Series: The Killer Cure (1 Of 11)

DEATHS TIED TO METHADONE ESCALATE ACROSS STATE, NATION

Feds Approve Outdated, Potentially Deadly Drug Information

One increasingly popular painkiller is helping to kill more people
than any other prescription narcotic, a Sunday Gazette-Mail
investigation has found.

Patients could die if they take the "usual adult dosage" on
methadone's package insert -- information that comes with the
prescription and was approved by the federal government.

Despite knowing about methadone's dangers, federal officials have not
strengthened the warnings most doctors and patients receive about
methadone, Sunday Gazette-Mail reporters discovered. - advertisement -

Methadone, once given mostly to heroin addicts to ease their
cravings, now is being prescribed by more doctors to treat pain.
Insurance companies favor it because it is cheap and effective.

But methadone helped to kill three times as many Americans in 2003 as
it did in 1999, death certificates reveal, and medical examiners
blame it for more overdose deaths than any other narcotic drug except
cocaine. This previously unpublished information comes from an
analysis of death certificates requested by the Gazette-Mail and
conducted by the National Vital Statistics System, part of the
Centers for Disease Control and Prevention's National Center for
Health Statistics.

West Virginia led the nation in accidental overdose deaths blamed on
methadone in 2003, with a death rate four times higher than the
national average, the data shows. It was followed by Kentucky, North
Carolina, Maine and New Hampshire.

Methadone contributed to 2,992 deaths nationwide in 2003, up from 790
four years earlier, according to the data.

That's more deaths in one year than the U.S. military has suffered
during the conflict in Iraq. Medical examiners ruled 82 percent of
those deaths accidental.

Methadone often is confused with the illegal drug methamphetamine.
But methadone is a completely different, legal medication.

The media often portray methadone overdose victims as drug addicts
and criminals who steal it or buy it illegally off the street. But a
significant number of victims were prescribed the drug to treat their
pain, according to studies shared with the Gazette-Mail by
researchers in three states.

Some of those victims took the drug as prescribed and died anyway,
family members said in legal filings and in telephone interviews.
That is what happened to 44-year-old Vince Verdecchio, a Denver lab
technician who was prescribed methadone for back pain after surgery,
said his wife Marianne Verdecchio.

Less than 36 hours after he filled the prescription, he was dead.

"He was only taking what was on the bottle," she said. "He took it as
directed and he passed away."

An "Extremely Dangerous" Dose

Some patients could die if they followed the "usual adult dosage" on
methadone's package insert, said several researchers and pain doctors
contacted by the Gazette-Mail.

Doses of 50 milligrams or less of methadone have killed people not
accustomed to the drug, according to several studies. Researchers now
recommend a starting dose of 10 milligrams a day or less for patients
not used to narcotic painkillers.

But the package insert says the usual adult dose is "2.5 mg to 10 mg
every three or four hours as necessary," or up to 80 milligrams a day.

The inserts are written by the drug manufacturers and approved by the
federal Food and Drug Administration.

"That's an extremely dangerous, liberal guideline," said Lynn
Webster, a physician and published researcher who runs Lifetree
Clinical Research and Pain Clinic in Utah. "I doubt any
board-certified pain specialist would say that is a safe starting dose."

Bush administration officials have known about the problem since at
least 2003, when they convened a conference on methadone-related
deaths. They paid Stewart B. Leavitt to be researcher/writer of a
report based on findings from the conference.

Leavitt, a longtime methadone advocate, is editor and principal
researcher/writer of two online newsletters funded by one of the
world's largest makers of methadone, Tyco/Mallinckrodt. His
for-profit company owns one of the Web sites.

In a recent interview, Leavitt said methadone unfairly is blamed for
overdoses that may have been caused by other drugs. He said methadone
has proven effective to treat both addiction and pain.

For the past 40 years, methadone has mainly been used to treat people
who are addicted to heroin and similar drugs. Methadone clinics sell
daily doses of the drug, which calm cravings for heroin without
getting the patients high.

Recently, doctors have begun to prescribe methadone as a cheap and
effective painkiller. Those pain pills are killing more people than
the liquid methadone sold by the clinics, according to medical
examiners in several states and a new study of methadone overdoses in Utah.

No nationwide data shows the number of people taking methadone. But
Lisa Borg, who has published methadone research in conjunction with
The Rockefeller University in New York, estimated that an extremely
small percentage of people who take methadone die from an overdose of it.

Negative publicity about methadone could lead to doctors and patients
being afraid to use painkillers in general, Leavitt said.

"It will get to the point where you'll go to an emergency room with a
broken leg and they'll give you a stick to bite on to deal with your
pain," Leavitt said.

"His Miracle Drug"

Vince Verdecchio had been living with back pain for years. Doctors
tried to fix his back with surgery. After one surgery in 2005, he
wound up with a staph infection.

"They had to open him up a couple more times," Marianne Verdecchio
said. "He had to have a home health nurse and an antibiotic bag 24
hours a day for six weeks. It was really hard on his body.

"And The Pain ..."

The doctors tried different pain medications on him. The fentanyl
patch didn't work -- "He was in such pain he just sweated it off," she said.

For months, he was in so much pain he could barely move. On June 15,
2005, the doctor put him on methadone.

Within hours, the pain was gone.

"That afternoon, he was up cooking dinner," Marianne Verdecchio said.
"He actually went to work the next day. It was his first full day back to work.

"He called me a couple of times from work. He said, 'You're not going
to believe me, but this is working. I'm still not in any pain.'

"We thought it was his miracle drug."

Verdecchio took exactly what his primary care physician had
prescribed, she said: three 10-milligram tablets twice daily. On the
night of June 16, he took his third regularly scheduled dose.

"We went to bed about midnight," Marianne Verdecchio said. "And then
I found him three hours later and he was dead."

The coroner did an autopsy. He ruled Vince Verdecchio's death
accidental, due to probable complications of acute methadone toxicity.

Too Many Deaths To Count

On death certificates filed in 2003, medical examiners listed
methadone as a cause of death more often than any other narcotic drug
except cocaine, said Lois Fingerhut, special assistant for injury
epidemiology at NCHS.

Narcotics include the illegal drug heroin and legal painkillers such
as oxycodone and morphine. Federal law officially classifies cocaine
as a narcotic drug, even though it is a stimulant.

There has been a rapid increase in the number of accidental overdose
deaths blamed on methadone since 1999, when it was separated into its
own category.

Some of the increase is because of improvements in data collection,
Fingerhut said, but most of the growth is real.

"The fact that those deaths have continued to go up is a good
indication we are experiencing a real and significant increase," she said.

The number of people dying from methadone overdoses is probably even
greater, according to several medical examiners contacted by the
Gazette-Mail. Many overdose deaths are blamed on other causes and
never investigated.

Ten years ago in West Virginia, almost no one died from a methadone
overdose, said James Kraner, toxicologist for the state medical
examiner's office. In the first 10 months of 2005, methadone was
listed as a cause of death for 97 West Virginians.

In Reno, Nev., Coroner Vernon McCarty said he has seen a fourfold
increase in methadone deaths in the last three years.

"There's too many methadone deaths to keep track of," McCarty said.
"I've given up trying to count them all. You ask any medical examiner
in the state -- he'll tell you the same thing."

Not Just Drug Addicts

Here's the stereotypical scenario of a methadone death: A young man
wants to get high. He buys methadone illegally from a street dealer
or he steals it from a relative who is taking it for pain. He takes
the methadone pills with a toxic combination of other painkillers and
alcohol. He passes out, stops breathing and dies.

Most methadone overdose victims had more than one drug in their
system at the time of their deaths, according to studies in West
Virginia, Maine, North Carolina and Utah.

In 2004, a combination of methadone and cocaine killed 17-year-old
Brandi Bragg, granddaughter of West Virginia's biggest lottery
winner, Jack Whittaker. She did not have a prescription for
methadone, according to her death certificate.

But in West Virginia, one in five methadone overdose victims had no
other drug in their system, according to a Gazette-Mail analysis of
state toxicology and vital statistics data.

Others victims had trace, usually harmless amounts of alcohol or acetaminophen.

Sometimes, methadone victims were prescribed the drug for pain.
Sometimes they accidentally took too much. Sometimes their doctors
unintentionally prescribed a lethal dose.

A new study says almost half of methadone overdose victims in Utah
were prescribed the drug for pain.

Of the 114 Utah residents who died in 2004 from methadone, at least
48 of them had a valid prescription to use the drug, according to the
report provided to the Gazette-Mail. More than two-thirds of them
died within the first four days of starting their prescriptions, said
Christy Porucznik, a Utah epidemiologist.

Only two were using methadone as part of a drug treatment program.

Other states that have studied the problem have discovered similar
trends. People with valid prescriptions for methadone made up at
least 37 percent of methadone overdose deaths in North Carolina and
one-quarter of such deaths in Las Vegas, according to recent studies
provided to the Gazette-Mail.

Sometimes, doctors prescribe methadone with other drugs that in
combination are potentially lethal.

Vince Verdecchio also was prescribed diazepam for anxiety. His wife
found out later that benzodiazepines such as diazepam (commonly known
as Valium) increase the risk of overdose when combined with opioids
such as methadone.

"To me, it should have been a red flag for his doctor," she said.

Often, patients make the fatal mistake. They fail to follow their
doctors' advice and take more of the drug than prescribed, or they
take it with other drugs.

Other painkillers are more forgiving. Make a mistake with methadone
and the results are often deadly, Porucznik said.

"With methadone, you can't just take extra pills," she said. "You could die."

Not On FDA's Radar Screen

Across the country, some medical examiners and health researchers
told the Gazette-Mail they have tried to alert federal officials and
the media about the dangers of methadone. But brand-name drugs like
OxyContin have received more attention.

Bruce Goldberger is director of the Forensic Toxicology Laboratory at
the University of Florida. He has published several studies about
methadone overdose deaths in his state.

Goldberger said in a telephone interview that he has tried for years
to get the FDA and other federal agencies to pay attention to
methadone deaths with little success.

"What does it take to reach the FDA's radar screen?" Goldberger
asked. "Clearly, there has been a huge increase in methadone-related
deaths, and they have done nothing."

FDA officials have increased the warnings on one type of methadone --
the type given intravenously to patients in the hospital. But an
agency spokeswoman told the Gazette-Mail they were reluctant to put
similar warnings on the pill form given to most pain patients,
because it could scare off potential drug treatment patients.

"The mortality rate associated with untreated opioid addiction is
extremely high and the effect of placing a 'boxed warning' regarding
the potential cardiotoxicity was determined to have a potentially
negative impact on appropriate treatment of these patients," FDA
spokeswoman Suzan Cruzan said in an e-mail.

The FDA is now working with methadone manufacturers to "make
appropriate changes" to the pain-pill labels, she said.

Marianne Verdecchio said patients need stronger warnings about
methadone's risks.

"I think people need to be educated," she said. "I don't think they
should have to go online and educate themselves. The doctor needs to
say, 'You really need to be careful with this medication, because
it's really strong.'

"I think they should try really, really low dosages and see how a
person reacts before they even write a prescription for it."

The Verdecchios had two children, a son, 25, and a daughter, 23.

"We had just had our 25th anniversary," Marianne Verdecchio said. "I
shouldn't be a widow at 46."

[Sidebar]

What Is Methadone

What it is: Methadone is a synthetic opiate developed by the Germans
during World War II as a substitute for morphine.

What it isn't: Methadone often is confused with "meth," or
methamphetamine, an illegal stimulant commonly cooked in clandestine
labs. Methadone is a completely different -- and legal -- drug.

Uses: Until recently, methadone was given mostly to heroin addicts to
suppress their cravings. Now, doctors are increasingly prescribing it
as a painkiller.

Dangers: Methadone acts differently from other painkillers. It can
stay in the body for an unusually long time, making it possible for
therapeutic doses to build up to a toxic level.

Methadone may take a while to make its effects felt. Patients may
take an extra dose, thinking the first one isn't working, and an
overdose can result.

An overdose of methadone may cause a patient to fall into a deep
sleep and eventually stop breathing. Methadone is more dangerous when
taken with certain other drugs, such as Valium and Xanax.

Reactions to methadone vary dramatically. A dose that is therapeutic
for one person might kill someone else.