Conversations With. The Honorable Dick Thornburgh The Honorable Rudolph W. Giuliani. The Issue: Prescription Drug Abuse

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1 Conversations With The Honorable Dick Thornburgh The Honorable Rudolph W. Giuliani WINTER 2005 The Issue: Prescription Drug Abuse In this edition of Washington Legal Foundation's CONVERSATIONS WITH, former New York City Mayor and former United States Attorney Rudolph W. Giuliani discusses the abuse and diversion of prescription medications with former U.S. Attorney General Dick Thornburgh. The focus of the conversation is on the work of a consortium of private and public entities he chairs the -Rx Action Alliance - which promotes greater public awareness of the various issues at stake. As Mayor Giuliani's comments emphasize, it is critical that policy makers and others involved in the debate understand that a balance must be struck between addressing illegal abuse and ensuring that patients still have access to lifesaving drugs. Governor Thornburgh: Let's start out by discussing the Rx Action Alliance which you chair. Who's involved with it, and what are its goals? Mayor Giuliani: The Rx Action Alliance is a consortium of leading healthcare professionals, patient advocacy groups, law enforcement associations, educators, and pharmaceutical manufacturers who share a concern for the need to address the public health problem of prescription drug abuse and the need to ensure appropriate access for patients to vital prescription medications. The primary goal of the Alliance is to promote a balance between these concerns by increasing public awareness and improving understanding of the various issues at stake. We have to do everything we can to stop the abuse and diversion of prescription drugs, but we also have a responsibility to protect the rights of patients to have access to these life-saving medications; we must be careful not to limit our ability to help those who are suffering as we attempt to solve problems of abuse. The Alliance is dedicated to a balanced approach for finding effective solutions. Governor Thornburgh: What was the genesis of putting this effort together? How have your personal experiences and work as a federal prosecutor and Mayor of New York informed the creation of the Alliance and your work with it so far? Mayor Giuliani: The concept for the Rx Action Alliance grew out of the work of our consulting firm, Giuliani Partners, with one of our clients, Purdue Pharma. Purdue produces one of the most effective pain management medicines in history, which helps millions of people around the world. Unfortunately, this medication, along with a number of others, has been significantly abused in some communities, and has caused real harm in parts of our country. As you know, prescription drug abuse is not a new problem, but it is a complex problem, and it is very important that the right approach is taken in addressing that problem. Balance is the key. As U.S. Attorney for the Southern District of New York and Mayor of New York City, I had a number of opportunities to see drug abuse from a law enforcement perspective, and I know how important it is that we fight illegal drug use and protect our children and our neighbors. As a cancer survivor, I understand the pain and distress that accompanies illness, and I Dick Thornburgh Kirkpatrick & Lockhart Nicholson Graham LLP Rudolph W. Giuliani Giuliani Partners LLC WLF publications are available on Lexis/Nexis

2 THE ISSUE: PRESCRIPTION DRUG ABUSE We must address both sides of the issue. If we focus only on fighting prescription drug abuse - at the expense of patients in need - we will be ignoring half of the problem, and we will be missing the real solution. know that proper medications are necessary for people to treat their sicknesses and improve their quality of life. We must address both sides of the issue. If we focus only on fighting prescription drug abuse - at the expense of patients in need - we will be ignoring half of the problem, and we will be missing the real solution. A balanced approach to the problem is necessary in order to both prevent drug abuse and continue to provide appropriate and effective care to the millions of patients who rely on modern medicine to improve their lives. A critical aspect in addressing any problem is good information. As both Mayor and U.S. Attorney, having the best information available was crucial to all decisions that we faced. A primary mission of the Alliance is to increase the understanding and awareness of the important issues surrounding prescription drug abuse in order to help patients, doctors, policy-makers and law enforcement officials make the best decisions and to ensure the best outcome. Governor Thornburgh: As you've pointed out, a large part of addressing the abuse and diversion of prescription drugs is understanding the problem. Please summarize for us the nature of the problem. Mayor Giuliani: As I mentioned, prescription drug abuse is a significant public health concern and the problem is going to get worse if not addressed properly. It affects many people in terrible ways. Those who abuse prescription medications destroy their lives and the lives of their families. Alternatively, when patients who are suffering can't get effective treatment, or treatment at all, it has a devastating impact on the individual and on their loved ones. Sometimes, the lack of effective treatment of a disease can lead to unintentional misuse of medications. We live in a time when advancements in medicine have given us the tools to help people who are suffering, and for many, the best options are strong prescription medications. At the same time, these medicines carry a great risk, which is why they are designated as controlled substances by the government. Prescription drugs are, as we know, abused or diverted to illegal markets. We have to address the sources of diversion, we have to prevent the abuse, and we have to make sure patients in need can get proper treatment. Governor Thornburgh: Who should be targeted as the facilitators of the abuse and diversion? Mayor Giuliani: That's one of the questions the Alliance is trying to help answer. We need to better identify and understand the sources of diversion. You can't place blame on any one group. There are the drug dealers and basic criminals who steal medications and sell them on the street. International drug smuggling and Internet pharmacies illegally supply prescription drugs. There are physicians who are victims of patient fraud. Unfortunately, there are also a few physicians who break the law. We have to further investigate each of these areas to address them effectively. Governor Thornburgh: There seems to be a lot of uncertainty over what constitutes "addiction" to medications versus concepts like "dependence." How do misunderstandings on these issues impact our ability to address prescription drug abuse? Mayor Giuliani: You've mentioned an example of a key misunderstanding. There is a significant difference between physical dependence and addiction. Although the two phrases are often used interchangeably, they are distinct. Physical dependence is a condition where one's body has become so accustomed to the presence of a drug that when the drug is no longer present, the body must adjust to its absence. In contrast, addiction is a disease where the individual has impaired control and continues to use a drug despite knowing the harm it is Washington Legal Foundation

3 WINTER 2005 causing. Certain blood pressure medications, for example, create a physical dependence and can be dangerous when abruptly discontinued. But that does not translate into addiction. Similarly, a diabetic is physically dependant on insulin, but again, that is not addiction. As you can see from this one example, education is essential - without understanding the problem, we can't implement the right solutions. Governor Thornburgh: How will the Rx Action Alliance work to educate the public on the illegal use of prescription drugs? Mayor Giuliani: The Rx Action Alliance is working on a number of different ways to promote our message of balance. One way is the Alliance website at which has information on the Alliance, events, and links to our member organizations. Additionally, many members of the Alliance, such as the Washington Legal Foundation, have wonderful outreach programs, resources, and publications which help get the message out. Another one of our projects is the creation of a library of information and resources related to prescription drug abuse. Academic work, statistics, fact sheets, patient testimonies, regulations and other sources will make up a reliable clearinghouse of information on the subject. But this resource isn't just for doctors and policy-makers, members of the public will be able to access the clearinghouse on the website and gain valuable assistance in understanding this important issue. The Alliance is also involved in a number of research projects that will help bring us closer to finding answers to some of the questions we've been discussing here today. Governor Thornburgh: Let's talk a bit about the federal and state agencies and officials involved in the fight against abuse and diversion. Is there a risk that the Drug Enforcement Agency (DEA) could effectively curtail the proper administration of pain medication through criminal enforcement actions? DEA is currently examining whether to place more restrictions on the prescription and use of various pain killers and cough suppressants. Would this be an effective change in policy? Mayor Giuliani: The DEA has significant responsibility here. Law enforcement and regulatory agencies, including the DEA, need to effectively address the prescription drug abuse problem in this country. However, they also need to keep the patients in mind, and allow physicians to provide the best treatment they can for their patients. Again, a balanced approach is necessary. I believe the DEA understands the complex nature of this issue. Regulation is an important tool. Increased regulation may be one way to help win this battle, but, as I have said, it needs to be only a part of a balanced solution. The right regulations, that do not hinder patient access to necessary medications, can have a considerable positive impact. Governor Thornburgh: Let's focus for a moment on the agency that approves these drugs, the FDA. At least one pain medication producer has worked with the FDA to implement and utilize risk-management programs to help reduce diversion and abuse of their products. Are these plans effective and do you think the FDA will be encouraging producers of other frequently abused legal drugs to adopt and utilize them? Mayor Giuliani: These risk-management programs are a great step in the right direction to help prevent abuse and diversion of prescription medications. The FDA should encourage the use of risk-management plans for all drugs in danger of being abused. It is essential that the government work closely with the pharmaceutical manufacturers to address the problem. The only way we will Washington Legal Foundation 3

4 THE ISSUE: PRESCRIPTION DRUG ABUSE succeed is to work together. I hope that the Rx Action Alliance will help foster even more cooperation among regulatory agencies, the health care community, patients, and pharmaceutical companies. Governor Thornburgh: What role is the White House and its National Drug Control Strategy playing in the battle against prescription drug abuse and diversion? Mayor Giuliani: The President's National Drug Control Strategy is crucial to the battle against prescription drug abuse and diversion. The Strategy coordinates the efforts of the various Federal agencies involved and puts the vast resources of the Federal government behind reaching one goal. It is very important that the President has taken such an active approach on this issue. The Strategy itself is also significant because it recognizes both the need to address prescription drug abuse and the need to protect patients' access to these medications. The concept of balance that we have been talking about is incorporated in the President's plan, and this helps to ensure that whatever actions are taken will reflect a balanced approach to the problem. The goals of the Rx Action Alliance are consistent with the National Drug Control Strategy, and we look forward to working with the Bush Administration on finding solutions to this difficult problem. Governor Thornburgh: Another layer in enforcement of non-medical use of drugs is state and local law enforcement. Where do they fit in? Mayor Giuliani: State and local law enforcement agencies are the first line of defense against abuse and diversion. It is extremely important that state and local officials have the right information and resources to address these issues. Coordination between local, state and federal law enforcement is critical. Governor Thornburgh: How much of a role does the Internet play in illegal sales of abused prescription drugs? What options exist for law enforcement to address such sales? Mayor Giuliani: We're not sure yet how great a role the Internet plays in illegal prescription drug sales, but we do know that the Internet is one of the most dangerous places to buy any kind of prescription medication. The controls on the Internet are not fully developed and law enforcement challenges are considerable. Nevertheless, emerging methods are very promising and we are applying them with coordination and effectiveness. As with many things in law enforcement, monitoring the Internet for prescription drug diversion is a difficult task, but we are working on it. Governor Thornburgh: Obviously a greater understanding in the medical community is also critical. What has been done to expand doctors' and other health care providers' knowledge, and what more can be done? Mayor Giuliani: Another goal of the Alliance is to increase the focus in medical schools and continuing medical education programs on both the proper prescribing of medication and prescription drug abuse. In treating their patients, doctors need to prescribe medications appropriately and they need to be able to recognize the signs of addiction and detect patient fraud. Most medical schools today do not offer classes that adequately address these issues. We need to do more to introduce the study of this subject earlier in medical education - in medical school, during residency - and in continuing medical education. Many organizations, such as the Federation of State Medical Boards, which recently issued a new model policy and guidelines for treatment with prescription medications, are already contributing to this effort, and we need to do more Washington Legal Foundation

5 WINTER 2005 Doctors want to help people and heal people, and we need to make sure that they have the right tools to do so. Governor Thornburgh: Do you feel that policy makers and law enforcement are grasping the Alliance's message that a delicate balance needs to be struck with legitimate patient access to pain medication and other critical prescription drugs? Mayor Giuliani: Over the last few years, issues of prescription drug abuse have received a great deal of attention and publicity. There has also been a great deal of effort to work with law enforcement officials and policy-makers on these complicated issues. This is an ongoing process, but I believe that many law enforcement officials and policy-makers understand how important access to these medications is, and we will be able to balance that with enforcement and regulation as we work to address this problem. As an example, and as we just mentioned, the concept of balance is encompassed in the President's National Drug Control Strategy. Governor Thornburgh: What is your perception of the importance of the media, in relation to the issue of prescription drug abuse and diversion? Mayor Giuliani: The media can play a central role in informing and educating people about these issues. A fair and balanced look at the various aspects of the problem by the media can help inform patients and policy-makers alike, and can help to make solving this problem a priority. Governor Thornburgh: Pain medication manufacturers have been the target of a growing number of class action lawsuits, which they have consistently and, thus far, effectively fended off. What impact can such lawsuits have on patient access, and how might they affect other abused prescription drugs? Mayor Giuliani: These class action suits can create barriers to patient access in at least two ways. One is that these suits can create fear in patients, based on misunderstandings, which can result in patients who need these medications being afraid to use them. The other is the potential chilling effect such suits could have on manufacturers. Millions of Americans are helped each year by the important medical advances in pain management. We do not want patients to give up the relief they need because of unfounded fears nor do we want to stifle the creativity and innovation of these companies. The class action suits focused on attacking pharmaceutical manufacturers are not a productive part of the solution to the problem of prescription drug abuse. Governor Thornburgh: Is there a concern that aggressive law enforcement can deter innovative drug companies from developing new, potentially life-saving products which may contain ingredients that are frequently abused? Mayor Giuliani: Pharmaceutical companies understand that effective and efficient law enforcement will help ensure that their lifesaving products are used properly. Law enforcement that succeeds in reducing abuse and diversion can only encourage pharmaceutical companies. Governor Thornburgh: One final question for you - what does the future hold for the Rx Action Alliance? Mayor Giuliani: We think the various projects of the Rx Action Alliance can significantly contribute to the current progress being made in addressing the issues of prescription drug abuse. We all have to work together to find a balanced solution; one that meets the healthcare needs of individual patients and also prevents abuse of these important medications. The Alliance hopes to continue to be a part of that effort. Class action suits focused on attacking pharmaceutical manufacturers are not a productive part of the solution to the problem of prescription drug abuse. abuse Washington Legal Foundation 5

6 THE ISSUE: PRESCRIPTION DRUG ABUSE Governor Thornburgh: Thank you for talking to us today about these very important issues. Mayor Giuliani: Thank you. Washington Legal Foundation s (WLF) seventh and newest publication format, CONVERSATIONS WITH, provides an occasional forum for leading experts from business, government, academia, and the legal profession to discuss current legal policy issues. In spontaneous and informal question-andanswer conversations, our participants give frank thoughts on a wide range of important contemporary subjects. Southern District of New York, where he spearheaded efforts against drug dealers, organized crime, government corruption, and white-collar criminals. From 1981 to 1983, Mayor Giuliani served as Associate Attorney General, the third highest position in the Department of Justice. To receive information about WLF publications, contact Glenn Lammi, Chief Counsel, Legal Studies Division at (202) or visit BIOGRAPHIES The Honorable Dick Thornburgh is a former Attorney General of the United States, Governor of Pennsylvania, and Under- Secretary-General of the United Nations. He is currently Of Counsel to the law firm Kirkpatrick & Lockhart Nicholson Graham LLP, and Chairman of Washington Legal Foundation s Legal Policy Advisory Board. The Honorable Rudolph W. Giuliani is Chairman and Chief Executive Officer of Giuliani Partners LLC, which he founded in January Mayor Giuliani was recognized in Spring 2002 as "Consultant of the Year" by Consulting Magazine. Mayor Giuliani served two terms as the 107th Mayor of the City of New York, elected first in 1993 and re-elected in 1997 by a wide margin. Prior to this, Mayor Giuliani served in a variety of law enforcement and legal positions. In 1983, he was appointed U.S. Attorney for the Washington Legal Foundation