Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: SUNDAY, March 20, 1994 TAG: 9403200034
SECTION: NATIONAL/INTERNATIONAL PAGE: D-1 EDITION: METRO
SOURCE: By LAURA WILLIAMSON STAFF WRITER
DATELINE: LENGTH: Long
Brenda's 22-year-old son, Brian, wants desperately to make friends, but fears talking to other people. He worries that they will find his comments silly or dumb. Brian has a brain disease called schizoaffective disorder.
Until recently, Brian's doctor treated him with Haldol, a drug that brought little improvement and some pretty unpleasant side effects. The drug sedated Brian so heavily he had to struggle to get out of bed each day.
Today, Brian looks forward to getting up in the morning. He is alert and more talkative. He also is one of the first people in the Roanoke Valley to take Risperidone, a drug approved last month by the Food and Drug Administration.
Marianne Todd also wants to take Risperidone. A manic-depressive, she now takes two drugs: Mellaril and Clozaril. The Mellaril makes her muscles move in a distorted way. The Clozaril - a breakthrough drug for treating mental illness - reduces that problem, but it makes her drool.
It also can cause agranulocytosis, a fatal disease that drastically lowers a person's white blood cell count. Every week, Todd takes a blood test to make sure she is not among the 2 percent of patients who suffer from that life-threatening side effect.
If Todd switches to Risperidone, she could drop the cumbersome blood tests and avoid the dangerous health risk - while saving thousands of dollars each year. Risperidone is cheaper and appears to be safer than Clozaril, an anti-psychotic drug heralded for its ability to bring vast gains to patients who fail to respond to standard treatments.
But does the new drug work as well?
"The answer is, we don't know," said Dr. Robert Leadbetter, a psychiatrist at Western State Hospital in Staunton, who recently received $25,000 in state money to find out. Leadbetter will test 10 patients for 18 weeks, randomly assigning them to one of the two drugs.
If the pilot study - one of the first in this country to compare the two drugs - goes well, Leadbetter hopes to expand his research to include more patients. At Western State, he treats people with some of the most severe mental illnesses in Virginia.
Even if his work shows that Risperidone can't help treatment-resistant patients, the drug is still good news, Leadbetter told about 50 people last week at the annual meeting of the Alliance for the Mentally Ill of the Roanoke Valley.
"Risperidone has a lot of potential," he said.
The drug is given mainly to schizophrenics, people who suffer from a brain disease that can cause hallucinations, delusions, social isolation and withdrawal. There are many variations of the disease, but it is thought to strike one in every 100 people.
That means there are roughly 2,250 schizophrenics in the Roanoke Valley. Local mental-health professionals say the number may be even higher, since people from outlying areas often move to Roanoke to take advantage of the city's mental-health services.
Risperidone offers hope to the mentally ill because, like Clozaril, it causes fewer side effects than standard treatments for schizophrenia, such as Haldol and Mellaril, Leadbetter said.
Patients taking those and a dozen other drugs on the market often complain that their medications overly sedate them, kill their sex drive or cause involuntary and distorted muscle movements, shakiness, a stiff walk and a dry mouth.
"These patients suffer terribly," Leadbetter said.
Brenda worried that, over time, her son would begin to suffer worse side effects from his drugs. Months ago, she learned through the Alliance that the FDA was testing Risperidone. Since then, she has repeatedly called the FDA, local pharmacies and her son's psychiatrist to find out when it would become available.
Finally, last month, a Roanoke pharmacist told her the drug had been approved. She immediately called Brian's psychiatrist, Dr. Jitendra Desai, who ordered the new pills.
Within five weeks, they saw a difference in Brian.
"He said, `Mom, I feel so alert. I actually feel like getting out of bed and doing something,' " his mother said.
Desai, medical director at Lewis-Gale Psychiatric Center, said he has placed a few other patients on the new drug but is cautious about handing it out too liberally.
Until more is known about the drug, he said, "one has to be selective about who gets to take this medication."
For now, he prescribes it for young patients who can be counted on to take their pills regularly, who fail to respond to other medications, or who suffer too many side effects from other drugs.
"Once we have a larger body of evidence, then we can be more lenient with it," he said.
Not everybody has the luxury of waiting that long.
Millie Willis, the newly elected president of the Alliance, had hoped the drug would help her son, Daniel, a severely ill schizophrenic who felt tortured by voices in his head and was making little progress on other drugs.
Last summer, before the drug was approved for American markets, she wrote a letter to Tipper Gore, wife of Vice President Al Gore, asking that an exception be made and that her son be allowed to use Risperidone as a patient at Catawba Hospital.
Gore forwarded the letter to the FDA, which issued a "compassionate-use" exception.
It came too late. The medication arrived in mid-October - a week after Daniel hanged himself.
by CNB