Aug 11, 2004 By: Bethanne Fox, et al. Burgess Communications

Operator: Good day ladies and gentlemen and welcome to the media briefing conference call. At this time all participants are in a listen only mode. Later we will conduct a question and answer session and instructions will follow at that time. If anyone should require assistance during the conference, please press “*” then “0″ on your touch-tone telephone. As a reminder, this conference call is being recorded. Your host of today’s conference is Dr. Russell Portenoy. Sir you may begin your conference.

Dr. Russell Portenoy: Good morning everyone. I would like to welcome you all to this — to this media briefing. My name is Dr. Russell Portenoy. I am chairman of the Department of Pain Medicine and Palliative Care at the Beth Israel Medical Center in New York. And I am here with several colleagues to discuss the release of a — of the new documents by the drug enforcement administration, the pain and policies studies group at the University of Wisconsin and the last (indiscernible) — the last ex partnership for caring. This is a unique educational document and we are very pleased to be able to answer your questions about that today. I want to start just by introducing who’s on the line with you. These are my — my colleagues and the principal writers of the frequently asked questions. They include Patricia Good who is the Chief of the Liaison & Policy Section in the Office of Diversion Control of the Drug Enforcement Administration. David Joranson who is senior scientist and the Director of the Pain and Policy Studies Group at the University of Wisconsin in Madison. And Father William Byron who is the last ex-partnership board member and the research professor at the (indiscernible) business school, Loyola College in Maryland. We have arranged the morning so that each of us will make some very brief comments in sequence and then we will open it up to take your questions. I will start and just make a few comments from my perspective as a pain specialist who has been involved in this area for a very long time. I wanted to point out to you that this documents, which is an effort to create in a very user-friendly format, information relevant to the safe and appropriate use of control prescription drugs. The need for this document can be traced to trends that have been occurring in United States during the past decade. We have witnessed a large increase in prescription of opioid drugs to treat chronic pain, which is a change that many pain specialists have welcomed, recognizing that there is an epidemic of — of chronic pain and that opioids appear to be very much under used and stigmatized. At the same time that that has happened however we are coming to recognize an increase in rates of abuse and diversion. Although we don’t know whether those increasing rates relate directly to the increasing medical use of the opioids, the fact that abuse and the diversion has increased, has itself — has itself been a wake up call to the medical community. And made us understand that we need to approach these drugs and this area of medical practice from the perspective of balance. By balance I mean that we have to recognize that these are legitimate treatments. They are essential for good — good medical care and that — that recognition has to be maintained by both the medical community and by those in the law enforcement and regulatory communities. But at the same time, we have to recognize that they are potentially abusable. They could be diverted to an illicit market and all appropriate things have to be done to reduce that from — reduce that risk. In an effort to — to highlight the importance of balance in 200, a consensus statement was jointly issued by the drug enforcement administration and more than 20 professional societies. That basically said that this paradigm of balance is the way to go forward in the United States, with both the medical community and the law enforcement and regulatory communities recognizing the fundamental role the other has and — and ensuring that patients have access to these drugs, at the same time as trying to limit the potential adverse effects that can come from abuse and diversion. After that meeting, after that consensus conference was issued, meetings were held in an effort to create educational material that could provide essential information not only to physicians who prescribe but also to those in the regulatory law enforcement communities that would embody this concept of — of balance. And we came up with the concept of — of frequently asked questions, which could be widely disseminated both online and off line, it could be updated as frequently as — as is necessary and would be a user friendly way of — of providing information. And so we now have these frequently asked questions. They are being released today on multiple web sites and we hope that they will be a very important piece of the education that will be required going forward to ensure the safe and effective use of these medications. I would like to now turn the floor over to Patricia Good from the drug enforcement administration to talk a little bit about their perspective.

Patricia Good: Thanks Russ. DEA is really honored today to present to be presenting this valuable educational material regarding prescription pain medications, which we developed with experts in the medical field such as Dr. Portenoy. Over the years, we have — it’s — it’s become clear to us that there are many misconceptions about DEA’s role and even DEA’s fundamental belief about the use of prescription opioids. Many of these mis-conceptions lead to unwarranted fear that doctors who treat pain aggressively are somehow singled out for enforcement actions and that the goals of protecting the public health from drug abuse have come into direct conflict with the goals of promoting the public health through effective pain control. Our hope is that this document will clarify the DEA as well as society in general — is well served by ensuring both the ready access to prescription opioids and the elimination of their abuse and diversion. Under treated pain and drug abuse have equally devastating effects on the individual and society. The goal of effective pain treatment or any other medical treatment for that matter is to reduce suffering, enhance the person’s quality of life, increase the patient’s ability to function. The hallmarks of drug abuse though are just the opposite. They are — they show a downward spiral in a person’s life. Addiction causes persons to place the need to require more drugs above everything else, above personal relationships, employment, social functioning and often leads to crime and even death. Many people associate this type of addicted behavior with illicit drugs like cocaine, heroin and crack and also identify this with DEA’s primary role, which is to eradicate the supply of illicit drugs. But there is a link between addiction and pain treatment and its not as some may have — may want to think, we think and some sure believe that long term legitimate use equals addiction. The link really consisted a fact that many drug abusers — abusers of street drugs are happy to turn to safer, sometimes more potent and more profitable legal drugs when they are available and not go to great lengths to acquire them. These people don’t become abusers as a result of medical treatment, they already misuse drugs and abuse the medical system to get their drug of choice. Conversely there is a small portion of the population that may have an undiagnosed dis-addictive disorder and these may run into trouble when they are introduced to opioids in the course of medical treatment. With accordance to the oversay or investigation of illicit drugs, DEA has a much different role than it does in the illicit drug world. Prescription or legitimate controlled drugs by definition have a very valuable medical purpose. They are controlled substances though, but purged with the fact that they have the same ingredients and the same properties as many of the street drugs from which they are derived for opium, heroin, (indiscernible) morphine and all the other opioids. The goal however, isn’t to eradicate them or limit their legitimate use, but to prevent their illicit use. Over the past ten years, there has been a significant emphasis on the need to promote adequate pain treatment leading as Dr. Portenoy said to a growth in the consumption of opioids and also a growth in what we see as — in the abuse world. The 2002 monitoring the future study that’s conducted by the Center for Substance Abuse Treatment, demonstrated that among adolescents even 13 — over 13 percent of people between 12 and 17 have reportedly used prescription drugs such as opioids, non-medically at least once in their lifetime. If our shared goal is really to protect the public health, we must all embrace our various aspects of that role. It may sound like common sense. Doctors and other health care practitioners must act out of genuine concerns for their patient’s welfare using all the tools at their disposal including opioids to effectively treat pain. But they must do so with a healthy dose of respect, not fear for the properties these drugs themselves have. Acknowledging after world history, they have been (indiscernible) both for their ability to relieve pain, as well as their ability to cause harm to those who suffer from the — disease of addiction. By treating the whole patient, that means monitoring their progress and ensuring that the drugs have a therapeutic rather than a harmful effect, they will automatically do the right thing when they are confronted with a disease of addiction and that will be to seek treatment for the people who suffer from it. They will accept full responsibility for providing the right treatment and the right drugs including opioids to the right patients for the right reasons. Fairly with this publications to professionals, is sort of clear descriptions of the common sense approach should help them with the risk benefit analysis in treating their patients and it also should assist in minimizing any diversion that might result from well intentioned medical treatment. Or how (indiscernible) by providing this information on the extend of opioid abuse, methods of diversion and risk and the legalities of treating pain patients, we will create a sense of perspective and — and reinforce the fact that the vast majority of practitioners are operating within the best intentions and have nothing to fear from the law enforcement community. I would also like to stress that the contents of this document are going to be widely provided to not only medical professionals but also for the regulatory and law enforcement community, to prosecutors and public policy makers at both the federal and state levels. This critical information on what constitutes good medical technique is essential to us also as we do our job to protect the public from abuse and diversion without curtailing any legitimate medical treatment. We will continue to do our jobs to prevent crime by going after those who divert drugs whether they are doctor shoppers, forgers, individuals who rob pharmacies, bogus Internet sites that offer drugs to anyone who ask, or the small minority of medical professionals who deals drugs rather than treat patients. But we strive to do this with the same degree of common sense, balance and perspective that we have worked to convey throughout the development of both the consensus statement and this educational document. I really appreciate the working group, especially Dr. Portenoy, David Joranson who are with us today and also Steve Passik of the University of Kentucky, Bob Williams, formerly of DEA and the driving force behind this initiative, Karen Caplan the former President and CEO of (indiscernible). It has been a great experience and I hope it will be well received by the medical and public.

Dr. Russell Portenoy: Thanks very much Pat. I want to let everybody know on the call that you can go online to get the entire press kit, which includes the news release and the whole consensus statement and the FAQ. And I will give you the — the web address here, it’s a bit long so I will spell it out for you, it’s www.medsch.wisc.edu/painpolicy — it’s www.medsch.wisc.edu/painpolicy and you can log on there to get the entire press kit. I would like to introduce now David Joranson who is the director of the pain and policy studies group at University of Wisconsin.

David Joranson: Thank you very much Russ and by the way that web site can also be found if you happen to drop that link somewhere just by a simple search for the word pain policy. I would like to just emphasize a few points that were made by Dr. Portenoy and also by Pat Good. First I would like to say why I think this educational initiative is important. Among clinicians, law enforcement and also those who regulate drugs and professional practice, the research has shown that there is a need to update knowledge about pain management with accurate information about pain, about drugs and about addiction because a lot of this information is relatively new and it’s replaced earlier outdated information. But it really is more than that. The medical and regulatory environment for pain management seems to be worsening. We already knew that for years, physicians have been concerned about being investigated if they prescribed controlled substances. But now we hear that doctors are becoming even less willing to prescribe because they fear the profession ending high profiler risks that they are hearing more about in the media. Even if they are acquitted of state charges as some have been, their professional reputation in medicine can be damaged or even ended. We already knew that some patients were weary of using pain medications but now we hear that patients can’t find a physician who will prescribe opioids or who are being cut back or even dropped entirely from health care provider’s treatment list. We already knew also that some pharmacies did not carry opioids but now we hear that some have posted signs that say this. In some ways, pain management and the use of pain medications has become a crime story when it really should be a health-care story. This situation is due in part to the perception that I think Pat was referring to that increased abuse of pain medications in the US is only due to the excessive medical use of opioids for pain management. And no doubt there is some of this going on, although it’s relatively rare in the medical system, it is a significant issue and clinicians should be alert for the problem and the FAQ provides very valuable risk assessment information that physicians can use. But the FAQ also reminds us that we have major drug abuse problem in this country that creates an illicit demand for opioids just like with other drugs of abuse. And there are individuals and criminal enterprises that divert drugs every day across this country. Pat Good mentioned them including theft from manufactures, armed robbery of pharmacy’s, forgery and illegal Internet sources. These sources can account for large amounts of pain medications and when they reach the illicit market and are abused, they lead to overdoses and death. And there is absolutely no connection at all with medicine, prescriptions or patients when it happens in this way. Another point that I would like to emphasize is that the FAQ makes it clear that the use of opioids for pain management is not the same as addiction. Addiction can occur in vulnerable individuals and it is marked by useful reasons other than pain management such as to get high. If a pain patient however abruptly stops using pain medications and experiences symptoms of withdrawal, this is not addiction. Decades ago the world health organization — even the WHO used to believe this. But it is now considered outdated and incorrect information. Nevertheless this belief continues and is even reflected in some state’s laws and regulations. Our hope here at the pain and policy studies group is that this joint educational initiative will be a step in the right direction to reverse what appears to be an increasingly unfriendly environment for pain management and bring a greater sense of balance back to pain management. By balance I mean the clinicians, in addition to treating pain adequately will have the knowledge and skills necessary to assess their patients and avoid contributing to drug abuse. And also that law enforcement officers will be able to target the major sources of diverging and do so without interfering in medical practices and patient care. To accomplish this, the FAQ contains up to date information about pain management and regulatory policy for clinicians that is physicians, pharmacists, nurses, physician’s assistants and also for law enforcement — that is federal and state drug agents, medical examiners, prosecutors and defenders as well. And if I was a pain patient or a family member or a friend, I think I would probably read this FAQ so that I would know, more about what I could expect from health-care professionals and from law enforcement. Thanks very much.

Male Speaker: Thank you David. Our final speaker is Father Byron who is representing the Last Acts Partnership. After his comments, we will throw this open for questions and answers. Father Byron?

Father William Byron: Thanks Russell, as you indicated earlier, I’m a member of the board of directors of Last Acts Partnership and that of course is a Washington based not for profit advocacy group, interested in promoting quality and of life care. I am neither an author nor a contributor to the study but as a director, I just been encouraging Last Act’s to participate in the production and this really valuable resource. The resources intended to advance the purpose of Last Acts namely to improve end of life care, in this case by offering guidance on the appropriate use of prescription pain medication as the end of life draws near. The words that come to my mind earlier reading the report and have been repeated today by other presenters the words are balance and prudence — all interested parties including law enforcement must be prudent. Hence the importance of clear information and informed even general but well informed guidelines — there are as we all know, risks of abuse, there are risks of illegal even criminal uses of pain relief drugs by both patients and providers. There are also risks that are a major concerns to providers and they relate to the unintended consequences for example, addiction. So prudence simply has to be a permanent partner — a constant guide of those committed to end of life care. So balance of many interests — not least among in the interest of patients, their families and their caregivers and easing — even eliminating pain is the goal. And this document helps all interests in moving towards that goal. And there is what might be called an end of life constituency that is reasonably well informed, but there is that broader public in need of education, on all these issues. And the media — the media gathered here in this conference call, can be of enormous help in communicating the questions and the answers to the general public. I am really pleased and proud to be associate with this venture.

Male Speaker: Thanks very much, I would like to ask the operator now to open up the call for questions and answers.

Operator: Thank you sir. Ladies and gentlemen, if you have a question at this time, please press the “1″ key on your touch-tone telephone. If your question had been answered or you wish to remove yourself from the queue please press “#” key, one moment please. Our first question comes from Lauren Neergaard of Associated Press.

Lauren Neergaard: Hi, my question is to Patricia Good. I am wondering from DEA’s perspective, what is really different here, is this — does this constitute sort of a — a pledge on the part of DEA that, there will be less aggressive checks of doctors prescribing records or something or what — what’s really different as opposed to what you have been doing for the last couple of years?

Patricia Good: What’s different is the publication of this document from a medical perspective that — that gives a great deal of guidance as to what would constitute — right way to do things. And with DEA’s sanction on that document — so that it’s clear that we truly agree with the medical statements made in it. Much have been made of our “aggressive tactics” in the past several years. I have been here for 33 years and our goal has really always been the same and that’s only to look at people who are causing drugs to be diverted, either through their negligence or through criminal activity. Our focus is not on pain doctors; our focus is on people who divert drugs. And I think if, if we look back at our statistics over the past ten years or so, there has not been a significant upswing in the number of doctors that we have investigated. In fact in the past year we — we arrested the total 50. Years prior it ranged from 70 to 80 and that (indiscernible) back ten years historically. So I think we are not it is not as much a change in any focus but in a amplification and a public statement of exactly what that focus is and should be.

Lauren Neergaard: And of those 50 that you arrested, how many are specifically for diversion of narcotics?

Patricia Good: Well, the 50 doctors arrested were all involved in diversion of — of narcotics or some other controlled substance.

Lauren Neergaard: Okay.

Patricia Good: That was the reason they were investigated and indited.

Lauren Neergaard: Okay and so the other statistic that you have in this FAQ about investigating less than a 10th of a percent of doctors last year, all of those investigations also were related to this particular issue?

Patricia Good: Not specifically related to opioids in pain. When we investigate doctors for drug diversion, it could be any type of controlled substance not — not specifically an opioid.

Lauren Neergaard: Okay. Do you have specific opioid numbers?

Patricia Good: Not, right at my fingertips but I believe the larger percent was involving opioids, but there were some that were other drugs.

Lauren Neergaard: And how many acquittals were there last year?

Patricia Good: I don’t have an information in front of me. I believe though — if — my memory serves me, there were maximum of about one.

Lauren Neergaard: Okay, so this is more — your — you consider this sort of clarification of existing policy?

Patricia Good: Clarification and also, it will be also provided to every one of our diversion employees, so that, they have up to the minute information as well.

Dr. Russell Portenoy: And this is Russell Portenoy.

Lauren Neergaard: Uh-huh.

Dr. Russell Portenoy: I just — from the perspective — from the medical perspective, the notion that there can be education, that there can be guidelines, that have been formally endorsed by DEA, could potentially be very powerful for prescribers because prescribers in general view DEA as a — as a potentially scary organization that doesn’t have an — any idea at all about what the medical imperatives are. And they are single minded and that they potentially are antagonistic to the — to the goals of good patient care and so to see a document in which the goals of good patient care guidelines for prescribing that are accepted by major medical societies and education that is fact based is all endorsed by DEA and by by medical groups and a consumer advocacy group, carries a lot of weight and is I think the most important instinct about a document like this.

Lauren Neergaard: Okay and so is this really a first?

Dr. Russell Portenoy: In in my experience, there is nothing like this that has ever been done before and if my colleagues feel differently, please chime in but it is going to be a first for me.

Lauren Neergaard: Okay. And do you have a sense that — that the medical community was waiting for this sort of clarification in order to decide which way to go, was this what was really missing?

Male Speaker: David you want to answer that question. David Joranson, are you on the line?

David Joranson: Yes that’s a good question. I — I’m not sure that it is something that is missing that has been sort of specifically identified out there, but we think it’s missing. And it needs to — this kind of clarification will be helping, making it more clear that the Drug Enforcement Administration understands good medicine and would be avoiding it in their investigations and I think there is a lot of people who — who don’t feel that that’s the case and therefore that need is created.

Lauren Neergaard: Okay. And if I could ask you all just one more thing. If you could give us the latest statistics on untreated pain what — what are the estimates out there, for numbers of people who would be candidates for opioids but are not getting them?

Dr. Russell Portenoy: Right. This is Russell Portenoy. The — the current numbers suggest that about 30 percent of the US population have chronic pain and as many as third of that group have chronic disabling pain. The — the issue of under treatment can only be clarified in those populations where already exists a clear consensus about the use of opioid drugs. So — so under treatment is typically discussed in terms of populations like those with cancer, those with AIDS, those with — with pain at the end of life. In those populations, the numbers suggest that — that greater than 40 percent of patients are under treated. The proportion who are under treated with opioids and have other disorders like low back pain or nerve pain, can’t be stated at this time because there is no broad consensus yet about what would constitute optimal care.

Lauren Neergaard: Uh-huh.

Dr. Russell Portenoy: However we know that — that physicians generally lack knowledge about opioid drugs. They overestimate the risk. They — they accept the stigma that’s surrounds these drugs and on the basis of that information, the inference is that these drugs are used much less than they (indiscernible) potentially should be used, even in those populations for which we don’t yet have a clear consensus.

Lauren Neergaard: Okay. Thank you.

David Joranson: can I add something to that?

Lauren Neergaard: Yeah.

David Joranson: This is David Joranson. It’s important to of course realize that this is coming as a matter of Federal policy, but in addition we need to remember that there are 50 states out there that have their own policies and enforcement organizations, some of which are quite committed to the principle of balance. For example, the National Association of Attorney’s General, but — from time to time there are concerns about enforcement actions that needs some clarification and this may help in that process as well.

Lauren Neergaard: Thank you.

Male Speaker: Other questions?

Operator: Our next question comes from Czerne Reid of Milwaukee Journal.

Czerne Reid: Hi, Patricia Good, you said that — the FAQs will be put in the hands of divergent employees and medical professionals. But what realistically would do you expect that this document will accomplish? Information is there but how are you going to measure, what it’s accomplishing, you have a sort of evaluation process in place for just measuring what the effect is?

Patricia Good: Oh, within DEA, our goal is to make sure that we have adequately trained our own personnel to the sensitivities that many mentioned that perhaps they believe DEA doesn’t quite get it that addiction and physical dependence are not the same things. This is an effort to — re-emphasize that even though we have trained everyone in that regard, this is — this is putting it right in front of them in writing, in black and white. What is more important and what we are probably cannot measure as well other than through what we see in the press is this aura of fear that is often attributed to DEA but in reality is — it’s much broader than that. DEA has about 500 investigators nationwide and if you were to read all the accounts of, all the — all the awful things we have done, we would need 5000 people. I think there was a much broader network of people involved in investigations. And we want to make sure that you all understand good treatment, so they will recognize bad treatment when they see that was — bad — when there is not treatment but you know, drug abuse and drug diversion and not confuse the two. So we are really trying to get a philosophical message out to every one who is involved in the investigative field and I — I don’t know that we have a tool to measure outside agencies and the effectiveness are — are probably our primary result will be in a public relations type of appeal and a measurement.

Czerne Reid: So you are saying, you are just putting the message out but — and just hoping people get it, but we have no way of knowing whether people are getting it?

Patricia Good: Well, we are putting it out, so we are building it out into the registration system for physicians to get the information. We are conveying it to every organization that represents investigative and prosecutorial efforts. We are probably going to start some onsite educational campaigns of our own, so are we making sure they get it, we making sure they get it. Yes, whether they embrace it and understand it is probably not some thing that any one can ever control, but information is power and we intend to give it to them.

Czerne Reid: Right. And so this will be mandatory, for you said — you mentioned registration of physicians and so on. So this will be mandatory.

Patricia Good: It will be provided to them at the time they apply.

Czerne Reid: okay.

Patricia Good: Has to really think it is just information being provided.

Czerne Reid: Okay — okay. Can you tell me what disagreement, for your working you know, physicians and pain policy people, drug enforcement — what disagreements did you guys have among yourself in the principal working group, when you were trying to put this together? Did you guys have any major issues where you –?

Dr. Russell Portenoy: Well — well the document — the document went through a process, that started of with a request — a broad request out to the medical and law enforcement community for what might be important questions.

Czerne Reid: Uh-huh?

Dr. Russell Portenoy: And there was a lot of agreement about that, you know every body seemed to know what the questions where and then the writing of the the writing of the answers for the questions were assigned to a writing committee. That was actually larger than the four of us and it included a variety of others who don’t need at this to write the answers. And then there was an editing process that is probably amounted to about eight iterations of the document, I think I don’t know if my colleagues - correct me if I am wrong on that, but many added (indiscernible) back over and over again so the final result was almost sculpted. There wasn’t any at least from my perception, there wasn’t any major disagreement, a barrier to getting this done, a stumbling block. What there was, was a tweaking of revision and again it was from my prospective as a physician it was an interesting process because the constructs that I live with every day are obviously different than constructs that people in law enforcement live with every day. And so the way we use language is a little different, the way we review information may be a little different. And there has been such a schism between the law enforcement community and the medical community for a such a long time over this issue that– that you know you wouldn’t be surprised that a paragraph would have to go back and forth in order to make sure that the edits are comfortable to everybody. So unfortunately I can’t — and I’ll let my colleagues jump in — I can’t point to an issue and say well there was a — there was a breach on this one. I don’t really think that happened, but there was iterative process where in the mindset of law enforcement and mind set of the medical community came together in providing single answers to very common questions.

Czerne Reid: And perhaps Dr. Portenoy, what are the implications of this action for the use of medical marijuana? Is this — is this sort of setting some precedents with respect to (indiscernible)?

Dr. Russell Portenoy: I don’t think that — I don’t think that this is specifically setting a precedent or making a statement about medical marijuana, but I will say that the — that the principle — the principles in this document which I would call bringing balance down to the bed side, apply to the — the issue of other potentially abusable prescription drugs (indiscernible), we have a (indiscernible) as available as a prescription drug. Obviously, we don’t have marijuana, what will happen with that I don’t know and — and wouldn’t try to predict but the bottom line is that even with the (indiscernible) now available on the market, just like (indiscernible), just like with (indiscernible), just like with (indiscernible), any control prescription drugs currently on the market, should be addressed by clinicians with the same respect for the principle of balance. We need to say that you do what’s best for the patient but with cognizance of the responsibility to monitor risks with respect to these issues of abuse and addiction and diversion and the responsibility to society at large to make sure that the use of the drug doesn’t lead to diversion and irrespective of what the drug is that is going to apply.

Czerne Reid: Thank you.

Operator: Our next question from some Mark (Koffman) of the Washington Post.

Mark (Koffman): Thank you. The first question just a (precedal) one. Do you folks plan to put your opening statements online, so that we could have them available?

Dr. Russell Portenoy: Not that I know of.

Carol: This is Carol. I wanted to let you know that the transcript from the entire thing will be up within 48 hours on the same web site where the press kit is.

Mark (Koffman): Okay.

Carol: Thank you.

Dr. Russell Portenoy: Okay the answer is yes.

Mark (Koffman): Okay but — but too late for it to be of use for us. That the question that I have — has to do with hydrocodone which, is my understanding the DEA is interested in rescheduling. And did that issue come up and do you folks see that as a part of this whole discussion as — as I again — as I understand that the DEA wants to tighten the scheduling there, make it more difficult to — for doctors prescribe it and for patients to get it. And I think that a lot of doctors disagree with that.

Dr. Russell Portenoy: Patricia, do you want to start?

Patricia Good: Sure, I can start on. When we wrote this document on we were discussing opioids and it wouldn’t — irrespective of what schedule they were in. And the — the document does not distinguish so — so what would apply regardless of whether we are talking (indiscernible) in schedule three where the hydrocodones are now or the schedule two opioids — which most others are already in schedule two. With respect to placing hydrocodone products in schedule two, as you know that — that is a process that’s generated through a petition that DEA received to move in that direction. It’s quite a long process, it’s overall HA just for review and regardless of what schedule the drugs end up in, the requirements for writing a prescription may be a little more detailed in terms of it has to be in writing and it — it can’t be refilled. But it does not truly make it any more difficult to obtain the drugs in our opinion and — and that’s not our intention.

Male Speaker: David did you want to comment?

David Joranson: I think that Pat’s explanation of the process is excellent and there is a division of authority between law enforcement and medicine at the — for federal scheduling actions. And I think it’s going to remain to be seen what the outcome is of that medical review. I think they will have to take into consideration whether indeed there is a practical matter or the lack of refills or the requirement for a written prescription would have an effect — a negative effect on patient care.

Mark (Koffman): And Dr. Portenoy, do you have any thoughts on this as well. Again the context here was as — as I understand that this is — you know these guidelines are supposed to bring kind of balance and — and greater clarity, as I understand that at the same time there is this outstanding issue of what’s going to happen to the largest class of opioids. And if it is rescheduled, as I understand it, many in the medical profession believe in the — in the pain medicine profession believe that that would make things much more difficult and make it more open to the same kinds of problems that we have seen with the — with the oxycodone and so on.

Dr. Russell Portenoy: Yeah, you know I almost view frankly the — the process of generating this educational material and the process of decision-making concerning a drug like hydrocodone as being — as being distinct. Whatever has — ends up happening with hydrocodone, in this review process the physician who has to prescribe an opioid, whether and regardless of the schedule has to — has to make judgments based on the medical evaluation and those judgments have to be informed by knowledge of the regulations and the laws and also informed by a risk assessment focussed on a kind of risk that — that doctors generally have not been trained to perform before, which is the — the risk of abuse and addiction. And — and what we try to convey in this educational material is, it doesn’t matter whether the drug is — is placed in one schedule or another after review. What matters is does the drugs fall into a category known as a control prescription drug which are inherently — potentially abusable by a sub population of patients. And that pharmacology — that reality drives a certain set of responsibilities that’s physicians by and large in the past, haven’t understood they have to own. And — and so I think you know, whether this ends up being — whether hydrocodone ends up being scheduled two or schedule three. But this — this is still a very — this is a very valuable document because it basically tells on medical side any way — because it basically tells physicians that you have to own this — this responsibility to know about the medical as well as to know about the issues of risk assessment and management, including the impact of laws of regulations.

Mark (Koffman): And with the final question, primarily productive (indiscernible) I’m sorry (indiscernible) and Dr. Portenoy, from your perspective does this document — kind of bind DEA to — to a kind of behavior that is in anyway different than what we’ve seen in the recent years?

Male Speaker: That — I think that’s really a question that Pat should answer.

Mark (Koffman): Well I think that she has already she has already said that — that this was a clarification but that — and that there was information that was going to be given to other law enforcement agencies but that there is nothing that would be a new policy direction from their perspective and correct me if I’m wrong.

Male Speaker: Okay, I see what you mean. As a matter of policy, I don’t see a difference but I think one of the valuable elements of DEA endorsing this policy is that there is a clear distinction then, between the use of opioids and for pain and the phenomenon of addiction as is expressed in the definitions. At the same time for the medical profession, there is recognition by the medical experts and this is part that the medical people drafted not DEA that there is a need to develop skills in the area of risk assessment to avoid contributing to diversion. So in that sense, the key message I think, which is perhaps new for some people, both in medicine and in law enforcement and regulation, is that we have these symmetrical kinds of responsibilities. Pain medicine is not to contribute to abuse and law enforcement is not to interfere in patient care. And I think that is a new message even though it’s embedded in — in the law and general practice. It hasn’t become as visible as we are trying to make it now, in an effort to draw attention to it and to exhort people in the professions as well as in enforcements and regulations to think about these things more carefully, as there go about their daily duties.

Mark (Koffman): And I would only add that — that you know, as a person who does program development and administration, this is an important recognition that having policies is only the first step in order to achieve what you want to on the front lines. Policies provide the parameters but then you need to create a culture that respects the policies. And you need to create guidelines and resources, so that people know how to act overtime and then you need to have corrective actions as well. And I think part of what you see in these — in these FAQs is the spirit of, let’s get it down in black and white, let’s get it right and, let’s show that we are all in the same page, that we are all willing to endorse the same set of principles and whether or not that already exists in policy, it has value and it should be done repeatedly overtime if we want to contribute to a positive culture where — where isn’t an appropriate (indiscernible) on the part of prescribers and there isn’t inappropriate behavior on the part of law enforcement too, is not at the high leadership level but it’s out there on the front lines. They need reinforcement overtime as well, to act in a way that’s consistent with policy. So this document is an effort to get it right, get it in writing, get it out there for people to see and get it out there in a way that shows them that we are on the page. Law enforcement on the one hand and the medical community on the other, about this issue of balance.

Mark (Koffman): Thank you.

Male Speaker: I could add to that too — as an example of some of the next steps that could occur, that Czerne Reid was asking about a few moments ago. Perhaps, the state conferences on pain management and on law enforcement in the near future could begin to incorporate a discussion of this document and the principle of balance into their conference and meeting agendas.

Male Speaker: Other questions?

Operator: Our next question comes from Rita (Rueben) of US Day to Day.

Rita (Rueben): Hi, I am — this kind of picks up where you just left off, Mr. Joranson and you mentioned earlier during your opening remarks, I am just going to read it back to you. That — talking about the conception that withdrawal is addiction and that is even reflected in some state laws and regulations. And I wondered if you could, may be expand on that a little and I am just curious of are there any states in particularly using, do you have laws and regulations that they kind of have a chilling effect on proper treatment of pain?

David Joranson: I think so, the pain and policy studies group has over the past several years, with support from the (Robertwood Johnson) foundation kind of developed a methodology for evaluating state and federal laws regulations and other governmental policies, which includes one of the — which is based on the principle of balance and which includes several criteria having to do with whether a state policy has the potential to confuse pain management and addiction or whether it has the potential to clarify that they are different. And we have identified policies like that throughout the country and various states and these appear in documents that are published on our web site — that pain policy web site that was mentioned earlier. And so there are a number of states that have definitions that are — define terms like addiction or drug dependence which are about the same as including physical dependence and which is a phenomenon that occurs when a chronic pain patient uses opioids over a period of time and this really isn’t drug dependence/addiction. Yet these two concepts have been repeatedly confused because some of the original definitions from expert bodies decades ago, did in fact make these confusions. That is what they thought.

Rita (Rueben): Uh-huh.

David Joranson: We don’t anymore and we are trying to identify the policies that caused that problem today.

Rita (Rueben): I looked at your web site but I just want to — I mean what proportion of states do you think still have outdated policy, laws, regulations and — and you know are you hopeful that this document may have some impact on the states?

David Joranson: We are hopeful with this would have some impact on the states, particularly with — with your assistance. But I was just checking with staff here and we think that is approximately 20 states that have policies that would can have the potential for confusing pain management with addiction.

Rita (Rueben): Thank you.

David Joranson: I can list those states for you. If you want to contact us directly.

Rita (Rueben): Okay, great thanks.

Operator: Our next question comes from Derrick Berry of American Pharmacists.

Derrick Berry: Yeah, hi. I have a two-part question. Just wanted to find out how much input that you have got from pharmacists in developing the FAQs and the second part would be how can pharmacists help in the process of pain management in your opinion?

Male Speaker: In terms of the first question, I know Carol is on the phone and Carol do you — can you tell us in the writing committee about the pharmacist’s issue?

Carol: There was one pharmacist on our review committee as you look at the neutral (indiscernible) he has listed, (indiscernible) is listed in the review committee.

Derrick Berry: Okay.

Male Speaker: And — and concerning the second question, I can start with that. I think pharmacists play a very critical role and can be part of the problem of our dissolution. In terms of communicating with patients, the potential for pharmacists to — to provide mis-information or increase the fear of patients or even discourage patients from using medications that are appropriate, exists if the pharmacist is not educated about exactly what we have included in these FAQs. On the plus side, an enlightened pharmacist can be very re-assuring and can treat a patient with the kind of respect that — that the taking of these pigmentised drugs often seems to just strip away. And — in totally — I can tell you that — that speaking for myself and also hearing anecdotally from many other physicians there are patients who commonly have the experience of — of — of — going to a pharmacy and if you are finding it to be negative — because the pharmacist is either implying or — or stating directly that the therapy is inappropriate, that it is dangerous, not respecting the patient’s privacy around the therapy and this — and this sort of — this sort of behavior need not happen if the pharmacist was educated. There is also — there is also a movement to — to engage professional pharmacy practice in a more collaborative role and to have pharmacists who are educated enough about opioid pharmacal therapy to actually contribute in a very positive way to drug selection and titration, management of side effects and the monitoring of patients. And these practices as — as I am sure you know are popping up around the country and — and when they are done well, the feed back about them has been very positive. So pharmacists have great potential — pharmacists have great potential to — to contribute to the solution here. And — and the hope is that this information can get out to them as well as — as well as other information that would come through professional societies and — and the states.

David Joranson: I would like to add to that. This is Dave Joranson. Actually there were two pharmacists on the project. (Hart Lipman) as well as Michael (indiscernible), who was representing the American Pharmaceutical Association and (indiscernible) as described, what the issues are here and what the potentials are, very well. In addition, we would like to be able to encourage physicians and pharmacists to have a dialogue whenever there is a question about the legitimacy of a — legitimacy of a prescription so that a pharmacist feels free to call and is received well by the physician.

Male Speaker: Other questions?

Operator: Our next question comes from Myra Christopher.

Myra Christopher: I am Myra Christopher. I am the president and CEO of the Center for Practical Bio Ethics Center. And I have had the opportunity to work on this issue with our speakers and others today. And I want to congratulate you on this wonderful document which I believe really will push the — our efforts forward to have more balance to policy. It does seem to me that the fear and paranoia that Pat referred to is still a huge barrier to accomplishing our goals of having balanced policies and that we are making progress. I think David mentioned the work of the National Association of Attorneys General and I — I am excited about their efforts to make sure that the rights of consumers to receive good pain medication is going to be protected by those — those officials as well as the new guide lines for the Federation of State Medical Board. So I — I feel like that we are making tremendous progress. But in my experience, one of the major barriers continues to be balanced reporting and so I am so pleased about the people here on the call and the questions that I have heard. I am curious about — and I would ask the organizers of the conference, what the response has been by the media invited today? How many where invited, how many are participating and — and in addition what are — what other efforts will there be to reach out to the media and the press about this document?

Male Speaker: Carol, could we ask for your help with that?

Carol: Myra, this is Carol. We have reached out extensively, not only to media but beyond. The point of doing the document was to get it into as many hands as possible as Pat Good has mentioned and — and everyone on the call. So we are going to be sharing it via e-mail. And a print version in October will be available from the DEA. That’s — that’s the extent at the moment.

Myra Christopher: And those of us, who have the tool on hand now, are we free to distribute it within our network?

Carol: Absolutely.

Myra Christopher: Okay, great. Thank you.

Male Speaker: Thank you.

Operator: Our last question comes from Jennifer Lobb of National Pain Foundation.

Jennifer Lobb: I have a question more from the patient perspective. What sort of suggestions do you have for patients regarding this perception of doctor shopping or how are you planning on — is there any plans to translate this in sort of a patient awareness tool?

Dr. Russell Portenoy: This is Russell Portenoy. There are no plans at this point to that I am aware of to turn this into information for patients specifically. Although I will say that having it on the web, gives it great potency. For example, one of the web sites on which it will be posted is stoppain.org which is the web site of my department at the Geo medical center and we we receive about 18,000 unique visitors and 800,000 heads per month, the vast majority being from the public who can now click on this information. And — and so that the — the possibility that the information in this document will have — will have legs far beyond the medical community and the law enforcement community is there. And I think that’s very important because — physicians and pharmacists or clinicians are — all have to function within these parameters that are set by conventional medical practice and an awareness of the laws and regulations that regulations that govern these control prescription drugs and to the extent that patients have an appreciation for that. I think the possibility for a better therapeutic alliance is there. Physicians sometimes act in a way that patients may perceive to be capricious or punitive or idiosyncratic when — when actually it’s just the — the process is one the physician has adopted to make sure that he or she is acting with the right kind of documentation and within the parameters of the — of the regulations that exist. And so even though we don’t have any specific plans, my hope is that it’s out there, it’s in the public domain, the language is readable, the — the patient advocacy groups hopefully will begin to let people know that they will get this information on the web sites and it will part of a gradual culture change that patients obviously have to contribute to if they are going to benefit from it.

Jennifer Lobb: Follow up question. Some of the education we provide for patients — for example bringing a list of medications that you have previously tried, not giving up — trying to find physician who understands the issues related to chronic pain can be seen as contradictory in terms of doctor shopping — doctor shopping or drug seeking behaviors. What would be some suggestions that you or the DEA would have patients in terms of trying to final up right treatment for their problem?

Dr. Russell Portenoy: Again this is Russell Portenoy. You know, I think the behavior is right. The interpretation can sometimes be wrong. There is clearly a difference between doctor shopping for the purpose of identifying a physician who will write up a specific prescription and — and having multiple consultations until there is there is an ability to click with the physician who is willing to take pain seriously. And you know there are nuances there and there is a grace (indiscernible) there. And what I would suggest is that patients should be educated about the difference and that — and that if they are seeking a consultation, in order to identify a physician who will take their pain seriously, they have to understand that each consultation will involve a history and a physical examination and sometimes some additional tests that each physician will request prior records not just a list of medications they have been on but prior records that each physician is — is going to want to have a relationship with the patient as a — as a foundation for making therapeutic decisions and so, the decisions about prescribing control prescription drugs which — drugs may not be on their first visit. And — and I think patients who go into the process with the recognition of — of how physicians have to work when they are being responsible. Well, hopefully be — be viewed and will act in a way that will help people view them as merely seeking an appropriate — an appropriate physician as opposed to seeking a specific treatment. And — and thereby being open to the interpretation of doctor shopping. Anybody want to add to that?

Male Speaker: I would add one thing. I think that both patients and clinicians who sometimes benefit from knowing what the State’s policies are in this regard, for example some states have passed laws or regulations or guidelines that strongly encourage physicians to treat pain adequately and some other states have passed laws that address patient’s rights in this area that a data base of the full text of all those laws, regulations and policies at the state level is on that — pain policy web site. It’s called a database. You can find it on the left-hand site guide. In addition, I suppose just as — speaking as a person who might have chronic pain someday, I think my main advise for pain patients is if your doctor doesn’t seem to be taking your pain seriously, try one more time and then find another doctor.

Jennifer Lobb: One final question. We are seeing more and more patients asking us for advise with previous addiction issues but who now have legitimate chronic pain problems. Are there any sort of guidelines in the works or thoughts about developing guidelines for treating patients who have legitimate chronic pain problems and but also previous addiction issues?

Male Speaker: Yeah. This is — this to me is a good news — bad news story. The good news is that there is now beginning to appear some data which show that the problem of chronic pain and patients with the history of addiction or abuse is a major problem, that under treatment is more likely in the population that is identified as having — had the problem of abuse than in other populations and that the — and that the knowledge of practitioners who are treating those patients such as the practitioners who work in (indiscernible) maintenance treatment programs, is not adequate to handle chronic pain. So the problem has been identified, there is also a good news in the — in the sense that the American Society of Addiction Medicine is trying to educate addiction medicine specialists about the points of pain management and provide some guidelines for treatment. And there are individual programs around the country. There is also a recognition on the part of NIDA who is seeking grants as an RFA out to seek grants that will look at the issue of any chemical dependency. So, this — this issue which to me was — was really hidden from view for decades as if it was a non issue and in fact is a huge issue, is now coming out as — as something that we are going to how to deal with, in a society with addiction and abuse as prevalent as it is. Because the patients with addiction and abuse too get severe chronic pain as well as acute pain and — and they deserve to be treated just as any other patient does but they require a special attention and a skill set. The bad news part of the story obviously is that ability to attend to those patients, that skill set required to treat them, that willingness to treat them if they have chronic pain is not widely available yet in the United States. So, I think we just have to try to keep the pressure on and if - if the — the media can be helpful in highlighting the problem that these patients face, that would be a good thing because the — the progress that is needed for that specific sub-population is — is very great.

Male Speaker: Russell, could I add to that — that the FAQ specifically recognizes the legitimacy of the use of opioids for the treatment of chronic pain and people with the history of substance abuse, recognizing as you said of course, that are some more complex phenomenon, requiring input from pain and addiction medicines specialist. But it’s — it still would be considered legal and accepted medical practice. And further a number of the guidelines issued by state medical boards based on the federation of state medical boards model, also recognized the legitimacy of this even though surveys have shown that many regulators tend to view this as not being accepted medical practice.

Jennifer Lobb: Thank you.

Male Speaker: I would like to thank you all for joining us this morning. We are really delighted that you are here. We think this is important and — and your willingness to take time out to listen to us and ask some questions are really a makes us feel good about having volunteered the time and effort to create this thing so, hopefully with your help, it will be disseminated widely. And it will evolve over time and be at least one little part of a — of a process that has to take place in order to improve the use of these drugs in the in United States. So thanks very much.

Operator: Ladies and gentlemen, this concludes today’s conference. You may now disconnect. Have a wonderful day.