zyprexa caused his heart attack.

Zyprexa, taken by about two million people worldwide last year, is approved

to treat schizophrenia and bipolar disorder. Besides causing severe weight

gain, it increases blood sugar and cholesterol in many people who take it,

all risk factors for heart disease.

In a statement responding to questions for this article, Lilly said it had

reported the death of Mr. Kauffman to federal regulators, as it is legally

required to do. The company said it could not comment on the specific causes

of his death but noted that the report it submitted to regulators showed

that he had “a complicated medical history that may have led to this

unfortunate outcome.”

“Zyprexa,” Lilly’s statement said, “is a lifesaving drug and it has helped

millions of people worldwide with schizophrenia and bipolar disorder regain

control of their lives.”

Documents provided to The Times by a lawyer who represents mentally ill

patients show that Eli Lilly, which makes Zyprexa, has sought for a decade

to play down those side effects — even though its own clinical trials show

the drug causes 16 percent of the patients who take Zyprexa to gain more

than 66 pounds after a year.

Eli Lilly now faces federal and state investigations about the way it

marketed Zyprexa. Last week — after articles in The Times about the Zyprexa

documents — Australian drug regulators ordered Lilly to provide more

information about what it knew, and when, about Zyprexa’s side effects.

Lilly says side effects from Zyprexa must be measured against the

potentially devastating consequences of uncontrolled mental illness. But

some leading psychiatrists say that because of its physical side effects

Zyprexa should be used only by patients who are acutely psychotic and that

patients should take other medicines for long-term treatment.

“Lilly always downplayed the side effects,” said Dr. S. Nassir Ghaemi, a

specialist on bipolar disorder at Emory University in Atlanta. “They’ve

tended to admit weight gain, but in various ways they’ve minimized its

relevance.”

Dr. Ghaemi said Lilly had also encouraged an overly positive view of its

studies on the effectiveness of Zyprexa as a long-term treatment for bipolar

disorder. There is more data to support the use of older and far cheaper

drugs like lithium, he said.

Last year, Lilly paid $700 million to settle 8,000 lawsuits from people who

said they had developed diabetes or other diseases after taking Zyprexa.

Thousands more suits are still pending.

But Ms. Beik is not suing Lilly. She simply wants her son’s case to be

known, she said, because she considers it a cautionary tale about Zyprexa’s

tendency to cause severe weight gain. “I don’t think that price should be

paid,” she said.

Mr. Kauffman’s story, like that of many people with severe mental illness,

is one of a slow and steady decline.

Growing up in DeKalb, Ill., west of Chicago, he acted in school plays and

was a goalie on the soccer team. A photograph taken at his prom in 1982

shows a handsome young man with a messy mop of dark brown hair.

But in 1984, in his freshman year at Beloit College in Wisconsin, Mr.

Kauffman suffered a breakdown and was found to have the most severe form of

bipolar disorder. He returned home and, after medication stabilized his

condition, enrolled in Northern Illinois University. He graduated from there

in 1989 with a degree in political science.

For the next year, he worked as a bus driver ferrying senior citizens around

DeKalb. In a short local newspaper profile of him in 1990, he listed his

favorite book as “Catch-22,” his favorite musician as Elvis Costello, and

his favorite moment in life as a soccer game in which he had made 47 saves.

A few months later, he followed his mother and stepfather to Atlanta and

enrolled in Georgia State University, hoping to earn a master’s degree in

political science.

“He wanted so much to become a political science professor,” Ms. Beik said.

But trying to work while attending school proved to be more stress than Mr.

Kauffman could handle, Ms. Beik said. In 1992, he suffered his most severe

psychotic breakdown. He traveled around the country, telling his parents he

intended to work on a political campaign. Instead, he spent much of the year

homeless, and his medical records show that he was repeatedly admitted to

hospitals.

Mr. Kauffman returned home at the end of 1992, but he never completely

recovered, Ms. Beik said. He never worked again, and he rarely dated.

In 1994, the Social Security Administration deemed him permanently disabled

and he began to receive disability payments. He filed for bankruptcy that

year. According to the filing, he had $110 in assets — $50 in cash, a $10

radio and $50 in clothes — and about $10,000 in debts.

From 1992 to 2000, Mr. Kauffman did not suffer any psychotic breakdowns,

according to his mother. During that period, he took lithium, a mood

stabilizer commonly prescribed for people with bipolar disorder, and

Stelazine, an older antipsychotic drug. With the help of his parents, he

moved to an apartment complex that offered subsidized housing.

But in late 1999, a psychiatrist switched him from lithium, which can cause

kidney damage, to Depakote, another mood stabilizer. In early 2000, Mr.

Kauffman stopped taking the Depakote, according to his mother.

As the year went on, he began to give away his possessions, as he had in

previous manic episodes, and became paranoid. During 2000, he was repeatedly

hospitalized, once after throwing cans of food out of the window of his

sixth-floor apartment.

In August, he was institutionalized for a month at a public hospital in

Georgia. There he was put on 20 milligrams a day of Zyprexa, a relatively

high dose.

The Zyprexa, along with the Depakote, which he was still taking, stabilized

his illness. But the drugs also left him severely sedated, hardly able to

talk, his mother said.

“He was so tired and he slept so much,” Ms. Beik said. “He loved

Shakespeare, and he was an avid reader in high school. At the end of his

life, it was so sad, he couldn’t read a page.”

In addition, his health and hygiene deteriorated. In the 1990 newspaper

profile, Mr. Kauffman had called himself extremely well-organized. But after

2000, he became slovenly, his mother said. He spent most days in his

apartment smoking.

A therapist who treated Mr. Kauffman while he was taking Zyprexa recalls him

as seeming shy and sad. “He was intelligent enough to have the sense that

his life hadn’t panned out in a normal fashion,” the therapist said in an

interview. “He always reminded me of a person standing outside a house with

a party going on, looking at it.”

The therapist spoke on the condition that her name not be used because of

rules covering the confidentiality of discussions with psychiatric patients.

As late as 2004, Mr. Kauffman prepared a simple one-page résumé of his

spotty work history — evidence that he perhaps hoped to re-enter the work

force. He never did.

As Mr. Kauffman’s weight increased from 2000 to 2006, he began to suffer

from other health problems, including high blood pressure. In December 2005,

a doctor ordered him to stop smoking, and he did. But in early 2006, he

began to tell his parents that he was having hallucinations of people

appearing in his apartment.

On March 16, a psychiatrist increased his dose of Zyprexa to 30 milligrams,

a very high level.

That decision may have been a mistake, doctors say. Ending smoking causes

the body to metabolize Zyprexa more slowly, and so Mr. Kauffman might have

actually needed a lower rather than higher dose.

A few days later, Mr. Kauffman spoke to his mother for the last time. By

March 26, they had been out of contact for several days. That was unusual,

and she feared he might be in trouble. She drove to his apartment building

in Decatur the next day and convinced the building’s manager to check Mr.

Kauffman’s apartment. He was dead, his body already beginning to decompose.

An autopsy paid for by his mother and conducted by a private forensic

pathologist showed he had died of an irregular heartbeat — probably, the

report said, as the result of an enlarged heart caused by his history of

high blood pressure.

Ms. Beik acknowledged she cannot be certain that Zyprexa caused her son’s

death. But the weight gain it produced was most likely a contributing

factor, she said. And she is angry that Eli Lilly played down the risks of

Zyprexa. The company should have been more honest with doctors, as well as

the millions of people who take Zyprexa, she said.

Instead Lilly has marketed Zyprexa as safer and more effective than older

drugs, despite scant evidence, psychiatrists say.

Ms. Beik notes that Stelazine — an older drug that is no longer widely used

even though a federally financed clinical trial showed it works about as

well as Zyprexa — stabilized Mr. Kauffman’s illness for eight years without

causing him to gain weight.

“He was on other drugs that worked,” she said.

 

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