FAMILY FIGHTS TO RETAIN A LITTLE-USED EPILEPSY DRUG

MEDICINE: A mother sues Hoffman-LaRoche to force it to keep distributing
nitrazepam,the only cure for her daughter's seizures.

San Marino-For years,Amy Harris suffered up to 50 epileptic seizures
day. The child's convulsions were so intense, her shoulders often
dislocated when she crashed to the floor.

A drug called nitrazepam stopped her attacks and transformed her life.
But now it may no longer be available in the United States.

In April, Pat Harris received a letter from Children's Hospital at the
University of California, Los Angeles, saying it would no longer
dispense nitrazepam. "There was just no way my daughter was going off
that drug," said Par Harris.

Amy Harris, 18, has Lennox-Gastaut syndrome, a rare childhood
epilepsy. She endured violent, frightening attacks until age 5, when
her mother enrolled her in an experimental study for nitrazepam, used
overseas to treat sleep disorders.

Amy Harris' seizures stopped immediately and never
reappeared.

Her UCLA doctor has agreed to take extraordinary steps to acquire
nitrazepam from a foreign pharmacy. Pat Harris fears that is not enough.

She has mobilized dozens of nitrazepam-using families throughout the
country, trying to guarantee the drug's availability. But for each
step forward, there have been two back.

Swiss-based pharmaceutical giant Hoffman-LaRoche decided in the early
1980s to abandon pursuit of U.S. Food and Drug Administration approval
for nitrazepam. Instead, the company agreed to free shipments for
needy patients such as Amy Harris.

Meanwhile, new epilepsy drugs drastically reduced the number of people
who rely on nitrazepam. Except for Amy Harris. Only nitrazepam stops
her seizures.

Hoffman-LaRoche, saying only a handful of patients use the drug,
recently announced it would no longer pay for shipping and
distributing nitrazepam in the United States.

Pat Harris disagreed. She documented about 120 Americans using the
drug, she said, and she wrote a protest letter.

An executive wrote back: "The resources that become available to us
following closure of this program will allow us to better focus on
developing new medicines for patients with major illnesses."

The company offered another option: Doctors could import the medicine
if the applied for a special Drug Enforcement Administration license.

The process, however, is confusing and takes several weeks. Amy
Harris' doctor is willing to do it, but Pat Harris and other parents
fear what would happen should their doctors retire or relocate.

The drug is expensive. Without FDA approval, it's not covered by
insurance. A bottle of 100 pills costs $40. Some patients take up to
10 pills each day.

Things got more complicated last month when Hoffman-LaRoche sold the
rights to nitrazepam to Costa Mesa-based ICN Pharmaceuticals Inc. A
spokesman for ICN said the company probably won't sell the drug in
America, but will try to help patients such as Amy Harris.

Her mother has not given up. She and a Nebraska family have filed a
federal discrimination lawsuit against Hoffman-LaRoche.

"You have to be tenacious and hang in there and fight like heck," Pat
Harris said.

Checked-by: Rich O'Grady