[House Hearing, 113 Congress] [From the U.S. Government Publishing Office] EXAMINING THE GROWING PROBLEMS OF PRESCRIPTION DRUG AND HEROIN ABUSE ======================================================================= HEARING BEFORE THE SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS OF THE COMMITTEE ON ENERGY AND COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED THIRTEENTH CONGRESS SECOND SESSION __________ APRIL 29, 2014 __________ Serial No. 113-140 [GRAPHIC NOT AVAILABLE IN TIFF FORMAT] Printed for the use of the Committee on Energy and Commerce energycommerce.house.gov _____________ U.S. GOVERNMENT PUBLISHING OFFICE 90-923 WASHINGTON : 2015 _______________________________________________________________________________________ For sale by the Superintendent of Documents, U.S. Government Publishing Office, http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center, U.S. Government Publishing Office. Phone 202-512-1800, or 866-512-1800 (toll-free). E-mail, [email protected]. COMMITTEE ON ENERGY AND COMMERCE FRED UPTON, Michigan Chairman RALPH M. HALL, Texas HENRY A. WAXMAN, California JOE BARTON, Texas Ranking Member Chairman Emeritus JOHN D. DINGELL, Michigan ED WHITFIELD, Kentucky Chairman Emeritus JOHN SHIMKUS, Illinois FRANK PALLONE, Jr., New Jersey JOSEPH R. PITTS, Pennsylvania BOBBY L. RUSH, Illinois GREG WALDEN, Oregon ANNA G. ESHOO, California LEE TERRY, Nebraska ELIOT L. ENGEL, New York MIKE ROGERS, Michigan GENE GREEN, Texas TIM MURPHY, Pennsylvania DIANA DeGETTE, Colorado MICHAEL C. BURGESS, Texas LOIS CAPPS, California MARSHA BLACKBURN, Tennessee MICHAEL F. DOYLE, Pennsylvania Vice Chairman JANICE D. SCHAKOWSKY, Illinois PHIL GINGREY, Georgia JIM MATHESON, Utah STEVE SCALISE, Louisiana G.K. BUTTERFIELD, North Carolina ROBERT E. LATTA, Ohio JOHN BARROW, Georgia CATHY McMORRIS RODGERS, Washington DORIS O. MATSUI, California GREGG HARPER, Mississippi DONNA M. CHRISTENSEN, Virgin LEONARD LANCE, New Jersey Islands BILL CASSIDY, Louisiana KATHY CASTOR, Florida BRETT GUTHRIE, Kentucky JOHN P. SARBANES, Maryland PETE OLSON, Texas JERRY McNERNEY, California DAVID B. McKINLEY, West Virginia BRUCE L. BRALEY, Iowa CORY GARDNER, Colorado PETER WELCH, Vermont MIKE POMPEO, Kansas BEN RAY LUJAN, New Mexico ADAM KINZINGER, Illinois PAUL TONKO, New York H. MORGAN GRIFFITH, Virginia JOHN A. YARMUTH, Kentucky GUS M. BILIRAKIS, Florida BILL JOHNSON, Missouri BILLY LONG, Missouri RENEE L. ELLMERS, North Carolina Subcommittee on Oversight and Investigations TIM MURPHY, Pennsylvania Chairman MICHAEL C. BURGESS, Texas DIANA DeGETTE, Colorado Vice Chairman Ranking Member MARSHA BLACKBURN, Tennessee BRUCE L. BRALEY, Iowa PHIL GINGREY, Georgia BEN RAY LUJAN, New Mexico STEVE SCALISE, Louisiana JANICE D. SCHAKOWSKY, Illinois GREGG HARPER, Mississippi G.K. BUTTERFIELD, North Carolina PETE OLSON, Texas KATHY CASTOR, Florida CORY GARDNER, Colorado PETER WELCH, Vermont H. MORGAN GRIFFITH, Virginia PAUL TONKO, New York BILL JOHNSON, Ohio JOHN A. YARMUTH, Kentucky BILLY LONG, Missouri GENE GREEN, Texas RENEE L. ELLMERS, North Carolina HENRY A. WAXMAN, California (ex JOE BARTON, Texas officio) FRED UPTON, Michigan (ex officio) C O N T E N T S ---------- Page Hon. Michael C. Burgess, a Representative in Congress from the State of Texas, opening statement.............................. 1 Prepared statement........................................... 3 Hon. Diana DeGette, a Representative in Congress from the state of Colorado, opening statement................................. 4 Hon. Marsha Blackburn, a Representative in Congress from the State of Tennessee, opening statement.......................... 6 Hon. Henry A. Waxman, a Representative in Congress from the State of California, opening statement............................... 7 Hon. Tim Murphy, a Representative in Congress from the Commonwealth of Pennsylvania, prepared statement............... 101 Witnesses Michael Botticelli, Acting Director, Office of National Drug Control Policy, Executive Office of the President.............. 9 Prepared statement........................................... 12 Answers to submitted questions............................... 106 Daniel M. Sosin, Acting Director, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention..................................................... 26 Prepared statement........................................... 28 Answers to submitted questions............................... 126 Nora D. Volkow, Director, National Institute on Drug Abuse, National Institutes of Health.................................. 35 Prepared statement........................................... 37 Answers to submitted questions............................... 137 H. Westley Clark, Director, Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration...... 53 Prepared statement........................................... 55 Answers to submitted questions............................... 150 Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Agency, U.S. Department of Justice........................................................ 65 Prepared statement........................................... 67 Answers to submitted questions............................... 161 Submitted Material Op-ed entitled, ``Senate must pass bills to fight tragedy of drug addiction,'' The Courier-Journal, April 1, 2014, submitted by Mr. Yarmuth.................................................... 103 EXAMINING THE GROWING PROBLEMS OF PRESCRIPTION DRUG AND HEROIN ABUSE ---------- TUESDAY, APRIL 29, 2014 House of Representatives, Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, Washington, DC. The subcommittee met, pursuant to call, at 10:00 a.m., in room 2322 of the Rayburn House Office Building, Hon. Michael Burgess (vice chairman of the subcommittee) presiding. Members present: Representatives Burgess, Blackburn, Gingrey, Scalise, Harper, Gardner, Griffith, Johnson, Long, Ellmers, DeGette, Braley, Lujan, Schakowsky, Castor, Welch, Yarmuth, Green and Waxman (ex officio). Staff present: Carl Anderson, Counsel, Oversight; Karen Christian, Chief Counsel, Oversight; Brittany Havens, Legislative Clerk; Sean Hayes, Deputy Chief Counsel, Oversight and Investigations; Tom Wilbur, Digital Media Advisor; Phil Barnett, Democratic Staff Director; Brian Cohen, Democratic Staff Director, Oversight and Investigations, Senior Policy Advisor; Kiren Gopal, Democratic Counsel; Hannah Green, Democratic Staff Assistant; Anne Morris Reid, Democratic Senior Professional Staff Member; and Stephen Salsbury, Democratic Investigator. OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS Mr. Burgess. Good morning. I now convene the hearing of the Subcommittee on Oversight and Investigations, entitled Examining the Growing Problems of Prescription Drug and Heroin Abuse. Just a brief housekeeping detail for those of you who were expecting to see Dr. Murphy here in the chair, he was called away back to his district for a family issue, so you are stuck with me, as the saying goes, but we will get through this together. On the issue of prescription drug and heroin abuse, these are separate and distinct problems, but unfortunately, they do share a common endpoint; addiction, abuse, overdose, and death. As we know, the abuse of prescription drugs, and illegal drugs such as heroin, have plagued our nation for decades, however, over the last several months, there have been increasing reports that prescription drug and heroin abuse in communities around the country continues to grow. Sadly, those reports indicate that overdose deaths as a result of prescription drug and heroin abuse are also on the rise. Families have lost sons and daughters, mothers and fathers to this addiction. Data from the federal agencies charged with addressing drug abuse paint a startling picture of the severity of the public health crisis. Prescription drug abuse kills more than 16,000 people a year. From 2007 to 2012, heroin use rose by almost 80 percent in this country, and 3,000 people die each year from heroin overdoses. The United States Attorney General, Eric Holder, declared recently that heroin abuse constitutes ``an urgent and growing public health crisis.'' Certainly, there is a law enforcement aspect to solving this problem, and stopping the bad actors who illegally distribute prescription drugs or traffic heroin, but the other part of the equation is treating the addiction, the addiction to prescription drugs and heroin, and preventing deaths. The answer to a burgeoning heroin epidemic, as the Administration has called it, is not to wage war on all opiates. To address a complex issue, the solution cannot be simple. The purpose of today's hearing is to examine the federal response, including the public health response, to prescription drug and heroin abuse. Our oversight has revealed that this is a complex problem. Those who abuse drugs also have, often, an underlying mental illness. Treating their addiction means that the underlying mental illness must be successfully diagnosed and treated. As the testimony of Mr. Botticelli states, the substance abuse is a progressive disease. Those who suffer from addiction often start at a young age with alcohol, maybe marijuana, move on to other drugs like opiates. In examining opiate abuse, we must also consider the factors that lead people to abuse, and what we are doing to address those factors. Many Americans also suffer from chronic and debilitating pain. It is important to remember that the millions of individuals who safely use opiate narcotics under the guidance of their physicians, pain that we hope a loved one would never have to suffer is involved. As Dr. Volkow of NIH recognizes in her testimony, we need to recognize the special character of prescription drug abuse. On the one hand, we have a growing prescription drug and opiate addiction. On the other, we have a very real need for these drugs to treat chronic pain, treat acute pain, and alleviate suffering where it exists, especially in patients with chronic conditions who are suffering from illnesses like cancer. These drugs are safe when used as directed. It is their improper use that leads to abuse, overdose, and death. Over recent years, we have heard a great deal about doctor shopping, about pill mills, and about the efforts of the prescription drug monitoring plans to address these problems. We need to ensure that doctors and pharmacists have the tools at their disposal to adequately fill their role with ensuring appropriate prescribing, but addicts also get these drugs through illegal channels, such as rogue Internet pharmacies, off the street, and obtaining them through family members who may have an outdated prescription. Although some question whether federal efforts to crackdown and prevent prescription drug abuse have contributed to the recent rise in heroin abuse, and whether this should have been anticipated, there is no question that both are on the rise, and as a consequence, we have a responsibility to recognize and solve that problem. While most prescription drug abusers do not go on to abuse heroin, there is data from the White House Office of National Drug Control Policy, and the Substance Abuse and Mental Health Services Administration, that indicates over 80 percent of people who started using heroin in 2008 to 2010 had previously abused prescription drugs. The Federal Government is devoting resources to drug control programs. Some would say significant resources; over $25 billion annually, of which about $10 billion goes towards drug abuse prevention and treatment programs across 19 different federal agencies. We will ask today's witnesses to identify the specific policies, the programs, the initiatives that have been the most effective in combatting prescription drug and heroin abuse, and which have not. With 19 agencies having a hand in over 70 drug control programs, we need to know what is working and what is not. What can we do better? Is oversight by the federal agencies also an important issue as significant funding is block granted to the states for their treatment programs? Testifying before us today are representatives of five of the agencies with lead roles in addressing opiate abuse. Mr. Michael Botticelli, the Acting Director of the White House Office of National Drug Control Policy; Mr. Daniel Sosin of the Centers for Disease Control and Prevention; Dr. Nora Volkow of the National Institute on Drug Abuse; Dr. Westley Clark of the Substance Abuse and Mental Health Services Administration; and Mr. Joseph Rannazzisi of the Drug Enforcement Agency. This is a prestigious panel, and we are very grateful for your presence here today. We certainly look forward to your testimony. [The prepared statement of Mr. Burgess follows:] Prepared statement of Hon. Michael C. Burgess Good morning. I now convene this hearing of the Subcommittee on Oversight and Investigations entitled ``Examining the Growing Problems of Prescription Drug and Heroin Abuse.'' These are separate and distinct problems with a common end point; abuse, overdose, and death. As we know, the abuse of prescription drugs and illegal drugs such as heroin have plagued our nation for decades. However, over the last several months, there have been increasing reports that prescription drug and heroin abuse in communities around the country continue to grow. Sadly, those reports indicate that overdose deaths as a result of prescription drug and heroin abuse are also on the rise. Families have lost sons and daughters and fathers and mothers to this addiction. Data from the federal agencies charged with addressing drug abuse paint a startling picture of the severity of this public health crisis. Prescription drug abuse kills more than 16,000 people a year. From 2007 to 2012, heroin use rose by 79 percent in this country and 3,000 people die each year from heroin overdoses. U.S. Attorney General Eric H. Holder declared recently that heroin abuse constitutes ``an urgent and growing public health crisis.'' Certainly, there is a law enforcement aspect to solving this problem and stopping the bad actors who illegally distribute prescription drugs or traffic heroin. But the other part of the equation is treating addiction to prescription drugs and heroin--and preventing deaths. The answer to a burgeoning heroin epidemic, as the administration has called it, is not to wage a war on all opioids. To address a complex issue, the solution will not be simple. The purpose of today's hearing is to examine the federal response, including the public health response, to prescription drug and heroin abuse. Our oversight has revealed that this is a complex problem. Those who abuse drugs often have an underlying mental illness. Treating their addiction means that the underlying mental illness must be successfully diagnosed and treated. As the testimony of Mr. Botticelli, states, substance abuse is a ``progressive disease.'' Those who suffer from addiction often start at a young age, with alcohol and marijuana, and then move to other drugs like opioids. In examining opioid abuse, we must also consider the factors that lead people to abuse--and what we are doing to address them. Many Americans also suffer from chronic and debilitating pain. It is important to remember the millions of individuals who safely use opioids under the guidance of their physicians, pain that we all hope us or a loved one would never suffer. As Dr. Volkow of NIH recognizes in her testimony, we need to recognize the ``special character'' of prescription drug abuse. On one hand, we have growing prescription drug and opiate addiction; on the other, we have the very real need for these drugs to treat chronic pain and alleviate suffering, especially in patients with conditions like cancer. These drugs are safe when used as directed--it is their improper use that leads to abuse and overdose. Over recent years, we have heard a great deal about doctor shopping, pill mills, and the efforts of Prescription Drug Monitoring Plans to address these problems. We need to ensure that doctors and pharmacists have the tools at their disposal to adequately fill their role in ensuring appropriate prescribing. But addicts also get these drugs through illegal channels, such as rogue Internet pharmacies, off the street, and obtaining them through family and friends. Although some question whether federal efforts to crackdown or prevent prescription drug abuse have contributed to the recent rise in heroin abuse, and whether this should have been anticipated, there is no question that both are on the rise and we have a responsibility to examine this issue fully. While most prescription drug abusers do not go on to abuse heroin, there is data from the White House Office of National Drug Control Policy (ONDCP) and the Substance Abuse and Mental Health Services Administration (SAMHSA) that indicates 81 percent of people who started using heroin in 2008 to 2010 had previously abused prescription drugs. The federal government is devoting significant resources to drug control programs -over $25 billion annually, of which about $10 billion goes toward drug abuse prevention and treatment programs across 19 federal agencies. We will ask today's witnesses to identify the specific policies, programs, and initiatives have been most effective in combatting prescription drug and heroin abuse--and which have not. With 19 agencies having a hand in over 70 drug control programs--is this working? What can we do better? Oversight by the federal agencies is also an important issue, as significant funding is block granted to states for treatment programs Testifying before us today are representatives of the five agencies with lead roles in addressing opiate abuse: Mr. Michael Botticelli, Acting Director of the White House Office of National Drug Control Policy; Dr. Daniel Sosin of the Centers for Disease Control and Prevention; Dr. Nora Volkow of the National Institute on Drug Abuse; Dr. H. Westley Clark of the Substance Abuse and Mental Health Services Administration (SAMHSA); and Mr. Joseph Rannazzisi of the Drug Enforcement Agency. This is a prestigious panel, and I thank you for being here today. We look forward to your testimony. Mr. Burgess. I would now like to recognize for 5 minutes for the purposes of an opening statement the ranking member, Ms. DeGette from Colorado. OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO Ms. DeGette. Thank you so much, Mr. Burgess, and we are glad to have you presiding today. Prescription drug and heroin abuse is a public health crisis and it is growing every day. In many communities across the country, we are seeing an epidemic of opioid overdose deaths. I am interested in learning from the panel about what more we can do to prevent the abuse of these drugs, and also to save lives. The non-medical use of opioids has escalated in recent years. In 2011, hospitals tallied nearly \1/2\ million emergency room visits related to these medications. The number of these visits nearly tripled over a 7-year period. The link between prescription opioid use and heroin abuse is also deeply troubling, and as the Chairman noted, only a small percentage of people who use pain relievers go on to abuse heroin, but the opposite is not true. The vast majority of those who abuse heroin previously abused prescription drugs. While far more people continue to abuse prescription drugs, the number of individuals who reported heroin nearly doubled between 2007 and 2012. There is also evidence to suggest that people who abuse prescription drugs move on to heroin as pain relievers become less available or too costly. A 2012 study in the New England Journal of Medicine found heroin use rose dramatically after the introduction of an abuse deterrent form of Oxycontin. The use of drugs that ultimately lead to addiction and abuse often begins innocently. The majority of people who illegally use a prescription drug get that drug from a friend or a family member often, and sometimes the drug has been stolen, but at other times, a parent may even give the drug to a child, unaware of the risks. We must educate patients on the dangers of abuse of these drugs, as well as the need to properly store and dispose of them. If we can reduce inappropriate access to drugs, we can also reduce the incidence of their abuse. We must change the public perception of the prescription opioids. We face the inaccurate perception that just because a drug is legal, it is somehow less harmless, less addictive and less risky. Providers should also be better educated on the use and potential abuse of these drugs, so they can be more effective in recognizing problems of abuse, and, in turn, more effective in educating and treating the patients. Studies show that even brief interventions by healthcare providers can be successful in reducing or eliminating substance abuse by patients who began abusing prescription opioids but have not yet become addicted to them. When prescribed appropriately, these medicines provide much-needed relief, and many patients have had their suffering reduced by opioid pain killers. However, a patient with an acute short-term pain may be able to find relief from a less addictive pain killer. Prescription drug abuse is a public health problem, and it is not just a law enforcement problem. Reducing this abuse will require a multifaceted approach, and partnership among federal, state and local agencies. Every state should effectively use prescription drug monitoring programs. These databases help states identify and address drug diversion, so they should be as robust and effective as possible. States should be able to share information with due regard for privacy expectations. Information should be added to the databases regularly, including by encouraging prescribers and pharmacists to use the databases. When used, they can help doctors and public health authorities prevent and respond to the potential devastating effects of prescription drug abuse. I am interested in learning from our witnesses today about the effects of this medication assisted treatment that we are hearing about, and also whether we have the resources to meet the demand for these treatment programs. I am also interested in learning about the state of research into new medications with lower abuse potential, and how we can expand access to overdose interventions like naloxone. Prescription opioid and heroin abuse, as you said, Mr. Chairman, is a serious public health threat. I look forward to hearing from all of the witnesses, and to working with all of my colleagues on both sides of the aisle to ensure that Congress plays a vital role in protecting families from the growing danger of these drugs. And I yield back the balance of my time. Mr. Burgess. The gentlelady yields back. The Chair now recognizes the gentlelady from Tennessee 5 minutes for purposes of an opening statement please. OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE Mrs. Blackburn. Thank you, Mr. Chairman. And I know we are all cheering for Congressman Murphy and his daughter, as they are about to welcome that new baby into their family. What an exciting, exciting time. I can only tell you the joys of being a grandparent are marvelous. It is a big part of my day. Well, I thank you for the attention that we are putting on this issue. Prescription drug and heroin abuse are epidemic in our country, and I think you can tell by what is being said in this room this morning; it is an issue that our committee is concerned about, and I applaud the efforts of the committee to take a very thoughtful approach and process as how we move forward. It is clear that we need to understand the factors that have contributed to the rise in prescription drug and heroin abuse. We need to understand which prevention, treatment, and law enforcement efforts are the most effective in reducing the abuse of prescription drugs and heroin. On the other side of this issue are the millions of Americans who have legitimate need for prescription medication for the control of pain, reduction of anxiety, and the overall improvement of their lives. These medications must be available to them. H.R.4069, the Ensuring Patient Access and Effective Drug Enforcement Act of 2013, that is a Bill by Representative Marino and I, it will establish a combatting prescription drug abuse working group. This group will include members from the DEA, FDA, ONDCP, State Attorney Generals, patient groups, pharmacists, industry, healthcare providers and others. Within one year of enactment, the working group shall provide, they must do this, provide recommendations to Congress on initiatives to reduce prescription drug diversion and abuse. We think this is the right approach. We welcome each of our witnesses. We look forward to hearing your testimony and to the discussion. And with that, Mr. Chairman, I yield back my time, or to anyone who is seeking time. Mr. Burgess. Seeing no one seeking time, the gentlelady yields back. The Chair now recognizes the ranking member of the full committee, Mr. Waxman, 5 minutes for an opening statement please. OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA Mr. Waxman. Thank you, Mr. Chairman, for holding this important hearing today. We are here to discuss the epidemic of opioid abuse. The numbers are stark. Each year, approximately 17,000 people die from prescription opioid overdoses, and 3,000 die from heroin overdoses. For far too long, prescription opiate pain relievers were prescribed too easily, without enough attention paid to the potential risks, and a large number of people became addicted. Some of those who became addicted to prescription opiates eventually moved on to heroin because that is a cheaper alternative, offering the same high. Fortunately, there are steps that we can take to fight this problem. I appreciate our witnesses being here today to discuss their efforts to educate the public and providers about the dangers of abusing these drugs. We will also hear how we can change prescribing practices, monitor the use of opiates, effectively treat those who are addicted, and investigate and prosecute those involved in diverting and trafficking these drugs. Our five witnesses, Mr. Rannazzisi from the DEA; Mr. Botticelli from ONDCP; Dr. Sosin from CDC; Dr. Volkow from NIH; and Dr. Clark from SAMHSA, represent an all-star panel of experts, and we are delighted that you are here. There are many reasons to be thankful for the launch of the Affordable Care Act. Let me repeat that. There are many reasons to be thankful for the launch of the Affordable Care Act. One that is often overlooked is the help the law offers to individuals addicted to prescription opiates and heroin. The lack of insurance and the high cost of treatment could present an insurmountable barrier to receiving the help they need. The Affordable Care Act addresses this problem by expanding insurance coverage, and requiring all policies to cover the costs of substance abuse services. This will mean that millions of individuals with addiction disorders will have access to the tools they need to help break their addictions. We need to build upon this hopeful step, and increase our efforts to combat this epidemic. Mr. Chairman, at this point, I wish to yield the balance of my time to Mr. Welch from Vermont. Mr. Welch. I thank the member from California for yielding, and I thank the committee for having this hearing, but I want to give some credit to Governor Peter Shumlin of Vermont. He did something extremely unusual. He dedicated his entire State of the State Address to this single problem, and that was a bold decision for two reasons. One, most of the time, the State of the State is a laundry list of objectives and hopes. This got very specific about one topic. But second, in taking this on, he made public what people knew was real, but didn't want to acknowledge. And what we have seen in Vermont as a result of that was that we are facing what is a terrible problem that creates enormous anxiety for the folks that are in the grip of this addiction, but their families. And before we began talking about this, it was restricted to our law enforcement folks and our mental health folks who were dealing with these isolated individuals as though they were the only ones in the world that faced this incredible challenge. And what Governor Shumlin did is he brought it out in the open, and that was in large part because in his travels around, and governors do get around, he was talking to our law enforcement people, like Chief Taylor in Saint Albans, like Chief Baker in Rutland, and they were dealing on the street with kids that they knew and with adults that they knew who had jobs, but had this horrible addiction, and they had to deal with it. And what our police kept saying, who have frontline responsibilities, you cannot arrest your way out of this. And there is a distinction that they make between the dealers who came from out of state and started inflicting our kids and others with this opiate addiction, throw the book at them, forget about them, but a lot of the kids who are in the grip, they are our kids, they have a future, they have a challenge. And what has happened in our communities with the leadership of our police and our mental health people and our mayors, like Liz Gamache in Saint Albans, and like Chris Louras in Rutland, is that by bringing this out into the open, it has helped us talk about this in concrete ways so that there is not only the treatment program, the Hub and Spoke Program, which I hope you might talk about, but it also is allowing parents and the community to see this as something where we all have to be engaged to provide some basis of support for these kids and adults who want not to be in the grip of this horrible opiate addiction. So I thank you, the committee, for having this hearing, and making it a collective effort to try to bring our resources together to help people get whole. Thank you. Mr. Burgess. The gentleman yields back. I would now like to introduce the witnesses on the panel for today's hearing. Mr. Michael Botticelli is the Acting Director of the Office of National Drug Control Policy in the Executive Office of the President; Dr. Daniel Sosin, who is the Acting Director of the National Center for Injury Prevention and Control at the Centers for Disease Prevention; Dr. Nora Volkow is the Director of the National Institute on Drug Abuse at the National Institute of Health; Dr. Westley Clark is the Director of the Center for Substance Abuse Treatment within the Substance Abuse and Mental Health Services Administration; and Mr. Joseph Rannazzisi is the Deputy Assistant Administrator in the Office of Diversion Control within the Drug Enforcement Agency at the United States Department of Justice. I will now swear in the witnesses. As you are aware, this committee is holding an investigative hearing, and when doing so, has had the practice of taking testimony under oath. Do any of you have any objections to testifying under oath this morning? Seeing a negative response from the witnesses, the Chair then advises that under the rules of the House and the rules of the committee, you are entitled to be advised by counsel. Do any of our witnesses desire to be advised by counsel during testimony today? And negative response was received from the panel of witnesses. In that case, if you would please rise and raise your right hand, I will swear you in. [Witnesses sworn.] Mr. Burgess. Let it be noted that the witnesses answered affirmatively. You are now under oath and subject to the penalties set forth in Title XVIII, Section 1001 of the United States Code. We would now welcome a 5-minute summary of your written statements. We will start with Mr. Botticelli and move down the table. STATEMENTS OF MICHAEL BOTTICELLI, ACTING DIRECTOR, OFFICE OF NATIONAL DRUG CONTROL POLICY, EXECUTIVE OFFICE OF THE PRESIDENT; DANIEL M. SOSIN, ACTING DIRECTOR, NATIONAL CENTER FOR INJURY PREVENTION AND CONTROL, CENTERS FOR DISEASE CONTROL AND PREVENTION; NORA D. VOLKOW, DIRECTOR, NATIONAL INSTITUTE ON DRUG ABUSE, NATIONAL INSTITUTES OF HEALTH; H. WESTLEY CLARK, DIRECTOR, CENTER FOR SUBSTANCE ABUSE TREATMENT, SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION; AND JOSEPH T. RANNAZZISI, DEPUTY ASSISTANT ADMINISTRATOR, OFFICE OF DIVERSION CONTROL, DRUG ENFORCEMENT AGENCY, U.S. DEPARTMENT OF JUSTICE STATEMENT OF MICHAEL BOTTICELLI Mr. Botticelli. Chairman Burgess, Ranking Member DeGette, and members of the subcommittee, I want to thank you for the opportunity to appear today to discuss the tremendous public health and safety issues surrounding the diversion and abuse of opioid drugs, including many prescription pain killers and heroin, in the United States. I know that, given recent media attention to overdose deaths, there is a heightened public interest in the threat of opioid drug use, but this is something many communities have been dealing with for a very long time, and it is a matter of great concern for this Administration. 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 for which nationwide data are available, approximately 100 Americans died on average from overdose every day. Prescription analgesics were involved in almost 17,000 of those deaths that year, and heroin was involved in about 3,000, and more recent data posted by several states indicates 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 cannot arrest our way out of the drug problem. Science has shown us that drug addiction is a disease of the brain, a disease that can be prevented, treated, and from which one can recover. We know that substance use disorders, including those driven by opioids, are a progressive disease. Many people who develop a substance use disorder begin using at a young age, and often start with alcohol, tobacco and/or marijuana. We know that as an individual's abuse of prescription opioids becomes more frequent or chronic, that person is more inclined to purchase the drugs from dealers or obtain prescriptions from multiple doctors, rather than simply getting it from a friend or relative for free or without asking. This progression of an opioid use disorder may lead an individual to pursue a lower cost alternative such as heroin. With these circumstances in mind, we released the Obama Administration's inaugural National 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 in the United States. 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 abuse 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 medications. The Plan expands on the National Drug Control Strategy, and brings together a variety of Federal, state, local, and tribal partners to support: 1) the expansion of state-based prescription drug monitoring programs; 2) more convenient and environmentally responsible disposal methods for removing expired or unneeded medication from the home; 3) education for patients and training of healthcare providers in the proper prescribing practices and treatment of substance use disorders; and 4) reducing the prevalence of pill mills and doctor shopping through enforcement efforts. This work has been paralleled by efforts to address heroin trafficking and use. The Administration is also focusing on several keys areas to reduce and prevent opioid overdoses, including educating the public about overdose risks and interventions, increasing access to naloxone, an emergency overdose reversal medication, and working with states to promote Good Samaritan laws and other measures that can help save lives. Because police are often the first on scene of an overdose, the Administration strongly encourages local law enforcement agencies to train and equip their personnel with this lifesaving drug. It is not enough, however, to save a life from an overdose. A smart public health approach requires us to catch the signs and symptoms of substance use early, before it develops into a chronic disorder. We have been encouraging the use of screening and brief intervention to catch risky substance use before it becomes an addiction, and since only 11 percent of those who needed substance use disorder treatment in 2012 actually received it, the Administration is dramatically expanding access to treatment. The Affordable Care Act and Federal parity law are extending access to substance use disorders and mental health benefits for an estimated 62 million Americans, helping to close the treatment gap and integrate substance use treatment into mainstream healthcare. This represents the largest expansion of treatment access in a generation and can help guide millions into successful recovery. The standard of care for treating substance use disorders driven by heroin or prescription opioids involves the use of medication-assisted treatment, an approach to treating opioid addiction that utilizes behavioral therapy along with FDA- approved medications, either methadone, buprenorphine, or naltrexone. Mediation-assisted treatment has already helped thousands of people in long-term recovery, and I applaud the recent commentary by my HHS colleagues in the New England Journal of Medicine to expand the use of medications to treat opioid addiction and reduce overdose deaths. There are some signs that our national efforts are working. The number of Americans 12 and older initiating the non-medical use of prescription opioids in the past year has decreased significantly since 2009. Additionally, according to the latest Monitoring the Future survey, the rate of past year use of Oxycontin or Vicodin among high school seniors in 2013 is at its lowest since 2002. And recent studies have shown that implementation of robust naloxone distribution programs and the expansion of medication-assisted treatment can reduce mortality and also be cost-effective. However, continuing challenges with prescription opioids and the re-emergence 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 for the opportunity to address the committee today. [The prepared statement of Mr. Botticelli follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Burgess. The gentleman yields back. The Chair recognizes Dr. Sosin for the purposes of the 5- minute opening statement please. STATEMENT OF DANIEL M. SOSIN Dr. Sosin. Good morning, Chairman Burgess, and members of the subcommittee. Thank you for the opportunity to testify about the public health issues related to prescription drug overdoses, and the Centers for Disease Control and Prevention's role in preventing them. It is an honor to be with you today to talk about CDC's approach to prescription drug overdoses and the prevention of them. Drug overdose death rates are higher than they have ever been, with prescription opioids being a key driver of this trend. More than 125,000 Americans have died from prescription opioid overdoses in the last decade. CDC has played an important role in raising the visibility of the health impact of prescription opioid overdoses, and helping to identify the role of increased inappropriate opioid prescribing in fueling this epidemic. Research also suggests that the growth in heroin use may be due in part to the increased addiction caused by the rise in prescribing of opioid pain relievers. The doubling in heroin use in the past 6 years is a worrisome trend, and undoubtedly has a relationship to prescription opioids. Reducing inappropriate opioid prescribing is one of the approaches needed to keep people from becoming addicted to opioids, and prevent them from later transitioning to heroin. Because of the complexity of these issues, the response demands engagement from a diverse group of federal, state and local partners. The partners at this table are all critical in the overall goal to reduce abuse and overdose of opioids while ensuring that patients with pain are safely and effectively treated. As the nation's health protection agency, CDC is focused on upstream drivers of this epidemic, in this instance, the prescribing behaviors that created and continue to fuel this crisis. Our approach fits into three pillars that leverage CDC's unique expertise: One, improving data quality and use to monitor the trends and causes of the epidemic. Timely, drug- specific information on prescribing, and the health effects of prescription drugs is critical. We generate, use, and improve data to identify threats, assess local trends, and evaluate the impact of prevention measures. Two, strengthening state prevention efforts. States maintain prescription drug monitoring programs, or PDMPs. States regulate healthcare professionals and institutions, they monitor the problem through their health departments, and they run large public insurance programs, including Medicaid. CDC provides resources and technical assistance to states to implement interventions and evaluate and adapt their approach to have the most impact. And three, improving patient safety by supporting healthcare providers and systems with tools and data needed to respond effectively. For example, CDC is working to promote responsible opioid prescribing through guidelines and decision support tools. While CDC has ongoing work in each of these areas, we are focusing this year on accelerating state prevention efforts. We will be funding four to five state health departments for up to a total of $2 million per year to implement and evaluate the strategies I just outlined. The 2015 President's Budget includes a request for $15.6 million in new funds to expand CDC's Core Violence and Injury Prevention Program, which is a state-based program addressing injury and violence prevention. This will allow us to include additional states with the high burden of prescription drug overdose, to prevent injuries and violence, and expand the investment of these programs on reducing prescription drug overdose. In conclusion, prescription drug abuse and overdose is a serious public health problem in the United States. The burden of prescription drug abuse and overdose affects people of all walks of life, and many sectors of our economy. Addressing this complex problem requires a multifaceted approach and collaboration. CDC is committed to tracking and understanding the epidemic, supporting states working on the frontlines of this crisis, and rigorously evaluating what works to improve patient safety, prevent overdoses and save lives. Thank you again for the opportunity to be here today. [The prepared statement of Dr. Sosin follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Burgess. Thank you. The gentleman yields back. The Chair recognizes Dr. Volkow for 5 minutes for an opening statement. Thank you. STATEMENT OF NORA D. VOLKOW Dr. Volkow [continuing]. Is a component of the NIH to speak about the value of science in helping address the problem from the diversion and abuse of prescription opioid pain killers, and the related rising abuse of heroin. Opioids medications are the most effective intervention we currently have for management of severe pain. Unfortunately, these drugs not only inhibit pain censors in the brain, but they also potently activate brain reward regions, which is why they are abused and they can cause addiction. 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 pain killers, which reflects, in part, the widespread availability of these drugs. Indeed, the number of yearly prescriptions for opioids has more than doubled over the past 20 years, from 76 million to 207 million prescriptions per year, during a period that in parallel saw a fourfold increase in death overdoses from prescription opioids. Pain killers, like Oxycontin and Vicodin, affect the brain similarly to heroin. They interact with exactly the same opioid receptors. Their difference depends on the potency, that is, how strongly they activate those receptors, and how rapidly they do so. So as for heroin, they can produce euphoria, which some abusers of prescription medications intensify by taking higher doses, crushing the pills so that they can snort them or inject them, or taking them in combination with other drugs like alcohol and Benzodiazepines. These practices make opioids far more dangerous, not only because they are more addictive, but also because they increase the risk for respiratory depression, which is the main cause of death from overdoses. Recent trends, as the other witnesses have mentioned, also indicate a rise in heroin abuse which currently affects more than \1/2\ million Americans, and this rise is possibly driven in part by people switching from prescription opioids to heroin because it is cheaper and, in some instances, more available. Heroin is dangerous not just because of its high addictiveness and the overdose risk that it poses, but also because it is frequently injected which increases the risk of diseases like HIV and Hepatitis C, predominantly from the use of contaminated injection material. So what is NIDA doing about the problem? We are funding research in two major areas. One, research that will allow us to manage pain more effectively, research that will allow us to prevent deaths from overdoses from opioids, and that research will allow us to treat substance use disorders more effectively, including prescription medications. As it relates to the safe management of pain, we still don't know enough about the risk for addiction among chronic pain patients, or about how pain mechanisms in the brain interact with prescription opioids to influence their addictive potential, but ongoing research will help us clarify some of these issues. So with respect to treatment, we are funding research to develop non-opioid-based analgesics that are non-addictive, opioid medications that have less risk for diversion and abuse, as given by different formulations, or different ways of administering them, and finally, non-medication strategies such as transcranium magnetic stimulation, or electrical brain stimulation for the management of pain. Research related to preventing overdoses, making the effective opioid overdose antidote, naloxone, which is also very safe, more available, will help prevent many deaths. The FDA recently approved a handheld auto injector of naloxone that patients and others can use easily. NIDA is supporting the development of user-friendly naloxones in the form of nasal spray to be used by non-medical personnel or the overdose victim. Also, since many overdoses occur when no one is around or during sleep, NIDA is supporting the development of self- activated systems that initiate an emergency response when wireless sensors signal that an overdose is occurring. As it relates to opioid addiction, methadone, buprenorphine and naltrexone have been shown to be effective in treating opioid addiction, and in preventing overdoses, but these medications are not being used widely. NIDA is working to overcome the barriers that interfere with their adoption. In parallel, research of new interventions such as vaccines for heroin will allow us to treat this problem in a different way and to prevent it. Additionally, we work with our partners, CDC, SAMHSA, ONDCP and ONC in implementing and evaluating evidence-based interventions. Again, I want to thank you for recognizing the urgency of the problem posed by the abuse of prescription opioids, and for inviting NIDA to discuss how science can help address this problem. [The prepared statement of Dr. Volkow follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Burgess. The Chair thanks the doctor. The gentlelady yields back. Chair recognizes Dr. Clark 5 minutes for the purposes of summary of your opening statement please. Your microphone, sir. STATEMENT OF H. WESTLEY CLARK Dr. Clark. Thank you for inviting the Substance Abuse and Mental Health Services Administration to participate in this panel. I echo the testimony of my colleagues regarding the importance of the topics of this hearing. I will focus on SAMHSA's programs and activities, but I want to point out that we work with our federal partners: with states, tribes and local communities. According to the National Survey on Drug Use and Health, which SAMHSA conducts, 4.9 million people reported non-medical use of pain relievers during the past month in 2012, 335,000 reported past month use of heroin, a figure that has more than doubled in 6 years. In 2012, more than 1.89 million people reported initiating non-medical use of pain relievers, and 156,000 reported initiating use of heroin. One challenge in combating the misuse of pain relievers is educating the public on dangers of sharing medications. According to our national survey, 54 percent of those who obtained pain relievers for non-medical use in the past year received them from a friend or relative for free. Another 14.9 percent either bought them or took them from a friend or relative. Thus, we have both the public health problem intertwined with a cultural problem. SAMHSA has 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 activities in communities of high need. Our Screening, Brief Intervention and Referral to Treatment Program includes screening for illicit drugs, including heroin and other opioids. We have developed programs to help physicians maintain a balance between providing appropriate pain management, and minimizing the risk of pain medication misuse. Our expert medical residency program includes a module for prescription opioids for pain management and opioid misuse. Over 6,000 medical residents and over 13,700 non-residents 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. SAMHSA funds a Prescribers' Clinical Support System for Opioid Therapies, a collaborative project led by the American Academy of Addiction Psychiatry, with six other leading medical societies. We will be funding a Providers' Clinical Support System on the Appropriate Use of Opioids in the Treatment of Pain and Opioid- related Addiction this fiscal year. Last week's article in the New England Journal of Medicine, authored by HHS leadership, including Dr. Volkow and SAMHSA's administrator, 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: agonist therapy, which includes Methadone maintenance; partial agonist therapy, which includes buprenorphine; and antagonist therapy, which uses an extended release injectable naltrexone, or Vivitrol. SAMHSA is responsible for overseeing the regulatory compliance of certified Opioid Treatment Programs which use methadone and/or buprenorphine for treatment of opioid addiction. We estimate that there are approximately 300,000 people receiving methadone maintenance. There are currently 26,000 physicians with a waiver to prescribe buprenorphine; of these, 7,700 are authorized to prescribe up to 100 patients. We estimate that there are 1.2 million people receiving buprenorphine. SAMHSA also issued an advisory encouraging drug courts to utilize Vivitrol in their treatment programs. In August of 2013, we published the Opioid Overdose Tool Kit to educate families, first responders, individuals, prescribing providers, and community members about steps to take to prevent and treat opioid overdose, including the use of naloxone. When administered quickly and effectively, naloxone restores breathing to a victim in the throes of an opioid overdose. This can be used as a teachable moment to assess treatment need and refer the person to the appropriate resources. We inform states and jurisdictions that the Substance Abuse Prevention and Treatment Block Grant primary prevention set-aside funds may be utilized to support overdose prevention education and training. In addition, we notified jurisdictions that block grants, other than the primary prevention set-aside funds, may be used to purchase naloxone and the necessary materials to assemble overdose kits to cover the costs associated with the dissemination of such kits. SAMHSA continues to focus on our mission of reducing the impact of substance abuse and mental illness on America's communities, and we thank the subcommittee chairman and members for convening this important hearing, and providing SAMHSA with the opportunity to address this very critical issue. [The prepared statement of Dr. Clark follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Burgess. The gentleman yields back. The Chair now recognizes Mr. Rannazzisi 5 minutes for the purposes of summarizing your testimony please, sir. STATEMENT OF JOSEPH T. RANNAZZISI Mr. Rannazzisi. Thank you, Chairman Burgess, and distinguished members of the subcommittee. On behalf of DEAAdministrator, Michele Leonhart, and the men and women of the Drug Enforcement Administration, I want to thank you for the opportunity to discuss today the relationship between prescription opioids and heroin, and how DEA is addressing the public health problem. First, let me say that the present state of affairs is not a surprise. DEA has been concerned about the connection between the rising prescription opioid diversion and abuse problem, and rising heroin trafficking use for several years. The DEA believes that increased heroin use is driven by many factors, including the increase and the misuse and abuse of prescription 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 began their cycle of abuse with prescription opioids. Treatment providers report that opioid addicted individuals switch between 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 this, and are relocating to areas where prescription drug abuse is on the rise. To give you an example, we know that many teens and young adults first get their prescription opioids for free, from medicine cabinets or friends. Let us assume that a teenager gets hydrocodone, a Schedule III prescription opioid, and also the most prescribed drug in the United States, from a family medicine cabinet or friend. Once that free source runs out, it could cost as little as between $5 and $7 a tablet on the street, but then the teen will eventually need more opioid to get the same effect that he is trying to achieve. Black market sales for prescription drugs are typically 5 to 10 times their retail value. On the street, a Schedule II prescription opioid can cost anywhere from $40 to $80 per tablet, depending on the relative strength of the drug. These increasing costs make it difficult to continue purchasing, especially for teens and young adults who don't have steady sources of income. Given the high cost to maintain this high, 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 prescription drugs. It is just that easy. Any long-term solution to reduce opioid abuse must include actions to address prescription drug diversion and misuse, while also educating the public about the dangers of non- medical use of pharmaceuticals, educating prescribers and pharmacists and treating those individuals who have moved from misuse and abuse to addiction. The DEA currently operates 66 tactical diversion squads in 41 states, the District of Columbia and the Caribbean. These groups capitalize on combined law enforcement authorities of task force officers and DEA agents to conduct criminal investigations in the diversion of pharmaceutical drugs. The DEA regulates more than 1.5 million registrants. DEA diversion groups concentrate on the regulatory aspects of enforcing the Controlled Substances Act, utilizing increased compliance inspections. This oversight enables DEA to proactively educate registrants, and ensure that DEA registrants understand and comply with the law. The tactical diversion squads and the diversion groups have brought their skills to bear on what was previously known as ground zero for prescription drug use, Florida-based Internet pharmacies and pain clinics. As the current pill mill threat is driven out of Florida and moves north and northwest, DEA will continue to target the threat with the tactical diversion groups' proven law enforcement skills, the diversion groups' regulatory expertise, and by educating registrants. DEA and our law enforcement partners have aggressively targeted both prescription drug diversion and heroin trafficking. From 2001 to 2012, there has been a staggering increase in drug analysis of opioid pain medications, 275 percent for oxycodone, 197 percent for hydrocodone, and 334 percent for morphine. There has also been a significant increase in heroin cases. From 2008 to 2012, there was a 35 percent increase. If the data for the first half of 2013 remains constant, the increase from 2008 to 2013 would be approximately 51 percent. The increase in heroin abuse and trafficking is a symptom of our country's appetite for prescription opioids that will eventually lead to abuse and addiction. It is a natural progression from the abuse of prescription opioids. There is a dangerous misperception that abusing prescription drugs is safer than abusing heroin. Both abuse of prescription opioids and heroin can lead to addiction and death. Preventing the availability of pharmaceutical controlled substances to non-medical users, and educating practitioners, pharmacists, and the public about pharmaceutical diversion, trafficking and abuse are priorities at DEA. As such, DEA will continue to work in a cooperative effort with other federal, state, and local officials, law enforcement, professional organizations, and community groups to address this epidemic. Thank you for your invitation to appear today, and I look forward to answering any questions that you may have. Thank you. [The prepared statement of Mr. Rannazzisi follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Burgess. The gentleman yields back. I thank the gentleman for his testimony. We will now hear from the members for questions, 5 minutes for each member. I will begin. Well, Mr. Rannazzisi, you just gave some rather startling statistics. Mr. Botticelli, you said in your testimony we can't arrest our way out of this problem. So let me just ask you, from a federal perspective, we have put a lot of money and a lot of effort on behalf of taxpayers into this, what is it about this that is not working? Mr. Botticelli, we will start with you, and maybe we can just go down the line and just answer the question, how has this become the problem that it is? Mr. Botticelli. Sure. I think a number of my Federal panelists have articulated some of the problems, and I think, first and foremost, a lot of this issue is driven by the vast overprescribing of prescription pain medication. A recent report by the GAO showed that the vast majority of physicians get little to no training in substance use disorders and little to no training in safe opioid prescribing. And a part of our-- -- Mr. Burgess. Let me stop you there because this is not a new problem. I mean this was a problem 40 years ago when I was in medical school, and I would disagree with the statement that we got no training, but OK, the training may not be adequate to the scope of the problem, but honestly, can we say that this is something that just happened to us, and we were completely unaware that this was an issue? I mean how could you possibly make a statement like that? Mr. Botticelli. I think part of what the balance has been, and I think it has been out of kilter, is that physicians, quite honestly, were pushed in terms of making sure that we adequately treated pain in the United States. And we absolutely need to make sure that we do that. I think we need to have a balanced strategy that understands the tremendous addiction potential of these drugs, the risky patients that we have before us in terms of who should be prescribed prescription medication, as well as monitoring those who are developing a problem. So I do think that this is a balanced approach in terms of both making sure that we are adequately treating pain, but we are also not inadvertently creating a problem by overprescribing these medications to people who are developing a problem, or who are at risk. Mr. Burgess. I don't want to put words in his mouth, but Mr. Rannazzisi seemed to imply that we are overprescribing. Is that a fair assessment of your testimony? Mr. Rannazzisi. I think that if you are talking about 99.5 percent of the prescribers, no, they are not overprescribing, but our focus is in rogue pain clinics and rogue doctors who are overprescribing. Actually, they are prescribing illegally, they are not overprescribing, they are illegally prescribing. So, yes, if you are considering that overprescribing, yes. Mr. Burgess. Well, that is your job. You are law enforcement, so you get to close them down, right? Mr. Rannazzisi. And we are trying. They are overwhelming us with numbers. Mr. Burgess. All right, I do want everyone's response to that because in the interests of time and wanting to keep to the 5-minute interval, I am going to submit that in writing to each of you. I want to bring up something because each--or several of you have brought it up, and that is the issue of making naloxone much more available. Maybe we should also be talking about making Ambu bags available for people who are going to overdose. I mean it is hard to know who is going to overdose, but, Mr. Botticelli, you brought it up, and I think, Dr. Sosin, you brought it up as well, but what is the issue here with making this available? Mr. Botticelli. I think that we have been tremendously heartened, both at the Federal level, as Dr. Volkow talked about, in terms of the approval of new delivery devices for doing that. One of the main areas that ONDCP has been working with our state partners is the passage of state legislation to look at naloxone distribution. And so I think we have now 17 states that have enacted naloxone distribution legislation, which I think has really been helpful here. We have also been, quite honestly, working with many law enforcement agencies across the state---- Mr. Burgess. Pardon me for a moment. It is a federally controlled substance, is it not? Naloxone? Mr. Botticelli. It is not a controlled substance, if I remember correctly. Mr. Burgess. OK. Is there a cost issue? Mr. Botticelli. There is a cost issue, and one of the things, Chairman, that you asked is what are the opportunities that we have in terms of looking at this, and again, I think it was really helpful that SAMHSA looked at how we might use existing Federal funds, but I think if there is an area that we can continue to explore together it is how we might enhance resources for many overdose prevention efforts. One of the things that I have heard as I have traveled around the country is that having state legislation and having these devices is a great start, but many states and local areas are under-resourced in terms of implementing it. Mr. Burgess. Yes, and again, I may submit that in--for answer in writing as well, but, Dr. Volkow, let me just ask you. You mentioned in your testimony to address this problem, we have to recognize the special character of this phenomenon, and part of which is that opiates play a key role in relieving suffering. So as providers and policymakers, are we doing a good job of walking this line? Dr. Volkow. Based on the numbers, I don't think we can say we are, and the reality is that in this country, we have both an under-treatment of pain and over-prescription of medications. These are not exclusive. And one of the issues that we have been faced with, and Mr. Botticelli had been discussing is, in 2000, when the Joint Committee for Accreditation of Hospital demanded that you treat pain, you see a steep increase in the number of prescriptions. So what you are doing in parallel, there has not been an increase in education in medical schools. So each 7 hours average in the United States there is a diversity of opiate medications that are currently available, and there are many indications where actually patients are being given the opioids when it is not severe pain, and this, for example, is the case in many cases for young people with dentists that are prescribing the opiate medication, so there is a room for improvement on that education of providers. The other issue too that we have not understood very much when we were--I mean certainly, when I was in medical school, they will tell you if you prescribe an opioid medication with someone that is suffering from pain, they are not going to become addicted. Now, we can come to recognize that it is not the case, that there are patients that are taking the medication as prescribed, and they can become addicted. So the issue is who are they, how do we recognize them so we can prevent that transition. And---- Mr. Burgess. Well, and my time has expired. I will just offer the observation, 40 years ago, I was given the admonition by a professor in anesthesiology, this stuff is so good, don't even try it once. So clearly, it was known 40 years ago. I recognize Mr. Welch for 5 minutes for questions please. Mr. Welch. OK, I want to thank the panel and the Chairman as well. You know, in Vermont, as I mentioned in my opening statement, we are just trying to face this directly, which is, I think, a much better approach than denial, and it has engaged the community in some very effective ways. And it has developed--I think it has helped our providers develop what they call a Hub and Spoke System where there is an emphasis on medication, which really does seem to be helping some folks who are willing to be helped, and then some wraparound treatment services for people who can benefit by that. And a lot of our ability to do that is because we are getting some federal help. We get about $6 million out of the Substance Abuse Prevention and Treatment Block Grant. That has been level funded. And my question really to Mr. Clark, can you explain the decision, I guess this is the Administration decision not to propose an increase in that program, given the intensity of the crisis. And I think with this discussion occurring all around the country, obviously, you are going to have many more states that are willing to roll up their sleeves and try to get engaged, which would suggest the resource need is there in order to help make this successful. Dr. Clark? Dr. Clark. Mr. Welch, we are working very closely with state authorities, with organizations like NASADAD and NASMHPD to address these issues, but we also, as Mr. Botticelli pointed out, are approaching this from a comprehensive approach rather than simply using a single funding mechanism to address the issue. We need to keep in mind that we need multiple strategies to address this problem, and with those multiple strategies, we believe that we can make an impact. So relying, indeed, on the Affordable Care Act and other strategies, we can leverage the Block Grant Funding to target this. We are also allowing jurisdictions to prioritize using our prevention efforts, as well as our treatment efforts. The problems that they are experiencing---- Mr. Welch. All right. Dr. Clark [continuing]. In their respective jurisdictions-- -- Mr. Welch. OK, thank you. No--but no more money. Money is tight, I get it. And, Mr. Botticelli, your predecessor came up and had a great visit with us in Vermont. It was tremendous to have him there. And we have expanded the use of naloxone--how do you say that? Mr. Botticelli. Naloxone. Mr. Welch. Naloxone. Yes, and we have had some success with that. We have had a number of instances of it being used successfully just recently about 15 times. But do you think that the FDA should consider making that an over-the-counter medication? Mr. Botticelli. Yes. So, first of all, like you, I really want to applaud you and Governor Shumlin in terms of calling significant attention to this issue. I spent the better part of my career in Massachusetts, and am very familiar with---- Mr. Welch. Right. Mr. Botticelli [continuing]. The heroin issue that we have had in New England for a long, long time. Our office, as part of our prescription drug abuse plan and overdose, has been looking for continued ways to expand the use of naloxone. Again, I think we are heartened by this delivery device. Our partners at NIDA are looking at and researching the expansion of and use of other ways. So we are having conversations with both Federal partners and, quite honestly, some external stakeholders who are really, really interested in terms of looking at how do we increase the--not only the availability of naloxone, but continue to promote easier to use and, quite honestly---- Mr. Welch. OK. Mr. Botticelli [continuing]. Perhaps some cheaper versions of---- Mr. Welch. Right. Mr. Botticelli [continuing]. Naloxone. Mr. Welch. I have time for one more question. Dr. Volkow, I want to ask you about this issue with doctors and with patients. I have known close friends who have had serious medical issues and have been in a lot of pain, and once that line is crossed where they are getting the prescription medication, it almost seems like there is an undertow where the answer to the pain question always is essentially to get more medication and more powerful medication. And a patient in that moment is pretty vulnerable. And the doctor gets really persistent advocacy by the patient and sometimes the patient's family. You have got to do something. So how do we help the doctors deal with what, Dr. Burgess, of course, we have another doctor here, but how do they, there are a lot of doctors around here, but how do we--the doctors really have to be on the frontline, and it is very tough because they have a patient who is in pain, they have a family who is saying will you do something, but the something that is getting done in many cases is resulting in long-term problems. Dr. Volkow. Yes, and you are touching on one of the hardest issues to deal with clinically: how do you manage severe chronic pain. What many people don't know is that the risk of suicide for patients with chronic pain is double that of the general population, so it is extraordinarily debilitating. And the strongest medication we have are opioids. The problem with opioids, apart from addictiveness, is that you become tolerant very rapidly, and so that requires that you increase the dose. So chronically, and then you have to shift to something more potent, and that is exactly where the whole problem lies around. They are not ideal, but it is what we have, and it can relieve the patients in the moment that they need them. The strategy is what other alternatives we can use other than just relying as--in opioids as the only alternative, and that is where research is ongoing to see--that is what I was mentioning in the whole area of brain neuroscience, the feasibility of devices that can actually be used potentially to handle and manage pain will be a breakthrough. You will rely less on medications. And I also think the aspect of we as a society have created the expectation that anything that is wrong with you should be treated with a medication. So zero tolerance for pain. And I think that as a culture, we need to revision that also. Mr. Welch. Thank you. I yield back. Thank you very much. Mr. Gingrey [presiding]. Thank you. Thank you, Mr. Welch. And I am sitting in, obviously, for Dr. Burgess. Let me just make a brief statement, and then I will ask my question. As a physician of many years, I don't think that even back in the day we were given the proper training in regard to pain medication. Also I will say this, there has been a lot of emphasis over the past 10 years or so about advanced directives and the necessity for that, and, of course, the hospice programs that have developed and that sort of thing, but I don't hear hardly any discussion about patients given their wishes in regard to how they want their pain controlled in a terminal situation where there is no chance for recovery. I don't know that people really understand, and in many instances pain medication is started because the family members don't want their loved one to suffer. That is quite natural and appropriate, but before you know it, the patient has gone beyond the stage where they can say, look, I don't want to be totally zonked out at the time of my demise. So that is just, I guess, food for thought in a way. I am going to ask my specific question, Mr. Rannazzisi. You said earlier in your testimony that the DEA is just getting overwhelmed by all these rogue pain clinics that are popping up everywhere. How is that happening? How do these places just pop up, as you put it, and why is it happening, why are you getting overwhelmed? Mr. Rannazzisi. Well, that is a great question, sir. It is not just DEA that is overwhelmed. Our state and local counterparts are overwhelmed. Think about this. Prior to the Ryan Haight Act, the Internet drug bill that was passed, there were, say, seven clinics--pain clinics in Broward County, in 2010 there were 142 clinics in Broward County. Now, if you look, when we moved our enforcement groups down there, and we moved 10 tactical diversion squads to work with our state and local counterparts, and we started knocking off these rogue pain clinics, they moved up into Georgia. If you looked at the 75 corridor, there were over 100 pain clinics going up that 75 corridor. Some of them were right off of the interstate. You just get off and get back on. Then they moved into Tennessee. Tennessee now has approximately 300 clinics. Now, if you think that--state and local law enforcement and DEA doesn't have the capacity to go after every one of these clinics quickly, because these are legal drugs that they are peddling, and we have to establish that that doctor is prescribing outside the usual course of professional practice, and not for legitimate medical purposes. It takes time. These cases take time. So what they are doing is they are just counting on the fact that they are going to run the clinic that is not being hit by DEA. So we are all overwhelmed, everyone in law enforcement. Mr. Gingrey. Yes, but what percentage would you say of these clinics are fraudulent? Mr. Rannazzisi. In Florida, the vast majority of them. In Georgia, I believe that the vast majority of those clinics that popped up were. There are good pain clinics, don't get me wrong. Every pain clinic is not bad. Mr. Gingrey. Yes. Mr. Rannazzisi. But the pain clinics that we are looking at are absolutely atrocious. There is no medical care. Mr. Gingrey. Yes. Mr. Rannazzisi. It is the modern-day crack house. Mr. Gingrey. Thank you for that answer. And any of you could answer this. Last year, GAO, the Government Accountability Office, found an overlap in 59 of the 76 programs it identified in the drug abuse and prevention area. What steps are any of your agencies taking to minimize overlap and more efficiently spend out taxpayer dollars? I mean you would think that we could get some efficiency here. Anybody? Mr. Botticelli. Sure, Chairman. Our office has looked at that report and has been working with our Federal partners to look at the breadth of our prevention programs, and to make sure that we are not, quite honestly, duplicating programs. I do think that, however, if you talk to many, many people at the local level, they will tell you, however, that we don't have enough prevention, and I think you heard from many, many folks up here that while we may have programs that are addressing the same issue, they are reaching not the entirety of the population. So we really want to make sure that, one, that we are not kind of duplicating the programs that we have already---- Mr. Gingrey. Well, very important, I would think that you guys are talking to each other, of course. Others? I have a little time left, 2 seconds, 1 second. Wait a minute, I am the chair now, aren't I? I have 5 minutes left. Mr. Clark? Dr. Clark. Well, as---- Mr. Gingrey. Dr. Clark, excuse me. Dr. Clark. One of the things we are concerned about in the Administration is the issue of fragmentation, overlap, and duplication, and that we do work very closely with our federal partners to make sure that we minimize fragmentation, overlap, and duplication. And working under the assistance of ONDCP, we are able to address that. As was pointed out, communities need multiple resources, and you find that sometimes you cannot completely eliminate some overlap because, indeed, the unique issues of individual communities require that there be some overlap, but we are very sensitive to both the GAO concerns and OMB's concerns about fragmentation, overlap, and duplication, and assiduously try to avoid that. Mr. Gingrey. Thank you all. I thank the panel. My time has expired, and I yield 5 minutes now to Mr. Lujan. Mr. Lujan. Mr. Chairman, Doctor, thank you so very much for the time today, and I am glad to see that we are having this hearing. This is important. By the chairman and the committee staff acknowledging that this hearing needed to take place, I think we are acknowledging there is a problem across the country. The question after this hearing today though is, are we going to sweep this under the rug again, or are we going to do something significant with recommendations that are going to come from experts? This is a problem plaguing America. The case in New York brought more attention to what was happening with heroin abuse and overdoses, but we have been losing lives across the country for years. And what are we going to do? There are recommendations that have been put on the table by many experts. It has been studied over and over and over. There is a program from 2011 on the prescription drug side to reduce abuse significantly over 5 years, I will be asking the question where are we with that, but every life that is lost as a result of this is one life too many. There are only so many parts of the world that are growing poppies. Do we not know, as the United States of America, where poppies are being grown and how they are migrating into the United States in the form of heroin and illegal substances? Seems to me we should. And what are we doing to stop that flow? That is very troubling. Now, going back to the prescription drug side, there have been presentations that we have seen in New Mexico that have been put together by some people that I respect very much, that show a correlation with drug overdoses with increased prescriptions that are coming out, not just pain medication facilities that are popping up. And so one of the questions that I have is, is there data that is reported to any of you that you do analysis on, where there is a court--at least with the data that I have seen, there is--it is shown that there is a correlation between overdoses and increased prescriptions that are being administered, and what do we do with that data? Are we able to go in or is that an area where we don't have enough support now between the federal and the state partners? And I would ask anyone that would like to tackle that. Dr. Sosin. Thank you, Congressman Lujan. You mentioned a New Mexico report. Dr. Paulozzi from CDC worked with scientists in New Mexico and health department staff there to analyze and demonstrate those relationships, and absolutely, there is a very tight relationship between the volume of opioid prescribing and opioid overdose deaths. That information does get used at a national level, and thinking about the areas to intervene, but also at the state and local level where it has to be, to better understand how the problems in each individual jurisdiction, and the factors that are influencing the prescribing practices are being addressed there. One of the ways that CDC in particular works is by trying to liberate data by working with state and local health departments to understand the context of prescribing, of health system data, and of mortality data, to put a better picture and understand the context within which overdose deaths are occurring and abuse is occurring, and then be able to target programs like through their PDMP's, like restriction programs, et cetera, that address those problems. Dr. Volkow. If I may, first of all, I want to thank you for bringing up that issue because the way that I view it, this is an urgent issue and we cannot put it under the rug, under no conditions. And I feel passionate because I do get the parents coming to me and say when we went to wake up our child, it was dead, and we didn't even know that they were abusing opioids. The other issue is that we do have the tools to actually address the problem of opioid prescription abuse and opioid deaths. We need to implement them. We have treatments that work for drug addiction that can decrease the number of overdoses, but also we need to address the problem that we have with chronic pain in this country. How many people suffer chronic pain in this country? Estimated IOM, 100 million. 100 million. There is the notion on that 100--that there is an increase in chronic pain, and that needs to be addressed. So from the healthcare perspective, we need to address it. Mr. Lujan. And, Dr. Volkow, as my time expires, there are some questions that I will be submitting in to the record, but I would welcome your response as well. And, Mr. Chairman, I just wanted to share with you that there is a program in New Mexico that appears to be working with the distribution of Narcon, where there has been a reversal of more than 250 overdoses last year, where they are getting it into the hands of first responders and nurses. So it is not necessarily on the street, but it is with those that are responding to these accidents. And there may be a way for us to work on that with some ideas down the road. Mr. Chairman, again, I share, before you return to the hearing, how much we appreciate that you are doing this and you have brought this hearing, but I certainly hope that there is more that will be done, and that this hearing won't be the last of hearings and conversations, and an approach that we can take as a Congress to work with our state partners to do something. This is a bad problem across the country, but it is also plaguing New Mexico. And I thank you for your attention to this, Mr. Chairman. Mr. Burgess. The Chair thanks the gentleman, and does also observe that further hearings are likely to be necessary, and as Mr. Welch pointed out, to hear from governors, and I would like to hear from some of our mayors because they are on the first lines of this battle. The Chair now recognizes the gentlelady from North Carolina, Mrs. Ellmers, 5 minutes for questions please. Mrs. Ellmers. Thank you, Mr. Chairman, and thank you to our panel for being here today, addressing this very important issue. I would like to start by asking a question of Mr. Botticelli and Dr. Volkow. Understanding the path of addiction, there is, and I think you have both identified a genetic basis for that, one of the things I would like to know is, again, the progression. Is this something that starts with tobacco use, smoking, use of alcohol, drinking, and then how does it progress and how do you feel? And I will just start with you, Mr. Botticelli, and then have Dr. Volkow comment. Mr. Botticelli. I do have to acknowledge that just about everything that this field knows about this has come from the work of Dr. Volkow. Clearly, we know that there is a genetic predisposition for many people in terms of family history of substance abuse, but we also know that there is, like many diseases, there are environmental factors that go into that issue. We know that substance use disorders are a disease of early onset, so that many people who do develop, left untreated, left undiagnosed, develop a substance use disorder, largely because of starting alcohol, tobacco and/or marijuana use---- Mrs. Ellmers. Yes. Mr. Botticelli. At a very young age. Clearly, there are some particular issues as it relates to the addiction potential of prescription drug medication---- Mrs. Ellmers. Yes. Yes. Mr. Botticelli [continuing]. But the vast majority of people that, at least, I have talked to, and the data show that those folks who do have a significant opioid use disorder have started from a very young age. And if you saw the Philip Seymour Hoffman story, he actually started with alcohol abuse at a very young age. So we know that there are prevention and intervention opportunities that we can have along the way to really make sure that we are identifying people early in their disease progression, and then we are intervening in this issue. Mrs. Ellmers. Yes. Mr. Botticelli. The other piece that you talked about, and again, I think it still warrants further work, is what about the progression from prescription drug use to heroin addiction. Mrs. Ellmers. Yes. Mr. Botticelli. Clearly, we know that it is a progressive disease, and people, left untreated, will often progress to more significantly harmful use patterns, but we also know that price plays a role, as the DEA mentioned, in terms of the progression. So we know that there are multiple factors that really affect peoples' progression, not only in terms of overall development of a substance use disorder, but from prescription medication to heroin. Mrs. Ellmers. Yes. Yes. Dr. Volkow? Dr. Volkow. Yes, and the questions you ask intrigue many scientists, and it is called--has led to the term of gateway-- -- Mrs. Ellmers. Right. Dr. Volkow [continuing]. Hypothesis because all of the epidemiological studies have repeated corroborated that most individuals that become addicted to illicit substances started with nicotine or alcohol, then transition into marijuana and then the other drugs. So the question is that just because it is more accessible that you start with nicotine or alcohol---- Mrs. Ellmers. Yes. Dr. Volkow [continuing]. Or could it be that these drugs, including nicotine, alcohol, and marijuana, are changing your brain in such a way that it makes it more receptive to the addictiveness of drugs. Mrs. Ellmers. Yes. Dr. Volkow. And there is data now from genetic studies and from studies in animals that suggest, at least for the case of nicotine and alcohol, and also marijuana, that it is changing the sensitivity of the brain reward sequence in a way that primes you---- Mrs. Ellmers. Yes. Dr. Volkow [continuing]. To the addictiveness of these other drugs. And in the case of prescription opioids, that is also what they are observing, that most of the individuals that end up addicted to prescription opioids had a history of nicotine addiction earlier, or had started abusing alcohol. Mrs. Ellmers. Yes. Thank you. My last question is for Mr. Rannazzisi. Obviously, your agency is working with many other agencies on this issue, and I am going to ask you a question that really falls under the FDA, but from your opinion, in the work that you are doing, do you believe that some of the prescription drugs, the deterrent formulas such as, you know, for Oxycontin, some of the deterrent formulas, will that make a difference and is it feasible that if we take this approach, that that is going to help on the wide and broad scope that you have outlined if we are using these deterrent forms? Mr. Rannazzisi. Absolutely. The abuse deterrent formulations will make a difference. But those drugs will still be abused---- Mrs. Ellmers. Yes. Mr. Rannazzisi [continuing]. Orally with a potentiator, like a muscle relaxer, or a Benzo, but in the end, it is going to stop them from crushing and snorting, or crushing and injecting. Mrs. Ellmers. Yes. Mr. Rannazzisi. And we know that when you crush and inject, or crush and snort, you are raising the risk---- Mrs. Ellmers. Yes. Mr. Rannazzisi [continuing]. Of overdose and death---- Mrs. Ellmers. Yes. Yes. Mr. Rannazzisi [continuing]. Just in that method of delivery. So, yes, do I think it is important? Absolutely, it is important. Look at what happened with the Oxycontin product, when it went from the OC to OP, you could bang that tablet with a hammer and it is not going to break. Mrs. Ellmers. Yes. Mr. Rannazzisi. It balls up in your nose when you try to snort it. It is crazy---- Mrs. Ellmers. Yes. Mr. Rannazzisi [continuing]. That, if you try to abuse that drug, but what do we see everybody doing? Immediately, they started moving to the Oxymorphone product---- Mrs. Ellmers. Yes. Mr. Rannazzisi [continuing]. Or the immediate release Oxy 30s. OK, so they are adapting. Mrs. Ellmers. Yes. Mr. Rannazzisi. If we could figure a way to get an abuse deterrent formulation across the board, then we are going to see some significant results---- Mrs. Ellmers. Thank you. Mr. Rannazzisi [continuing]. Absolutely. Mrs. Ellmers. Thank you so much for your answers, and your insight on this issue. And, Mr. Chairman, I yield back the remainder of my time. Mr. Burgess. Gentlelady yields back. The gentleman from Kentucky, Mr. Yarmuth, recognized 5 minutes for your questions please. Mr. Yarmuth. Thank you very much, Mr. Chairman. And I thank the panel as well for the testimony, and for what is obviously a very committed effort across the spectrum of government to deal with this problem. I am glad to know that, I shouldn't say glad, but it is somewhat reassuring to know that this is not just a Kentucky problem. Certainly, in my travels in my district and around the state, and talking with law enforcement and with mental health professionals, and everyone who is involved in this area, we have a huge problem in Kentucky. During the first 3 quarters of 2013 there were at least 170 Kentuckians who died from heroin overdoses, and that was 41 more people who had died the entire previous year, and is actually a 200-plus percent increase since 2011. So we have a problem that is there and growing. And one of the young people who died was the nephew of a Kentucky state representative, Joni Jenkins, a good friend of mine and a great representative. Her nephew, Wes, they suspected, began with prescription drugs and then moved to heroin because of expense. He died in May of 2013. And she told her story in the Louisville Courier-Journal, and I would like to read one of the things she said because it prompts a question. She said, for an entire year, our family kept the addiction private. They were well aware of it, he had been in and out of treatment and they were working with him, but they kept it private so Wes would not suffer the social stigma of being a drug addict. I now know that there is a terrible shame attached to this illness, but we have to break through the silence to find a cure. And she said, I also know that I will search for answers the rest of my life for that. Is this a problem that you have seen? You are nodding your head, Mr. Botticelli, so respond to that, that much of the the access to treatment or the willingness to treatment is deterred because of a social stigma? Mr. Botticelli. I have--and many of us have heard that story countless times from parents. Many of us were just in Atlanta with a conference sponsored by Chairman Rogers. And we hear that story repeatedly, and I think our collective efforts have really been to raise the visibility of ensuring that people know that addiction is a disease, and this is not about shame, this is not about guilt. We know that one of the reasons why people don't seek treatment, and why parents don't ask for help, is because of the shame and embarrassment that is related to that. And so part of what I think all of our Federal partners are doing is how do we raise the understanding and visibility, and, quite honestly, the compassionate treatment of people with addiction--of addictive disorders into this work. And I think that we are seeing, quite honestly, a movement in terms of--like we did with other disorders that were shameful and stigmatized---- Mr. Yarmuth. Yes. Mr. Botticelli [continuing]. That we have to elevate the voice of parents and people in recovery so that we do know that hope is possible, and that it would be easier for them to come forward and ask for help, but unfortunately, we have heard that story way too many times from---- Mr. Yarmuth. Yes. Mr. Botticelli [continuing]. From parents and people who are affected. Mr. Yarmuth. Have you come up with any great answers? I mean what can we do to help that just as individual members? We do span the country anyway. Mr. Botticelli. Yes. I think there are a couple of things that we are doing. A lot of our work at the Office of National Drug Control Policy, we actually established an Office of Recovery to really promote the fact--we are looking at the development of recovery support services, so that people in the community can see that recovery is possible. I think we have been promoting--those of us who are in recovery, talking very publicly about the fact that we are in recovery, because it shows to other people that this is not just about death and destruction, that there really is hope on the other side of this. So I think all of us play a role in terms of destigmatizing that. Just having these hearings really shows the fact that we have leadership in this country who are concerned about this, and it is not a shame. This is not a moral choice, this is not a moral failing, this is about a disease, and we have to deal with it from a public health perspective. Mr. Yarmuth. Yes. Mr. Botticelli. So I really appreciate your acknowledgement of that--those challenges. Mr. Yarmuth. Well, it seems to me that much of this problem involves education. I assume that when these young people, or whether it is young or not, but predominantly young people begin on prescription drugs, they have no idea that this is the course that they could likely be on. And I don't know whether that is a school issue, a PTA issue, what it is, but it seems to me like information is one of the greatest avenues for combatting this problem. Well, anyway, Mr. Chairman, I would request unanimous consent that this OpEd that I mentioned from Joni Jenkins be made a part of the record. Mr. Burgess. Without objection, so ordered. [The information appears at the conclusion of the hearing.] Mr. Yarmuth. Thank you, and I yield back. Mr. Burgess. The gentleman yields back his time. The Chair now recognizes the gentleman from Ohio, Mr. Johnson, 5 minutes for your questions please. Mr. Johnson. Thank you, Mr. Chairman, and I really appreciate the opportunity to hear from the panel today on this very, very important issue. You know, prescription drug and heroin abuse are very serious--is a very serious epidemic in Ohio, and parts of my district in eastern and southeastern Ohio are some of the worst hit. In 2012, 5 Ohioans died every day from unintentional drug overdose with opioids, both prescription and heroin, as the driving factor. Attorney General Mike DeWine identified heroin as contributing to as many as 11 fatal overdoses a week. It is a major public health crisis. However, prescription opioids continue to be the lead contributor to fatal overdoses in the state. In 2012, for example, an average of 67 doses of opioids were dispensed for every Ohio resident. Law makers, nonprofit organizations, medical, industry leaders, communities and parents across the state have been working to coordinate their response to this epidemic, but in a corner of Ohio that shares borders with 3 other states, communities are struggling to get drug abuse under control. Individuals identified as abusing in one state may cross state lines to escape detection and abuse in another. A nonintegrated system also makes it harder to identify prescribing providers and pill mills. So for all of you on the panel, anyone that wants to try and respond to this, I realize that states are largely in charge of implementing their own prescription drug monitoring programs, but in multistate areas like I serve, the importance of working together to curb abuse cannot be emphasized enough. So what is being done at the federal level to encourage states to share information compiled by their respective PDMPs? Mr. Botticelli. Thank you, Congressman, and as you have articulated, both the establishment of vibrant prescription drug monitoring programs, and, quite honestly, the interstate interoperability of those programs, has been key for much of the work that we have been doing on the Federal level. So, we are happy that in 2006 we only had about 20 operable prescription drug monitoring programs in the United States, and now we have 48 that are operable, one in the process and unfortunately, one state that doesn't have a prescription drug monitoring program. And as part of this strategy, we have been working with the Bureau of Justice Assistance and the Boards of Pharmacy to really look at interstate operability so that those states that share a border can make sure that they are sharing data. So now we have 20 states that are able to share information across borders, and clearly, we have a goal of making sure that all of these programs share data among particularly neighboring states. Mr. Johnson. Yes, I will share with you that, as a 30-year IT professional myself, I can tell you that architecture and data standardization, interface standards, those are very, very critical components. If you don't know where you are going, any road will get you there. And it is one thing to have a monitoring system, it is quite something else to have a monitoring system that adheres to standards so that it can be effectively used. How do we make the nationwide PDMP system more effective, and what still needs to be done to fully achieve a fully- integrated network? Dr. Sosin. Congressman Johnson, thank you for your question. Clearly, the PDMP and the ability to achieve successful, effective PDMPs is critical to the law enforcement side, the public health side as well, the clinical side as well. And as Mr. Botticelli commented, we are making progress, meaning that we are better understanding the components of these PDMPs, and what it is that needs to be shared and how to share them. The work that you all are doing in raising visibility, that governors and mayors are doing, saying that this is an issue that they are going to address, also allows this opportunity to set the standards for what we need to share and how we will share that information across borders. The CDC, working with the FDA and the Bureau of Justice Assistance, has been funding at Brandeis, the prescription behavioral surveillance system, which takes from 20 states the PDMP data they have, to better understand what these factors are that increase the success of PDMP's. Mr. Johnson. Let me get to one more quick question. I have to move quickly. How can we shift drug abuse prevention efforts from the collection of silo data like we are talking about, to a system in which this information isn't lost every time an individual realizes that they are being tracked, and takes evasive measures like leaving a health plan, for example, because not only do you have working across state lines, but an abuser that goes from one health plan to another can also hide. So how do we solve that problem? Mr. Botticelli. And some of my colleagues can add on to this, but part of what we have been really trying to focus on is make sure that we are treating and integrating substance use issues as part of mainstream healthcare, of really looking at things like making sure that people are getting screened and intervened as part of their overall health plan so that, you know, for a very, very long time, we have had two systems of care in the United States. We have had medical care over here and behavioral healthcare over here, and that we haven't necessarily really looked at how we make sure that we are treating substance use disorders as a medical condition. So part of our goal is more thorough integration of mental health and substance use services within our primary care settings---- Mr. Johnson. Sure. Mr. Botticelli [continuing]. Because it is really important that we not see these as two separate issues. Mr. Johnson. Yes. Mr. Chairman, I have many, many more questions. Obviously, this is a complex and sensitive issue for many Americans, but I have run out of time so I yield back. Thank you. Mr. Burgess. The Chair thanks the gentleman. The gentleman yields back his time. The Chair recognizes the gentlelady from Florida, Ms. Castor, 5 minutes for your questions please. Ms. Castor. Thank you, Mr. Chairman, and thank you to the panel very much. This hearing is really hitting home for me today because yesterday I learned that the death of a friend last month was tied to her long-term opioid addiction. Her sister sent me an email, I got it just yesterday, and she committed suicide, and her sister said because of her long-term addiction. So she left a daughter and a husband and an entire family, and the sister is asking please do more. So I hope we can all come together to tackle this. It is causing so much pain for so many families. And the State of Florida has really been at the heart of the problem. And still in Florida, they say that every 7 to 8-- every--I can't believe it, 7 to 8 minutes, someone overdoses in the State of Florida. I am also hearing from my local hospitals. They have had to add rooms in the NICU units of hospitals because of babies being born addicted, and these babies typically will cost $1 million to take care of, and they are in the hospital for a month. So we had better invest in prevention or else we are going to be spending a lot on the outside. So, Mr. Rannazzisi, Florida--the general talking points are, well, Florida has improved. There was a huge law enforcement crackdown. We have adopted a prescription drug tracking system, the PDMP. The problem is that doctors are not using it. The last statistics I saw, only 3.5 percent of all prescriptions being written are being checked on that database. What is your view right now in Florida? Have we made progress? What is left to do? Mr. Rannazzisi. I think under the leadership of Attorney General Bondi and law enforcement leaders down in Florida, yes, we have made progress, absolutely. The problem is, again, we are overwhelmed by the numbers. There are so many people down there in Florida. We actually have cases where Florida rogue pain clinic operators were funding clinics in northern states, so when when the heat is on them, they are going to move into another state. I think that we are making progress, but again, it is going to take time. Now, the PDMP issue, I would love to see mandated PDMP use. The National Association of Boards of Pharmacy have gone out of their way to ensure that there is interoperability and interconnectivity between the PDMP's. I think they have 25 states that are already connected, and they have done a phenomenal job, but if no one is looking at that PDMP, or very few are looking at that PDMP, it is not going to help. Ms. Castor. So do you agree that the local law enforcement efforts--what I see on the ground in my community, in the Tampa Bay area, we used to have these long lines with cars from out of state, people waiting outside in the alley for these pill mills to open up. You don't really see that anymore, but with these statistics on the rate of deaths from overdose, something else is happening. We are not really making a dent there. Has it shifted to the internet, are they going out of state, is it both? What is going on? Mr. Rannazzisi. I think they are moving to more rural areas where there is less law enforcement presence. I think the operators understand--I have a great video I would have loved to have shown you of a clinic, and what happens as soon as the clinic opens. I think that they are adapting. The clinic owners are adapting very well, and they are one step ahead of us right now, but in the end, local law enforcement is doing a phenomenal job, and they are moving people out of the Tampa Bay area and out of the 3-county area, but it is still there---- Ms. Castor. Yes. Mr. Rannazzisi [continuing]. It is just moving to more rural areas where they can't address the problem as quickly. Ms. Castor. So in this very sad e-mail from my friend that I got yesterday, she said she has read now about the FDA approval of Zohydro, pure Hydrocodone, non-tamper resistant, 10 times stronger than Vicodin, the Vicodin prescription opiate. I know that the Advisory Committee to FDA had some very serious concerns with this, yet it has been approved. Dr. Volkow, could you give me your opinion on whether this drug should be readily available? Dr. Volkow. Well, we clearly have a very large number of opioid medications, and we are overprescribing them. I wouldn't point my finger at one or the other. I do think that the feasibility of getting formulations that cannot be diverted is something that is very powerful, and the FDA should be commended because it came up--pharmaceuticals can come up with an indication for a medication that is deterrent proof, and that is incentivizing to the development of these types of medications. Zohydro is Hydrocodone, it is slow delivery over 12 hours, and it actually does not have Acetaminophen, and because the way that you have--correctly which is Vicodin, the way that you have it is combined with Acetaminophen which produces liver toxicity, which led the FDA to consider if someone needs Hydrocodone, do you need to give them Acetaminophen, and it was in that context that they approved it---- Ms. Castor. And---- Dr. Volkow [continuing]. But---- Ms. Castor [continuing]. Could I ask, since my time is short, Mr. Botticelli, do you agree with the FDA's approval, or do you have concerns? Mr. Botticelli. I think the important point, and again, I don't think the FDA has their own process in terms of how they approve medications. I would agree that how we continue to make sure that we have abuse-deterrent formulations is really important. I also think that this really underscores the importance of prescribing, and training on prescribing, because I think the point is that we have many medications that are open for a potential to abuse, and we want to make sure that physicians and other prescribers really understand the risks associated with these drugs. Ms. Castor. And, Mr. Rannazzisi, local law enforcement has expressed concern about this new drug on the street because it is so potent, and because it is likely, if a child takes it, it could death. What is your view? Mr. Rannazzisi. Yes, local law enforcement and DEA and our federal partners have all expressed. We all lived through the Oxycontin problem back in the '90's into the 2000's, and we just don't want history to repeat itself. Too many people passed from the abuse, circumventing that delivery system. Mr. Burgess. The gentlelady's---- Ms. Castor. And my---- Mr. Burgess [continuing]. Time has expired. The Chair recognizes the gentleman from Virginia, Mr. Griffith, 5 minutes for your questions please. Mr. Griffith. Well, let me pick up there. You are concerned about this newer drug, and so my question is what do you all do, and I would ask it of all of you but I start with you, Mr. Rannazzisi. Mr. Rannazzisi. Rannazzisi. Mr. Griffith. Rannazzisi, thank you. And that would be, how do we do a better job of predicting where we are going to see spikes and abuse on drugs as they come forward, because some people say that we should have probably seen the increase in the prescription drug abuse of opioids and heroin? Mr. Rannazzisi. Well, we monitor the amount of drug going into a particular state through our ARCOS system, but in the end, what we generally see is the drug being abused in the Appalachian area of the country, and then it spreads out from there. So when we were looking at Oxycontin, for instance, the Oxycontin abuse epidemic started in that area, Kentucky, Tennessee, southern Ohio---- Mr. Griffith. Southwest Virginia. Mr. Rannazzisi. Yes, southwest Virginia--well, yes, absolutely. And then spread out. And we believe that pattern is going to happen again with this new product. It is just a matter of time. We know that product is now in the pharmacies and being dispensed, so---- Mr. Griffith. And, now, for the people that we--that you have identified, I think that one of the other speakers said abuse-deterrent formulations. Once we know somebody is abusing, I have always liked the lock-in, where you lock into a pharmacy and you lock into a doctor, because one of the problems in southwest Virginia that you mentioned a minute ago is, is that you can be in West Virginia, Tennessee, Kentucky and North Carolina all within--no matter where you are in southwest Virginia, within an hour or 2 hours, you can be in any one of those states because of the way the geography is, and you can go from one rural area to another. So what are we doing on that? Are we looking at that as a possible means? Dr. Clark, if you want to answer, that is fine. I am just trying to find answers. Dr. Clark. Clearly, there is no simple answer, and your question is a very important one, and this committee is trying to address it. We are working with the Association of State and Territorial Health Offices, and the Federation of State Medical Boards, and the Boards of Pharmacy. We do collect surveillance data from our household survey and working with our colleagues in the CDC, so part of the issue is monitoring the movement of individuals, getting practitioners, whether they are pharmacists, nurse practitioners or physicians, to monitor what it is that they are doing. Getting people to access and actually use the PDMPs, and having interoperability, as was pointed out. So--and then involving community coalitions, because, as was pointed out from the representative from Florida, people know where the places are. And what we need to do is---- Mr. Griffith. Sure. Dr. Clark [continuing]. To get community coalitions---- Mr. Griffith. Well, that is why---- Dr. Clark [continuing]. To carry that information. Mr. Griffith. That is kind of why I like the lock-in because then, you lock them into a doctor, into a pharmacy, if you know, now, I don't want to do that to folks who haven't been identified as having a problem, but once you know they have a problem, then that gives you a better handle on what they are doing if you lock them in and that is the only place they can go. Wouldn't you agree, and I need to hurry because I have other things I want to ask? Dr. Clark. That is one strategy that can be employed. So you want to make sure that if you do that, that they have access to the resources necessary to be in that---- Mr. Griffith. Sure. And here is the dilemma that we have, because one of the things that the DEA is--has done, and we talked about this the last time you were here, is that they are asking the distributors to, you know, say, OK, don't sell so much to a pharmacy if that pharmacy looks like they are above the average, or if you see some sign that they may be abusing. And I told the story about what happened when I went to my local pharmacy, and there were two people in there who were both being told you have to come back next month, which was not a few--but a few days away, because we used up our allotment. And I intuited that maybe they only had 1 supplier, and then that supplier said, he's above average for other people who have more than 1 supplier. I went back and checked and that is exactly what is going on. He didn't know that was the problem, but I said, you only have one supplier, don't you? He said, yes, I use one distributor. And I think that is the problem. So we have on the one hand, we want to lock out people who are abusing it. On the other hand, we want to make sure people who need it, get it. So I guess what I am saying in the second matter is, for the rural areas, it may be a problem because that is less law enforcement, and we recognize that, and why a lot of my region is in different HIDA designations. At the same time, you want to make sure people are getting the drugs they need, and if you are in a rural area, you are a small pharmacy, you may only be using one distributor. While the DEA doesn't have a quota, the distributor then is putting a quota on because, based on other pharmacies, that particular pharmacist or drugstore is ordering more drugs, but it is because they are only using the one supplier as opposed to using two or three. How do we solve that problem? And I think Dr. Volkow wants in on this. Dr. Volkow. Yes, I was smiling because the notion is we have situations where a patient cannot get their medication, and yet at the same time, the DEA has to collect this massive amount of pills that people are not using, which tells you we are overprescribing the number of pills that are necessary. So coming back to the point that we have been discussing, we really need to educate the healthcare system on the optimal way of prescribing them, not just when they need them, but the number of tablets that you are given. I mean all of us have the idea, go to the dentist, 2 weeks of opioid prescriptions. I mean you need one day. So it is the whole notion of educating the healthcare system, and educating the lay public, and making the responsibility too of--why do we need to provide so many pills. And the insurers can get involved into these type of solutions. Dr. Clark. And the lock-in approach works as part of a treatment plan---- Mr. Griffith. That is right. Dr. Clark [continuing]. With someone who suffers from chronic pain, the practitioner develops a treatment plan, the patient agrees, and that actually benefits everyone. Mr. Griffith. Very good. Mr. Burgess. The---- Mr. Griffith. I know my time---- Mr. Burgess. The gentleman's time has expired. We will give an opportunity perhaps for a second round, but I wanted to go to Mr. Griffith because he has been waiting so long. Mr, Griffith. Absolutely. Mr. Scalise. Thank you for that, Mr. Chairman, and for our panelists for this important discussion. I know in my home parish of Jefferson, Louisiana, we have seen spikes in increase of drug-related deaths over the last few years, and each year it just seems to be going up higher. When I talk to my coroner in Jefferson, Gerry Cvitanovich, who works very closely in trying to, of course, they see the end result of it, but they also try to work on the front end in doing some of the education that Dr. Clark has talked about and others. They have seen that heroin is the one that seems to be popping up the most. I think last year, heroin deaths accounted for a majority of all the drug-related deaths, over 100 of those. And in my home parish of Jefferson, like I said, we are seeing this across the board. One of the things they do work on is just trying to educate people in the community. And I know, Dr. Clark, you have talked about this in your testimony, and alluding to work with not just pharmacists but others. What are the different things that you have been doing, and if you have had success on the education front, especially not just within the medical community, but within the targeted populations of those folks that might have the highest likelihood of being exposed to heroin? Dr. Clark. Again, one of the things, a comprehensive strategy becomes critical, and I talked with prevention, working with community coalitions, so that we have that message. We have already heard about the issue of chronic pain management, and people moving from the use of a prescription opioid to drugs like heroin. So having good strategies for pain treatment, working with state health and territorial health officers, federation and state medical boards, nursing organizations, dental organizations and even veterinarians, because they, too, have access to prescription---- Mr. Scalise. Right. Dr. Clark [continuing]. Opioids, we can address that end of the agenda, then---- Mr. Scalise. Yes, I want Mr. Rannazzisi---- Dr. Clark [continuing]. Probably---- Mr. Scalise [continuing]. To answer this too because I know you talked about this in your testimony as well, so if you can touch on your experiences there. Mr. Rannazzisi. We never turn down the opportunity to go out and speak to professional organizations. We have a very good relationship, or a fine relationship with the National Association of Boards of Pharmacy, the individual pharmacist associations, and the medical associations. When they ask us, we will come out. The Pharmacist Diversion Awareness Conference, we go out and we have been to 14 states, and trained over 6,000 pharmacists in their corresponding responsibility, the trends and trafficking for pharmaceuticals, to make them aware of what is going on so they know how to deal with this when a bad prescription comes in and what they are supposed to do. We have industry conferences. We bring industry in. October of last year, we brought the distributors in to talk about what we are seeing trendwise, and what they need to do as far as their legal obligations under the Act. We bring the manufacturers and importers in. In April or May of last year, we brought them in. And we do this on a regular basis to show the trends and trafficking. We are out there educating as much as possible because it is one of the pillars in the pharmaceutical initiative that the White House is pushing for. Mr. Scalise. One of the things when you talk to the people on the ground, our local, whether it is coroners, law enforcement, there are a lot of different federal programs out there, and I do want to touch on that GAO report because there are some concerning issues that they raised that have been touched on a little bit, but I want to get into a little bit more, but on that front, when you look at all the grants that are out there, I know in Louisiana, I think grants come in from five different departments through thirty different programs for some of these treatment programs. So there is a lot of overlap and duplication, but is there a better way maybe to block grant these, to put them together in a way that would be more flexible? And maybe, Dr. Clark, you can answer, are we giving states enough flexibility today and with the duplication can we do a better job and maybe consolidating those grants in a way that allow the states to do what they do best, without having to go through so many different processes, through so many different agencies, where you have this duplication? Dr. Clark. Well, clearly, we have to work with states and their discretion in how to prioritize what it is that they view as important epidemiologically in their jurisdiction. And so we have supported the use of block grant funds to the discretion of the states, and worked with both the individual state authorities and the national organizations associated with that. We are also working with recovery-oriented organizations so that we have peers, people who are recovering from substance use disorders to help speak up and carry out the message, working with community coalitions and others because, indeed, they can tell a better story than professionals or regulators, et cetera. So---- Mr. Scalise. OK, and---- Dr. Clark [continuing]. The---- Mr. Scalise [continuing]. And let me apologize, my time is about to go, I do want to at least ask for the record, if I can get this information on the GAO report, because it did identify, you have, what, 15 different federal agencies, 76 different federal programs that all have abuse prevention or treatment programs, and they also identified overlap of 59 of the 76 programs. And so I think Dr. Gingrey had earlier asked Mr. Botticelli and Dr. Clark to talk about what your agencies are doing to address that overlap, those problems that were identified in the GAO report. If, Dr. Sosin, I am sorry, Dr. Volkow and Mr. Rannazzisi can also get me their information to--just to show what you all are doing to try to address the overlap problems that were raised in that GAO report. And with that, I will---- Mr. Burgess. Well, the gentleman's time has expired. I think that information will be generally interesting to the committee, so if the committee staff will provide that information to the committee. Mr. Scalise. Would you all be OK with getting that to the committee? Thank you. Mr. Burgess. And the Chair would recognize the gentleman from Texas, Mr. Green, 5 minutes for your questions please. Mr. Green. Thank you, Mr. Chairman. And I thank the O&I Committee for having this hearing. Prescription drug abuse is a real growing and public health threat that must be addressed. The consequences of abuse and addiction to opioids such as prescription pain relievers and heroin has a devastating effect on our communities. We need a comprehensive solution that protects public health, preserves patient access to the needed therapies, and improved access to treatment. Last week, an article was published in the New England Journal of Medicine discussing the Department of Health and Human Services' efforts to address the prescription opioid overdose epidemic, including improving access to the addiction treatment services. Dr. Volkow, you were one of the authors of this article, and, Dr. Clark and Dr. Sosin, the heads of your respective agencies also authored this article. The article makes clear that the treatment of addiction to prescription drugs and other opioids with proven approaches like Methadone and other medication assisted therapy is of crucial importance. It describes the importance of the Affordable Care Act in increasing access to care for many Americans, including those who are struggling with addiction disorders. Dr. Volkow, can you elaborate on how the ACA builds on the Mental Health Parity and Addiction Equity Act, and improve on insurance coverage for people who are addicted to prescription drugs, heroin or other substances? Dr. Volkow. Yes, the problem is that, as I mentioned in my testimony, is that less than \1/3\ of patients that require, that could benefit from opioid medications, are getting them for the treatment of their addiction. And these reflect, among other things, the fact that many of the people that are addicted to drugs do not have an insurance, and rely on the state funding to get their treatment. And as a result of that, we have removed the healthcare system for a position there-- where they could not just act in preventing substance use disorders, but on treating them. The healthcare act, by providing insurance to those that currently don't have it, will give them the opportunity to be treated in the healthcare system for substance use disorders, as well as, in those instances where the addiction has not occurred, for the healthcare system to intervene in prevention. So that is why it is so important. Mr. Green. Dr. Clark, do you agree with that? Dr. Clark. Indeed. When people who present for treatment can't get treatment, are asked why they couldn't get treatment, the largest reason is cost and access to treatment. Mr. Green. OK, thank you. I understand the ACA provision creates an optional Medicaid state plan, benefit for states to establish health homes for the coordination of beneficiaries with chronic conditions, has also supported some states in their effort to address the drug abuse. Dr. Clark, can you elaborate on how the Health Home Program is beneficial in tackling the problem of abuse? Dr. Clark. Well, we have actually, with regard to opioids, we have got several jurisdictions that are looking at health homes as a way of dealing with opioids. So in Vermont, one jurisdiction, I think, Rhode Island, I will have to clarify that, is also taking that approach. Comprehensive services being offered where a person's care is adequately monitored offers us an opportunity to reduce some of the complexities associated with opioid misuse. Mr. Green. Thank you. It is clear from the comments the Affordable Care Act makes it possible for many people with substance use disorders, whether it is addiction to prescription drugs, heroin, or other substances, to access the treatment they so desperately need. Mr. Chairman, I know we have had our differences over the Affordable Care Act, but I would hope we all share the goal of providing more robust treatment to those who are working to overcome this addiction. And I yield back my time. Mr. Burgess [presiding]. The gentleman yields back. Our discussion with the Affordable Care Act will continue at a later date. Mr. Green. I am sure it will. Mr. Burgess. We have now I think heard from all members who wanted to ask a question. I would ask unanimous consent that a follow-up question be allowed for those of us who remain. Mr. Green. I don't have any problem with that. I can't stay, but---- Mr. Burgess. Very well, but I wanted to get that unanimous consent agreed to before you left, so it is not just on my shoulders. Mr. Green. I trust the Chairman. Mr. Burgess. Mr. Griffith, I interrupted you before. Would you like to follow up on your line of questioning? Mr. Griffith. Well, I would just like to give an opportunity, Mr.---- Mr. Rannazzisi. Rannazzisi. Mr. Griffith [continuing]. Rannazzisi. Mr. Rannazzisi. Yes. Mr. Griffith. Thank you. I am sorry I have such a hard time with that this morning. But Mr. Rannazzisi was about to comment on the dilemma that we have with the small rural pharmacists, or pharmacy, that has one distributor. Mr. Rannazzisi. Yes, and I want to thank you for clarifying that DEA has not set a quota downstream for the distributors. The distributors are working through their issues regarding due diligence to determine if there is a problem pharmacy or if it is not a problem pharmacy. I think that the rural pharmacies present a specific problem because they do need to get medication to their patients, and they need that downstream supply. We are hoping that the distributors are on site, looking at their operations before they completely cut off the distributor, or limit the pharmacy, but again, that is a business practice and, unfortunately, I have no control over their business practices. Mr. Griffith. Well, and I would just say it is because of the concerns and I am sure some memos have been put out by the DEA, we are all trying to do the right thing, that has caused the distributor to be concerned, and maybe if there could be some acknowledgement from the DEA to the distributors, hey, keep an eye out if it is rogue, but if it is just you are looking at, you know, this pharmacy is more than another pharmacy, find out if they have just one distributor because that makes a huge difference in whether or not they are truly distributing more of the opioids than somebody else. And if you all could do that, that would be greatly appreciated. Mr. Burgess. The gentleman yields back. I thank the gentleman for his follow-up. Dr. Volkow, you made a statement that was really fairly provocative a few moments ago, and I just wanted to follow up on it a little bit with you when you were discussing the effect of nicotine, alcohol on developing--I guess you were talking about developing brains and then you added the--with the addition of marijuana, and I ask you not to say anything about the rightness or wrongness of the public policy, but as you know, this nation is right now engaged in a significant experiment where some states have legalized marijuana. Are you all studying that and the effect of this decriminalization in some states? Are we prepared for what might happen next? Dr. Volkow. Yes, definitely. I know, unfortunately, it is one of those experimental situations that is happening, whether we like it or not. So what we have done is provided, identified the grantees, the researchers, in those communities where there has been legalization for recreational or medical purposes to actually give them supplemental money so that they can look at the consequences of these changes in policy, in the education of systems, in accidents, in emergency room admissions, in productivity in the workforce. We need to have evidence that can then--hopefully can guide policy, as opposed to doing policy in darkness on the beliefs of people, and what--since you brought up the issue, to one of the things that is also a concern as discussing the prescription, people are using prescriptions because they feel that are prescribed by physicians, they cannot be so harmful. The notion that marijuana has so-called medical purposes is also changing the perception of this drug cannot be so harmful if it has medicinal properties. And the whole perception of risk is changing, which, again, has opened the willingness of young people to take marijuana and to consume it regularly. Mr. Burgess. Well, I do hope that you are monitoring the situation, since society has provided you the experimental situation. I also hope that you are preparing to deal with what the downstream effects are from this rather bold social experiment that some of the states are undertaking right now. And I hope that is more than just sending more money to those states. I hope that it is something that you are--that oversight is happening at your level, that there will be a national monitoring of this. Dr. Volkow. The way that we oversee research protocol is very, very rigorous. If the scientist is not producing or the methodology is not adequate, we do not fund them. Mr. Burgess. Just speaking of downstream effects, there is also the issue, and it has been brought up several times this morning, and any of you feel free to comment on this, the issue of, of course, the device by which the drug is administered, and then the possibility for exposure to Hepatitis B or C, or HIV. From a public health perspective, are we preparing ourselves for any differences in the incidence of these illnesses as a consequence of the delivery device? Mr. Botticelli. I will start on that. One of the main concerns of HHS has been, obviously, the increase in viral hepatitis and hepatitis C among the very young cohort of injection drug users. So we have been working in concert with the Health and Human Services who has put forth actually an action plan to diminish viral hepatitis, and clearly, there is a lot of overlap in terms of the issues that we are talking about here. So this is obviously a significant public health concern, so we want to make sure that we are dealing with this in a concerted way. Mr. Burgess. Yes, and, of course, the good news right now is Hepatitis C is one of those things that looks very well like there may be a cure that is not just on the horizon but is here. The only problem is it is very expensive. And my differences with Mr. Green over the Affordable Care Act aside, ultimately though, someone has to pay for that, so I hope we are doing the necessary--I hope we are monitoring and doing the necessary preventive things to keep that in check, and to prevent the disease, rather than just simply now being able to cure it with a very expensive therapy that, thankfully, is available. Mr. Botticelli, did you have some additional observations on the issue of the states that are legalizing marijuana? Mr. Botticelli. I do, and what I wanted you to know is that in addition to the additional NIDA grants that are out there, our office has actually convened a group of Federal partners to look at the eight criteria that the Department of Justice has laid out for Colorado and Washington, and are really committed to gathering data on the Federal, state and local level, looking at what is the impact in terms of legalization in Colorado and Washington have on both the public health and public safety consequences that we have. So in addition to some of the public health-related work that Dr. Volkow has funded, we are also looking at what are the public safety consequences, things like increase in drugged driving, interstate transportation of marijuana from Colorado to other states. So our office has really been committed in terms of ensuring that we have good public health and public safety data to monitor what is happening in Colorado and Washington. Mr. Burgess. And, Mr. Rannazzisi, I would assume that your agency is participating in that as well? Mr. Rannazzisi. It still is a Schedule I controlled substance. We are still doing investigations concerning marijuana downstream. Mr. Burgess. And are you monitoring the downstream effects in neighboring states, in the incidences--as Mr. Botticelli talked about, the incidence of driving while impaired, the incidence of even just crime, are you compiling those statistics so they will be available to policymakers in subsequent hearings? Mr. Rannazzisi. We are talking to our state and local counterparts in all of the surrounding states, and we are gathering information. I don't know how all-inclusive that information is because, quite frankly--some of the state and locals are not keeping that type of information, but we are keeping tabs with our state and locals on what is going on within their states. Mr. Burgess. Very well. Mr. Griffith. Mr. Chairman. Mr. Burgess. Yes, the Chair recognizes the gentleman from Virginia. Mr. Griffith. I would be remiss, since we have taken on marijuana, not to mention that I have just introduced a Bill to legalize the use of marijuana in medicinal circumstances, akin to the Virginia plan that was passed in 1979, that requires a doctor's prescription, thus, changing the scheduling. The Bill actually calls for the changing of the scheduling. The DEA is in a tough spot. Some of these states are doing it, but it is still a Schedule I, which means that the DEA has a hard time collecting the data that you just asked for without stumbling across felons that they are not prosecuting. So they are in a catch 22. I think it is much better to have doctors and pharmacists, and the regular system working, because then you get real data for your scientists to look at and see if it is effective, as they designed it to be. So the Bill doesn't go as far as Colorado or Washington might want it, or the Crazy California Plan as I often call it, but it allows real doctors with real pharmacists and real distributors, controlled by and under the laws of the United States, to use true marijuana if it can be used in a real way medicinally. Mr. Burgess. Very good. The gentleman yields back. I am all for giving doctors more power. That actually concludes all of the questions that we have from members. I neglected to mention at the start of the hearing, ask unanimous consent that members' written opening statements be introduced into the record. Without objection, the documents will be entered into the record. In conclusion, I would like to thank all of our witnesses. I will thank the member that have participated in today's hearing. I will remind members they have 10 business days to submit questions for the record, and I will ask the witnesses to all agree to respond promptly to the questions submitted in writing. With that, the subcommittee is adjourned. Thank you for your attendance today. [Whereupon, at 12:06 p.m., the subcommittee was adjourned.] [Material submitted for inclusion in the record follows:] Prepared statement of Hon. Tim Murphy Three months ago, the country was shocked and saddened by the death of actor Philip Seymour Hoffman. Like many who battle addiction, Mr. Hoffman struggled to stay clean as he alternated between pain pills and heroin. His story is far too common. Opiate addiction surrounds us--from cities, rural towns, and affluent suburbs--and it breaks our heart to see so many families torn apart by abuse of drugs that are both legal and illegal. My own district has suffered terribly from opiate overdoses. Last year, more than 90 people in Westmoreland County lost their lives to prescription drug and heroin abuse. That was four times the number of overdose deaths in the county compared to a decade ago. Allegheny County saw more than 20 deaths linked to fentanyl-laced heroin this past January. Heroin-related deaths have increased 400 percent in Cleveland. Vermont Governor Peter Shumlin dedicated his entire annual ``State of the State'' address to what he called the ``fullblown heroin crisis'' facing his state. Kentucky, West Virginia, New Mexico, and other states are also experiencing rising rates of prescription drug overdoses and heroin abuse. Here's the awful truth about this public health crisis: prescription painkillers are involved in more overdose deaths than cocaine and heroin combined. Prescription drug abuse kills more than 16,000 people a year. While most prescription drug abusers do not go on to abuse heroin, data from the White House Office of National Drug Control Policy (ONDCP) and the Substance Abuse and Mental Health Services Administration (SAMHSA) indicates that 81 percent of people who started using heroin in 2008 to 2010 had previously abused prescription drugs. As authorities have cracked down on access to legal pain killers in the last five years, heroin use has risen by an astonishing 79 percent. Certainly, there is a law enforcement aspect to solving this problem and stopping the bad actors who illegally distribute prescription drugs or traffic heroin. But the other part of the equation is treating addiction to prescription drugs and heroin--and preventing deaths. The purpose of today's hearing is to examine the federal public health response to prescription drug and heroin abuse. Our oversight has revealed that this is a complex problem. For example, 40 percent of those who abuse drugs have an underlying mental illness. Treating their addiction successfully necessarily means that the underlying mental illness must be successfully diagnosed and treated. But just as when someone has a mental illness, those who are battling addiction are unlikely to get effective treatment, too. More than 90 percent of persons with a substance abuse disorder won't get medical care. And of those who are enough to access care, 90 percent of them will not get evidence-based treatment. There are effective treatments available, but too often the substance abuse debate is divided between those who adhere to the abstinence or 12-step model, and those who promote medical assistance therapies. These groups must come together and find a solution because thousands of lives are at stake. As the testimony of Mr. Botticelli, the Acting Director of the Office of National Drug Control Policy, states, substance abuse is a ``progressive disease.'' Those who suffer from addiction often start at a young age, with alcohol and marijuana, and then move to other drugs like opioids. In examining opioid abuse, we must also consider the factors that lead people to abuse--and how federal programs are addressing them. Prescribing practices are an issue. Roughly 20% of prescribers prescribe 80% of all prescription painkillers. Those suffering from chronic and debilitating pain need access to opiates, but we also need to make sure those individuals who develop an addiction are referred to treatment. Right now, too many states lack a robust prescription drug monitoring program that would help physicians and emergency rooms keep tabs on patients receiving powerful opiates. Educating doctors and pharmacies about appropriate prescribing will address one part of the problem--but addicts also get these drugs through illegal channels, such as rogue Internet pharmacies, off the street, and even from the medicine cabinets of family members and friends. The federal government is devoting significant resources to drug control programs--over $25 billion annually, of which about $10 billion goes toward drug abuse prevention and treatment programs across 19 federal agencies. With 19 agencies having a hand in over 70 drug control programs, we have to ask, `is our current approach working and what can we do better?' Oversight by the federal agencies is also an important issue, as significant funding is block granted to states for treatment programs. How are you confident that we are funding treatments with the best chances of success in preventing and treating opiate abuse? ---------- [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] [all]