Pubdate: Wed, 27 Feb 2008 Source: Wall Street Journal (US) Page: A17 Copyright: 2008 Dow Jones & Company, Inc. Contact: http://www.wsj.com/ Details: http://www.mapinc.org/media/487 Author: Scott Gottlieb Note: Dr. Gottlieb, a resident fellow at the American Enterprise Institute, was deputy commissioner of the Food and Drug Administration from 2005 to 2007. Bookmark: http://www.mapinc.org/topic/Drug+Enforcement+Administration Bookmark: http://www.mapinc.org/find?232 (Chronic Pain) Bookmark: http://www.mapinc.org/find?136 (Methadone) Bookmark: http://www.mapinc.org/oxycontin.htm (Oxycontin/Oxycodone) COPS AND DOCTORS The death of actor Heath Ledger from an accidental overdose of six pain and anxiety medicines -- including the narcotics OxyContin and Vicodin -- has prompted warnings about misuse of prescription drugs, which ranks as one of the fastest growing segments of drug abuse. Nobody disputes the problem. But the strategies for tackling it aren't changing the trends, they are just hobbling doctors and patients, and may retard the development of new medications. The Drug Enforcement Administration is, sensibly enough, targeting the small number of physicians who inappropriately prescribe drugs in violation of current laws, the "patients" who doctor shop for painkillers and hoard drugs to abuse or sell them, and the criminal diversion of these medications from pharmacies and distribution centers. But the DEA is also trying to influence clinical decisions about when these drugs are prescribed. This is a mistake. Clinical issues are not the expertise of the DEA. Placing more restrictions on the legitimate prescribers can harm real patients and ethical physicians. Innovative new drugs such as OxyContin that have been developed in the last two decades provide targeted relief for intractable pain. While they have helped innumerable patients, they have also been abused. The DEA response? One was to try and get the power (now exclusively vested in the FDA) to have a final say over whether new narcotic medications should come to the market. Legislation to do so was temporarily passed in 2004 and the DEA sought its reauthorization in 2005 -- as a "rider" attached to its appropriations bill, without Congressional debate. At one time, the DEA even sent out solicitations to hire clinicians to review new drug applications for narcotics, a role reserved for the FDA. The DEA has stepped back from that effort -- at least for now. There have also been efforts to place additional restrictions on existing drugs. The DEA is carving out a role for itself in the creation of risk-management programs that manage how new narcotics are used. These programs often place burdens on doctors and patients that can discourage legitimate prescriptions, for example by requiring additional reporting by physicians who dispense these drugs, as well as certification that they received additional training in handling them. The DEA is leading a campaign to "reschedule" drugs like Vicodin into a stricter classification -- placing them under the same restrictions as opium, methadone and morphine. It is widely believed that the DEA has also been quietly pressuring the FDA to reach a similar conclusion. The hope is that tighter controls will help control illegal diversion -- although medical studies show that determined abusers don't typically get their drugs through legal channels. But there's a danger that the DEA will wade into areas that involve appropriate clinical practice. There will always be some trade-off between access and enforcement -- between the docs and the cops. The ensuing tension helps ensure the right balance between enabling legitimate prescribing, and maintaining restrictions that aid in reasonable enforcement efforts. The problem is when DEA activities end up influencing legitimate prescribing. For one thing, they prompt some law-abiding doctors to think twice before writing legitimate scripts. A 2001 study of California doctors found that 40% of primary-care physicians said fear of investigation affected how they treated chronic pain. A recent survey of physicians by the Center for Addiction and Substance Abuse found that one-third worry "a great deal" or "somewhat" about review of their own prescribing of controlled drugs by law enforcement agencies; and 44% report that this actually influences which medications they prescribe. The expansion of DEA regulatory authority could slow development of improved medicines, by chasing away companies that fear added uncertainty about whether new products will get approved. This includes new generations of narcotics more resistant to abuse. It would actually be better for the public if the FDA made these abuse-resistant painkillers immediately eligible for priority review, which can shave time and cost off the development process. The DEA for its part can take additional steps to curb the abuse of prescription drugs without intruding into legitimate medical practice. The agency could step up its work with individual states on prescription-monitoring programs that enable collection of information on dispensing of controlled drugs. This could help curtail doctor shopping and alert doctors to dangerous polypharmacy. The National All Schedules Prescription Electronic Reporting Act -- which has passed but hasn't been implemented -- would create a grant program housed at the Department of Health and Human Services to fund state-run prescription drug monitoring programs. Currently 20 states have these programs, but information is not yet shared between them, so doctors can't view what other prescriptions a patient was given in another state. Part of the barrier to getting the system started has been maneuvering by DEA's parent, the Justice Department, to create its own rival scheme -- a law-enforcement tool geared more toward monitoring doctors as opposed to irregular purchases. As prescription-drug abuse and criminal diversion escalates, there is a need for stepped-up law enforcement. But when it comes to managing legitimate medical practice issues, the cops should step aside. The risk is a return to an era when pain often went unrecognized, treated patients were commonly undermedicated, and doctors were reluctant to prescribe powerful narcotics -- sometimes out of fear of those looking over their shoulder.