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Report: OxyContin maker made false claims
GAO cites manufacturer for minimizing risks of drugThe Associated Press
Updated: 5:51 p.m. ET Jan. 22, 2004The maker of OxyContin sent doctors promotional videos that made unsubstantiated claims minimizing the dangers associated with the pain relief drug, congressional investigators said Thursday.
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The General Accounting Office also said that in 1998, Stamford, Conn.-based Purdue Pharma failed to submit one of the videos to the Food and Drug Administration for review, as required, when the company started circulating it to thousands of doctors.
The company said its failure to send the video to the agency was an oversight. It did submit a 2001 video for FDA examination, but the agency did not review it "because of limited resources," the report said.
On the 1998 video, a doctor says less than 1 percent of people who take pain relief medication like OxyContin become addicted. That's a figure the FDA says has not been substantiated, the report said.
The FDA looked at the later video after GAO investigators inquired about it. The agency said it "appeared to make unsubstantiated claims regarding OxyContin's effect on patients' quality of life and ability to perform daily activities and minimized the risks associated with the drug." FACT FILE 'Scripts that addict
� About
� OxyContin
� Vicodin
� Percodan
A record 36 million Americans have abused prescription drugs at least once in their lifetime, a government study found. To find out more about some of the most commonly abused prescription painkillers, select a medication above.
Maker: Purdue Pharma L.P.
Known as the 'hillbilly heroin,' OxyContin is the brand name for an opioid analgesic prescribed for chronic moderate to severe pain. Its active ingredient Oxycodone is more potent than hydrocodone and has a greater potential for abuse. Oxycodone is also found in at least 45 other drugs on the market, including Percocet. Since hitting the U.S. market in 1996, OxyContin has become one of the most popular -- and most abused -- medical painkillers. More than 7.2 million prescriptions were dispensed in 2001, according to the company. It is a time-released narcotic which provides continuous relief for up to 12 hours.
Like other opioids, it works primarily through interaction with the mu opioid receptors, especially in the brain and spinal cord. It produces a euphoric effect.
Because of its time-release function, the medication comes in large doses and can be fatal if it is crushed or chewed. According to published reports, maker Purdue Pharma is researching for a method to mask the drug's effects if it is crushed, a common way it is abused by addicts.
Maker: Knoll Pharmaceutical
The drug taken in large doses by Rush Limbaugh and that nearly killed 'Friends' star Matthew Perry, Vicodin is the brand name of an opioid analgesic similar to heroin and morphine. One of the most frequently prescribed medications for moderate to severe pain such as migraines, back pain and cancer, Vicodin's active ingredients are hydrocodone bitartrate and acetaminophen, which work on pain receptors in the brain. It can become physically addictive after only several weeks of use. In fact, it is one of the top 20 most abused controlled substances in the United States, according to drug addiction researchers. It is an older drug than OxyContin and is effective for only a 3-4 hour period. Chronic use of opioids can result in tolerance, which means that users must take higher doses to achieve the same effects.
Side effects:
Dizziness, drowsiness, lightheadedness, constipation, nausea, or vomiting. Some doctors assert that abuse of Vicodin can cause hearing loss.
Maker: Endo Pharmaceuticals
Prescribed for moderate to severe pain, Percodan is the brand name for a combination of two pain-killing drugs, the narcotic oxycodone and aspirin. Percocet combines oxycodone and acetaminophen. Both are in a class of opioids that includes morphine, heroin, Demerol and others. It works by blocking pain signals from the brain and spinal cord. Available in tablet, capsule, and liquid form, it is taken every 6 hours by mouth.
Side effects: Sleepiness or dizziness, nausea or vomiting and constipation. People taking the drug should avoid alcohol or any other medications containing aspirin or acetaminophen.
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Drug's safety overstated, FDA says
The FDA also publicly cited Purdue Pharma last year for overstating OxyContin's safety in print ads. OxyContin was initially hailed as a breakthrough in the treatment of severe chronic pain when it was introduced in 1996. The drug has become a problem in recent years, however, after users discovered that crushing the time-release tablets and snorting or injecting the powder yields an immediate, heroin-like high.
Lawmakers asked GAO, the investigative arm of Congress, to study Purdue Pharma's marketing of OxyContin because of the drug's widespread abuse, especially in Appalachian states.
'Why did it take the company three years to use their highly detailed data on physician prescribing practices to identify patterns of abuse?'
� Rep. Hal Rogers
R-Ky.
The drug's potency may have made it an attractive target for abuse, the report said, and a safety warning advising patients not to crush tablets because of the rapid release of a drug component may have tipped abusers off about how to misuse the drug.
The report said it was difficult to pinpoint the relationship between the increase of OxyContin prescriptions in recent years and the diversion of the drug to abusers, because data on drug abuse isn't reliable.
Purdue Pharma spokesman Jim Heins said that lack of information about why the drug has been abused means critics shouldn't point fingers at the company without obtaining more proof.
"There's not a clear indication that our marketing has led to diversion and abuse," Heins said. "Unfortunately, prescription drug abuse has been a problem in the U.S. for a long time, particularly in Appalachia.'
Heins confirmed that Purdue Pharma is facing roughly 340 lawsuits for its marketing of OxyContin, but he said 70 of them have been dismissed.
Republican Rep. Hal Rogers, who represents an eastern Kentucky district hard-hit by OxyContin abuse, is among the lawmakers who called for the investigation.
Rogers said one thing that upset him was the report's finding that the company didn't analyze physician prescribing reports, which the company regularly uses for marketing purposes, to identify possible abuse of the drug until 1999. That was three years after reports of widespread abuse surfaced.
"Why did it take the company three years to use their highly detailed data on physician prescribing practices to identify patterns of abuse?" Rogers asked.
The GAO investigators recommend that the FDA encourage drug makers to submit plans to the agency identifying potential problems for abuse and diversion of new drugs.
FDA spokeswoman Kathleen Quinn said the recommendation is similar to one made by an advisory panel.
"FDA does agree with both that committee's recommendation and GAO's in their encouragement of stronger risk management plans," Quinn said. "We are working to put those types of plans in place."
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