UNITED STATES OF AMERICA
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
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ANESTHETIC AND LIFE SUPPORT DRUGS
ADVISORY COMMITTEE
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MEETING
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WEDNESDAY,
JANUARY 30, 2002
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The Advisory Committee met in the Holiday Inn, Two Montgomery Village Avenue, Gaithersburg, Maryland, at 8:00 a.m., Dr. Nathaniel P. Katz, Acting Chairman, presiding.
PRESENT:
NATHANIEL P. KATZ, M.D.
JIM ANTHONY, Ph.D.
MICHAEL A. ASHBURN, M.D., M.P.H.
JANICE BITETTI, M.D.
JEFF BLOOM
AMANDA S. CARLISLE, PH.D., M.D.
MARIA K. CONNOLLY, D.N.Sc.
PRESENT (Continued):
DEBRA FRIEDMAN, M.D.
KATHLEEN M. FOLEY, M.D.
ERIC S. HOLMBOE, M.D.
TERESE T. HORLOCKER, M.D.
BRUCE ALLEN LEVY, M.D., J.D., Guest
LLYN A. LLOYD, R.Ph.
MITCHELL B. MAX, M.D.
CHARLES H. McLESKEY, M.D.
LAURA F. McNICHOLAS, M.D., Ph.D.
WINSTON C.V. PARRIS, M.D., FACPM
RUSSELL PORTENOY, M.D., Guest
MARCUS M. REIDENBURG, M.D.
RICHARD G. ROBERTS
NEIL L. SCHECHTER, M.D.
MARK SCHREINER, M.D.
CHARLES SCHUSTER, M.D.
RICHARD M. SMILEY
JOSEPH R. TOBIN, M.D.
C O N T E N T S
PAGE
Introduction, Acting Chairman Katz 5
Introductory Comments, Bob Rappaport, M.D. 19
Public Comment:
John Giglio 23
Chris Mullikin 26
Lorraine Reeves 27
Nancy Kowal 31
Cheryll Cusimano 33
Rhonda Garrett 36
Dr. Swerdlow 39
Dr. Handel 42
Jim Broatch 44
Kathleen Anderson 47
Kathy McLaughlin 50
Dr. Michael Levy 53
Dr. Peter Wilson 56
Dr. Jeff Ramirez 58
Dr. Randy Merrick 62
Dr. Najib Babul 65
Dr. Art Van Zee 68
Jay Steffler 71
Dr. Glenda Dahlquist 74
Opiate Analgesic Development and Use:
Introduction, Bob Rappaport, M.D. 79
Pain Treatment Guidelines, Bruce Allen Levy,
M.D., J.D. 80
Opioid Therapy of Chronic Pain, Evolving
Trends, Russell Portenoy, M.D. 106
Opiate Analgesic Trials and Drug Development
Plans, Gerald DalPan 152
Opiate Analgesic Use in Pediatric Patients:
Introduction, Bob Rappaport, M.D. 224
Pediatric Analgesic Use, Debra Friedman,
M.D. 226
C O N T E N T S (Continued)
PAGE
Pediatric Exclusivity and the Pediatric Rule,
Bill Rodriguez, M.D. 248
Pediatric Opiate Analgesic Trials and
Development Plans: Case Studies,
Bob Rappaport, M.D. 263
Questions to the Committee and Discussion 279
P-R-O-C-E-E-D-I-N-G-S
(8:14 a.m.)
ACTING CHAIRMAN KATZ: Good morning. Can everybody hear?
I'd like to call the meeting to order. I'd like to thank everybody for coming. My name is Nathaniel Katz. I'll be chairing the meeting this morning.
This is the Anesthetic and Life Support Drugs Advisory Committee meeting. The topic for the next two days will be opioids. So if you're in the wrong place, you can make yourself aware of that right now.
Let me begin by again thanking all of you for coming and thanking the folks at the FDA for inviting me to participate in this meeting.
What I'll be doing first is I'll begin with a few moments of introductory comments to try to set a context for today's meeting.
The subject as you all know is opioids, and I'd like to just take a moment and provide a historical context for the discussions that we'll be having over the next two days.
As many of you may know, opioids have been used for therapeutic purposes for a long, long time. The first reports that we have of the use of opioids come from actually the first historical writings which were from ancient Sumeria in about 4000 B.C., and there were clear-cut writings then about the therapeutic of opioids.
And we have awareness of the use of opioids from most cultures since that time. Already in about 300 B.C., there was a vociferous argument going on in the literature where some people were saying, some physicians were saying that opioids should never be used because of their horrible side effects and complications, whereas others, including Galen in the 2nd Century A.D., decided that opioids should be used for everything because they cure all illnesses.
And since that time up until the present day, we've seen that the discussions of opioids have typically been framed in that context, where people have taken either one dramatic view or another one and have sort of shouted at each other over these gulfs.
And that applies up until the present day, I think, in the year 2002. Today I think we have an opportunity to start to discuss these issues in a different way in that we can actually in one of the few occasions in history start to have a rational discussion where we all try to understand differing points of view and get them all on the table so that we can inform each other and understand the issues rather than just shouting from our positions, and so that we don't take the risk of being like the blind men feeling the elephant where the one on the tail thinks that he's feeling a rope and the one on the leg thinks that it's a tree, and all of them suffering because they don't really see the whole picture. They just know what their one little part is.
So today and tomorrow what we're going to try to do is understand the whole picture.
So with that context, I'd like to set forth what the goals of the meeting are for the next two days, which are to share ideas about opioids with each other, exchange information, synthesize the whole picture for ourselves, help inform this division of the FDA about these issues.
What we're not going to be doing over the next two days or what the goals are not are necessarily to come to any consensus or agreement on some of the major issues. I think it will be enough if we can simply inform each other and understand these issues better.
The goal of this meeting is not to take any particular drugs off the market. It's not to focus on any specific drugs. We're trying to deal with the opioids as a class since they all share very similar properties; not to focus on any particular members of that class. We're not going to try to come up with any black and white prescriptions for what anybody ought or ought not to do about some of the issues that we'll be discussing today, but to really try to bring all of these issues to light and understand them better, and I'll look forward to the help and support of the Advisory Committee in achieving the goals of getting all of these issues on the tabled without necessarily being overly prescriptive if it's premature to do so.
So those are our goals, and I look forward to everybody's support in achieving those goals. There are a few housekeeping rules that I'll want to mention to help us achieve those goals. My main role will be to make sure that everybody gets heard today in the light of getting all of this information out there on the table.
And so in order to do that, we're all going to have to stay on time. So I'm going to be the big, bad guy that's rude and obnoxious when people spill over their allotted time. That will be particularly important for the public speakers.
We have a very packed agenda today. There were a huge number of pieces of information received for this meeting. The last count that I heard is that there were over 1,600 submissions of opinions to this meeting. When I asked how many more that is than one usually gets at a meeting like this, the answer was, oh, about 1,500 more than we usually get.
(Laughter.)
ACTING CHAIRMAN KATZ: So I guess there was a lot of excitement about this issue. So it's going to be very important for people to stay within their focus and within their allotted time, and I'll deal more with that later.
So I'll be the rude guy, and I'll ask for everybody's forgiveness in advance if I cut off your microphone or do something obnoxious like that so that everyone can have their opinions heard.
With that, I'll introduce Kimberly Topper, the Executive Secretary of the committee, who will read the conflict of interest statement.
MS. TOPPER: The Food and Drug Administration has prepared general matters waivers for the following individual special government employees: Michael Ashburn, Janice Bitetti, Richard Gorman, Eric Holmboe, Terese Horlocker, Mitchell Max, Laura McNicholas, Winston Parris, Marcus Reidenburg, Richard Smiley, Joseph Tobin, Nathaniel Katz, Llyn Lloyd, Maria Connolly and Amanda Carlisle, who are attending today's meeting.
The committee will meet in open session to discuss the medical use of opioid analgesics in various patient populations, including pediatric patients and patients with chronic pain of nonmalignant etiology, as well as the risk-to-benefit ratio of extending opiate treatment into these populations.
The committee will also discuss concerns regarding the abuse potential, diversion, and increasing incidence of addiction to opiate analgesics, especially to the modified release opiate analgesics.
The FDA is in the process of amending its policy concerning disclosure of financial interests to give rise to waivers for participation in meetings in which particular products are at issue. Unlike issues before committee on which a particular product is discussed, the issues of broad applicability, such as the topic of today's meeting, involve many industrial sponsors and academic institutions.
The committee members have been screened for their financial interests as they may apply to the general topic at hand. However, because of general topics' impact on so many institutions, it's not prudent to recite all potential conflicts of interest as they apply to each member.
FDA acknowledges that there may be potential conflicts of interest, but because of the general nature of the discussion before the committee, these potential conflicts are mitigated.
Should the discussion turn to issues related to a specific party matter, the Chair of the committee will either terminate the proceedings or redirect the discussion only to matters of general interest.
With respect to invited guests, the following are reported interests which we believe should be made public to allow the participants to objectively evaluate their comments.
Dr. James Anthony serves as a researcher and has contacts and grants from NIDA, NIMH, NIA, CSAT, CSAP, and NIJ. In addition, in the past, Dr. Anthony has given a talk for Purdue Pharma and has served as a scientific advisor for Star Scientific.
Dr. Steven Passik is a researcher on contracts and grants from Eli Lilly, Janssen, Ortho Biotech, Organon, and Pfizer. He consults for Eli Lilly, Janssen, Ortho Biotech. Additionally, he's the scientific advisor to Eli Lilly, Janssen and Adolor. He receives speaker fees from Eli Lilly, Janssen, Ortho Biotech, Organon, Pfizer, Purdue Pharma, Roxanne, and Knoll.
Dr. Richard Roberts is a scientific advisor to Pharmacia's Detro Global Advisory Board and the Pfizer/Pharmacia Bextra Primary Care Advisory Board.
Dr. Charles Schuster has consulted for Alza Corporation in the past.
Dr. Neil Schechter served on Astra-Zeneca's Speaker Bureau.
Dr. Mark Schreiner is a Medical Director for Children's Clinical Research Institute, AFSA (phonetic), and he's involved in clinical trials sponsored by Baxter Pharmaceutical, Sanofi Synthelabo, Novartis, Purdue Pharma, L.P., King Pharmaceuticals, Abbott and Glaxo SmithKline. He receives no direct compensation for the pharmaceutical sponsors.
Dr. Kathleen Foley in the past ten years has consulted with of the companies that make analgesic drugs. In the past year she's worked with Purdue Pharma, Janssen, Knoll, and Abbott.
She is also on the Speaker's Bureau for Purdue Pharma, Knoll, and Janssen. Additionally she is a Scientific Advisory for the American Pain Foundation.
Dr. Russell Portenoy has constituencies with Merck, Ligand, and Akros. He is also on the Speakers Bureau for Purdue Pharma and Janssen.
Dr. Portenoy also serves as Scientific Advisor for Cima Pharmaceuticals, Direct, and Chrysalis. Additionally, he reports involvements on contracts and grants with Parke-Davis, Boehringer Ingelheim, Elan, Ortho Biotech, Endo, Ametek, Medtronic, Purdue Pharma, Pfizer, Janssen, Abbott, Curatech, Ortho-McNeil, Elon, Pfizer, and Searle.
In addition, we'd like to disclose that Dr. Charles McLeskey is participating in this meeting as our industry representative acting on behalf of regulated industry. As such he has not been screened for any conflicts of interest.
In the event that any discussions involve any other products or firms not already on the agenda for which FDA participant has a financial interest, the participants are aware of the need to exclude themselves from such involvement and their exclusion will be noted for the record.
ACTING CHAIRMAN KATZ: Thank you, Kimberly.
What I'd like to do now is to do introductions. I'd like to go around the table and to have everybody on the committee and invited guests take a moment to introduce themselves, tell us who you are and what you do.
Why don't we start at that end of the table, please?
DR. KWEDER: Good morning, everyone. I'm Sandra Kweder. I'm the Director of the Office of Drug Evaluation II at FDA. What that means is my office oversees the work of the Anesthetics, Critical Care Life Support Division, as well as several others.
DR. RAPPAPORT: Good morning. I'm Bob Rappaport. I'm the Deputy Division Director of the Division of Anesthetics, Critical Care and Addiction Drug Products at the FDA.
DR. DalPAN: Good morning. I'm Gerald DalPan. I'm a medical reviewer in the Division of Anesthetics, Critical Care and Addiction Drug Products at FDA.
DR. MAX: My name is Mitchell Max. I'm a neurologist, and I do chronic pain clinical trials at the National Institutes of Health and the Dental Institute.
DR. LLOYD: I'm Llyn Lloyd. I'm the Executive Director of the Arizona State Board of Pharmacy.
DR. REIDENBURG: I'm Marcus Reidenburg. I'm an internist and pharmacologist, head of the Division of Clinical Pharmacology at Cornell Medical College.
DR. HOLMBOE: I'm Eric Holmboe. I'm a general internist from Yale University.
DR. ASHBURN: My name is Michael Ashburn. I'm the Director of Pain Programs at the University of Utah and at Primary Children's Medical Center in Salt Lake City.
DR. McNICHOLAS: Good morning. My name is Laura McNicholas. I'm from the University of Pennsylvania in the Philadelphia VA. I'm a psychiatrist specializing in the treatment of substance abuse.
DR. HORLOCKER: I'm Terese Horlocker from the Mayo Clinic. I'm also Vice President of American Society of Regional Anesthesia and Pain Medicine.
DR. SMILEY: Good morning. I'm Rich Smiley, Director of Obstetric Anesthesia at Columbia University.
DR. ROBIN: Good morning. I'm Joe Tobin. I'm a pediatric anesthesiologist and intensive care specialist at Wake Forest University.
ACTING CHAIRMAN KATZ: As I said earlier, my name is Nathaniel Katz. I'm a neurologist. I run the Pain Clinical Trial Center at Brigham Women's Hospital in Boston, and for many years I ran the Pain and Symptom Management Program at the Dana Farber Cancer Institute at Brigham Women's Hospital in Boston, as well.
DR. CARLISLE: Good morning. I'm Sue Carlisle. I am an anesthesiologist and intensivist and Chief of Anesthesia at San Francisco General Hospital in San Francisco.
DR. PARRIS: Good morning. I'm Winston Parris. I'm a pain consultant at the Tampa Pain Relief Center and clinical professor of anesthesiology, University of South Florida in Tampa.
DR. BITETTI: And I'm Janice Bitetti. I'm an anesthesiologist/intensivist at George Washington University here in Washington, D.C.
DR. McLESKEY: Charlie McLeskey, an anesthesiologist by training. I work at Abbott Labs and serving as industry consultant to the committee.
MR. BLOOM: My name is Jeff Bloom, and I'm a retired AIDS patient advocate since 1994. I retired with complications from myelopathy, and since 1994 I've been an AIDS patient advocate volunteer in Washington, D.C.
DR. PORTENOY: I'm Russ Portenoy. I'm a neurologist, and I'm Chairman of the Department of Pain Medicine and Palliative Care at the Beth Israel Medical Center in new York.
DR. ROBERTS: Good morning. I'm Richard Roberts. I'm a simple country doctor in Belleville, Wisconsin, where I'm a professor of family medicine at the University of Wisconsin.
DR. SCHREINER: I'm Mark Schreiner. I'm a pediatric anesthesiologist at the Children's Hospital of Philadelphia, and I'm the Medical Director for Children's Clinical Research Institute.
DR. ANTHONY: Good morning. I'm Jim Anthony. I'm a professor at Johns Hopkins, Bloomberg School of Public Health and School of Medicine. I direct a drug dependence epidemiology training program and am an epidemiologist.
DR. SCHUSTER: My name is Charles Schuster. I'm professor of psychiatry and behavioral neurosciences and the Director of the Addiction Research Institute at Wayne State University.
DR. FOLEY: I'm Kathy Foley. I'm a neuroncologist at Memorial Sloan Kettering Cancer Center, and I direct a project on "Death in America" to improve the care of the dying, and I am an expert consultant to the WHO for developing initiatives in drug availability in developing countries for the treatment of cancer and aids.
DR. LEVY: Good morning. My name is Bruce Levy. In my prior life I was an anesthesiologist and a pain specialist, but since 1993 I'm a regulator, and I was Executive Director of the Texas State Board of Medical Examiners for eight years. In the past year, until a few months ago, I was a Deputy Executive Vice President of the Federation of State Medical Boards of the United States.
DR. FRIEDMAN: Good morning. My name is Debra Friedman. I'm a pediatric oncologist at Children's Hospital and Regional Medical Center in Seattle, Washington, and I'm also a member of the End of Life Task Force for the Children's Oncology Group.
ACTING CHAIRMAN KATZ: Thank you very much, everybody.
With that I'd like to reintroduce Dr. Bob Rappaport, who is Deputy Director of the Division of Anesthetic Critical Care and Addiction and Drug Products, who will deliver some welcoming and introductory comments.
DR. RAPPAPORT: Dr. Katz -- can you hear me? -- Dr. Katz, members of the committee, ladies and gentlemen, I'd like to thank you for joining us here today to participate in what we hope will be an educational and enlightening experience for all of us.
The cover memo that Dr. McCormick included in the front of our briefing materials eloquently addressed the purpose of this two day meeting. Unfortunately Dr. McCormick is not going to be able to participate in this meeting due to a medical problem.
So I'm going to read from her memo some of the words with which I think she had hoped to unify our sense of purpose in this room.
This year begins the decade of pain. After a long struggle to raise pain management to a new level of importance among medical specialties and to begin to remove some of the stigmata associated with pain therapies, particularly the opioids, pain management will certain gain greater visibility in the next ten years.
Pain management guidelines are proliferating. Many states have adopted legislation to insure that quality of life and pain relief are taken into full consideration in the terminally ill patient.
There are many challenges ahead, and we have a great opportunity to continue this effort in a studied and responsible way.
There are newer and more elegant opioid formulations and drug delivery systems on the market and in the development pipeline. These have the ability to provide opiates to the patient in more convenient, palatable, and effective ways.
The awareness of the importance of good pain management has made its way into new populations, such as the pediatric treatment community. In spite of the difficulties in characterizing pain in the child and the infant and in conducting adequate clinical studies to assess proper dosing, the FDA will invite discussion about the unmet needs in this age group, the kinds of delivery systems and agents that might be appropriate at various ages, the risks of having these medications in the home where small children may have access, and how these risks should be communicated and managed.
Our hope for this meeting is that you as the experts in pain management and addiction treatment will provide the agency your views on what is need in the arena of drug development and risk management. It is our hope that you will bring the FDA up to date on your views regarding the unmet needs of the pain community and assist the FDA in thinking about ways in which we can carry out our mission responsibly with solid programs to develop good drugs while managing the risks associated with them, always keeping in balance the needs of the public.
Thank you.
ACTING CHAIRMAN KATZ: Thank you, Dr. Rappaport.
What we'll do now is we'll proceed to the public speaker portion of our agenda. I do want to go over a few housekeeping rules with our public speakers to make sure that everybody gets heard in a reasonable way.
Everybody from the public has three minutes to speak. There will be a light on, a yellow light for -- I'm sorry -- a green light for the first two minutes, and then a yellow light for your third minute, and then once that third minute is up, there will be a red light, and I understand also a very obnoxious buzzer will go off at that point in time, and then we can even cut off your microphone if you're still speaking beyond that point. Hopefully that won't be an issue.
And then we have even worse punishments for you after that that I'm not privileged to divulge at this point in time.
(Laughter.)
ACTING CHAIRMAN KATZ: So there is a list of all speakers that everybody should have. So if you see that you're up next and you're on deck, go sit in one of those speaker ready chairs, and there are some folks from the FDA who will help chaperon you to the right place so that we don't waste a lot of time blundering back and forth.
Now, all of the public speakers, you need to begin with your disclosure. So if there are any potential conflicts that you think people ought to be aware of, please lay those out right up front. Anybody funded your trip down here, any financial relationship you have, research relationships, if you belong to an organization that's funded by anybody in particular, please lay that all out right up front.
If you have no such disclosures, just say, "I have no disclosures." And if you begin your discussion without a disclosure statement, I'll probably rudely interrupt you and remind you that we need to hear that. And we do appreciate that.
There have been two cancellations from the original list that we had. So there will be two folks who will be able to be popped in from the top of the waiting list. That will be Dr. Babul today and Dr. Van Zee tomorrow. You'll be at the end of all of the regular speakers for today.
So with that, why don't we proceed?
MR. GIGLIO: Thank you.
I'm John Giglio, the Executive Director, American Pain Foundation.
We have received unrestricted grants from several pharmaceutical companies, some of whom make opioids, including Purdue Pharma. We also receive funds from nonprofit foundations and many individuals. Our single largest grant was from an individual who died in serious pain.
In our last fiscal year, we received approximately 60 percent of our unrestricted funds from industry. Purdue did not ask us to testify.
We are a national nonprofit that supports people with pain through information, education, and advocacy, including a Web site and a toll free number. In the last year we've logged several thousand calls from consumers.
We're the largest nonprofit representing the interests of consumers with pain, and our goal is to help people with pain get the care they need.
We're deeply concerned that in an effort to stop the abuse of Oxycontin, FDA and DEA will take steps that will severely hurt consumers who use opioids for legitimate medical purposes. As you know, for many people with moderate to severe chronic pain, opioids are the most effective treatment available and often the only one.
In the last few months, we've received requests for help from consumers. They've doubled, mostly as a result of fear from stories generated in the media. Many people are telling us that they're worried about being taken off their opioid medication, including products than Oxycontin.
Others have been telling us that doctors have already done so or reduced their dosage to an ineffective level. Still others have expressed concerns about becoming addicted to or even dying from their prescribed opioid.
On several occasions we have had people who were literally threatening suicide as they were speaking to us. Unfortunately most of the media reports fail to convey the other side of the story, that millions of people suffer from serious chronic pain; yet most go untreated or under treated, especially the elder, minorities, the poor, and children.
The fact is when prescribed appropriately by a physician and taken as directed, opioids are safe, effective, and rarely lead to addiction. They give relief and allow people to resume their lives.
We recognize that opioids are sometimes diverted by criminals and abused by thrill seekers and people with addictive disorders. We acknowledge that regulation is needed to minimize diversion and abuse, and we agree that those who produce, prescribe, and dispense opioids must understand these risks and comply with all laws.
Yet even the DEA agrees that we already have a powerful regulatory scheme to pursue these bad guys, and we believe that adding new restrictions will have the unintended effect of killing the legitimate use of opioids. It will unravel years of slow progress that has been made in their acceptance by physicians and the use of patients.
We ask that as regulators you should be tough in combatting diversion and abuse, but you must do so in a way that doesn't inhibit the legitimate use of opioids.
Thank you.
ACTING CHAIRMAN KATZ: Thank you very much. You win an award for not using all of your three minutes.
(Laughter.)
ACTING CHAIRMAN KATZ: Next, please.
MS. MULLIKIN: Good morning. My name is Chris Mullikin, and I've been a registered nurse for the past 38 years.
For the past three years I've been fortunate enough to be an active member of the Purdue Pharma's National Speakers Bureau, which has afforded me the opportunity to provide much needed education to both public and professional groups about the inadequate and inappropriate pain management.
I entered nursing for the same reasons that most of us do: a desire to help our fellow man and to advocate for those in need. After many years in a variety of nursing roles, I find myself working in an area of medicine where the need for patient advocacy is greater than almost anywhere else, that discipline being pain management.
About 15 years ago, I found myself in the uncomfortable position of caring for my mother, who was dying of pancreatic cancer. Dealing with the death of a loved one is traumatic enough without feeling helplessness associated with my inability to manage her rapidly increasing pain.
I questioned the logic behind her physician's concerns about respiratory depression or even addiction.
After Mom died, I decided to switch my career focus to pain management. As I said, this was 15 years ago, and there was a lot of ignorance and misunderstanding out there. Education about pain management and the use of opioid medication was practically nonexistent.
Well, we've come a long way, or have we? I now manage the Pain Management Center at Shore Memorial Hospital. It's a small health care system on Maryland's Eastern Shore. Our program consists of an in-patient acute pain management team and an out-patient pain center that treats primarily chronic pain patients.
Patients' statements such as, "You've given me my life back," and daily hugs are part of our routine. This patient population is one of the most labeled and under treated in the history of medicine.
Pain is described as the universal human experience. It affects all of us at some point in time in some way. So why do we try to cover it up, ignore it, or tell our patients just to live with it?
We have the knowledge, the medical research, and treatment modalities to successfully manage most pain that our patients can suffer. So what's stopping us? We have the same fears and concerns of 15 years ago. They're still with us today.
We are allowing the abuse and the ignorance of the few to affect the potential health for the many. The restricted use of opioid medication in non-cancer pain will do a disservice to the population already living with many unfounded fears and restrictions.
Please do not through misguided intentions inhibit the quality of care that we can easily provide to that population. Remember the biggest form of drug abuse today is under treatment, and this is a crime that we can all eradicate.
Thank you for this opportunity to be an advocate for that population that I serve daily.
ACTING CHAIRMAN KATZ: Thank you very much.
Next please.
MS. REEVES: My name is Lorraine Reeves, and I'm Executive Director of the Chronic Pain Advocacy League, and I have no disclosures.
I've also been coping with my own pain for 16 years now. So I understand too well what it's like to try to get treatment and also to be treated with respect.
While no one wants to interfere with the treatment for those who need it while addressing the drug problem, outdated attitudes and fears are already doing that. A clinic that did not want to deal with the hassles of their patients on opiate therapy dumps them even though they previously agreed not to.
A local pharmacy announced suddenly that it would no longer fill prescriptions for anyone unless they are with Hospice. Their longstanding clients were left scrambling trying to find their meds.
A doctor, while giving a lecture on pain management, is asked what would she do if one of her patients lost a prescription. They could be lying. Would she rewrite it?
She said, no, they're adults. They'd have to tough it out for a month.
No one would do that to a patient with heart disease or diabetes.
Another woman who has had great success taking Oxycontin, has a career, has a life because of the pain relief it affords here, is informed by her doctor he wants her off of it. There's too much media coverage.
This is just a sampling of what I hear every day. I get calls from people desperate in need of pain relief who are struggling to find care and just want to have a life. My own situation, I take Oxycontin, and without it I would not be here today. At the very least I'd be in bed. At the worst, I don't even want to think about it.
Yet following an interview I did a while back, the reporter informed me that he got a number of calls from people who said, "I shouldn't take anything for my pain. God gave me the pain. I should live with it."
Now, this may sound extreme, but attitudes like this, that pain won't kill you, it's all in your head, you're weak if you take something, are causing very serious problems. And now we are caught in the middle of a failed drug war, which is actually the reason for the increase in addiction, not the use of opiate therapy.
We are fighting for our lives. Chronic pain kills who you are, destroys your self of self while slowly destroying the body. Don't let us become casualties in a misdirected war.
ACTING CHAIRMAN KATZ: Thank you very much.
MS. KOWAL: My name is Nancy Kowal. I'm immediate past President of the American Society of Pain Management Nurses, and I stand before you today as not only a patient advocate because the nursing component of who I am says that I must be, but also for my patients that I care for on a daily basis.
I do do lecturing for multiple pharmaceutical companies, and I also have been involved in research projects through professional venues in university settings.
Today I wish to make a statement for my patients and as a representative for pain management nursing. To insure that the 21st Century provides a healthier quality of life regarding pain management issues, let us stop as professionals and reflect on the health care issues surrounding inadequate pain management.
The ASPMN organization has always fully supported education and clinical expertise in pain management. Grave concerns have surfaced regarding the recent negative discussion resounding around the utilization of opioid analgesics in all patient populations. Many populations are at risk currently for the non-treatment of pain.
If pain management's use of opioids becomes criminalized in the public's eye, further barriers to pain treatment will occur. The continued discussion of abuse potential, diversion, and addiction, as well as the politicizing of quality pain management can only prove detrimental to the clinical outcomes of our patients.
As immediate past President of the American Society of Pain Management Nurses, I stand for education, for research, for standards, and most of all for patient advocacy. The organization encourages and supports the systematic study of pain, along with evaluation of clinical care and research.
Built into this mission is the ultimate responsibility to speak for pain management as a profession publicly and in the government forum. If routine practice does not meet the patient's needs, then we are responsible to change the practice. The mission of ASPMN is to promote and provide optimal care to pain patients, including the management of its sequelae.
This includes the option of opioid analgesic based on a quality pain assessment, an appropriate evaluation of outcome, the risk-to-benefit ratio of providing opioid analgesia to all patients must be determined with a picture of the patient in mind.
As a professional organization, quality of life and patient outcomes are our key concern. We must advocate for those that are too weak and debilitated to speak for themselves. Hear the plea of pain professionals and the patients who surround them daily. As the issue of opioid analgesic use is evaluated and discussed --
ACTING CHAIRMAN KATZ: I'm sorry. Could you close your comments? Your three minutes are finished.
Sorry.
MS. KOWAL: Yes. Common goals and process must be established with pain clinicians to provide the best outcomes for our one focus, the patients.
Thank you.
ACTING CHAIRMAN KATZ: Thank you very much.
Next speaker, please.
MS. CUSIMANO: My name is Cheryll Cusimano, and I am a pain management nurse. I take care of chronic nonmalignant pain patients.
I am speaking today, a pain nurse clinician, as an advocate for free choice of long acting opiates in an equal position amongst all of the treatments for pain management. We now have drugs that for both the long term and short term can both relieve pain and maintain function.
Although these drugs are potentially addicting, this represents, in fact, a very narrow view of the situation. If you were a diabetic on insulin as a model for prescribing, you can see how a patient can be adjusted safely on a very dangerous drug. Pain prescribing should be no different.
Carrying a patient on an opiate medication is guided by clinical skills and not fear. Just as with the insulin, we adjust the doses and we document responses. In the end, everything relies on knowing and following the patient.
I am the nursing specialist for a chronic pain service which has functioned continually for over 23 years. Our care of patients, including opiates, as well as other modalities, follow guidelines and goals based on successful outcome studies. Although we stabilize patients on opiates, many of them are able to transfer to alternative therapies. When we decide to use a long-term opiate, we have an up front agreement with our patients about goals and ending points.
If we encounter opiate abuse by a patient, then we treat this as a problem in its own right, but this situation is rare given our guidelines.
Since there is proper technology for the use of opiates, we must not withhold this choice for this care. The policies and guidelines for a proper practice may be the same as those for any other dangerous drug.
As Americans committed to patients' rights, we must not discriminate. Decisions are made on our skills and our patients' needs without threats or fears of policies that are too rigid or the abuse problems of a small but very visible subgroup of patients.
All of us who are clinicians and policy makers are walking the same tightrope. We all need to focus on education and guidelines for proper practice. We should not fool ourselves. There will always be unskilled and misbehaving clinicians, just as there are abusing and even criminal patients.
The policies and disciplinary actions for violations should follow a parallel but separate agenda under public law and policy making. At all costs we must develop regulations to protect and guide the skilled and the honest efforts of good clinicians and the proper needs of our patients.
Thank you.
ACTING CHAIRMAN KATZ: Thank you.
Next speaker, please.
MS. GARRETT: My name is Rhonda Garrett, and I'm here representing the Interstitial Cystitis Association.
The ICA is a nonprofit, voluntary health organization that receives funding in part from the pharmaceutical industry via educational grants to support programs and services for IC patients.
Interstitial cystitis, known as IC, is a nonmalignant, chronic inflammatory disease of the bladder that causes severe pelvic pain, urinary urgency and frequency, up to every 20 minutes both day and night. The cause is unknown, and there are no uniformly effective treatments.
A diagnosis of IC is made on the basis of symptoms and the absence of other definable causes, such as infection or bladder cancer. At the present time there's no specific diagnostic test for IC.
Approximately one million people in the U.S. suffer from IC, an incidence similar to Parkinson's disease. Epidemiological studies reveal that it takes an average five to seven years to get diagnosed, and sometimes even longer.
The quality of life for IC patients has been shown to be worse than that of patients undergoing dialysis for end stage renal disease.
Economic impact is estimated at 1.7 billion per year.
Suicides occur every year because patients are left in severe pain with nowhere to turn to for help. Because physicians are often not familiar with the condition, patients are frequently told that their symptoms are all in their heads or caused by stress, thereby minimizing or invalidating the patient and compounding an already devastating condition.
Opioids are an absolute necessity for many patients with IC, particularly for those who do not respond to any of the available treatments. For IC patients it can mean the difference between life and death.
I am an IC patient currently on MS continin, and it has given me the opportunity to come here today.
Opioids, when used appropriately, rarely cause dependency. Addicts use pain medication to escape life while people in chronic pain use pain medications to get their lives back.
While preparing for this testimony, we received the following E-mail from an IC patients. "I'm having a very hard time finding a urologist that understands IC. I'm in constant chronic severe pain, and every doctor I see seems to be afraid to give me the pain medication I need for fear of dependency problems. What they don't understand is that my life can be no worse than it is now. I am unable to leave the house and am struggling with severe pain, hopelessness, and depression. Please help me."
When we contacted this patient to offer our help and support, we also asked her permission to present her poignant statement at this meeting today, and this was her response.
"You have my permission if it is at all necessary to use my name. I'm not ashamed of this disease. It is the medical profession that should be ashamed of themselves."
Physicians confronted with patients in severe pain due to IC often ask themselves whether this patient should receive treatment for their pain. Perhaps the question should be why should this person be left in pain.
Thank you.
ACTING CHAIRMAN KATZ: Thank you.
Next, please.
DR. SWERDLOW: Good morning. I represent the Sickle Cell Disease Advisory Committee of the National Heart, Lung and Blood Institute at the NIH. This committee includes ten outside experts plus governmental representatives to provide policy advice to the NHLBI.
Sickle cell disease is characterized by intermittent, unpredictable episodes of severe disabling pain beginning early in childhood. Many patients develop chronic pain. Those with very mild disease may have efficacy from non-opioids, but the vast majority of patients require opioid therapy to control their acute and chronic pain.
The pain of sickle cell may well be different from other pain states in that it is quite severe, unpredictably intermittent, involves both acute and chronic pain, and begins early in childhood, possibly altering pain sensations and coping skills.
Patient are routinely accused of being addicted to opioids. Substance abuse behaviors may just be desperate attempts to get badly needed opioids. Many patients require extraordinary doses for pain control, which is a long considered addiction by many physicians. The average dose of long acting opioid upon discharge from our hospital for a pain episode is one gram of morphine equivalent per 24 hours.
The more tolerant patients require doses over ten grams of morphine equivalent for 24 hours. Lack of stronger dosage forms can be a major inconvenience when patients have to literally take ten to 50 tablets at a time for a single dose of pain medication.
Those who treat sickle cell patients and the patients themselves are in a constant battle with physicians in emergency departments in hospitals, not to mention pharmacists and insurers, to provide adequate amounts of pain medication.
Current barriers are excessive and often discourage or prevent adequate treatment.
Children over seven can generally learn to take tablets and use patient controlled analgesia device as well. The greatest practical difficulty for pediatric patients is finding plain opioid preparations to avoid acetaminophen or NSAID toxicity.
Acetaminophen toxicity is the single greatest substance abuse risk to the sickle cell population. Desperate patients will consume large amounts of combination medications if that is all that is prescribed.
Additional pure opioid preparations and dosage strengths would be most helpful in treatment of this disease.
Despite the high dosage requirements, opioid addiction is highly unusual in the sickle cell population, possibly because of the great degree and frequency of pain. We see far more opioid abuse by proxy with a parent or housemate taking the patient's medications, but such abuses are usually easily detected with accurate pill counts and frequent patient visits and review of patient diaries.
Diversion is rare in the adult sickle cell population because the patients place such high importance on the medication for themselves.
ACTING CHAIRMAN KATZ: Thank you, Dr. Swerdlow. Did you have any disclosures to make?
DR. SWERDLOW: The committee has no disclosures. I have been on the Purdue Frederick Speakers Bureau, but not within the last year.
ACTING CHAIRMAN KATZ: Thank you very much.
Let me just remind the subsequent speakers to begin with your disclosures, if you don't mind.
Next, please.
DR. HANDEL: Good morning. It's an honor to be here on behalf of the Pain and Palliative Care Service at the NIH. I am speaking in the place of Ann Berger, who is the department chair, and I have the disclosure that I have in the past been, but am not currently on the Speakers Bureau for Purdue Frederick and Janssen Pharmaceuticals.
In speaking for our service, I see the founder of our service, Mitchell Max, is here and present, and I wanted to make a couple of comments about suffering.
My belief is that our service is and has been founded at the NIH specifically to deal with suffering of patients on protocols in our institution, and we have found that there are many sources of suffering, one of which is fear.
Our patients commonly find themselves in situations where they have significantly uncomfortable conditions, are under intense therapy, and then find themselves in situations where they're going back to their communities to continue trying to live in between their courses of therapy.
Our patients find that while they may have significant dedication towards comfort and increased quality of life while they're in-patients, they oftentimes find a very different situation upon leaving the institution.
We find that this is, because of a number of different factors, one of which is fear, one of which is lack of education in the community both in professionals and in the lay community.
There are fears about safety and there are fears about actually accessing the appropriate medications. We have found that there is a pattern where patients will be calling back on a regular basis asking if there's a way that we could either liaison with their physicians or their community or actually at time talks to their family.
Our hope in presenting to you is that there is a way that you can balance this very difficult job that you have, the job of assuring safety for patients who are on these significant medications that are necessary and are important for their quality of life with the opportunity to give them appropriate access to these medications.
And I believe that only in dealing with both of those sides of this balance will we stop dealing with the tail of the comment, the effects of abuse, and start getting ahead of the comment to maybe redirect the course towards better care.
Finally, I believe that -- and I know I speak as many of you know about sustained opioids simply being tools, and that tools can be used or misused. We have two populations using them: those that absolutely need them and have to have access and need to be managed expertly -- we need to assure that -- and those who misuse. I think we need to address those populations very separately.
Thank you.
ACTING CHAIRMAN KATZ: Thank you very much.
The next speaker, please.
MR. BROATCH: Good morning. My name is Jim Broatch, and I'm Executive Director of the Reflex Sympathetic Dystrophy Syndrome Association of America. We're dedicated to promoting greater awareness of an encouraging research into reflex sympathetic dystrophy, or RSD, also known as complex regional pain syndrome.
About ten to 15 percent of our budget is provided by unrestricted grants from pharmaceutical medical device companies.
RSD is a neurological syndrome characterized by intense burning pain, pathological changes in skin and bone, sweating, tissue swelling, and extreme sensitivity to touch. It generally results from some kind of trauma, and the consequence pain is much greater than the original injury.
Some patients report that a breeze created by a ceiling fan causes excruciating pain. A Johns Hopkins spokesperson remarked about RSD severity thus, "If hell were a clinical medical condition, it might look like RSD."
Anyone could get it. Most people have it between 25 and 55. It's more frequently seen in women than men. The incidence is unknown, but it's estimated between 1.2 million and six million individuals in the U.S. have it. It could literally rip your life apart, destroying your career, social network, finances, marriage, and family.
I'm here today to present this committee with hundreds of personal communications from our members and others in the chronic pain community who are incredibly fearful that the FDA will restrict the availability of opioids or withdraw or restrict Oxycontin in the market. It's not a farfetched notion.
Already in a number of states Medicaid has restricted patients' access to Oxycontin. Increasingly we are receiving reports that patients are switching chronic pain patients from Oxycontins to often less effective pain killers because of their fear of increased regulatory scrutiny.
To help chronic pain sufferers in the medical community manage the use of opioid painkillers, we have published the opioid contract on our Web site. The testimonies that I'm presenting to the committee are from concerned patients, patients with RSD, others suffering with chronic pain. They represent a wide range of educational, socioeconomic levels, including disabled police officers, registered nurse, truckers, stay at home moms, the formerly rich, and the poor.
Their message to the committee and to the FDA is simple. Using opioids for chronic pain has improved the quality of their lives, although most are not working and subsist on some kind of disability related compensation. Opioids, especially Oxycontin, have allowed them to be more productive members of our society.
Donna Isaacs, a six year RSD sufferer, summarized the current situation well when she wrote, "I take Oxycontin every day for my pain. I'm find it more and more difficult to get my medicine because of all the media coverage. I've been to at least four drug stores that don't carry my medication because of the media coverage, and I panic every day I go to get my medicine praying that I'll be able on that day to get it filled. I need my medication every day just to get out of bed."
Thank you.
And I'm going to present this to the committee, and I hope you'll have time.
ACTING CHAIRMAN KATZ: Thank you, sir.
Next, please.
MS. ANDERSON: Good morning. My name is Kathleen Anderson. I'm the Director of Governmental Affairs for the American society for RSD/CRPS. I have no disclosures.
The recent bad press regarding Oxycontin and the future of opioids is of great concern to the members of the American Society for RFD and the community of patients and caregivers we represent. Reflex sympathetic dystrophy has one of the highest chronic pain ratings as indicated on the McGill pain index. Placing additional restrictions on opioid analgesics will prolong the suffering of RSD patients.
Presently pain management centers are limited. Treatments revolve around medications, physical therapy, psychological therapy, and invasive surgical procedures. It takes an average of two years to be diagnosed with reflex sympathetic dystrophy, and once diagnosed, most patients must see an average of 4.5 physicians before their pain is treated.
How much longer will it take these patients to get relief if tighter restrictions are enforced? Will they live that long?
Suicide is one of the leading causes of death in RSD patients in the United States today. Until more facilities are established and HMOs cover their costs, patients will continue to use primary care doctors and a variety of specialists to obtain medications for pain relief.
Knowing these facts, we cannot limit the dispensing of opioids.
I am the parent of an 18 year old who has been suffering with reflex sympathetic dystrophy for the past three years. Do I worry about the effects of her medications? Yes, of course I do. But my worries about the effects of these drugs are secondary to the torture she endures with this illness. The pain is debilitating and relentless. It is inhumane.
Last week I watched with a broken heart as my dear friend buried her 20 year old daughter, Britney McMurty of Glastonbury, Connecticut. Her spirit was much stronger than her body after being ravaged by the pain of the RSD for the past four years.
Is that the same fate I have to look forward to?
The federal government needs to appropriate fund to establish multi-disciplinary pain clinics to insure that RSD and other chronic pain patients get timely and proper medical treatments. It would eventually allow a majority of opioids to be prescribed from centralized facilities by the pain experts. These facilities could house training seminars to educate the medical community.
I ask this committee to rethink the idea of enforcing additional restrictions on the dispensing of opioid analgesics. People in pain are a vulnerable population. We need to pursue education, awareness, and research in the area of chronic pain. Until pain is better understood, we need to place the burden on those responsible for opioid abuse, not the victims themselves.
Thank you.
(Applause.)
ACTING CHAIRMAN KATZ: Thank you very much for your comments.
Next please.
MS. McLAUGHLIN: Hi. My name is Kathy McLaughlin from Hospice in Northern Virginia. I'm representing the Hospice and Palliative Nurses Association Board of Directors today.
The HPNA has received small amounts of pharmaceutical monies to assist in publication costs for clinical publication tools. That's the only thing I can disclose at this point.
Our membership represents about 4,000 professional nurses across the nation, and I'm a registered nurse, a member of the Hospice and Palliative Nurses Association, and I'm a Board certified Hospice palliative nurse.
I'm presently practicing as the nurse case manager of children and adult patients and their families in their own homes through the Hospital of Northern Virginia.
Every day thousands of patients with unrelieved pain are referred to Hospice or palliative care programs across the nation. Opiate analgesics are a critical element in the appropriate management of pain, especially cancer pain.
Time released opiate analgesics available in multiple strengths have been the mainstay of most of our programs. They're prescribed in increasing amounts because of the simple reason that they're cost effective and they work.
Unfortunately, though they work well for adults, the present available formulations are not always appropriate for children and dying patients.
At present Hospice care providers of at least two groups are confronted with the task of tailoring the adult preparations of the market for diverse size patients. Calculating initial dosages are based upon the patient's height, weight, age, and medical status. The doses are then titrated to patient response and by frequent medical and nursing assessment.
The concentrated oral solutions are the easiest to administer due to the small volume needed. Extreme care in calculating dosage and instruction of the caregivers is paramount for safe delivery. These can be administered via feeding tube if present, but most of our patients don't have that.
Unfortunately, these preparations are relatively short acting in duration and require frequent dosing, a burden to patients' families and caregivers, especially in a home setting.
The long acting tablets are not often the answer because they can't be crushed, and as we've seen in the news, it's not a good thing.
The transdermal patch in the long acting, microencapsulated forms are often too high a dosage for the children in our population, as well as the very old and some of the dying.
Intravenous, subcutaneous, and rectal routes are also other choices for administration, but need to be used judiciously since they are invasive and often anxiety provoking for many of the children and their families.
All of the above-mentioned preparations have helped maintain many children comfortably in their own homes with the support of the Hospice interdisciplinary team. By my own practice, it would seem that a long acting opiate analgesic solution or suspension would be extremely beneficial not just for infants and children in a population, but for all those who have difficulty swallowing tablets.
And also the HPNA Board of Directors urges very careful consideration surrounding any action that might restrict the availability of opiate analgesics and any further action to limit the availability of opiate analgesics either by decreasing production or require any sort of preauthorization for the medication would undoubtedly serve to inhibit affected pain management. The result would be unnecessary and unrelieved pain and suffering.
Thank you very much.
ACTING CHAIRMAN KATZ: Thank you.
Next, please.
DR. LEVY: Good morning. My name is Michael Levy. I'm the Director of the Pain Management Center of the Fox Chase Cancer Center in Philadelphia. I'm here on my own accord and support as a pain expert from an NCI designated comprehensive cancer center.
In the past 20 years, I've received research support and been on the Speakers Bureau of ANESTA, Janssen, Knoll, Purdue Pharma, Ortho-Biotech, and Centicor.
We are in the midst of two epidemics: the epidemic of unrelieved chronic pain and the epidemic of Oxycontin abuse. I speak today on behalf of the patients with chronic pain and the health care providers that treat them.
The cure for the current Oxycontin abuse epidemic must not increase the suffering of legitimate patients with chronic pain. Ready access to Oxycontin is essential to our ability to provide safe and effective comfort and function to thousands of patients throughout this country.
Despite heroic efforts over the past 20 years by individuals and organizations to teach clinicians how to properly assess and treat chronic pain, surveys still show that half of the chronic pain patients in this country are under medicated. Last year the Joint Commission on Accreditation of Health Care Organizations enacted new standards for pain control to try to correct these system-wide inadequacies. Just when physicians are advocating or being pressured to provide better pain management, one of their best tools is being threatened.
Over the past six years Oxycontin has set a new standard for the relief of chronic cancer and non-cancer pain. Oxycontin has been shown to be a safe and effective analgesic in the control of pain caused by cancer, osteoarthritis, post hepatic neuralgia, major surgery, and degenerative spine disease.
Oxycontin has the characteristics of an ideal opioid analgesic, short half-life, long duration of action, predictable pharmacokinetics, absence of clinically active metabolites, rapid onset of action, easy titration, no preset ceiling dose, and minimal adverse effects.
The escalating abuse of Oxycontin is a double tragedy. The first tragedy is the fact that individuals with a disease of addiction have found a new substance to abuse. Oxycontin abuse has led to violent crimes by abusers, pushers, and prescription diversion by deviant physicians and pharmacists.
The popularity of Oxycontin abuse has also resulted in the inadvertent deaths of inexperienced drug abusers.
The second tragedy of Oxycontin abuse is the fact that legitimate pain patients are having increasing difficulty utilizing their appropriate prescribed Oxycontin. Patients are afraid of taking their Oxycontin, afraid of becoming victims of violent crime, afraid of being ridiculed by their friends, family, and uninformed health care professionals, and afraid of not being able to obtain adequate prescriptions.
In conclusion, the interventions aimed at reducing the public problem of Oxycontin must not interfere with the safe and effective use of the patient problem of unrelieved chronic pain. Substance abusers need to be kept from obtaining their Oxycontin and need comprehensive mental health care services to deal with their addiction.
Legitimate pain patients need ready access to Oxycontin. Legislators, regulators, and law enforcement agents and health care professionals must work together to heal our society and reduce the suffering of our citizens.
Thank you.
ACTING CHAIRMAN KATZ: Thank you, Dr. Levy.
Next, please.
DR. WILSON: Good morning. I'm Peter Wilson, professor of anesthesiology and pain medicine at Mayo Clinic, Rochester, Minnesota. I represent the American Society of Anesthesiologists, some 35,000 physician anesthesiologists.
I've been working in the anesthesia subspecialty field of pain management for more than 20 years, and although I've published animal and clinical studies in opiates, I haven't received pharmaceutical industry support for this. I have not received pharmaceutical industry support.
It's quite clear that opioids are essential for the control of pain during surgery, other acute pain states, cancer, AIDS, other terminal illnesses and for some chronic pain states.
Long acting opioids provide a more stable blood level orally than short acting opioids and are, therefore, more effective for pain management. Methadone is the only clinically available oral opioid with an intrinsically long half-life, but it's extremely variable and quite tricky to use.
Other opioids have to be formulated at a sustained release preparations.
Misuse or aberrant behavior and diversion of appropriately prescribed opioids by legitimate chronic pain patients is rare. The use of patient contracts and/or random blood or urine screening for substances has note been shown to improve compliance or reduce diversion.
Inappropriate patient selection, inappropriate prescribing usually reflects a lack of training and experience of the prescribers rather than malfeasance. Aberrant patient behaviors with respect to opioids, including doctor shopping, really should be monitored by the DEA and state medical and pharmacy boards, not by the FDA.
The DEA and state medical board should also monitor and enforce legislation and regulations against aberrant prescriber behavior, including unethical, inappropriate, and illegal activities, pill mills, Internet, and absentee prescribers.
Aberrant prescriber behavior leading to diversion is a function of the prescriber, not the medication, and again, the DEA and state medical and pharmacy board should address this, not the FDA, and we do not believe that any non-physician representative should be in the position of making clinical judgments.
Restriction of a legitimate supply of opioids will lead to rationing, which will adversely affect provision of pain relief to all pain patients, acute, chronic, terminal, the young, the old the disabled and the disadvantaged.
Thank you.
ACTING CHAIRMAN KATZ: Thank you, Dr. Wilson.
Next, please.
DR. RAMIREZ: My name is Jeff Ramirez. I'm representing the Veterans Health Administration. I have no personal disclosures, though my agency does conduct medical research that is funded by the pharmaceutical industry, and we do receive educational grants.
Many veterans, like 20 to 30 percent of civilians, annually suffer from pain. Further, these veterans had devastating injuries related to the service to their country that may have resulted in chronic pain. In many cases their suffering has not lessened with time, but rather made worse by the accompanying degeneration occurring with age.
In some cases, surgical interventions may provide some relief. However, in most patients with chronic pain related to chronic disease or musculoskeletal injuries, there is no simple procedural cure. In these patients, the use of chronic opioids has provided a means of controlling their pain and increasing their ability to participate in society.
The VA has been in the forefront of recognizing the treatment of the significant health care problem of pain. We have implemented pain as the fifth vital sign throughout all of our medical facilities, in recognition of its importance and to emphasize assessment and treatment.
In addition, there are large scale efforts to develop provider and patient educational programs, treatment guidelines, and promotion of research activities and training programs related to the understanding and treatment of pain that has been undertaken throughout the VA. Within these efforts are programs specifically to address opiate prescriptions and management.
Proactive, aggressive management of both acute and chronic pain is universally recognized as an essential component of health care. However, substantial evidence indicates that neither acute nor chronic pain is adequately treated within most United States health care systems.
This has been recognized as a new standard of care regarding the assessment and treatment of pain as we have implemented it throughout the VA. When patients report with pain, we teach our physicians and other health care providers to believe their statement of pain.
When encountered by patients in pain, we would all like to provide them relief if possible. In many cases the most important treatment is opiate therapy.
When patients are prescribed opiates for pain control, there's no question that there is a potential for diversion or misuse of the medication. These problems, which are infrequent, can be minimized by the prescribing physician for following things like having careful discussions with a patient on the use of opioids before the first prescription is written, and entering into opiate contracts with patients and maintaining appropriate records.
The VA is responding to concerns about diversion by developing guidelines in this area and utilizing many of our electronic medical records and our electronic prescription records in order to check for patients who do try to get opiate medications from various medications.
But to summarize, the currently available, long acting opioid pain medications have improved pain control for patients needing these medications. The misuse of these medications by a small number of individuals does not negate the very positive impact that these sustained delivery systems have on patients with chronic pain from a variety of conditions. The removal of these medication or excessive regulation will have a negative impact on the willingness of health care practitioners to provide pain treatment throughout the VA and throughout the United States.
Thank you.
ACTING CHAIRMAN KATZ: Thank you.
Next, please.
DR. MERRICK: Good morning. My name is Randy Merrick. I am a Board certified family physician from a rural county in Virginia. I'm here speaking on behalf of myself and my patients. I am self-funded with no disclosures.
I appreciate being invited to comment today as a practicing family physician who has treated Hospice and non-cancer chronic pain patients for over ten years.
The use of opioids to treat these patients has been a cornerstone with other complementary treatments if available.
Once visited by an intimidating group of State Police and Board of Health profession officers, I took advantage of my situation and became a member of a task force for the Medical Society for the State of Virginia and helped co-author guidelines for the State of Virginia for the treatment of chronic non-cancer pain.
These guidelines later became one of the templates for the National Federation of Medical Board's guidelines published. I have long held the belief that the family physician who deals with all of the bio-psychosocial aspects of our patients, children and adults, are one of the best trained physicians to deal with our patients in chronic pain.
After the attempts of our colleagues in the specialties, such as neurosurgery and orthopedics, failed, eventually the buck stops here with me, the family physician. Testimony after testimony from those I treat who have been returned to qualify of life faced with chronic pain proved to me that my treatment of their pain is as legitimate as my treatment for their diabetes, hypertension, depression, et cetera.
As the buck stops here, I also realized that I have an obligation and a responsibility to insure that my patients adhere to my patient-doctor contract that allows me to use opioids to treat the chronic pain.
When I hear of even the slightest insinuation by any source that one of my patients may be diverting their opioid medication or exhibiting addictive behavior, I take action by informing my local authorities of possible diversion or requiring my patients to be evaluated for substance abuse and treated for addiction.
We have an obligation as family physicians to assume that what our patients tell us is true regarding their pain. There lies the essence of the doctor-patient relationship. When nothing else is left to be offered for treatment of their chronic pain, we as family physicians are obligated to use whatever we need, whatever message, whatever medications that we need to treat these patients, to allow them to return to a quality of life.
As a coroner for two counties, I have recently investigated over the last two years three suicides because patients were unable to gain treatment for the chronic pain. We certainly have a job to do.
The American Academy of Family Physicians and my state chapter are aggressively educating all of our physicians in the treatment of chronic pain.
Thank you.
ACTING CHAIRMAN KATZ: Thank you, sir.
What I'd like to do now since all of the speakers have come up is just make sure that some of the folks on the list for this morning haven't lost the opportunity to go, and what I'll do is read through the names very quickly of people who are on the list for this morning, and if you're here, please come up and take your turn. If I mispronounce your name, I apologize.
Dr. Manchikanti, Skip Baker, Cynthia Simonson, Barbara Ann, Stephen Plotnick, Aaron Gilson, Ronald Kurstin, Myron Yaster, F. Michael Gloth, Michael Kaplan. Any of those folks here?
Since we do have a little bit of time, we'll proceed on to the list of folks who requested an opportunity to speak and were put on a waiting list. Let me read through your names quickly, too, so you can prepare yourselves if you're still interested in speaking to come up and sit in the speaker ready chairs.
Dr. Babul, you'll go first.
Dr. Van Zee, if you're here, you'll be next.
And the other folks in order are Mary Kelly Sohm, Laurie Torres, Cyn Hoard, Katt Morris, Jay Steffler, Lynda Langhorne, Mary Winfield, Robert Root, Lonna Gutierrez, and Dr. Dahlquist.
I'm not sure we'll have time for everybody, but if you're around, please prepare yourself to come to the speaker ready position.
Dr. Babul, please.
DR. BABUL: Good morning. My name is Najib Babul. I'm with TheraQuest Biosciences in East Norriton, Pennsylvania. I've been involved with analgesic drug development for over a decade. I'm here on my own accord due to my scientific interest in opioid drug development and my interest in public policy issues surrounding patient access to opioids.
I do consult with a number of pharmaceutical companies in analgesic drug development, some of whom market or are developing opioid analgesics.
I would like to speak to the committee on the issue of a core development program for analgesic drug development, which is the subject, I believe, of your morning deliberations.
I think the committee and the division need to consider a number of key questions in the development of analgesic agents, and I'd like to identify at least some of the questions that may help the committee with its discussions.
The first issue really is whether if a drug is pharmacological effective in acute pain and in chronic pain and there are no formulation related barriers to its developments for both indications, whether the agency should consider approving the drug just for acute pain or just for chronic pain or whether it should be a requirement that both indications be studied simultaneously.
The other issue is whether acute pain data in any way support the efficacy of a drug in chronic pain. How many chronic pain disorders or models, as we like to call them, need to be evaluated? What are some of the suitable models that we are to consider? Is it reasonable to study mixed models given the clinicians often see a very heterogeneous group of patients?
What is an appropriate duration for a clinical trial in chronic pain? And should cancer pain be in the mix of studies in chronic pain or should that be a separate indication?
And if it is a separate indication, is it likely to become orphaned, given that cancer pain studies, as a number of us know, are challenging?
Now, I would like to in the interest of time restrict my comments just to new chemical entities that are the subject of a 505(b)(1) approval and would like to suggest that drugs that are in process right now at the FDA perhaps require different consideration.
I would suggest that it's important for us to do a proof of concept study to very carefully identify a no effect dose or a minimum effective dose for any new chemical entity that's approved as an opiate analgesic; that we need to carefully characterize the dose response characteristics of the drug, and that we need to establish very carefully prospectively the dosing frequency of such drugs.
In addition, I would suggest that at least one and possibly replicate evidence should be necessary for the approval of drugs involving at least a 12 week duration of efficacy so that we can clearly assess not just efficacy, but the durability of response which is a question that clinicians have.
And finally, that if cancer pain is part of the mix, then we ought to have at least one adequate and well controlled study in cancer pain involving a minimum two week duration.
One additional point is that for centrally acting drugs, as opioids are, clinicians need guidance on acute and chronic effects on psychomotor and cognitive skills, and this is something that perhaps the committee and the agency ought to look at for approval of such drugs.
Thank you.
ACTING CHAIRMAN KATZ: Thank you, Dr. Babul.
Next, please. Dr. Van Zee, are you here?
Please begin with any disclosures.
DR. VAN ZEE: Yeah, my name is Dr. Art Van Zee. I have no disclosures.
I've practiced general internal medicine in a small Appalachian coal mining town, St. Charles, Virginia, for the last 25 years. My region of the country, as you probably well know, was one of the earliest areas affected by Oxycontin abuse and addiction.
It would be very difficult to overstate the degree of devastation this has brought to central Appalachia and now widespread in many regions of the country. There have been at least three major factors which have played a major role in this epidemic of Oxycontin abuse.
First, there's been an obvious problem with misprescribing and over prescribing of this drug.
Second, this epidemic has been a vicious indicator of the extent of prescription drug abuse in our society.
Thirdly, and the one which might be closest to the FDA here is that of the promotion and marketing of Oxycontin by Purdue Pharma, which I think has played a major role in the problem.
Purdue Pharma in the most extensive opioid promotion in the history of the industry has used sophisticated marketing data to determine which physicians in the country prescribe opioids most liberally or least discriminately, if you will, and couple this data with lucrative financial incentives to their sales representatives.
One sales representative in Florida made $100,000 over and above their $50,000 of salary in the year 2000 based on the high Oxycontin sales in her territory.
Purdue has used thousands of company sponsored talks and seminars that have been well documented in the medical literature to influence physician prescribing and practices. Purdue has lobbied the primary care physician to a great extent, and primary care physicians as a general rule have the least amount of skills in pain management and addiction issues, at least suboptimum.
Purdue continued free Oxycontin promotion pills up until July 2000 in a campaign to promote it. The company has had an extensive and sophisticated non-branded promotion of opioids in general in which the benefits of opioids for chronic, nonmalignant pain have been much overstated and the risk trivialized. And all of this has contributed to the commercial success for Purdue at the expense of the public health.
This now is the opportunity for the FDA simply that the current regulations governing the way the pharmaceutical industry can market and promote opioids or any controlled abusable drug has not served well the public health. Not to radically change those type of regulations at this point would give sanction and safe harbor to the drug companies for the continuation of such business practices, which do not serve any of us well.
Thank you.
ACTING CHAIRMAN KATZ: Thank you, Dr. Van Zee.
To my surprise we have time left in this open session, and so what I would like to do now is in the few minutes that we have if there is anybody in the audience among us who would like to take three minutes to share an thoughts, then people come forward and have a seat in the speaker ready chair, and we'll take you in turn as time allows.
Please begin by saying who you are and what you do and if you have any disclosures to make. Go ahead.
MR. STEFFLER: Hi. My name is Jay Steffler. I've no disclosures to make.
I've suffered from RSD since 1992. I spent eight years with my doctor, doctors, trying every modality known to medicine to try to cure me of the RSD, and from all of the sympathetic lumbar blocks that they gave me, I developed myofacial syndrome and arthritis.
After finishing all and trying every modality, the doctors would give me small amounts of opioid medication when, in fact, it was not enough, and too little actually is worse than taking the proper amount.
And the only way that a chronic pain patient can abuse their medication is to give it to someone to whom it's not prescribed. The only other way is if the doctor that they are seeing is not giving them enough medication. then they are forced to go see several doctors which ends up in mixed medication which can kill the patient.
When the patient with RSD sees one physician who is regulating their medication, they're entire life returns to them. I feel like I have come out of a coma. I haven't had to use a cane for two years. I was bedridden for those eight years. I am now going back to work, working through OVR. Before that I was, as I said, completely bedridden.
And now the only problems I have now is that I'm a slave to the insurance company. I am only allowed to -- because they will only dispense so many days of my medication at a time, I'm only allowed to leave my house for ten days at a time maximum.
So the opioid therapy -- when they took me off all of the experimental medications that they tried me on, I came out of a coma. I literally do not remember what went on during those eight years from the Soma (phonetic) and all of the different families of antidepressants, not for depression, but for the side effects. I couldn't remember what happened during those eight years, and I literally feel like I've got a second chance at life. I feel like I've just been born, and it's a whole new world to me.
In the past two years since I've started the opioid therapy, I've been getting my body back into shape. Atrophies muscles over eight years do not come back after a couple of months. It takes quite a while.
So after the two years -- it's been two years, and I am now working. I'm going back to college, get my second degree, and I'm also teaching, and it has given me a whole new life.
And in fact, even the pharmacists are shocked when they see the medication that I take. They say themselves, "How are you standing here?" when, in fact, before I couldn't do anything and I couldn't stand there when I was on the other medications that didn't work.
Suddenly my mind came back. I'm able to think again. Movies that I saw during that eight year period I don't remember, I have no recollection of. Now my mind is back. My desire for life and everything, my who life has come back to me.
ACTING CHAIRMAN KATZ: I'm sorry. I'm going to have to ask you to bring your comments to a close.
MR. STEFFLER: The problems with the Oxycontin, I think the DEA needs to focus more on the people who are healthy who abuse the medication instead of focusing on the chronic pain patients and doctors who are for people who need it.
ACTING CHAIRMAN KATZ: Thank you very much.
MR. STEFFLER: Thank you.
ACTING CHAIRMAN KATZ: Next speaker, please.
DR. DAHLQUIST: I'm Glenda Dahlquist. I'm a chronic pain management physician from Dayton Ohio. I'm a member of the American Academy of Pain Medicine, and I'm also the Chairperson for the local pain society in Dayton, Ohio, and we are currently in the process of gaining state chaptership from the national organization, the AAPM.
I am a speaker on the Board for Purdue Pharma and Janssen. I have no other disclosures, no research grants.
And I'd like to make one comment. I'm not on the Speaker Bureau for Purdue. I mean, I don't use Oxycontin because I'm a speaker. I'm on the Speakers Bureau because I believe that Oxycontin has benefitted so many of my patients, and they finally asked me to speak on their bureau after I had prescribed it for four years, seen the benefits that it's given to my patients when used appropriately.
One other comment I'd like to make is with our local pain society. With the recent media coverage and fears of license or sanctions, even chronic pain physicians in our area have decreased their prescribing of Oxycontin, and I think this is very sad because we as chronic pain physicians, we're the top of the ladder when it comes to dealing with chronic pain patients. The family doctors may not feel comfortable prescribing high doses of opioids. The internal medicine specialists may not feel comfortable delivering high doses of opioids to patients who have high drug tolerances and high needs in order to function appropriately.
We as chronic pain physicians are the ones who deal with these most severe patients, and now we're seeing an epidemic of chronic pain physicians who are afraid they're going to lose their licenses, and nobody in the community will treat these patients.
I'd like to point out real quickly, too, I haven't heard anybody speak about not the detriments just relating to the humane part of treating pain management, but what about the medical problems? When a patient is in pain, their stress hormones increase. This can lead to worsening other chronic diseases such as hypertension, heart disease, diabetes. They have to increase their insulin doses if the blood sugar goes up too high because they're under too much stress.
Suicide rates. I had a patient who finally did commit suicide because she had left my practice and gone to another pain physician who wouldn't treat her appropriately, and we heard just from another coroner that he has done an autopsy on patients who have committed suicide because of that.
These patients, if they're not given the appropriate pain medicine, will turn to over-the-counter medications, nonsteroidal anti-inflammatory agents, handfuls of nonsteroidal anti-inflammatory agents causing GI bleeding and things like that.
We really need to be able to treat these patients appropriately before we cause worsening medical problems --
ACTING CHAIRMAN KATZ: I'm sorry. I'm going to have to --
DR. DAHLQUIST: -- people on the welfare system --
ACTING CHAIRMAN KATZ: -- ask you to bring it to a close.
DR. DAHLQUIST: -- and people not being able to be treated appropriately because of the inadequacies of the medical profession.
ACTING CHAIRMAN KATZ: Thank you very much.
Why don't we then call the open session to a close? Let me thank all the folks who took time out of their schedules and made the effort to make it here to share their thoughts with us, in particular, the folks with chronic pain themselves. Thanks very much for coming.
It seems like there are one or two folks on the Advisory Committee or guests that have drifted in since we did our morning introduction. So perhaps they could take a moment to introduce themselves and let us know what your names are and who you are.
Dr. Connolly, would you like to begin?
DR. CONNOLLY: I'm Maria Connolly.
ACTING CHAIRMAN KATZ: You have to press the red button on your mic.
DR. CONNOLLY: I'm Maria Connolly, and I'm a consumer representative on this panel. And I flew in from Chicago with a big snow storm, but in San Diego yesterday afternoon it was pretty nice.
ACTING CHAIRMAN KATZ: Thanks.
Dr. Schechter.
DR. SCHECHTER: Hi. I'm Neil Schechter. I'm a pediatrician, and I run the pain relief program at the Connecticut Children's Hospital, and I'm interested in pediatric pain specifically.
ACTING CHAIRMAN KATZ: Thanks.
Was there anybody else that drifted in that I didn't notice?
(No response.)
ACTING CHAIRMAN KATZ: All right. Then what we'll do now is I'll reintroduced Dr. Rappaport from the FDA, who will give some introductory comments for our morning session, which will be on opiate analgesic development and use.
DR. RAPPAPORT: This morning's session is on opiate analgesic development and use. The framework for the agency decisions includes the regulatory restrictions and requirements defined by the Food, Drug, and Cosmetic Act.
This allows not only for decisions to be based on scientific integrity. It also provides a level playing field for the commercial sponsors of the new drug applications, thereby preventing arbitrary and capricious decisions by the FDA.
One of the final products of our labor is the product labeling. The label may contain only information supported by data submitted in the new drug application. However, this data may lead to difficult choices on how the label is written.
For instance, for new, modified release opiate analgesics studied in only low back pain patients, we may result in an indication limiting the drug's use to the low back pain patient population.
In your discussions this morning, keep in mind the difficulties we at the agency face daily when we try to mesh the available data with the regulatory framework in order to provide product labeling that clearly states the findings of the clinical studies in a manner which will be most beneficial to prescribers and patients.
We hope that the following presentations will provide you with a foundation upon which you can build your discussion of the points we have raised in the background package for this meeting.
Thank you.
ACTING CHAIRMAN KATZ: Thank you, Dr. Rappaport.
Dr. Levy will now get up and give us a discussion on pain treatment guidelines.
Dr. Levy.
DR. LEVY: Good morning, everybody. We've been sitting here for a while. Let's take two minutes to stand up and relax for a second before you start listening to lectures.
Don't go outside. Just relax.
(Pause in proceeding.s)
DR. LEVY: Okay. Now you can sit down. We don't want anybody getting chronic pain here just from sitting and having dependent limbs.
This morning I will try to speak to you on three specific issues. One, just to describe my background from an historical perspective very briefly because I may be probably the person who has treated pain here the longest, or one of them, over the years.
Two, I'd then like to tell you about the Texas perspective and how that led to the first guidelines in the country, and then the federation guidelines, which were a result of those in some other states.
Twenty-six years ago I was attending in the pain clinic at the University of Washington, which was probably the first multi-disciplinary pain clinic in the United States. That was the days before any of these initial organizations ever existed.
We created the International Association for the Study of Pain then, and that was an innovative creation. None of this had occurred before.
I tell you this for one reason: because when I started treating pain, opioids were an anathema. None of us were to use opioids in any way, shape or form, except to put people on pain cocktails which were a combination of methadone and sedatives to get them off narcotics. And that was the whole purpose, and it was that way for many years until the writings of Dr. Portenoy and others that led us to believe that these drugs had a basis for treatment in chronic pain, end of life care, et cetera.
So my mindset had to go full circle to get from where I started to where we came in '93, and now, like anything else, we may have gone a little too far, and we have to come back.
I tell you that because that is the history of what you do when you look at different aspects of things.
Now, in Texas, we had an intractable pain statute in 1989. It did nothing. It did not increase the use of drugs or help patients get treatment, and the reason being is that doctors were still afraid that if they prescribed, they would be disciplined by the Board.
Now, I was recruited by then the governor's office, et cetera, and I became the Executive Director of the Texas State Board of Medical Examiners, which regulates the practice of medicine in the State of Texas.
At that point there were really no states with guidelines or ways of prescribing or advice to physicians. In fact, the word was that if you prescribed, you were going to be disciplined.
Now, the reason was we were given a count from the Department of Public Safety on every narcotic written, and I would get a readout every month of all the narcotics written or opioids and sedatives written by physicians in that state.
And prior to 1993, investigations would be open just on prescribing habits. When I became the Director, that stopped. What we did was bring all the pain directors together in that state. We brought the professors. We brought the public groups, et cetera, and we got together and decided how pain should be practiced.
And that's what led to our guidelines. And we had some definitions that other people then came to accept. Nontherapeutic prescribing was a medical use or purpose that is not legitimate. That goes back to the law of the 19-teens.
A prescribing pharmaceuticals are practicing consistent with public health and welfare, is prescribing pharmaceuticals and practicing medicine for legitimate medical purpose in the usual course of professional practice.
What is intractable pain? A pain state in which the cause of the pain cannot be removed or otherwise treated and which in the generally accepted course of medical practice no relief or cure of the cause of the pain is possible or none has been found after reasonable efforts.
You're all familiar with this, but in 1994 when we wrote these, no state had ever taken this position before. We basically that if you're going to prescribe narcotics, counting pills is not the issue. The issue is: are you going to practice good medicine?
And how to determine whether you practice good medicine is whether you take a documented medical history; you do a proper physical examination; you do and have recognized medical indications for the use of those drugs; you have a written treatment plan; you discuss the risk and benefits of the medications with the patients; you do periodic review at reasonable interviews; you keep complete and accurate records; and you closely monitor the patients with any kind of history of substance abuse.
If you do this, you're not going to get in trouble. If you don't, you were, and it became very obvious which physicians were having a problem in the State of Texas because they didn't practice this way. You would go and look at their medical records, and they would write, "Low back pain. Dispense 100" -- whatever the drug was, and that was it.
Well, you don't have to be a rocket scientist to figure out this is not good medical practice, and those physicians we disciplined. But the ones who followed the guidelines were not.
What are the red flags? Issuing prescriptions for large amounts of controlled substances or in excess of prescribed dosage, but knowing certain physicians' practices and how they practice, this became less of an issue as time went on. But failing to keep accurate records, failing to evaluate or monitor their patients, prescribing to drug dependent persons without adequate consultation, evaluation, or monitoring, these were red flags that enabled us to discipline physicians that were not practicing good medicine.
When you look at these numbers, those are the number of disciplinary actions against physicians in the United States from 1993 till 2000 that we've tabulated. The numbers, they're a little rising, but they're pretty much the same in that proportion.
What you can see thought is that controlled substances violations have stayed down pretty low since the time that guidelines have come into play. Prior to this, there were a large number of disciplinary actions solely on the writing of narcotics.
The other thing is contrary to what you heard today, there are not a lot of suspensions or revocations of licenses because of controlled substances writing. They are not happening. They are only happening when there is improper prescribing and improper management of the patient.
They are old wives' tales. They are fear tactics, but they are not occurring.
Now, what's the challenge? The challenge is to protect the medical uses of controlled substances and simultaneously preventing drug diversion and abuse. That's the challenge we all have here.
But in the same time we have to insure public access to effective pain control. We have to weigh both. If you overregulate, the public doesn't get adequate care. If you under regulate, you don't have the proper vehicle for proper medication and proper treatment. This is what the boards must do.
The present status is that only eight states have no policy. In 1993, only two states had policy, Texas and California. So this has been a major jump in the last seven or eight years.
Those that have guidelines and statements amount to the majority of the states. You'll see that the numbers overlap. It's not that I can't count. It's that certain states have more than just a guideline. They may have a statute, et cetera, and they have chosen to either create regulations or create statements or guidelines or a combination.
The real critical factor here is that only eight states have not taken action on this. At that point, after the Texas guidelines came out, the Federation of State Medical Boards then felt that this was an issue and brought together a committee on which I served, as well as, I believe, another seven or eight members, and we created national guidelines that the federation would publish. We had public hearings, and then were recognized by all the states and used as model guidelines.
That was funded by the Robert Wood Johnson Foundation.
We developed those model guidelines for the use by state medical boards and other health care regulatory agencies to promote the appropriate prescribing of controlled substances in the management of chronic malignant and nonmalignant pain.
Our objectives were to establish consistent standards for managing chronic pain based on current research data. And we wanted to promote a nonlegislative approach, a regulatory approach that the state boards could advocate to address the use of controlled substances in the management of chronic pain.
Why was that important? Because we wanted a mechanism in which those people that were regulating the practice of medicine -- and most boards are made up of usually about two thirds physicians and one third public members, who had been in this kind of practice or could get the information from that kind of practice without making it a statute, but still have the regulatory aspects.
Why is a regulation so much important versus a statute? Statutes are difficult to change. Regulations are not. If the research had changed or there was some other issue that had come up, a board could change their regulations in a few months. They could tweak them, but you can't do that with a statute.
So the recommendation was to keep this on a regulatory aspect, and that has worked well in most states.
So what do these model guidelines really advocate? I'm not going to read all of them to you. I'm going to basically tell you this. When it's all said and done, they dome down to if you do a physical examination of the patient, treatment plan, informed consent of the patient, periodic review of drug treatment, consultation and referral if necessary, accurate, timely, and complete medical records, you will not get in trouble with the medical board.
You will if you're writing prescriptions and people are hanging out of your office around the block.
The grant was extended through last year. We created workshops for board investigators. We developed position papers. We communicated with all of the member boards. We created the position, the model guidelines, and we targeted those eight states without policy to work on those.
The next phase will be to improve the quality of patient care through appropriate and effective pain control and build relationships to increase physician knowledge of current standards for appropriate pain treatment. And we must insist and inform the license population of state specific regulations regarding physician responsibilities and treating pain.
Thank you very much.
ACTING CHAIRMAN KATZ: Thank you, Dr. Levy, for a very lucid presentation.
Dr. Levy, why don't you stay there for one minute?
Does anybody sitting around this U-shaped table have any questions for Dr. Levy about his presentation?
DR. LEVY: Yes, sir.
DR. HOLMBOE: Hi. Eric Holmboe from Yale University.
Just out of curiosity, as we know, there are a proliferation of guidelines for a myriad of conditions, and one of the biggest problems is to get physicians to use them. Simply putting out a guidelines has not been shown to be effective in changing the quality of care.
I'd be curious if you could just spend a moment or two describing how you disseminated these guidelines to your physicians and whether or not that was effective.
DR. LEVY: One, I will tell you that guidelines that are practice guidelines must be differentiated between regulatory guidelines. For the first time, the medical board took a position in saying in this condition, we require this to be the good practice of medicine.
We didn't do that for diabetes of hypertension or heart disease, et cetera. We did do it for chronic and malignant pain and acute pain in this management. So that was a unique difference.
If the physician's license is on the line for these kind of guidelines, they listen a lot more than if it's recommended by their society, et cetera.
The second issue is I went out and promoted them. I taught in my position as a director. I went to all of the medical schools in the state, and I spoke to each of the senior classes, each one of the eight years, and I promoted these guidelines and spoke with all of the students, but at the same time I spoke with the residents as well.
The second issue was I went to the pain societies in our state and spoke to them.
The third issue was they were promulgated in our news report which came out boldly printed in the Texas letter.
The fourth issue was that the Texas Medical Association was very helpful in this regard, and they published them as well, as well as the Texas Osteopathic Medical Association in their bulletins. And so this became an issue.
We also had certain reporters around the state who wrote articles in our newspapers promoting this and speaking about this change on the Texas board.
I will tell you that after this time, it became much easier to discipline those physicians who were off the site. But the ones that practiced good medicine found that they were hassled less and were able to practice with less difficulty from intervention by the state medical board.
And my belief, after running a medical board, is that 98, 99 percent of the physicians are there to practice good medicine and do a good job, and your outliers are one or two percent. And when you can set up a regimen where you can really define who those outliers are, it's a lot easier to get at, and they don't make up a large percentage.
DR. MAX: I want to congratulate you on a very wise, beautiful document in our handout on your policies, but let me ask. Now a big issue is doctors who might be sloppy or naive or inexperienced getting deceived by patients who can say they have symptoms. Do you have a position on something like -- and doctors don't know the patients are going to multiple pharmacies.
Does your federation of boards have a position on, say, electronic data collection from pharmacies to inform physicians when multiple doctors are prescribing?
DR. LEVY: Well, you have asked a multi-phasic question. The first one is what do you do about those physicians who are naive.
You give them one bite of the apple. If they have those problems, if they're sloppy in record keeping, you bring them in for a little talk in front of your board. And if they are deficient, then they shouldn't be because that may be a symptom of their entire practice, and it might just not be with pain, but with every other disease they treat. And if that's their practice, they need some remedial help.
If they get it, fine. If that physician would come before us again for the same reason, that physician would be disciplined. So that's the first issue.
The second issue, the federation has not taken a position on the issue that you're describing as of yet.
DR. MAX: Do you have an opinion on that?
DR. LEVY: Ask your question again. I want to be specific in what you want me to have an opinion on. Ask me my opinion.
DR. MAX: Specifically, I think more interestingly we heard the doctor from Virginia, from the Epicenter of the Oxycontin.
DR. LEVY: Right.
DR. MAX: You're sounding like there really isn't much of a problem if you leave it to the state boards. So what do you have to say to that physician from Virginia?
DR. LEVY: I say that the regulations are written already for the states. It is up to the state boards to do their jobs and evaluate these physicians, and if those physicians are allowing diversion, allowing doctor shopping; if they're practicing irresponsibly, then those physicians must be disciplined by the Board.
And then you get into other issues of whether there should be criminal prosecution of those physicians if they knowingly or intentionally did something that was absolutely harmful to a patient.
Your second issue is whether you should collect information on the Internet if you're doctor shopping. Well, you have a responsibility. We have not taken a position on the collection of information at this point.
But if you're going to manage these patients, you have a responsibility to manage them in the best care, and one of the aspects of informed consent is to tell them you are going to take care of them and not to doctor shop.
DR. MAX: But how do you know if patients are doctor shopping? Can you expect a doctor to call all of the pharmacies?
DR. LEVY: No, you cannot.
ACTING CHAIRMAN KATZ: Dr. Foley.
DR. FOLEY: Thank you very much for your presentation.
What has been the role from the federation's perspective of really educating doctors about pain management? Are there any guidelines related to that and any responsibilities?
It is the responsibility of the boards -- I've recently been talking with the board in Florida -- for them to try to make these kinds of guidelines available, but they've stated that they don't have funds to send them out every member in the state, and many states don't, in fact, provide these guidelines to every physician at the time that they're licensed.
So what, in fact, is the role of the boards in setting these guidelines to also play a role in educating physicians about proper pain management?
DR. LEVY: Well, that was part of our second phase. We believe that it is the responsibility of the Boards to educate their physicians, and when I was the Director in Texas, every physician to get a license had to pass a jurisprudence exam and have a visit with me. And part of that visit was to understand pain guidelines, et cetera.
So we presented them to all physicians as well as publishing them in our newsletter periodically, and it doesn't cost any money to publish them as part of your articles in your newsletters, which --
DR. FOLEY: Yeah, I think I'm confusing it. It's teaching about pain as opposed to teaching them the guidelines.
DR. LEVY: That's a unique issue that we all have seen. There has not been any increased teaching of pain in the 25, 26 years that I've been involved in pain work, and I think you have the same experience, Dr. Foley. We haven't seen this great increase in training physicians in the management of pain.
ACTING CHAIRMAN KATZ: Dr. Smiley.
DR. SMILEY: Yeah, I just want to maybe have you elaborate or respond to the following question. You state that the anecdotes that we've been hearing today from patients and from professionals about sort of a chilling effect of medical board actions or regulation in general on physician prescribing for patients in pain, prescribing of opioids, pharmacies not stocking drugs, those kind of problems that we hear that you kind of say are just anecdotes.
And you know, we all know -- at least I do -- that there are certainly physicians I deal with who have problems, who hesitate to prescribe opioids when they're indicated. There are patients who can't get drugs at various pharmacies. Is it your position that this is doctors not knowing what they're supposed to do? Is it the fault of the medical board, or is it, in fact, sort of a nationwide anti-drug hysteria and it's just easier to ignore pain and not deal with it?
And doesn't the medical board, I guess, have a responsibility to be promoting good medical care and not just being many DEAs?
DR. LEVY: Well, one, I believe that medical boards do promote good medical care by creating these guidelines.
Two, if you look at most of the medical practice acts though, they don't specifically tell you that you should create guidelines for every treatment of every type of disease.
Third, I would never question anecdotes. These are experiences people had. My opinion is that they are anecdotes though; that if you look at the regulation, that physicians can practice this way. They can practice good medical care in chronic pain management, and if they are not practicing good medical care, one could be an excuse by that physician that they don't want to or, two, they could be uneducated.
Now, it is the responsibility of the medical boards to educate those physicians on guidelines. It's not the responsibility of medical boards to educate them on practice.
Yes, sir.
ACTING CHAIRMAN KATZ: Dr. Ashburn.
DR. ASHBURN: Thank you very much.
I have a couple quick questions. On two of your slides you talked about the number of violations that have occurred. I wanted to refer back to those --
DR. LEVY: Okay.
DR. ASHBURN: -- for a minute because if I understood you correctly, you felt that these were evidence that the perception that physicians were at risk for regulatory scrutiny that might cause them to lose their license or undergo other issues was actually not valid.
So on the first slide entitled "Controlled Substances Violations by Prescribing Physicians" --
DR. LEVY: Yeah, I'm trying to get back there.
DR. ASHBURN: One more.
DR. LEVY: That one?
DR. ASHBURN: That one.
DR. LEVY: Yeah.
DR. ASHBURN: Is this -- I wanted to make sure I understood. Now, this slide is based on national data.
DR. LEVY: This is the federation data of all the boards collected from the year 2000.
DR. ASHBURN: Okay. So this is not violation of the Controlled Substances Act.
DR. LEVY: This is all violation --
DR. ASHBURN: This is violation of state medical board -- these are lists of state medical board actions.
DR. LEVY: These are disciplinary actions against --
DR. ASHBURN: Okay.
DR. LEVY: -- physicians in all the states of the Union for these years.
DR. ASHBURN: Okay. So one thing that should be pointed out is that physicians can get into trouble with regard to prescribing of opioids in two ways essentially, maybe more, but we worry about actions against our medical license, which this is represented by, as well as scrutiny for violation of the Controlled Substances Act, which one would be subject to investigation by Department of Justice and the DEA.
DR. LEVY: Well, let me try to explain this then. When you look at these total actions, the majority of those are for quality of care cases, and others may be sexual abuse of patients or --
DR. ASHBURN: Sure, I understand.
DR. LEVY: -- et cetera. What I'm trying to point out is of those 4,600 disciplinary actions only 319 were directly related to controlled substances.
DR. ASHBURN: No, and I appreciate that, but as somebody who has to listen to other physicians who express a little bit of the paranoia, I just want to also point out that 319 disciplinary actions against physicians is one action a business day. I mean, that's not an insignificant number of nationwide areas with regard to physicians being concerned about actions.
On your second slide on actions' percentage by total, the numbers didn't add up, and I was wondering whether or not these were, again, national numbers on state medical board actions, revocations, suspensions, probations, and miscellaneous. These usually are about 100, give or take. The actions under controlled substances usually are about 300 a year, give or take.
These are percentages?
DR. LEVY: Yeah, these are percentages.
DR. ASHBURN: All right. I just don't know how to read well.
DR. LEVY: Can we go back to your last comment though?
DR. ASHBURN: Sure.
DR. LEVY: You said 319 were significant or 300 are significant. When you add that up, that's approximately of 700,000 physicians in this country. You believe that is a significant number of physicians who are disciplined? Six maybe per state?
DR. ASHBURN: No, it doesn't surprise me. I'm just -- you know, I know anecdotally, again, of only one or two cases where physicians have been disciplined for under prescribing of opioids. So I'm just presenting this scenario.
Now, you know, frequently in policy making and frequently in physician practices, the decisions are based on their perception of reality as well as what reality is, and if I'm an odds maker and I'm looking at the risk of being sanctioned for doing nothing, which is extremely low, or the risk of scrutiny by doing something, then I'm going to tend to shy away particularly with all of the publicity about risk with opioids, tend to shy away from prescribing opioids for my patients based on concern of regulatory scrutiny whether it exists or not.
And I think I was just -- I wanted to make that observation.
DR. LEVY: Since I've seen most of these actions and have read the orders, I would say that these people are what I would describe as true outliers Okay? By and large, and for the physician who's practicing good medicine are not going to fall in this 319 in any way, shape or form.
So to equate that this should concern physicians is incorrect. That it does you may be correct, that the perception is there.
What I'm trying to point out is that the reality is not there.
DR. ASHBURN: Okay. Thank you.
ACTING CHAIRMAN KATZ: Dr. Carlisle.
DR. CARLISLE: Do you have any idea of what percentage of that 319 that you actually found violations -- the question is: what is the n for that? How many investigations produced this 319?
DR. LEVY: That I can't tell you because this is an aggregate data of all the states, and we don't collect investigation numbers. Each state does, but the federation doesn't. It only collects final actions against physicians.
DR. CARLISLE: Do you have any sense of that number?
DR. LEVY: I can only speak from Texas, and I would open approximately 1