http://www.latimes.com/news/nation/reports/fda/lat_serzone001220.htm
Wednesday, December 20, 2000
A Girl Is Given an Adult Medicine and She Pays a Heavy Price
Serzone: Company hasn't published study of effect on children.
By DAVID WILLMAN, Times Staff Writer
Alissa Robinson, 18, looks out the front door of her family's
Norwood, Ohio home while her parents Jimmie and Brenda enjoy a warm
autumn afternoon on their front porch. Alissa underwent a liver
transplant 3 years ago following complications while taking the
anti-depressant drug Serzone.
BRIAN WALSKI / Los Angeles Times
NORWOOD, Ohio--When a hospital psychiatrist prescribed an
antidepressant called Serzone for their 15-year-old daughter, Jimmie
and Brenda Robinson assumed it was safe.
The episode in February 1997 haunts them--Alissa Robinson nearly
died while taking Serzone. After suffering liver failure and
undergoing a transplant, she now faces a lifetime of uncertain health
and worry over how she will pay for her care.
Serzone, it turns out, was not intended for children or
adolescents, and the label said its safety and effectiveness "have
not been established" among the young. However, when FDA officials
approved Serzone in December 1994, they suspected its use would not
be confined to adults.
"Since it is likely that [Serzone], once marketed, will be used
in children and adolescents . . . we ask that you commit to
conducting, subsequent to approval, studies in these populations in
order to provide the safety and efficacy data needed to support such
use," wrote an FDA administrator, Dr. Robert J. Temple, in a Nov. 7,
1994, letter to Serzone's manufacturer, Bristol-Myers Squibb Co.
The company agreed to conduct the research, among patients age 7
to 17, and to report the results to the FDA. But nearly six years
later, no results have been made public. Doctors may continue to
lawfully prescribe it for any purpose they deem appropriate.
A spokeswoman for Bristol-Myers said it hopes to report results
to the FDA "in the early part of 2002."
In an interview at the family's home, Brenda Robinson said she
was unaware that the FDA had not endorsed Serzone's use in
adolescents.
"That comes as a big surprise," Brenda Robinson said. "If it's
an adult medicine, why did [the doctors] give it to her? . . . These
drugs should be tested for the people they're going to be used in."
Serzone has been an important drug for Bristol-Myers, generating
sales of $1.1 billion through October, according to IMS Health, an
information services company.
Eighteen cases of liver failure involving Serzone patients were
reported to the FDA from 1996 to June 2000. The product labeling was
changed, subsequent to Alissa's use of Serzone, to note "rare reports
of liver . . . failure, in some cases leading to liver transplantion
and/or death."
According to an article coauthored by one of Alissa's physicians
and published Feb. 16, 1999, in the Annals of Internal Medicine,
Serzone was "the most likely cause" of her liver failure.
For now, Alissa and her parents are left to wonder what her life
might have been if she had not taken the drug.
Brenda Robinson points to the maroon "puke bucket," Alissa's
constant companion in the spring of 1997. By Memorial Day weekend
that year, three months after going on Serzone, Alissa was nauseated
and vomiting twice or more daily, according to medical records and
interviews. Her eyes and skin had yellowed, a sign of jaundice.
When specialists at Children's Hospital Medical Center in
Cincinnati admitted Alissa on June 12, they found she was suffering
liver failure. Alissa was placed on a waiting list for a transplant.
Amid the gantlet of tests and diagnostic procedures, Alissa's
flowing, auburn hair was cut, her head shaven.
"That was the worst part," Brenda Robinson recalled. "When she
woke up bald . . . she went to pieces."
The morning of June 14, Jimmie and Brenda said, one of the
doctors told them that Alissa, by then in a coma, could die within
days unless a donor organ came available. Brenda, an upbeat woman who
works in the auditor's office at the local city hall, lived at her
daughter's bedside.
On June 16, Alissa underwent the transplant. "She came this
close to dying," Brenda recalled, struggling with her emotions at the
memory.
Alissa was reluctant to discuss the difficulties. But when an
earlier portrait of her was brought to the family's kitchen table,
she said evenly, "That was in my pretty days."
Alissa's father worries that no employer will offer her health
insurance, that she will unable to pay for essential prescriptions
and care. Just in the last year, Alissa was twice hospitalized: Three
days because of a bug bite that became infected; more recently for
surgery to repair a rupture in her transplant incision.
"It's destroyed her for life; it's destroyed us," said Jimmie
Robinson, a machinist in this blue-collar suburb of Cincinnati.
The family is suing Bristol-Myers in state court, alleging that
Serzone is a defective product and "unreasonably dangerous."
The company declined to comment on the litigation. Other named
defendants include Good Samaritan Hospital of Cincinnati and two
doctors, including the psychiatrist who prescribed Serzone to Alissa.
All of the defendants are contesting the lawsuit.
An FDA spokesman, Jason Brodsky, said the agency has within the
last three years "issued a formal written request to Bristol-Myers
Squibb to study [Serzone] for the treatment of depression in children
ages 7 to 17."
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