The Appeal of OxyContin
Time-Released Painkiller Packs Unusually Large Punch
By Jenette Restivo

Aug. 20 — Just what has makes the prescription painkiller OxyContin so coveted by so many?

The appeal to the roughly 1 million people who rely on the drug to fend off chronic pain is its time-release mechanism, which allows a patient to take only one pill every 12 hours, a vast improvement for chronic pain sufferers who may have had to take other painkillers as often as six times a day.
The level of relief is achieved by the drug's 40 to 160 milligrams of the morphine-like active ingredient, oxycodone while other painkillers like Tylox, for example, contains just 5 milligrams of the ingredient.

Addicts, unfortunately, have found a way to get to the high dose of oxycodone while circumventing the time-release mechanism: by crushing the pills.

After being crushed, the drug can be snorted or dissolved and injected, resulting in a powerful morphine-like high. And valuable: A 100-tablet bottle of OxyContin that is sold for $400 at the pharmacy can go for as much as $4,000 on the street.

In an effort to thwart such abuse, Purdue Pharma earlier this month that it was working to develop a painkiller like OxyContin that would also contain an ingredient to prevent abuse. The formulation will likely take three to five years to develop and be tested.

Abuse Proof?
Oxycontin Maker Getting Patent to Reformulate Often-Abused Drug
By Chris Kahn
The Associated Press

R O A N O K E, Va., Aug. 8 — The maker of OxyContin, a prescription painkiller linked to a growing number of overdoses and deaths, said today that it has come up with blueprints for a "smart pill" that would be tougher to abuse.

The new painkiller, which has yet to be named and would not be available for at least three years, would destroy its own narcotic ingredients if crushed into a powder and snorted or injected — the typical manner in which OxyContin currently is abused.

Not the Good Stuff
"Addicts and abusers are going to find this very undesirable," said Dr. J. David Haddox, senior medical director for Purdue Pharma LP of Stamford, Conn. "Before long they're going to say, 'Don't mess with that stuff; that's no good."'

Purdue spokesman Jim Heins said the drug could become an alternative to their top-selling painkiller in areas like rural Appalachia where prescription drug abuse is especially high.

OxyContin is a slow-release narcotic painkiller that is widely prescribed for victims of moderate to severe chronic pain resulting from such problems as arthritis, back trouble and cancer. One pill is designed to last 12 hours, but abusers usually crush the medicine and then snort or inject it, producing a quick, heroin-like high.

The drug has been blamed for contributing to more than 100 deaths nationwide. Purdue, which has become the target of at least 13 OxyContin-related lawsuits in five states, says those estimates are unreliable and that in the vast majority of those cases, the victims were abusing other drugs at the same time.

Beads Would Block Narcotic Effect
Like OxyContin, which was introduced in December 1995, the new drug would be for victims of moderate to severe chronic pain.

However, it would be embedded with microscopic "beads" of naltrexone, a narcotic antagonist that counteracts the medicine.

The beads would be coated with a chemical to keep them from dissolving, so the pain medication will work just like OxyContin if taken as directed.

But if the pill is crushed or chopped up, the coating on the beads would break, releasing the naltrexone and canceling the drug's effects, Haddox said.

Three Years Off
Purdue is still conducting tests on the new drug, which could be ready in three years. Officials have not decided yet whether to make oxycodone the active ingredient, or to include a different narcotic altogether, like morphine.

If the Food and Drug Administration approves the drug, it would be one of only a few abuse-resistant drugs on the market. The first smart pill, a painkiller called Talwin NX, uses an antagonist called naloxone to achieve similar effects.

Richard S. Weiner, executive director of the American Academy of Pain Management in Sonora, Calif., applauded the new formula.

"Hopefully, this will assuage law enforcement that … painkillers can be safe," Weiner said.

Purdue has been criticized for not reformulating OxyContin to be like Talwin. Company officials decided against doing so, Haddox said, because they were concerned that naloxone might create a "ceiling" effect in OxyContin. Such a drug would not increase in potency past a certain point, even if a patient takes higher and higher doses.

"We think this is a much more elegant solution to the problem," Haddox said.

Purdue officials said the timing of the patent has nothing to do with lawsuits from people claiming they're addicted to OxyContin and others who want to hold the company responsible for illicit abuse of the drug.

This week, Purdue said it expects an international patent application will be published on their "sequestered naltrexone" technology, an initial step that expedites the formula protection process in some countries. Heins said the company also will seek individual patents in the United States, Japan, Europe and other major markets.

‘Black Box Warning’
FDA, Drug Maker Caution Doctors on Prescribing Controversial Pain Drug
By Michael S. James

July 25 — The Food and Drug Administration is beefing up warning labels for doctors prescribing the controversial prescription pain medication OxyContin.

In a "black box warning," the strongest type of warning for an FDA-approved drug, the agency is telling doctors not to prescribe the narcotic with addictive properties similar to morphine except for patients with the most severe, continuous pain. OxyContin "can be abused in a manner similar to other opioid agonists [drugs of its type], legal or illicit," reads the new warning, announced today. "This should be considered when prescribing or dispensing OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion" to illegal distribution channels.

The stern warning comes amid continuing reports of abuse and overdose deaths linked to the drug.

Manufacturer: ‘A Cooperative Effort’

The six-paragraph warning appears at the top of an insert in OxyContin packaging sent to doctors and pharmacists who dispense the drug. A spokesman for Purdue Pharma, the maker of OxyContin, said the warning amounts to a stronger, briefer and more direct restatement of technical information previously contained within the drug's lengthy product labeling, but possibly missed by some doctors.

Purdue Pharma also has sent 800,000 copies of a letter explaining the labeling changes and risks of improper OxyContin use to health-care professionals.

"It is a cooperative effort" between the FDA and Purdue Pharma, said Robin Hogan, executive director of public affairs for the Stanford, Conn.-based company. "It's bad business to have these pills misprescribed, misused, overprescribed. … The FDA feels that in some cases this is happening and this is an effort to prevent that."

The opiate acts on the same receptors in the brain as heroin and is prescribed for moderate to high pain relief. Percocet, Percodan, and Tylox are other trade name oxycodone products. But OxyContin is the longest lasting oxycodone product on the market, acting for 12 hours.

OxyContin is said to be more commonly prescribed than Viagra. Hogan said there are a million people who take OxyContin legally every year.

Sometimes Abused

The drug has been blamed for dozens of overdoses across the country, and apparently is sought by illegal users through fraud and theft. Abusers commonly grind the drug to defeat the tablets' timed-release mechanism and get a more rapid dose.

The new warning tells doctors — in boldfaced, capital letters — to instruct their patients on how to properly take the medication.

"Tablets are to be swallowed whole and are not to be broken, chewed or crushed," the warning reads. "Taking broken, chewed, or crushed OxyContin tablets leads to rapid absorption of a potentially fatal dose of oxycodone."

On Monday, a man in Virginia pleaded guilty to a murder charge after admitting to injecting OxyContin into the arm of a partially paralyzed friend who later overdosed. It is believed to be the first murder charge connected to the drug.

OxyContin is so popular as a recreational drug that armed robbers recently struck pharmacies in the Boston area seeking it, and police in Massachusetts, parts of the Midwest and Delaware have decided to bulk up patrols around pharmacies to defend against theft.

Painkiller ‘Epidemic’
Drug Busts Uncover Abuse of OxyContin

L E X I N G T O N, Ky., Feb. 9 — A drug intended for use as a painkiller for terminal cancer patients has sent detectives in dozens of rural areas of the East scrambling to stem its illegal sale and abuse.

The United States Attorney's Office for the eastern District of Kentucky, along with the FBI and the DEA, conducted an 8-month investigation into the illegal distribution of the powerful painkiller, OxyContin. ABCNEWS and the New York Times collaborated on this story.

Operation Oxyfest
There have been 59 confirmed overdoses from the drug — in five counties in Kentucky, since Feb. 1, 2000, according to Joseph Famularo, the United States attorney for eastern Kentucky.

Famularo compared the OxyContin problem to the crack epidemic during the 1980s on GMA this morning.

"Unfortunately abusers snort it, shoot it, take it orally," said Famularo. "It has very, very profound and many times deadly consequences."

Famularo's office directed a roundup of 207 suspects this week in what officials dubbed "Operation Oxyfest 2001." It was the biggest drug-abuse raid in Kentucky history.

Those arrested ranged in age from 50 to as young as 20 years old.

"The investigation is continuing and quite frankly, I anticipate arrests later on this month and perhaps health care professionals," said Famularo.

A Wave of Abuse
Dealers of the drug — called "oxys" on the street — have used suffering patients, and faked symptoms to get their hands on the drug. Pharmacy break-ins, emergency room visits and arrests of doctors and other health care workers have been on the rise as a wave of people seek to illicitly obtain OxyContin.

"One of the commonwealth attorneys in the eastern part of the state related an incident where a gentleman, I use that term loosely, went in a store with a deer rifle and demanded OxyContin," ," said Famularo."It was an armed robbery in daylight asking for this drug."

Addicts like the drug because they can get a powerful morphine-like high by chewing or crushing the pills, short-circuiting the drugs intended, slow time-release protection. Kentucky authorities say that some teens have been carrying pill crushers normally used by elderly patients.

After being crushed, the drug can be snorted or dissolved and injected.

Law enforcement soruces cite cases of abuse in Maine, Maryland, Ohio, Pennsylvania, Virginia and West Virginia.

In Maine, law enforcement officials say their state is among the country's largest consumers of OxyContin on a per-capita basis. The U.S. attorney there says the drug is becoming a major problem in areas of the state not normally plagued by traditional recreational drug abuse.

"What is most unusual and disturbing,," says Jay P. McCloskey, U.S. District Attorney for Maine "is the number of high school kids and those in the early 20s who got addicted."

In fact, McClosky said some of Maine's best high school students and athletes have become addicted to the drug.

Morphine-like Substance
OxyContin, which came on the market five years ago, is made by Purdue Pharma in Stamford, Conn.

The drug's active ingredient is oxycodone, a morphine-like substance that is similarly found in Percodan and Tylox, which are also painkillers.

But Tylox, for example, contains five milligrams of oxycodone; OxyContin contains 40 to 160 milligrams in a time-released formula that controls pain over a longer period.

Some law enforcement officials, and Famularo, say abuse of the drug may be responsible for dozens of deaths. But Purdue Pharma strongly disputes those claims.

The company says it would like to see states tighten up prescription-writing practices with electronic data monitoring programs that track prescriptions and patients.

Accidental Painkiller Murder
Virginia Man Pleads Guilty in OxyContin-Linked Death
The Associated Press

T A Z E W E L L, Va., July 24 — A man faces up to 81 years in prison for what is believed to be the first murder charge related to OxyContin, the powerful painkiller that has been blamed for dozens of fatal overdoses across the country.

Robert Stallard pleaded guilty Monday to murder, drug distribution and unlawful disposal of a human body in the death of his friend Nicholas Dickerson.

"All I can do is pray and hope for the best," Stallard said before being led back to jail.

Gregg Wood, a health care fraud investigator for the U.S. attorney's office who monitors OxyContin-related crimes nationwide, said he knows of no other murder charges resulting from an OxyContin overdose.

Dickerson, 40, died after coming to Stallard's apartment last September in search of the prescription painkiller.

Stallard, 43, admits he injected OxyContin into the partially paralyzed man's arm as they sat at a kitchen table.

After administering the drug, police said, Dickerson went to lie down in a bedroom. When Stallard found his friend dead, he panicked and dragged the body outside before calling 911.

"Nick asked to be injected and he got what he asked for," defense attorney Penny Nimmo said. "It wasn't as if it was an innocent person who got held down and injected with drugs."

Just Like Shooting a Gun?

Tazewell County authorities decided that in this case, selling Dickerson the drug and helping him inject it was tantamount to shooting him with a gun.

"This is such a dangerous drug that dealers need to know that if and when the worst happens, you may very well wind up with a murder conviction," Tazewell County Commonwealth Attorney Dennis Lee said.

Nimmo said she will ask that Stallard's felony-murder charge be reduced to manslaughter before next month's sentencing in Tazewell Circuit Court.

"Clearly to me there was no malice in Robert's heart and mind," she said. "They were friends."

Drug Linked to 120 Deaths

Dickerson's brother Larry said he was happy to see Stallard in prison.

"I hope the man passes away behind bars," he said. "Robert's got a life ahead of him. Robert has his wife and children. Nick has none of this. The only thing we've got of Nick is memories."

OxyContin is a federally approved pain reliever that is a synthetic morphine with a derivative of opium. The drug, intended for use by terminal cancer patients and chronic pain sufferers, has been linked to at least 120 overdose deaths nationwide.

In May, drugmaker Purdue Pharma suspended shipments of its largest dose, the 160-milligram tablet, and took steps to make people aware of the dangers of the drug, also known by its generic name, oxycodone.

Heroin in a Prescription?
Painkiller OxyContin Has Pharmacies on Alert

July 9 — In parts of the country, a powerful painkiller has become so popular for recreational use it has pharmacies and lawmakers on alert.

Pharmacies and law enforcement agencies are on alert for thefts of the narcotic oxycodone hydrochloride, which, sold as OxyContin, is one of the best-selling brand-name drugs in the world, topping even Viagra.
Police in Massachusetts, parts of the Midwest and Delaware have decided to bulk up patrols around pharmacies because of the thefts.

Armed robbers have hit a dozen Boston area pharmacies in the past few months. So far, just one suspect has been arrested. To combat future attacks, Boston's Shaw's supermarkets announced its pharmacies would no longer carry the drug.

In Delaware county, there have been 23 deaths this year attributed to abuse of the prescription painkiller, according to a spokesman for the Delaware state District Attorney's office.

And, in at least six other Eastern and Midwestern states, the drug has been identified as a major or significantly growing problem, according to the Department of Justice.

Pharmacies Pulling Drug Off Shelf

Pharmacists are worried, too. Paul Hackett tells his employees never to be alone in his Weymouth, Mass., pharmacy.

"It's such a problem now," he says.

The drug is the subject of a conference by Delaware County officials today who are part of a growing coalition of lawmakers and pharmacy owners concerned about the drug. They want to spread the word about increasing robberies and addiction to the drug.

The Drug Enforcement Agency has suggested that Purdue Pharma, L.P., of Stamford, Conn., the company that makes the drug, reformulate the medication so it is not so prone to abuse. But the drugmaker, which made more than $1 billion last year from its sales, says the problem lies with the abusers and not the drug.

"When drug abusers determine the medical care for the rest of us that is a travesty," says Dr. David Haddox, Purdue Pharma's medical director.

On the company Web site, the firm says it has taken several actions to limit the problem of prescription drug abuse, including giving brochures to pharmacists and doctors, developing tamper-resistant prescription pads, meeting with law enforcement officials and funding a study to prevent patients who "shop for doctors" who might prescribe the drug without proven medical need.

The DEA, along with the Food and Drug Administration, only has authority to make recommendations. It cannot force the company to change its policy.

Works on Pain Relief

The opiate acts on the same receptors as heroin and is prescribed for moderate to high pain relief. Percocet, Percodan, and Tylox are other trade name oxycodone products. But OxyContin is the longest lasting oxycodone product on the market, acting for 12 hours.

OxyContin was approved in 1995 by the FDA as a moderate-to-severe painkiller. But abusers tend to crush the pills to snort it and shoot it like heroin. Because oxycodone is water soluble, crushed tablets can be dissolved in water and the solution injected.

The latter two methods lead to the rapid release and absorption of oxycodone. The drug produces a powerful heroin-like high. By chewing or crushing the pills, the slow time-release protection built into the drug is short-circuited.

In Milwaukee, a 34-year-old unemployed man attempted to rob a pharmacy for his wife last week. She is battling cancer and the family can't afford the drug. He walked into a Walgreen's with a hat pulled over his face and handed a note to the pharmacist that read "give me all your Oxycontin and nobody will get hurt."

He ran to the parking lot with a bag full of drugs, worth $400, and doubled back.

"That's not me, and I started thinking about how much trouble you could get into and stuff and I just turned around and gave it back to the fella and said I'm sorry," said Kevin May, who was reportedly arrested but not charged in the incident.

Abuse of Pain Killer OxyContin
A News Analysis By Terence T. Gorski, March 2, 2001

There are indicators of growing abuse of and addiction to the synthetic narcotic painkiller OxyContin. OxyContin is a form of synthetic morphine taken in tablet form designed to kill pain over several hours. It is primarily used by cancer patients.

The drug is being abused by addicts who intensify it’s euphoric heroin-like effects by by injecting or snorting it. Dr. J. David Haddox of Purdue Pharma said OxyContin, when abused, can significantly slow breathing and is easily overdosed. The abuse of OxyContin appears to be most common in small, isolated areas, although no one is sure why.

According to the Associated Press, there was a meeting between the drug maker, Purdue Pharma, and law enforcement officials from five states on March 1, 2001. Those attending the meeting included officials from West Virginia, Ohio, Maryland, Kentucky and the federal Drug Enforcement Administration. OxyContin has caused an increase in crime and death in Virginia, where 32 overdose deaths have been reported.

Purdue Pharma said it would help combat abuse by making tamper-resistant prescription containers for areas of southwest Virginia where authorities say abuse is rampant and spending $100,000 on a study of prescription monitoring programs in Virginia. The company will also form two drug abuse task forces and investigate the illegal sale of drugs over the Internet.

Authorities said doctors may be over-prescribing the drug and making it too widely available. But Maryland Attorney General J. Joseph Curran Jr. said he hoped doctors would not hesitate to provide it to those truly in need. ``Where there is pain that can be relieved, we want it to be relieved,'' Curran said.

9 Investigates: Oxycontin
CHARLOTTE, Feb. 12 -- The powerful drug oxycontin has been in the news recently over its rise in use.

One doctor in Cleveland County is the center of an investigation over the drug. Federal officials say Dr. Joseph Talley may have been the number one prescriber of Oxycontin in the nation.

Maudie Nanney's daughter, Vicki, began taking prescribed Oxycontin two and a half years ago for back pain. Before Nanney knew it Vicki was addicted to the drug.

"She said momma I want it so bad I'd kill for it. When you get on it like I am you would kill for it," Nanney said.

Last summer Vicki Trivette died near the town of Elk Park. Sheriff deputies and family members believe Oxycontin was the reason.

The sheriff's office says the area, which is known more for its beautiful waterfall than tragedies, has seen five people die from the drug in the last year. Maudie Nanney believes there also needs to be more treatment for people who abuse the drug.

"I'd tell parents do whatever it takes to be able to get them off of it cleaned up and not to get started with it if they can help it," Nanney said.

Dr. Mary Brittain says Oxycotin is prescribed orally for long-term management of pain.

"You don't want to crush chew or inhale because it is a sustained release that causes an immediate release and absorption of the drug and that causes an overdose and then potential death," said Dr. Brittain.

Because of the high potential for addiction and because Brittain works at an urgent care facility there are signs posted outside her Hickory office letting patients know Oxycotin is not prescribed here.

In Iredell county, the abuse of Oxycotin was so widespread undercover narcotic officers set up a sting with phony pills. They busted an organization, based in Iredell County, that was distributing Oxycotin in three states.

During their investigation, officers discovered the group made phony prescriptions on a computer and then passed them to get the Oxycotin. Over a year's period they estimate the organization was able to obtain between 60 and 75,000 pills of oxycontin illegally.