Company: N.C. Officials 'Welcomed'

CLINICS PROBED IN DEATHS LINKED TO METHADONE

At Least 16 Tied To Drug Used To Help Addicts; Fatalities Rise In N.C.
As Prescriptions Grow

N.C. health officials are investigating the deaths in the past year
of at least 16 patients treated for drug addiction at clinics run by
a Charlotte company. The probe comes as the state tries to combat a
growing number of deaths involving methadone, a drug traditionally
used to help heroin addicts but increasingly prescribed as a painkiller.

In 2004, North Carolina's 245 methadone-poisoning deaths trailed only
Florida's, according to a new federal study.

The N.C. Department of Health and Human Services is investigating 13
patient deaths this year and three from late last year involving
McLeod Addictive Disease Center. Health officials list the probable
cause of death as methadone toxicity or a lethal combination of
methadone and other drugs. Little comparative data exist on methadone
deaths involving clinics; state and federal authorities couldn't say
for certain whether McLeod's 16 deaths are unusually high.

"I can only say that would be troubling to us here," said Robert
Lubran, head of the federal agency that regulates methadone clinics.
He said N.C. officials have asked for help in responding to the
deaths at the company's clinics. McLeod President Eugene Hall said
his company runs an exemplary program that follows all state and
federal guidelines. McLeod operates eight clinics throughout the
Charlotte region and in Marion and Boone. It bills itself as the
Carolinas' largest methadone treatment program.

Hall said his clinics serve more than 6,000 people each year, an
increase of about 2,000 in the past three years. By his company's
count, 19 patients died this year in methadone-related cases -- the
same number as in each of the two previous years. (McLeod defines
methadone-related deaths more broadly than the state, thus the higher
number.) "I've welcomed (state officials) down to look at our
program," he said. "If we're not doing it right, then nobody's doing
it right." State rules require clinics to report all deaths to
county-based regulators, and state officials are supposed to track
such statistics. But methadone clinics, like group homes and other
state-regulated facilities, operate largely on an honor system when
it comes to reporting deaths. When asked last week how many clinic
patients have died statewide, N.C. officials said they did not have
the data readily available. Prescribed more as painkiller Methadone
traditionally has been used to wean heroin and other drug addicts of
their habits. Increasingly, doctors have prescribed it for chronic
pain, or for patients who've become addicted to powerful painkillers
such as OxyContin.Methadone prescriptions nationwide jumped from
about half a million in 1998 to more than 4 million last year,
federal statistics show. Most of the new users are patients with
prescriptions for pain medication. Experts say methadone is so
powerful that improper dosages, or combining it with other drugs such
as cocaine, Valium or Xanax can prove fatal. In North Carolina,
methadone-related deaths of all types jumped from 121 in 2001 to 318
in 2005, state figures show. South Carolina had 37 deaths in 2004,
according to a federal study.

Government and academic researchers say clinics aren't to blame for
much of the increase. Instead, they point to the growing use of the
drug as a prescription painkiller. The amount of methadone sold to
N.C. pharmacies and hospitals quadrupled between 1997 and 2001, one
study showed. Patients who take the drug at home, rather than in the
controlled doses offered at clinics, are more likely to misuse it,
said Lubran, with the U.S. Department of Health and Human Services.

Federal officials in recent months have been warning all states to
keep an eye out for increases in methadone deaths.

N.C. health officials say such federal advisories prompted them to
investigate McLeod, a nonprofit company with nearly 300 employees.
Lethal drug combinations McLeod treats addicts on a walk-in basis,
charging them $10 per day for pre-measured doses of methadone after
they've been examined by a doctor. Some come to McLeod because judges
have ordered them to get treatment. Hall said his clinics saw a
series of deaths from the fall of 2006 until this spring. In an Oct.
17 letter to state officials, McLeod's medical director, Jana Burson,
said the company investigated and found that most cases involved
fatal combinations of methadone and other drugs. Patients nationwide
have been known to use it with Xanax or Valium in search of the kind
of euphoric high methadone alone can't provide. The McLeod clinics
responded to the deaths by restricting admissions of patients
suspected of such addictions and by more aggressively warning of the
dangers of such lethal drug cocktails, Burson wrote.

Hall said investigators have visited five of the eight McLeod clinics
in recent weeks. "The findings have been absolutely minimal in terms
of finding anything wrong," he said.

State health official Spencer Clark declined to discuss what was
found on those visits, saying the information is part of an ongoing
investigation. But Hall provided a copy of a report filed after state
auditors in September visited the McLeod facility in Marion. The
report showed minimal problems. The Observer, using the N.C. open
records law, also received copies of the state reports McLeod filed
for each fatality. State officials blackened out the patients' names
and personal information, and many of the reports shed little light
about the deaths.

One case, though, involved a woman who traded her methadone to a drug
dealer, then overdosed on what she received in return. Several others
died after mixing methadone with alcohol and other drugs. Two other
companies operate methadone clinics in Mecklenburg, but neither has
reported any deaths since 2004, said Grayce Crockett, head of
Mecklenburg Area Mental Health.

Crockett's agency is responsible for monitoring the sole McLeod
clinic in Mecklenburg and submitting quarterly reports to the state.
She said a visit this summer to the facility on Remount Road turned
up no problems. "We found everything was appropriate and in place,"
she said. "Our medical director didn't have any recommendations for
them as a result of the review." McLeod only clinic probed Clark, of
the Division of Mental Health, said his agency also is checking to
see if any deaths have been reported at the 27 other clinics around
the state. But he stopped short of saying whether any of those
facilities is being investigated.Lubran, the federal methadone
regulator, said N.C. officials have expressed concern only about
McLeod's numbers, but he wants a statewide look at clinic deaths.

Depending on the results of the state investigation, McLeod could
lose federal certification and be forced to close. Lubran said three
out of more than 1,100 clinics nationwide have been closed this year.
Hall, the McLeod president, said the state would not know of his
clinics' deaths had he not been scrupulous about reporting them. The
state doesn't have accurate totals, he said, because many other
clinics don't report. "We're being punished, essentially, because we
were attempting to comply." Methadone Precautions Last year, the U.S.
Food and Drug Administration issued a public health advisory about
the use of methadone: Patients should take methadone exactly as
prescribed. Bigger doses can slow or stop breathing and can be fatal.

Patients taking methadone should not start or stop taking other
medicines or dietary supplements without talking to their health care
provider. Taking other medicines or dietary supplements may reduce
pain relief. They may also cause a toxic buildup of methadone.

Trouble signs: Difficult or shallow breathing, extreme fatigue or
sleepiness; blurred vision; inability to think, talk or walk
normally; and feeling faint, dizzy or confused. If these signs occur,
patients should get immediate medical help.

For more, visit www.fda.gov/CDER/Drug/advisory/methadone.htm History
of Methadone Methadone is a synthetic narcotic similar to morphine.
Synthesized in Germany, it came into clinical use after World War II.
When methadone is given to a heroin addict who is later withdrawn
from methadone, the addict will undergo methadone withdrawal instead
of the more severe heroin withdrawal. In the 1960s, Drs. Marie
Nyswander and Vincent Dole promoted methadone as a therapeutic tool
to rehabilitate narcotics addicts. The drug is now in use in
maintenance programs in the United States, Thailand, Sweden and Hong
Kong. Methadone is mostly dispensed in oral form, as a liquid or a
wafer, under supervision.

Source: Columbia Electronic Encyclopedia