Source: Miami Herald
Date: 13 January 2004

Generic OxyContin worries authorities

By DAVID HENCH, Portland Press Herald Writer


The prospect of a generic brand of OxyContin is welcome news to people with chronic pain, but some in law enforcement are concerned that abuse of the powerful painkiller will get worse.

A federal judge last week ruled that the patents held by the manufacturer of OxyContin are invalid, which opens the door for other drug companies to make it. That would likely lower the price of the effective and popular medication, which now can cost between $500 and $600 for a month's supply.

That is good news for legitimate users of OxyContin. But authorities worry that a drug that is already widely abused in Maine could become even more popular on the street.

"If the price is reduced because the source is able to get it cheaper and sell it cheaper, then there's going to be more widespread distribution to a wider customer base," said Sgt. Darrell Crandall, the Maine Drug Enforcement Agency supervisor for Washington County, one of the areas where OxyContin addiction and abuse first took hold in Maine in 2000.

OxyContin is a time-release form of the painkiller oxycodone, which enables a person suffering from chronic pain, such as from surgery or cancer, to receive 12 hours of medication from a single tablet.

Recreational drug users found that by crushing OxyContin and sniffing it into the nasal passages, the entire dosage of painkiller is delivered immediately, producing a euphoria.

In early 2000, health care professionals and police in eastern Maine became aware of many people who had become addicted to the drug. Similar problems developed in Appalachia.

"It was a trickle around here at the time, and pretty soon it was a tidal wave," said Gregory Wood, a health-care fraud investigator with the U.S. Attorney's Office in Roanoke, Va., and a crusader against OxyContin abuse.

Other painkillers and depressants such as Percocet, Dilaudid and Valium remained popular on the illicit market. But OxyContin became among the most popular and was associated with a new crime wave as addicts sought money to satisfy their cravings.

An outcry eventually led manufacturer Purdue Pharma to adopt measures aimed at reducing abuse and diversion of the drug to the illicit market. In some areas the problem has subsided, though caregivers in eastern Maine say it continues to be a serious problem there.

The drug also continues to be pricey on the illicit market. In Washington and Aroostook counties, two of the poorest in the state, people still find ways to buy an 80 mg pill of OxyContin for $80, Crandall said.

Now a U.S. District Court judge in Manhattan has ruled that the patents Purdue Pharma had on its time-release painkiller are invalid. Companies that already have Food and Drug Administration approval to make generic forms of the medication say they could begin doing so shortly.

Endo Pharmaceuticals Holdings Inc., one of those planning to manufacture the generic version, has not indicated how much the drug would cost or when it would begin manufacturing. Purdue Pharma says it will appeal the judge's decision.

A generic form would likely cut the price of time-release oxycodone significantly.

That's an important savings for many people who cannot afford, or whose insurance does not cover, the brand name OxyContin, said Janice Reynolds of the Maine Pain Initiative, a group that advocates for people with chronic pain.

Reynolds said diverting the drug for illicit use is a complex problem, but people with severe chronic pain shouldn't suffer more because of it. "It shouldn't be harder for people to get adequate pain medication," she said.

Purdue Pharma has asked the FDA to withhold final approval of any generic forms of OxyContin until the generic drug companies institute measures to minimize abuse, misuse and diversion of their products, much as Purdue Pharma has had to do for OxyContin.

The company says it conducts education on safe use for prescribers, pharmacists and patients, monitors sales statistics for signs of abuse, and teaches police and health care professionals ways to thwart diversion of the drug to illicit use.

Sgt. Scott Pelletier, a Portland officer who supervises Cumberland County's MDEA office, agrees that generic companies also should be required to institute safeguards against diversion.

"I don't think there's as much OxyContin being prescribed and ultimately diverted," Pelletier said. "I think there's more restrictions. . . . If we don't have some of those restrictions on these new generic brands and that floods our markets, I think you're just asking for trouble."

A new tool to prevent diversion could be in place before a generic version of the drug even reaches the market. The state Office of Substance Abuse is setting up an electronic prescription-monitoring system that will enable doctors and pharmacies to track a patient's use of certain medications.

"It would allow a physician to see that his or her patient is going to four or five other doctors, or if people are filling prescriptions early," said Kim Johnson, director of the Office of Substance Abuse. Such practices have been linked to the illegal diversion of prescription opiates, including oxycodone.

The state is analyzing vendors and should have a system in place within six months.

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