Methadone

[palmspringsbum]

June 12, 2006
Health pros to get methadone briefs


By Scott Finn and Tara Tuckwiller
Staff writers
The Charleston Gazette

Pharmacists statewide will soon get information from the West Virginia Board of Pharmacy that will help them explain to patients the need to be careful with the pain drug methadone.

Also, the West Virginia Medical Association plans to educate doctors about the risks involved in prescribing methadone, and the state Division of Alcoholism and Drug Abuse is educating addiction counselors about methadone.

A Gazette investigation published last week found that methadone is helping to kill more people nationwide than any other prescription narcotic, and West Virginia’s methadone death rate is the nation’s highest.

“We’re going to try to educate the pharmacists about the severity of this issue,” said William Douglass, executive director and general counsel to the Board of Pharmacy.

Since 2003, the board has collected data on prescriptions dispensed in West Virginia. Between 2003 and 2005, the number of prescriptions for methadone rose 26 percent, from 22,246 prescriptions to 27,976.

Prescriptions for the strongest formulation, 40 milligrams, more than tripled, Douglass said.

The prescription database tracks only methadone prescribed by doctors for pain. Its figures do not include methadone that is sold by clinics to treat drug addiction.

West Virginia’s addiction counselors are seeing a flood of people hooked on prescription narcotics that shows no sign of abating, said Steve Mason, director of the state Division of Alcoholism and Drug Abuse.

Mason ranks prescription drugs behind only alcohol and marijuana as the most common substances being abused in West Virginia today.

“Methadone is a good drug when it is used legitimately for pain. Unfortunately, the addict can be very creative and will mix methadone with other drugs to try to get high,” Mason said.

The division is spending $100,000 on a prescription drug awareness campaign, Mason said. The money comes from a settlement Attorney General Darrell McGraw received from the makers of OxyContin, another prescription painkiller.

The money will educate addiction counselors about methadone and other dangerous prescription drugs, he said. Counselors will educate addicts about how to stay safe if they choose to continue to abuse drugs.

Mason said doctors and pharmacists also need more training about the safe prescribing of methadone.

“If we had better education of physicians in medical schools around addiction, if they could be more aware of the dangers of what they’re prescribing, that would help,” Mason said. “Doctors are trying to relieve pain and that’s their job. But there are some physicians who prescribe too much.”

The West Virginia Medical Association plans to educate doctors about methadone’s risks, said spokeswoman Helen Matheny.

The association will publish an article about methadone by West Virginia University professor Chris Terpening in its medical journal, she said.

The Appalachian Pain Foundation has been trying to educate local health providers for years on the proper use of painkillers, said its director, Skip Lineburg.

The group got its start with the help of drug manufacturers, but now relies solely upon federal grants, he said. It sponsors workshops for medical professionals about how to diagnose and safely treat pain.

The Appalachian Pain Foundation’s Web site is www.paincentral.com.

To read the rest of the series, The Killer Cure, go to www.wvgazette.com/section/Series/The+Killer+Cure.

To contact staff writers Scott Finn or Tara Tuckwiller, use e-mail or call 357-4323 or 348-5189

[palmspringsbum]

June 04, 2006
Deaths tied to methadone escalate across state, nation

Feds approve outdated, potentially deadly drug information


By Scott Finn and Tara Tuckwiller
Staff writers
The Charleston Gazette


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.”


<span class=postbold>An “extremely dangerous” dose</span>

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.


<span class=postbold>“His miracle drug”</span>

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.


<span class=postbold>Too many deaths to count</span>

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.”


<span class=postbold>Not just drug addicts</span>

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.

<table class=posttable align=right width=300><tr><td class=postcell>
<font size=2><b>What is methadone?</b></font>

<span class=postbold>What it is</span>: Methadone is a synthetic opiate developed by the Germans during World War II as a substitute for morphine.

<span class=postbold>What it isn’t</span>: Methadone often is confused with “meth,” or methamphetamine, an illegal stimulant commonly cooked in clandestine labs. Methadone is a completely different — and legal — drug.

<span class=postbold>Uses</span>: Until recently, methadone was given mostly to heroin addicts to suppress their cravings. Now, doctors are increasingly prescribing it as a painkiller.

<span class=postbold>Dangers</span>: 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.

</td></tr></table>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.”


<span class=postbold>Not on FDA’s radar screen</span>

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.

<span class=postbold>See Also: Opiate related deaths soar</span>

<span class=postbold>See Also</span>: Alert escalates on drug mix: 'Too many dying'

<span class=postbold>See Also</span>: Prescription Drug Abuse in Teens

<span class=postbold>See Also</span>: Las Vegas Prescription Drug Abuse Growing Problem

<span class=postbold>See Also</span>: Cannabis as a Substitute for Alcohol: A Harm-Reduction Approach - Tod H. Mikuriya

[palmspringsbum]

In New Hampshire, there have been 19 heroin-related deaths since 2001. In the same time frame, there were 178 deaths related to methadone -- the synthetic medication used to treat heroin addiction. In 2005, there were 52 methadone-related deaths, according to information provided by the state Division of Vital Records.

Nine times, almost ten times, as many deaths from methadone as from heroin, and this is called treatment?


[quote="Portsmouth Herald"]
Heroin: The Seacoast's 'silent epidemic'

By Adam Leech
aleech@seacoastonline.com
The Portsmouth Herald
September 17, 2006

Note: <i>The recovered heroin addict used as a source in this story asked that his real name not be used for privacy concerns. It has been changed to "Steve."</i>

<table class=posttable align=right width=300><tr><td class=postcell><img src=bin/methadone.jpg width=300></td></tr><tr><td class=postcap>Joan Mann, nurse manager for Community Substance Abuse Center, simulates how doses of methodone are administered from the secure windows at the new Newington facility on Shattuck Way.</td></tr></table>While growing up in Portsmouth, Steve had a core group of best friends. They rode their bikes, played Little League, went to school, and graduated from Portsmouth High together. They remained close as they entered adulthood, and it appeared their friendship would never end.

Now, at age 30, Steve looks back at the circumstances that not only ended their friendship, but their lives.

"I lost kids I went to high school with, kids from Portsmouth High, Dover High, Kittery are dead," he said with a quiver. "Most of my friends ... of the ones close to me, six."

Heroin killed Steve's friends. It almost killed him. Clean for nearly three years, Steve credits the love of his fiancee and years of methadone treatment for giving him a second chance.

As a heroin dealer and addict for nearly a decade, he scoffs when he hears people across the Seacoast say they don't think it's a problem here.

"It's everywhere," he said. "And it's ridiculous for people to think it's not."

Heroin is not a new drug by any means, but police say its potency is higher than ever. What was once a mix of around 3 percent pure heroin and 97 percent other chemicals can now be found at up to 80 percent pure, making the side effects more dangerous. And at between $3 and $10 a bag, it is affordable and not difficult to find.

"It's everywhere. I'd be willing to say you could buy heroin at any high school in this county," Rockingham County Attorney Jim Reams said. "Ten to 15 years ago, the drug problem was mainly marijuana and alcohol. To law-enforcement officers, that seems like the good-old days."

The increased purity also allows the user to reach the euphoric state by snorting the powder rather than injecting it. Reams said this makes use of the drug more justifiable to young people.

Steve said he was first introduced to heroin while camping with friends. Someone brought a bag and they snorted it. The next time he used it was at a party a few months later.

"Next thing you know, a year later, you're sniffing all kinds of bags," he said. "A year after that, I was just not getting high, so I had my neighbor shoot me up. After that, that's all it is. When you're that bad, every few hours, it gets real bad."

Withdrawals are very painful and include flu-like symptoms and bone pain. They were so painful for Steve, he had to shoot up every few hours to avoid the searing pain. Finding a steady supply to support his addiction wasn't easy and it was impossible to keep a job.

"At first, it's just experimenting. You meet certain people and think,

[palmspringsbum]

US WorldMeds Initiates Phase III Trial of Lofexidine for Treatment of Opiate Withdrawal Symptoms

Oct 9 2006, 8:30 AM EST
BIOWIRE
genetic engineering news

US WorldMeds, a Kentucky-based specialty pharmaceutical company, today announced that it is enrolling patients in a Phase III clinical trial, USWM-001, investigating the use of lofexidine hydrochloride (Lofexidine) for the treatment of opiate withdrawal symptoms in opiate dependent individuals. If approved by the Food and Drug Administration (FDA), Lofexidine would be the first non-addictive, non-narcotic treatment for relieving the distressing withdrawal symptoms associated with opiate detoxification approved in the United States.

Investigators are currently recruiting 264 patients to participate in the in-patient, randomized, double-blind trial that will be conducted at 14 sites throughout the United States. The withdrawal treatment period will be eight days per patient. US WorldMeds expects the Phase III trial will support a new drug application (NDA) filing with the FDA for Lofexidine for this indication.

"The distressing physical symptoms associated with opiate withdrawal are a major impediment for those who want to end their addictions," said Paul Breckinridge "Breck" Jones, CEO of US WorldMeds. "The only FDA approved treatment alternatives for opiate detoxification today are drugs that have their own addictive properties. Lofexidine will give a new option to hundreds of thousands of people who are struggling with addictions to heroin and widely prescribed opiate based pain medications such as OxyContin."

Lofexidine, an alpha-2-adrenergic agonist, is the only non-addictive, non-opiate treatment approved in the United Kingdom (UK) to manage the often debilitating withdrawal symptoms that occur during opiate detoxification. These can include vomiting, sweating, stomach cramps, diarrhea, and muscle pain. Lofexidine has been used in an estimated 200,000 detoxifications over 13 years in the UK, where it is marketed by Britannia Pharmaceuticals as Britlofex(R).

Lofexidine has been studied in six prior clinical trials in the United States. In 2003, the National Institute on Drug Abuse (NIDA) took the unusual step of stopping a similar Phase III trial when its Data and Safety Monitoring Board determined it unethical to continue administering placebo to research subjects in withdrawal in the face of lofexidine's overwhelming efficacy. NIDA is also playing a central role in the oversight of US WorldMeds' latest clinical trial of lofexidine.

"Lofexidine could be the first non-opiate drug for the management of opiate withdrawal. As such, it would occupy a unique niche in managing patients during the opiate withdrawal period," said Dr. Frank Vocci, Director of the Division of Pharmacotherapies and Medical Consequences of Drug Abuse at NIDA.

The National Institutes of Health (NIH) estimates that drug and alcohol addiction affects millions of people in the United States, costing the nation nearly $500 billion a year - more than diabetes and cancer combined. The number of hardcore heroin abusers in the United States is estimated between 600,000 and 1 million. Addiction to prescription pain medication is on the rise. In June, the U.S. Substance Abuse and Mental Health Services Administration reported that 2.4 million persons initiated non-medical use of prescription pain relievers over a 12 month period - 300,000 more than those who initiated use of marijuana.

Opiate addicts who seek treatment for withdrawal symptoms are most often offered the replacement drug Methadone, an addictive opiate derivative, through community treatment centers.

"Opiate abuse has grown to epidemic proportions," said Jones of US WorldMeds. "Addicts in communities with minimal healthcare resources could have much greater access to addiction treatment if Lofexidine comes to market. I expect that Lofexidine will not need to be closely administered like currently available narcotic treatments. Therefore, once approved, any licensed physician could prescribe it through any pharmacy anywhere in the US. Its availability would not be limited to community clinics that are often located in more urban areas."

US WorldMeds was founded by a diverse group of financial investors who share a strong commitment to impact national and world health. The company's founders acquired a license for Lofexidine from Britannia Pharmaceuticals in 2003 after they became inspired to help solve the chronic addiction problem in their home state of Kentucky, which has experienced significant prescription drug abuse, particularly in rural areas.

Lofexidine trials are currently being conducted at medical facilities throughout the United States, including: <ul><li>Alexian Brother Behavioral Health Hospital, Hoffman Estates, IL</li>

<li>Atlanta Center for Medical Research, Atlanta, GA </li>

<li>Aurora Psychiatric Hospital, Wauwatosa, WI </li>

<li>Research Across America, Dallas, TX </li>

<li>CNS Psychiatric Institute of Washington, Washington, D.C. </li>

<li>Ocean State Research, Providence, RI </li>

<li>St. Vincent Catholic Medical Center, Staten Island, NY </li>

<li>University of Kentucky Center for Human Behavioral Science, Lexington, KY </li>

<li>University of Texas Health Science Center, San Antonio, TX </li>

<li>Vanderbilt Psychiatric Hospital, Nashville, TN </li>

<li>Western Institute of Biomedical Research, Salt Lake City, UT </li>

<li>Veterans Administration Puget Sound Health Care System, Seattle, WA </li>

<li>Wayne State Addiction Research Institute, Detroit, MI </li></ul>For further information on clinical trial enrollment contact: (502) 753-2095

About US WorldMeds

US WorldMeds is a closely held specialty pharmaceutical company based in Louisville, Kentucky. Founded in 2001, US

[palmspringsbum]

<span class=postbold>See</span>: Prescription drug death more common in rural communities