Pubdate: Wed, 03 Dec 2003 Source: Wall Street Journal (US) Copyright: 2003 Dow Jones & Company, Inc. Contact: http://www.wsj.com/ Details: http://www.mapinc.org/media/487 Author: Anna Wilde Mathews and Gary Fields Bookmark: http://www.mapinc.org/oxycontin.htm (Oxycontin/Oxycodone) FEDERAL AGENCIES SEEK TO CURB ABUSE OF POTENT PAINKILLERS Federal regulators are preparing plans to deal with the rising problems of abuse and addiction tied to powerful prescription painkillers. The plans, from the Food and Drug Administration and the Drug Enforcement Administration, include pushing companies that seek to market the most potent new drugs to develop programs to reduce the risk of abuse. The agencies' focus is particularly on products with time-release mechanisms that are supposed to help a patient absorb a large dose of medicine gradually over a long time period. One such painkiller, OxyContin, has been widely abused partly because users are able to defeat the time-release mechanism to get all of the drug's effect at once. The issue is becoming more important as drug makers roll out a growing number of new formulations of opioid drugs -- narcotics with effects similar to those of opium-derived products. Sales of narcotic painkillers, OxyContin among them, were $4.67 billion last year, up 18% from the year before, and 136% from 1998, according to market researcher IMS Health. Purdue Pharma LP, the maker of OxyContin, is currently seeking FDA approval for Palladone, a new extended-release opioid that is even more potent. Before these new drugs will be allowed on the market, the FDA is expected to make abuse-management programs a part of the approval process, people briefed on the effort say. The agency is expected to stop short of saying it will explicitly require such programs, which generally include elements such as physician education, because officials believe it may not have the legal authority to do so. But drug companies are almost certain to comply with the FDA's approach. The FDA is expected to revamp the labeling on some existing medicines to include more detailed information on appropriate prescribing, these people say. The agency will also likely urge doctors to screen patients to pinpoint those who may be at higher risk of addiction. For its part, the DEA is planning to work with state medical boards to add training in opioid use to their continuing-education requirements for physicians. The agency has struck agreements with pain-specialty groups to develop educational initiatives. These efforts stop short of some of the more stringent proposals discussed in a recent meeting of an FDA advisory panel, which included seeking to limit the distribution of potent and easily abused drugs to certain pharmacies or physicians. The FDA has never limited any opioid to certain pharmacies, and agency officials say they don't have the authority to block certain physicians from prescribing a drug . The DEA isn't expected to immediately move toward a federal doctor-education requirement for opioids, which like other prescription drugs with addictive potential are overseen by both agencies. The two agencies are trying to strike a difficult balance. Many researchers and pain doctors argue that patients with severe pain often don't get the drugs they need. One major 1998 study of 13,625 nursing-home cancer patients found that more than a quarter of those who suffered daily pain got no analgesic at all. Sharp restrictions on prescribing opioids risk "greatly decreasing the availability of these drugs to people who need them," says Russell Portenoy, chairman of the Beth Israel Medical Center department of pain medicine and palliative care. Allowing only pain specialists to prescribe the drugs "would be a disaster in terms of access," he says. Dr. Portenoy, who served on the FDA panel that examined opioids, has consulting arrangements with several drug makers that make painkillers. At the same time, the agencies need to keep the drugs out of the hands of potential abusers. Last year, a federal survey estimated that 29.6 million people had at some point used painkillers without a medical need. An estimated 4.4 million had used one in the past month. About 1.9 million people had at some point used OxyContin without a medical need. DEA officials, and some members of Congress, urged the FDA advisory panel to support tougher restrictions on the distribution or dispensing of powerful opioids. The DEA also wanted to narrow the number of situations in which the powerful painkillers are recommended. "By having the indications so broad, you enable [doctors] to prescribe these substances for back pain or neck pain or any other pain, and as an initial treatment that is not appropriate," says Terrance Woodworth, departing deputy director of the DEA's office of diversion. The FDA advisory committee voted against the more severe limits, disagreeing with the DEA, and the FDA is expected to generally follow the panel's lead. The committee also generally supported the risk-management plan proposed by Purdue for Palladone but recommended an extension of a planned four-month limited rollout to evaluate risks. Committee members expressed concerns about Palladone's risks. The drug is "going to be more sought-after and more appealing to addicts than OxyContin," says Gregory Skipper, an FDA panel member who is a professor at the University of Alabama. In the committee meeting, an FDA official said Palladone's active ingredient, hydromorphone, may be more appealing to addicts than OxyContin's oxycodone, though a committee member challenged that conclusion. J. David Haddox, Purdue's vice president for health policy, says the "jury is out" on which opioids are most appealing to addicts, and "desirability of a drug to abusers is a complex function and includes a number of factors," including the drug's formulation. Purdue says it plans to meet with FDA to discuss its risk-management plan for Palladone. Palladone is one of a spate of expected new opioids. Aradigm Corp., Hayward, Calif., is developing asthma-style inhalers to administer morphine and fentanyl, a synthetic opioid. The company says it plans special safety measures to ensure that only patients can use the products. Endo Pharmaceuticals Holdings Inc., Chadds Ford, Pa., is seeking to market both immediate and extended-release versions of oxymorphone, another opioid drug . Johnson & Johnson, which makes the Duragesic fentanyl patch, is also hoping to sell other painkilling patches. The FDA has already begun requiring precautions for some opioids. OxyContin was approved in 1995, but it wasn't until 2001 that the FDA reviewed a risk-management program for it. The program's measures include tracking of diversion and special prescription pads for doctors. In 1998, the agency approved Cephalon Inc.'s Actiq, which offers the opioid fentanyl in a sweet-flavored lozenge, with several childproofing measures. The majority of opioid drugs , some of which were approved decades ago, still have no formal FDA-reviewed safety plans tied to their distribution or use, the agency says. Even some of the powerful extended-release opioids have no risk-management program, the FDA says. "We are very attuned to keeping an eye out for situations where we might need to initiate formal risk-management plans," says Robert Meyer, director of the FDA's Office of Drug Evaluation II. He declines to comment on the agency's planned new moves. A coming study from the congressional General Accounting Office is expected to focus on problems associated with OxyContin. Purdue's Dr. Haddox says the company is "committed to being a leader for risk management" for opioids, and Purdue officials believe their safety measures for OxyContin are beginning to have some effects. - --- MAP posted-by: Beth Wehrman