Second of two articles

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1 1 of 6 2/25/2016 1:27 PM By Tina Rosenberg February 16, :21 am Fixes looks at solutions to social problems and why they work. Second of two articles America s drug crisis, which now kills more people each day than car crashes or gun violence, has challenged the conventional wisdom about recovery. With addiction inside the homes of families who thought themselves immune, we are starting to embrace the idea that addiction is a not a character flaw but a chronic disease requiring long-term management the subject of last week s Fixes column. This week, another idea whose time has come: trying to kick opioid addiction without medicines is as smart as relying on willpower to overcome diabetes or asthma. Medicines greatly increase the chance of success and reduce the risk of death. Here s what s out there now. The standbys: methadone and Suboxone These work. (See here, here and here, just some of many studies). They reduce illicit drug use and keep people in treatment, compared with recovery programs that don t include medicine. These medicines also cut the risk of fatal overdose by half. I ll repeat: People on these medicines were half as likely to die of overdose as those

2 2 of 6 2/25/2016 1:27 PM getting psychological or social interventions alone in large part because the patient is getting some opioid and therefore has some tolerance. Methadone, a liquid opioid that patients must drink every day under supervision at a methadone clinic, has been in use since the Vietnam War; it was approved to help the many soldiers coming back with heroin addiction. Before that, treatment usually consisted of a) jail and b) nothing else. Suboxone, approved to treat addiction in 2002, is a pill (in generic form) or film that dissolves under the tongue, and is prescribed by a doctor for home use. It combines two drugs, the opioid buprenorphine and naloxone, an opioid antagonist that makes buprenorphine less prone to abuse. If the pill or film is crushed and snorted or injected, the naloxone blocks the high. Waiting lists for these therapies are enormous. According to research by the RAND Corporation, 90 percent of the counties in the United States have no methadone clinic or fall very far short of the need, even though having a local clinic is crucial, because patients must visit daily. The shortage is especially acute in rural areas, where opioid and heroin addiction are spreading fast. As for Suboxone, 43 percent of counties don t have doctors who can prescribe it, or have far fewer than needed. According to the Pew Charitable Trusts, while 900,000 doctors across the United States are licensed to write prescriptions for opioid painkillers, only 32,000 are allowed to prescribe Suboxone. After a lethargic start, the Obama administration has begun a push to recruit, train and certify new providers for Suboxone, and earlier this month asked Congress for $1.1 billion in new money, half to be used to increase access to medications. That s an important beginning. But laws blocking access need changing as well. For example, doctors must be trained and certified by the federal government to prescribe Suboxone, and may treat only 100 patients at a time. In part, these laws are designed to guard against illegal resale of the drug. But the laws also reflect many Americans unease with opioid maintenance therapy. There is still some level of pervasive stigma against medication, Michael

3 3 of 6 2/25/2016 1:27 PM Botticelli, director of the White House Office of National Drug Control Policy, said in an interview last week. Some people still think there is some hierarchy of who s more in recovery people who are not on this versus people who are. It can be a real barrier for some people for whom these medications are totally appropriate. Drug courts sometimes even force patients off opioid maintenance therapy into abstinence programs. Last February, however, the administration cracked down, requiring drug courts that receive federal financing to give patients access to opioid maintenance therapy. People who have opioid use disorder do far better when they are on these medications than when they re not, said Botticelli. There are multiple pathways to recovery. But we are trying to ensure that people are not denied access to these medications because their program doesn t support it or their insurer doesn t cover it. Long-lasting opioid blocker Naltrexone blocks the effects of opioids and alcohol. It s been around for a long time in the form of a daily pill costing a few dollars a month. Vivitrol is the brand name for a new, extended release and very expensive (over $1,000 a month) formulation. The new formulation is a big deal. The evidence on naltrexone pills is mixed one review of studies found that daily naltrexone pills were no better than a placebo at reducing illicit drug use or keeping people in treatment. That was probably because patients stopped taking them. A daily pill requires the patient to recommit to sobriety every day. A monthly injection requires one-thirtieth of the willpower. Two studies of patients with opioid dependence, in Russia and in the United States, found that Vivitrol was associated with increased abstinence and time in treatment, and reduced cravings. At Gosnold on Cape Cod, an addiction treatment organization, a majority of patients use Vivitrol after they leave residential treatment, said Kristoph Pydynkowski, a recovery manager. It really helps, he said. I can t tell you how many people said, I was out there at a using spot, driving down the street, and then I turned around: I m on Vivitrol. I m not doing that. In 2012, Sheriff James M. Cummings of Barnstable County, Mass., began

4 4 of 6 2/25/2016 1:27 PM offering it to inmates in the Barnstable County House of Corrections. Vivitrol is part of a larger program to help keep inmates from coming back, which includes job counseling and connections to social services. Inmates get the injection right before they leave prison (Alkermes, the drug s maker, donates it to the jail) and set up plans for counseling and continuing Vivitrol shots once they leave. About 200 inmates have received Vivitrol so far. Cummings said that 50 percent remain sober, and only 12 percent have ended up back behind bars. And we re dealing with the worst of the worst people whose addiction is so bad they ended up committing crimes and going to jail, he said. On the other hand, the inmates who volunteer to get Vivitrol are likely a more motivated group than those who don t. Barnstable was one of the first jails in the country to use Vivitrol. Many corrections officials from elsewhere have visited the program, and some have started their own. What I like is that it s not a narcotic, has no street value, it s not something going to be diverted, Cummings said. But I m a little frustrated that it hasn t been taken on by more correctional facilities. Cost is an issue. Another potential problem is the risk of death. This Australian study found the risk of overdose high when patients stop using naltrexone; as with people coming out of residential treatment, naltrexone users have lost their tolerance, turning a once-survivable dose into a lethal one. Still, it s crucial to have some options in a field with very few, especially when many people don t want Suboxone. There are 16,000 Americans on Vivitrol, said Richard Pops, chief executive of Alkermes, and 1 million on methadone and Suboxone. I don t know what the correct ratio is, but 100 to 1 it isn t, he said. Long-lasting buprenorphine implant Just as a contraceptive implant in a patient s arm releases a steady dose over time, the new Probuphine implant releases a consistent, low dose of buprenorphine for six months. Three studies this one, this one and a not-yet peer-reviewed study found that Probuphine was better than a placebo implant and better than Suboxone pills at reducing illicit drug use, measured by urine tests.

5 5 of 6 2/25/2016 1:27 PM It s not available yet, but it may be soon. A committee advising the Food and Drug Administration voted in January to recommend that the agency approve it, although some committee members voted no, citing the dearth of studies and some methodological issues. Richard Rosenthal, a co-principal investigator on the latest study who is medical director of addiction psychiatry at Mount Sinai Behavioral Health System in New York, said that Probuphine was designed to solve three problems with Suboxone. One was the chance of resale or accidental exposure to the pills. Also, there s the opportunity for non-adherence people forget, or don t take their dose, which leaves them vulnerable again, he said. The other issue is that medicines have peaks and troughs. People on various medications may have increased cravings during those troughs, he said. I spoke with a man named David, a firefighter in a Boston suburb who wanted to be identified only by his first name. After doing well on Suboxone, he participated in the latest trial of Probuphine. When he was taking the pill, he said, he could feel it kick in every morning, like drinking a good cup of coffee, he said. With the implant there was a much more consistent feeling of normalcy. I just felt perfectly normal all the time. Medicines for alcohol use disorder Alcoholics Anonymous is not the only way. And some medicines have what A.A. lacks scientific evidence of success. A lot of people credit A.A. with saving their lives (some of them contributed comments last week.) But people s experiences, even a lot of them, aren t scientific proof; A.A. works for the people it works for. No scientific study has shown that A.A. is more effective than no intervention. (This article in The Atlantic by Gabrielle Glaser explores the lack of evidence behind A.A.). There is evidence, though, for medication. Vivitrol does increase abstinence from alcohol, and both it and oral naltrexone forms have been found effective (studies are here and here) in helping people to

6 edicines to Keep Addiction Away - The New York Times of 6 2/25/2016 1:27 PM moderate their heavy drinking. Yes, moderate. Another great American myth, which accompanies A.A. s dominance, is that abstinence is the only solution for problem drinkers. That s far from true: according to the National Institute on Alcohol Abuse and Alcoholism, non-abstinent recovery is just as common (Table 3) as abstinent recovery. The F.D.A. approves three medicines to treat alcohol-use disorders (here s guidance on how and when to prescribe them from Samhsa, the federal agency working against substance abuse). Glaser writes that at least three others that are available for off-label use have been found promising by researchers. Also, nalmefene, which has advantages over naltrexone, is used in Europe to help people drink less, but it is not yet approved for alcohol disorders in the United States. Only 1 percent of people treated for alcohol problems in the United States are prescribed medications. We ve begun to understand that while 12-step programs may be very helpful for many people, there are many people who suffer from these disorders who need more than that, said Bradley Stein, a psychiatrist who is senior natural scientist at the RAND Corporation. The same way other chronic diseases don t have a single intervention, we need other tools in our toolbox. Join Fixes on Facebook and follow updates on twitter.com/nytimesfixes. To receive alerts for Fixes columns, sign up here. Tina Rosenberg won a Pulitzer Prize for her book The Haunted Land: Facing Europe s Ghosts After Communism. She is a former editorial writer for The Times and the author, most recently, of Join the Club: How Peer Pressure Can Transform the World and the World War II spy story e-book D for Deception. She is a co-founder of the Solutions Journalism Network, which supports rigorous reporting about responses to social problems The New York Times Company