FEDS ACT ON METHADONE DEATHS

A federal agency is developing a plan to deal with an increase in
deaths tied to the prescription drug methadone, one month after a
Sunday Gazette-Mail series revealed a spike in overdoses nationwide.

The U.S. Substance Abuse and Mental Health Services Administration
(SAMHSA) is coming up with a strategy to deal with the spike in
deaths, said spokeswoman Leah Young. The agency plans to work with
the White House Drug Czar and the Drug Enforcement Administration to
reduce the number of overdose deaths, she said.

The agency is developing a standard to determine just what should
qualify as an overdose death caused by methadone -- something that
was called for three years ago during a federal conference on
methadone deaths convened by SAMHSA. - advertisement -

Also, SAMHSA plans to provide training on the proper use of methadone
for health-care providers before the end of the year, according to
Mark Parrino, president of the American Association for the Treatment
of Opioid Dependence.

Methadone contributes to more deaths nationwide than any other
prescription narcotic, and West Virginia's methadone death rate is
the nation's highest, a Gazette-Mail investigation found.

Methadone was a factor in the deaths of 2,992 people in 2003, up from
790 in 1999, according to an analysis of death certificates conducted
by the National Center for Health Statistics for the Gazette-Mail.

The drug was blamed for more deaths than heroin and about 1,500 fewer
deaths than all other narcotic painkillers combined, including
oxycodone, fentanyl, morphine and hydrocodone.

Criminals and addicts are not the only people dying. Some overdose
victims took the drug as prescribed and died anyway. A Utah study
found that 42 percent of methadone overdose victims had a valid
prescription for the drug.

Once, methadone was given mostly to heroin addicts to stop their
cravings for the illegal drug. Recently, more doctors are prescribing
it to treat pain. Insurance companies favor it because it is cheap
and effective.

Most overdose deaths are caused by pill-form methadone, the kind that
is prescribed for pain, not the liquid methadone usually given out at
methadone treatment centers.

The bad publicity regarding methadone-related overdoses could scare
drug users away from methadone treatment centers, said Parrino, who
represents the nation's methadone clinics.

Most of the overdose deaths are coming from doctors who improperly
prescribe the drug, patients who don't take it as prescribed and
people getting the drug illegally, Parrino said.

The federal government should send a letter to all doctors who
prescribe methadone for pain that warns them of the danger of
overdose, he said.

Parrino said he recently spent three days in Washington, D.C.,
meeting with federal officials about overdose deaths tied to
methadone. He encouraged federal agencies to join together to fight
the problem.

"I think they realize this is an issue," he said. "They understand
the serious nature of this."

'That devil drug'

Last month, one of the nation's largest newsletters dealing with
addiction devoted its lead article to the Sunday Gazette-Mail series.

"Methadone Painkiller Overdoses Causing PR Problem for Treatment
Field," read the headline in "Alcoholism & Drug Abuse Weekly."

"'Killer Cure' Series in West Virginia Paper not Helpful," read the
second headline.

"The problem for the treatment field is that each time the overdoses
make headlines, many people in the public, including lawmakers, don't
understand the difference between methadone the addiction medication,
and methadone the painkiller," the article says.

Actually, there is no difference in the chemical composition of the
two forms of methadone. But methadone clinics in most states are
highly regulated and must closely monitor patients, whereas doctors
with little training in pain management can prescribe methadone.

In the article, Parrino said too many doctors and pharmacists are
ignorant about methadone's unique properties.

"Unlike with other prescription opioids, the doctors aren't
sufficiently educating the patients. The pharmacists aren't doing
anything. There's no education," he said.

Also, the package insert that comes with methadone contains dangerous
and potentially deadly language about the "usual adult dosage" of
methadone, according to several physicians and pain researchers
contacted by the Gazette-Mail. The drug manufacturer writes the
language and the U.S. Food and Drug Administration approves it.

"The usual adult dosage is 2.5 mg to 10 mg every three or four hours
as necessary," reads the drug's package insert under "For Relief of Pain."

Someone reading that label could believe it is safe for an adult to
consume up to 80 milligrams of methadone a day.

But 50 milligrams of methadone or less can kill a patient not used to
strong painkillers, studies say.

"Most people would die if they took 80 milligrams a day," said Lynn
Webster, a pain doctor and researcher from Utah. "That's an extremely
dangerous, liberal guideline."

Last month, Sen. Jay Rockefeller, D-W.Va., and Sen. Chuck Grassley,
R-Iowa, called on the FDA to strengthen the warnings to consumers
about methadone.

An FDA spokeswoman said the agency was working with the makers of
methadone to make appropriate changes to the labeling for methadone
painkillers. But one of the largest manufacturers of methadone said
the FDA hasn't talked to them, and the other major manufacturer
referred a reporter to the FDA.

The FDA has not responded to a Freedom of Information Act request
from the Gazette-Mail asking for information about its effort to
change the methadone labeling.

Parrino said the label might need to be changed, but he opposes
adding a "black-box warning" or other strong language about overdose
risks because it might scare away people who need methadone treatment.

"If this goes unchecked, somewhere along the line some elected
official will want a black-box warning," he said. "But is more harm
done than good? It further stigmatizes a medication, a treatment and a disease.

"[The deaths] further stigmatize the treatment system," Parrino said.
He added that during a recent trip to Charleston, someone told him,
"We don't want that devil drug here."