TREATMENT STILL FACING HURDLES IN REGULATION

Five years after the release of a much-heralded drug that blocks opiate
addicts' cravings, state officials are grappling with how to regulate the
treatment.

Federal officials spent years helping to develop and promote
buprenorphine and encouraged doctors to dispense it. The hexagonal
orange pill -- marketed as Suboxone -- is manufactured by the
pharmaceuticals subsidiary of the British company Reckitt Benckiser.

Providers say state regulations make it difficult for inpatient and
outpatient facilities to prescribe the medicine and receive
reimbursement. However, some obstacles to dispensing Suboxone could
soon fall. In late December, state Secretary of Health Calvin Johnson,
M.D., approved recommendations by the Buprenorphine Workgroup, a
collection of addiction experts who studied barriers to the treatment.

State officials said they hope to enact within a year the
recommendations, which include easing state regulations so operators
of outpatient clinics can more easily prescribe Suboxone.

Currently, clinic operators who wish to prescribe the drug must apply
for a Modified Narcotic Treatment Facility license from the state.
These would-be Suboxone providers argue that the application process
is lengthy, cumbersome and expensive.

Meanwhile, primary care doctors can easily prescribe Suboxone from
their offices by taking an eight-hour course to get a license from the
federal Drug Enforcement Agency.

Clinic operators say the "double standard" makes no sense because they
are addiction specialists capable of caring for substance abusers with
expertise, counseling and other treatment resources family doctors
can't provide.

Eric Flaherty, Ph.D., is executive director of the Institute for
Research, Education and Training in Addictions in Pittsburgh and
served with the Buprenorphine Workgroup. He said he is puzzled why it
is easy for clinic doctors to prescribe potentially dangerous drugs
such as Oxycontin and Vicodin, yet difficult for them to dole out Suboxone.

"I know the intent of the state regulations was to be cautious and
safe, and to do this for patient safety," Dr. Flaherty said. "But it
ended up adding more barriers than were necessary."

State officials counter that Suboxone was specifically designed for
doctors to quickly and easily prescribe it from their offices. Plus,
state officials say the state is addressing Suboxone access issues at
outpatient clinics by reviewing the workgroup's recommendations.

Regulators will create a system to issue waivers to expedite the
process for outpatient clinics to prescribe Suboxone, according to a
copy of the letter Dr. Johnson sent to workgroup members.

State officials are carefully and gradually reforming the system so,
for now, inpatient clinics still will have to go through the state's
standard application process to prescribe Suboxone, said state
Department of Health spokeswoman Stacy Kriedeman.

The state health secretary also wants to ensure that managed care
organizations that administer prescription medication benefits don't
try to steer patients to methadone first, instead of Suboxone.

Methadone treatment is cheaper, but usually not appropriate for
Suboxone candidates, providers said. Suboxone works better with
addicts who used opiates for two years or less, while methadone is
preferred for long-term users.

Meanwhile, patients complain there aren't enough primary care doctors
taking the course required to dispense the medicine.

Scranton physician Paul Remick, D.O., with the Horizon Medical Group,
prescribes Suboxone and has decades of experience treating substance
abusers. He agreed that there is a shortage of local addiction
specialists.

Opiate addicts "are very difficult patients," Dr. Remick said.
"They're highly manipulative. They lie, they cheat, they steal.
.They also may present an unkempt appearance in the office."

"But the people in my Suboxone program look normal to you or me," Dr.
Remick added. "Most of them aren't unkempt -- they are in recovery."

Among Northeastern Pennsylvania counties, Lackawanna and Luzerne each
have nine doctors qualified to prescribe Suboxone, according to
Reckitt Benckiser's Web site, Suboxone.com. Pike and Monroe counties
have one and three doctors, respectively, though not all doctors put
their names on the Web site's list.

Also, the federal government limits the number of Suboxone patients a
doctor may treat.

Federal laws allow each doctor to see 30 Suboxone patients during the
physician's first year of certification to prescribe the drug. Doctors
can see up to 100 patients annually thereafter, but most doctors set
caps for Medical Assistance patients and addicts.

"Doctors don't want to be on the (Suboxone.com) list, because of the
stigma -- they don't want to be known for treating opiate addicts,"
said Dona Dmitrovic, buprenorphine project coordinator for the
Recovery Advocacy Service and Empowerment organization, a
Harrisburg-based nonprofit that champions the drug.

"But I've had doctors tell me having people that are addicted to
heroin come in and be able to get better and think clearly and recover
is one of the most rewarding things they've ever done," Ms. Dmitrovic
said.

The state health secretary, Dr. Johnson, has vowed to promote more
courses to certify doctors to prescribe the drug.

Clinic operators said more doctors prescribing Suboxone won't help
substance abusers break their addictions, because counseling and other
services are vital to recovery, too. A study in the Journal of
Addiction Medicine, however, found that doctors are recommending
Suboxone users get counseling only 40 percent of the time, Dr.
Flaherty said.

Federal regulations are vague about whether doctors must make patients
go to counseling before receiving Suboxone.

The law states that doctors must be capable of recognizing when
Suboxone recipients need counseling, and physicians must have the
ability to refer patients to the service. It doesn't say doctors must
refer patients to counseling when they prescribe the drug.

Meanwhile, some providers still doubt Suboxone's efficacy.

"I don't care what the elixir is, the vast majority of these people
will fail," said Kevin McLaughlin, executive director of the nonprofit
counseling center Drug and Alcohol Treatment Service Inc. in Scranton.

Mr. McLaughlin said trendy new addiction treatments are always popping
up, with varying results. In most cases, he thinks, substance abusers
are better off not taking prescriptions to try to kick addictions to
illegal drugs.

He has not decided whether he thinks Suboxone is effective, though so
far he has been disappointed with his clients' results using the drug.

"There are people who supported buprenorphine in the beginning, and
now they frown upon it," Mr. McLaughlin said. "I think part of the
reason is that there are doctors out there that prescribe Suboxone and
don't mandate counseling, too."

However, Mr. McLaughlin does refer DATS clients who ask for Suboxone
to Dr. Remick. Dr. Remick said he has only prescribed the drug for a
few years and needs more time to gauge its effectiveness. He thinks it
has shown great promise with some of his patients, but it is not a
panacea for addiction.

The notion Suboxone is not a silver bullet is among the few points
addiction experts agree on.

Like methadone, Suboxone must be prescribed carefully, because it
carries its own risk of abuse, treatment providers said. An illegal
street trade has already emerged as addicts crush pills, remove their
chemical safeguards and use them to get high.

Experts also say addicts need to be carefully monitored while on
Suboxone. Along with counseling, they should have access to social
services and classes for anger management, communication and
vocational skills.

"Let's say you get a guy out of jail or the hospital," said Stanton
Peele, Ph.D., a widely published addiction psychologist.

"If he's going back to a totally drug-infested environment, and he
doesn't have stable housing or job skills, you're just going to get to
the same end point as before."