Victorville, CAA drug that was once the bastion of the recovering drug addict has now entered the pain med mainstream, and used properly has been a godsend for people with chronic pain. However, it has been reported that many prescribing doctors have yet to appreciate the complexities of the drug, and methadone is killing people.
In fact, up until a couple of years ago the US Food and Drug Administration (FDA) was unknowingly contributing to the problem.
Methadone is a synthetic form of opium, which, in similar fashion to OxyContin, has a history of abuse. However, when prescribed correctly the opiate provides much-needed relief for people with chronic pain. How it is prescribed, however, is key—and doctors need to understand that variances seen amongst individuals aside, methadone is generally slow to metabolize, posing the risk that doctors start patients on the drug too aggressively, rather than easing them into it. The first week, it has been reported, is considered critical in order to avoid putting the patient at risk.
In 2006 the FDA addressed that concern by revising its product labeling to support no more than 30 mg as a safe limit for starting patients on methadone for pain. However, this is down from the previously supported limit of 80 mg per day, and "this could unequivocally cause death in patients who have not recently been using narcotics," said Dr. Robert Newman, former president of the Beth Israel Medical Center, in comments published in the New York Times.
The FDA had the upper limit pegged at 80 mg for decades, in what critics call a 'stunning oversight.' In its defense, the FDA says that it wasn't made aware of the problem until reports and overdoses among pain patients began flooding in, and a newspaper in Charleston reported on the danger associated with the existing package instructions.
"As soon as we became aware of deaths due to mis-prescribing for pain patients," Dr. Bob Rappaport of the FDA said, "we began the process of instituting label changes."
And none too soon, according to the statistics. Methadone has the dubious distinction of being the fastest-growing cause of narcotics death. It has been reported that between 1999 and 2005, deaths which identified methadone as a contributor increased nearly five times, to 4,462—and that figure could be understated given the fact that many States don't specify the drugs involved in death attributed to overdose.
Florida, however, does—and its meticulous record keeping suggests that 785 deaths in 2007 alone happened in association with methadone. That's up from 367 five years ago.
It gets even worse when you mix the stuff with sedatives, or alcohol.
Like OxyContin before it, methadone has proven a godsend for patients with chronic pain. On August 17th the New York Times profiled a young patient who could barely function until her doctor began prescribing methadone within a carefully structured, and monitored program that included a contract between patient and physician and the provision for physical therapy. Sticking to the plan rigidly has worked wonders for Alexandra Sherman, but that success has come at the end of a carefully cultivated regimen. Her doctor started her on a low dose and built up gradually. He also gets her to bring her pill bottles in so he can track the number of tablets ingested.
Some doctors even require urine tests, to ensure their patients aren't mixing the methadone with other drugs.
Tony Davis was a contractor from California who suffered from chronic migraines and back pain. A new pain doctor assigned to him by his health care plan had already given him the sedative Xanax, when he also prescribed methadone for continued pain.
On the second day on the two medications, Davis observed to his wife that he was feeling really strange. Later that day, in 2004 at the age of 38, he lay down for a nap and never woke up.
His widow sued and was awarded $500,000. She claims they were never warned about the risks.
Robby Garvin was just 24 when he lay down for a nap and never woke up in June 2006. The South Carolina man suffered from excruciating spinal deterioration, and was ecstatic when the methadone prescribed by his doctor succeeded in stemming the pain.
However, the initial dosage of one, or two 10mg tablets three times a day proved too much for Garvin. His doctor was cleared of any wrongdoing by his State Medical Board, and even though it has been reported that some specialists would have started Garvin on a lower dose more in line with the recent FDA labeling revision, it should be noted that the potential for ingesting 60mg of methadone in a day for Garvin was, in June 2006 well within the FDA limit of 80 mg at the time.
Concerned health care professionals feel that physicians need to be properly trained on the complex prescribing requirements for methadone and other opiates, and feel that the federal government should step up to the plate. Critics to this idea, feel that it would just slow down the availability of an effective pain treatment to those suffering from chronic pain.
As the debate rages, there is fear that things will only get worse before they get better. Methadone is much less expensive than its opiate sibling OxyContin, which means health care plans are more apt to support the drug by having it in their formularies. And there will always be physicians too quick to write the prescription, but lacking the time to properly educate, or monitor the patient.
Methadone is manufactured by Roxane Laboratories Inc. of Columbus, Ohio, and Covidien-Mallinckrodt Pharmaceuticals of Hazelwood, Mo.
As an aside, John Lennon famously brought methadone to the forefront after he appeared with the Beatles on a worldwide satellite telecast, performing 'All You Need is Love.' Reported as attempting to kick a heroin addiction, methadone therapy allegedly helped him to rally for the performance. In 1968 the best addiction specialist money could buy was said to be easing a drug-addict client out of his addiction with the help of another opiate, few understood.
Today, as that same methadone is prescribed for back pain and migraine headaches, it seems most heath care professionals, and until recently the FDA, remained in the dark about this powerful medication that is taking lives needlessly.