much, senator grassley. senator klobuchar. >> first, i'd like to thank you, senator feinstein and also senator grassley for holding this important hearing, for inviting me to participate. just yesterday afternoon, i was with president clinton at johns hopkins where the clinton health matters initiative held a very important forum on this very topic with the focus on prescription drug addiction and some discussion about heroin. i was on a panel with commissioner hamberg and the former representative patrick kennedy that followed president clinton's speech. and he is really taking this issue on, which i thought was a positive. and he has a lot of energy, as you know. i'd say -- i start with prescription drugs because when i look at the facts on heroin, the fact that while the vast majority of prescription drug users do not start to use heroin, something like 97% of them, in fact, 4 out of 5 heroin users today started with

prescription drugs. so i start with the demand issue with the prescription drugs and how we get to that. and i'd say, first of all, we have to do everything we can to reduce the supply. this means to me the drug takeback programs and getting them out of the hands of kids when it's the number two thing they're addicted to. senator cornyn and i passed a bill back in 2010. seems like quite a while ago, but still waiting on the rules that makes it easier and sets out some clear standards for how these drugs can be transported when they are put into takeback programs. we did that because there's certain police departments and long-term care facilities that still are not doing these programs. and they're concerned about liability. what the bill does, it makes it easier for pharmacies, which would be excellent if they voluntarily did this. i've done some events with pharmacies, if you can imagine, people bringing back their prescription drugs, getting them out of their medicine cabinets, bringing them back voluntarily

and doing it long-term care, you name it. so that is one thing. and if you think it's a small thing, how many tons do you think were collected just last april in one day in the united states of america prescription drugs? maybe you're thinking ten tons, 20, 390 tons of prescription drugs were collected and the day in april just this last month. and so that's what we're dealing with when we talk about the problem. second is drug courts, the more we can cut down the demand by getting people involved in drug courts and we're working on more funding for that because it's 3 out of 4 of the graduates never get in trouble again with the law. and then, the last thing i'd say on the supply side would be prescription drug monitoring. it's a patchwork system where the head of hazelton in minnesota isn't able to tell doctors when someone comes in who he knows is doctor hopping to get different prescriptions

of oxycontin. it's patchwork, not mandatory, not interoperable, won't go across state lines and there are funding issue as well. i think that would be a big thing. so then we get to the heroin. we have had a huge increase in heroin overdoses in minnesota in the first half of 2013, 91 people died in just hennepin and ramsey county in the twin city area. why? well, we've heard the heroin is more pure, it's coming up on 35w corridor, mostly out of mexico. 50% of the heroin in the u.s. is grown in mexico now, 60% is transported through mexico. because of that and other reasons, including sex trafficking, i led a trip down to mexico last month with senator senator hicamp and cindy mccain, the wife of senator john mccain. and we focused on two issues, sex trafficking and heroin. we met with the head of the federal police in mexico, met with the attorney general. coming out of those meetings, i came back with this. i think the mexican authorities

are more devoted than ever to do something about the violence and drugs in their country. they want to be part of this new economy in north america, they see getting rid of these drug problem and the violence is the key to that. they have gone after el chapo the head of their long time powerful drug cartel, but there's much more work to be done. this includes eradication of the new poppy fields that are pure white heroin, different than the black tar they used to be using in mexico. it includes strengthening their southern border where the heroin is coming up from countries south, not just our border but the southern border. and the third thing would be continuing coordination with u.s. law enforcement and the work that we have to do on the demand side back here. so i'm very excited you're doing this hearing as i heard the other senators talk about a major problem, but i think we have to be really smart in looking at what the answers are. and i'm looking forward to hearing from our witnesses. thank you. >> thank you very much, senator klobuchar. let me introduce our witnesses

today. and we'd ask each one of you to confine your remarks to five minutes. and if they're in writing, we'd like to have them for the record so that we can have a robust discussion. let me begin with the acting director of the office of national drug control policy. michael botticelli has been here before and we welcome him back. he's had more than two decades of experience of of supporting americans who have been affected by substance use disorders. prior to joining, he served as director of the bureau of substance services at the massachusetts department of public health. next we welcome dr. nora volkow back to the caucus, she's the director of the national institute on drug abuse, which coincidentally founded 40 years ago today. let me be the first to wish the institute a happy birthday.

dr. volkow's work has been instrumental in demonstrating that drug addiction is a disease of the human brain. among her many accomplishments, she pioneered the use of brain imaging to investigate the toxic effects and addictive properties for drugs -- for drugs that are abused. next, we are pleased to have dr. westly clark. he is a director of the center for substance abuse treatment within the substance abuse mental health services administration. as director, dr. clark leads the agency's nationwide effort to provide effective and accessible treatment for addiction disorders. he is a noted author and educator in the field of substance abuse, treatment and has received many awards for his service.

next, we have joseph rannazzisi, and we are pleased to welcome you, sir, back to the caucus. you're the deputy assistant administrator of the office of diversion control at the dea. as deputy assistant administrator, mr. rannazzisi is responsible for ensuring the more than 1.5 million dea registrants comply with the controlled substances act and it's implementing regulations. he was named as deputy assistant administrator in january of '06 and served with the dea for some 25 years from now. and last but certainly not least, we're pleased to have dr. andrew kolodny. dr. kolodny is the chief medical officer of the phoenix house, one of our nation's leading nonprofit drug rehab organizations. he's an expert on our nation's opioid addiction epidemic and he's a practicing psychiatrist in the field.

he's helped develop and implement multiple effective substance abuse treatment programs in new york and is a past recipient of the daniel x. friedman congressional health policy award. so we welcome you all and perhaps we would begin with mr. botticelli and just go right down the line. hopefully with five minutes statements so that we can then have some time for questions. please proceed. >> chairman feinstein, senator klobuchar, co-chairman grassley, thank you for the opportunity to appear here today to discuss what is perhaps the most important public health issue facing the united states. namely, the abuse of opioid drugs, including prescription painkillers and heroin. i know that given recent media attention to overdose deaths, there's a heightened public interest in the threat of opioid drug use. while this might be a new phenomena for many of our communities, some have been

dealing with this issue for a very long time, and it's a matter of great concern for this administration. as we discussed, according to the centers for disease control and prevention, drug overdose deaths primarily driven by prescription opioids now surpass homicides and traffic crashes in the number of injury deaths in america. in 2010, the latest year of which we have nationwide data, approximately 100 americans died on average from overdose every single day. prescription analgesics were involved in almost 17,000 deaths that year and heroin was involved in another 3,000. more recent data posted by several states indicated that deaths from heroin continued to increase. while heroin use remains relatively low in the united states as compared to other drugs, there has been a troubling increase in the number of people using heroin in recent years. from 373,000 past year users in

2007 to 669,000 in 2012. it is clear that we can't arrest our way out of the drug problem. science has shown us that drug addiction is the disease of the brain, a disease that could be prevented, treated and from which one can recover. we know that substance abuse disorders, including those driven by opioids are a progressive disease. it's important to consider and understand that many people who develop a substance abuse disorder begin using at a very young age and often start with alcohol and tobacco. we know that as individuals' abuse becomes more frequent or chronic, that person is more inclined to purchase these drugs from dealers or obtain prescriptions from multiple doctors rather than simply getting them to friends and family for free or without asking. left untreated, this progression of an opioid use disorder may lead an individual to pursue lower cost and more potent alternatives, particularly heroin.

with these circumstances in mind, we release the obama administration's inaugural drug control strategy in 2010 in which we set out a wide array of actions to expand public health interventions and criminal justice reforms to reduce drug use and its consequences. that strategy noted opioid overdoses as a growing national crisis and set specific goals for reducing drug use, including heroin. three years ago, the administration released the first comprehensive action plan to combat the prescription drug use epidemic. the prescription drug abuse prevention plan strikes a balance between the need to prevent diversion and abuse and the need to ensure legitimate access to prescription pain medication. the plan expands on the national drug control strategy and brings together a variety of federal, state, local and tribal partners to support, one, the expansion of state-based prescription drug monitoring programs. two, more convenient environmentally responsible disposal methods to remove

expired or unneeded medication from the home. three, educating patients about opioid drugs and instructing health care providers in proper prescribing practices and treatment of substance use disorders. and four, reducing the prevalence of pill mills and doctor shopping through enforcement efforts. this work has been paralleled by efforts to address heroin trafficking and heroin use. the administration is also focusing on several key areas to reduce and prevent opioid overdoses, including educating the public about overdose risk and preventions and increasing access to noloxone, an emergency overdose reversal medication. because police are often the first on the scene of an overdose, the administration has strongly endorsed local law enforcement agencies to train and equip their personnel with this lifesaving drug. 22 states, plus the district of columbia, have implemented a law or developed a pilot program to

allow the administration of this medication by a professional or layperson to reverse the effects of an opiate-related overdose. we are also working with states to promote good samaritan claws so that bystanders to an overdose will take appropriate action and help save lives. we are heartened that 17 states plus the district of columbia have now adopted good samaritan laws. while it is critical for us to save lives, we also need a comprehensive response to prevent overdose deaths. a smart public health approach requires us to catch the signs and symptoms of substance use earlier before it develops into a chronic disorder. we've been encouraging the use of screening and brief intervention to catch risky substantial abuse before it becomes an addiction. and, since only 11% of those who need substance abuse disorder treatment in 2010 actually received it, the administration is dramatically expanding access to treatment. the affordable care act and federal parity law are extending

access to substance abuse disorders and mental health benefits for an estimated 62 million americans helping to close the treatment gap and integrate substance abuse treatment into mainstream health care. this represents the largest expansion of treatment access in a generation and will help guide millions of americans into successful recovery. the standard of care for treating substance abuse disorder is driven by heroin or prescription ownership opioids. and an approach to treating addiction that utilizes behavioral therapy along with fda approved medications. either methadone or naltrexone. medication-assisted treatment already has helped thousands of people in long-term recovery. a prime goal of our office is to increase access to medication assisted treatment within existing treatment programs and through integration with primary care. there are some signs that these national efforts are working. the number of americans 12 and older initiating the nonmedical

use of prescription opioids in the past year has decreased significantly since 2009. additionally, according to the latest monitoring the future survey, in 2013 the rate of past year use of oxycontin and vicodin among high school seniors was at the lowest since 2002. and recent studies showed the implementation of the robust naloxone distribution programs and the ax pension of medication assisted treatment programs can reduce overdose deaths and also be cost-effective. nonetheless, the reemergence of heroin use underscore the need for leadership at all levels of government. we will therefore continue to work with our federal, state, tribal and community partners to continue to reduce and prevent the health and safety consequences of prescription opioids and heroin. thank you. >> thank you. could you just tell me, you said that heroin use has doubled. that's in the last five years? was that --

>> i believe since 2007. >> five years. >> i'm sorry. >> this is information from the most recent national survey on drug use and health, and it looked at people who used heroin in the past year, and that went from 373,000 past year users in 2007 to 669,000 in 2012. >> that's a very striking figure. five years. >> five years. >> very striking figure. thank you. dr. volkow, please. >> chairman and senator feinstein and senator grassley, i want to thank you for the opportunity to invite me to speak about the prescription opioid abuse in our country. opiate medications are the most effective interventions we currently have for managing acute, severe pain. unfortunately, these drugs not only inhibit pain centers but also activate brain reward

regions which is why they are abused and why they are so addictive. so we face the unique challenge of preventing their abuse while safeguarding their value for managing severe pain which if untreated is terribly debilitating. it is estimated that 2.1 million americans are addicted to opioid painkillers, which reflects in part the widespread availability of these drugs. indeed, the number of yearly prescriptions for opioids more than doubled over the past 20 years from 76 million to 207 million prescriptions a year while at the same time in parallel there was a four fold increase in overdose deaths from these medications during that time period. painkillers like oxycontin and vicodin affect the brain similarly to heroin. they can use euphoria which some

intensify by taking stronger doses, snorting, or injecting them or combining them with alcohol which makes them more addictive and also much more dangerous because it increases the risk of respiratory depression which is the main cause of death from opioid overdoses. recent trends also indicate a significant rise in heroin abuse in our country which currently affects more than 500,000 americans and is driven in part, basically the predominantly the new cases, by individuals switching from prescription opioids to heroin because it is cheaper and easier to access. what are we doing about the problem? it relates to three things. safe management and better management of pain, prevention of overdose deaths, and the treatment of opioid addiction. how we treat pain better and how we protect those from becoming

addicted and dieing from overdoses. we don't know enough about the risk of addiction among people that have chronic pain. so there's basic research on that area. but in parallel, we're developing medications to treat pain effectively that are not addictive. at the same time, we're funding research to develop ways of administering opioids that minimize the diversion and abuse. and finally, we're funding research for nonmedication strategies to help manage pain such as magnetic or electrical brain stimulation. what about preventing overdoses? we have a very effective medication that is actually quite safe, naloxone, that prevents that from overdoses. recently, the fda approved self-injecting naloxone. nida is funding other user-friendly ways of administering naloxone.

such as if the patient themselves can use it. also, since many of the overdoses occur when no one is around or the patient is asleep. nida is supporting the development of self-activated systems that initiate an emergency response when it's signaled that on overdose is occurring. finally research related to the treatment of opioid addiction. medication assisted therapies, methadone, naltrexone are all effective and they are effective in decreasing overdoses, but these medications are used in less than one-third of patients who need them. we are working to overcome the barriers that interfere with their adoption and we are doing research for alternative treatments such as vaccines against heroin addiction. we work closely with our partners, in implementing interventions towards preventing and treatment of this problem. i want to thank you again for organizing this meeting and for inviting us to participate. >> thank you very much, doctor.

dr. clark? >> good afternoon, chairman feinstein and senator klobuchar and senator grassley. i want to thank you for inviting the substance abuse and mental health services administration to participate in this panel. i echo the comments of my colleagues regarding the importance of the topics of this hearing. i will focus on samhsa's programs and activities though we work with federal partners, states, tribes, and local communities. according to the national survey on drug use and health, which we conduct, 4.9 million people reported nonmedical use of pain relievers in the past month in 2012. 335,000 reported past month use of heroin, a figure that has more than doubled in six years.

in 2012, more than 1.89 million people reported initiating nonmedical use of pain relievers, and 156,000 reported initial use of heroin. one challenge in combating the misuse of pain relievers is educating the public in the dangers of sharing medication. according to the national survey, 54% of those who obtained pain relievers for nonmedical use in the past year received them from a friend or relative for free. another 14.9% either bought them or took them from a friend or relative. thus we have both a public health problem intertwined with the cultural problem. we have several programs focused on educating the public, including the not worth the risk even if it's legal campaign, which encourages parents to talk to their teens about preventing prescription drug abuse, our prevention of prescription abuse in the workplace effort, supports programs for employers, employees, and their families. our partnership for success grant includes prescription drug abuse prevention as one of the

capacity building in communities of high need. our referral to treatment program includes screening for illicit drugs, including heroin and other opioids. we've helped physicians maintain a balance between providing appropriate pain management and minimizing the risk of pain medication misuse. our screening brief intervention referral to treatment medical residency program includes modules for prescription opioids for pain management and opioid misuse. over 6,000 medical residents and over 13, 700 nonresidents have been trained nationally. our physician clinical support system for medication assisted treatment training is available via live in person, live online and recorded modules accessible at any time. we fund the clinical support system for opioid therapies, a collaborative project led by the american academy of addiction in psychiatry with six other leading medical societies.

we will be funding a clinical support system on the appropriate use of opioids in the treatment of pain and opioid related addiction this fiscal year. at the end of april, in an article in the new england journal of medicine, describes the underutilization of vital medications and addiction treatment services and discusses ongoing efforts by major public health agencies to encourage their use. medication assisted treatment includes three strategies, therapy which uses methadone, partial which uses buprenorphine and antagonist therapy. we are responsible for overseeing the regulatory compliance of certified opioid treatment programs which use methadone and/or buprenorphine for the treatment of addiction and are being encouraged to use naltrexone. we estimate there are approximately 300,000 people receiving methadone maintenance.

there are currently 26,000 physicians with a waiver to prescribe -- >> can i stop you. 300,000 people receiving what did you say? >> methadone. >> methadone. and that's throughout the united states? >> that's throughout the united states. there are currently 26,000 physicians with a waiver to prescribe buprenorphine. 7700 are authorized to prescribe 100 patients. we estimate there are 1.2 million people receiving buprenorphine. we also issued an advisory encouraging drug courts to utilize vivitrol in their treatment programs. we estimate between 7,000 and 10,000 people are on vivitrol and, unfortunately a low number because it's useful for alcohol dependence and opioid dependence. in august of 2013 we published the opioid overdose tool kit to educate individual, families, and first responders about steps to take to prevent and treat opioid overdose including the use of naloxone. when administered quickly and

effectively, it restores breathing to a victim in the throes of opioid overdose. it can be a teachable moment to refer a person to the appropriate resources. we inform states and jurisdictions that the substance abuse bloc grant may be utilized to support overdose prevention education and training. in addition, we notify jurisdiction that is block grants other than their primary prevention set aside funds may be used to purchase the drug and the necessary materials to assemble overdose kits and cover the costs associated with the dissemination of such kits. we continue to focus on the mission of reducing the impact of substance abuse. and meant at illness in america's communities. we thank you and the members of this caucus for convening this important hearing and providing us with the opportunity to address this very critical issue. >> thank you very much. before mr. rannazzisi speaks i was just astonished at a statistic i just found, and this is for the most recent take back day. nationally there were 6,000 collection sites.

390 tons of medication was picked up. that's 780,000-plus pounds. it's amazing. >> it's amazing in the fact that we brought all these federal, state and local law enforcement agencies together with community groups on one saturday for four hours to pick up that much. and it was a collaborative effort. 6,000 sites. all that are stocked with police officers, local, state, county officers, as well as community groups, pharmacists, whoever would like to come out and work with law enforcement. so it was truly a collaborative effort. a wonderful, wonderful day. >> thank you. please proceed. >> thank you. chairman feinstein, distinguished members, on behalf of dea and the men and women of the dea, thank you for the opportunity discuss today the relationship between prescription opioids and heroin

and how the dea is addressing this public health problem. first, let me say the present state of affairs is not a surprise. dea is concerned about the connection between rising prescription opioid diversion and abuse and rising heroin trafficking and abuse for several years. we believe increased heroin use is driven by many factors, including increase in misuse and abuse of precipitation opioids. the signs have been there for some time now. law enforcement agencies across the country have been reporting an increase in heroin use by teens and young adults who begin the cycle of abuse with prescription opioids. treatment providers report opioid addicted individuals switched to prescription opioids and heroin depending on price and availability. non-medical prescription opioid use particularly by teens and young adults can easily lead to heroin use. heroin traffickers know all of this and are relocating to where prescription drug abuse is on the rise. to give you an example, young adults can get prescription

opioids for free from the medicine cabinet or their friends. let's assume a teenager gets hydrocodone, a schedule three prescription opioid and also the most prescribed drug in the united states today from a family medicine cabinet for a friend. once that free source runs out, it can cost as little as $5 to $7 per tablet on the street, but then the teen will eventually need more opioid to get the same effect, so increase the dose or move to a stronger opioid. thus, the cycle begins. black market sales of prescription drugs are typically five to ten times their retail value. on the street, a schedule two prescription opioid can cost $40 to $80 a tablet depending on the relative strength of the drug. it makes it difficult to continue purchasing especially for teens and young adults who don't have a steady source of income. given the high cost to maintain the prescription drug abuse habit, the teenager turns to heroin at a street cost of generally $10 a bag. the teenager gets a high similar to the one he got when he abused the prescription drugs. it's just that easy. any long-term solution must

include actions to address prescription drug diversion and misuse while educating the public about the dangers of nonmedical use of pharmaceuticals. educating prescribers and pharmacists in treating those individuals who have moved from misuse to abuse and addiction. dea currently has 66 operational tactical diversion squads in 41 states, the district of columbia, and puerto rico. these groups capitalize on task force officers and dea agents, to conduct criminal investigations and diversion of pharmaceutical drugs. dea regulates more than 1.5 million registrants. dea diversion groups concentrate on the regulatory aspects of enforcing the controlled substances acts with increased compliance inspections. this oversight enabled dea to proactively educate registrants and ensure that dea registrants understand and comply with the law.

the diversion groups have brought their skills to bear on what was previously known as ground zero for prescription drug abuse. florida based internet pharmacies and pain clinics, as the pill mill threat is driven out of florida and moves to the north and northwest, dea will continue to target the threat with groups proven law enforcement skills, and diversion groups, regulatory expertise, and by educating registrants. dea and law enforcement partners have aggressively targeted both prescription drug diversion and heroin trafficking. from 2001 to 2012, there was a staggering increase in opioid pain medications. a 275% increase for oxycodone, 197% increase for hydrocodone, and a 334% increase for morphine. there's also been a significant increase -- >> would you repeat that once again? >> these are coming from our national forensic lab information data. from 2001 to 2012, we saw an increase of hydrocodone to the extent of 197%. a 275% increase in analysis of

oxycodone. >> of what does analysis mean? >> when a drug -- >> increase? >> when a drug is submitted for analysis, it's either seized pursuant to arrest, purchased undercover. what it shows is our cases are moving from the standard drug cases over to -- an increase in cases related to prescription drugs. these analyses occur across the country. if an undercover agent or undercover officer at local county sheriff's department makes a purchase undercover of oxycodone, he submits that for analysis. we get those reports. >> so what is it, tripled? is that the figure? >> 275% in an 11-year period. >> almost. so what do you deduce from that? >> i deduce we have a major prescription drug problem. >> yeah. >> it's just getting worse. heroin is just a symptom of

prescription drug problems. >> what you're also deducing is that the prescription drug is a gateway drug to heroin, because if it gets too expensive, then the young person turns to heroin, which is much cheaper. >> i would absolutely agree with that. >> yeah. >> there was an increase in our heroin cases from 2008 to 2012. about 35%. if the data for 2013 remains constant, the increase will be about 51% for 2013. we're still getting reports in. the increase in heroin abuse and trafficking is a symptom of our country's insatiable appetite for prescription opioids that can ultimately lead to abuse and addiction. it's a natural progression from the abuse of prescription opioids. there's a dangerous misperception that abusing prescription drugs is safer than abusing heroin, but the abuse of both opioids and heroin can lead to addiction and death. preventing the availability of pharmaceutical controlled substances to nonmedical users, pharmacists, and the public

about diversion trafficking and abuse are priorities at the dea. as such, we'll continue to work and cooperate with the federal, state and local officials, our law enforcement partners, professional organizations, and community groups to address this epidemic. thank you for your invitation to appear today and i look forward to any questions you may have. >> thank you very much. dr. kolodny? >> chairman feinstein, senator whitehouse, and senator klobuchar, thank you for the opportunity to discuss our nation's opioid epidemic. the increasing use of heroin in suburban and rural counties across the country is easily explained. if you speak with a new heroin user, they will tell you that they began using heroin after becoming addicted to opioid painkillers. this phenomenon is not new. people have been switching from painkillers to heroin since the epidemic began 18 years ago. like heroin, opioid painkillers

are made from opium, and the effects they produce in the brain are indistinguishable from heroin. what this means is that when we talk about opioid painkillers, we are essentially talking about heroin pills. that said, these are also important medications for end-of-life care and when used to treat pain on a short-term basis. but these noncontroversial uses, cancer care or short-term use for acute pain, account for a small portion of our overall consumption. the cdc has been perfectly clear about the cause of this crisis. the chart with the three lines rising behind you is a cdc chart. the rising green line representing opioid consumption, according to the cdc, is pulling

up the red line, which represents deaths, and the blue line which represents addiction. please keep in mind that the red line represents the loss of 125,000 lives. what this graph represents is a public health disaster of catastrophic proportion. according to the cdc, increased prescribing of opioids has led to parallel increases in addiction and overdose deaths. in other words, this epidemic was caused by the medical community. we didn't do this out of malicious intent. for most of us it was a desire to treat pain more compassionately that led to overprescribing. we were responding to a campaign that encouraged long-term use. the risks were minimized, especially the risk of addiction, and benefits were exaggerated. in fact, most patients with chronic pain on long-term opioids are not doing well.

we are probably harming far more chronic pain patients than we're helping when we put them on long-term opioids. to help bring this crisis under control, the cdc is calling for reduced prescribing, especially for chronic pain. unfortunately, the fda has not been listening to the cdc. fda continues to approve dangerous new opioids, even over the objection of its own scientific advisers. and fda continues to allow marketing of opioids for common problems like low back pain, where risks are likely to outweigh the benefits of use. with only 5% of the world's population, we now consume 84% of the world's oxycodone and 99% of the hydrocodone supply. on what basis is fda concluding that we need more opioids?

to end this epidemic, the two things we must accomplish are the same two things we would need to do for any disease epidemic. one, we must prevent people from developing the disease in the first place, and two, we must see that people who have the disease are able to access effective treatment. to prevent people from getting this disease in the first place, the medical community, including dentists, must prescribe more cautiously so that we don't directly addict our patients and so that we don't indirectly cause addiction by stocking medicine chests with a hazard. for the millions of americans now struggling with addiction, we have effective treatments that will allow them to lead fully productive lives. unfortunately, in communities hit hardest by the epidemic, treatment capacity does not come close to meeting demand. especially for buprenorphine treatment, where strict limits of who can prescribe and patient caps prevent many from accessing a treatment that could save --

>> explain what you mean by patient caps. >> well, the law data of 2000, which is the law that makes prescribing possible out of offices, limits doctors to treating 30 patients in their first year. after they have a year of experience, they're limited to treating only 100 patients. whereas a doctor who wants to treat low back pain with oxycontin can prescribe to hundreds -- as many patients as they'd like, no limits. and buprenorphine i should as is a much safer medication than oxycontin, much lower risk of overdose. if we don't rapidly expand access to treatment, the outlook is grim. overdose deaths will remain at historically high levels. heroin will continue flooding into our neighborhoods. and our families and communities will continue to suffer the tragic consequences. thank you.

>> well, thank you very much. we've just been joined by senator udall of new mexico. candidly, as i listened, i am really struck -- you know, 30 years ago i was mayor of a big city and, we had our share, nothing like today. nothing like today. i think this testimony is amazing in terms of the tripling of heroin users, the enormous abuse of oxycontin and oxycodone and hydrocodone. the question is, you mentioned the fda just keeps on licensing regardless. i think that's something that i am going to look into. i have this question. i was the senate sponsor of the ryan haight act which went into effect in 2008 and that provided that no controlled substance

that's a prescription drug as determined under federal food, drug, and cosmetic act may be delivered, distributed or dispensed by means of the internet without a valid prescription. and then it describes what it takes to do a valid prescription. i thought that would cut down on some of the use, which ryan haight, and his mother called me from san diego, was an 18-year-old who essentially overdosed on it and died, bought it over the internet. has that been controlled do you think by these -- by this restriction, that you have to have a prescription? >> well, evidence would -- maybe that was effective. because internet purchase of schedule two opioids doesn't seem to be a big problem right now. >> really? >> these opioids are coming from doctors who are prescribing them. >> wow. >> vicodin can be phoned in very

easily, prescribed with multiple refills because it's in the wrong schedule right now. but for other opioids, it does require a doctor's visit. >> well, let me -- i'm -- so we solved that problem. so now we have the problem of doctors overprescribing. what would you recommend? >> well, for doctors to prescribe more cautiously, they need accurate information about the risks and benefits of these medications. what caused this epidemic in the first place, but caused the prescribing to just take off, was a very well-funded campaign with quite a bit of misinformation. doctors were taught -- i was taught that you shouldn't worry about getting patients addicted, that the compassionate way to prescribe is aggressively. and there isn't that much being done to correct the record. >> anybody else on this point? mr. botticelli and then we'll go right down the line. >> i would absolutely agree that part of what we have to look at and all of our colleagues talked

about the vast overprescribing of prescription medication by physicians. that part of the efforts that the federal government has been doing in conjunction with nida and samhsa is providing online training courses for physicians to look at appropriate and safe opioid prescribing. we think there's more to be done in this area and we think promoting mandatory prescriber education as many states have done is really part of providing and ensuring that physicians are getting accurate information other than information that's been provided in terms of the pain prescribing patterns. you know, we keep pointing to the data and it's very, very clear that this is driven by well-meaning physicians in many cases who don't understand the lethality of these drugs, the addictive properties and are not trained in terms of looking at alternatives and how do we monitor people who might be developing an addiction. >> anybody else on this? dr. volkow? go ahead. >> in addition to the issue of education which is crucial and that overall there is missing

education on the screening and proper prescription and management of pain in medical schools and pharmacy schools, there's also what you're mentioning, improving the access and friendliness of the prescription monitoring programs so that physicians when faced with a patient can access that information not just in their states but in other states, and i think the third issue we need to address is the fact that we have also a serious problem of severe pain of -- numbers of people with severe pain and we do not have adequate treatments to address pain for patients. it's another reality we need to face. >> thank you. dr. clark. >> we also have with the advent of the affordable care act, we have an opportunity to offer alternatives to pain medication for the treatment of pain, and i think that's something we should also keep in mind, that historically one of the problems was that there were few alternatives to pain medication for pain management because physical therapy was not available to a lot of people who suffered from pain depending on the community in which you live

and other strategies could not be supported if the insurance companies chose not to support them. so pain medications themselves were actually relatively inexpensive despite some of the new formulations, and so with the aca having an opportunity to get nonprescription strategies to address pain becomes more available. >> thank you. dr. rannazzisi. >> just pre-ryan haight we had a massive problem with schedules 3s and 4s coming off the internet. we had one case -- well, average pharmacy in 2006 was dispensing about 66,000 hydrocodone tablets a year. that's not that much. in one case we had 34 internet facilitation sites, 34 brick and mortar pharmacies that dispensed over 98 million hydrocodone tablets. what ryan haight did was shut that down, but what did we see overnight?

these were not physicians, they were traffickers. they gave up their white coat for trafficking and money. what we saw is overnight they moved from internet trafficking to pain clinic trafficking. we went from four to seven clinics in broward county in 2006 to over 142 in 2010. that doesn't make any sense. >> so what the you're saying, that the pain clinic is part of the problem. >> the rogue pain clinic, true, the rogue pain clinic is definitely part of the problem. these are doctors that are not practicing medicine. these rogue clinics, these are doctors that are just dispensing due to patient directed -- >> i thought that had been abated in that i think in florida, a big one was shut down. is that right? >> we decreased the number in florida through a collaborative effort between law enforcement, federal, state, and local law enforcement. they just moved into georgia. now they're up in tennessee. there's over 300 clinics

operating in tennessee right now. georgia has over 1 -- almost 200 clinics operating right now. they're moving north and west, and these are just prescription pain mills. >> so what can we do? >> we need to get aggressive -- it's a two-prong approach. we need to aggressively attack these clinics and get them out of business as soon as possible, but the regulatory boards in the states need to take control. a lot of these clinics could have been shut down if the regulatory boards would have exercised their authority. some states don't give them enough authority. >> i'm way over my time. so senator grassley, thank you. >> my first question would be to mr. rannazzisi, and it comes from news reports that we've had about the countless deaths linked to a mixture of heroin and the painkiller fentanyl.

in philadelphia just this week it said at least 28 people have died from the mixture. so it gives you a chance to educate us and the public. take the opportunity to tell the public what dea knows about the dangers associated with the mixture and explain why drug dealers might mix and tell us what steps dea can take to locate its sources and arrest traffickers. >> well, first of all, a little bit about fentanyl. it's a synthetic opioid. it's totally synthetic. it's not manufactured from the plant. test it's manufactured in a lab. . . he fentanyl is clandestinely produced. most recently in 2005 or 2006 we had a rash of fentanyl deaths that were related to a lab that we tracked back into mexico to toluca, mexico, and working with the mexican authorities we

closed that lab down. fentanyl rears its head pretty much every few years. now, this particular drug, it could be fentanyl or it could be an analog of fentanyl. it could be another analog that we're just not familiar with. but the reason they use it is because it's approximately -- fentanyl i think is approximately 100 times more potent than morphine on a standard dose. so what -- if they have bad heroin or heroin is not potent enough or if they don't have heroin, they will use the fentanyl and sell it as heroin. people don't realize how potent fentanyl is. people don't realize how difficult it is to cut fentanyl. it's measured in micrograms, so the fact is if you don't know how to cut it, people are going to be getting hot shots and die of overdoses. so it's very important that we find the labs. we have specific clandestine lab groups as well as heroin groups out there looking for the source

just like we did in toluca. once we find the source, we'll take care of it. >> dr. volkow, common sense tells us that efforts to prevent all kinds of addictive behavior should begin as early as possible in life. i'm concerned about the increase in use of marijuana among young people leading to other addictions. you are obviously an authority on drug abuse and addiction and you have been outspoken in your views about marijuana itself being addictive. are you concerned that marijuana use by young people elevates their risk for other addictions later in life such as abusing prescription painkillers or heroin and what does science tell us about this? >> well, epidemiological studies tell us that most people that are addicted to drugs started by consuming marijuana and many of them started also by consuming tobacco and alcohol. so this leads to the concept of the gateway theory of addiction

and what we know is exposure to marijuana-like substances in animals early on during the period of adolescence or even younger increases the sensitivity to the addictiveness of other drugs, and in studies they have shown that when the twin that starts before age 17 has a greater use of marry fwha before age of 17 has a risk of becoming addicted to a wide variety of drugs than the other twin that started after that period of time. that is important because it controls for vieftal factors that are very important to drivers of using and experimenting with drugs. so the does data does subject the use of marijuana could have an affect of making that person more vulnerable to the addict e addictiveness of other drugs.

>> you referenced in your testimony about the administration's prescription drug prevention plan. that goes back to april 2011. the plan focused on prescription opioids. one of the goals was to reduce deaths associated with the drugs. do you think the plan needs to be revised in light of alarming developments over last three years? if so, how? or are the solutions to this epidemic a question of do dg a b better job of implementing it. >> we have to look at the emerging effort. any strategy worth its salt has to acknowledge the changing times and really look at how our trat gi continues to evolve to address the issues. as we have talked about today, the prescription drug abuse prevention plan falls in area of how we attack in a multifaceted

way the issues. we will continue to update our strategy to talk about the evolving heroin issue. we have been continually promoting the use of medication-assisted treatment, expansion of access to treatment, particularly in primary care settings and the more widespread use of overdose prevention tools. we will evolve our strategies to reflect the changing demographic and changing use patterns and changing strategies that we need to address it. >> also, my last question in writing, i appreciate your answer. >> thank you, senator. we will do early bird. >> thank you very much, senator feinstein. i wanted to follow up, senator feinstein asked some question g questi about the drug take back question. you know have i the bill that we passed four years to make it easier to do drug takebacks.

she talked about the 390 tons. our problem is we don't have the rules. i have talked to the director leonard three or four times. she's from minnesota. i like her a lot. i know you are working on this. i know we got them back from omb. when do you think the rules will be done? we can't support these drug take back programs to the extent that we want if we don't have the rules from the dea when it has taken four years. >> thank you for that question. thank you for your support and your leadership on that bill. that was very important for us. right now, there's just -- there's one issue that we're trying to address. >> long-term care facilities. or something like that. you don't have to tell me. i don't know what it is. >> there's one issue we're trying to address. the fact is is that omb has done their job. they vetted it through. came back to us. we're trying to work it out. >> i just know i would -- given what the senator said about the importance of that 390 tons, we

could multiply that over if we could make it easier to have these drug take backs on a weekly basis or have them on a daily basis in pharmacies so people can bring them back. >> the problem with this bill in particular was this bill and these regulations touch on several -- >> transportation and -- >> but transportation, epa, even the military. and so we have to be very cautio cautious, because we don't have to have them go back and make serious corrections in their statutes. >> i understand. you also brought up about synthetic drugs -- thank you for bringing up that issue which is contributing to the addictions. the fact that people can manufacture them from compounds. we, of course -- senator feinstein was helpful until this and supported moving on the synthetic drugs. she and i have two different bills that are both supporting each other's bills about

synthetic drugs with analogs and things like that. do you think that would be helpful to make it easier to prove up the cases? >> i believe any help we could get at this moment in time is going to be beneficial. we have about 200 compounds we have identified that are outside the act, non-controlled drugs representing every class of drug of abuse out there including pcp. >> thank you for what you are doing. as you know, the fda just approved maloxin, quicker than usual to be used in emergency situations. my state this month passed a bill allowing first responders to use it. i'm going to move on, because i'm obsessed with this prescription drug monitoring issue. i wanted to thank you for raising it. it's a very important -- it was the number one thing that president clinton talked about

yesterday in baltimore. it's a very big deal. thank you. prescription drug monitoring. this is this idea that as we see all of this -- the clinics that shouldn't prescribe -- i had never heard the numbers. what did you say about the increase in the number of prescriptions, the number you used? >> more than double over 20 years. >> more than double. >> 7 million prescriptions per year. >> without that much change in our population. i don't know what -- so it's no way that all -- senator whitehouse is saying i guess this many more people are in pain. i think we know that's not the case. people are being preprescribed drugs that shouldn't be. tell me how you think if this prescription drug monitoring where at least we can put a check on these could help? >> when you say that, 390

tons -- >> that's the drug take back. >> what it tells us why are we ending up with so many medications. >> that's a good question. >> it speaks for itself. >> that gets to the root of it. the take back is good. i want to get it done. i'm not naive to think that's going to fix our problem. it's going to help. it's going to get it out and help with kids, especially that are grabbing it from their parents' medicine cabinet. what can we do. >> we need to prescription better and we need to treat pain better. we have the technology, the prescription monitoring program should work. if i can order from google and get things immediately, why can't we not have a system like that that is interoperational that i can have one information from one state to the other. >> very quickly and then i'm out of time. >> these are complimentary strategies. when they misuse the drugs, they get them from the cabinet.

they often turn to doctor shopping to do this. a large part of our drug abuse strategy is getting every state to have an operational and effective prescription drug monitoring program. we have 48 now that are operation operational, one in the process and one state unfortunately that refuses to invest in a prescription drug monitoring program. a big part of our work with the office of national coordinator has been easier to use programs as well as interoperable programs. they said they need to communicate across state lines. we have 20 states that have interoperable -- >> i know, senator udall has a question. they are teasing me for going >> that's all right. we have all been known to go beyond our time. i'm a relaxed chair.

senator whitehouse, you are -- >> welcome. this is a terrific panel. i thank chairman feinstein and our ranking member for pulling us together. this is a very, very important topic. 38 rhode islanders died of opioid overdoses in the first six weeks of this year. if you expand that to the population of the country into a full year, that's 100,000 americans dead per year. it's really very serious. good steps have been taken. the state police have just issued a drug to all their local police departments as well as first responders to have it available. i think we're responding in good ways. one that worries me a little bit is something that's been raised a bunch here, that's these prescription drug monitoring programs.