Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: SUNDAY, July 15, 1990 TAG: 9007130433
SECTION: EXTRA PAGE: E-1 EDITION: METRO
SOURCE: CHARLES HITE MEDICAL WRITER
DATELINE: LENGTH: Long
Among the stacks of red and clear plastic medication trays is one marked for Chandler. It contains pale yellow pills that have been divided for his daily dosage: one in the morning, two at night.
In the space of a few weeks, these pills took away the 23-year-old's rage and wild-eyed tirades and paranoid fears. Gone were the all-night sessions in his room where he would carry on one-way, nonsensical conversations with voices that no one else could hear. Gone was Chandler's sudden hatred of the color green and his unfounded belief that he was adopted.
Workers at the adult home were amazed. Steven Chandler, they learned, was actually a nice guy.
"He was a mean little rat when he came here," Lois Keaton says. "He'd cuss you out in a flash."
"He'd walk the halls at night and ring doorbells," Betty Hodges says. "You'd tell him to go back to his room and he'd go off jumping and squealing like a monkey."
The new medication - Clozaril - changed all that.
"He's different," Keaton says. "I've never seen anything like it."
"He's just an entirely different person. He's more cooperative, his appearance is much better. He gets along with other people. Before he was such a loner," Hodges says. "If there ever was a miracle drug, this is it."
Steven's mother, Elinor Holmes, believes Clozaril saved her son - a schizophrenic - from spending the rest of his life in a state mental institution.
But the high cost of the drug - nearly $9,000 a year - worries Holmes. Her company's health insurance now picks up 80 percent of the Clozaril bill. If she should lose her job or die, however, the cost of the drug would not be covered by Medicaid, the government health insurance program for the poor or disabled.
"At this point, if something happens to me, Steven will not get the drug unless someone comes up with $688 a month," she says.
The expense of Clozaril has touched off a controversy overshadowing its potential as a "breakthrough" drug that could help 200,000 or more schizophrenics nationwide whose mental illness has failed to respond to other treatments.
At the heart of the debate is the way Sandoz Pharmaceutical Inc. is selling the drug. Clozaril cannot be bought at pharmacies or drugstores. The drug can be obtained only from Caremark, a home health company that has a contract with Sandoz to deliver the drug to patients once a week. Before receiving the drug, the patient must give the Caremark representative a blood sample.
Sandoz officials say this "no blood, no drug" policy is necessary in order to monitor against a rapid drop in white blood cells, a potentially fatal side-effect in 1 to 2 percent of patients. The policy has stirred complaints from mental health groups, pharmacists, and officials from state Medicaid programs and the Veterans Administration, two of the largest potential buyers of Clozaril.
"Most of us feel that Sandoz is charging what it thinks the market will bear. It's basically all about greed," says Michael Berryman, a hospital pharmacist in South Hill and chairman of the board that oversees the Virginia Medicaid program. 4 1 DRUG Drug
Other than to "justify more profits for Sandoz," Dr. William Reid, medical director of the Texas Department of Mental Health and Mental Retardation, says he can see no real reason for the elaborate monitoring system for Clozaril.
Reid and Berryman say the most important aspect of the marketing of Clozaril could be the precedent it sets for other drugs.
As the price of prescription drugs skyrockets, state Medicaid programs have been trying to negotiate price discounts with drug companies similar to those that are given to hospitals, Berryman says.
"To me, Clozaril is just a new marketing technique that closes out any sort of competitive bidding for drugs," Berryman says. "If Sandoz is able to get by with this, then you'll see the industry applying this monitoring system to every decent drug that comes along."
Beyond that, Reid says, it could be possible for drug companies to set up exclusive agreements with hospitals for drugs used in cancer therapy or heart disease. "They'll say, if you want your cancer treated, then you have to come to one of our hospitals," Reid says.
Since an estimated 80 percent of those who might benefit from Clozaril treatment are indigent, one national mental health group sees lack of access to the drug as its major concern.
"It's a tragedy that this is a potential wonder drug and it's not being made available in many states," says Chuck Harman, public relations director for the National Alliance for the Mentally Ill.
The alliance is encouraging all states to make Clozaril available through Medicaid programs. The high price of the drug, Harman says, is being used as an excuse by many state Medicaid and mental health officials for dragging their feet in approving the drug.
"It's not just a price war by Sandoz," Harman says. "We feel many state mental health departments are using price as an excuse and that patients are being used as pawns in a greedy battle."
The unwillingness of many states to pay for Clozaril treatment, he adds, is typical of the short shrift often given to patients with mental illnesses.
Even for someone who has private health insurance coverage, obtaining Clozaril can be an elusive goal.
Life without Clozaril
Joe Pakush Jr., who has been in and out of mental hospitals and halfway homes for 15 years, is an ideal candidate for Clozaril. In fact, his psychiatrist has filled out the forms necessary to obtain the medication from Sandoz.
But Pakush, 34, lingers in an adult home in Buchanan - withdrawn and silent - because his parents can't raise the money to help pay for Clozaril.
Part of the cost of the drug would be covered by the health insurance policy of Pakush's father, a retired Norfolk and Western worker. But Joe Pakush Sr. says the policy has some co-payment requirments that he can't afford.
First, Pakush Sr. says, the insurance coverage doesn't kick in until he pays for the first month's treatment of Clozaril - $688. After that, the policy will cover 80 percent of the cost of the drug up to $4,000. Pakush Sr. says he has to come up with the other $800. After that, the entire cost of the drug will be covered for the rest of the year.
That means Pakush Sr. must pay nearly $1,500 for his son to get Clozaril. "We're in a very tight financial squeeze," Pakush Sr. says of himself and his wife. "We don't have the money."
Pakush Sr. says he and his wife are trying to use what little money they have to help their daughter pay for her first year of college this fall. They feel torn in trying to do what's best for each child. "We're having to weigh one child against the other," he says.
Joe Pakush Jr. was a honor student, a lineman on the football team at William Fleming High School, an Eagle Scout, and a member of the Order of The Arrow. But in his senior year of high school, Joe told his parents he didn't feel right. He began to withdraw into his own world.
That withdrawal is now nearly total. About the only time he communicates is to ask someone for a cigarette. "He just sits there like a lump on a log," his father says. "It's hard to know what's going on in his mind."
Pakush Sr. believes Clozaril could bring back the son he once had. He believes it could motivate him and make him take an interest in people again. But he won't know until he saves more money, until Clozaril's price is lowered, or until the drug is covered by Virginia Medicaid.
`Unbundling' drug's costs
The high price of Clozaril has certainly been a factor in the refusal by most state Medicaid programs to fund the drug. Medicaid officials say part of their concern is the refusal by Sandoz to "unbundle" the costs of Clozaril. They want to know how much of the $172 weekly charge is the cost of the drug, how much is due to the home health visit, and how much is for the blood test.
Clozaril is available in some European countries for as little as $20 a week, says Bruce Kozlowski, director of Virginia's Medicaid program. In Great Britain, it's available with a monitoring program for an annual cost of about $1,500.
Sandoz has touted the potential cost savings of treating schizophrenics with Clozaril, claiming the $9,000 annual cost for the drug is cheaper than the $40,000 or more it costs to keep a schizophrenic in a state mental facility.
Is the price too high?
Kozlowski, however, says that just because Clozaril might save money doesn't mean that its price is justified. "If something costs me $100 and it means I can save $200, does that automatically justify I pay the $100? Or do I investigate to find out if the $100 price is exorbitant and unjustified?"
A new drug advisory committee to the Virginia Medicaid Board is reviewing whether Clozaril should be made available to recipients. The committee's recommendations are expected to be reviewed by the board in August.
In the meantime, state Medicaid and mental health officials are awaiting the outcome of a legal challenge to the way Clozaril is being distributed. The Virginia attorney general's office has joined in a civil lawsuit filed by Minnesota claiming that Sandoz is violating federal antitrust laws by linking the sale of Clozaril to the purchase of other services.
The notion that Clozaril will save states money by allowing them to close down wards in mental facilities has been oversold, state mental health officials say.
"There really are some false illusions about cost savings with Clozaril," says King Davis, Virginia's commissioner of mental health services.
Other treatment costs
The price of Clozaril represents only part of the total cost for treating schizophrenic patients, says Dr. Glenn Yank, a specialist in public mental health for Virginia. Patients who once were merely warehoused in institutions often will require intensive therapy after being given Clozaril in order help them become active in their communities. And the schizophrenics being treated as outpatients in community health centers also will need more therapy.
Clozaril will give many schizophrenic patients a better quality of life, but it won't necessarily mean savings on their treatment, Yank says.
"As patients get well enough to leave psychiatric hospitals, there are others that will come in," Texas mental health director Reid adds. "We won't be shutting down wards for quite a while."
In Virginia, there are an estimated 35,000 to 40,000 schizophrenics. Generally, about 10 percent of the schizophrenic population doesn't respond to any treatment, making them likely candidates for Clozaril.
Of the 3,500 to 4,000 schizophrenics in Virginia who would be candidates, about 2,000 to 2,500 are in the state mental health system, officials estimate.
About 1,400 of those are in state mental hospitals. The rest are in community health centers.
Anywhere from 30 to 50 percent of schizophrenics who fail to respond to other therapies are likely to be helped by Clozaril. If 1,000 of the schizophrenics under state care ended up on Clozaril, the cost of caring for them would be nearly $10 million a year. If 2,500 patients in the system respond to Clozaril, the annual cost would be about $24 million. The state system now spends about $1.5 million on drugs for all mental health patients.
Sandoz won't budge
At the Veterans Affairs Medical Center in Salem, 50 to 60 patients proabably would be good candidates for Clozaril, says Dr. Frank Tellian, director of pyschiatric research.
"We just don't have half a million dollars lying around to spend on Clozaril," Tellian says. As a way to reduce costs, the VA offered to set up its own monitoring system if Sandoz would agree to sell Clozaril without the mandatory home health and laboratory services.
Sandoz refused to go along with the plan, saying it needed to control monitoring to assure patients were protected against agranulocytosis - a suppression of the body's ability to produce white blood cells that could lead to death from overwhelming infection.
Reid doesn't buy that argument. Insulin - a drug for diabetics that can be bought without a prescription - is a dangerous drug, he says. Yet it has no monitoring system like that set up for Clozaril, Reid points out. Digitalis - used to treat heart rhythm disorders - and Coumadin - used to treat or prevent blood clots - also can have fatal side effects, Reid says, but there is no elaborate monitoring system for them.
Clozaril is available in other parts of the world with reported deaths of only one to three patients a year, Reid says. That shows the drug can be given relatively safely by relying on monitoring by physicians and pharmacists, he says.
Elinor Holmes says she's grateful to Sandoz for developing a drug that has rescued her son from a life of being warehoused. But she worries that its high price may one day mean it will be taken away from him.
"It's done wonders for him," Holmes says of Clozaril. "But what good is it if you can't afford it? I wonder how many people are out there that need this drug and can't afford it? To me that's no different in denying insulin to a diabetic whose life depends on it."
by CNB