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Thursday, January 31, 2002
Essentially, the advisory committee's mission is to ensure that the powerful narcotics do not fall into the wrong hands.
By LAURENCE HAMMACK
THE ROANOKE TIMES GAITHERSBURG, Md. - A country doctor from far Southwest Virginia who wants OxyContin off the market found little support Wednesday as the Food and Drug Administration convened hearings on the use of opium-based painkillers. Dr. Art Van Zee of Lee County, who is organizing a petition drive to have OxyContin recalled, told an FDA advisory committee about abuse of the prescription medication, which has caused fatal overdoses and widespread crime. "It would be very difficult to overstate the level of devastation this has brought to Central Appalachia," he said. But as the FDA's Anesthetic and Life Support Drugs Advisory Committee began a two-day hearing to discuss the use of opiate painkillers, the prospect of recalling OxyContin was not on the table. "The goal of the meeting is not to take any particular drug off the market and not to focus on any particular drug," said Nathaniel Katz, a Harvard Medical School professor who is leading the hearings. Despite those opening remarks, much of Wednesday's discussion involved OxyContin - and the fear by many that the FDA will restrict the drug's availability to curb abuse, only to cause untold suffering by legitimate patients who rely on it to lead normal lives. John Giglio of the American Pain Foundation said calls to his organization from concerned patients have doubled since OxyContin abuse became the topic of national media attention last year. "Some literally threatened suicide as they spoke to us," he told the panel. The foundation estimates that 50 million Americans suffer from chronic pain, and the general consensus among health care experts is that pain has been undertreated for years. That is now changing, experts say, as more doctors are using opiates and other methods. Approval of OxyContin by the FDA in 1995 came during a "sea-change in the way pain specialists have viewed opiate drugs" for the treatment of pain, said Dr. Russell Portenoy of the Beth Israel Medical Center in New York. But as OxyContin sales skyrocketed to more than $1 billion in 2000 and abuse spread from isolated rural areas to other parts of the country, the FDA and law enforcement came under increased pressure to ensure that the powerful narcotics do not fall into the wrong hands. That essentially is the advisory committee's mission. Although it will not make any formal recommendations to the FDA, the committee is being asked to address a number of questions. Among them: How to identify the patients best suited for opiate drug treatment; how to determine the risk of addiction those patients face; to what degree opiate drugs should be used to treat children; and steps the FDA might take to reduce abuse of opiates without restricting access to legitimate patients. A transcript of the hearing will be used to guide the FDA in future decisions. When the hearing resumes today, officials from the Drug Enforcement Administration will discuss prescription drug abuse. A representative from Purdue Pharma, the Connecticut company that makes OxyContin, will also address the committee. During a public hearing Wednesday, Van Zee was vastly outnumbered by speakers who implored the committee not to restrict OxyContin. Some did not seem convinced by assurances from the FDA that a recall is not being considered. Some states have already cut back on Medicaid coverage for OxyContin prescriptions, they said, and bad press the drug has received is making doctors reluctant to dispense it. While some say physicians are afraid of getting in trouble for prescribing potent drugs, numbers presented by Dr. Bruce Levy, former head of the board of medicine in Texas, did not support that theory. Of the 4,617 disciplinary actions taken against doctors nationwide in 2000, only 319 involved prescriptions of controlled substances. "They are old wives tales, they are fear tactics, but they are not occurring," Levy said of reports that doctors are facing increased scrutiny. Levy did not have figures on the number of doctors who have been charged criminally. In Western Virginia, where more than 60 fatal overdoses have been linked to OxyContin's active ingredient, five doctors have been convicted of overprescribing painkillers in recent years. While police say careless or unscrupulous doctors are the main source of the region's OxyContin problem, Van Zee lays equal blame on Purdue Pharma, which he says has excessively marketed its best-selling product while downplaying its propensity for abuse. Using marketing data, the company has identified doctors who prescribe large amounts of opiates and have dispatched sales representatives to their practices, Van Zee said. A Purdue Pharma sales representative who makes $50,000 a year pitching OxyContin to doctors can earn another $100,000 in bonuses for high sales, the doctor said. To back his assertions, Van Zee points to figures from the DEA that show the average use of OxyContin in some of Virginia's coalfield counties is 25,000 grams per 100,000 residents - far more than the national average of about 3,074 per 100,000. Purdue Pharma, which has defended its promotion of OxyContin as conservative and responsible, maintains the number of prescriptions is not a reliable indicator of whether its drug is being abused. Areas such as Southwest Virginia, which have a high incidence of injuries from coal mining jobs and other forms of hard labor, are likely to experience greater use of pain medications than some urban areas, the company says. Van Zee, who sees the impact of OxyContin addiction through his patients at a clinic in the small coal-mining town of St. Charles, says about 8,000 people have signed his petitions asking the FDA to recall OxyContin. He has not presented the petitions to the agency yet.
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