[House Hearing, 107 Congress] [From the U.S. Government Publishing Office] DEPARTMENTS OF COMMERCE, JUSTICE, AND STATE, THE JUDICIARY, AND RELATED AGENCIES APPROPRIATIONS FOR 2002 _______________________________________________________________________ HEARINGS BEFORE A SUBCOMMITTEE OF THE COMMITTEE ON APPROPRIATIONS HOUSE OF REPRESENTATIVES ONE HUNDRED SEVENTH CONGRESS FIRST SESSION ________ SUBCOMMITTEE ON THE DEPARTMENTS OF COMMERCE, JUSTICE, AND STATE, THE JUDICIARY, AND RELATED AGENCIES FRANK R. WOLF, Virginia, Chairman HAROLD ROGERS, Kentucky JOSE E. SERRANO, New York JIM KOLBE, Arizona ALAN B. MOLLOHAN, West Virginia CHARLES H. TAYLOR, North Carolina LUCILLE ROYBAL-ALLARD, California RALPH REGULA, Ohio ROBERT E. ``BUD'' CRAMER, Jr., TOM LATHAM, Iowa Alabama DAN MILLER, Florida PATRICK J. KENNEDY, Rhode Island DAVID VITTER, Louisiana NOTE: Under Committee Rules, Mr. Young, as Chairman of the Full Committee, and Mr. Obey, as Ranking Minority Member of the Full Committee, are authorized to sit as Members of all Subcommittees. Gail Del Balzo, Mike Ringler, Christine Kojac, and Leslie Albright Subcommittee Staff ________ PART 10 OXYCONTIN________ Printed for the use of the Committee on Appropriations ________ U.S. GOVERNMENT PRINTING OFFICE 77-734 WASHINGTON : 2002 COMMITTEE ON APPROPRIATIONS C. W. BILL YOUNG, Florida, Chairman RALPH REGULA, Ohio DAVID R. OBEY, Wisconsin JERRY LEWIS, California JOHN P. MURTHA, Pennsylvania HAROLD ROGERS, Kentucky NORMAN D. DICKS, Washington JOE SKEEN, New Mexico MARTIN OLAV SABO, Minnesota FRANK R. WOLF, Virginia STENY H. HOYER, Maryland TOM DeLAY, Texas ALAN B. MOLLOHAN, West Virginia JIM KOLBE, Arizona MARCY KAPTUR, Ohio SONNY CALLAHAN, Alabama NANCY PELOSI, California JAMES T. WALSH, New York PETER J. VISCLOSKY, Indiana CHARLES H. TAYLOR, North Carolina NITA M. LOWEY, New York DAVID L. HOBSON, Ohio JOSE E. SERRANO, New York ERNEST J. ISTOOK, Jr., Oklahoma ROSA L. DeLAURO, Connecticut HENRY BONILLA, Texas JAMES P. MORAN, Virginia JOE KNOLLENBERG, Michigan JOHN W. OLVER, Massachusetts DAN MILLER, Florida ED PASTOR, Arizona JACK KINGSTON, Georgia CARRIE P. MEEK, Florida RODNEY P. FRELINGHUYSEN, New Jersey DAVID E. PRICE, North Carolina ROGER F. WICKER, Mississippi CHET EDWARDS, Texas GEORGE R. NETHERCUTT, Jr., ROBERT E. ``BUD'' CRAMER, Jr., Washington Alabama RANDY ``DUKE'' CUNNINGHAM, PATRICK J. KENNEDY, Rhode Island California JAMES E. CLYBURN, South Carolina TODD TIAHRT, Kansas MAURICE D. HINCHEY, New York ZACH WAMP, Tennessee LUCILLE ROYBAL-ALLARD, California TOM LATHAM, Iowa SAM FARR, California ANNE M. NORTHUP, Kentucky JESSE L. JACKSON, Jr., Illinois ROBERT B. ADERHOLT, Alabama CAROLYN C. KILPATRICK, Michigan JO ANN EMERSON, Missouri ALLEN BOYD, Florida JOHN E. SUNUNU, New Hampshire CHAKA FATTAH, Pennsylvania KAY GRANGER, Texas STEVEN R. ROTHMAN, New Jersey JOHN E. PETERSON, Pennsylvania JOHN T. DOOLITTLE, California RAY LaHOOD, Illinois JOHN E. SWEENEY, New York DAVID VITTER, Louisiana DON SHERWOOD, Pennsylvania VIRGIL H. GOODE, Jr., Virginia James W. Dyer, Clerk and Staff Director (ii) DEPARTMENTS OF COMMERCE, JUSTICE, AND STATE, THE JUDICIARY, AND RELATED AGENCIES APPROPRIATIONS FOR 2002 ---------- Tuesday, December 11, 2001. OxyContin FEDERAL LAW ENFORCEMENT WITNESS ASA HUTCHINSON, ADMINISTRATOR, DRUG ENFORCEMENT AGENCY, U.S. DEPARTMENT OF JUSTICE Hearing Opening Statement--Chairman Wolf Mr. Wolf. Good morning. The hearing will come to order. I first want to thank the members of the subcommittee for participating in this important hearing, particularly since the House won't be voting until late this evening. The hearing, as many know, was postponed from September 11th as a result of the September 11th terrorist attack. Our country is a different place as a result of those attacks, and many of our priorities have shifted as a result. Everyday stories have faded into the background and issues that were important on September 10th have dropped off many people's radar screens. While stories about OxyContin are not regularly appearing on the front page because of September 11th, people are still affected by this drug, both positively and negatively. On November 30th, the Richmond Times Dispatch reported that a doctor from southwest Virginia was sentenced to 6 years in prison for writing hundreds of unnecessary prescriptions for OxyContin and other drugs. Two days earlier, the paper reported the sentencing of two parents from Franklin County, Virginia for felony child neglect after their 16-month-old daughter overdosed on OxyContin pills she allegedly picked up off the floor of their home. Just yesterday, the New York Times did a piece on the high volume of prescriptions issued from a pain management clinic in Myrtle Beach, South Carolina that closed in June, after the DEA suspended the narcotic license of six doctors who worked there. The story said people, sometimes 15 to 20 deep, would be lined up outside the clinic, and the parking lot of the strip mall housing the facility would be jammed with cars, many from out of town, and from morning until night. This morning we will hear from people on the front lines of law enforcement as well as the medical community with regard to trying to halt the continued abuse of this drug. I am fully aware of what good this drug does, how it can be a saving grace for someone dying from cancer. Before I would begin, I would ask each of the witnesses to read their statement for the Record, and then we will open it up for questions. And if it is a very long statement, although I know individuals have traveled a long distance, perhaps you can summarize, because I think we have a full day, and the hearing will go on for a long period of time. This is a difficult subject for many, many people. First and foremost, I want to assure everyone that it is not the intent of--certainly of me or of the subcommittee--to take OxyContin away from legitimate users. I understand that OxyContin is a very powerful legal drug that has brought relief to many people suffering from cancer and chronic pain. Both my mom and dad died of cancer, and I can recall my mother in the hospital when she was dying, and the pain was so excruciating and she asking for more; and the nurse at that time said they could not give her more. But as a father of five children, my heart goes out to the parents who have had a child addicted to drugs. So you have a balance. You have a drug that has done some very good things, and you have a drug that has done some very bad, bad things. Sadly, parents today are more concerned than ever about drug abuse. Drug abuse often destroys--families, teenagers and young adults get hooked on drugs like OxyContin, and the damage left in the wake is often unrepairable. When taken properly, OxyContin is a wonder drug, but when it is ground up, the time release mechanism in the tablet is disabled, providing the abuser with a heroine-like high. states where oxycontin is problem Communities, particularly rural communities in Virginia-- and now coming to the rural part of my congressional district, in Kentucky, West Virginia, Maine, Ohio and Pennsylvania are being devastated by the illegal use and abuse of OxyContin. The news stories I have read about what is happening in some of these communities is extremely troubling: a mother getting her teenage son hooked; pharmacies being robbed; big spikes in crimes; entire neighborhoods and communities being overtaken either by users or drug dealers; murder; suicide. A pharmacy in my district was robbed earlier this year. I also understand that the abuse is now becoming a problem in urban areas like Boston. In August, a Boston area nursing home was robbed at gunpoint for OxyContin, a nursing home at gunpoint. That is an indication of how powerful this drug must be to somebody who is addicted and wants it. Boston reports there have been dozens of other OxyContin- related robberies this year. There is a problem. Some law enforcement officials I have talked to said the illegal use of this drug could be the next crack cocaine. The New York Times story yesterday said, no other drug in the last 20 years has been abused more widely, so soon after its introduction, than OxyContin. On the other side of the coin is the issue of pain management. According to the Purdue Pharma Web site, the American Pain Foundation estimates that some 15 million people live with chronic pain. OxyContin and other important pain- killing medications have brought relief to many Americans suffering from pain. More doctors have taken the issue of pain management more seriously, and they are paying more attention to addressing pain felt by their patients. Again, it is not the intent of the subcommittee to deny anyone with a legitimate, and I stress the word ``legitimate'' need, access to this or any other medication. We are simply trying to figure out a way to maintain legitimate use of the drug while stopping illegal diversion, which is obviously a reality. It is a fact. It is not a myth. It is not a story. It is not an anecdote. It is a fact. How we go about doing this and what I hope we can begin to focus on today, working on a quick, meaningful, and successful solution. One solution might be to require that all States institute prescription monitoring programs. I understand that 18 States have prescription monitoring programs now. We will be interested in hearing more from the panelists about the benefit of those, and perhaps even a nationwide system. resources for oxycontin I am pleased to report that the fiscal year 2002 Appropriations Act for the Department of Commerce, Justice, State, and the Judiciary includes $2 million for the Department of Justice to fund grants to help States that don't have prescription drug monitoring programs established. We are also looking forward to hearing from the State and local law enforcement representatives about the day-to-day experiences with OxyContin and its devastating effect on their communities. Through that same vein, we will be hearing from a father of a recovering OxyContin addict. We are also looking forward to hearing from Dr. Sullivan who has experience in treating drug addicts. I also want to thank the representatives of Purdue Pharma for appearing today. You have developed a drug that has brought relief to many. Regrettably, it has also brought with it many problems in essence, of hurting communities and destroying some families. We look forward to your testimony. Finally, we will hear from pain management experts and other medical professionals about the importance of OxyContin in their efforts to treat patients suffering from severe pain, and assure that people who need access to these powerful medications can retain that access. We will also be hearing representatives from the American Cancer Society, the American Academy of Pain Medicine, and the Johns Hopkins University. Opening Statement--Congressman Serrano Mr. Wolf. Before we hear from our first witness, the head of DEA, our former colleague, Mr. Hutchinson, we will first have opening statements from Mr. Serrano and then Mr. Rogers. Mr. Serrano. Thank you, Mr. Chairman. I will be very brief. Let me first thank you for putting together this hearing. I know how important this issue is to you, indeed it is important to all of us. As you know, Mr. Chairman, and my colleagues, I represent a district in the South Bronx, and so the issue of drug abuse is one that I am very familiar with in terms of the pain that it has caused all my constituents. For a long time, my district was one of the districts with the most crime in the Nation, and yet that crime was very much related, mostly related to the issue of drug abuse. And so today I sit here with you, wanting to be helpful in every way I can to deal with this issue, which is not one yet seen in the inner city, but one that I am sure will be seen in a short time. However, I could not pass up the opportunity to deal with what I think is the greater issue at hand, and that is that our great Nation has, in my opinion, in the past not paid attention to the issue of drug abuse the way it should, perhaps because at times drug abuse was seen as an inner-city problem. We spent too much time blaming those people for their condition and just tied it to other problems that existed in the society rather than deal with it for what it was, a serious problem. And so if you look at our budgets, one could argue that we haven't spent enough money on prevention in this area and certainly have not spent enough money and resources on treatment centers. I have known too many people, just too many people, who have wasted their lives away and their youth away, people I grew up with, with different kinds of drugs, the last one being crack cocaine. And so I join you today in this, with the knowledge that I, perhaps more than a lot of other members, can see what is coming on the horizon if we don't do something about this. But let us just not concentrate on this, let us concentrate on the fact that we still have a lot of unmet needs in this country and that we have a lot of drug addicts throughout this Nation and drug abusers who have been totally forgotten because they are part of the inner city. And the inner city somehow was supposed to have caused these problems by itself and not through any other way. And with that, again, I repeat to you my support for this issue. It is a national crisis. It doesn't belong to one area. It belongs to the whole country. Especially since September 11th, we have learned that we in this country can, in fact, work together. And let me just close by saying that I am so glad to see our former colleague with us. He is doing the kind of job that we need him to do, and this member certainly continues to pledge my support to your efforts. Thank you, Mr. Chairman. Opening Statement--Congressman Rogers Mr. Wolf. Mr. Rogers. Mr. Rogers. Thank you, Mr. Chairman. More importantly, thank you for holding this hearing at a very opportune time, as our former colleague in this body has assumed these heavy responsibilities to head the DEA. You have inherited in OxyContin in my area, the worst scourge that we have had in the drug wars. There is an absolute epidemic of OxyContin misuse in eastern Kentucky. This substance is running rampant through the small rural communities of Appalachia, wreaking havoc on the adolescent population. In my 20 years of service in this spot, and 11 years before that as a D.A. in Kentucky, I have never seen the devastating effect from one substance on people, particularly young people. A review of autopsy data has found that OxyContin played a major role in 296 overdose deaths throughout the Nation over the last 19 months. There were actually 803 cases of Oxycodone related deaths, the active ingredient of OxyContin. Not all of them can be attributed solely to OxyContin, as there is no sound toxicological test to distinguish between the two. But between January of 2000 and May of 2001, there were 69 deaths in Kentucky, in which medical examiners found Oxycodone in the bodies, 36 of which reported toxic levels. Many of these deaths are suspected of being solely the result of OxyContin abuse. OxyContin has been linked to more than 100 overdose deaths in southern New Jersey and Philadelphia in the last 2 years. In the first half of the year, 54 people died in Palm Beach County, Florida, in cases involving overdoses of Oxycodone. In Virginia, 49 individuals died between January 2000 and June 2001, a direct result of Oxycodone intoxication. Appalachian Regional Hospital in Hazard, in the Appalachian area of Kentucky, in my district, reported treating at least 10 OxyContin overdoses a week last year. OxyContin topped $1 billion in sales in 2000. It has the highest retail sales of all brand name prescription drugs. Between 1996 and the year 2000, Oxy prescriptions jumped 2,000 percent, compared to just 23 percent for all other common opioid analgesics. In Kentucky, there were 9.4 million Oxy pills dispensed to residents from Kentucky pharmacies in 2000. That is almost double from the previous year, and does not include the pills residents got from pharmacies outside of the State. You will hear this morning from former Hazard Police Chief Rod Maggard, who estimates that between 65 and 85 percent of high school students in Hazard have tried this substance at least once. Drug treatment programs in Kentucky, West Virginia, Virginia, and Pennsylvania report that 50 to 90 percent of newly admitted patients identified OxyContin as their primary drug of use. And then there are the associated problems with overuse or abuse of OxyContin. Just yesterday, nine armed men overpowered guards at a distribution point in Mexico City and stole 31,000 bottles of OxyContin. That is 936,000 pills. Street value, $20 million. A 4-month joint sting operation in Hazard, led by local, State and FBI, resulted in the arrest and indictment of over 200 alleged dealers last February. Several other minor busts in the State have accumulated over the year, including the arrest of a local police dispatcher in the town of Beattyville. Increased use of OxyContin has led to a general rise in lawlessness in eastern Kentucky and around the eastern seaboard itself. Pharmacy robberies and health care fraud incidents are dramatically up. In the Appalachian region, Kentucky had the highest number of pharmacy robberies or burglaries for OxyContin. 6.9 percent of all pharmacies reported OxyContin- related crimes between January 2000 and June 2001. As of July of this year, 37 pharmacies had been robbed in Massachusetts. In Harlan County, Kentucky, in my district, authorities there are blaming OxyContin for bringing the big-city problem of prostitution to that city. They recently broke up a prostitution ring in the county where women were selling their bodies to feed their addictions to this drug. This is a very special problem. This wonder drug, if you will, invented for the purpose of relieving pain for severely ill people has had wonderful results. One pill for a long period of time. However, that feature of this drug, the 12-hour relief built into this pill, allows it to be misused by being crushed and used all at once. Mr. Chairman, this is a special problem for my part of the country. I appreciate the fact that the Chairman has responded to the interest of a number of us and has become himself motivated and has seen fit to hold this hearing and focus the attention of the country on this growing abuse problem. I thank you. Mr. Wolf. I thank you, Mr. Rogers. Opening Statement--Congressman Mollohan Mr. Wolf. Mr. Mollohan? Mr. Mollohan. Mr. Chairman, I want to compliment you for holding this hearing. This is part of a devastating problem in our country. It is, as Mr. Rogers described, in our area of the country, particularly exasperating and growing fast, as is evidenced by the fact that two of the members of the panels that you bring forward are from West Virginia. I look forward to the hearing, to the information that is presented in it, and I again compliment you for holding the hearing. Mr. Wolf. Thank you, Mr. Mollohan. Opening Statement--Congressman Latham Mr. Wolf. Mr. Latham. Mr. Latham. Thank you, Mr. Chairman, and I just want to compliment you for having this hearing. I think it is an extremely timely topic, and one that is very, very important; and also to welcome our good friend and former colleague here, Mr. Hutchinson, to the committee. But as someone who serves on the Speaker's Drug Task Force and has seen methamphetamines come into our part of the country, and now seeing this scourge come in, again I compliment you for holding this hearing and thank you. Mr. Wolf. Thank you, Mr. Latham. Opening Statement--Administrator, DEA Mr. Wolf. I would like to recognize now Mr. Hutchinson, the Administrator of DEA. Before I do, I just want to say I share the comments, the views of other members. So I appreciate very much the fact that you were willing to leave the House and go and take this job for public service. And so I want you to know that I personally appreciate it, and I know most members do on both sides of the aisle. So with that, thank you, and it is now your turn. Mr. Hutchinson. Thank you, Mr. Chairman, and members of the committee. I am very grateful to you for your leadership on this issue and for holding this hearing. I might point out that while I was still in the House, both Chairman Wolf and Mr. Rogers came to me and said, you have got to get a handle on this OxyContin problem as you go to the DEA. So, really, my first education in this whole arena came from the leadership of this committee, and I thank you for that and for following up by holding this very important hearing. Obviously, since I went over to the DEA, my education has moved in a very, very broad arena, much of it centering on the extraordinary problem that has resulted from OxyContin abuse. As you know, the DEA, Drug Enforcement Administration, has its authority under the Controlled Substances Act not just to go after those that deal in illegal drugs, but also those that divert legal substances; and we are mandated to prevent, detect, and investigate the diversion of those legally manufactured controlled substances, while making sure that there is still an adequate supply of those that have medicinal purposes for our society. There are five schedules under the Controlled Substances Act, and OxyContin falls in Schedule II, which includes those controlled substances that are approved for medical use and have the highest potential for abuse among the controlled substances. diversion of drug The drug OxyContin is produced by Purdue Pharma. It is intended for use in the treatment of chronic, moderate-to- severe pain when there is a continuous, potent, narcotic pain reliever that is needed for an extended period of time. The drug OxyContin has experienced extraordinary growth since it was introduced in 1995. The prescriptions have risen to 5.8 million prescriptions in the year 2000. This means that OxyContin has become the number one prescribed Schedule II narcotic in the United States, and during that time, while the sales have increased astronomically during the last 2 years, DEA has noticed a dramatic increase in the illicit availability and abuse of OxyContin. It appears the appeal is clearly in the large amount of the active ingredient that is present as compared to other products. In addition to the oral abuse of the intact tablet, as Mr. Rogers pointed out, crushing the tablet enables the abuser to circumvent the controlled release mechanism and to swallow, to snort, or inject the drug for a more rapid and intense high. And there have been many examples of diversion. As the Chairman noted, a physician in southwestern Virginia recently was convicted of 430 counts of prescribing narcotics without legitimate medical purpose, and faces multiple life prison terms. That was investigated by the Drug Enforcement Administration. In North Carolina, there was an organized forgery ring in which computers were used to create prescriptions to divert thousands of dosage units of OxyContin to abusers. And now the abuse that started in the rural areas has spread to the urban areas. In the rural setting, I was down in Congressman Vitters' district in Louisiana very recently, and there we went to the rural area of Louisiana, in which I was told that the sheriff actually had an addiction problem in which he subsequently had to resign because of forging prescriptions for OxyContin. And so really you cannot escape the difficulty. Yesterday, Purdue Pharma, the general counsel for Purdue Pharma alerted me and I alerted the committee, when we were informed that Purdue's Mexican licensee, Azo Pharma in Mexico City, was robbed yesterday by nine masked armed men who overpowered the guards on duty and destroyed the vault. They took 31,200 bottles, each containing 30 tablets of OxyContin, the 20-milligram variety. They did not take the bottles of 10- milligram OxyContin tablets that were also in the vault. And, again, we were notified of this through the cooperative efforts of Purdue Pharma, but it certainly points up the examples of diversion that seem to be growing at a very alarming rate. In addition to the straightforward diversion, as mentioned by the Mexico City--or the Mexico criminal activity, there is increased abuse through theft and through robberies. In Massachusetts, pharmacies have been targeted for robberies by individuals demanding OxyContin by name. Through the last 6 months in the Boston area, they have experienced 36 robberies of pharmacies involving stocked OxyContin supplies. A nursing home in Massachusetts had its medical staff and patients held hostage by three robbers demanding OxyContin. And so clearly, the diversion, the criminal activity, has alerted law enforcement all across this Nation as to the potential for abuse of this drug, OxyContin. national action plan to stop diversion of oxycontin The DEA's response initiated a national action plan, which is a comprehensive enforcement effort and regulatory effort to stop the diversion and to address the criminal activity associated with the forged and fraudulent prescriptions, the pharmacy theft, the doctor shoppers, and the inappropriate medical professionals that abuse this drug. This plan includes a number of components. One, working with industry, including Purdue Pharma, in a cooperative effort to increase the education among the doctors, the broad variety of the medical community, as well as the public at large, to alert the law enforcement communities so that they will be on guard in this regard as well. In the regulatory arena, we have taken some very stringent measures to monitor the OxyContin that is produced and is available through the cooperative efforts of industry labeling changes that have been accomplished, and so some progress has been made. We have also encouraged a State prescription monitoring program. The majority of States that report significant abuse in diversion do not have prescription monitoring programs that are so instrumental in alerting law enforcement and the medical community to abuse of this drug. To illustrate this, the existing data reflects that the five States with the lowest number of per capita OxyContin prescriptions all have longstanding mandated prescription monitoring programs. So clearly this is an effective deterrent, and once the State adopts this, this is a strong tool that law enforcement and the medical community can use. The DEA has also taken steps to better evaluate the magnitude of the OxyContin abuse problem. We have requested more specific information from the 800 members of the National Association of Medical Examiners to provide us with information on any Oxycodone-positive deaths occurring within their jurisdiction. As of December 1, 2001, we have received findings and reports from 803 cases of Oxycodone-positive deaths from 31 States. We have asked to more specifically clarify the nature of the Oxycodone-related deaths, and of these deaths, 117 were verified as having involved OxyContin specifically, with an additional 179 deaths deemed to be likely related to OxyContin. In addition, the treatment society certainly reflects the growing problem of OxyContin, with the American Methadone Treatment Association reporting an increase of patients admitted for OxyContin abuse. Programs in West Virginia, Pennsylvania, Kentucky and Virginia report that 50 to 90 percent of newly admitted patients identified OxyContin as their primary drug of abuse. And so as with any Schedule II controlled substance, DEA recognizes that there is, as well as a potential for abuse, a legitimate medical use and benefit for OxyContin. And so we have agreed, with the Pain Management Society, with the medical profession, that there is a legitimate use and that we are not taking action to diminish the legitimate benefit of OxyContin to those patients that are in legitimate need of this medical treatment. At the same time, they took the extraordinary step of acknowledging DEA's important role in presenting the abuse, and we released a joint statement, consensus statement previously, and with the permission of the Chairman, I would like to have this submitted as part of my testimony. Mr. Wolf. Sure. Without objection. growth of oxycontin Mr. Hutchinson. I know the question comes about, well, what happened that led to the extraordinary growth of OxyContin abuse and even their sales? Clearly, it is a pain treatment that has beneficial effects, and so that is a part of the component of its large increase in sales. But, in addition, a disproportionate abuse of OxyContin may be partially due to a very aggressive marketing and promotion campaign, particularly as it was presented as a less abusable substitute for a variety of less addictive medications. And because we have pushed, they have agreed to reduce some of their marketing campaigns. We have always opposed marketing directly to consumers, and that has not been a part of it, but the aggressive marketing to the pharmaceutical industry, as well as the medical community, I believe has contributed to the extraordinary and disproportionate abuse of this drug. To illustrate this point, one of the marketing tools was this very simple pen that was left with the doctors. And when this is opened--let us see if I can find the magic to this-- this opens up with a very handy conversion chart, and the conversion chart illustrates how easy it is to take a patient off of another pain relief medication and put them on OxyContin. And, for example, it starts out with Percocet, and it provides the conversion dose. And then it also goes down, though, even to Schedule III and even Schedule IV substances. It has Tylenol with codeine that is easily convertible to OxyContin, and it provides the conversion table. And so the message is that if you have a patient that only needs Tylenol or Darvocet, something of a less severity, you can simply convert it to OxyContin which is a Schedule II. And so that very effective marketing tool has led to, in our judgment, an overprescription in some instances of this particular drug. Finally, I want to conclude by saying that the DEA is trying to take a measured and reasonable approach to dealing with OxyContin and other drugs of abuse and is committed to making sure that there is an adequate supply of pain medication for those with legitimate needs, but also protecting the public from the consequences of abuse and trying to carry out our law enforcement responsibilities. So thank you again for the opportunity to address this subcommittee. Mr. Wolf. Thank you, Mr. Hutchinson. [The information follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] solutions for combatting the diversion of oxycontin Mr. Wolf. Has it come to the big cities? I notice you mention Boston. What about Philadelphia, New York, Washington, L.A., San Francisco? Is it moving to the big cities like that, or is Boston an exception? Mr. Hutchinson. I believe it is--Boston is somewhat of an exception. It is certainly moving to some big cities. For example, though, in California it has not become the level of problem as it has in other rural and urban areas. Again, the States--for example, California, has a very stringent prescription monitoring program which has been a discouragement for the abuse of OxyContin and other similar drugs of abusive potential. But we are very alert to it, and Philadelphia and Boston, are areas of concern to us. Mr. Wolf. When did DEA first become aware that OxyContin was being diverted? Do you know when? Mr. Hutchinson. We became alerted to this, of course, about 2 years after it was put on the market. It was brought to our attention, and it has been, of course, growing on our radar screen in the last couple years. Mr. Wolf. When did you first approach the manufacturer that there could be a problem? Mr. Hutchinson. Shortly after we became aware of the problem, we approached the manufacturer and set up a series of meetings with them, addressing what they can do from an industry standpoint, and we have continued those meetings regularly since this problem was drawn to our attention. Mr. Wolf. Now, I had heard that the company had brought a number of doctors together to market the product--and that pen that you refer to. Do you know if the company--and I can ask the company this, too--have they gone back to all of those doctors that they marketed this to, to warn them of the potential dangers? Do you think if every doctor that has been talked to initially were urged to purchase and switch--have they gone back to them to tell them the potential dangers? Mr. Hutchinson. Yes, they have. It is my understanding that they have written to the medical community. They have engaged in a mass mailing campaign to make sure that the appropriate information is available to them on the abuse potential. And so in that regard, Purdue Pharma has been cooperative. We have continued to meet with them. Not all of our demands have been met, necessarily, but they have taken serious steps to engage in the education program. I know they have also been very supportive of the development of laws in the States to carry out the prescription monitoring program. Mr. Wolf. If they actually spoke to the doctor directly, either by a sales rep or if they had them at a conference, would it not be appropriate that they follow up the same way? You know how many letters you get through the mail, and people might not quite focus. It would seem to me that if you had a doctor in, or your sales rep came out to the doctor's office and made this pitch verbally or with a series of charts, there would almost be the same responsibility to come back and warn them the same way, so that there is an equivalency of the warning with regard to the initial contact. Do you have any thoughts about that? Mr. Hutchinson. Well, certainly it is very important, and the most important education would be the pharmacy rep, as they have their discussions with the doctor. It is the sales presentation that is the greatest concern, and that is the source of some of what we would argue would be misperceptions on the medical community's part as to its abuse potential at the outset. And so it is helpful when they send out a mass mailing, if the communication goes forward to the medical community in that fashion. But you still have the problem of the pharmacy reps that are going out, calling on the doctors, that presumably are on an incentive basis or a commission basis whenever they make the sales. They have an incentive to make sales, and so you never know whether the same level of communication is being carried on in the one-to-one basis between the rep and the doctor versus what is communicated in the mass mailing. And so obviously there could be a potential for a disconnect there, but certainly we applaud their efforts on the mass communication. That is certainly helpful. Mr. Wolf. Well, if you recall in your latter job in politics, the personal contact, the door-to-door asking a constituent for the support had a greater impact than a brochure that was just mailed to the door, that may or may not be read; depending on did it hit on Friday, did it hit when they were on vacation, did it hit whenever. And it would seem to me--and I know the company wants to deal with this issue--I would think it would be a responsibility for the company to go back and make the same kind of contact that they made initially, because if a person were to come by and sit down and explain, that may trigger the doctor to be much more sensitive as to how it should be prescribed, rather than a flier or a brochure or a good package comes through. I know if most of us look at our mail, you know, sometimes Mondays or Tuesdays or Wednesdays, there is so much of it. Sometimes it may never be opened, or if it is opened, it is put aside so that you have that opportunity to look at it when you have time; and generally, sometimes, that never happens. So it would seem to me that there would be a good responsibility and obligation for the company to make the same. If they brought the doctor to an event, then bring the doctor back to an event to make the case. If they went personally to the doctor's office, go back personally to the doctor's office. potential for diversion of other drugs One last question before I recognize Mr. Serrano. We understand--the committee has been told that other time-release medications are being developed. Are we just seeing the beginning of a really big problem? That is one concern. If this is the first wave out of the box, if you will, I think what the company does and what the industry does and what the Congress does and what DEA does will really make a difference. You may be setting a tremendous precedent and, again--I stress ``again''--I feel this burden, this obligation to do it. And I can't speak for the whole committee, but I can speak for myself, I certainly do not want to take away the legitimate use of a drug, as I made the comment. My mom was in Lankenau Hospital up in Philadelphia, and I can still remember, and it just seemed to me that when it was clear that the hospital should have, you know--and yet they couldn't because of the law. So if this is the first of a wave, shouldn't we be particularly careful as we do everything, to make sure that we are not setting bad precedent? Mr. Hutchinson. Oh, absolutely, Mr. Chairman. And you are certainly correct that we have to approach this in the right way, and clearly you pointed out the obligations of industry, and I will let Purdue Pharma address those questions in their testimony. But we have not simply relied upon what they are doing. The DEA has engaged in a strong education campaign. I think through our media comments, as well as our one-to-one comments with the medical community, working with the Pain Management Society, I believe that the information on the abuse potential is out to the medical community. And so I think that we have had a great deal of positive impact in that regard. Your concern is absolutely correct that I do not believe we have reached the peak of this problem yet. I believe we are still on the incline as to the growth of this problem, and I think that what we saw yesterday with the theft of the extraordinary amount of OxyContin in Mexico and the concern that we are going to be seeing those pills here in the United States, without any doubt, and at our request Purdue Pharma has labeled these drugs as to the source and the place of distribution. And so those that have been stolen in Mexico will have a specific label that we will be able to trace and detect, and so we will be able to follow that. But I believe because of the diversion potential, what we are now seeing is just straight-out criminal activity, it is still in the upswing. I think that we will be able to get a handle on this, but we have not got there yet. Mr. Wolf. Mr. Serrano. further steps industry should take to combat drug diversion Mr. Serrano. Thank you, Mr. Chairman. First of all, thank you for your testimony, which was very informative. You said that in dealing with the manufacturers, not all of your demands have been met. What in particular has not been met that you would want to see? Mr. Hutchinson. I want to be careful to make sure I provide you the information, and I have tried not to dwell upon the negative. They have been responsive, but there is--I am talking to Laura Nagel here, who has done an outstanding job with us. We simply asked them to continue with greater education with the medical community, and, you know, to be more conservative in their marketing approach. And they have been somewhat responsive here, but always there are the extra steps we would like to see taken, as the Chairman pointed out; but we simply can push from our standpoint, and they have been responsive, but we would like for them to continue their educational message to the physicians they work with. Mr. Serrano. And you have asked them just to be careful, conservative, as you said. This is one time I think I enjoy the word ``conservative''. Conservative in their marketing approach. I know you are being careful not to be negative and I appreciate that, because you need to continue this relationship if we are going to dent this at all. But would it be fair on my part to say that, in typical fashion, manufacturers usually feel that the abuse is coming from elsewhere and not from them, and so they don't feel responsible for some of their marketing techniques? Mr. Hutchinson. Well--and, of course, they have an obligation to their patients and they want to provide good pain medication and appropriate pain medication and make it available, and so that is the positive thing. Obviously that they look at. And when I talk about our relationships with industry, anytime there is an abuse problem that arises, there is, I believe, a reluctance by industry to take a greater responsibility and to address the problem. And so, you know, initially there was some resistance. I believe we have overcome that resistance, and part of it is because of congressional leadership. Part of it is because the of media attention to this. They have taken some extraordinary steps, but initially there was certainly some resistance on their part, but I believe that now, particularly with their emphasis on the prescription monitoring legislation that can be handled in the States, with their education campaigns, that we are really moving forward in the correct direction. And DEA and FDA work together on these issues. The Food and Drug Administration plays an extraordinary role in determining what is the appropriate message that has to be delivered on the controlled substances to the doctors, and what is the proper restrictions on the industry-to-doctor marketing programs. And so we have worked with them to accomplish that, and the industry has as well. public perception of abuse of legal drugs Mr. Serrano. Let me ask you a question. I hope I am right on this. When most Americans think of drug abuse, they usually think of illegal drugs, and cartels preparing these drugs for sale to invade our communities. But in this case, you have a legal drug, a legal substance, which is very good for what it is intended to do. Do you in your job find it much more difficult to convince the American public that this is a problem because it is a legal drug? Mr. Hutchinson. Yes. You know, I believe that the American public understands there is a problem with prescription drugs. But there are a couple difficulties here. One, young people have a sense that because it comes in pill form, because it is something that belongs in a medicine cabinet or comes from a doctor originally, that they are somehow--this is safer than going out and buying cocaine on the street, and it doesn't have the same type of abuse potential. And so there is that difficulty, educating the American public about the dangers of prescription drugs. And then, secondly, most people do not understand that the DEA has a role in this and that we actually have an enforcement operation that addresses the abuse potential of prescription drugs as well. And so there is that education gap there that we are trying to overcome. profession that contributes most to drug diversion Mr. Serrano. Okay. One last question, Mr. Chairman. In your statement you list how basically this drug gets misused. And it says, including fraudulent prescriptions, pharmacy theft, doctor shoppers, and unscrupulous medical professionals. If you had to break them into percentages, which one is which? Mr. Hutchinson. I am not sure you could quantify those quite that easily. They are all a serious problem, but initially it wasn't simply an unscrupulous doctor. It might have been a doctor that didn't receive the proper information or education or have a proper understanding of abuse potential, and maybe was prescribing it to a patient in which it was not required. And I believe we have overcome that education problem, and so now it is primarily looking at pharmacy theft. I think there is probably the greatest problem of prescription forgeries. And then you always have the problem of a doctor who, in violation of his commitment to the profession and to the law, allows scrips to be written, writes the scrips without there being a legitimate medical reason, and really is engaging in the diversion of that. So we have to address all of these. But I think right now one of the greatest concerns is not simply the diversion of it, but it is the criminal activity that engages in the theft of it, and then the marketing of it on the street. Mr. Serrano. All right. Thank you, Mr. Chairman. Mr. Wolf. Mr. Rogers. Resources Used on OxyContin Mr. Rogers. Thank you, Mr. Chairman. And thank you, Mr. Director, for being with us today. Let me focus on your national action plan that you mentioned in your opening remarks, focusing on diversion and doctor fraud. You have been provided over $86 million this fiscal year in the diversion control account. How much of that will be spent on OxyContin-related problems? Can you give us a handle on that? Mr. Hutchinson. We could probably break some of it down into agent hours, but what we have done is to move OxyContin as one of the top priorities of the diversion program, and not just the diversion program where we have the diversion investigators investigating pharmacies, doctors that might lead to the abuse of it, but also on the enforcement side the agents are investing their time. So for that expenditure of money, it is one of the top priorities; but in that budget of money, you are looking at looking at the precursor chemicals to methamphetamine. You are looking at all of the range of controlled substances, as well as on the OxyContin side, we would use our regulatory controls to be looking at the manufacturer to make sure they have the proper protections for their plants and to look at the diversion every step of the line. So it is hard to quantify exactly how those dollars flow through, one of the top priorities. Mr. Rogers. Give us an idea of how many investigators are assigned just to OxyContin problems. Mr. Hutchinson. Mr. Rogers, we do not assign agents by drug or investigators by drug, and so all I can tell you is that we have told them to put this at the top of the list for work. And we just do not do our work simply by drug, because whenever they review, for example, a doctor's records, they are looking at all of the prescription drugs, not just one. And whenever we are reviewing the work of a manufacturer, we are looking at all of the controlled substances that they would review. And so we really do not break it down in that category. Mr. Rogers. Well I am trying to get an idea of how far up the list of problems that you have to deal with--and there are many--this one is. Mr. Hutchinson. This would be a better way to express it from our standpoint. In 1999 we had a half a dozen OxyContin cases; in 2000 we had 37 cases; and in 2001, up to August, we had 168 cases. So over a year's time--really in 2001, we have over five times as many cases as in the entire year of 2000. And so you can see that it is dramatically eating up our investigative resources. Mr. Rogers. Regarding these diversion officers that have been described--can they initiate criminal investigations? Can they secure search warrants? Can they make arrests? Can they do a real criminal investigation? Mr. Hutchinson. They do the background work for it. They review the records for it. They initiate it. And then for the actual criminal activity, from the search warrants to the surveillance, we have the special agents that would be working with the diversion units to carry out the investigation. So they do have responsibility, but they use the agents to carry it out. Mr. Rogers. And how many special agents do we have assigned to this? Mr. Hutchinson. Each diversion unit will have in each State, in each division, will have special agents that will be assigned to the diversion program that will carry out the investigative responsibilities. Resources In Kentucky Mr. Rogers. For example, in Kentucky, how many special agents would that be? Mr. Hutchinson. Let me check Kentucky here for a moment. Mr. Rogers, we will have to get that information to you. In regard to Kentucky, though, I can give you the number of agents that we have, as well as investigative personnel. In fact I have that in front of me. In Kentucky we have on board--these are diversions. We have 7 diversion investigators for the entire State of Kentucky. And then supplementing that, we would have the special agents that would work with them. But the diversion are ones that initiate the investigations. They have a huge responsibility to all the doctors and all the pharmacies in the entire State of Kentucky. Mr. Rogers. Well, there are 120 counties in the State. You are severely undermanned, do you admit? Mr. Hutchinson. Absolutely. Coordinating Resources With State and Local Enforcement Mr. Rogers. But you have an army of law enforcement people out there. Local city police, sheriffs, and other law State enforcement personnel who are capable of big-time help in this problem. Some of the people that we will hear from today testifying from State and local law enforcement express a frustration about the lack of Federal resources to help them combat the problem on the local level. You have a report due on this, on how you plan to coordinate your resources with the State and local law enforcement people. Can you tell us the status of that report and when we can expect it? Mr. Hutchinson. In regard to our cooperative efforts, that is a high priority. And, for example, we indicated we have 7 diversion investigators in Kentucky, but they work alongside State and local task forces, and so we try to multiply our efforts with their resources; and so we are working with them, as well as engaging in educational efforts with our law enforcement and diversion components in the States. In regards to the report, we will shortly forward that report to the Committee. [The information follows:] DRUG ENFORCEMENT ADMINISTRATION, STAFFING FOR KENTUCKY, AUTHORIZED POSITIONS AND ON-BOARD STAFFING REPORT [Pay Period 24--Ending December 15, 2001] -------------------------------------------------------------------------------------------------------------------------------------------------------- SA DI IS TC Total Office location -------------------------------------------------------------------------------------------------------- Auth O/B Vac Auth O/B Vac Auth O/B Vac Auth O/B Vac Auth O/B Vac -------------------------------------------------------------------------------------------------------------------------------------------------------- Lexington, KY Resident Office.................. 4 5 1 ..... ..... ..... ..... ..... ..... 1 1 ..... 5 6 1 London, KY Resident Office..................... 4 2 -2 2 2 ..... 2 2 ..... 1 1 ..... 9 7 -2 Louisville, KY District Office................. 9 10 1 5 4 -1 ..... ..... ..... 3 3 ..... 17 17 ..... Madisonville, KY Post of Duty.................. 2 2 ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... 2 2 -------------------------------------------------------------------------------------------------------------------------------------------------------- Key: SA--Special Agent; DI--Diversion Investigator; IS--Intelligence Specialist; TC--Technical Clerical; Auth--Authorized; O/B--On-Board; VAC--Vacancies (Negatives=vacancies, positives=overages). Note.--All Kentucky Offices report to the Detroit, Michigan Division Office. Mr. Rogers. Shouldn't you consider stepping up your drug diversion efforts in the local communities? I mean, there are a thousand pharmacies in Kentucky. You have seven diversion officers for the whole State, and a few special agents. Every one of those places where pharmacies are located have local police forces, local sheriff's forces and other--State law enforcement, and yet we are hearing from those people that DEA is not really plugged into this. They are not getting the proper resources from DEA and the Federal agencies. And I am asking you, do you need more money for that type of thing? Mr. Hutchinson. The answer is yes, Mr. Chairman. Mr. Rogers. How much money do you need? Mr. Hutchinson. We have put in a budget request for FY 2003, and we have asked for 50 additional diversion investigators, which would be funded out of our diversion fee account. And this is absolutely essential for us in terms of our diversion investigators. Whenever you look at what we have to do to support, you know, our local counterparts, I would assure you, of those 50 diversion investigators, we will get some resources in Kentucky. Mr. Rogers. Well, what I think the local law enforcement people need, and I am speaking generally here, not just about my State, what they need is money and support for undercover operations, for drug buys, for going underground and rooting out the problem from where it exists. What can we do to help in that respect? Mr. Hutchinson. Well, we do fund drug buys. We work with our local counterparts and our task forces in sharing intelligence. As to the criminal activity, we develop informants. We give them the buy money to accomplish that in a very cooperative effort. For example, as I have traveled around the country to the different DEA offices, I will have an all- hands meeting--which is what we call it--and I will have all the DEA employees in there, and I will ask them how many are task force officers. And I will have, probably, at least a third--if there are 100 there, a third of them will be task force officers, which will be the Louisville Police Department, the Kentucky State Police, will all be a part of these task forces. So we work alongside of them, we develop these cases. And the same is true for the diversion side. Obviously we need to do much in that arena. And the monitoring part, once we get a better handle on where the abuses are, then we are going to be able to respond more quickly and be able to get a handle on it much quicker. purdue pharma's marketing program Mr. Rogers. Let me quickly deal with the Purdue Pharma matters. Did they offer incentives to patients and/or doctors to try OxyContin? Mr. Hutchinson. They had a very aggressive marketing program. I could not give you the details of that, other than what I have described in their direct doctor marketing that we have demonstrated. Mr. Rogers. They would go to see a doctor, and what would they use to induce the doctor to try OxyContin? Are there some incentives to the doctor to do that? Mr. Hutchinson. I am not aware of anything in terms of financial incentives. Obviously, you have information concerning a retreat or a seminar that they might have an expense paid trip to. That is just in general how the industry works from time to time. Mr. Rogers. Was that used in this respect? Mr. Hutchinson. That was my understanding, yes. Mr. Rogers. Free trips. Mr. Hutchinson. Correct. Mr. Rogers. Anything else? Mr. Hutchinson. That is the substance of it. I am not aware of any other financial incentives. Mr. Rogers. Is it common for a pharmaceutical company to sell a drug that is a Schedule II narcotic such as OxyContin? Is that a common practice? For a company to market a narcotic in this fashion? I can understand maybe selling the idea of a doctor prescribing an aspirin or something, but a Schedule II narcotic? Mr. Hutchinson. I don't believe we have seen as aggressive a marketing program for a Schedule II drug as we have seen with OxyContin. Mr. Rogers. Was this drug marketed more aggressively in certain parts of the country; say, Appalachia? Mr. Hutchinson. I could not specify the particular rural areas of the country. I know they were marketing to doctors that had a record of prescribing other types of analgesics. So that is where they had a very targeted audience for those doctors that were prescribing pain medication. Mr. Rogers. In certain parts of the country; for example in Appalachia, coal mining has been a way of life and injuries and disease from that occupation have impacted a disproportionate number of our citizens. A larger proportion of our people, perhaps, need pain medication than other parts of the country. Did you find any indication that they sought out that particular area for marketing? Mr. Hutchinson. Well, that is consistent with their marketing plan to go after the doctors that had a history of prescribing pain medication. And so if you are looking at Appalachia where you have a significant portion of the population needing pain medication, then that would certainly be part of the targeted market area for the industry in marketing OxyContin. restricting prescription of oxycontin Mr. Rogers. Has there been given any thought to restricting who can prescribe OxyContin; for example, restricting the number of doctors who would be allowed to prescribe OxyContin so that there could be tighter control on the number of medications that are dispensed? Mr. Hutchinson. Yes. That has been debated and discussed. Obviously it would be easier from the standpoint of the DEA and those who are concerned about abuse potential if only pain specialists, doctors who were certified pain specialists, that they would be restricted and limited to be the ones that prescribed this OxyContin. Whenever you have family practitioners, you have every type of doctor out there with a potential of prescribing it, it is a very, very broad arena and you wouldn't have the same level of expertise in pain management as you would with the pain management specialists. But the problem would be in some rural areas you don't have that level of expertise, and so that has only been discussed. drug cartels and oxycontin distribution Mr. Rogers. But the real problem now, it seems to me, is the problem has gone underground. Distribution of OxyContin-- the illegal use of it--you get it buying it on the street. Perhaps those pills that were stolen in Mexico City is a good example of the illegitimate sequestration of these pills away from their legitimate use, and then selling it underground. So therefore the law enforcement end of the problem is the big end. Are there indications that any of the cartels, organized crime, are involved now in the distribution of OxyContin illegally? Mr. Hutchinson. There have been very limited instances of Mexican organizations that would, as they transport marijuana or cocaine, they would have a certain amount of OxyContin. There have been limited instances of that. But there is a great concern. We are monitoring, certainly, the robbery in Mexico of nine armed men, I believe it was, yesterday. This will certainly cause us to monitor that very carefully. And you are right, Mr. Rogers, that is a growing concern, the criminal activity, but the diversion by doctors is still a concern that we will keep looking after. oxycontin sales over internet Mr. Rogers. I have even noticed an increase on the Internet, the so-called one-stop pharmacy shops on the Internet boldly claiming how anybody, any consumer, can get OxyContin without a prescription, just a click of the mouse. Many of these sites on the Internet say that they are getting their supply directly from Mexico. Have you seen that? Are you aware of that? Mr. Hutchinson. We are aware of that. Mr. Rogers. Is that legal? Mr. Hutchinson. It would not be--you cannot prescribe anything without a legitimate medical reason, and if a doctor operates on the Internet there is not the doctor/patient relationship, and there is a question immediately as to whether there is a legitimate medical need that is documented; and there is a much higher potential for abuse and we are investigating a number of those cases. Mr. Rogers. It would be really easy for anybody, a law enforcement officer for example, to click on the Internet, and say, yeah, give me some and then track it down. They are saying it is coming from Mexico. Have we tracked down that particular effort? Mr. Hutchinson. It is illegal to bring in the OxyContin from Mexico back into the United States. Mr. Rogers. It is also illegal to purchase it without a prescription. Mr. Hutchinson. Absolutely. Mr. Rogers. Are we cracking down on the Internet access to OxyContin without a prescription? Mr. Hutchinson. We are cracking down on that. We are investigating a number of cases. It is resource intensive, but we are utilizing every investigative tool, including our review of the Internet. Mr. Rogers. I don't want to advertise this Internet site but I have one in my hand here, a copy of an Internet site, and it is blatant. No prescriptions required. Yes, we have a reliable OxyContin source; U.S. and foreign doctor consultation now available. Seizure protection plans; 100 percent reimbursement if your order gets seized. Advocacy protection plan, 50 to 100 percent reimbursement. And so on. This is blatant. How are you letting them get by with that? Mr. Hutchinson. Well, I don't believe we are letting them get by with that. Obviously if you go to the Internet, there is a great concern, because you can see recipes for methamphetamine, you can learn how to manufacture Ecstacy; because on the Internet, as you know, Mr. Rogers it is not just simply United States source of information, but it is international source of information that is designed to be difficult to regulate and to pursue cases. We are doing it, but that is clearly resource intensive. There are many protections that try to make it difficult to prosecute those cases but we have a number of cases that are ongoing. We hope to have some success. Mr. Rogers. I thank you. Mr. Chairman, thank you. Mr. Wolf. Thank you. Mr. Mollohan. Mr. Mollohan. Thank you. Welcome to the hearing. Mr. Hutchinson. Thank you. first knowledge of oxycontin as a problem Mr. Mollohan. In the previous question about when did this problem come to your attention, you said 2 years after the product came on the market. When did the misuse of OxyContin come to your attention? Mr. Hutchinson. We first met with Purdue Pharma on August 5, 1999 to discuss the issues regarding the purchase of raw material, their sales history and forecast. We again met with them on February 24th of 2000. During that meeting we talked about their marketing campaign and the dramatic increase in sales of the product. We again met with them on March 22nd of 2001 regarding the concern on the diversion of OxyContin. At that time we requested additional information about rapidly increasing sales. Mr. Mollohan. But the problem first came to your attention in 1999, I take it? Mr. Hutchinson. It was during that time, because that was around the first time we had met with Purdue Pharma. Mr. Mollohan. At that time, how would you characterize the problem or how was it characterized to you? Mr. Hutchinson. As a looming battleship on the radar screen. growth of oxycontin Mr. Mollohan. Where did the problem first arise and where was it when it first came to your attention? Mr. Hutchinson. Well, it first arose in the more rural areas, Kentucky, Virginia, in that arena. I was not at the DEA at that time, but that clearly was the history of the development of the problem of OxyContin. Mr. Mollohan. And what I want to do is get some sense of the scope of it when it first started, and to what extent it has grown, and what is the scope of it today, both quantitatively and geographically. Can you talk about that, how it is spreading, and what are the trend lines? Mr. Hutchinson. Well the trend line almost grows off the chart. I asked them to quantify---- Mr. Mollohan. Who is ``them''? Mr. Hutchinson. My diversion investigators at the DEA. But the prescriptions grew from 1996 to 2000 up to--1,850 percent. But, obviously, you are starting down at zero, and so when you go up the percents are just astronomical. But during that same time period---- Mr. Mollohan. What time period? Mr. Hutchinson. From 1996 to 2000. Other prescriptions for opioid analgesics only grew 23.4 percent, so you can see the extraordinary growth. Mr. Mollohan. You are talking about prescriptions here? Mr. Hutchinson. Yes, I am speaking of prescriptions. Mr. Mollohan. You are not talking about the misuse of prescriptions? Mr. Hutchinson. No. To represent the misuse of it and to show how our education process worked, these are emergency department episodes as to how they grew, and these are for oxycodone emergency room mentions, and you can see that in 1997 they were a little over 4,000 and they grew to over 10,000 in the year 2000. So these are emergency room mentions of abuse potential of oxycodone, which is the subsidy narcotic in OxyContin. So we followed this through the emergency room admissions, the mentions, as well as through the sales of it. Mr. Mollohan. Do these numbers track--I am not sure what correlation you are trying to make here, but do these emergency room visits track the increase in prescriptions of OxyContin? Mr. Hutchinson. Yes. In other words, as the use of OxyContin increased in our society as prescriptions rose, you saw, in a correlated fashion, the increase in the number of oxycodone-related mentions in emergency room departments. Mr. Mollohan. Is the emergency room incident increase your measurement of the increase in the problem, the growth in the scope of the problem? Mr. Hutchinson. That is one measure. Mr. Mollohan. What are other measures? Mr. Hutchinson. Oxycodone, of course, does not specify which particular brand name, and so the industry would say we don't know whether that was OxyContin or not. That is why we tried to develop a stronger statistical base and did our own survey of the medical examiners that I referred to in my original testimony, in which we not only asked them for the oxycodone-related deaths but to specify were there OxyContin tablets found in the body; were the pills next to the deceased; was there a documented source of it as OxyContin versus the generic oxycodone? And because of that, we were able to tie down more specifically the number of deaths related to OxyContin. Mr. Mollohan. Is there an oxycodone problem outside the misuse of OxyContin? Mr. Hutchinson. There are other prescriptions that are subject to abuse, but none of them have received or developed the same abuse potential and misuse as OxyContin. investigating misuse of prescriptions Mr. Mollohan. What you described here is the manifestation of the problem or the end result of the problem, people taking the drug and getting ill or dying from it. What about the misuse of prescriptions? Are you being successful in investigating that? Do you have statistics with regard to misuse of prescriptions or misuse of the drug on the supply side? Mr. Hutchinson. In general for controlled substances? Mr. Mollohan. No. For OxyContin. Mr. Hutchinson. Well, OxyContin came on the scene I believe in 1995 or 1996, so we don't have a handle on that. I do believe that because of the education efforts and the States adopting prescription monitoring programs, we are getting a handle on certain aspects at the present time. But we can demonstrate success on other prescription drugs. Mr. Mollohan. But that is the problem, isn't it? It is the abuse of this drug--the misprescription of it. Either you have doctors who are violating the law or people are taking the drug and misusing it. Obviously this is an extremely hard problem. It is not where you have an illegal drug which is being misused. How do you sort through the problem of making sure the drug is available for proper use and at the same time eliminating the misuse of it? It seems to me there has to be a primary focus on that misuse, either doctors misprescribing it or patients misusing it. And so I am asking you to discuss that focus of your effort in controlling this problem. Mr. Hutchinson. Well, first of all, we do try to have a balanced approach. We have had some criticism that we were using heavy-handed tactics, which I don't think were justified, but doctors get a little bit concerned and they want to have the freedom to be able to prescribe legitimate pain medication. And so we don't want to discourage the legitimate use of pain medication, including OxyContin; but on the abuse side, we are taking aggressive efforts to, for example, restrict the quota for the industry as to how much they can produce and put on the market. Secondly, we are doing the education campaign with the medical community, law enforcement, as well as with the public, on the abuse potential. And, thirdly, we are doing everything we can in the enforcement area by pursuing any doctors that are acting inappropriately, as well as the pharmacies, as well as patients, such as the sheriff down in Louisiana that engaged in prescription fraud. geographical spread of oxycontin Mr. Mollohan. Let me back up a second because I would like to get a quantitative handle on this before you get into how you are addressing it. Describe for us how it has spread geographically. We know it is a problem in rural areas, and it is a problem in southern West Virginia and Kentucky. Is that where it started? Mr. Hutchinson. It started in those rural areas. Mr. Mollohan. Where has it spread to? Mr. Hutchinson. It has spread---- Mr. Mollohan. Geographically. Mr. Hutchinson. Well, to the urban areas; for example, in the New England area, and actually that was one of the original States of concern as well. I mentioned Kentucky and Virginia, but the New England States were one of the first areas of difficulty in the rural areas there. The Boston area has had serious problems with OxyContin going down to Florida. Whenever we talk about drug education programs, we think about teens. Florida has an aggressive drug education program for the elderly because of OxyContin abuse. So it has moved dramatically into Florida. They are looking at prescription monitoring program legislation. So that is an example. You are looking all across the South as abuse potential and areas of concern for us. Mr. Mollohan. Where is it happening now, where is it increasing? New England, Florida? Where else? Midwest is not a problem? California is not a problem? Mr. Hutchinson. No. Actually, in many of those areas the methamphetamine is a growing problem and OxyContin is just an area of concern. California is not a problem. So it is along the East Coast and the South that is the greatest concern. Mr. Mollohan. Have you prosecuted any of these cases? Mr. Hutchinson. We have prosecuted many cases. trend line of oxycontin Mr. Mollohan. What does that trend line look like? Mr. Hutchinson. Well, it is increasing. As I indicated, we have handled in 1999 a half dozen OxyContin cases, criminal cases. Mr. Mollohan. Six criminal OxyContin cases in 1999. Mr. Hutchinson. That is correct. In 2000 we handled 37 prosecutions, and these are all at the Federal level; and in 2001 we handled 168 cases up through August. So you can see the dramatic increase in the investigative resources and the prosecutions. Mr. Mollohan. These are for what violations of law? Mr. Hutchinson. These would be for illegal diversion of it. These would be diversion cases, which would include whether it be a pharmacy, it would be a doctor that diverts it, or prescription fraud. Mr. Mollohan. In your concluding remarks here, you say DEA recognizes that the best means of preventing the diversion of controlled substances, including OxyContin and all other drugs, is to increase awareness of the proper use and potential dangers of the product. That just seems so inadequate to me, that the best means of preventing diversion is to increase awareness of the proper use and potential dangers of the product. People who are going to be responsive to proper use and potential dangers are going to be people that are easily convinced not to abuse the drug. People who are going to abuse it, I wouldn't think would be responsive to that tactic at all. Mr. Hutchinson. Certainly there is more to it than that, but whether you are talking about OxyContin or methamphetamine or cocaine, I believe that drug education is critically important. Mr. Mollohan. This is a legal drug, though. Mr. Hutchinson. It is important with reference to legal drugs as well. Clearly the education we are referring to primarily goes to the doctors so it is legitimately used and not overprescribed. Secondly, with patients when they are aware of an extraordinary addictive substance, they are more hesitant to ask for the drug or to push the doctor to prescribe it. Thirdly, whenever you are talking about young people or adults out there, whenever they see the death potential of it they are less likely to purchase it on the street. But clearly that doesn't address the robbery in Mexico, it doesn't address the pharmacy robberies in Boston. That is an enforcement activity. And so you balance what we said in that statement about education with the aggressive enforcement activities, reflected in the fact that five times as many cases are being prosecuted. Mr. Mollohan. And you are undertaking that aggressive enforcement activity? Mr. Hutchinson. Yes, sir, and we will continue to do so. Mr. Mollohan. Thank you. Mr. Hutchinson. Thank you. Mr. Wolf. Mr. Latham. the oxycontin customer Mr. Latham. Thank you, Mr. Chairman, and I will be brief. I guess I would like to go to who the customer is for the diverted drugs. Is there--and I hate to use the word ``profile,'' but is there an idea of who the user is in an illegal basis out there? Could you tell me, how have people found out about it? Is there any kind of organized effort, as in my part of the country, with methamphetamines to promote and sell and give away the drug itself? Who is using it illegally and how are they finding out about it? Mr. Hutchinson. You have a number of different abusers. First of all, you have the added population that look at this as a substitute for heroin. So it is a way that they can fulfill their addiction. Secondly, you are looking at the criminal side of it, the organizations that might engage in a robbery in order that they can sell it on the street for profit. Thirdly, you are looking at the accidental addict that becomes addicted to it, and then because of that addiction engages in, like the sheriff did, forging a prescription. So all of those are areas of concern for us. And on the street, you ask about how do they find out about it. The education on the street is much quicker than it is in law enforcement circles, I regret to say. The word spreads as to new drug of abuse, a new potential out there. So they will figure out the means to be able to forge a prescription, to be able to go to the doctor, talk them into a prescription of the OxyContin, but then in addition it is on the street and there is profit in the sale of it. cost of oxycontin on the street Mr. Latham. Speaking of the profit part of it, how does the cost for an illegal user compare to other, say, heroin or comparative drugs? Mr. Hutchinson. Well, the costs for a 10 milligram tablet, $10 for OxyContin; for a 40 milligram tablet of OxyContin, $40. So you can see that kind of sale value on the street. Mr. Latham. What does one tablet do? Is this a 3-hour high? Are you out for 2 days, or what? Mr. Hutchinson. I probably couldn't give you as much specifics as you would like. I would be glad to get back to you on that, but part of the compilation construction of OxyContin is that it is a controlled release, and so if it is taken in pill form, then the pain relief component of it is gradually released over a 24-hour period. If you crunch it, which of course the addicts do, and you destroy the time-released capsule, then you get an immediate rush that comes from it. And, of course, the more powerful, whether it is a 10 milligram or a 40 milligram, will make a huge difference in the capacity of it. But as you can see, this is sold in 10 milligram, 20 milligram, 40 milligram, 80 milligram, and 160 milligram tablets, obviously with increasing abuse potential in each of those increasing dosages. Mr. Latham. How much would be lethal for an average, say, 170-pound male? Do you have any idea? Mr. Hutchinson. What would be lethal? It would depend upon the previous usages and tolerance. For example, whenever we see death resulting from it, many times that will not be from the addict population, heroin addicts, because they have built up that tolerance and their system is able to ingest it and tolerate even the higher dosages of it. But if you have a first-time user or a casual user, then even a smaller dosage could lead to death or serious illness. addictive characteristics Mr. Latham. Could you give me any idea of the addictiveness? You and I have talked many times about methamphetamine, which is in our part of the country, and how potentially with just one use you are addicted, possibly. How does this relate to that? How long do you have to use it to really be totally addicted, or is there, say, a casual user? Is that possible over time? Mr. Hutchinson. Clearly it can be prescribed in a way by doctors who are treating pain. That would not lead to addiction if it is carefully done, and that is why you need a doctor who is trained in pain management, who has a great understanding of the abuse potential here. But in reference to the strength and its comparison to, say, heroin, I simply asked a similar question that you did, Mr. Latham, about why is this so popular. And the answer came back to me by my experts, ``Because it is better than heroin.'' so clearly it has the same addictive characteristics as that drug. Mr. Latham. The heroin user would be the main target for someone who is already a drug addict or involved with drugs. Does it replace any other drugs or is it the drug of choice; or is there a steppingstone--marijuana, cocaine, then you go to this? Or have you seen any profile like that? Mr. Hutchinson. Well, it certainly serves as a heroin substitute, and so the heroin addict population is certainly a good target or market base for those who would want to divert it and develop that market. But also it is those who are experimenting in drugs. It is those that might be sold it on the street and not being told all the information. You know there are polydrug abusers that are out there. So you know it is--all the varieties that you described are potentials of the abuse of OxyContin. oxycontin classified as moderate drug Mr. Latham. Thank you, Mr. Chairman. I am going to have to leave for another appointment. Thank you very much. Mr. Wolf. Thank you very much. When you made the last comment about the addictive nature of it and how strong it is, and I looked through all the testimony last night and there was one where it was said the high is felt before the needle is out of the arm. Maybe the Food and Drug Administration made a mistake when they allowed this to come out under the definition of moderate to severe. Clearly, again, if someone is suffering from cancer, clearly this is an outstanding drug and the opportunity for a doctor to prescribe it, but if somebody maybe just has a moderate--I pain don't have any definition of ``moderate.'' But the dangerousness of this with regard to moderate, where you could slip into overuse--I also read the testimony of this gentleman, Donnie Coots from Hazard, Kentucky, with regard to his son. Maybe the Food and Drug Administration made a very big mistake when they used a definition of ``moderate.'' This may be a very good drug that doctors ought to have the ability to deal with, but maybe ``moderate'' is not the right word. And I think this is something that I would urge you as you are dealing with your colleagues in another agency, at the Food and Drug Administration, to make sure that the next one that comes out, that they may not be as lax as they were. Or maybe I am wrong in my analysis, just thinking this thing through, and I am not going to get you into defining ``moderate,'' because you are not a doctor and I am not a doctor, but what is an example of ``moderate''? Is it a backache after a weekend of cutting wood and sawing wood, as I have cleared my property and sometimes on a Saturday night I come in and I just know the next morning I am in pain, and then I take Advil. So maybe the ``moderate'' thing is where we have kind of slipped into this thing and now we have families that are being devastated. So I am not going to put you in a position to give us a definition, but it does say ``moderate to severe,'' and if you want to comment you are welcome to comment, but I would urge you to talk to your colleagues at the Food and Drug Administration, because here we may have a very good thing that we really need and maybe there is another drug coming that is even better than this, that will help people like my mom and dad, or people we all know who are going through a difficult time. And many of us may very well be in that role in some years in the future, and neither the day nor the hour do we know, as it says in the Bible, but in the process of getting there I want to be careful that we don't open the door and flood it out. And then young kids start using it, as Mr. Rogers was talking about, high school and all, because the definition of ``moderate'' makes it seem okay and a doctor who is really trying to serve his patients may see this and is so busy in seeing 50 patients a day, may think that is okay. So I think you ought to be talking to the Food and Drug Administration. They may have messed up here. Mr. Hutchinson. You are absolutely correct that the FDA plays a critical role in setting those types of standards and the abuse potential, because that creates a framework for the message that the industry uses for the doctors. And so they play a very critical role in it. And you are right I don't want to describe the pain---- Mr. Wolf. I don't want to get you into that. I am going to ask the subcommittee to send a letter to the Food and Drug Administration and ask if they were to redefine and do this today, would they make it ``moderate to severe,'' or would they have it for ``severe,'' and ask the Food and Drug Administration to tell us with clarity just yes or no, and not some long word where they may not want to admit they made a mistake; but tell us, looking back on this, because we can learn from this so we never have to go through this again, so that the pain and suffering and agony in little villages like in Harold Rogers' district, where it is coming to my district, where moms and dads are faced with the situation whereby the only way they can deal with this, because they cannot afford treatment, they can't send their children to Betty Ford Clinic out in Palm Springs, so therefore they turn them in to law enforcement, so they get sent to prison with the idea that that may be their only hope. So we will send that letter to the Food and Drug Administration and we will be glad to share with you what they say. But I want to again thank you for your testimony, and I appreciate it very much. Mr. Hutchinson. Thank you. Mr. Wolf. I see people leave top jobs in the Administration and they go run for Congress. You left Congress to go for a top job in the Administration. Mr. Hutchinson. I have always been backwards. Mr. Wolf. No. I think it is a public service, and I for one appreciate it very much. Mr. Hutchinson. Thank you, Mr. Chairman. Mr. Wolf. Maybe you are like Esther for just a time like this. So thank you very much. Tuesday, December 11, 2001. STATE AND LOCAL LAW ENFORCEMENT WITNESSES PROSECUTOR TAMMY McELYEA, LEE COUNTY, VIRGINIA LIEUTENANT STEVEN HUDSON, PRINCE WILLIAM/MANASSAS NARCOTICS TASK FORCE ROD MAGGARD, FORMER POLICE CHIEF, HAZARD, KENTUCKY CAPTAIN RICK HALL, WEST VIRGINIA STATE POLICE Mr. Wolf. The next panel would be Prosecutor Tammy McElyea from Lee County, Virginia; Lieutenant Steven Hudson from Prince William/Manassas Narcotics Task Force; Rod Maggard, former Police Chief at Hazard, Kentucky; Captain Rick Hall of the West Virginia State Police. If you would all come up together and begin in that order. And perhaps in the interest of time, we are going to stay here as long as the hearing goes on, but I feel an obligation to Dr. Goldenheim and also to the medical community to make sure they have a fair opportunity. So if you could summarize your statements, and then there will be an opportunity for questions and answers. Your full statement will appear in the record as if read. Tammy, you may begin. Ms. McElyea. Thank you, Congressman Wolf. I sincerely want to thank the subcommittee for giving their time and attention to this. I am going to try to summarize this because I realize it was a fairly long statement, and I honestly think that if you had spent a month with me, I couldn't tell you all that we have been through, but I hope to hit the highlights here. Lee County is of course located in the western-most part of Virginia. We are in the Appalachian Mountains and we are close to Kentucky. You actually border us, and we are bordered by Tennessee as well. I have been a Commonwealth attorney there for 10 years, and frankly I thought I had probably seen everything that one could see, but I had a hard lesson to learn. I would like to say that like Congressman Wolf, recently both my father and my grandmother passed away, and at the end of their lives they were in terrible pain, and I can remember standing in that long hallway listening to my grandmother cry out, and I know what a family feels. And I certainly know that OxyContin can be a miracle drug, but what I have learned is that we must very closely guard such miracle drugs or they can quickly become our worst nightmare. And that's truly what happened to my county. We were not new to drug abuse, like I think every other county in the Nation, but what we had seen in the past didn't come close to prepare us to what we were going to face. And it all started basically in 1999, and we were overwhelmed without warning. Before this, we had seen sort of a progression of drug use among our addicts. They went basically from marijuana to the harder drugs, but OxyContin changed this definitely for the worst. We saw first-time drug users who were actually starting out with OxyContin. It was amazing to see how quickly people became addicted, and all of a sudden the most important thing in their lives was to get this drug, and whatever it took was not beyond their comprehension or their ability to try to do. It was literally like nothing we had ever seen before. Its abuse transcended all ages, all economic barriers, and it transcended all educational backgrounds. It seemed to basically become an epidemic overnight for us. And, fortunately, I was the one who had talked to an addict and have talked to basically several addicts and asked them why they preferred this to the other drugs, particularly heroin, and it is because of the immediate high that they can receive from it. They literally tell me they do not get the needle out of their arm before they are high. They inject even underneath their fingernails, underneath their toenails, in between their toes. Anywhere that they can basically stick a needle in, that is what they do. The profit margin is extraordinary on the street. That has been one of the major things we have had to deal with. If you obtain it legally, it is about 10 cents per milligram. If you sell it on the street, it is about $1 per milligram. The most recent that we have bought off the streets, the 80 milligram pills, cost us a range of $120 to $150. The 40 milligrams are costing us $70. So the profit margin has drastically increased, we hope due to the efforts of law enforcement to try to take some of this off of the streets and to reduce the quantity that is available. Theft crimes. I couldn't begin to tell you what has happened to us with regard to theft crimes. They have soared in our county. The average annual value of reported property stolen--now, this is reported property--has exceeded $250,000 a year for the past few years. Many people do not report their property stolen because they feel like there is so much theft, it is basically a useless activity for them to report it and a waste of their time. Violent crimes have soared in Lee county. We rarely saw an armed robbery before we became involved with this rampant OxyContin abuse. Perhaps, most sadly, a lady in her mid- seventies, from Florida, had come back to our county because we were safe and we were rural, we were a nice place to live. What happened was that as she waited for her husband to come out of a medical clinic for a doctor's appointment, she was physically beaten and robbed of her purse by a young man in his mid- twenties. This was something that we really had not seen before, and the fact that this occurred on a main street in the middle of a small town was absolutely no deterrent; it did nothing to stop the crime. We have had young people in their homes and robbed couples at gunpoint. That was something we had not seen before. And we have seen the occasional robbery of a store, which was something we really had not seen before. We have a problem with doctor shopping. Where we are situated makes it very easy to travel into Kentucky, makes it very easy to travel into Tennessee. What happened was that addicts go from one doctor to another. They go from psychiatrists, dentists, and physicians, to secure multiple prescriptions for this drug. We have even had occasions where they have traveled across State lines and had their teeth pulled, one at a time, to get multiple prescriptions for the drug. The addict now turns dealer. What they do is sell to continue to foot the costs for their multiple prescriptions that they have, and to continue the profit margin. A 900 percent profit margin is a pretty difficult thing to combat on the streets. The money is difficult for the law enforcement to come up with, and the manpower is difficult. Our investigators have worked exhausting hours. It has been something that has totally consumed them. It has consumed the prosecutor's office, it has consumed the courts, and it is consuming the taxpayers, whether they realize it or not. A lot of these prescriptions, particularly in our area where we are economically dependent a great deal on government benefits, you pay for this prescription with your tax dollars. A Medicaid patient pays $1 for it, and turns around and sells it on the street; they can get 60 40-milligram pills. That is $2,400, and it costs them a $1 investment. We basically were to the point that the sheriff and I sat down and spent many hours talking about this. We didn't know what to do. Virginia has lenient sentencing guidelines. We were marching people into the courts, and they would come right back out under our guidelines. We turned to the Federal authorities for help. It was interesting to listen to the DEA. We turned to the ATF for help. The ATF stepped in and assisted us in a way that we have never been helped before. Lee County has a lot of guns. We hunt. And what happened was that anything that could be traded for a pill became a target of theft. Anything they could get their hands on was stolen and traded. This led the ATF to assist us, because anytime that we could put a guns for drug trade or felony possession of a firearm, it meant that they would face a lengthy Federal sentence. The ATF worked with our local sheriff's department. We had some very aggressive ATF agents, and through their efforts we have--in fact, we have had the first two kingpin in the Nation prosecuted that arose out of a Lee County investigation. We currently have awaiting--not under the kingpin statute--but a prosecution in the county for a gentleman who is alleged to have distributed in excess of 122,000 OxyContin pills. And that may not sound like a lot, but our population in our county is only 24,000. This has literally affected every family in our county, and I cannot stress that to you enough. They were either dealing with an addict or dealing with theft or with both. Check fraud just overtook us. Prescription forgery also was a problem for us. It has been something that has been a nightmare, and I do not know if it stopped today how long it would take us to recover from it. We work still night and day to try to deal with this, and some of the ways that it has been dealt have been certainly less than desirable for parents of addicts. We have had people turn in their own children out of desperation. Those children have ended up serving lengthy penitentiary sentences in the Federal system, and the sad thing is they would rather see their children in jail than free to continue to abuse this drug. We have had eight confirmed deaths of OxyContin, and again you have to consider our population. That is a lot for our population. We will continue to work. We have done something "called reverse stings" through Purdue Pharma's assistance. They provided us with placebos that look like OxyContin, we set up shop in two known drug dealers' residences, and we arrested an alarming number of people in a very short number of hours. We got 24 on the first such occasion and 15 on the second. That was just a few customers and only two dealers. So that tells you, I think, some measure of the problem that we have run into. It has driven people in our county to bankruptcy. They have literally lost everything they have had, everything that they have worked a lifetime to accumulate. Many of them will never, never recover. Many of them will continue to struggle with this for many, many, many years. We, unfortunately, appear to be seeing a substitution perhaps now of the drug for other things. We got our first methamphetamine lab over the weekend, and we worked on that for a while. We hadn't seen that before. That has been new to us, and we suspect that is to somehow stop and help reduce the supply, or help supplement to reduce the supply of OxyContin. We have had people travel to Mexico and bring it back. The profit margin is so great, they don't care to hop a plane and go across the border and bring it back. We have had one gentleman who was caught in Nashville with a pile of it taped to his back. He faces Federal prosecution in Nashville. We have had various people look to try to get off of this. It is terrible when it comes to trying to get off of it. Our circuit court judge even made the observation the other day, something that law enforcement has seen for a while, and that is that it appears that our addicts are not getting off. They keep coming back through the system and the taxpayers keep paying for it. We pay for the overdose medical bills. We pay for the medical bills of the addicted jail population. We would appreciate any help that we could get. We are working on a prescription monitoring plan through the Attorney General's Office in Virginia, and we have a lot of hope for that. I would sincerely appreciate any help you could give us on a national level, because when you are bordered by two other States, it is so easy to go across the lines that even if we had a prescription monitoring plan in Virginia, it is probably not going to help us a great deal, but it would be a place to start. Again, I appreciate your time. I have tried to summarize this, and any help that you can give us by all the people in Lee County, we would sincerely appreciate. Mr. Wolf. Thank you very much. [The information follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Wolf. Lieutenant Steven Hudson, Prince William/Manassas Narcotics Task Force. If you could summarize too, we would appreciate it. Mr. Hudson. I would be happy to. Thank you, Chairman Wolf, and members of the subcommittee for having me here today. I am a lieutenant with the Prince William County Police Department, have been so in that Department for 20 years, and have been assigned to the Narcotics Task Force for about a year. Our Narcotics Task Force is comprised of Prince William County and the cities of Manassas and Manassas Park. And as you know, we are a small county, relatively small, about 25 miles southwest of Washington, D.C., comprised of just over a quarter of a million people. Up until 2000, we had not experienced any difficulties with OxyContin. We were hearing about it especially in the areas of southwestern Virginia, and saw the difficulties that people were dealing with. Beginning in 2000, it started off with a bang. In January of 2000, we prosecuted our first case of felony distribution of OxyContin, and, in the 20 months following that, prosecuted 20 cases of OxyContin felony distributions or possession with the intent to distribute. The cases continue. We are investigating probably twice that many at this time and are running into it in a variety of different circumstances. Just earlier this year, we arrested a lady in the Dale City area of Prince William County who was a drug addict and was selling the drug along with many other drugs. And as we arrested her, we found her son, 16 years old, had been taught to shoot her, inject her with OxyContin, as it had been ground and put into an injectable formula. When we arrested him, we also found that he had track marks on his arm. We took a 9-year-old daughter out of the same home. Fortunately, she was not led into the drug use, but was found in a bed that was in despicable condition, including dog feces on the bed. There are several anecdotes of incidents like that, of families that have just degraded terribly in connection with prescription drug abuse, and specifically lately with abuse of OxyContin. Our situation has been improved because we had sufficient help, in our view, from the Federal agencies, especially with the DEA. We have officers from our Department assigned to DEA, HIDTA, groups in the northern Virginia area, and we have been able to receive sufficient help from them whenever we requested it. The only problems we have run into in that regard are in the Federal thresholds of quantities for the prosecution required within the U.S. Attorney's office. In some cases that threshold has been too high for us to try to take cases federally. And then we have run into rather lenient State guidelines, as Ms. McElyea already told you. This is an epidemic like many we have seen in the past. We have experienced crack, we have experienced Ecstasy, and we still are experiencing those drugs as well as the typical drugs that you have seen. But it is a drug that we are seeing in a variety of different circumstances. We may run into it in a patient who is simply addicted and is using that drug only, or we are running into it in many, many polydrug cases in which people are using it in connection with and together with many other drugs, and the abuse has been very, very serious in those cases that we have seen. Thank you, Mr. Chairman. Mr. Wolf. Thank you very much. [The information follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Wolf. Rod Maggard, former police chief of Hazard, Kentucky. Mr. Maggard. Yes, sir. Thank you, Mr. Chairman. I appreciate the opportunity to be here. Forgive me a little bit for the cold that has hit me. I want to start with recalling my last official days as police chief in the city of Hazard, if I may, before I get to the introduction. My pastor and I went to Pennington Gap, Virginia to address a community meeting of over 600 people interested in OxyContin abuse. It was a very memorable day for me. My day actually started just a little after midnight when a call came in that somebody had been shot and killed in the city of Hazard. And we had not had a homicide in more than--1995; and I arrived at the scene with the other police officers. We found it wasn't homicide. It was a self- inflicted gunshot wound. This gentleman and his girlfriend had fought. He had sent her to the hospital to try to get some pain medication. She came home without any, and I really believe it was an unintentional suicide. They fought, and he walked down the street and stuck a 9 millimeter to his head, and it went off and killed him. As I was wrapping up addressing the Lee County, Virginia group, I got a call on my cell phone that we had had a murder on the main street of Hazard, and I called back and told them to go ahead and handle it till when I got back to Hazard, which was about a 2 hour and 45 minute drive. As the crow flies, it is probably 25, 30 miles, but across the mountains it is a little bit different. When I got back, I found out it was the sister of the young man that had taken his life earlier that morning, and it was because of a drug problem. That is just simply the way I wanted to start it out. It has been a nightmare for me. I first started hearing in 1999 the terminology of OC this, and OC that. I didn't know what OC was. So I went to my pharmacy, and he told me it was a slang term that was being used on the streets for OxyContin. It didn't take me too long to find out about that. Prior to that time and just before, I may get one call. And you have got to consider yourself as a small town police chief, chief of police in a small town, you know everybody, you know all of the families, you know all of their hurts, you go to church with them, your children go to school with them. And, therefore, they think you can help them with any kind of problem you can. So being a friend, a fellow with a lot of people, I would offer my services. So I would get a call about every 3 months, wanting to know if I could help some child or some person or family that may be addicted and I would gratefully do that. Sometimes we would use scare tactics and cause the child to go to a rehabilitation, and it may cost the family 35 to $38,000, an extreme amount of money, and within 3 weeks, a period of time from the time the child got back, they were back in the same cycle again. But it got to the point to where, in mid-2000, I was receiving three or four phone calls a day from parents of children or relatives wanting help, and it gets to be so frustrating when you know that there is nothing you can do to help them, except advise them to have them involuntarily hospitalized, you know, in the psychiatric ward, that maybe while they were there--and we even got it down to a point, it was an art. We would put them in on Friday night, because the weekend didn't count. So they would stay on Monday, Tuesday and Wednesday before they had to appear before a judge. So we would actually wait to do that. And this really wasn't--I want to go back to a statement Congressman Rogers made, and Congressman, in the paper misquoted--well, they didn't misquote me. They left part of it off; 65 to 85 percent of all the high school students we dealt with, that was the ones we were dealing with on a daily basis, told us flat out that they were supporting their habit by the thieving, by the thefts that they were doing. Well, it really blew over the top when I heard them referring to our little city park as Pillville, and this was where all of the young people--and when I say young, I am talking 50 and younger, because there is no age limit. This doesn't have any barrier for age, but most generally, I was seeing a lot of juveniles, a great deal of juveniles that were partaking in this. In one particular instance in my statement that I gave you, it began with an early morning call from the Hazard Housing Authority, informing me that the Hazard senior citizen's high- rise had been burglarized. Many items from the high-rise, such as sofa, loveseat, pictures and other furnishings had been stolen sometime during the previous night. We were able to locate all of those items, not just many of them but all of them, and learned that the burglar and his accomplice for two 20-milligram pills, sold this for two OxyContin pills. Now, the person that bought these belongings was a 73-year- old individual who was doctor shopping. He was going from doctor to doctor. But he was also prescribed these illegally. He had some problems. But he was one of the biggest--and all of our young people knew about him. The day that we got the sofa and whatever back, I recovered a 6 foot--I didn't recover it. I didn't know where it came from, a bandsaw. And later that afternoon I was notified by a parent that said that her son has stolen a bandsaw, a Sears bandsaw. I told her where it was, she could go get it if she wanted to get a warrant. But in our area, the addiction to OxyContin was actually--it truly was an epidemic and may still be, but you have got to understand that I have not been in the circle that I was from March up until this day, even though I still get calls wanting help with this situation. It demoralized our community, and when I say community, I am not talking about the City of Hazard. This is a regional- type effort. Everybody comes into our area for one reason or another. All the young people come to that area, but it has demoralized it, bankrupted, spiritually, morally and financially, families all over our area. The abuse was so widespread that small town and rural police departments really became overwhelmed. We do not have the ability nor the resources to culminate investigations of this magnitude. If this had been measles or smallpox, our community would have been quarantined from the rest of the world. You know, and I hate to make this analogy, but we have had four deaths from anthrax, and that has been a serious threat, but there has been hundreds of deaths from people abusing this drug, and it is quite serious. To me, it is as serious as anthrax in my community, as it is to the Nation, for those people that have lost their lives. It has had a big impact on law enforcement. The rural small law enforcement does not have adequate human needs, technology, resources to address the problem. We have got limited budgets. We are sort of like an elderly couple that lives on social security. Our budgets are fixed and they only get smaller, you know, and as long as you have a police officer and a car driving around, that is all they really want. They don't think about the technology or the use. Congressman Rogers is helping us on that aspect and being able to tie together some operability in that may be a result of some of this work going on, that we will have interoperability capabilities. But we didn't have any kind of funds to do the type of investigations that we needed to detect the problems early on. It is only when they reach a crisis point that you really have to pull out all of the stops. You have to be very innovative. I went to the Kentucky State police. They have money for buys. We have the knowledge. The officer that I assigned to the task force that we started with Kentucky State police and the FBI was just assigned to it. We sat down 2 days prior to the meeting with them and compiled a list of 163 people that we thought would be dealers. As it turned out, there was a little over 200, and after that first Oxyfest, as we called it, was over, I asked the same officer, how many more out there? He said, just as many, just as many. So everybody that saw an ample opportunity to sell this, you know--and what gets me is the people that try for the first time. The OC-80s, as I understand it, is equivalent to about 16 Tylox, and if you get a child that has never taken any of this and tries it for the first time and either snorts or injects that, then it is almost instantaneous. He has signed his death warrant and that is scary. That is scary when you are responsible for the safety of our citizens and for the children in the community. Now, the lack of interoperability was another problem that we faced. We didn't know where to turn, except to go back to-- and I am a real big advocate of community policing--to go back to our community. Well, unfortunately or fortunately for me, the pastor of my church had counselled over five families in our own church that had children that had this problem. So one Wednesday night at a prayer meeting, instead of going to a prayer meeting, it turned into actually a testimonial, I guess, about the problems that we were all facing and the ones that I was facing, the challenge that I was facing trying to help people that I couldn't help. And out of that became a county- wide or community-wide--we had people from other counties come in from all around eastern Kentucky. Over 400 people attended this meeting, and out of that meeting, we brought in an expert to tell about drug abuse, and he spoke, and then the floor was taken over by people giving their own testimonies about the problems that they had. And Mr. Coots was there that night. He can tell you a little bit more about that later on. But out of that meeting arose hopefully something that could help us. It was a nonprofit organization, faith-based. And we split that into, oh, I guess seven different departments, subcommittees I guess, neighborhood crime watch. We would go into all the area and teach the people on what to look for when you have 300 cars going to a house within a period of 3 hours, you know, try to jot down some license numbers, get the information back to us so that we can pass it on and do a surveillance, similar to that judicial review. We weren't having very much success in having anything prosecuted in a drug line. And that is one of the reasons we incorporated the FBI so that we could take this federal. And as the lieutenant said, it is quite hard because of the number of appeals that you have to buy or the weight to be able to get this prosecuted federally. So, you know, it does place a burden on you sometimes when you are trying to purchase this stuff. We had a recovering addicts committee, family support, education committee and youth committee. It is important to note that in organizing this group we had no outside funding to continue to operate, and we operate on a volunteer basis. The objective of the People Against Drugs Group was to curtail the drug abuse but also provide help to those who have been affected. There is no rehabilitation center nearby that isn't cost prohibitive, and one of those is in Minnesota and one them is in Nashville. But we have become successful without any operating capital. We have got people like Pastor Coots that is going to testify. We have learned to be resourceful, to get on the Internet, Congressman, and find out those places that we could take people that didn't have any funding to give them, and those are the people that are really hurting. And those people that had insurance, they wouldn't accept the insurance. But law enforcement officials continue to train the neighborhood crime watch committees. We continue to be involved in our police, our people against drugs. It is still active, but it could be a lot more active, because the only thing that we have had after that group is some volunteers that donated a hundred dollars here or there, that we could put some signs up, some neighborhood crime watch signs and then the highway department makes us take them down because they say it is not correct, so we move them in lawns. Then maybe mailing for the people that is on the list. All in all, I would like to say that it is probably one of the biggest challenges. I have been in both public and private law enforcement as of April of this past year for the past 34 years as a Kentucky State policeman, as a private corporate security director with a large coal company and then as police chief in the City of Hazard, and I have never seen anything in my lifetime in law enforcement that has taken over a community so fast and has been so devastating, and hopefully we will get some help from the Federal Government to be able to solidify what we have already started to do. Maybe we could make it better. Thank you. [The information follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Wolf. Thank you, Mr. Maggard. Captain Hall, West Virginia State Police. Mr. Hall. Yes. Thank you, Mr. Chairman. Besides the statement I submitted with all the comments from the panelists and all of your questions, I know that you all have given considerable attention to this matter, and you need to be commended. You understand the problem very well. You have a lot of statistics before you. I don't have any additional statistics to give you. Somebody asked a while ago if this was the first wave. Well, this is actually the second wave. In Appalachia, in southern West Virginia, there was another wave earlier called the Tylox. The chief mentioned it. And I would like to say that I think you all know, with my statement, I have spent 15 years in an undercover unit with the State police, the Bureau of Criminal Investigations. I ended up running that unit for 6 years in southern West Virginia. In the mid-1980s, we had a Tylox epidemic. Tylox is oxycodone, 5 milligram capsules, easily opened, snorted directly up the nose, immediate effect. It was put into a solution and injected. In the late 1980s and 1990s, we were having big investigations over Tylox. Of course crack cocaine, cocaine, marijuana, meth, those were our bigger cases, and that took more of our attention, but we made some big cases with the U.S. Attorney's office. And that was the only way we could prosecute prescription drug cases. Local prosecution and local prosecutors really didn't look at a prescription drug as a prosecutable case. You know, these are people taking their parents' medication. Well, that wasn't the case with Tylox. It was so big, I mean, we even arrested pharmacists selling them to organized crime, large organizations, family organizations, all addicted to oxycodone, 5 milligram pills. OxyContin, as you all know, is 10, 20, 40, 80, and it is just so potent. And once it is crushed and the potency of that OxyContin at one time, it is worse than crack ever was in our State, and it is going to be worse than any drug we have ever encountered. It is not going to halt yet. But we have always done narcotics cases. We can't continue at the pace that OxyContin is to keep up with the street deals that we do. We don't have the money. It is cost prohibitive. We have to try to do stings. Like in Lee County we try to catch people with a whole bottle full that they have for sale and put that amount on them. And also I would like to say in southern West Virginia, DEA has done a tremendous job with the State police and with the task forces, and so is the U.S. Attorney's office in the Southern District of West Virginia. They have made some cases that would not have come to court unless it was federal prosecution. Just this year alone we have been involved with some brothers from Maryland. They come in and what do they do? They make millions of dollars bringing in OxyContin. OxyContin is the second wave, and it is going to surpass anything we have seen in southern West Virginia. And it affects everybody, as you know, every community. There is some dealer in every community in southern West Virginia, and these dealers became--well, they are addicts, too, or they wouldn't be dealers. They have to deal to support their own habits. If they are using, they are eventually going to become drug dealers, and some of them have become criminals as a result of an injury, a legitimate injury. And now they are committing crimes. OxyContin has turned them into criminals, and it is the drug of choice in southern West Virginia. People have left cocaine. In Webster County, in Pocahontas County, in the western counties where meth was the drug, the people on meth are actually wanting OxyContin. We have crack dealers that are now--they are not only dealing crack, but they have OxyContin, too. We have people in wheelchairs, elderly people who had a hip injury in wheelchairs that are selling their OxyContin. They are on fixed incomes. They are good people. Now they are doing criminal acts. You know, for all the good that this drug has done, it has devastated Appalachia, and it is not stopped yet. One of my young troopers has a brother who took his own life. He came from a good family of five brothers. He had a potential pro baseball career. A sports injury made him give up that. He ended up on OxyContin. He couldn't get off of it. He couldn't stay away from the group of people that supplied it. He took his own life in his parents' yard, and some of the last words he said was that he just--he couldn't live with his self anymore. He couldn't put his family through the suffering. So, I mean, it hits home. So it is an emotional issue for me. But in West Virginia, in southern West Virginia, people have called it an epidemic. It is not. It is an explosion. And it happened in 1998. In March of 1998 the legislature enacted a law, the pain management law we call it, and that is a very short law. You have a copy of it for your record. It doesn't take a real experienced investigator to see where this law came from. It is for the--what it does is it frees doctors from being fearful of criminal or any other sanctions for overprescribing or for prescribing to addicts. The law says that just overprescribing alone will not bring sanctions on them. Now, this law--and I know how laws are enacted. The legislature only heard one side of this, and it was a well thought out campaign in West Virginia to get these OxyContin addicts in southern West Virginia. It was aggressive, and when you only hear one side of the miracle drug and pain management and people deserve to have their pain taken away so they can live productive lives, that all sounds good, but what they don't take into account is the culture of addiction. And I have worked with drug addicts for 15 years, and as other colleagues have said, they will do anything to get that drug, anything. They come from good families, but they are going to steal, they are going to forge prescriptions. They will do anything. If they can--and whatever you come up with, whatever form the OxyContin is in, they are going to extract it from whatever it is in, they are going to take it. There were other drugs on the market before OxyContin. We had Dilaudid, which was given to terminally ill cancer patients for severe pain. It is hydromorphone. It is more potent than this, but it was more controlled. We did have Dilaudid addicts, but they were few, and pharmacists got on to them pretty quick. Their names got into the system. And this pain management law that West Virginia got shoved down its throat is part of West Virginia's problem. At least in 1998 we had a drug enforcement diversion officer, Dominique Grant, who saw this coming, and he warned us. He called all the drug coordinators to Charleston, and he said, look, he said, this law, gave us all a copy of it, in 1998--this was in April of 1998--he gave us a copy of this law and said, you are going to have a flood, and he was right. What we thought of--we didn't know it was OxyContin. We thought, well, okay, this is going to--that the Dilaudid addicts are going to be at it more. We are going to have to gear up our resources and go after more of them. They already had narcotics organizations in place. This just exploded. We started buying them in 1998 and haven't stopped. It takes all the resources we have just to buy them on the street. If it wasn't for the DEA and the U.S. Attorney's office realizing in southern West Virginia what the problem is, we wouldn't have any prosecutions. But to continue, we do need help. West Virginia does not have a monitoring system. We had a semblance of one, but it lost funding. Funding is a big key in West Virginia. We need a monitoring system, and it has to be--I think it needs to be mandatory, and it should be incumbent upon doctors to do more investigation of their patients. They shouldn't just come in and say, you know, do you have pain. I mean, all they are required to do on examination is just ask you questions, take your temperature, your blood pressure, and a good addict, he has a story that you will believe. He could walk into your house and you will believe that this guy has really terrific pain. They are good. That is their life. They live to get their next pill. That is what they do all day. That is the only job that they have, most of them, sell pills and find out where they are going to get theirs. They go from doctor to doctor till they find another one. And doctors, like has been testified to and will be by Dr. Sullivan probably, he knows how an addict works. This isn't going to stop. If this was a product like a car tire or something, it would be recalled. And I am not so sure it shouldn't be recalled. I am not a politician. I am just a police officer who has been involved in the drug culture in southern West Virginia for a long time, and this is one we can't fight, not without a lot more help than what we have. You know, we do need tremendous help, and I am not sure that it shouldn't be recalled. I mean, it is our children. It is our parents. I had two 60-year-old men on different occasions this year after being arrested cry. They come--their families tried to get them off of these things. They cried because they could not get off of them themselves. They ended up being dealers, and they cried. I mean, that is what it does to a good person. Well, what about the criminal element, the true criminals that we have out there? They are ruthless when it comes to dealing these things. But I could go on and on, and I won't. You have my statement there, and I just wanted to add some comments to it. Thank you. [The information follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Wolf. Well, thank you very much, Captain. That was very powerful. All four very, very powerful, and very telling, and actually your oral comments were better than your written comments, I might say. So hopefully we will put your written comments in the record, but your oral comments will also be there. In the interest of time, I have a whole series of questions, we may send them to you, but I guess there are two that I would like to cover, and I guess yes or no would be the first, and then the second one will be a little more elaborate. As Tammy was saying, do you all, the other three agree this is a very difficult drug for rehabilitation, that the success rate of people getting off is not very high? Is that what you are sort of saying? Mr. Maggard. May I speak to that point? It is extremely hard to be able to find a place to rehabilitate them. Mr. Wolf. So you don't have a great record in your area of people going to X place and---- Mr. Maggard. No. A lot of people that went to a rehab unit, I believe, came back and said they had never heard of OxyContin. They were not capable of dealing with that problem at that particular time. So they had to go through, I guess, a phase of learning how to do that. But I guess in my testimony I told about the people that go through the cycle again. It was simply because they got with the old friends again and they didn't follow through with the rehab, not the fact that the rehab department didn't help. We just don't have a rehab. We don't have anything. Mr. Wolf. Tammy. Ms. McElyea. The same problem. A lot of the families that had the assets to afford it would send their children, particularly--and even we have had some older adults go to a methadone clinic---- Mr. Wolf. Is that daily or weekly or what is that? Ms. McElyea. It starts out for a period of time daily. Mr. Wolf. And where was the clinic? Ms. McElyea. Knoxville, Tennessee. Mr. Wolf. And how far a drive there? Ms. McElyea. Five-hour round-trip drive. Mr. Wolf. Every day? Ms. McElyea. Every day for a period of 5 months. The last gentleman we had in circuit court was last week and he had to attend the methadone clinic every day for a minimum of 3 months. Mr. Wolf. Has it been successful? Ms. McElyea. Frankly, I doubt that it will be. I haven't seen the methadone--personally I have seen a lot of people run to the methadone clinic. It is extremely expensive, particularly when you look at a low-income area. It is not covered by insurance and I have not seen a single person be successful. Mr. Wolf. Captain. Mr. Hall. If they didn't have to return back to their homes and get out of the environment they were in, it might be successful, but that is the biggest problem, is we are--I mean, once an addict goes and gets rehabilitated, where would he have to move to get away from it, to stay away from it? California? Mr. Hudson. No, sir. I have also not seen any successful stories of rehab yet. I am sure there are some in existence. The folks in our county go to Fairfax County for rehabilitation clinics and I have yet to see any of the people that we have dealt with be successfully rehabilitated. Mr. Wolf. Okay. I have one other quick question. Answer, if you could. I want to make sure the other members have time and the panelists. If there was one thing the government could do or the company could do, what should that be to deal with this problem? We will go in the same order that we---- Ms. McElyea. I am not sure---- Mr. Wolf. Either/or, the government, ATF, DEA, Food and Drug or the company, if there is one thing that you think could be done to help to deal with this problem. Ms. McElyea. I think certainly the supply has to be tightened up. I think that it is just--and this is my personal opinion. I think that it has just been handed out far too liberally. I think that that perhaps started our initial problem. I certainly think that it needs to be very stringently controlled as to who receives this drug. I don't think I should get this drug because I have a tooth pulled. I think that that is the first and perhaps the front line for us. The other thing, of course, is the age-old problem of funds and manpower. It is something that we simply need more money and more officers to try to combat, and in conjunction with that, then--I don't want to sound--you know, sit here and sound like I am saying lock everybody up. I don't think that is the answer, but some tougher sentences would help, and perhaps some reduced guidelines as far as getting some of the cases into federal court I think would help from a prosecution standpoint, and of course we would like to see Virginia toughen our State sentences. Mr. Maggard. I agree with that, Tammy. I think the manpower--I think the company has already undertaken a large educational need, and I think that is something that we as law enforcement need to look at instead of waiting till the fifth grade. You know, our society is a feel-good society. There is a pill for anything. I think we need to start indoctrinating the pre-school all the way through the fifth grade instead of waiting till the DARE program to educate our young people, you know, that you don't take a pill. You know, we have got soldiers in Afghanistan that are suffering from anxiety, but they are not asking for Xanax or Valium. God forbid they do. We would be in terrible shape. But our children have been indoctrinated to a feel-good society. There is a fix-it for everything advertised. So I think education is the true answer. Mr. Hudson. I agree with Tammy and the chief, and if I was to point to one thing, I would say education for the doctors in pain management. Those who are involved in the practice of pain management seem to have a good grasp on it, but the doctors I have spoken to in general practice or family practice have very little formal education in pain management, and many of them are so trepidatious about the use of OxyContin, they won't even deal with it. They will put signs on their windows that say we do not prescribe OxyContin, and that tells me that there is a level of ignorance or naivete that presents to them a significant fear. And I appreciate the fact that that fear exists, but I think it is an education issue. Mr. Hall. I think we need to mandate monitoring systems with doctors and with pharmacists. I think the doctors should-- it should be mandated that they actually track their patients and see who else these patients are seeing and then likewise with the pharmacy, with the monitoring systems, West Virginia has none, and we should. And not only that, it should link up with Virginia's and Kentucky's and Ohio's, Pennsylvania's. They should be able to inquire nationally. And of course that is a federal issue there, and that takes federal dollars, and I think that is what we need throughout Appalachia. Mr. Wolf. There is a new $2 million grant program--through the good auspices of Mr. Rogers who really brought this to the committee's attention last year, in this bill. Not enough now, I see. Hopefully it is a program that we can continue, but I would urge--I am asking our State, Tammy, to be involved. They say they can't act until the general assembly comes in, but hopefully our new Attorney General will participate and then that helps Mr. Rogers' State, because he is surrounded, and then West Virginia participates I think regionally, then that person can't shop around. Mr. Serrano. Mr. Serrano. Thank you, Mr. Chairman. I just have one quick comment and a question. Were you referring to tougher sentences for users or for all involved? Ms. McElyea. I think the dealers need to have tougher sentences. I think that it is a sad statement that society has to turn to the criminal justice system to try to get an addict off of drugs. That, to me, that is a pretty sorry position that we have gotten ourselves into, that that is our last resort, is we have to start locking our children up to try to save them, and that is what we are doing. Mr. Serrano. Right. I am glad you said that, because for my part I totally agree with you. You know, we in New York are still trying to undo the so-called Rockefeller drug laws, which were considered by some people to be so harsh that now, after we did all of that, now we have spent the last 5 years trying to undo them, and it is very difficult to do that. The political climate is not for that. But I would agree with you. I have always been for tougher laws for the medical professional in this case or the dealers on the street, and so on. As far as the users, again, I agree with you. We have to turn a corner in this country to realize that these people are sick, and when you are sick you shouldn't be treated like a criminal. Now, if you engage in crime while you are sick, that is a different question altogether that you folks have to deal with, but we treat sick people here as criminals, and I don't think we are ever going to solve that problem. My question is, again, based on my experience--I come from New York--we still have areas in inner cities where you can go to a corner and see 15, 20 people who sort of have their own world. And you are right, what they do all day is plan on how they are going to get high, how they are going to deal with their pain or stay pain-free in their world. And that is what they do. And in those areas, there have been many successful programs in collaboration with the Federal Government. So I listen to you, and then I listen to you and then I listen to you, and three different communities in many ways but very similar. But is there anything happening that will coordinate from the federal level to get you folks involved? In other words, I know we were talking about help, but right now on this particular issue, since it is the one that is least known throughout the Nation--for cocaine, for heroin, we reached a point where there was a national effort that you could tie into. Do you have such a thing right now, or are you basically on your own? Mr. Hall. In southern West Virginia, we received the back end assistance of the U.S. Attorney's office and DEA, especially in the last couple years, on narcotics investigations particularly. There is not enough DEA officers. They don't have enough money. Guidelines are difficult to reach when it comes to prosecution, because of the--you have to literally buy thousands and thousands of dollars worth of the drug on the street or catch somebody with that amount to get them in a federal prosecution. But we are doing that. The State police and West Virginia law enforcement as a whole doesn't have the manpower. We need more manpower. We need more federal grant money to buy these drugs and attack these organizations, but I think everybody there is doing--is working together well now. There just needs to be more of it. Mr. Serrano. One last question. You mention of course the ever important educating our children. Do you folks know if the substance abuse prevention programs in the schools are including this particular drug as part of their discussion? Mr. Hudson. Ours is. I am sorry, Chief. Mr. Maggard. I think after February of this past year, yes, ours is, but unfortunately that was a crisis period when over 200 and some dealers have been arrested. But I don't know that it has gone any farther than the fifth grade. So I think-- personally I feel like it needs to go--start down a little bit younger. Mr. Hudson. Our effort with the DARE program started this past school year, and it has been successful, and we also incorporated narcotics detectives in that education program, both in the community and in the schools. But it is still at a relatively small level. The assistance from the federal agencies in law enforcement for our agency has been significant, and it has been sufficient. So I guess to answer your question, I think the federal agencies have helped us very well. Mr. Serrano. Well, I thank all four of you for your testimony, for the work you do. You are there in the front line, and certainly through this opportunity that the Chairman has offered you, you are bringing an issue that a lot of Americans have no clue about, and hopefully--in fact, I am pretty sure--your presence here will begin to manage to deal with this situation properly. So I thank you. Mr. Wolf. Mr. Rogers. Mr. Rogers. Thank you, Mr. Chairman. I want to thank also the four witnesses for riveting testimony that, as Mr. Serrano has said, will be the landmark occasion in the Federal Government's efforts to tackle this problem of OxyContin. So we appreciate your traveling here and giving us this expert insight into this depressing problem. Let me ask you, do I hear you correctly say that a great, great majority of the OxyContin available is from doctor shopping? Is that where most of it is coming from? Captain? Mr. Hall. Yes, sir. Doctor shopping and forged prescriptions. There has been elaborate schemes. We have uncovered telephone schemes. People can act like doctors and nurses on the phone very easily. The addicts are very familiar with the DEA control numbers of the doctors. Forging a prescription, stealing prescription pads. If they can't get the doctor to write them one, they will actually move around in the doctor's office. You know how you are left alone in a little room, well, they will move around until they find a prescription pad, and they will take it. I mean, they will stop at nothing. And if they are caught, nothing happens to them in the doctor's office. Mr. Rogers. So most of the OxyContin on the street comes from a pharmacy, through either a forged prescription or a legitimate prescription, correct? Mr. Hall. I believe so. Mr. Rogers. You don't know of many instances, I gather, where the OxyContin has been imported from another area, or is that---- Mr. Maggard. Yes, sir. Mr. Rogers. Chief. Mr. Maggard. We have big importers from Indiana, and I am sure that they would come from doctor shopping in that area, too, and OxyContin coming from Mexico. And I think the company now has made it plain to where--we have people that are actually driving to Mexico. They can walk across the border without a prescription and buy any number they want at very, very, very reasonable---- Mr. Rogers. Let me get back to the essential point, that practically all of the OxyContin you have encountered really comes from either fraudulent prescriptions or doctor shopping. Mr. Maggard. Sure. Mr. Rogers. How can we from the federal level help in that regard? Should we limit the number of doctors or pharmacies that are legally allowed to dispense this drug? Or is there another way? Ms. McElyea. I think that a national--a nationwide prescription monitoring plan is critical. Mr. Rogers. What do you mean by that? Ms. McElyea. It would be a tool, as I understand it, and I am certainly not an expert on the prescription monitoring plan, but as I understand it, it would be basically a computerized system that if a doctor writes a prescription or if a pharmacist fills a prescription, it will be entered into a computer network and will be a tracking device to see basically prescribing habits. It would allow doctors to hopefully check on patients that they may suspect is doctor shopping and allow law enforcement to check on addicts that we believe are doctor shopping. Mr. Rogers. Well, could the small corner drugstore afford to link up with this national system? Ms. McElyea. My understanding is most of the computer equipment that is already available and being used in the pharmacies will accept this type of a system, that it is not a great burden. I think the cost--of course it is eventually probably going to be passed on to the consumer, but it is basically minuscule compared to the hopeful benefits we would achieve. Mr. Rogers. Well, that would get at a person seeking multiple prescriptions from two different doctors in different locations. Right? Ms. McElyea. Right. Mr. Rogers. But what about the other problems, the forged prescriptions, maybe travelling to Indiana versus the next town over to get your prescription? Ms. McElyea. That is why I think it has to be nationwide. The forged prescriptions seem to have been an area harder to get by with to get filled, because pharmacists, particularly in our areas, have been sort of acclimated to looking for those. They check those things. I think also to introduce tamper resistance prescription pads--and Purdue Pharma has been an advocate of that--has helped. Mr. Rogers. What is that? Ms. McElyea. It is a pad that does not wash easily. My understanding is they take basically what I would call nail polish remover of some sort and wash these prescriptions and reformulate them. They change the numbers on them very easily. One of the shocking things to me was that the medical community--I suggested that instead of writing out just 60, you know, 60 40-milligram OxyContin tablets, that a doctor actually take the time to write that out in longhand instead of numbers so they wouldn't be so easily changed, and I was shocked at the reaction that I got to that. And I sat down, I was curious to see how long it would take me to write out in longhand a prescription. You know, I can do that in less than 60 seconds. Mr. Rogers. Should we send doctors back to school to learn how to write? Ms. McElyea. It would help, apparently. That is a terrible thing to say, but I think they should--if I go to a doctor, I think he should devote more than 2 seconds to me. I should be worth 60 seconds of his time to write out a prescription for me and that would help. Mr. Rogers. Chief Maggard, speaking about the prescription monitoring system, Kentucky has such a thing? Mr. Maggard. Yes, sir. Mr. Rogers. 14 States have prescription monitoring systems that assumedly would get at this problem. Does it? Mr. Maggard. To a certain extent. Ours is a little bit antiquated, probably much antiquated, but you can get your result in a couple, 3 days. At least you can find out how many physicians or how many pharmacists these perpetrators have gone to and what they have been given. It does--it is probably the single greatest aid in our Oxyfest investigation, was the Casper system, as we know it, in Kentucky. Mr. Rogers. Does Virginia have that? Ms. McElyea. No, we don't. We hope that--we are working now through the Attorney General's task force to try to propose some legislation on that, and we hope---- Mr. Rogers. Does West Virginia have it, Captain? Mr. Hall. No, sir. Mr. Rogers. And---- Mr. Hudson. No, sir. Mr. Rogers. Well, you have it in Kentucky, but all they have to do is cross a 50-mile drive. Mr. Maggard. And that was a problem, too. Mr. Rogers. Virginia or Tennessee or another State that doesn't have it and it is meaningless, right? Mr. Maggard. Yes, it is. Mr. Rogers. So that is the reason, ma'am, you are saying there has to be a federal monitoring system before it would be effective? Ms. McElyea. Right. Mr. Maggard. Congressman, it could be placed just like the--each law enforcement--or most of the law enforcement agencies in each State have--we have what is the Law Enforcement Network Information associated with the NCIC, and that could be very easily related to most police departments; you know, that they would have this access to that information if they could come up with a program that could make it nationwide. But it will--as she said, we have people going to-- we had a doctor in Harlan County, though, that was dispensing to hundreds of people a day that was coming from Virginia that they were not aware, but working together they were able to make a dramatic kingpin bust on that same situation. Mr. Rogers. Well, it seems to me that if we are going to solve this problem it is going to require that, among other things, at least that we limit places where you can legitimately secure OxyContin. Obviously it is a drug that is of great benefit to people who are desperately ill, and we can't make it illegal. I don't think anybody wants to do that, do you? Mr. Maggard. No, sir. Ms. McElyea. No. Mr. Rogers. But we do need to control who has access to it, do we not, more than we are now? Mr. Maggard. Yes, sir. Ms. McElyea. Yes. Mr. Rogers. And how would you do that? Mr. Maggard. I personally think if you have that much pain that you should be hospitalized, you know. And then on the same token, I lost a dear friend of mine just recently who was terminally ill with cancer, and that sustained her up until the end where she was viable and productive, but it seems like if you are hurt bad enough to take an OxyContin 80 or, God forbid, an OxyContin 160, I mean, that is a terrible lot of pain medication to last you particularly over a 12-hour period of time. Mr. Rogers. So you would limit it to hospital medications? Mr. Maggard. I personally would, with exceptions, rare exceptions. There has got to be some exceptions and that could be those terminally ill people, but not everybody just because they had a toothache would get a prescription of 120 OxyContin. We shouldn't get a prescription for 120 to begin with. It should be only two a day, because they are 12-hour time released. But yet we saw prescriptions for that much or more. Mr. Rogers. Shouldn't a local doctor who wants to prescribe OxyContin to a local patient be required, or should the pharmacy be required, to check with a central source somewhere before they would be allowed to dispense it? Mr. Hall. Excuse me. That is the whole idea of the monitoring system, a program where they can type in that patient's name or social security number and see where else they get it or and if they--did they get some 10 days ago, 5 days ago, should they already have their adequate supply. I mean, doctors normally prescribe these for 30 days at a time and some of them for less if they worry about the patient. But the monitoring system, the way I thought they envision it is, they can automatically check as an automated based system, and they will see if they got 30 of them yesterday in Kentucky, is what we would hope for. Mr. Rogers. So you think the answer is a monitoring system, a national---- Mr. Hall. Yes, sir. Mr. Rogers. National monitoring system where everybody who gets a prescription has to clear the computers locally. Mr. Hall. Yes, sir. And pharmacies are already--most of them are automated already. They just don't have a program like this. Mr. Rogers. It is called Kasper. Mr. Hall. Well, in Kentucky it is called Casper, but it needs to be immediate. Like he says, NCIC checks we do and law enforcement, it is immediate, and it needs to be that kind of a program. And really most pharmacies have the equipment. They just need the software programmed in and the---- Mr. Rogers. In Kentucky the governor has an OxyContin task force, and one of the recommendations they have made is to require the Kentucky monitoring system to be realtime, an automatic response. But that would require a change in the law, wouldn't it, Chief? Mr. Maggard. I think so. Mr. Rogers. In the State law. Mr. Maggard. State law, yes. Mr. Rogers. But on the Federal level, is that something that should be required: That it would be realtime as opposed to delayed? Mr. Maggard. Yes, realtime. I think that is the only way you could go, because the pharmacist before he issued that prescription would know if he had just been to some other doctor on that same third of the month and obtained 60 or 30 or however many pills that he got. Mr. Hall. And not only that, but if it was a stolen prescription pad, they would know that also. Mr. Maggard. From the other States, and that is something we don't find out for a period of days sometimes. Mr. Rogers. Well, I appreciate your testimony on this point. It seems to me that that is where we ought to be looking. Thank you, Mr. Chairman. Mr. Wolf. Mr. Mollohan. Mr. Mollohan. Thank you, Mr. Chairman. This is excellent testimony from this panel. We really appreciate it. Captain Hall, I heard your testimony. I think, that this problem is so excruciating and that the resources that you have to address it are so inadequate, that one of the things you have considered recommending is taking this drug off the market. Did I hear that testimony correctly? Mr. Hall. Yes, sir. I think that was my implication, yes, sir. Mr. Mollohan. Have there ever been any drugs that you felt the same way about that you have dealt with? Mr. Hall. No, sir. Even the more powerful drug Dilaudid, hydromorphone, for terminally ill patients, I never even considered taking it off the street, even though we have had quite a few Dilaudid convictions or investigations. It is closer controlled by a pharmacist and doctors. Mr. Mollohan. What is it about this drug, the properties of this drug, that are so different from these others, anybody? Mr. Hall. The sheer potency. Tylox was all--Tylox was oxycodone, 5 milligrams. We had enough problem with it, but not to the extent that it overshadowed crack cocaine and cocaine and marijuana and LSD and meth. It never overshadowed those. It was always a problem. This is going to overwhelm all of the other illicit drugs that we investigate. Mr. Mollohan. And the time release aspect of this is the key to it. Once you defeat the time release, you get the full does at once. Mr. Hall. Dose. Mr. Mollohan. The full dosage. Mr. Hall. Probably an 80 milligram would probably put me into an arrest, because I don't have the tolerance to the medication. I don't have a tolerance to the narcotic. Mr. Mollohan. The chairman discussed the idea of changing the classification, that maybe the Food and Drug Administration made a mistake in including moderate pain in the classification. Would a reducing of the classification or a changing of the classification to exclude moderate pain as a criteria for prescribing the drug be effective? Ms. McElyea. I think it would help. I think it would go somewhat toward the education of physicians of exactly what they are putting out there on the street. I think that is one of the things we have got to keep in mind. This is not an aspirin. This is something that we are putting out on the streets that is potentially lethal, and I think that that certainly would justify it being reclassified to only being given in cases of severe long-lasting pain, more than 2 or 3 days of pain. Mr. Hall. Congressman Mollohan, I consider moderate pain--I think it is treatable with hydrocodone, not oxycodone. Hydrocodone, which is a Schedule III narcotic, lower tabs, one of the brand names is Loraset. It is--I think it is made for moderate pain. I think oxycodone is for severe pain, and I am surprised, I have had considerable pain recently after a hospitalization myself. I went to a doctor just so I could sleep, and I was prescribed hydrocodone, not oxycodone. Mr. Mollohan. Well, the way you and everybody on the panel has described this problem is that it is rampant. It is hard sitting here to imagine, particularly in our small communities, that there are enough people out there receiving prescriptions of this product, that are not using it legitimately such that it is getting diverted into misuse. Collectively you would think the medical community would understand that there is this tremendous diversion going on and they would be self-regulating in that aspect, because there has to be a lot of this stuff that is being prescribed that is obviously not being used for its intended purpose. There is a tremendous amount of it, given your description of the problem out there. Mr. Maggard. I think that has happened, sir. To a tremendous extent in south West Virginia, in my area of Kentucky, the doctors are very reluctant now. As I said before, if you had a toothache, you could get, you know, OxyContin, but not now, and as I heard it stated here, my new office for my new job is in a clinic building, and there is a big sign up front that says no pain medication administered here, and it is not just OxyContin that they were talking about. They just don't want to be caught in that trap. At that same place prior to all of this happening, there was a line of people that was continuously running in and out, you know, so I think that has happened. I think our doctors are aware of the situation a little bit better than they were. Mr. Mollohan. You think there was a decrease in the prescription rate in your communities for this drug? Mr. Maggard. I think it is, absolutely. Ours were coming-- most of ours was coming from a different source than the State anyway, other than doctor shopping. It was a pain clinic that was administering most all of the OxyContin that was coming back into our area. Mr. Mollohan. Where was the pain clinic located? Mr. Maggard. In Lexington. Well, the physicians worked for the pain clinic. I shouldn't say the pain clinic itself. But, you know, we walked into one section of town--or the county-- they will be there waiting in that office. You know, all of them were going to see the same physicians, and all of them were coming back with the same amount of OxyContin, and all of them were dealing, keeping 10, selling the rest. Mr. Rogers. Would the gentleman yield? Mr. Mollohan. Yes, sir. Mr. Rogers. Is that still going on? Mr. Maggard. It is still ongoing, sir, it is just---- Mr. Rogers. What is the name of the clinic in Lexington? Mr. Maggard. I don't know the name of the clinic. It has been a while. It is just a pain clinic. Mr. Rogers. Are they still doing the same thing? Mr. Maggard. No. I don't think so. We had the Attorney General's office involved in the investigation with us when we were doing the doctor shopping to go to those places. They identified it and they---- Mr. Rogers. Will you keep this committee posted on any such activity in the State of Kentucky or anywhere else you know about? Mr. Maggard. Oh, yes. Mr. Rogers. Where a particular office is dispensing--or prescribing large amounts of OxyContin? Will you keep us posted on that? Mr. Maggard. Absolutely. Mr. Rogers. If you will keep us posted, I think we can solve the problem. Mr. Maggard. I can do---- Mr. Rogers. Because I guarantee you, I double guarantee you, as they say back in Kentucky, that if we find out that is going on, we will bust them. Mr. Maggard. Well, that has been done in some instances, too, Congressman, as you are well aware, in eastern Kentucky, in Johnson County, and also in Harlan County, we have had some unscrupulous doctors that have been taken down. Those doctors were chastised. I think they had legitimate patients coming to them, but they didn't know what they were doing with the pills. But I don't think it is persistent now as it was then, but I can assure you if you ask me to notify you, I will. I have been out of that loop a little bit, but I still get some information. Mr. Rogers. Well, you stay in touch with your fellow chiefs and---- Mr. Maggard. Yes, I do. Mr. Rogers. And if they will funnel that information through you to us, we can make certain things happen. Mr. Maggard. Thank you. Mr. Mollohan. What I am getting at here is if there is a decrease in the prescription abuse, and there is an increase in the use of this product, we have more addicts out there who are relying upon this product. What source is picking up the slack? First of all, is that premise right, that there is a decrease in the misuse of legitimate prescriptions and there is an increase in their use by addicts? Mr. Hall. Sir---- Mr. Mollohan. If that is true, then what sources? Mr. Hall. Maybe some doctors have quit writing it. There are some pharmacists who have quit filling it, that don't-- there are pharmacies that don't carry it because they don't want to get robbed, but they are still--I mean, the one ingredient here that maybe we are all forgetting is profit, not just profit on the---- Mr. Mollohan. Well, I think we are forgetting the power of addiction too. Mr. Hall. Well, for every doctor that doesn't write it, there is a doctor that will, and doctors inherently aren't looking for--they don't think addicts are coming through their door generally. I mean, these people come in with real sob stories. I mean, they have got real--they come in, whether they have pain or not. Mr. Mollohan. I can only imagine. Mr. Hall. A doctor believes them. I mean, that is what they are supposed to do. They are supposed to try to---- Mr. Mollohan. So whether it is abuse by the doctor or abuse by the alleged patient, prescriptions still remain the greatest source of the problem? Mr. Hall. Yes, I mean---- Mr. Mollohan. It is not coming from Mexico, in other words? That is what I am trying to understand. It is not coming from outside your community? It is still coming from within your communities? Mr. Hall. It is supplemented by people actually bringing it in bulk---- Mr. Mollohan. Increasingly? Mr. Hall. There is money in it, yes. Mr. Mollohan. It is increasingly coming from outside? Mr. Hall. As long as there are addicts on the street, they are going to be bringing it in, stealing it, robbing and bringing it to Appalachia to sell. It is free for them if they steal it, and they make 40 dollars a pill on the 40 milligram and they can sell them as many as they have. If they had a million of them, they would be able to sell a million of them. Mr. Mollohan. Prosecutor McElyea---- Ms. McElyea. McElyea, yes. Mr. Mollohan. McElyea, sorry. You talked a little bit about--maybe some other members of the panel did as well--an aspect of this that you wouldn't at first think was a prosecutor's angle on it, I guess. That is the method of dealing with the addict, and you suggested in your testimony that using the criminal system for the addicts, is an imperfect way of dealing with them. I agree with that. Would you agree that that is the only way it works, because it involves incarceration, which means forcibly keeping the addict away from the drug? Ms. McElyea. That is what we are doing. Like you, I would not have thought about that perhaps even 2 years ago, and most people who would know me and see me in court would say that I argue to lock up everyone, and perhaps there is part of me that does. The problem is that locking up the addicts doesn't work. We have to--if you are going to lock them up, first of all, you have got to keep them approximately 1 year for them to have any chance of being successful, but the greater problem is that when you are turning them out, you are putting them right back into the same group of friends, shall we say, and the friends are users, and they are right back into the same pattern of behavior. Crime continues to escalate. So it appears to me that somewhere down the line--and I know nobody wants to spend money on drug addicts, myself included. I pay taxes, but I think that in the long run we are going to have to recognize that we have got to deal with addicts at some point. Mr. Mollohan. Okay. Before we get to the point of what you do after they have been separated from the drug for a year or 2 years let's talk about the system. The way we are dealing with it now, is in the criminal system. What would you think about the prospect of the national government or state governments--I think it would be more effective, perhaps, if it were a national system--if you had a remedy whereby you could certify a person as a certified drug addict through whatever due process you went through to achieve that goal. Then you would be able to incarcerate them on the civil side, much as we do for insanity or for other kinds of illnesses. You can do this now for a very short period of time. In West Virginia, I think, Captain Hall, you can incarcerate somebody if they are a danger to themselves or a danger to others for a 3 or 4 week period. But if, on the civil side, you had an incarceration remedy much as you incarcerate somebody for other sicknesses, what would be your response to that idea, either nationally or at the state level? Ms. McElyea. I would love to see it. That is what--when you get the calls at home and when you get the calls into the office and you listen to parents that want help for their children, they don't want to turn them into felons. When we turn an addict into a felon, we mark them for life, and a lot of these addicts, these OxyContin addicts, are from very good families. But we are marking them literally for the rest of their life and we are placing a badge on them they may never be able to overcome. We are eliminating them from a lot of the work force, the parents of these people and the family members of these people, and we have seen father's steal from daughters. I have a case pending right now that a father wiped out a daughter's account, checking account. They want help. They want civil help first, but they don't find it in Virginia. We can hold them a matter of hours. We don't have the bed space or the funds to treat them, but that is what the real cry is, is that give us something to look at other than criminal incarceration. Mr. Mollohan. I think it would be wonderful if the law enforcement community came forward with that concept. Chief, what do you think of this approach? Mr. Maggard. I agree wholeheartedly. I have seen too many young people that have now been convicted of a felony simply because of their addiction, that are not able to go hunting again, not able to purchase a weapon. Their rights have been taken away from them. That was our goal as a community anyway, find some source, some resource where we could develop a rehab center, where we could civilly be able to take care of them. The jails are overcrowded now. They are full of people and we can't--it is not the criminal way. I mean there is a difference between the addicts and the normal everyday criminal that you get, and something needs to be devised to where we can place them in a safe place where they are not criminals and where the family won't suffer from the ramifications of their being convicted if they go to the--so I agree. Mr. Mollohan. Thank you, Chief. I want to get everybody on the record if I might, and I don't have much time. Lieutenant Hudson. Mr. Hudson. I think in an ideal sense it sounds like it might provide some solutions to what is going on, but the way that the civil laws are now with detention of either mentally ill people or circumstances where people are a threat to themselves or others, the provisions certainly aren't even close to being there, and it seems to me the trend is towards less incarceration of those individuals rather than greater---- Mr. Mollohan. Of those individuals you've described, the mentally ill? Mr. Hudson. That is correct. Mr. Mollohan. But the aspect of this problem is the necessity for a long-term separation from drug use and that can only happen today in the criminal system. This is not because they are a drug addict but because they have committed a crime to support their drug addiction, and end up in that system and get separated from the use of a drug for a long period of time. That is what legislatures are about, federal and state legislatures, and I heard you say it is an imperfect system and you couldn't do that now. Would you support a system that would allow addicts to be treated in that alternative way? Mr. Hudson. As a general question I guess I would say yes, with some clear definition having to be made in the future as to what an addict is, what types of addicts you are looking at, et cetera. It is awfully vague to simply sit here and say, yes, I will support that. Mr. Mollohan. Or starting with a broad concept here? Mr. Hudson. Absolutely. The concept of separating the addict with their problem for a long period of time is what is creating the solution for treatment and/or healing, if you will. Mr. Mollohan. If you can't get that separation, you can't really deal with the issues that can possibly result in long- term success? Mr. Hudson. Which is where we run into the problems when they come back into social circles. Mr. Mollohan. Captain? Mr. Hall. Well, I think it would work. We do it with alcoholics now. We have public intoxication shelters. We don't put your normal drunk on the street in jail anymore like we did 25 years ago. We used to jail them for the weekend. If we caught them on the street, we would take him to jail. At least we would know where he is for the weekend. So he is not going to get in the car and kill somebody. But now we take drinks to PI shelters and they have to sober up. They may get drunk tomorrow night, but at least they have to sober up, and if they leave the PI shelter now then they have committed a crime---- Mr. Mollohan. Extrapolating for a little longer period of time, 2 years for drug addicts, do you think that is appropriate? Mr. Hall. I don't know how long it would take to detoxify somebody. I am sure if a judge adjudicates somebody is an addict and that he has---- Mr. Mollohan. On the civil side. Mr. Hall. On the civil side--for a week, a couple of weeks to be examined. Mr. Mollohan. Or whatever period the people in the medical community or the treatment community felt was adequate? Mr. Hall. Right. In the criminal system we have shock treatment now where people are evaluated for 60 days. Instead of going to prison for 1 or 2 years, they can be evaluated for 60 days to see if they will have to do those things, and a lot of times that is enough, just the shock treatment may work on them. So I think maybe you are onto something. Mr. Mollohan. Thank you all very much for your comments. I agree with the Chairman and Mr. Rogers. It is an outstanding panel and riveting testimony. Thank you. Mr. Wolf. Thank you, Mr. Mollohan. I want to thank you again, the four of you for taking time to come--except for you, I know, live in my area. You haven't come very far unless there was a lot of traffic in the morning. But we appreciate all of your testimony and I think it will make a big difference. So thank you. Tuesday, December 11, 2001. ADDICTION EXPERTS AND RECOVERING ADDICTS WITNESSES DR. ROLLY SULLIVAN, PROFESSOR OF BEHAVIORAL MEDICINE AND PSYCHIATRY AND DIRECTOR, ADDICTIONS PROGRAMS, WEST VIRGINIA SCHOOL OF MEDICINE DONNIE COOTS, HAZARD, KENTUCKY, FATHER OF AN OXYCONTIN ADDICT Mr. Wolf. On the next panel we are going to have Dr. Sullivan, Professor of Behavioral Medicine and Psychiatry, Director of Addictions, West Virginia University; and Mr. Donnie Coots, Hazard, Kentucky, father of an Oxycontin addict. And again if you can summarize your statements, the full statements will appear in the record, because we do still have two more panels. But we want to thank you both and we can proceed in that order, Dr. Sullivan first and then Mr. Coots. Dr. Sullivan. Let me thank the committee for allowing me to be here, and I will try to be brief. One of my counselors a long time ago told me that the brain can only absorb as much as the fanny can stand, so I know we are getting to that part. First of all, let me say I have been a career academician, I am a treating physician on an inpatient addiction unit. When I was a resident in the early 1980s and I did my residency in internal medicine and psychiatry, so I got boarded in both, I find that, unlike many doctors, I liked working with addicts and alcoholics. I thought they were interesting people and in some ways had a real noble struggle. These were not weak people. These were people who strove very hard to try to get through their addiction and there was something about being a physician and working with these folks that I really, really admired. Since 1985, I have run the addiction program at West Virginia University. It was mostly alcoholics in the 1980s. Cocaine came along in the late 1980s and we saw a fair amount of that. In the early 1990s, primarily out of necessity, I got involved with treating the chronic pain patient who was an addict because other docs didn't know what to do with them and this was a special population of patients who really did have both chronic pain and addiction and over the past 10 years have developed some expertise and some notoriety for that and have gotten a fair number--probably at least a third of all my patients now are chronic pain patients who are also addicted. In early 1999, I first became aware of OxyContin--and this was partly in the testimony or in my statement--when a fairly astute counselor in Charleston said, hey, Dr. Sullivan, there is this new drug and it is OxyContin, and the docs down here are being notified of it and they are being marketed and I think we need to put a panel together and sort of, you know, at least talk about the potential for addiction. Now, at that point I had never seen a patient that was hooked on OxyContin. That very quickly changed and over the past 2 years since that period of time I have had an enormous number of patients who were hooked on OxyContin, which actually peaked last summer in August of 2000. I now have a ten-bed patient unit and at that point in August of 2000 there was 1 day that all ten patients were OxyContin addicts, and the great irony to me after all these years was I couldn't get a run of the mill alcoholic into treatment because the beds were all full of OxyContin addicts, or if somebody had a problem with cocaine, there was no way to get them in. Since that time, as most of you know, the newspapers have picked up on this and there has been a flurry of activity in the papers and doctors have gotten scared and they have started to write far less prescriptions. So to be absolutely honest to you, the peak for me was 2000 of August. And since that time there has been a trailing off of the number of patients who have come to me whose primary drug is OxyContin. Now, as I left the unit yesterday morning, I looked at those 10 faces because I am always full. You have heard the testimony about how hard it is to get somebody in addiction treatment and I am always full, and I looked at those 10 faces and five of them were OxyContin patients, although one of them would--probably the cocaine beat out OxyContin by a little bit. I think it has been an interesting and very intense past couple of years. I see the number of patients decreasing. I would want to say one other thing, and I think it is important because it got lost in the--sometimes gets lost in this whole big picture. The Federal Government funded a large study several years ago called the Epidemiologic Catchment Area study that basically showed in the United States that about 13.5 percent of adults will at some point develop alcoholism and about 7 percent of adults in the United States will at some point develop drug addiction. So if you look at those and you combine them, there is a background of addiction here that is prevalent. It is not an uncommon disease. This is a very common problem, addiction in the United States, and unfortunately so is chronic pain, and because the two things are so common what we have ended up with is a lot of patients who have both and they really do have both. We have heard about how doctors get worked. Well, they get worked sometimes by people who have legitimate pain, and one of the things I have really strived to do is to try to respect the fact that many addicts do have pain and you need to address the pain in an appropriate nonaddicting fashion at the same time you try to address their addiction. So with that as a background I want to make sure that folks had time for questions. I didn't want to go on any further. Thank you, Mr. Chairman. [The information follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Wolf. Thank you very much. Mr. Coots. Mr. Coots. Mr. Chairman, I am just a country preacher. I am going to make this as simple as I can be. The only reason I am here is Mr. Rogers asked me to come and we need help in eastern Kentucky. We have heard the police officers and all those that deal with the illegal side. I don't deal with the illegal side. I deal with the addicts on the street that says I want off and there is no place to go and nothing to do with, and that is who I deal with. I am involved with the group called People Against Drugs, as Rod Maggard alluded to, and there is a program at my church called New Life. It is all we can do. We do it every Saturday night. And the reason we do it every Saturday night is because there is young folks that come to us saying I am dying, I want off of this. I see young women go from beautiful young women to old ladies in a matter of months. I have personal experience with this because Joshua, he is with me today, got involved with OxyContin. He started with the so-called soft drugs and got involved with OxyContin, and it cost my wife and I our bank account. It broke us. People would tell me, like the good doctor said, send him to rehab. With what and to whom and who is going to pay for it? Because I didn't have the resources. I have friends at home that are prominent, that are broke today because they have paid the bad checks, they have cleaned up behind their kids, and they are your kid no matter what, and every time they do that they will promise to you they will not do it again and you clean up behind them and when you go to a rehab facility no matter where they are, there is none there. I never heard of a thousand dollars a day, you know, and you can set back and say I can send my kid. Well, I couldn't send anybody for $50 a day, and I wish I could tell you that my story is just unique but it is not. We normally have from 16 to 20 people on a Saturday night. Some of those people are high. Some of those people are drunk. Some of them come to our--and they want off. Whether or not this drug is positive or negative--and I wrote in my statement if we had a creek that was poisoned, we would damn it up, we would divert it, we would do something with the creek but we would do something to keep it from flowing into our community and poisoning our water. OC's have changed, it has changed, as you already heard in my original statement from September that it was a dollar a milligram. Well, it is not that way anymore. It is more. The price has gone up, so the suppliers come from everywhere. Every rat in the community comes out with a pill in his hand. I have a friend that buried 12--well, the rate has gone up since September. I stood and looked at a little girl's coffin. 24 years old, beautiful blonde headed young lady that OxyContin killed. Now if it quacks like a duck, walks like a duck and flies like a duck, it has got to be a duck. OxyContin is killing folks and it is killing them now. I have heard the question asked, would you take it off the market? It is on the market. How do you go back to 1996 and jerk it off the market? We have got to deal with what is there. I don't know what this committee hopefully will do with it, but you've got to do something from 1996 up until now. Those are the people I am dealing with. If the company wants to do something, see me after this, whoever is here for the company. I will give you some place to put your money. If I can ask the Congress, I will give you some place to put your money. For people who can't afford it, Mr. Rogers, please. A company has already given us buildings, but when I went into the buildings the buildings need refurbished. There is no money there to do it. I don't have it. What do you do? Well, I can tell you one thing that what we are doing now is not working. He said 30 percent and that is not running him down. How about 60 or 70 or 90 percent? Put them in jail? I see them every day in jail. I go see them in jail and Time Magazine--Newsweek Magazine went with me to jail and the lady looked at me and said are these the young people that are going to prison? Because they are good people, they are trapped. They are trapped with whatever drug it is, but they are trapped and this OxyContin helped--it was a better mousetrap. It might have been a better drug, and incidentally in my statement I also told you, and it being part of the record, that my dad is a coal miner and being a coal miner, he has black lung and they gave him medications that actually eat the bones up over time and his back breaks. The bones in the back are the thinnest and they break. The only thing that would relieve his pain is OxyContin, and thank God for OxyContin at that time. It is not an easy question. It is not. But it is awful when I look at a young man who has lost his wife, his two children have been taken away from him and they are with a relative who supposedly is dealing, and there is nothing I can do, and he says let me go to the methadone clinic. Well, you are trading one drug for another and in our area it is $80 a week. I wish I had some real wisdom from God to tell you or tell the company do this and it would fix it, but I really want to plead with you and plead with our government to help us help these people at zero cost. I know it is another giveaway. I had to--we were allowed to send Joshua to a place called Mission Teens. They don't charge. There are no doctors there, but they are drug addicts who used to take drugs and are now off drugs and are counseling. He would do 300 milligrams a day. Somebody asked how many. He would do 300 milligrams a day. I once went to a hospital to visit a lady that called me. She said, Pastor, I want you to go see my daughter. She is dying, her kidneys have shut down and her liver is not functioning. And I knew she was an OxyContin addict, so I went. From her bed in intensive care, she said, ``How in the world--why am I here? Tell me why I am here. Joshua and I did drugs together. He did as much as I did and I am here.'' How long? You ask how long? At least a year. You can't do this. They didn't do this in 2 months and they are not going to get over this in 2 months and then the community, somebody in the community, hopefully the faith-based people that like PAD, like Petri Baptist, like the First Baptist Church, like the Church of God in Macy Street will come out and say let us help you continue to be clean, and if they fall pick them up and if they skin themselves up, put a bandage on them. But we can't throw away an entire generation from 1996 to now and say, well, let us do something about it, okay. I too don't believe in drugs for two things. When I had a tooth pulled they gave me a Tylenol and told me to go to the house. That simple. I am a coal miner, I have got three ruptures in my neck and three ruptured discs in my back and a cracked vertebra, and no, I don't take drugs every day. We have come to the place somehow in our world--we have come to the place if it hurts you got to take something. Sometimes you have just got to get up and go do something and take your mind off the hurt and the hurt will go away. My point to you, please, please, I am begging as a pastor, a country preacher, I am begging you to do something, please do something for the country. Not enough money in the world was worth me looking at that little girl in the coffin and the church being full. She is dead at 25 years old. Nothing in the world is worth that. Thank you. [The information follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Wolf. Well, I thank you both for your testimony. I have a number of questions that we won't in the interest of time ask. Let me just ask one each. To the doctor, Doctor, I don't know if you were here when I was questioning Mr. Hutchinson from the DEA, but should have this been used--and if you don't feel capable, that is okay, but you would probably have a better understanding for moderate as well as severe pain or should it have just, you think, at the time the Food and Drug Administration approved it been used for just severe pain? Dr. Sullivan. Well, I did hear you ask that question, and I understood what you were saying because I think the hook was the moderate part of that comment. The company studied it originally for osteoarthritis as well as for bad lower backs and the doses that OxyContin worked on those was a relatively low dose. I think if the company had stuck--see, my problem is I think there is lots of other great medicines already on the market that would have worked fine and I think that if OxyContin had really stuck with a market of just severe pain, that would have helped. I think that wouldn't have solved all the problems because the problem is the drug formulation itself and I have to say that it is--you know, there is a disclaimer in the formulary when you look at OxyContin that says it shouldn't be altered because you might have a big overdose and you could potentially have a life threatening consequence if you alter this drug. That really works great except for that 15 percent of folks who are addicts and rather than see it as a warning, they see it as an advertisement and so they use that. So I think even if it was marketed for severe pain, I think that the addicts would have found it. Mr. Wolf. You think it would have been to where we are now if it had just been severe or do you---- Dr. Sullivan. Absolutely not. I don't think we would have gotten to the same point, because there was a period of time if you had osteoarthritis or a bad back, I know some docs felt like they were almost--I talked to the Chairman of Medicine at West Virginia who is a rheumatologist. He said when he went to a meeting he felt like he was being almost incompetent if he didn't prescribe this medicine for the conditions I just spoke of and that is--you know, once again I think that it was pushed a little too hard. I understand that the company had wanted a medicine that would make them some money but also do a good job, but I think it was pushed too hard. Mr. Wolf. The last question for you, Doctor, is if there is any one thing where we are today unfortunately, but where we are, what do you think it would be that either the Congress or the company could do to help us remedy or deal with the problem? Dr. Sullivan. Well, I don't know. You know, part of me, I don't know if I want to address the OxyContin specifically. I come from the treatment aspect of this and I can tell you that addiction is a reality and treatment services, as you have heard repeatedly, are woefully inadequate. What we really need, if I could do one thing, is a level of treatment that virtually doesn't exist, and that is low cost residential treatment, because for addicts to get better it takes time and it takes time away from the problem and a low cost residential treatment I think would be--the system would be very helpful. Mr. Wolf. Well, I agree. I think the whole effort with regard to the law enforcement aspect has been a little too difficult insofar as I was in a group of federal prisons earlier this year and what some of the people needed was rehabilitation more than they needed imprisonment. I think Mr. Mollohan had a very good idea with regard to that because we don't want to have it whereby this is a form of illness whereby they can never again have a federal job or never do something. So I would think you are exactly right. Maybe with some of that money that was earned through different law enforcement proposals with regard to asset forfeiture, a portion of that. I have never felt we put adequate funding with regard to education and rehabilitation, particularly rehabilitation, because you can't just use someone up and throw them off to the debris. Also, lastly, without getting too brutal about it, we are going to be putting in legislation, maybe before the end of this session if this session ever ends--hopefully Friday, so we may miss it--a bill dealing with prison rape. Rapes in prisons are brutal. Prisons are brutal. It is just a brutality. So there are some people that you have to put in prison, but there are other people that they really ought not be there, and so anything we could do, Mr. Mollohan and I would be glad to. With regard to you, Reverend, I thank you for taking the time and publicly coming forward. If you could tell me, and there is a representative from the company here, and other representatives--I guess DEA has someone here and others--what is the one thing that the Congress or the government or the company could do to deal with the problem, as you see it, where we are today? Mr. Coots. I think--basically I think the President had a wonderful idea. I know that it doesn't set well with some, but to use the faith-based initiative to tie us, the ministry, together with the problems that we have. One of those things that we have tried to do or we are trying to do, but everywhere we go we end up with red tape, when we were looking just to open a center, we wanted a place where we could have a crisis center. I have people come to me looking for a place to stay, and there is the homeless shelter, but there is no place to actually take someone with drug problems in our area. So for me it would be for us to come together as two units to solve one problem that took a generation from us. I don't--money-wise, the figures just alluded me because they get--when you start talking about what we consider professional help, you can't hire a good doctor or a good counselor for $10,000 a year. It can't be done. You can't hire a residential housekeeper for that kind of money. So it is going to--we either spend the money in jails or in courts or we spend them trying to put together a system that will help our children. God never intended for us, for them, to live like that. He never intended for a nine-year-old, as was in the testimony today, to lie in bed with dog feces. He never intended for a 21-year-old, 17-year-old, a 19-year-old to die. He never intended for a brother and sister to die on the same day with OxyContin. God intended only good things for us. And they have no thought for tomorrow. They have no future. Their future is from pill to pill, from substance to substance. And somebody has to stop them, and if we can't hire those folks, then let us put together a faith-based program where we do have the good doctors, like my colleague here, that can at least assist us with some help and point us in the right direction and let us please help them. Mission Teens does that. And there are drug addicts in New York and New Jersey, and they will tell you I am not a drug addict anymore. 20 years they have been off drugs. They know. Nobody knows better than they know. So to put it together, first of all we need the housing. I have got the buildings, folks. I just need some help putting the buildings together in eastern Kentucky. Those type things. If we could do that, it would help. Mr. Wolf. Mr. Serrano. Mr. Serrano. Mr. Chairman, I don't really have any questions. The last questions you asked them were really the ones I was trying to find out, what we can do. And perhaps for you, Doctor, is the treatment understood to be any different than treatment in the past for addiction or is it the old question, are all addictions the same? Dr. Sullivan. Well, you know, OxyContin is a fast moving train but it was just the most recent train on the tracks and drugs of addiction have been around for a long time and they sort of tend to move around and new ones come along all the time. The treatment is pretty well known and was fairly well established in the 1960s and 1970s, and, you know, the outcomes, the best outcomes are when you provide long-term treatment. Short-term treatment, in and out, 2, 3, 4, 5, 6 days, is almost worthless, not completely but almost worthless. It is only when you can really engage an addict in a longer term meaningful relationship that you can start really making some moves on the big things that are important in people's lives in terms of how they organize their lives and education, who they live with and how they see themselves and get some time under their belt, that they start to get better. To be frank with you, I am pretty frustrated. I have lived with this whole system 15 years and I am frustrated because it is so difficult in this environment to really treat people. You can't keep them long enough to really do good. Mr. Serrano. Mr. Chairman, let me just say that this issue that you brought up today and that this subcommittee has taken up today may open up a discussion of how we deal with drug addiction in this country. It seems that for a while we have continued what we were doing and not revisited the question, and I would agree with you, Doctor, as I said before, friends, closer than that, folks that I have known all my life, and some have been wasted totally, some have died, some have never recovered, but the ones who are doing better because, you know, a drug addict is never cured---- Dr. Sullivan. Right. Mr. Serrano. An alcoholic is never cured. It is just one day at a time, and how much love and respect you get helps you stay sober that one day to see what happens tomorrow. The ones who have been able to say I have been okay for the longest stretch, other ones who are able in my experience, to go away for a while, go into a community, be it locally or in New York City, upstate where you see some trees and some grass and stuff and be able to have a community atmosphere, those are the ones who succeed, and so perhaps, Mr. Chairman, what this will accomplish today is that because it is the latest addiction and it is one that is legal and then becomes illegal at the same time, that all of this will begin to take us down that road of looking at this again. We can spend a lot of time talking about how these people got this way and fight that and control some of that, but if we don't educate, as the doctor said, the gentleman who was here before, you know we in this country, and I am one of them, get nervous about what happens in the schools, but I don't think anyone should be nervous about telling kindergarten that drugs are no good. That should not be a problem. And I thank you both for your testimony. Mr. Wolf. Mr. Rogers. Mr. Rogers. Thank you, Mr. Chairman. Let me talk to you, Doctor, about the typical OxyContin addict. Is their rehabilitation harder than it is for other drugs? Dr. Sullivan. Drug addicts in general have it more difficult than alcoholics do as a group. OxyContin addicts I have only had about the past 2 years, and I would say they are pretty typical for most opiate addicts, people with heroin, a number of other opiates. The bigger problem with the OxyContin seems to me to be when they leave the treatment it is so prevalent where they go it makes it difficult for them to stay clean for any length of time. Mr. Rogers. Do I hear you say that the OxyContin addict who recovers more frequently goes back to the use of the drug than other drugs? Dr. Sullivan. It is hard for me to say. There has been less recovery from OxyContin probably in general than other opiates, once again because I guess their environment they go back to so frequently is poisoned for them. The ones who do get better-- let me say in West Virginia we have five halfway houses and if I can get an OxyContin into one of those halfway houses, which is a rare commodity to come by, if I can get them into that, they do better. That is the ones that have gotten some legitimate and consistent recovery. Mr. Rogers. Many people would say that Oxy abusers are nothing more than habitual, everyday drug abusers, that they are merely moving on to the next drug in their never ending cycle of abuse. Do you agree with that? Dr. Sullivan. I am glad you asked that question. I always check that on my patients and it is interesting to me that I find most of the OxyContin patients who I get in used to be hooked on something else. Now, I would say at least half of them, even though they may be chronic pain patients, at least half of them were alcoholic and who quit drinking alcohol and moved on to the pills and have gotten hooked on OxyContin. Of the five I have in treatment now who are hooked on OxyContin, they clearly had a history of alcoholism even though they may not have drunk now for several years and have done pills instead. So I think most of the time when you have somebody who is hooked on OxyContin, not always, but most of the time what you will do is either find a personal history of addiction that predated the OxyContin usage or you will find a family history, a very strong family history of either alcoholism or drug addiction in either one of their parents or grandparents. Mr. Rogers. So are you saying that the typical Oxy abuser is not a first timer on the scene? Dr. Sullivan. Typical Oxy user is not a first timer on the scene. I have a 22-year-old man in treatment right now. He had two DUIs by the time he was 19 years old. He hasn't had a drink since he was 20. He has been on OxyContin for 2 years. He has been shooting an IV for the past 3 or 4 months. That is a very typical young story of people I get in. Mr. Rogers. Reverend Coots, I don't think you would agree with this, would you? Mr. Coots. No, I wouldn't. Mr. Rogers. Tell me your views about a typical abuser. Mr. Coots. Can I introduce somebody to this committee? Mr. Rogers. Absolutely. Mr. Coots. Joshua, would you come and sit with me here? I want you to see and I wish I could have a picture that I could set here, before and after. Mr. Rogers. This is your son? Mr. Coots. This is my son. If you met him, if you want a used car, he will sell you one. He don't even have a car lot but he can sell you a car. These people are--the ones that I deal with are very, very intelligent, very intelligent. He talked a lady into selling him a car and didn't have a job, didn't have a down payment and got the car through the bank. That don't happen. My point to you is when I--the people that I am looking at in eastern Kentucky may be different from where the good doctor is from, but people I am looking at from eastern Kentucky, some of them have histories. I have no one in my family that I know about that is an addict, to my great grandparents, but my point is if you take a drug, and this is what I have been told, if you take a drug that as soon as you shoot it--please don't be offended by this, anyone, but as soon as you shoot it, it is like having an orgasm for 6 hours, you are warped. And no matter what you do you can't become unwarped. You don't just forget that drug. I had a young lady 24 years old that was in rehab with him, said it is my mother, it is my father, it is my sister, it is my brother, it is my lover, it is my everything to me. It doesn't matter. She is free and he is free today, but he will fight the battle tomorrow and the next day and the next day and the next day and the next day, and he has to have somebody there in his corner. All of them can't leave home, all of the drug addicts can't leave the door, Mr. Serrano, so somebody has to stay there and help. And I wish we could take this gentleman home with us. I would take him home with me and keep him there if he would stay down there and help us, but you can't. Mr. Rogers. Reverend Coots, can I ask you about your son's case? Mr. Coots. Sure. Mr. Rogers. How long ago did this start and how did it start? Mr. Coots. He started drugs about 7 years ago and he started drugs on his own admission because he wanted to fit in with the crowd at school. Mr. Rogers. You are talking about OxyContin? Mr. Coots. No. He started out with smoking dope, smoking pot. In eastern Kentucky someone said that is our national crop. You know, we have got policemen and DEA agents and everybody flying all over, everybody, and we see it every year, but now they are turning this crop into pills, they are trading marijuana for OxyContin. People in the cities like the marijuana and people in the cities like to export the OxyContin, I guess. I don't know, but he started there and he progressed, and nothing we could do. Mr. Rogers, the bad thing about it is Carlene and I didn't know what to do. We had no place to go, there were no centers to go to and say, look, I have got a problem with a kid. Now these parents come to us. I ignored him. I beat on him, and this is truth. I am not proud at all. I ignored it. I beat on him. I did everything wrong until I started saying, wait a minute, you are my son, I love you and you are better than this. And that is when we started to get better and I said that we started to get better. Mr. Rogers. So he started with marijuana? Mr. Coots. Yes. Mr. Rogers. And then what other drug? Mr. Coots. Thorocets, Percocets. It is a gradual thing. Mr. Rogers. When did OxyContin come into play? Mr. Coots. Two years ago. Mr. Rogers. And were you aware at the time that he was using OxyContin? Mr. Coots. I didn't want to be aware. I am a pastor. A pastor's kids are not supposed to be there, you know. I didn't--yeah, we were aware. Yes, me and my wife were aware but we didn't want to be and we said this will go away. We have got two other children, and Jeffrey liked to drink and the drinking went away. This didn't go away. It just got worse. Mr. Rogers. So what was the final straw that broke the camel's back? Mr. Coots. He--one of the things he did is he stole a book of checks from our church and he wrote--him and some of his drug buddies wrote checks to the tune of $3,000 on the church, broke into his brother's house and stole checks and wrote checks there and was arrested, and our local judge when I went to talk to him--of course I am dealing with other drug addicts too, and I went to talk to him. He said let us rehab, and I said okay. So we gave him an option, go to the local county jail, and our county jail is not pretty, and I think all county jails ought to be ugly. One thing that bothered him about the county jail is the toilet sitting right in the middle of the floor. I think there ought to be a toilet right in the middle of the floor wherever they take him. When they took him down there, I told him it is rehab or jail. So we trapped him. That is what we did, Congressman, we trapped him. Mr. Rogers. So I gather the rehab has worked? Mr. Coots. Up to right now. Mr. Rogers. How long ago did the rehab begin? Mr. Coots. June of this year and he just come home in November? Mr. Rogers. So he is living at home with you? Mr. Coots. Just behind me. I watch him a lot. Mr. Rogers. What is your son's age? Mr. Coots. 22. Mr. Rogers. Now, this among other things has spurred you at home to begin a crusade of sorts in your community? Mr. Coots. With other pastors, yes. Mr. Rogers. With other pastors. Tell us about that. Mr. Coots. We met--excuse me. It has been so long ago I don't remember the date, but we met and had about 400 people come together and I finally admitted I had a problem with a son and then other people would come up to me and say I have the same problem, and then they got to trusting me. I ended up being the chairman of the recovery committee for the PAD group, People Against Drugs, organization we started there and worked with them I guess 6 or 8 months and that group has--we are doing everything that we know how to do to help our community. Mr. Rogers. Is that strictly a local group? Mr. Coots. I think now it is probably all the way in Virginia. Mr. Rogers. But it started in Hazard? Mr. Coots. Yes. I didn't have the time to tend to four other places, so I deal with strictly our local community. Mr. Rogers. And you don't get any Federal funds for it? Mr. Coots. No. Mr. Rogers. You don't get any state funds? Mr. Coots. No. Mr. Rogers. It is all what you can gather locally? Mr. Coots. Whatever I can beg and twist somebody's arm to get, yeah. Mr. Rogers. Tell us what you do. Mr. Coots. Right now we have a Christian 12-step program that is going on in Petri Memorial. We have got what we call New Life at our church and we deal with 7 Steps to Freedom which was--is actually a program written by Neil Anderson, who is a noted psychologist dealing with addictions, and we love them a lot because these people, by the time they get to us nobody loves them anymore, nobody wants them around, nobody cares. Mr. Rogers. So I gather you have the community's ministers pretty much all involved in the group? Mr. Coots. I wish I could say that. Yes, some. Some don't want to be bothered. Mr. Rogers. What percent would you think you have? Mr. Coots. I wish you hadn't took me there. Probably 10 percent. Mr. Rogers. Do you have a lot of public support? Mr. Coots. Yes. I have businesses. We hoped an office in Hazard and I just went to the businessmen. They paid for the entire office, phones, everything was paid. We did the office for 6 or 7 months. The businesses in our area and the people in our area, yes, we have public support. Mr. Rogers. You mentioned the place where your son went for rehab, and I forgot the name of it. Mr. Coots. It is called Mission Teens. Mr. Rogers. Tell us about that. Mr. Coots. It is a program that actually absorbs their entire day and it is biblically based, so they are reading a lot of Proverbs and a lot of Psalms, and if they steal they are going to read a lot about stealing and if they are destructive they read a lot about destruction. And what they do is they took Joshua, who had a terrible attitude, and they kind of molded him because they took him in and they said here are the rules. First of all, these people don't follow any rules anymore. The only rule is give me something to shoot in my arm, and tomorrow the same rule applies. So they break all the rules. They steal, lie, they do everything that normal people wouldn't do. So what they do is they put them in a structured, really structured, I call it Biblical Bootcamp, and they put them in a real structured area. You can't go through this door, you can't open this window, you can't sit in that chair and if you do, there is a consequence and it is an immediate consequence to pay. It is not a terrible consequence, but it is a consequence. Joshua got to write a lot of--entire chapters out of the Bible and he would call the first week, and the second week he was there he wrote us and said you people are not my parents, you are the most awful people in the world, I hate you, I will never come home. And the good doctor is shaking his head. It is the worst thing because he went from a no structured world into a structured world. From 7 o'clock in the morning every hour was taken up until 10 o'clock at night and their world is upside down. You have to understand that we live in a day world; they live in a night world. They live in an upside down world. So they are up all night and sleep all day. They are chasing drugs all night and sleeping all day. Well, they took him out of his upside down world and put him in the right side up world, and he couldn't do anything. He couldn't call. There was nobody who could get in contact with them except us, the family, and he had to do it by letter. And you would be surprised how much more information you receive in a letter than you would with a phone call. What he felt in his heart would come out of those letters, what he would--then he started writing this is the best thing that ever happened to me. When he finally--the detox was over and all of the withdrawal was over, he started, ``This is helping. Dad, you guys really did good.'' and then he would revert back. He would get blessed, and a blessing was not a blessing. It was called a blessing, but it was something that he had done wrong. You could see it in his letters. And then we started to see him grow and he got better and as the months went by, as I indicated, months went by, he got better and better and better and then he said, ``Dad, I want to come home.'' I said, ``Are you ready to come home?'' ``Yeah. I want to come home.'' ``Are you ready to come home?'' He said, ``Yeah, I can come home.'' I told him the other day he can't go back to the old friends. That is the reason for New Life. You can't go back to jump in the same pit. That is where we come in. That is where our church comes in and churches like us come in. Mr. Rogers. The Mission Teens, is that a church group? Mr. Coots. It is a nondenominational group. Actually it was started in New Jersey and they have got 12 centers across the United States. Mr. Rogers. And where did your son go? Mr. Coots. He went to Brazil, Indiana, where they make Clabber Girl baking powder. Mr. Rogers. Is this a free rehab program? Mr. Coots. Yes. Mr. Rogers. It doesn't cost you anything? Mr. Coots. Didn't cost us anything. Mr. Rogers. How is it supported? Mr. Coots. Donations just by people like us. Our church got involved, other people get involved. By donations. Mr. Rogers. So in your opinion, you know him better than anyone except perhaps his mother, is he over this thing? Mr. Coots. No, he is not over it. He is better, but he is not over. I don't know--from all the professionals I read, I don't know if he will ever be, quote, over, but he is better. Mr. Rogers. But he is not using it? Mr. Coots. No. Mr. Rogers. Is he using any? Mr. Coots. No. Mr. Rogers. That is what I meant by being over. Mr. Coots. Yeah. Mr. Rogers. It will take perhaps a lifetime of commitment on his part to stay clean, but I would hope that appearing here with you in this very moving setting before a national television audience would encourage him even more. Mr. Coots. I would, too. Mr. Rogers. That is one of the sidelines I would hope from this hearing. Mr. Coots. Could I add one thing to that, Congressman? The thing that we find when they do come down and they are clean, they don't have anything to do. They don't have anything to do with their time because the community knows they are a drug addict. Normally they can't get hired. Nobody wants anything to do with them. He had a tough time getting a job, and he got a job. As a matter of fact, he got two jobs. But my point--the reason that I mentioned it is because coming out of that, they can't go to nothingness again. They have got to be constructive. So we have to have something for them to do, and that has to be a part of the marriage I was talking about between the faith-based and the Government hopefully or the companies or whoever, wherever we can get the money, so they have something to do and they can't just go back and sit and think about that again. Mr. Rogers. Well, I appreciate very much your traveling here, you and your wife and your son. It has been very helpful, very moving. I certainly want to tell you how much I admire you for taking the stand publicly the way you have, under very difficult circumstances. You are to be commended for what you and your wife have done publicly in this matter. Mr. Coots. Thanks, sir. Mr. Wolf. Mr. Mollohan. Mr. Mollohan. Thank you, Mr. Chairman. Again it is an excellent panel, riveting testimony. Reverend Coots. Mr. Coots. Yes. Mr. Mollohan. You indicated that months went by during Joshua's treatment and he went in for treatment in June and came back in November? Mr. Coots. Yes. Mr. Mollohan. About 6 months. Mr. Coots. Uh-huh. Mr. Mollohan. You indicated that he made gradual progress during that period, as was evidenced by your letters, and your communication with him. At some point you and Joshua decided, and the family decided, it was okay for him to come home. That is a long treatment. Six months seems like a long treatment. I don't think it is a long treatment for this illness, but it is very difficult to get people to submit to that long a treatment program. Was he under court order to go to this program? Mr. Coots. Yes, sir. That was the trap. And I would recommend for any parent who has a child that has an addiction with OxyContin, especially a child that is over 18 that you don't have any control over, trap them. There is nothing wrong with trapping them for help. I firmly believe if we hadn't trapped Joshua, he would be dead today. Mr. Mollohan. You said OxyContin because that has been your experience. Do you think your advice to a parent who had a child with any other opiate addiction, or any other addiction as far as they are concerned, would be any different for them? Mr. Coots. Yes, sir. We see alcoholics, like the good doctor said. An addiction, you are--an addiction is an addiction. You are controlled. Any life-altering problem has to be intervened. You have to intervene somewhere. Mr. Mollohan. So your answer is, yes, your advice would be the same for any particular addiction, an opiate addiction, which OxyContin is? Mr. Coots. With qualification. In our area, I already work with the courts in our area, both circuit and district, and both judges in our area are open. They don't want to put these young people in jail, because it doesn't help. They go in jail, they are back in jail again. What they want to do is get them into treatment, and that is what we do. Now I am working with actually two counties, possibly three counties, with the same court systems. If the court systems--all court systems should work the same way to help these young people get help. So he was arrested. It was a sentence that he would have served 2 to 5. Aren't you going to serve 2 to 5? Or are you going to go here? And it was mentioned diversion. It was diverted. So if he does well, he is still walking the line. He is going to watch him for 2 years. He was diverted. Mr. Mollohan. And he is on probation for 2 years? Mr. Coots. Well, it is actually not probation. It is diversion. So there won't be any record of Joshua if he continues to be well in these 2 years. Mr. Mollohan. There won't be any criminal record? Mr. Coots. Won't be any criminal record. Mr. Mollohan. Within the criminal system you talk about being trapped. That is a criminal system phenomenon, that you use the criminal system to trap the addict in order to achieve a desired treatment result. Correct? Mr. Coots. You have got to do what you have got to do. Mr. Mollohan. Right, but that is what trap means, that you use the criminal justice system. Mr. Coots. Yes. Mr. Mollohan. We are all looking for other alternatives to deal with this problem and to achieve the desired result, which you are describing here. I hope that Joshua, after this period, stays with it. We are all trying to look for better tools in order to do that. If you had a civil procedure you could use that might be helpful. Perhaps it is a judge or perhaps it is some sort of a magistrate, but in any event, it is a due process proceeding, whereby you would establish, under some carefully construed criteria, a drug addiction status, an active drug addiction status. Then, if the individual was certified with that condition, there would be a confinement, a treatment program which would involve confinement and separation, that would have been a lot easier way to achieve this, wouldn't it? Mr. Coots. Sure would, and it would have been a whole lot faster than trying to---- Mr. Mollohan. Trying to trap? Mr. Coots. Well, we had to wait. We had to wait until he did something. He stole everything in our house, but we couldn't prove he stole it. Mr. Mollohan. You are also waiting for him to do something serious or die in that same entrapment process, aren't you? Mr. Coots. Yes, sir. Mr. Mollohan. But it would be far better, and probably cheaper, because this young man and every other young addict would not be out there doing the things that they have to do in order to support their addiction. They are compelled by that powerful sentiment that you described--one of the most powerful feelings we have as animals--the orgasm. I was very taken with your testimony, because to me you have tied up all of the pieces with your story. It was a very brave thing for both of you to come and do that. You tied up the incentive, which in this case has to be the criminal system. You needed some period of time that you have to be incarcerated or incentivized to stay away from the drug as well as the aftertreatment program. I really want to compliment you for putting together, an after treatment program because it sounds like you are putting together a very strong aftercare community. Mr. Coots. We are trying. Mr. Mollohan. Yes. This is very much to your credit. You have touched on a lot of the key points that need to be considered as this country moves forward in dealing with this problem. OxyContin, of course, is the latest wave. It and the other addictions are rampant in our society. So your case study, I think, is very illuminating, and brought forward here in this way with this kind of publicity I hope will be a basis for Congress and the legislative bodies throughout the country to reconsider how they treat this, basically as a criminal matter. It could be far cheaper and humanely and accurately treated on the civil side. Dr. Sullivan, I wondered if you, hearing this case, can extrapolate from it and comment on it. Is it a case that is similar to the other addictions that you deal with? Can you comment on what are the advantages of the prospect of treating these situations on the civil side rather than the criminal side. Mr. Sullivan. Well, to the first question, I would say that Mr. Coots' story is pretty typical, and the outcome is certainly better than most, but his story of how he got there and where he ended up and before he finally got the treatment is a pretty--is a pretty typical story. I want to also make sure that the committee understands something I said earlier. Not everybody who has addiction or has alcoholism has it in their family. It is very common for that to occur, but it doesn't always occur, as apparently in this case. I think that the other comments you made are--you know, about the way that we might go about getting people into long- term treatment is long past overdue. I think that would be a much more efficient and effective way of trying to deal with this problem. I mean, the truth is right now, most people are getting their treatment in jail, and it doesn't make sense--we don't treat any other medical disease that way. We don't treat any other disease that way. We need to figure out a way that people can get in--a cost-effective way, because I am also sensitive to this whole cost issue, figure out a way to get people in treatment. And I think if we can do it through the civil means, then we should. Mr. Mollohan. I thank all the witnesses, and, Joshua, good luck to you. Thank you, Mr. Chairman. Mr. Wolf. I thank you very much. Well, I want to thank the panel. Joshua, we appreciate you very much coming forward, and your dad. And, Doctor, it was interesting watching when the Reverend was testifying, you were validating--I was watching you shake your head, and you were saying, you know, everything you just finished saying, and you two would make a great team. Dr. Sullivan. Yes. Well, I agreed with almost everything he said. Mr. Wolf. It was really kind of fascinating. I appreciate both of you driving so far to come here. Hopefully--you know, we have been here for 4 hours and 10 minutes, if I can keep time, and we haven't lost anyone--and everyone stayed, which is good--and everyone up here is busy, and I know everyone has missed meetings today, but I think you have gotten the attention of the committee, and this is a C-SPAN camera, I read. It says C-SPAN, serial number 1038, and so it has gone all over, and I think you really made a big difference, both of you, as has the recollection of the witnesses. And, Josh, you should be grateful for your dad, too, I think. But with that, we thank you all. I hope you have a safe trip home. Mr. Coots. Thank you. Tuesday, December 11, 2001. PHARMACEUTICAL MANUFACTURER OF OXYCONTIN WITNESS DR. PAUL GOLDENHEIM, EXECUTIVE VICE PRESIDENT FOR RESEARCH, DEVELOPMENT, AND REGULATORY AND MEDICAL AFFAIRS, PURDUE PHARMA Mr. Wolf. The next panel will be Dr. Paul Goldenheim, executive vice president for research, development and regulatory and medical affairs, Purdue Pharma. And, Doctor, we apologize for keeping you so long. We had assumed originally that maybe this whole hearing would be over at 2 o'clock, but we appreciate your patience. And your full statement will appear in the record. You can--obviously I am not going to cut you short on anything, because you have been so patient to be here, but if you could summarize it as you see fit, and we will proceed. Dr. Goldenheim. Mr. Chairman, thank you. Mr. Wolf. Go ahead. Dr. Goldenheim. My name is Paul Goldenheim. I am the senior physician at Purdue Pharma and, as you noted, executive vice president for research and development. On behalf of Purdue Pharma, the distributor of OxyContin tablets, thank you. Thank you very much for taking the time to hold this hearing. We at Purdue are very distressed that OxyContin, which, as you have heard, is providing so much relief to so many people, is being abused as well, and we deeply regret the tragic consequences that have resulted from the misuse of this medicine. The availability of OxyContin is critical for countless patients who are suffering from moderate to severe pain, where a continuous around-the-clock analgesic is needed for an extended period of time. Unfortunately for those patients, concern generated by the abuse of OxyContin has mushroomed to the point that some patients are asking their doctors to switch them to less effective medicines. Some doctors are refusing to renew patients' prescriptions for OxyContin, and some pharmacies are no longer willing to carry OxyContin for their patients. At the same time, naive teenagers out for a thrill and others are misusing and abusing OxyContin, and other prescription medicines. For some, as we have heard today, the consequences are tragic. They do not understand that the abuse of prescription medicines can be every bit as lethal as the abuse of illegal drugs. This is a terrible problem for this country that we all must join together to address. This hearing is important and timely. Today's testimony bears on a very significant question of health policy, how to address the problems of abuse and diversion which accompany the sale of a controlled medicine like OxyContin without restricting its availability to meet the needs of doctors and patients for the effective management of pain. The question is neither new nor unique to OxyContin. While all the voices in this debate are important, we must be especially careful to listen to the patients who, without medicines like OxyContin, would be left in pain. Purdue frequently hears stories of how OxyContin has enabled patients to return to their families and to productive lives after suffering disabling pain. We urge you to talk directly to some of those patients. They are people who. Because of cancer, sickle cell anemia, severe back injuries or some other physical insult or disease have had their lives taken away from them by unrelenting pain. Amidst all the publicity and controversy, a few facts stand out. First, the problem of chronic pain in this country is enormous and expensive. According to organizations like the American Pain Foundation, an estimated 50 million Americans, 50 million Americans, suffer from chronic pain, with a cost approximating $100 billion; $100 billion each year attributable to lost work days, excessive or unnecessary hospitalizations, unnecessary surgical procedures, inappropriate medications and patient-incurred expenses from self-treatment. But even though staggering, numbers fall far short from capturing the essence of chronic pain in America. Pain cannot be expressed in numbers. It is individual, and it is personal. Second, chronic pain has been historically undertreated. Only in this past decade has public and medical opinion swung decisively in the other direction based on the proven effectiveness of individualized therapy, including opioids, in treating pain and the targeting improvement in quality of life such therapy offers to patients. Third, OxyContin is widely recognized as a highly effective treatment for pain. When properly used under the supervision of a physician, it is also an extremely safe medication. Its 12- hour controlled release mechanism affords an extended dose of pain medication, allowing patients to sleep through the night and to avoid sharp spikes in blood levels of medicines that can cause side effects. Many patients have told doctors and Purdue that OxyContin has given them their lives back. Once Purdue became aware of the problems of abuse and diversion of OxyContin, its solution became a corporate priority. Senior executives have met and worked with law enforcement authorities throughout the affected regions, as well as with FDA and DEA. Purdue feels strongly that prescription monitoring programs, PMPs, would help and wants to recognize and thank Chairman Wolf and this committee for your leadership in making funds available in this year's appropriation bill to assist States in this effort. Purdue supports the adoption by all States of prescription monitoring programs meeting appropriate standards. The PMPs in Kentucky and Nevada can serve as useful models. PMPs can reduce doctor shopping and diversion from good medical practices by giving physicians a way to identify patients who are receiving controlled substances from other doctors, and you have heard a great deal about that today. Purdue's number one research priority is to develop medicines that would reduce drug abuse, while at the same time function as intended for legitimate patients in pain. This is a formidable undertaking as there is no existing, proven technology to achieve this goal. Purdue will spend $50 million this year alone to research and develop new forms of abuse- resistant pain relievers. Perhaps the single most important tool to prevent abuse is education, and we have heard a great deal about that today. A survey released last week by the National Association of State Controlled Substances Authorities, NASCSA, reveals that members of that group believe that diversion education and pain management education for prescribers are more effective than any other means of combatting prescription drug abuse. There seems to be a misunderstanding about our contacts with doctors and pharmacists, which we view primarily as an educational responsibility. Purdue sells and distributes OxyContin exclusively to distributors and wholesalers. As such, we comply with DEA restrictions and recordkeeping requirements, but our physical control of the tablets ends when we deliver them to the wholesaler. Our objective in communicating with doctors through trained sales representatives, literature and educational programs is to educate them about the proper use of OxyContin. Increasingly this educational role has focused on abuse and diversion. Criticism of Purdue's promotion of OxyContin tablets is squarely at odds with the facts. Purdue's marketing practices focus on the management of pain and on the proper use of OxyContin in patients for whom such a medication is appropriate. Responsible physicians will only prescribe OxyContin if it is the right product for their patients with pain. One of our great concerns is that naive teenagers are misusing and abusing OxyContin and other prescription drugs. Educating teenagers about the risks and dangers of prescription drug abuse is critical, and we have initiated an important program that we are calling Painfully Obvious. Materials are now being piloted in four test markets. We have established a Website at painfullyobvious.com. We want kids to know that prescription drugs can be every bit as dangerous as street drugs. The management of pain is a critical priority of health care in this country. OxyContin has proven itself an effective weapon in the fight against pain, returning many patients to their families, to their work, and to their enjoyment of life. We cannot turn back the clock. The answers to the problems of abuse and diversion require the cooperation of many elements in our community, many of whom were represented here today, in providing increased education, information, and enforcement, not restrictions that will deny patients effective treatment of their pain. Congressman, if I may just make a few more brief remarks. Mr. Wolf. Sure. Dr. Goldenheim. I think we heard some excellent testimony from the DEA today, and naturally we value our relationship with the DEA greatly. We have worked with them extremely closely during this period of time, and proactively. And in most all areas, we are in complete agreement, but I do not agree with the statement made here today that Purdue has marketed OxyContin aggressively. That is simply not the case. We have not promoted this product as less abusable than other opioids, and we have not promoted it as a substitute for less abusable opioids, unless those other medicines are failing. We have focused on education. I also have an example of the pen that was referred to. Each time the pen was distributed, it was distributed with complete product prescribing information, the package insert also in here, and the conversion chart that is referred to where it was suggested that we were encouraging physicians--I think the example that was given--to take a patient off Tylenol No. 3, Tylenol with codeine, which is indeed a Schedule III drug, a lower classification, and convert them to OxyContin, a Schedule II drug, a drug that has a higher abuse potential, and that is why it is in Schedule II, like morphine and hydromorphone and a variety of other drugs. The purpose here is to teach physicians how to use the drug. The point here is that if the patient's pain is being controlled on Tylenol No. 3, a couple of tablets here and there, that is what they should stay on, and that is what we want. The purpose of these conversion charts is for the patients whose pain is not being successfully managed, where the physician has determined that OxyContin is appropriate therapy for that patient. And then and only then under those circumstances this provides information on how the product can be properly used. I would just like to point out to the committee--and I would be happy to furnish these--that not only does every other pharmaceutical company distribute virtually the same set of guidelines, but prestigious medical societies and academic institutions--I have got one here from Brigham and Women's Hospital in Boston--distribute the same information. These are teaching tools, not aggressive promotional tools. Also, Representative Rogers, you were particularly interested in what our representatives did with the new prescribing information and had we done something other than just send out mass mailings, and I want to reassure you that all of the physicians--as we called on them after that new labelling was put into place, the new labelling information was reviewed in person with the physicians. Copies of the labelling were left behind. In addition, frankly, most of our efforts in the last 6 months in some parts of the country exclusively have focused only on education about abuse and diversion. Finally, if I may just address one other item that came up, I think that there may be a bit of confusion about the term ``moderate pain,'' and I think an example that has been given a couple of times is a toothache. Clearly OxyContin is not, I repeat not, appropriate medicine for a toothache. The package insert is very clear. It has to be when an around-the-clock analgesic is needed, when this kind of analgesic is needed, an opioid analgesic, a narcotic analgesic, and where it is needed for an extended period of time. Well, those words have changed slightly. In fact, that has been the case since the start we launched this medicine. We have only wanted this medicine used for appropriate patients. It is not possible, however, to look at a level of pain--or excuse me, to look at a diagnosis and to understand the level of pain, so there is an understanding, for example, that we talk about cancer pain, we are talking about pain that is more severe than other kinds of pain. The fact is that cancer pain typically starts out as moderate pain. I think the distinction that we have to make here, and I think one of the Congressmen used the example of Advil or Tylenol, clearly if that pain, however significant that pain is--and tooth pain can be really quite significant, I think, as most of us know--if that pain can be managed with Advil, which is a very effective drug for tooth pain, then that is what the patient should be taking. The kinds of pain we are talking about are patients who have already tried all of those remedies. They have typically already tried things like Tylenol No. 3 in addition to the over-the-counter anti-inflammatory drugs and prescription anti- inflammatory drugs, and now we are left with patients whose pain is just not responding to simpler measures. Those are the patients for whom OxyContin or other drugs may be appropriate therapy, and that is the opportunity for the physician to consider the use of those medicines. I would also point out that moderate pain, if it is day in and day out and unrelenting and not responding to anything else, can interfere with sleep, interfere with life, and can make patients miserable. And we know of examples of such patients, whether it is moderate pain or severe pain, but it is chronic and it is unrelenting, who have contemplated suicide or committed suicide. I think moderate to severe pain under the appropriate guidelines that I have talked about is where these other medicines should be used. Thank you very much. I am eager for your questions. Mr. Wolf. I thank you, Doctor. [The information follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Wolf. Do you still give that pen--that conversion pen out? Is that still part of your marketing? Dr. Goldenheim. I don't think--no. The answer is no. We still give out conversion information. Mr. Wolf. Do you market to dentists at all? Your salespeople go by dentists' office? Dr. Goldenheim. No, we do not. Mr. Wolf. How do the dentists then know about this? So you think it is inappropriate for dentists to be prescribing this? Dr. Goldenheim. I am sure there are certain kinds of oral surgery where there might be, you know, extensive pain for a long period of time. I am not a dentist, and I am not all that knowledgeable about that, but certainly the day-in-and-day-out dentistry, absolutely not. OxyContin doesn't have a role to play. As you well know, any dentist or any physician who has got a DEA license and an appropriate license to practice can prescribe medicines as he or she sees fit. We have never called on dentists and do not promote to them. Mr. Wolf. Your testimony runs a little counter to--is it Dr.--the doctor from West Virginia, Sullivan. He referred to that one doctor who felt that he was not serving his patients well if he did not prescribe this medicine, and yet--is Dr. Sullivan here? I guess he went home. I don't--I have some concern about the definition of moderate pain, and I guess it is all how you define it. I am not a doctor, and what I plan on doing is--and I don't plan on debating your marketing here. I am going to ask the Government Accounting Office, the GAO, to monitor your marketing strategy and phrase it in a fair and objective way to see if they believe there was excess or there was not excess, I think that would be more appropriate. And I will share that with the members of the committee, too, rather than me--my sense is the marketing has been excessive. My sense is that you have a product--and, again, I don't think we want to remove this product from the market, particularly for people with a severe pain like cancer. I don't know if you were here when I read my opening statement. Dr. Goldenheim. Yes, sir, I was. Mr. Wolf. Then you understand, I think. In those circumstances, we really want this to be available. The problem is it has kind of gotten out of that range. It has gotten out of the box now, and you really had to be impressed or depressed, whatever the case may be, by the testimony today by a very varied group of men and women who have testified to the pain and the suffering and the agony at the very time your medicine has certainly alleviated a lot of pain and suffering. And as I said, I wish it had been available when my mom was dying in a hospital just up in Philadelphia going through terrible, terrible pain. But on the other hand, the testimony of the last two panels talks about the pain and the suffering of Reverend Coots and the prosecutor from Lee County. I believe that you really--you really have to do more. I think education is very, very important. For instance, I had asked earlier--let me ask you this. With all of the doctors that you have marketed this to verbally, whereby you have made house calls, you have actually come by their office, where you have had them to conferences, have they all been spoken to personally the way they were when the initial contract was made? How many conferences have you held whereby doctors were flown in for this medicine? Dr. Goldenheim. We have not held any such conferences for over a year. Mr. Wolf. Of those doctors who had that opportunity to come to these conferences, have they all been invited back whereby you could verbally make the case that you are making now with regard to the potential harm? Dr. Goldenheim. I think the answer is yes. Let me just try to explain a little bit. What those conferences were, they represented a minor, minor portion of our medical education efforts. Most of our medical education efforts take the form of providing grants to educational institutions to enable them to provide a speaker for a medical grand rounds or a medical society. We might make a grant to the American Academy of Family Practice or some other prestigious medical organization for them to have a seminar at their annual medical meeting. And there might be two or three or four speakers on pain management. Sometimes topics of abuse and diversion were covered as well. Increasingly, of course, they are covered with great---- Mr. Wolf. Let me ask you, how many doctors would participate in these conferences? Dr. Goldenheim. Again, these are not conferences where we provide any stipends for travel, sir. I think the answer to those is about several hundred thousand physicians a year. And again, let me emphasize, we don't pay travel. All we provide is a grant to an educational institution or a teaching hospital to provide speakers. Mr. Wolf. I assume they went to one--if you were from Philadelphia, you would go to the Philadelphia region or something like that? Dr. Goldenheim. Or the physician might be going to the annual meeting of the American Academy of Family Practice or something like that. I just use that as an example or collegial meeting of that society. Mr. Wolf. Well, would it not be a good idea to invite those doctors back to seminars to explain how perhaps the prescribing has gone beyond what you--because you have changed your marketing strategy. You are not using the pen anymore. You have done other things, to explain that based on information that we currently have, what you thought may have been appropriate is no longer appropriate. The point I was trying to make with Mr. Hutchinson, as a politician, if you go door to door, if I knock on your door and say, Doctor, how are you, my name is, I am running for office, there is that eyeball-to-eyeball, personal contact that we verbalize, I know what you are interested in, you talk to me, and then that makes a greater impact, assuming both are listening, there is an impact, versus I send a flyer through the mail. So for all the doctors you personally--not you, but your company personally spoke to, it may not be a bad idea--in fact, I think it would be a good idea to bring them back--back in, or give them the opportunity to come back in, whereby you could update them on marketing changes, on what the different pain thresholds were, what some of the potential problems were and different things like that, because if there had been a verbal communication marketing the product, I think there ought to be some verbal communication rather than just a letter. Dr. Goldenheim. Sir, I agree, and there has been. I think I have not been clear. Let me try again. The seminars, the symposia, the speaking engagements that I was referring to are not talks put on by Purdue or Purdue sales representatives. We simply provide a grant, let us say to a hospital, so that hospital can get a speaker who is an expert in pain management to talk to that group on Thursday at 12:00 o'clock when they have their normal grand rounds and talk to the doctors at that hospital about pain management. These are continuing medical education events. We don't control the program in any way. We don't have input into the program. This is a physician who is communicating information. I think the way that we have achieved your goal, if I understand you correctly, is that since the prescribing information was voluntarily changed by us in July of this year, every sales call that our representatives made after that to a physician in his or her office reviewed the new information and highlighted the change. So I believe we have had the kind of personal one-on-one, eyeball-to-eyeball communication that you are seeking and suggesting is more powerful, and I agree with you, than simply a mass mailing to 500,000 physicians. We also left the information with them, and every material that we leave behind at this point also has all of the new prescribing information. If I may, sir, we identified early on 100 counties based on many of the stories that we have heard today and that have been published in the media--we identified 100 counties in the country, most along the Appalachian spine, where we thought there either was a particular problem or we thought based on certain demographic and other variables, past histories of substance abuse, tobacco use, that sort of thing, there might be a problem, that a problem might occur. What we did in those hundred counties is we took those 160 sale representatives back to the home office, gave them very intensive training, and sent them--by the way, in cooperation with the DEA. The DEA participated in that training, and those representatives for months now have been in those hundred counties only talking to those physicians and pharmacists and other health care professionals about abuse and diversion. We have told them about doctor shopping. We have told them about the scams that are out there. We have talked to them about the criminal acts that some physicians are doing, and we have made it clear to them that if they can't prescribe our product according to these guidelines with proper evaluations of patients, with proper recordkeeping, paying attention to all State laws and guidelines for the proper practice and use of these medicines, then we don't want them prescribing our drug. And that is what we have told them. Mr. Wolf. Well, in the testimony of Mr. Hutchinson on page 5, he has the two charts. One is all common opioids, prescription in millions, which is levelly--increases gradually, but is almost flat, versus the one for an OxyContin prescription is a spike up. In your testimony, you note that pain management movement is relatively new, and the doctors have relatively little training in pain management. Why then would you market this potentially habit-forming drug to doctors, the majority of whom you say have very little experience with pain management? Dr. Goldenheim. Sir, with respect to the charts, I think it is important to note that we are looking at two very different scales. One starts from zero, because it is a brand new product, and the other is a mature set of products. In fact, the absolute growth in those mature products has been far greater than the growth in OxyContin. Mr. Wolf. Excuse me. Pardon me. The doctor said 10 of his beds in West Virginia had OxyContin. Dr. Goldenheim. Sir, I am not suggesting that OxyContin is not being abused. OxyContin is being misused and abused. It is part of a larger prescription drug abuse problem. I am simply trying to say I don't think that there is a clear connection between our sales curve, and I am trying to point out that we are looking at two very different scales there. Of course OxyContin grew more rapidly at that point in time. It was a new product. It was launched by a company with significant experience, and we knew how to educate physicians about its proper use. It was successful because it met a large unmet medical need. There are millions of patients suffering in pain, and the medical community and Congress, I would point out, have now recognized the importance of the undertreatment of pain. Mr. Wolf. You don't--this is not the only drug that you treat pain with. I mean, Schedule III, there are others in use. The concern is this is a drug that is being very much abused. Very few people are abusing Advil. Very few people are abusing Tylenol. Very few people, after taking Tylenol, are going out and robbing a nursing home in Boston. Very few people are robbing pharmacies for aspirin. And so in the interest of time, I have a number of other questions. I am going to recognize the other Members. What I am going to do, I think the marketing has been a problem. We are going to ask the GAO if they would examine your marketing, and some of the questions we were going to ask of you I will ask the GAO to look at, because then hopefully they can give us a fair analysis with regard to the whole marketing approach. Before I recognize Mr. Serrano, what do you think we ought to do? I mean, this is a problem. I mean, the Reverend is gone, but what should the Congress do? What should you do? Who has the greater responsibility? You know, in the first five books of the Bible, the Torah, it talks about justice and mercy. What is the justice thing? What is the just thing here? You have sat through these hearings, and you have seen the pain and the suffering, and do you have children? Dr. Goldenheim. Yes, sir. Mr. Wolf. Then as a dad, you would understand. You have seen the pain and the suffering and the agony, both of the individuals and also of communities. What do you think the government should do in addition to the prescription monitoring, and what do you think your company should do or you should do to make sure that this is put back in the box or--and to make sure that this doesn't happen again on--and I assume you are doing research on other drugs---- Dr. Goldenheim. Yes, sir. Mr. Wolf [continuing]. To make sure what took place with OxyContin doesn't happen the next time around. So what do you think the government should do, and what do you think your company should do? Dr. Goldenheim. Sir, we have heard a lot of talk today about prescription monitoring programs, and we, to the best of my knowledge, are the only pharmaceutical company that supports them. We have provided the committee a statement of some guidelines and standards that we think are appropriate to consider, whether it is a Federal program or individual State programs. I think we have heard today the problems that are associated with only one State having a program like Kentucky with Casper, and what happens when a neighboring State doesn't. So clearly we have to remedy that problem. We are strongly in support of such programs that meet appropriate standards, and we are prepared to help solicit the support of the medical profession. I think that we need to do them in a proper way to garner the support of the medical profession. I think we need much more education about abuse and diversion, and Purdue has an enormous initiative under way. We need more education of teenagers. We have heard testimony today that up until recently, that their program had no materials on prescription drug abuse, and I think in most States still doesn't. Well, we are in the process of trying to remedy that and work with drug education folks in local communities, and we are test-marketing our Painfully Obvious program, because there is some notion that because it is still manufactured by a pharmaceutical company, it is completely safe, even if you crush it and inject it and wash it down with a six-pack and snort some cocaine, and that that is somehow safer than a white powder that you buy in a bag because you don't really know what you are buying, and, of course, nothing could be farther from the truth. These medicines, when they are properly used under a physician's supervision, are very safe and are very effective, but when misused and abused, they can be as dangerous as illegal drugs. So I think making progress on abuse-resistant formulations--and you have alluded to them--we are committing an enormous amount of money. We have hundreds of scientists, some scientists who are the most knowledgeable in this field in the country, working on abuse-resistant formulations, a formidable goal to produce a tablet that on the one hand produces pain relief to the patient, for the patient for whom it is intended, and on the other hand can't be tampered with or won't produce a high, no matter how clever the abuser is. And I think we have heard today that abusers can be very clever in how they seek out these medicines, how they pay for these medicines, and so we need to accomplish those two very different things for these two very different groups of individuals. And so we are striving to do that. Another thing that we have heard a great deal about today was prescription tampering. I am not aware that another company is distributing prescription pads. We allow doctors to order them any way that they want from the company, and we pay the bill. This is a very interesting pad. It employs six different technologies so that the prescriptions can't be tampered with. And as we have heard in some parts of the country, that is a significant source of the diversion. We also heard about a very unfortunate situation, a robbery yesterday in Mexico. Within minutes of learning about it, as you heard today, we notified the DEA. We had already voluntarily--and, again, to the best of my knowledge, we are the only company that has ever done this. We voluntarily offered to and did change the indicia, or tablet markings, on the tablets shipped to both Mexico and Canada, and we did that at a time when most law enforcement officials were not telling us that reimportation from Mexico was a major problem. It was only a possibility, but we did it because we thought it was the right thing to do. We take this problem very seriously. We have taken the leadership role. I welcome the GAO's investigation of our marketing practices, because they will find that we have focused on education. We have tried to teach doctors how to select the proper set of patients. We have tried to teach doctors how to use these medicines appropriately. We have never encouraged misuse and diversion of our product. We have never encouraged anybody to tamper with a prescription. We have never done anything that could remotely be suggested that it was a good idea for a criminal physician to sell a prescription. We are supporting prescription monitoring programs. We welcome the investigation. We welcome any ideas that Congress has of ways in which we could help ameliorate this problem. I think we need to balance here. We need to provide the medicines that these patients desperately need. I talked to a friend yesterday that I didn't know was taking OxyContin. It turns out she has a very complex general urinary problem and has a lot of abdominal pain and was getting relief from 10 milligrams of OxyContin twice a day. She stopped taking it out of fear of all of the media coverage that she would be called an addict when she goes into the pharmacy to get her medicine filled. We have to protect those people, too. Those people suffer. Addiction and abuse---- Mr. Wolf. Yes. They do suffer. I don't think there is any question. But Joshua suffers. Hazard, Kentucky, suffers, the parents and many of them from Appalachia and inner city that have very little money, that aren't in Blue Cross and Blue Shield and health programs and everything. I think it is unfortunate that that is the case, and if she is able to go to the doctor and get the prescription and it is really helping, she ought to not feel that way. But there are many, the body count has increased. Mr. Hutchinson talked of people who have died of the overdose, that the community of Lee County literally has been devastated by it. So, maybe we should look at both sides, and you can stress that, because obviously that is to your advantage with regard to the case. But my sense is maybe your company could have moved faster and could have moved and dealt with the issue in Hazard, Kentucky, could have dealt with the issue in Lee County. And so those things have gone on. Maybe you should have been more involved. We will find out from GAO. But I think from here on out, and if this is the first drug of many that may potentially come down, we need to learn by this so that we don't have more cases and more families devastated by this, moms and dads. How would you feel, you know, if you had a situation like Reverend Coots, and your son or your daughter were involved, or he talked about the 21- year-old daughter in the casket, the young lady. So there is a balance, and if that balance is that friend of yours, God bless her, and I am glad it is working, who feels a little funny when she goes to the pharmacy, that is not nearly as bad in the big picture when we look at it as Reverend Coots or the mom or the dad, the grandfather, the brother, the sister, with the young girl who was in the casket who died. Dr. Goldenheim. Sir, it is a question of balance, and not for one second am I suggesting that the pain and suffering of those two are the same. The answer to your question is if I had a child that suffered the same way that the Reverend's child did, I would be devastated, and if I lost a child as a result of this or anything else, I would be devastated. It is a balancing act. We have patients in pain who are committing suicide because they don't have access to the medicines they need. Mr. Wolf. But, Doctor, we are not--we--I can't speak for the whole committee, but I think I can in this. The committee is not looking to stop that whereby someone who needs it gets it. That is not the subject of this hearing. Dr. Goldenheim. I understand, and if there is anything that I said that made you think that I was only concerned about one side of the equation, then I haven't been perfectly clear. We take prescription drug abuse and the abuse of OxyContin very seriously. We have been praised by law enforcement in a number of communities for all of the things that we have done to try to reduce abuse and diversion, and we have heard in some of the counties in this country, Washington County, Maine, and Lee County, Virginia, that were bellwethers for this problem, that OxyContin abuse is beginning to recede, if you will, to baseline levels. Sadly, prescription drug abuse is still there. In Maine, there is more abuse of dilaudid now than there is of OxyContin. People are abusing heroin again. OxyContin is not the only drug being abused. It is the drug of the day in many communities, and we need to take that seriously, and we do, and we are doing everything we can that we can think of to try to stamp out abuse and diversion. We take this problem very seriously, sir. Mr. Wolf. Mr. Serrano. Mr. Serrano. Thank you, Mr. Chairman. Your last comment, Doctor, was going to be my first question. How seriously do you take it? The article in yesterday's New York Times--now, there are papers, and there are newspapers. This paper has a pretty decent reputation for its analysis of issues. Are they wrong, because they weren't exactly nice to your company at all. Dr. Goldenheim. Which statement in particular were you referring to, sir? Mr. Serrano. Well, the fact that your salesmen have been approached by pharmacists, for instance, and told that there was a problem, and that they said, no. I mean, that the people understood it was all about making money and not necessarily about what the results were. You see, here is the problem. Here is the problem. We live in a free and open society, and so you have the right to be the only manufacturer--you are the only manufacturer, right? Dr. Goldenheim. Of controlled-release OxyContin, yes. Mr. Serrano. And you have control over it, and you have a monopoly over it, and your role is to produce this, and you do. And in the process some people, as the Chairman has said, who are hurting get pain relief. But at the same time you can't be blind to the fact that there is a serious problem, and while you take it seriously, my question is what is your responsibility to deal with this problem? Have you taken that seriously? If you tell me, you know, we worry about this, this is a major problem, and you saw people here and it is growing in certain parts of the country and will eventually spread--what do you intend to do, or do you feel that that is not your role? In other words, when you produce something that relieves pain, is it--is it like Russian roulette? Is it, look, if it is relieving your pain, that is what we are in business for; if it addicts you and causes you a problem, that is you, not us? Some people may think it is you also, both sides of the coin. Dr. Goldenheim. You have obviously asked a number of questions. Let me try to address them. I think we are far from blind about this issue, and if I may, I would like to show you a chart that illustrates how as soon as we became aware of this problem, we literally jumped in with both feet. While we are getting that chart ready, I would like to be-- have one thing be really clear. Right from the start this was sold in the most highly regulated class of prescription pharmaceuticals that exist in this country, Schedule II. There is no higher classification for a prescription product. The only things in Schedule I are things that you can't prescribe, like heroin and cocaine. So it is the same classification as morphine. We made it clear that it had the same abuse potential as morphine right from the start in promotional materials and a packet insert approved by FDA. It is the same classification as hydromorphone, as fentanyl and a variety of other products. And, of course, OxyContin was already on the mark in its immediate release form, and I think we have heard today how this is the second wave in that particular location, and the first wave was with the immediate release OxyContin, Tylenol or acetaminophen combinations. So we had the appropriate warnings right from the start. The other thing I want to be really clear about, and I think you will hear more about this later on from the medical panel, is that addiction is not common. Addiction is rare in the pain patient who is properly managed. Who we are dealing with here is a group of people who have another very serious medical problem, an addiction disorder, an abuse disorder, and they need treatment, too. They need treatment every bit as much as the pain patient. It is a different set of individuals. Let me show you how seriously we are taking this problem. Mr. Serrano. Wait a minute. Let me get something straight. You are telling me that people who are addicted to your drug, if you will, are addicted to other things? There are no people--there is no one or group of people who are addicted only to your product? Dr. Goldenheim. No, I didn't mean to say that. I think what we heard today about histories of people having problems with multiple drugs is the rule rather than the exception. People who have a--what they have is an addiction disorder that makes them prone to become addicted, makes them prone to abuse medicines. And I think we also heard from Dr. Sullivan that essentially all of these drugs in Class II are essentially interchangeable, which is why heroin addicts will try to crush OxyContin and inject it. And when the OxyContin supply dries up, they will go back to heroin, or they will go to hydromorphone. Mr. Serrano. Doctor, I don't want to drive this to death, but I thought we all had an addiction disorder. That is why some people get addicted to caffeine and others get addicted to tobacco and nicotine, and that is why people put sugar in drinks because they know we somehow keep coming back for more. So, I mean, if--you may be contradicting your good efforts, because if you know there are people out there that can be addicted and then you don't regulate how doctors--This is so available, aren't you part of the problem then? Dr. Goldenheim. Sir, I think the difference is sugar in coffee and caffeine are things that we do because we like them, and they are not dangerous behavior. Somebody who has an addiction will pursue a behavior despite harm to that individual. So it is very different to have a cup of coffee with cream and sugar in the morning as opposed to buying pills in a bar of OxyContin or Lortab or Loracet and grinding them up, putting them into a glass of water, and going into a bathroom stall and shooting them up. That is a very different kind of behavior, and I think what we heard today is that there are individuals in our society who either typically have a history of abuse, they have abused alcohol or they have abused other prescription drugs, and now some of them in some parts of the country are abusing OxyContin. But let me please tell you how seriously we are taking this problem, because I think that that is very important. First of all, we launched MSContin, which is controlled release morphine, as opposed to OxyContin, which is controlled release Oxycodone. We launched that in 1984. During the entire time that we sold MSContin in this country, we didn't see anything other than the normal episodes of abuse and diversion that other manufacturers of other controlled substances are seeing-- have seen, and I think you heard today a great deal of testimony about how everybody was taken by surprise what happened. We launched OxyContin in 1996, and for the first 4 years on the market, we did not hear of any particular problem. From 1996 or 1997 on, we also began working on abuse-resistant time formulations of a medicine called Vicodin or Hydrocodone, which you have heard about today, and if you are interested later, I can tell you more about them. Also since 1997, because we knew these medicines had the potential for abuse, and we--they were regulated and medicines that had a potential for abuse, we also distributed opioid therapy documentation kits, and we have distributed more than a quarter of a million of them to help educate physicians on how to properly use these medicines. As State guidelines became available--and there is a generic, in you will, set of guidelines. The Federation of State Medical Boards became available in 1998, late 1998. We distributed about 300,000 copies of those, and I have furnished a copy with the record. Those are very clear in proper history taking, proper documentation, proper patient selection. Right from the start we have only wanted this medicine used in the patients for whom it is appropriate therapy. No other company has distributed these guidelines, but we have, because we take this problem very seriously. In February of 2000 was the first time we became aware that something different was going on. In February of 2000, we got a copy of a letter that then U.S. Attorney Jay McCloskey of Maine sent to physicians in Maine warning them of problems in OxyContin that were occurring in certain communities, and I believe it was March of that year when that was published in the Bangor Times. That was the first time we had any inclination that something different was going on that required personal attention. And since that time, I am proud of our response. As a physician, I am very proud of our response. As an executive of this company, I am very proud to be working for this company. Nobody has taken the kind of initiative for a problem that is not just an OxyContin problem. This is a problem of drug abuse. This is a problem of prescription drug abuse, and OxyContin is now clearly squarely in the midst of that problem. We are leading, and we take that responsibility very, very seriously. As soon as we learned of the problem in Maine, we requested a meeting with Jay McCloskey. It took a while to arrange that meeting, because frankly he wanted to check us out, and he sent some of his diversion investigators to one of these medical education events that we had sponsored to find out what was going on, were these legitimate people. And his investigators came back and said, well, there is a pretty good darn series of talks on pain management. And much to their amazement, the people giving the talks--not Purdue people, the people giving the talks, never mentioned OxyContin once. We have been advocates of proper pain management, and we have in that period of time initiated an enormous number of activities. The most senior executives in our company, myself frequently included, have traveled up and down the East Coast meeting with attorneys general, meeting with U.S. Attorneys, meeting with local law enforcement. We called the DEA and said, we think something's going on, could we meet with you? We called the FDA and said, we are concerned, there is something going on, we need to make some changes in the labeling, we want to talk to you. We drafted the changes in the labeling prior to any meeting we had with the FDA and we worked cooperatively with the FDA. To this day we still do. To this day, as was obvious from the administrator's testimony, we are working very cooperatively with the DEA. We take this problem very seriously. We have been told by the DEA, by the FDA, and by the National Institutes of Drug Abuse that there was not a problem with the intravenous injection of prescription drugs, that prescription drugs were only abused orally. As a result, we weren't working on anything with maloxin. As soon as we heard that there was a problem with intravenous abuse, in days it went from a project that didn't exist to our highest research priority. We started that project in January. It is already in clinical trials, and we will file an application with the FDA next year. We are spending more than $100 million combatting abuse and diversion. We take this problem very seriously. Mr. Serrano. When did the McClosky report come out? Do you have a statement? Dr. Goldenheim. February of 2000. Mr. Serrano. That was in Maine, right? Dr. Goldenheim. Yes. And I think the States that were represented here today--give me a date. Summer of 2000, would that be fair? I think summer---- Mr. Serrano. Was Mr. McClosky still in that position? Dr. Goldenheim. Yes. I believe he was in that position until January of this year. Mr. Serrano. And now? Dr. Goldenheim. Now he is a lawyer in Maine and also working with us on abuse and diversion prevention efforts. Mr. Serrano. He works for you now? Dr. Goldenheim. He is a consultant, yes. Mr. Serrano. He works for you? He is on your payroll now? Dr. Goldenheim. He is not on our payroll but we do pay him as a consultant. He has an independent practice with the law firm. At the time, he was not. Mr. Serrano. Would you know if he still feels the same way as when he issued that report, or has he seen the light now? Dr. Goldenheim. I think at the time he was very concerned about abuse and diversion of Oxycontin, and I think along with the rest of us he remains concerned, which is--and we offered him an opportunity to work with us to continue to try to combat this problem. With his help we made our brochures called "How to Stop Drug Diversion and Protect Your Pharmacy." there is another one for medical practices. I want to point this out because you specifically asked about the New York Times and was that statement made that we weren't paying attention to this problem true. Answer, no. Yes, pharmacists did talk to our representatives and said they were concerned about a problem at that clinic. We gave them these brochures which told them of their responsibility to call and discuss with the DEA. We were aware that the pharmacists were already in discussions with law enforcement authorities, including the DEA. Pharmacists, of course, have an opportunity that we don't have. If a pharmacist is concerned about a prescription, he or she cannot fill the prescription. We are not involved in that. The whole prescribing process is an interaction between the patient and a physician behind a closed door. Those are personal, confidential, private interactions. We are not involved. And then the patient takes the prescription to a retail pharmacy and we are not involved in that transaction either, nor should we be. So I think there are certain things that we can do, and we have jumped in with both feet to do them. This is the highest priority of our company. We want this problem stopped. Mr. Serrano. I don't doubt that your intentions are right. Let me just give you some advice based on living all my life in New York, and watching a very serious drug issue in the inner city; this issue, from what I am seeing here today and what I am hearing from my colleagues who are affected much more than I am. I have other drug issues to deal within my district. This issue is going to become a major national issue, and when it does, it will carry with it--and I speak for myself, not for my colleagues on this panel who may disagree. But a lot of times when things used to happen in the inner city, they were always, as I said before, those people in the inner city. The decriminalization of marijuana didn't take place until it hit suburbia and the upper middle class, and you couldn't get people to go to jail for that, so the other people had done the time. They decriminalized it throughout the country and you see more than that. If I was advising you, I would say you are going to be at a disadvantage because this is going to spread in areas where people are not going to be able to say it is just those people in the inner city, it is all related to gang warfare and all that. And you are going to see an outcry in this country and, unlike cocaine, unlike illegal substances where you have to go track down the country producing it or the neighborhoods growing it or whatever, this one is an easy one to get ahold of. So my advice to you is be as committed as you are to what responsibility you carry with this, because if this keeps growing, you are going to see something happen in this country. You are going to be banned from selling it. I am not a doctor, I am not a lawyer, I don't know what to base that on; just that I do get a sense when people begin to react, and the sense I am getting more and more is that this is becoming a national problem with national awareness, and you are easy to get ahold of. All they have to do, these boys here, these ladies, is to say you are out of business with that product, and you really will be, and it won't matter how many people are being helped. The focus will be on how many lives are being lost, and I think you should pay attention to that. Dr. Goldenheim. Sir, thank you for your advice. We accept your advice. We understand that this is a serious problem, that this is a very serious problem. And as we talk to people, including today, as we talk to law enforcement, as we talk to the health care community, as we talk to the addiction community, and as we are given new ideas of things that we might pursue to help educate better, help educate physicians better, help educate teens better about the risks of prescription drug abuse, whatever it happens to be--tamper- resistant prescription pads--virtually all of the things we are talking about, all of the things on this board came because we sought out advice and listened, and I respect your advice and we do take this very seriously. Mr. Serrano. Thank you, Mr. Chairman. Mr. Wolf. Mr. Rogers. Mr. Rogers. Thank you, Mr. Chairman. Now, both the former and the current DEA administrators have expressed some level of frustration with your company when discussing marketing and other abuse-curtailing measures. Director Hutchinson in his testimony this morning mentions that Purdue's marketing techniques were at least partially responsible for the current problems, and different newspapers have done the same thing. Your company has even acknowledged that even after reports that Oxycontin had been getting into the wrong hands, you continued to distribute free 7-day samples of the drug through doctors to promote its use. Is that correct? Dr. Goldenheim. No, sir, that is not correct. Let me explain. Mr. Rogers. The New York Times is in error? They made a mistake? Dr. Goldenheim. Sir, the New York Times is sitting here today and---- Mr. Rogers. In their October 28 edition, just a few days ago, they made that statement; and they said that your company acknowledged that they continued to distribute free 7-day samples after reports that OxyContin had been getting in the wrong hands. Is that in error? Dr. Goldenheim. It is in error, sir. May I explain? Mr. Rogers. Explain it to us. Dr. Goldenheim. As a Schedule II controlled substance, we cannot provide samples to the physician, we cannot provide samples to the patient. Any other medicine can be sampled. This cannot. What we did was provide a voucher to the physician so that if the physician determined that OxyContin was the right medicine for that patient, and only then, he or she could give the prescription and the voucher to the patient, the patient would take them to the pharmacy, and that voucher would entitle the patient to one week's supply of OxyContin--and only one week. Mr. Rogers. Free? Dr. Goldenheim. Free. We would pay, and the reason for this---- Mr. Rogers. So your company did give free drugs---- Dr. Goldenheim. We did not provide samples. But let me finish, if I may---- Mr. Rogers. Well, the New York Times is not quite that wrong, then. Dr. Goldenheim. I think it is wrong. This is a very complex field of medicine. Mr. Rogers. Tell me about it. Dr. Goldenheim. That is right. We have heard a lot of testimony today. It is complex. But pain management is very complex. Not all these medicines will work for all patients. Someone made the remark earlier, aren't there other medicines? Yes. And we heard about patients today who got benefit for the first time only from OxyContin. So physicians need a choice, patients need a choice, and this was an opportunity to allow the patient and physician to see if this medicine made sense for that patient, but only after the---- Mr. Rogers. Do you know the advertising promotional budget for OxyContin in your company? Dr. Goldenheim. I don't, sir, off the top of my head; I don't. Mr. Rogers. Would you furnish that for us? Dr. Goldenheim. Yes, I will. [The information follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Rogers. In the marketing and distribution part of your company, I would assume that you keep track of how OxyContin is selling in different parts of the country, correct? Dr. Goldenheim. Yes. Mr. Rogers. And where you have a peak in sales in a given part of the country? That would come to the attention of the company's leadership, would it not? Dr. Goldenheim. Typically not. No. Mr. Rogers. They don't pay attention to how the drug sells? Dr. Goldenheim. We pay a great deal of attention to how the drug sells, but I don't know that the leadership focuses on every particular geographic area. Mr. Rogers. But where you would have a specific spike in sales, I would assume that would come to the notice of somebody in your company? Dr. Goldenheim. It certainly comes to the notice of somebody. Mr. Rogers. You had such a spike in Myrtle Beach, South Carolina, as the New York Times reported yesterday, did you not? Dr. Goldenheim. Yes, that is correct. Mr. Rogers. A huge spike. In fact, it came from one particular pharmacy, did it not? Dr. Goldenheim. No. I think it came mainly from one particular clinic. I had--it is important to emphasize that this was a clinic that specialized in pain management---- Mr. Rogers. Comprehensive Care and Pain Management Center of Myrtle Beach, South Carolina---- Dr. Goldenheim. That is correct, sir. And there were four individual pain physicians there whose practices were devoted to pain management. And in that kind of a community, it is not surprising that there would be a great deal of activity for these kinds of medicines, including OxyContin. Mr. Rogers. People were coming by the carload, we are told, from 100 miles away, to this center to get this prescription. They were lined up 15 or 20 deep, we are told, at the door trying to get in. The sales in that first quarter in Myrtle Beach of OxyContin grew by more than $1 million, $300,000 more than the second biggest region. Yet the company didn't check into it. It was obvious to me if you've got that kind of a spike in one location in the country, that somebody ought to have taken some attention to it. And you didn't, did you? Dr. Goldenheim. No, sir, I don't think that is correct; and let me explain it for you. Mr. Rogers. Explain it for us. Dr. Goldenheim. As we heard from pharmacists that they were concerned about what was going on in that clinic, we talked to them about abuse and diversion. We knew they were in regular contact with State pharmacy authorities and the DEA. We learned there was an investigation going on. I think we have to understand that our powers are limited here. We don't have investigative powers. Our representatives are---- Mr. Rogers. Give me a break. Give me a break. Here you have a section of the country, one city--a fairly modest-sized city. Myrtle Beach, South Carolina is no New York City. Yet you had a $1 million increase a quarter, more than any other part of the country. And we are told that people were lining up at this pain center, 15 or 20 deep, traveling by carloads, from 100 miles away, to get there. Not only that, but the Myrtle Beach Rehabilitation Center has experienced a nearly fourfold increase in the number of OxyContin addicts it has treated in just the last 18 months. How do you explain that? Dr. Goldenheim. Sir, I think---- Mr. Rogers. Why did you not notice that something was wrong in Myrtle Beach? Dr. Goldenheim. Our representative was concerned based on what he was hearing. I guess this is--let me start again. This is a very complex issue here. I guess one response is if this was so obvious, if carloads were really lining up 15 at a time, why weren't they shut down by local law enforcement whose job presumably it is to do that? That is not our job, sir. Mr. Rogers. It is not the job of the local police to shut down a pharmacy or a pain center, a medical office, a doctor's clinic. They don't do that type of thing, and you know that. Dr. Goldenheim. But it is not our job, sir. Mr. Rogers. The pharmacists in Myrtle Beach told your company their suspicions about this Comprehensive Care Pain Center months before it closed. Dr. Goldenheim. And the same pharmacists were reminded of their obligation. We encouraged those pharmacists to report their concerns to the proper authorities and were aware of the fact that they had reported their concerns. Mr. Rogers. Did you investigate Comprehensive Care? Dr. Goldenheim. No. What we did was continue to provide information on avoiding abuse and diversion in that practice and how to properly prescribe our product. All of the pharmaceutical companies who make these controlled products continued to call on that clinic. We have no way of knowing whether or not people are engaged in criminal activity at that clinic. Maybe those doctors are being duped, and by continuing to call on them and provide them information, we can allow and permit and encourage better medicine to be practiced. That is our job. We are not the police. Mr. Rogers. No, it may not have been illegal for you to ignore the spike in that one place, but in my judgment you had a moral obligation to go in there and investigate what was obviously a suspicious operation, using, as you said, a Schedule II drug, the most dangerous drug that can be prescribed legally. Dr. Goldenheim. It seems clear to me that what we can do is provide information. We can tell doctors how to properly use this. I think pharmacists can report to the authorities, and they did. Pharmacists can refuse to fill prescriptions that they are concerned about. We can't do that because we are not involved in that. If we see a crime, we do report it. Mr. Rogers. According to the New York Times story yesterday, a DEA agent, Ms. Crowley, said that she described the havoc that OxyContin was causing in Myrtle Beach in a very heated telephone conversation with your company's Mr. Wilson back in March. She says, ``I have told him your product is being diverted onto the streets of South Carolina, that it is being sold on the streets of South Carolina, and that people are dying from it in South Carolina.'' And yet that was March. Nothing happened. Dr. Goldenheim. Sir, we don't provide the DEA licenses to the physicians. We don't regulate their prescribing rights or authority. I don't know what that local DEA agent wanted us to do. We do not sell tablets to the clinic. We sell tablets to wholesalers, and the wholesalers sell them to retail pharmacies. So that clinic didn't have the tablets, and I don't know why the DEA would be telling us. So we knew the DEA was aware of the fact that there was a problem. Mr. Rogers. If you became aware that a particular clinic or doctor or hospital was abusing their prescriptive rights in issuing prescriptions for OxyContin, what steps would you take to stop that, if any? Dr. Goldenheim. If we knew that a clinic or an individual physician was writing fraudulent prescriptions for OxyContin, we would stop calling on that practice. But you have to remember, we don't supply the prescriptions, we don't supply the tablets, and it is very difficult for us to enter into that, nor is it appropriate for us to enter into that patient- physician relationship. If fraud is being committed, if prescriptions are being tampered with, if medicines are being prescribed by criminal physicians, that is a job for law enforcement. Our job is to provide education. Our job is to teach physicians and pharmacists how to avoid abuse and diversion. Our job is to encourage pharmacists to report anything that they are concerned about. In this case we were aware that they--that they were. Mr. Rogers. This year's first quarter sales, according to the New York Times, in Mr. Wilson's territory, which I gather was the Myrtle Beach area, showed the highest increase of any sales territory in the Nation; little old Myrtle Beach, South Carolina. Not only that, in Mr. Wilson's area, sales of OxyContin had increased as much in 3 months as the sales in some other territories of the country increased all of last year. I mean, there was obviously something going on in Myrtle Beach, South Carolina. A local doctor said in an interview that Mr. Wilson told him that 40 percent of those sales had gone to this one place, Comprehensive Care Pain Center, and your company did nothing. People were dying and your company did nothing. Dr. Goldenheim. We provided information on the proper use of our product. We had never done anything to encourage improper use---- Mr. Rogers. But why did you not notice this obvious problem in Myrtle Beach, South Carolina, and attempt to alert people to it and stop people from being killed by this drug? Dr. Goldenheim. Sir, with the DEA already investigating, what would you have us do? Mr. Rogers. I would have you go to that company and say, no longer prescribe OxyContin out of this office. Dr. Goldenheim. We did that. We have told people that if they will not follow proper prescribing guidelines, we do not want them to use our product. Mr. Rogers. Did you go to this Comprehensive Care Center and tell them to stop? Dr. Goldenheim. I believe the answer is yes. I will have to find out that answer for you. I can tell you what I think I know. That county was one of the 100 counties that I mentioned earlier where we focused all of our efforts on the prevention of abuse and diversion, and we told physicians that if they did not follow our guidelines we did not want them to sell our product. But, sir, we don't control what they sell. That is not our job. That is for the DEA and pharmacy societies, it is for medical boards to control the quality of prescriptions. Further---- Mr. Rogers. The Comprehensive Care Center that I am talking about obviously was a prescription manufacturing machine. I mean, you concluded that eventually, did you not? Dr. Goldenheim. No, I did not---- Mr. Rogers. You told them to stop, did you not? Dr. Goldenheim. No, I told them--excuse me. We told them to follow the guidelines for the proper use of the medicine. Mr. Rogers. So you didn't tell them to stop issuing prescriptions. Dr. Goldenheim. We told them to only issue prescriptions if they were proper prescriptions. Let me be clear. I don't know for certain whether we told that particular clinic, but that was our policy; that we told physicians in these high areas of abuse that we only wanted them to prescribe our product properly with properly guidelines, proper record keeping, proper documentation; and if they weren't willing to do that, we didn't want them to prescribe our product at all. But we can't stop them from prescribing our product. Mr. Rogers. We can. Dr. Goldenheim. Yes, sir. Mr. Rogers. Thank you, Mr. Chairman. Mr. Wolf. I think you do have a responsibility and---- Dr. Goldenheim. We agree. Mr. Wolf. But I just--we won't pursue it when we do the GAO letter, but I think you do have a responsibility in some respects. You should have acted, and I think you have a heavy moral burden and obligation. I think the moral burden broadens beyond just what Mr. Rogers was talking about. But every time you pick up a newspaper story and hear about the overdose, every time you hear about a Reverend Coots-type situation, you have got to feel awfully funny about that. And I think your company has a moral obligation to do everything and anything you can. That is like saying when you are watching an accident take place, the railroad car is coming down and is ready to hit somebody, it is not your responsibility, you are not the railroad inspector, you are not the policeman on the beat, you just happen to be there, but you have a responsibility to shout out, to say something, to do something, to try to help. And the other thing I kind of noticed, I have watched your people moving around the room. You must have six or seven people in this audience, in contrast with Reverend Coots who has his wife and his son Josh. And I noticed a question that Mr. Serrano asked you--the U.S. Attorney whom you were offering as an authoritative voice on this. Now you have hired a U.S. Attorney; is that correct? Dr. Goldenheim. Yes, sir. But when I offered him as an authoritative voice, he was not working---- Mr. Wolf. And then, if I recall, that triggered a thought. You hired one of the top people in the Virginia State Police. Dr. Goldenheim. That is correct. And, sir, we are doing that because we do take this seriously. We do have a responsibility to do everything we can. I don't agree that we should have jumped in sooner. I think, as the chart illustrates, we did everything we could as soon as we knew that a problem arose. And I mean, you are suggesting that there is something improper about surrounding ourselves with appropriate expertise. We want to hire the best people we can to tackle this problem because we do take it so seriously. Mr. Wolf. Or to keep you from having a problem or---- Dr. Goldenheim. We want the problem of prescription drug abuse and the abuse of our product--absolutely, we want it to go away. Of course we do. It is not in anybody's best interest. It hurts the patients in pain, it hurts the people who are abusing the drugs, some of whom are driving; it hurts us, our products. It is devastating for all of us. And we are trying to do everything we can think of to ameliorate the problem, to make it go away. Mr. Wolf. We thank you for your testimony. We apologize for keeping you the whole time. Thank you very much. Tuesday, December 11, 2001. MEDICAL COMMUNITY WITNESSES DR. MARY SIMMONDS, FIRST VICE PRESIDENT, AMERICAN CANCER SOCIETY DR. MICHAEL ASHBURN, PRESIDENT, AMERICAN ACADEMY OF PAIN MANAGEMENT DR. PETER STAATS, DIRECTOR OF THE DIVISION OF PAIN MEDICINE, JOHNS HOPKINS UNIVERSITY Mr. Wolf. The next panel--and again I apologize for keeping you--Panel V, the medical community: Dr. Mary Simmonds, First Vice President of the American Cancer Society; Dr. Michael Ashburn, President of the American Academy of Pain Medicine; and Dr. Peter Staats, Director of the Division of Pain Medicine, Johns Hopkins University. And, again, we did not believe we would be here this time. You probably thought you would be back there in Baltimore. With that, we can go in this order: Dr. Simmonds, Dr. Ashburn, and Dr. Staats, and as long as you want to stay here. I don't dare want to cut you off, because you have been so patient, but if you want to summarize, however you want to do it, just go ahead. Dr. Simmonds. Thank you. Good afternoon, Mr. Chairman. I am honored to testify before you regarding the use of OxyContin. I would like to ask that my statement be included in the record. Mr. Wolf. Without objection, the entire statements will all be in the record. Dr. Simmonds. Today alone--today, December 11--more than 1,500 adults and children will die from cancer in the United States. Unfortunately, over half of these people will die suffering more pain than was necessary. One of the ironies in the subject we are discussing today is that the knowledge of medications already exists to allow a person to die in comfort and in dignity, and yet people still die in pain. As you consider how best to control the abuse of OxyContin, I ask you to keep in mind the cancer patients and their families who are relying on you to be sure that they have access to effective treatment for their pain. Mr. Wolf. If I could just interrupt for a second, I commit to you that I will do that, and I hadn't talked about it for a while, but I remember. So we will do that. There is no intention of anyone on this committee restricting, I can assure you. And if at any time you begin to think that the process is doing that, I hope you will feel free to come in. Are you here in town? Dr. Simmonds. I am a medical oncologist from Harrisburg, Pennsylvania, not too far away. Mr. Wolf. You are only 2 hours away. But you have an open door to come into my office. Dr. Simmonds. Thank you very much. I have been here all day and I have learned a lot, and I appreciate the balance of the panels that have been constructed, and I appreciate especially your talking about your family and your experience. Mr. Wolf. Are you familiar with Lincoln Hospital? Dr. Simmonds. I am. Mr. Wolf. My mom's dad was Dr. Dever. Do you remember Dr. Dever? He is one of the four leading surgeons. Dr. Simmonds. Yes. Mr. Wolf. In fact, Dr. Dever's picture is in the hospital. And in those days, mid-sixties, with the pain--but many times after, it would seem like an hour, hour and a half, and if my memory serves me it was 4 hours I think before he could come back. We will not allow this, and we try to make it a balance, but we will not allow this. We spoke with DEA. For DEA to make this as a hunting season to put fear--on the other side, though, as you can see from the Reverend Coots and the State Police and others, the balance-- and I believe you can. I don't think that this is such a difficult thing, and I think the company will have to do some things differently. Perhaps DEA will have to do things differently. But there is no intention to suddenly even drive that to be part of the process. Excuse me. Dr. Simmonds. That is all right. I appreciate your saying that and making that part of the record. As I said, I am a medical oncologist. I think I am the only cancer physician officially here. I am also first vice president of the American Cancer Society. The American Cancer Society is the nationwide community-based voluntary health organization dedicated to eliminating cancer as a major health problem by preventing cancer, saving lives, and diminishing suffering from cancer. So we believe that adequate pain management is essential to improving the quality of life for people living with cancer and through the end of life. There are countless stories of people with pain that goes untreated or undertreated, and I appreciate your bringing up your parents' illustration. I personally want to illustrate these remarks with a positive story about one of my own patients. Denise Moffat Pasquale is a 25-year-old woman who has metastatic breast cancer. She has a great determination to live. At this point her time is short, with metastases to her lung, liver, brain, retina, and especially her bones. As difficult as it was for her to accept help from hospice services, the nurses that have gone to her home to see her try to get out of bed and be active have been able to help us adjust the dose of OxyContin so that she can be comfortable. Her sweet personality has been restored. She is enjoying the holiday and the holiday activities with her family. Her mother told me, ``Now I know what quality of life means.'' I want to add that she, just like all of my patients, get relief from their pain, they become functional, they do not get a high, they do not become addicted. We have heard a lot about that today and I want to make that point very clear. Now, unfortunately, as hard as we try and as much education more recently that there has been, there are still many instances where people do not have their pain controlled and they become despaired, they cannot function in important activities in their life. It is a complicated issue. We haven't had much discussion about that today. But I only have time for a couple of remarks. But, for example, there may still be many educational barriers. We have talked about that. It is hard to teach pain management sometimes in medical and professional schools. But apart from that, there are attitudinal barriers. We are all in the same society. Patients and families need to be comfortable to discuss pain issues with their doctors and nurses, and they are not always comfortable to do that. There are cultural issues. I won't give you any examples, but some cultures are brought up to think differently about pain than other cultures. And then there can be a disconnect and a lack of communication to simply prescribing the right pain medication to get pain relief. We are in this drug-oriented society and there are many misconceptions; the example that Dr. Goldenheim used about his friend being afraid that she is being labeled an addict and now her behavior is she is going to suffer pain again. That is a very common, clear example how complicated it is. And there are system barriers. By this I mean everything from time to talk to the doctor to discuss pain issues, to having insurance coverage to afford the appropriate medications and to having those medications available. On top of all this, we do not need regulatory barriers. The current laws and regulations concerning opioids are balanced. They provide for the legitimate use of opioid analgesics for persons suffering moderate to severe pain. People with legitimate need for pain medication should not be forced to suffer pain. People with cancer pain should not have their access to medications like OxyContin limited because of the illegal and abusive actions of others. Distinctions must be drawn between those with legitimate needs for pain medications and those with illegal intentions, to avoid placing further stigma on use of prescription pain medication. Now, the American Cancer Society wants to work with drug enforcement officials to maintain the carefully balanced policies that do not interfere with patient care. We should target the sources of drug diversion. We have talked about forgery, pharmacy thefts, improper prescribing. We are willing to work with the drug enforcement community to educate health care providers and patients about the laws and regulations controlling the distribution of opioids to those who need them. In fact, on October 23, the American Cancer Society released a joint statement with the Drug Enforcement Administration and more than 20 other health care groups affirming our commitment to developing balanced policies. The negative media coverage of OxyContin abuse is hurting people with legitimate need for this medication. One of our major concerns is that the sensationalized stories do not give any perspective to what is not a new issue, drug diversion in a drug-oriented society. Furthermore, the hype on OxyContin today will be repeated tomorrow with another drug, it is really the same issue and, as we have heard today, it has happened in the past already. Therefore, to focus simply on a particular opioid today is at best, I suggest, a waste of time, and at worst might put up yet another barrier to make it even more difficult to provide pain relief to those who need it. The American Cancer Society strongly supports the privacy of clinical decision-making between patients and their health care providers. The society opposes any efforts that might chill health care providers' willingness and ability to provide pain medication and pain management when treating patients with cancer and other serious or life-threatening illness. The Society also recognizes and supports strong societal interest in preventing abuse of controlled substances. The Society encourages the drug enforcement community to continue working with the health care community and patient advocates in maintaining a balanced policy toward controlled substances. Mr. Chairman, I want to thank you for your work to ensure that people who suffer pain caused by cancer, like Denise Moffat Pasquale, are able to get the best treatment available while you address the important problem of illegal drug use. Many of your own constituents will be most hurt by unbalanced actions to restrict the availability of effective pain medication. I would like to acknowledge those who have worked hard already to ensure that the best treatment is available to all who need it, and in that regard I would like to especially acknowledge the efforts of the American Alliance of Cancer Pain Initiatives, Last Acts of the Robert Wood Johnson Foundation, the Pain and Policy Studies Group at the University of Wisconsin, the American Pain Society, the Oncology Nursing Society, and the Project on Death in America. These groups and others have worked hard to try to lower the multiple barriers which impede proper pain management. The American Cancer Society is ready to work with you, the law enforcement community, medical professionals, and the pharmaceutical industry to reduce the number of Americans who suffer pain needlessly and still die in pain every day. Thank you. Mr. Wolf. Thank you very much, Doctor. [The information follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Wolf. Next is Dr. Michael Ashburn. Dr. Ashburn. Thank you for the opportunity to speak to you today. My name is Michael Ashburn, and I am president of the American Pain Society. I am also professor of anesthesiology at the University of Utah, where I am director of the pain programs at the University of Utah, and also director of pain programs at Primary Children's Medical Center. The American Pain Society is an interdisciplinary professional society of more than 3,500 members. Membership includes basic science researchers, physicians from many specialties--psychologists, nurses, physical therapists, pharmacists, and other professionals--interested in pain- related research and pain care. Pain is one of the most common reasons people consult a physician; yet frequently it is inadequately treated, leading to enormous social cost in the form of needless suffering, lost productivity, and excessive health care expenditures. Pain leads to suffering throughout the life span. In a recent publication, the American Pain Society and American Academy of Pediatrics reported that children commonly suffer from untreated or undertreated pain. These children suffer even though safe and effective pain treatment methods exist. Likewise, the elderly often suffer from poorly controlled pain, even though this pain also can be effectively treated. There are many barriers that prevent effective pain control. These barriers include poor training of our physicians and other health care providers on the diagnosis and treatment of pain. In addition, Medicare, Medicaid, and private health insurance companies have payment policies that prevent access to integrated care. To make matters worse, there are simply not enough pain experts to meet current patient need. Finally, NIH funding of pain-related research is very modest and important research still goes unfunded. Many strategies and options exist for treating chronic pain. Chronic pain is not a single entity but may have myriad causes and perpetuating factors. Treatment strategies and options include behavorial methods, rehabilitation, interventional therapy, and the sustained use of a number of different medications including opioids. Barriers to the use of opioids include often exaggerated concerns about addiction, respiratory depression, and other side effects including tolerance. In addition, fears of diversion and regulatory scrutiny weigh heavily on the physician's mind when he or she considers prescribing these medications. Some individuals within law enforcement have stated that physicians commonly inappropriately prescribe opioids for patients with chronic pain, leading to increased incidents of diversion of these medications. Medical evidence shows, however, that pain is not overtreated but is undertreated. Guidelines such as the American Academy of Pain Medicine/ American Pain Society consensus statement, which is entitled ``The Use of Opioids for the Treatment of Chronic Pain'' are valuable in establishing parameters for clinical practice in this area. This document clearly states that physicians must use principles of good medical practice to guide prescribing of opioids. This includes a complete patient evaluation, development and documentation of a treatment plan with stated goals of therapy, and monitoring of the treatment plan, with appropriate changes in the treatment plan as indicated by patient response. A stringent policy regarding access to opioids with the goal of decreasing illegal diversion may have the unintended effect of direct patient harm. Physicians need to retain autonomy and discretion of addressing pain. No legislation or regulation can take into account all the nuances of particular clinical situations as they involve. Only a qualified physician, together with his or her patient in the context of a doctor/patient relationship, has the information necessary to decide what approaches, structure, and therapeutic goals are appropriate for the management of pain in a particular situation. Some policymakers have proposed that we limit the prescribing of selected potent opioids to pain specialists only. Such a policy is ill-advised. While this proposed policy is well intended, it most certainly will lead to needless patient suffering and disability by limiting patient access to these important medications. There simply are not enough pain specialists in the United States to provide care to all the patients who are suffering from chronic pain. Rather than limiting access, efforts should be made to train all physicians in the proper treatment of pain, including the appropriate use of opioid medications. The American Pain Society shares the concerns of many about the diversion of potent opioids and other controlled substances for illicit use. Substance abuse including alcohol, tobacco, opioids, and other substances leads to individual, family, and societal harm. There are no simple answers to the harm to public health that substance abuse causes. We should continue to work hard to support research, education, and to improve care to patients with substance abuse disorders. However, we must not allow diversion and abuse of opioids by some to deny deserving suffering patients access to these medications that relieve suffering, lessen disability, and improve quality of life. When considering options to address opioid diversion, policymakers should carefully consider the following: Opioids are important in the treatment of chronic pain and benefits far outweigh risks in carefully selected patients. Opioids should be administered within the context of patient treatment guidelines regarding the use of opioids for the treatment of chronic pain. Physician and other health care provider education and training regarding the diagnosis and treatment of pain is poor. Patient care and outcomes can be improved by better education. Tension exists between efforts to decrease abuse and diversion of opioids versus access to these medications for legitimate use. Policymakers, regulators, and those in law enforcement should carefully consider the potential for harm to patients caused by efforts to control abuse and diversion. Full and open discussion should be held with knowledgeable specialists who represent the direct interests of the patients before any efforts are made to fundamentally change the laws and regulations surrounding the appropriate and legitimate prescription of opioid medications. There should be increased Federal support for public health infrastructure, including support for substance abuse education and treatment programs. And, finally, policymakers should strongly support increased funding for chronic pain research so that we can better understand the role opioids play in the treatment of these complex disorders. Thank you very much. [The information follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Wolf. Dr. Staats. Dr. Staats. Thank you, Mr. Chairman. I would like to thank you for holding this committee meeting today on recent concerns of the abuse that we have seen with addiction with OxyContin and prescription drugs in general. What I heard today was really devastating. I heard some really horrible stories about patients who were not patients at the time, but people who suffered with the scourge of addiction, in this case with what happened to be OxyContin. While I don't want to see that ever happen again, we also want to maintain a sense of balance, as you indicated in your opening comments. We don't want to see that this effective therapy is not made available to patients who need them. We must recognize that if we do that, there are going to be grave consequences to the American citizens, your constituents, all of our patients throughout America. We must be very careful to not penalize these most vulnerable patients, those who suffer with chronic pain disorders, our seniors, our children, with cancer pain, and others with severe pain, even as we maintain our vigilance against this diversion that we have talked about so much today. So, while we consider how best to address these recent highly publicized crises caused by the diversion and the abuse of this medication, it is important that we recognize the vital position that opioids occupy in the management of acute and chronic painful disorders. In fact, the opioid class of medication provides the most effective treatment for moderate to severe pain and could not be abandoned without grave consequences for countless individuals and for society as a whole. Instead of denying the legitimate access to opioids therefore, we must seek strategies that will eliminate this diversion we have talked about today. Over the past decade we have made great progress in understanding that opioids occupy a legitimate role in the management of pain, and I would like to put this in perspective for a moment. Early in the 1990s, many members of State medical examination boards, those who can take away physicians' licenses, believed that it was inappropriate to prescribe opioids for a prolonged period of time for cancer patients, for noncancer patients. These boards went so far as to countenance the investigation of any physician who prescribed opioids. This policy instilled an undercurrent of fear in the hearts of many physicians, decreasing their willingness to prescribe opioids and leading to poor-quality pain management throughout this great country of ours. Fortunately, these inaccurate and restrictive attitudes changed as a wealth of information accrued on the efficacy of opioids, the low incidence of addiction, and their manageable side effects. Today, literally hundreds of thousands of patients have been monitored while receiving opioids, and we know that we can deliver the quality of pain care delivered to millions of Americans currently suffering or destined to suffer from acute and chronic pain only if these opioids remain part of the clinical regimen. Numerous Federal and scientific societies have evaluated the appropriateness of administering opioids as part of clinical practice. The Agency for Health Care Policy and Research has published two guidelines on the management of cancer and acute pain, both of which incorporate opioids on the part of their good clinical practice. The Joint Commission on Health Care Organization has mandated the appropriate management of pain and the inclusion of pain control assurances as part of the Patient's Bill of Rights. This cannot be accomplished if opioids are withheld from the paradigm of good clinical practice. The American Pain Society and the Academy of Pain Medicine, as Dr. Ashburn noted, two of the most scientific and clinical societies who deal with pain issues in America today, issued a joint position statement indicating that the use of opioids is appropriate in select cases. As we move forward, it is important that we maintain our sense of balance. We need to reassure physicians that it is legally safe to prescribe opioids, including OxyContin, in the legitimate practice of medicine, even as we investigate any who may be engaged in the criminal activity that we have talked about today. We need to assure our patients that we will continue to have access to care for them, in some cases the only medications that will help them move on with life and engage in part of life, even as we assure that criminals will be unable to divert these prescribed substances for illicit use. We need to instruct our patients that selling their medications is a criminal act with criminal penalties. The DEA was established in 1973, as we heard from our leader from the DEA today, to enforce the Controlled Substances Act of 1970. This act specified as a basic premise that physicians should prescribe opioids in the legitimate practice of medicine. We need to assure physicians that they need not fear DEA scrutiny; rather, they must have a sense that the DEA continues to endorse the appropriate use of opioids, assuring access to our patients with pain. In return, physicians, I believe, need to assist the DEA by enforcing regulations to control the illicit use of this class of drugs. I believe that the physician community can come together and has come together to work in a collaborative manner with the DEA. This can be accomplished with a variety of educational programs that facilitate transfer of information from DEA legal authorities to physicians and vice versa. If criminals are diverting opioids from physicians and these substances illicitly, physicians should not fear prosecution; rather, they should work with the DEA to inhibit this behavior. It is important that the actions that are made don't restrike a current fear with physicians, but rather maintain access to care for patients who need them while we inhibit the diversion that we heard about today. I for one would be happy to contribute to any strategy that ensures continuation of access of care for patients while we incorporate ways to prevent diversion and abuse that we learned about. Thank you very much for your attention. Mr. Wolf. Thank you very much. [The information follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] Mr. Wolf. I agree with all three of the statements, and I think whatever policy does come up, we will really need the medical profession to be involved with it, maybe even taking the lead. Unfortunately, we live in a society where there are bad people. There is the fundamental problem of greed. There are bad politicians. There are bad people of every category. Overall, most are good. The same way in the medical profession, the same way in the military, the same way in the ministry, the same way in everything. It seems to me that I don't think anybody would disagree with what you said. The more, though, the profession or the company or whoever is silent on the abuses like Hazard, Kentucky, the greater likelihood that there will be some action taken by a well-meaning but ill-informed Congress perhaps, that will do precisely what you want to say. So it is important that the profession police itself. It is important that the pharmaceutical companies police themselves. My sense is that the company could have done a better job earlier and still could do even more. Nobody would hold anyone to an absolutely perfect standard, because we all have different views of what we are seeing at the different times; but to just move ahead and do everything you possibly can, I think would eliminate the potential problem that I could see happen. I think there could be an overreaction. If there were a Hazard, Kentucky--if Harrisburg became Hazard, Kentucky, if the Main Line of Philadelphia became a Hazard, Kentucky, if Fairfax County which I represent became a Hazard, Kentucky, if it were to spread all over, you would probably see an overreaction on the part of the Congress to try to get a handle, because good people want to solve problems. So I don't think we can ignore it. Stories in the New York Times I think cause public policy people to kind of try to deal with the issue. But I can assure you if the committee does anything, your views will be at the forefront, because at the outset we don't want to do anything rash; but even you would acknowledge that there must have been a doctor in Hazard, there must have been a doctor in Lee County that didn't have the same standards that 99.9 of the doctors have. We have had bad apples up here in Congress; you just go look at the history of them. And you have bad apples in every profession there is. I appreciate your testimony. If there is one thing that you think the Congress could do that would guarantee that what your concerns are don't take place, what could we do? I mean, obviously we could fund more this and more that, but next year we are going to actually go from a surplus to a deficit. I don't think there will be a lot more money with regard to pain research--we have in this Congress for the last 6 years--we have heavily increased research for cancer. We have heavily increased money for diabetes, we have heavily increased the funding for Alzheimer's. I mean, medical research--really, I give a lot of the credit to former Speaker Newt Gingrich who spoke out very eloquently and drove the Congress on both sides of the aisle on that issue with regard to research, and probably never got the credit for it that he should have. But I don't know that the levels will increase--I mean, you say more for pain. I don't know. We should try to. But what within the realm of what we could do up here with regard to enforcement, or with regard to the other side of the coin, what could we do here that would be responsible, that wouldn't create the problem that you are concerned with? Are there any thoughts that you think we could do--the prescription monitoring program? I know many doctors may not like that. Pharmacists may not like that. Would it be a good idea to do what the company said, to have a national prescription monitoring program for a Schedule II or III? This committee has funded a grant program for States to have a prescription monitoring program. Should we increase that maybe when it is regional, for instance, Pennsylvania, West Virginia, Maryland, Ohio and Virginia and Kentucky, so their region would be covered, or maybe New England, Maine, Vermont, New Hampshire, Massachusetts and Rhode Island? What should we be doing here that we practically could do that would make a difference, whereby these cases of Hazard's don't come along and therefore you don't get an overreaction by the Congress or by the DEA to, quite frankly, crack down, which ends up with somebody who should be getting the pain medicine not getting it? What are your thoughts? We can go one, two, three, if you have any---- Dr. Simmonds. Well, on the monitoring program, this is old news that hasn't been brought up here today. They call it the triplicates. I have never practiced that way since I am in Pennsylvania, but in my neighboring State in New York, and there were special prescription blanks. Not only did you have to have a DEA number but then you had to have a special prescription, and I could get you the quotes, but this has been studied. When those programs get instituted, what happens is the physicians, it is too much hassle. It brings up too many issues. It is a hassle factor. There is extra money perhaps in buying those prescriptions, getting the license, but also the stigma of this is different, and if the prescription is incorrect and the patient goes to the pharmacy and they are in pain to begin with and it is Mary A. Simmonds instead of Mary W. Simmonds, they have to go back to the health care facility and get a whole new prescription and on and on, and the bottom line is that what happens is the appropriate opioids, because this is for Schedule II, just don't get prescribed. And just take Tylenol. Well, that leaves a patient undertreated, and that is not appropriate. So if there is to be some kind of monitoring system--and I think there possibly could be--that would be done right and actually be constructive. I heard an idea today--just as you said that, it came to my mind. I need to know--in fact, just yesterday one of my--another patient of mine supposedly lost a few OxyContin tablets. And I need to know if she has gone to other doctors and, you know, what is happening as a responsible physician. And that would be something constructive that I as a physician would view constructively. So that is just one thought. Mr. Wolf. Well, that is a good point. I was out in my district in the Shenandoah Valley a week and a half ago, and they were talking about the drug problem there is methamphetamine and OxyContin in the northern part of the valley, but they put up on the screen one case of one person who was shopping around and the involved doctors' names. And the law enforcement people said most of these doctors are honest, good doctors who have lived here forever, and they didn't know that they were prescribing something that somebody in a town 15 miles away was prescribing. And they made the comment that somehow the doctors ought to be able to call up and find out if they are suspicious. Has this person been some other place? In essence, you are saying almost the same thing as the law enforcement. Dr. Simmonds. Let me add to that, though, because this is something in our State government--I can't quote you where it comes from. But every once in a while in managed care I will get this printout of a patient of mine and all the different either opioids or--all the different medicines, and so it could include a variety of medications and so on. And it looks suspicious, which is why I might--and any other physician might get that. And to this day, 100 percent of them have been inappropriate. I know all the medications the patient is getting. They are getting them for the right reason, and it has been a piece of junk. I throw it right in the trash can. So it has to be a monitoring system that really works, that is accurate, and that is not easy to do, perhaps. Mr. Wolf. Do you think more at the state level than at the federal level? Dr. Simmonds. Well, I understand the point about people going across the border. So that is, I suppose, for people who understand how drugs are regulated, and if it is a state one, then there maybe is a cross-fertilization. I think there are two levels, sure. Dr. Ashburn. Two suggestions. First of all, I would agree that a monitoring program can be developed and implemented in a way that strikes a balance between physicians and other health care providers concerned for undue oversight and the potential that that might have on us not writing medications, as well as its usefulness as a law enforcement tool and a monitoring tool. The State of Utah has a reporting database, a controlled substances reporting database, where all controlled substances, all scheduled substances are reported into the database. Physicians and other health care providers can access that database, and I use it as a routine part of my monitoring practice for all of my patients who receive opioid analgesics from the pain management centers, either Primary Children's or University of Utah. I find that program to be immensely helpful in identifying patients who are receiving opioids from multiple different sources. Mr. Wolf. So you can find out--in Utah you can go online and find out this patient---- Dr. Ashburn. Yes, sir. Yes, sir. The program in the past has been underfunded, and as a result the reports were several months behind, which makes it unuseful as far as a clinical management tool in realtime. Of late, the State of Utah has funded it at an adequate level where the data in the database are within 30 days of being realtime, and that is sufficient enough to allow us to obtain realtime data on patients and be able to monitor their use of opioids. Mr. Wolf. Do you know how much that costs? Dr. Ashburn. I do not. Mr. Wolf. Is OxyContin a problem in---- Dr. Ashburn. OxyContin is less of a problem than some of the areas that we have seen from the other speakers, but I think it is important to note, and we have seen throughout the evening that--or throughout the day, that while--it is getting close to evening--but while this presentation in this hearing is on the particular drug, OxyContin, opioid addiction and substance abuse permeates our society, and even if OxyContin were pulled off the market tomorrow, another drug would fill its place. And the same concerns would be on my mind as a clinician who uses opioids for the treatment of chronic pain. I still need to monitor my patients. I still need to strike a balance between providing them passionate care, access to opioids and a participant, as you suggested earlier, in the monitoring process to identify those individuals who have a primary substance abuse disorder, not so they can be punished but so that they can be referred to adequate substance abuse treatment programs, because they have a different disease which won't be helped by me continuing to prescribe them medications. Mr. Wolf. Now, is that--what you have in Utah, is that available to--I don't know what you call your DEA, but is that available to your law enforcement? Dr. Ashburn. To my knowledge, law enforcement officers can access the database under certain guidelines with regard to having--having appropriate concern to be able to check on a particular physician or a particular patient. Mr. Wolf. Like a court order or something they can get? Dr. Ashburn. As far as I understand, there is a due process that they have to go through. So the concerns of the physician community when this law was passed at the State was the concern of data drudging, where they would--where the database would be accessible to looking for data without cause. Mr. Wolf. You don't want to do that. You don't want to have it just so anybody could get on. You would want to have some protocols. Dr. Ashburn. That is correct. The other issue is the issue of confidentiality with regard to real patient data that is in this database by those individuals' names. The second issue is I do believe it needs to be at the state level. The practice of medicine is generally managed by state medical boards. As a result, I think this database should be linked with the state medical board or at the state level. That does not mean the Federal Government has no role. In fact, the $2 million that was appropriated to assist States in developing a database was an important effort. We also have problems, even in a rural State such as Utah, where patients do cross borders, and having databases available in other neighboring States for physicians that practice in Utah is an important part of our monitoring practice. Mr. Wolf. Well, we were thinking that we could have some sort of 50/50 match, and then maybe 100 percent for States to hook up with other States. I am not sure what that would cost. I am sure it is not a major cost. But therefore, if you wanted a State program and you didn't have one, you would have to match 50/50. Then after that if you wanted to be a part of the cooperative arrangement in order for you to participate, perhaps there could be a 100 percent share by the Federal Government. That way Utah could be together with Colorado and the surrounding States. Dr. Ashburn. The other issue I wanted to bring up very briefly is the focus on opioids and the connection with pain, in that one of the issues that we have seen in managed care or in the practice of medicine that is affected by the cost constraints within the health care system is a focus on the medical management of pain, of which opioids are an important part. Opioids do play a very important role in the treatment of patients who have complex pain problems, but there are other modalities, and there are increasing barriers to access to those treatment modalities. For instance, there is a 50/50 co-pay, 50 percent co-pay for psychological services for Medicare beneficiaries. That presents a significant barrier to cognitive behavioral therapy for individuals who have complex pain problems. There is increased barriers on access to activating physical therapy through the Medicare and the Medicaid system, and in fact the Medicaid regulations at the federal level have specific language which could preclude payment for the diagnosis and treatment of chronic pain. And so there are several barriers, both in our--the Federal Government system and in private health insurers which may tend to focus primary care--these patients to primary care physicians and away from the specialist and also focus towards medical management as opposed to interdisciplinary care, which has been clearly shown to have improved benefit. And another alternative, or something else that this committee might consider is asking MediPAC or GAO to study those barriers and identify whether or not changes in payment policies are necessary in order to improve the care of those individuals. Mr. Wolf. Well, we can do that. We will put that in the request when we do the---- Dr. Ashburn. Thank you. Mr. Wolf. Mr. Staats. Dr. Staats. Do we have one thing that you could do? I don't think there is one thing. Of course there are limits on the expenses that we can put into this important topic. On the other hand, can we afford not to invest in the care of patients with chronic pain? We have heard today that estimates are close to $100 million for pain. Think about also all the patients who are out there with co-morbid addiction problems who are in jail. We can come up with a comprehensive program for this that would potentially save money for society as a whole. This program could come under the confines of the decade of pain control and research that has already been enacted by Congress. Correct? Being this decade. This would have to include different aspects. It would have to include access to care for patients, include the issues that Dr. Ashburn just talked about actually funding this. Investment in research for nonaddictive over nonabusable drugs would be a very valuable tool. I am making an impassioned plea for maintaining opioids, because it is the best thing that we have today. I would love to find something better that doesn't have an abuse potential, and I think we can do that. We are smart in America. We can find those therapies if we invest in it and avoid some of the problems that are out there today. We can build rapport with physicians with a physician monitoring program. I think that if we were to simply enact a physician monitoring program there would be a backlash from physicians, but if there is a sense that the DEA and the Congress and working together to help have access to care for patients while we are trying to avoid the diversion, I think that many physicians would buy something like that. We need to continue our education on the problems of abuse. Many physicians, as you indicated, don't know about what is going on, and we need to continue to hammer home this is the appropriate management of pain and this is the appropriate treatment of addiction and maintaining the sense of balance. And I learned today again about maintaining treatment programs for addiction. I think that is an important medical and psychiatric disease that needs treatment, and whatever we do should be a comprehensive program that maybe we will actually save money for a society. Mr. Wolf. Well, we do need more treatment, and we--I don't know what you would tell a family in one of these areas. And it does seem that this has hit more rural areas, for some reason. And I have been reading articles that perhaps it is because there is more physical labor and agriculture and mining and different things. But, you know, for Reverend Coots and some of the others in those areas, the income level for a doctor is not very high in those regions. This is very difficult to--so that was my comment where I mention, if you are a movie star, you can go to the Betty Ford place, but if you are not, just the average person cannot afford treatment. Also, there are limits on the number of health insurance policies that provide coverage--30 days and you are out. And 30 days may be okay for one thing, but obviously for OxyContin and others it is certainly not enough. Well, I appreciate your testimony. Your full statements will appear in the record. We will add that to the GAO, and if you want to put one or two other things in there, you can even add that in. You can separate them out or add to, but we will ask the GAO to look at those things. We are at the end of this session. I am not sure what this Congress--the Congress traditionally has been home at this time. We are here this week, and some people are saying we may be here through the end of next week, but obviously this will be a subject as we begin here again in January and February next. But, again, thank you very much, and I hope you have a safe trip home. The hearing is adjourned. [The information follows:] [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] W I T N E S S E S ---------- Page Ashburn, Dr. Michael............................................. 269 Coots, Donnie.................................................... 87 Goldenheim, Dr. Paul............................................. 111 Hall, Capt. Rick................................................. 43 Hudson, Lt. Steven............................................... 43 Hutchinson, Asa.................................................. 1 Maggard, Rod..................................................... 43 McElyea, Prosecutor Tammy........................................ 43 Simmonds, Dr. Mary............................................... 269 Staats, Dr. Peter................................................ 269 Sullivan, Dr. Rolly.............................................. 87