POPULAR PAINKILLER MIRED IN CONTROVERSY

S.C. Severely Limits Use Of Oxycontin By Medicaid Patients, Fearing Drug Abuse

South Carolina has enacted the most rigorous restrictions in the country
for Medicaid patients seeking prescriptions for Oxycontin. Since June, the
state has required doctors to ask a state pharmacist's permission before
prescribing the drug, a powerful narcotic called the "hillbilly heroin" for
its popularity in Appalachia and the high it gives when crushed and snorted.

Medicaid patients who have cancer, sickle cell or terminal illness still
qualify for the drug. But hundreds of patients who were taking Oxycontin
for back pain or other problems do not.

Also, many doctors are moving patients to other painkillers rather than
spend 10 minutes or more on the phone, answering the state pharmacist's
questionnaire on prior approval.

The state said it restricted access to the drug to reduce the risk of abuse
and possible side effects, such as addiction and physical dependence. An
added bonus has been a monthly savings of about $400,000. Drug manufacturer
Purdue Pharma is striking back, saying the state is giving preferential
treatment to people with one kind of pain, such as cancer, over another.

Ruptured discs, osteoarthritis and fibromyalgia also can be treated by
Oxycontin. "Pain is pain," spokesman Jim Heins said.

Lobbyists Hired

The fight over Oxycontin is about health. But, critics say, it also is
about money, control and politics.

Purdue Pharma, based in Stamford, Conn., has hired two of South Carolina's
most influential political figures as advocates: attorney Dwight Drake and
political consultant Richard Quinn Sr.

Drake is a close friend of Democratic Gov. Jim Hodges and a former
colleague in then-Gov. Dick Riley's office with Bill Prince, now executive
director of the state Health and Human Services Department, the agency that
administers Medicaid.

Quinn is a Republican political strategist who is managing the
gubernatorial campaign of Attorney General Charlie Condon. He also is the
father of State Rep. Rick Quinn, R-Richland, House majority leader and head
of the House's health subcommittee.

Purdue Pharma also will step up a public-relations campaign in South
Carolina, beginning in early October. The program will include a new drug
prevention campaign for teens.

Powerful Form

Oxycontin is a powerful form of oxycodone, a painkiller in legal use in the
United States for decades and the key ingredient in drugs such as Percodan.
Oxycodone is a Schedule II controlled substance, considered by the federal
government to be second only to drugs such as heroin and cocaine in its
habit-forming potential.

What makes Oxycontin different from other oxycodone drugs is its
time-release formula.

The drug is released steadily over 12 hours, a boon to very sick people who
do not want to take pills every few hours. Also, patients say they feel
more alert on Oxycontin than other narcotics.

The time-release function that is the drug's boon also has been its bane,
however.

Drug abusers have found that by crushing and snorting a pill, they get a
euphoric high - the result of ingesting 12 hours of narcotics in seconds.

South Carolina has not had as high a rate of reports of Oxycontin-related
thefts, overdoses and deaths as other East Coast states, such as West Virginia.

But Oxycontin has risen quickly in popularity. Three years ago, it was not
on the list of the 40 most-prescribed drugs for Medicaid patients. Now,
that list includes three strengths of Oxycontin.

As for incidents of fraud, Health and Human Services had noticed unusually
high numbers of prescriptions coming from some locations, including a
Myrtle Beach pain clinic, closed in June as a result of Drug Enforcement
Agency sanctions.

The S.C. Department of Health and Environmental Control reported 32 of its
420 cases of prescription drug fraud were related to Oxycontin last fiscal
year.

Since July 1, 13 of 103 of all cases have been related to Oxycontin.

Much of the evidence about addiction is anecdotal.

Dr. Stephen Merlin, the director of chemical dependency at Palmetto
Richland Memorial Hospital, said he has seen more than 100 patients on
Oxycontin in the last six months.

"I've seen a 75-year-old woman addicted to Oxycontin, and I've seen an
18-year-old boy."

Doctors are over-prescribing Oxycontin because it is well-marketed and it
cures pain. But many patients don't need a drug as strong or as
habit-forming as Oxycontin, Merlin said.

Tighter Rules

Early this spring, the state looked at prior approval as a way to control
prescription drug costs, particularly for expensive name-brand drugs.

The state picked several classes of drugs, including heartburn and antacid
drugs.

The stated added Oxycontin after detecting fraud and hearing anecdotal
evidence about addiction and abuse.

Doctors questioned the changes at first, especially for the popular antacid
drugs.

But the most pressure by far has been expended by Purdue Pharma, said
Prince, director of Health and Human Services.

"I think by the people they've employed in the state, they're trying to
affect the change," Prince said, adding that there has been "significant
political pressure."

Purdue Pharma said it would not release specific statistics about S.C.
usage. But the Medicaid numbers show that more than half the patients who
had been taking Oxycontin before prior approval since have been prescribed
an alternative.

In June, the agency approved prescription requests 197 times and denied
them 9 times. Physicians changed the patient to another drug 380 times. In
July, the agency approved the drug 155 times and denied it 7 times. Doctors
changed to another drug 149 times.

Patients Or Profits?

Purdue Pharma posted more than $1 billion in revenues last year.

Said Prince: "If this was not affecting them in the pocketbook, they would
not have any concern about what we do with the Medicaid program."

But spokesman Heins said Purdue Pharma is concerned about patients, not
profits.

"When you get calls from patients every day who are often condemned to pain
the rest of their life and they can't get treatment because of drug abuse,
it's real sad."

Dr. Matt Midcap is the medical director at the Center for Pain Management,
affiliated with Palmetto Baptist Hospital.

Midcap maintains that Oxycontin is no more addictive than other narcotics.
When taken properly, the risks of becoming addicted are minimal: one in
10,000, according to a 1996 study.

Midcap often speaks to physicians about pain, sometimes at conferences
underwritten by drug companies, including Purdue Pharma. "My question to
the physicians I talk to is: Do you not treat the 9,999 patients for risk
of the one?"

He is outraged by requiring prior approval. "I think it's kind of
discriminatory, really."

Drake, the Columbia attorney, said the state is setting policy on the basis
of what saves money, not what makes people better. He sent the agency a
letter late last month, arguing that the agency changed its policy to
require prior approval of Oxycontin, but not other oxycodone drugs, without
notifying Purdue Pharma.

To avoid a lawsuit, Drake said the agency should change its policy to allow
patients to have up to six tablets a day, or 180 tablets a month, without
prior approval.

Drake said he is optimistic the state and the drug company can negotiate an
agreement. That, if anything, is all his relationships with Hodges, Prince
and others would help foster, he says.

"I trust them, I have confidence in them, I hope they would feel likewise."

Health and Human Services might consider some change, Prince said, but only
as a temporary "test-case" to compare usage with and without prior approval.

Prince, also a lawyer, said the department is on sound legal ground in
requiring prior approval.

The state was not obligated to notify drug manufacturers of any change,
just the physicians and pharmacists, Prince said, adding that it is
following established guidelines for prior approval.

House Majority Leader Rick Quinn said he supports prior approval for
Oxycontin and other drugs. Quinn said he has felt no pressure from his
father to change his position.

Drug costs have been a major factor in Health and Human Services' running a
deficit for the past four years, Quinn said.

"We have just got to control those costs," Quinn said. "I think prior
approval and some of the other things the agency asked for are right on
target."

Prince said the goal is to control Medicaid costs but also to ensure access
to appropriate drugs. "We're not denying anybody," Prince said. "We're just
regulating the use."