Pubdate: Wed, 13 Jan 2016 Source: New York Times (NY) Copyright: 2016 The New York Times Company Contact: http://www.nytimes.com/ref/membercenter/help/lettertoeditor.html Website: http://www.nytimes.com/ Details: http://www.mapinc.org/media/298 Author: Sabrina Tavernise IMPLANT FOR OPIOID ADDICTS URGED FOR FEDERAL APPROVAL SILVER SPRING, Md. - A panel of medical experts recommended Tuesday that the Food and Drug Administration approve a new way of treating opioid addicts, using a slender rod implanted into the arm that delivers medicine for months at a time. Some doctors say it could help ease the national epidemic of drug overdoses. The rod is about the size of a small matchstick and delivers daily doses of buprenorphine - one of the most common medical treatments for opioid addicts - for six-month periods. In controlled doses, buprenorphine can help the body withdraw from opioid addiction, but can also itself be addictive. That risk is increased by the fact that the medicine can be taken only by mouth, requiring patients, often ill from addiction, to manage their daily dosages. The advisory panel voted 12 to 5 to recommend approval. The panel concluded that flaws in the evidence the company presented, including missing data in a clinical study, were not fatal, and that the product was roughly as effective as the oral form of the drug. They agreed it would be a useful tool for doctors in the face of a major public health epidemic and could help stem the flow of illicit use of buprenorphine. "I think this will save some folks' lives," said Dr. David Pickar, adjunct professor of psychiatry at Johns Hopkins Medical School, who voted to recommend approval. "From a safety point of view I think we're in good shape." Dr. Thomas Grieger, a staff psychiatrist at the Maryland Department of Health and Mental Hygiene, said: "There is not evidence of significant risk using this agent, but there is evidence of significant benefit." Prescription drug abuse has become a major public health problem in the United States, with overdose deaths more than quadrupling since the late 1990s. In recent years, use of heroin, an opioid, has exploded, keeping the numbers of deaths from overdoses high. The federal health authorities reported recently that the number of opioid overdose deaths in 2014 was the highest on record. The F.D.A. often takes the advice of its advisory panels but does not have to. The implant is called Probuphine, and it is made by Braeburn Pharmaceuticals, based in Princeton, N.J. Supporters, who spoke at the meeting said the implant would make it easier for addicts to manage their addiction and reduce its stigma by eliminating the need to take the medicine every day. Recovered addicts said the implant would allow them to feel normal again. "I'm president of my own company again, I'm not a dirty junkie," said Scott Jernigan, one of the presenters. "But I need help. With the implant it will be one less hurdle for us as addicts to get over." People who run treatment centers said it could help stem the illegal use and sale of buprenorphine, a problem that has come to plague many of the areas worst hit by the prescription drug epidemic. Emergency department visits involving illicit use of buprenorphine more than tripled from 2006 to 2010, according to federal health officials. Buprenorphine is a partial synthetic opioid and can help wean the body off more powerful opioids like heroin and methadone by offering a milder version of their euphoric effects, thereby preventing patients from having full-blown withdrawal symptoms. "The problem is people are using buprenorphine to manage their addiction, not to recover from it," said Joe R. Gay, executive director of Health Recovery Services Inc., a nonprofit treatment agency with clinics in six counties in Ohio. "This is a major problem in our area, and it has really undermined the credibility of buprenorphine treatment, which is actually very effective." One criticism experts considered was what would happen when the patient with the implant needed to adjust the daily dosage, something that doctors on the panel said was common, particularly at early stages of treatment, when the doses of the medicine tend to be higher. That would require giving additional oral supplies, a practice that would defeat the purpose of having an implant and could reduce the potential to prevent illicit use. "I would not want to create the expectation that you can just implant this and say 'bye-bye,' " said Dr. Melinda Campopiano, a medical officer at the federal Substance Abuse and Mental Health Services Administration. Others worried that the implant would discourage patients from returning for other important parts of treatment, like counseling, that they say are needed to keep the patient on track. "The fear is that patients simply will not get the essential part of treatment beyond just the medication," said Dr. Carl Sullivan III, director of the addictions program at West Virginia University, who was not part of the panel. - --- MAP posted-by: Jay Bergstrom