Methadone Rises as a Painkiller With Big Risks

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August 17, 2008

 

Methadone Rises as a Painkiller With Big Risks

By ERIK ECKHOLM and OLGA PIERCE

 

 

Suffering from excruciating spinal deterioration, Robby Garvin, 24, of South

Carolina, tried many painkillers before his doctor prescribed methadone in June

2006, just before Mr. Garvin and his friend Joey Sutton set off for a weekend at

an amusement park.

 

On Saturday night Mr. Garvin called his mother to say, “Mama, this is the first

time I have been pain free, this medicine just might really help me.” The next

day, though, he felt bad. As directed, he took two more tablets and then he lay

down for a nap. It was after 2 p.m. that Joey said he heard a strange sound that

must have been Robby’s last breath.

 

Methadone, once used mainly in addiction treatment centers to replace heroin, is

today being given out by family doctors, osteopaths and nurse practitioners for

throbbing backs, joint injuries and a host of other severe pains.

 

A synthetic form of opium, it is cheap and long lasting, a powerful pain

reliever that has helped millions. But because it is also abused by thrill

seekers and badly prescribed by doctors unfamiliar with its risks, methadone is

now the fastest growing cause of narcotic deaths. It is implicated in more than

twice as many deaths as heroin, and is rivaling or surpassing the tolls of

painkillers like OxyContin and Vicodin.

 

“This is a wonderful medicine used appropriately, but an unforgiving medicine

used inappropriately,” said Dr. Howard A. Heit, a pain specialist at Georgetown

University. “Many legitimate patients, following the direction of the doctor,

have run into trouble with methadone, including death.”

Federal regulators acknowledge that they were slow to recognize the dangers of

newly widespread methadone prescribing and to confront physician ignorance about

the drug. They blame “imperfect” systems for monitoring such problems.

 

In fact, a dangerously high dosage recommendation remained in the Food and Drug

Administration-approved package insert until late 2006. The agency has adjusted

the label and is now considering requiring doctors to take special classes on

prescribing narcotics.

 

Between 1999 and 2005, deaths that had methadone listed as a contributor

increased nearly fivefold, to 4,462, a number that federal statisticians say is

understated since states do not always specify the drugs in overdoses. Florida

alone, which keeps detailed data, listed methadone as a cause in 785 deaths in

2007, up from 367 in 2003. In most cases it was mixed with other drugs like

sedatives that increased the risks.

 

The rise of methadone is in part because of a major change in medical attitudes

in the 1990s, as doctors accepted that debilitating pain was often undertreated.

Insurance plans embraced methadone as a generic, cheaper alternative to other

long-lasting painkillers like OxyContin, and many doctors switched to

prescribing it because it seemed less controversial and perhaps less prone to

abuse than OxyContin.

 

From 1998 to 2006, the number of methadone prescriptions increased by 700

percent, according to Drug Enforcement Administration figures, flooding parts of

the country where it had rarely been seen.

 

But too few doctors, experts say, understand how slowly methadone is metabolized

and how greatly patients differ in their responses. Some prescribe too much too

fast, allowing methadone to build to dangerous levels; some fail to warn

patients of the potential dangers of mixing methadone with alcohol or sedatives,

or do not keep in contact during the perilous initial week on the drug. And some

patients do not follow the doctor’s orders.

 

“Those problems were not soon recognized,” said Dr. Bob Rappaport, a division

director at the Food and Drug Administration. He added: “Methadone is an

extremely difficult drug to use, even for specialists. People were using it

rather blithely for several years.”

 

Dr. James Finch, an addiction specialist in Durham, N.C., said, “In the clinical

and regulatory communities, everyone is trying to run and catch up with and deal

with the causes of methadone overdoses.”

 

This year the federal government started sponsoring voluntary classes that teach

doctors the elaborate precautions they should take with methadone, like inching

upward from low starting doses and screening patients for addictive behavior.

(While Robby Garvin’s doctor could argue that the dosage he was taking was

reasonable — one to two 10-mg tablets, three times a day — and he was cleared by

his state medical board, many specialists would have started him on a lower

dose.)

 

In what critics call a stunning oversight, the F.D.A-approved package insert for

methadone for decades recommended starting doses for pain at up to 80 mg per

day. “This could unequivocally cause death in patients who have not recently

been using narcotics,” said Dr. Robert G. Newman, former president of Beth

Israel Medical Center in New York and an expert in addiction.

 

The F.D.A. says that in the absence of reports of problems by doctors or

surveillance systems, “we would have no reason to suspect that the dosing

regimen” might need to be adjusted.

 

In November 2006, after reports of overdoses and deaths among pain patients

multiplied and The Charleston Gazette reported on the dangerous package

instructions, the F.D.A. cut the recommended starting limit to no more than 30

mg per day. “As soon as we became aware of deaths due to misprescribing for pain

patients, we began the process of instituting label changes,” Dr. Rappaport

said.

 

Methadone, which is made by Roxane Laboratories Inc. of Columbus, Ohio, and

Covidien-Mallinckrodt Pharmaceuticals of Hazelwood, Mo., creates dependency and

is sometimes sought by abusers who say they experience a special buzz when

mixing it with Xanax.

 

While the greatest numbers of methadone-related deaths have occurred among the

middle-aged, the fastest growth — an elevenfold jump between 1999 and 2005, to

615 — occurred among those age 14 to 24, which experts say may be mainly a

result of pill abuse.

 

Pain experts say the country is seeing a reprise of the abuse and tragedies that

followed the introduction of OxyContin, a time-release form of oxycodone that

was heavily marketed in the late 1990s. It became a factor in hundreds of deaths

and a focus of law enforcement.

 

OxyContin is still widely prescribed, but a survey of Medicare plans in 2008, by

the research firm Avalere Health LLC, found that many did not even include

OxyContin on the list of reimbursable drugs. Critics like Dr. June Dahl,

professor of pharmacology at the University of Wisconsin, fault the insurance

companies for favoring methadone simply because of its monetary cost. “I don’t

think a drug that requires such a level of sophistication to use is what I’d

call cheap, because of the risks,” Dr. Dahl added.

 

Yet for the right patients, methadone can be a godsend. Alexandra Sherman, a

patient of Dr. Heit’s at his Fairfax, Va., clinic, suffered for years from hip

and shoulder pain that “felt like somebody stabbing me with a knife,” she said.

Pain began to rule and ruin her days.

 

Dr. Heit gave her OxyContin and later, because it seemed to work better and

because of the expense, switched her to methadone. Her insurance at one point

covered only $500 in prescriptions, which paid for just one month’s worth of

OxyContin, compared with methadone’s cost of $35 a month.

 

Methadone “has given me my life back,” Ms. Sherman said.

But Dr. Heit did not just throw drugs at her problem. He told her that she would

also have to try physical therapy as well. They signed a contract listing mutual

obligations — she would follow directions, he would be on call. He starts

patients at low doses, makes them bring in their pill bottles so he can count

how many are left, and may give urine tests to deter mixing drugs.

Some doctors, like Dr. Theodore Parran of Case Western Reserve University, also

require methadone patients to give them the names of relatives or friends they

can call from time to time.

 

But not all doctors have taken such precautions. Tony Davis, a contractor in

Victorville, Calif., had just turned 38 in 2004 when, after years of migraines

and back pain, he saw a new pain doctor in his Kaiser Foundation Health Plan.

The doctor, who had already given him the sedative Xanax, prescribed methadone

because of his continued pain.

 

The second day on the two medications, Mr. Davis said, “I’m feeling really

weird,’ ” recalled his wife, Pebbles Davis. The two lay down for a nap and when

she woke up, her husband was dead.

 

Ms. Davis recalled that the coroner had told her, “Given the medicines he was

on, his brain forgot to tell his heart to beat and his lungs to pump.” The case

went to an arbitrator, who ruled that although Mr. Davis had overused his drugs

in the past, the doctor had failed to warn him about the new risks of starting

methadone together with Xanax and that the care was substandard. Ms. Davis was

awarded more than $500,000. “I never had any idea of the risk nor did my

husband,” she said.

 

Another source of danger has been the conversion tables that doctors use when

switching patients from one opioid to another — telling, for example, how many

milligrams of methadone would be equivalent to the level of morphine a patient

had been taking. These charts, until recently, indicated dangerously high doses

for methadone. Newer ones suggest lower levels but many experts say these may be

useless because methadone affects patients so variably.

 

Now, as the government is making new efforts to teach methadone’s challenges,

some officials and doctors would go further, requiring prescribers to take a

course before using methadone.

 

But many physicians and patient groups are wary of any steps that would slow

access to pain treatments.

 

As early as 2003, alarmed by the rise in methadone-related deaths, the Substance

Abuse and Mental Health Services Administration made an urgent call for more

systematic and detailed state and national reporting about opioid deaths — a

call that still goes unanswered.

 

Misuse by abusers was first seen as the problem, but now, said Dr. H. Westley

Clark, director of the Center for Substance Abuse Treatment of SAMHSA, “We know

that a significant share of the methadone deaths involve doctors making

well-intended prescriptions.”

 

A majority of victims also used large quantities of alcohol or benzodiazepine

sedatives but few would have died without an opioid as the primary culprit. “You

can take a lot of benzodiazepines without dying,” said Dr. Charles E. Inturrisi

of Weill Cornell Medical Center, who said they strengthen the depressive effect

of methadone.

 

Some doctors prescribe to patients who may be expected to court danger, like

Anna Nicole Smith, who died from a drug cocktail including methadone.

Last February, Margaret Moore, 54, who lived alone in South Pasadena, Fla., with

a history of alcoholism, depression and chronic back pain from a car accident,

was found dead at home. Her doctor had prescribed methadone and valium and, he

told investigators, warned her to stop drinking.

 

Her body was surrounded by empty vodka bottles and a host of pills including

bottles of methadone tablets and sedatives. Her death was declared an accident

from methadone toxicity.

 

Since April, SAMHSA has sponsored nine voluntary training courses on the safe

prescribing of opioids, and many more are planned, though they will only reach a

fraction of prescribers. The agency is also contracting with the American

Society on Addiction Medicine to set up a mentoring program, through which

prescribing physicians can receive expert advice. The State of Utah has a plan

to educate every doctor and pain patient in the state about safe use of

methadone and other opioids.

 

Nancy Garvin, Robby’s mother, is one of many relatives of victims who, in the

absence of a national registry, have started educational and pressure groups to

fight bad prescribing and abuse of the drug.

 

Still, the death rate appears to be rising, raising the question of what more

may be necessary, in law enforcement and in doctor training.

 

“Methadone can be important for patients when other drugs don’t work,” said Dr.

Inturrisi, ”but unless the doctor has the training and resources to manage the

patient properly, he’s going to get in trouble at a rate that’s unacceptable.”

 

http://www.nytimes.com/2008/08/17/us/17methadone.html?_r=1 & th= & adxnnl=1 & emc=th & a\

dxnnlx=1218968928-1b/tD+B1y+q3UWWqqOaY0A & oref=slogin

 

The Methadone Boom

 

 

Related

F.D.A. Weighs Training to Dispense Narcotics (August 17, 2008)

Times Topics: Methadone