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.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 This previously unpublished information comes from an analysis of death certificates requested by the Gazette-Mail and conducted by the National Vital Statistics System, part of the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.?To contact staff writers Scott Finn or Tara Tuckwiller, call 357-4323 or 348-5189. 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.