Tim Guith Trigeminal Neuralgia, TN FAQ Info, Information Medical Disorder.

Trigeminal Neuralgia , TN, tic douloreaux, is the trigeminal nerve producing false signals from the brain sending excruciating lightening strikes of facial pain to one side of the face. Compendium. My new Dr. has prescribe a small does of methadone, an opiod. Therefore I had to add a little more research to this page. See my TN Story below or go to: http://www.PartyTentCity.com/mytnstory.html .

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102 WAR ON PAIN: THE FLEECING OF AMERICA'S PAIN PATIENTS UNDER OPIOID THERAPY

By katt52@webtv.net http://pnews.org/art/2art/warpain.html

There's a little known secret that's happening all across the nation, robbing people of their dignity and killing others. It is the same little secret that makes the suicide rate 900% higher than in the national average. (Intelihealth August 4,1997)

Chronic pain is the most under treated epidemic that our nation has ever faced. Millions of Americans suffer needlessly, shunned by a medical community that is running scared. On a regular basis, family physicians and pain specialists alike, are losing there ability to prescribe narcotics to their chronic intractable pain patients. The government's unsuccessful "War on Drugs" project has done nothing to stop the pouring of drugs over the borders or the black market, street drugs. What it HAS done is put the medical community under siege by the Drug Enforcement Agency (DEA). In the DEA's quest to look like they are winning the "War on Drugs", they have turned to your doctor's office for suspects.

Cases in point" Click Here:

Cases in point:

1992 Dr. McNiel- Mosheim, Tennessee

Notified that he was under investigation when two "badged" officers came into his office to look at patient's files. Over a year later, charges were brought against Dr. McNiel for "non-theraputic" prescription writing. Along with more than $20,000 in fines, Dr. McNiel was labelled as having a "co-dependent" relationship with his patients. He was court ordered into a co-dependency group. He fought back and won. He is now back in practice.

1996- Dr. McFadden- Tupelo, Mississippi

Federal and state investigators showed up with a search warrants, seizing the medical records of 36 of his patients. A few months later, Dr. McFadden was charged with eleven counts of violating the Mississippi Medical Practice Act. It took several years of exhausting all means, both financially and emotionally, but he fought back and won. He is now back in practice.

1998- Dr. Metellus- Davie, Florida

Two under-cover police officers went to Dr. Metellus' office posing as pain patients. Equiped with fraudulent X-rays, the officers received pain medication. The officers then filled the presciptions and later arrested Dr. Metellus for drug trafficking. This family physician, with no prior record, is serving a 25 year mandatory sentence and faces over 1/2 million dollars in fines.

Dr. Ronald Wright, the former Broward County Medical Examiner told reporter, John Grogan, "I think he was completely set up." Wright was hired by the state to interpret Metellus' medical records and has gone on record saying, "From my perspective, it's pretty clear. He's innocent." (Sun Sentinel, June 17, 1998)

"The Police State of Medicine"

Dr. William Hurwitz, who himself had lost his license in 1996 for over prescribing opiates, spoke to the Drug Policy Foundation in 1997, of his patients..." over 200 of these patients with crippling pain from failed backs, arthritis, multiple sclerosis, interstitial cystitis, arachnoiditis, RSD, TMJ, Trigeminal neuralgia, and phantom limbs. . . the list goes on and on and on. Many of them had come to me after years of unsuccessful attempts to obtain relief from a multitude of procedures, doctors, and pain clinics. They were treated like addicts and criminals.

They were stigmatized, insulted, neglected and abandoned. Betrayed by the whole medical profession with the refrain, 'I would like to help you, but I can't. I don't want to lose my license.' But who can blame the doctors, who are themselves the victims of the thuggish drug-control police and the heartless and mindless bureaucrats who serve on boards of medicine."

Skip Baker, president of the American Society for Action on Pain (ASAP) contributed the following, "If the public knew for instance that the chance of "addiction" was less than one half of one percent for a Pain Patient, or that tens of thousands MORE people die from LACK of drugs, than die as a RESULT of them, that millions of innocents are in jail for nothing, they would know the scare was all propaganda. By instilling FEAR in the American People about "Drugs" they can better control them. First it was FEAR of the USSR, now it's drugs. The entire undertaking is to get people so afraid of a non-threat that they are willing to give up the Constitution in order to be "protected" from the alleged threat. The only "threat" that's out there is the attack on the truth."

A recent New England Journal of Medicine editorial stated that 56% of cancer outpatients and 82% of AIDS outpatients received inadequate pain treatment.

In an article in the "Toronto Star" (July 17,1998) Don Colburn writes, "To the researchers who recently studied cancer pain in more than 13,000 nursing home patients, one finding stuck out like the proverbial sore thumb....

What stunned the researchers was that one out of four of the patients in day-in, day-out pain received no pain medication at all. "We thought we'd find a more ambiguous issue of undertreatment of pain - but not no treatment," says Vincent Mor of the Centre for Gerontology and Health Care Research at Brown University and co-author of the pain study. "That's the most disturbing finding -the absence of even very mild analgesics for 26 per cent of the patients in pain." "Daily pain is prevalent among nursing home residents with cancer and is often untreated, particularly among older and minority patients," the study concludes.

Previous studies also found that pain is widely undertreated in both hospitals and nursing homes.

Researchers offer several reasons why pain goes untreated, particularly in older patients. They include poor communication, inadequate training of doctors and exaggerated fears about addiction. "Drugs, particularly narcotic painkillers, are not viewed positively" by nurses and doctors, Mor adds. "There's a very strong worry about addiction." Yet the American Geriatrics Society guidelines, issued in March, concluded that addiction "appears to be very low" in such patients."

From a pain forum on the internet, these words tell a tale of frustration and despair,

"...how many more pain patients will become one of the 200 people who call Dr Kevorkian weekly, before this insanity stops? How can we watch the goverment "criminalize" pain patients while putting themselves in a position of practicing medicine without the benifits of a medical degree? When the DEA enters into the medical field and sets protocol for what constitutes "over-prescibing", a situation is created where non-medical people are deciding medical policy."

According to the "National Chronic Pain Outreach Association" an estimated 34 million patients suffer from chronic pain and that an estimated 7 million of these patients can't relieve their pain without opiods.

There's change in the air as people like Skip Baker over at ASAP, continue to fight for the rights of pain patients. An internet forum, created to exchange ideas and offer support, continues to grow in numbers. When contacted, Mr. Baker offered the following, "The War on Drugs has become a "War on People in Pain" and is effecting at least 8 million Intractable Pain Patients whose pain can only be controlled with powerful narcotic pain medicine. 30 million more have some form of Chronic Pain. For the DEA it's much easier to "go after" an unarmed doctor than a "drug dealer" in the streets. They have put so many caring doctors out of business for treating pain, that there are nearly none left to deal with the problem of Chronic Pain. As a result, thousands are taking their own lives each year, and at least 17,000 are dying as a result of the bleeding complications of NSAIDS, because doctors are afraid to prescribe "real" pain medicine."

K A T T

[NOTE: Attitudes must change. Doctors have been prevented from helping patients by not prescribing adequate pain medication to chronic-pain patients, for fear of losing their licenses to practice proper medicine. The problem for those with Chronic Pain has never been addiction, it is a quality of life often unattainable, and the solution is simply a lack of public information. Thanks katt for providing this timely article.-----TheGolem]

108 http://www.docgetty.com/Chronic.html

Chronic Pain

Dental/Oral Conditions seen frequently which can cause chronic pain:

Cavities (Dental Caries)
Inflamed Dental Nerve (Pulpitis)
Abscess of tooth (Periapical)
Abscess of gums or bone supporting tooth (Periodontal)
Fungal or viral infections of mouth lining
Poor bite (Malocclusion)
Joint Problems (TMJ)
Trauma

Non-Dental conditions which can cause pain in the teeth or oral structures.

Sinus infections, inflammation, drainage
Weather and altitude changes
Central nervous system disorder or disease

Infrequently seen painful conditions

Trigeminal Neuralgia
This very painful condition typically manifests itself as sharp, electric, lightning-bolt pain in the face, which can be triggered by touching the face, by a puff of wind, or it may come on spontaneously. It may be regular or very sporadic. True trigeminal neuralgia seems to be associated at times with pressure against the trigeminal nerve near its exit from the skull.
Atypical Facial Pain

This type of pain is more difficult to characterize, and depending upon the method of classification used may have several sub-categories, such as myofascial pain, idiopathic pain, and other types of rare pain. Idiopathic means that the cause is unknown.

Neuralgia Inducing Cavitational Osteonecrosis (NICO)

Also known as ischemic necrosis, and formerly referred to by some as non-supportive osteomyelitis, this condition is becoming more well known and better understood, as ongoing research is conducted. NICO is described in Oral and Maxillofacial Pathology, by Neville, Damm, Allen, and Bouquot. This is the textbook most frequently used in dental schools in the United States.

Symptoms may include severe pain in the face, behind the eyes, or even around the top, sides, or back of the head. In the case of NICO, this pain is referred from some area in the jawbones, either upper (maxilla) or lower (mandible).

Brian

The actual source of disease may be traced to abnormal bone, often where a tooth has been extracted earlier. Due to poor healing, pathogenic bacteria, suppressed immune system, clotting disorders, or a combination of these, the nerves in these areas can react in highly unusual ways, causing excruciating pain in areas seemingly unrelated to the source. For example, a NICO defect in the lower back jaw may cause a burning pain on the side or the top of the head. The clinical appearance of the diseased area may seem normal, and radiographs do not always show these pockets in the bone, due to the nature of density variations between inner and outer bone and the way in which radiographs are typically exposed. Certain tests may be performed to determine if an area of NICO exists and where it is located. Surgical exposure of the site of ischemic necrosis will reveal dead bone and poor healing, with seldom any trace of pus. Examination of the excised tissue from such sites shows a unique appearance under the microscope. Dr. Jerry E. Bouquot, oral pathologist, head and neck diagnostics, Morgantown, WV, has done much research into this disease, as has Dr. R.E. McMahon of the Oral Surgery Group, Merrillville, IN. For additional information, please visit The Maxillofacial Center for Diagnostics and Research.

Many patients who are determined to have ischemic necrosis of the jawbones may receive some relief from the surgical debridement of the bony lesion, with subsequent re-evaluation and retreatment as necessary. Actual treatment modalities vary, as do results.

Frequently this disease is not identified until the patient has exhausted all other avenues of relief, with no discovery of the source of the problem, until eventually the patient is told the pain does not exist, or until they come upon someone familiar with this rare anomaly.

Dr. Getty first encountered NICO when his father was successfully treated for it in 1981. After graduating from dental school, Dr. Getty continued his interest in this malady, and has studied with Dr. Bouquot. He has experience with treating numerous NICO/ischemic necrosis patients both locally and from as far away as New England, Florida, and even Brazil. He is a clinical investigator with the North American NICO Research Group, and has given testimony as an expert witness before the Superior Court of Washington, DC.

If you have unexplained head or face pain, and have already been determined to be free from known dental disease, such as cavities or abscesses, sinusitis or TMJ, you need to be sure to rule out a central problem, such as a brain tumor or arterial pressure on a nerve inside the skull. This requres a referral to a neurologist and should be done prior to exploring for any NICO lesion(s). The neurologist will undoubtedly order an MRI and/or CAT scan. If this is negative, and no other source of pain can be identified, please feel free to contact our office for an evaluation. A full examination, necessary radiographs, and in-office tests can be performed. This usually takes about 1-2 hours. Treatment will vary on a case by case basis. If you have been seen by multiple practitioners in the past, it is good to bring a concise summary of all such previous evaluations and treatments, as is relates to the pain problems you have had.

NICO has been identified most often in areas of previous extraction(s), but has also been seen in areas of failed root canals or in sinus infections which perforate into the maxilla. Often the pain will not occur until years, even decades after the initial extraction or root canal. Antibiotic therapy alone may temporarily decrease pain but seldom alleviates the underlying cause.

110 http://www.cpmission.com/main/model.html

THE FEDERATION OF STATE MEDICAL BOARDS OF THE UNITED STATES, INC.

MODEL GUIDELINES FOR THE USE OF CONTROLLED SUBSTANCES FOR THE TREATMENT OF PAIN(Adopted May 2, 1998)

Section I: Preamble

The (name of board) recognizes that principles of quality medical practice dictate that the people of the State of (name of state) have access to appropriate and effective pain relief.

The appropriate application of up-to-date knowledge and treatment modalities can serve to improve the quality of life for those patients who suffer from pain as well as to reduce the morbidity and costs associated with untreated or inappropriately treated pain. The Board encourages physicians to view effective pain management as a part of quality medical practice for all patients with pain, acute or chronic, and it is especially important for patients who experience pain as a result of terminal illness. All physicians should become knowledgeable about effective methods of pain treatment as well as statutory requirements for prescribing controlled substances.

Inadequate pain control may result from physicians' lack of knowledge about pain management or an inadequate understanding of addiction. Fears of investigation or sanction by federal, state, and local regulatory agencies may also result in inappropriate or inadequate treatment of chronic pain patients. Accordingly, these guidelines have been developed to clarify the Board's position on pain control, specifically as related to the use of controlled substances, to alleviate physician uncertainty and to encourage better pain management.

The Board recognizes that controlled substances, including opioid analgesics, may be essential in the treatment of acute pain due to trauma or surgery and chronic pain, whether due to cancer or non-cancer origins. Physicians are referred to the U.S. Agency for Health Care and Research Clinical Practice Guidelines for a sound approach to the management of acute1 and cancer-related pain.

The medical management of pain should be based upon current knowledge and research and includes the use of both pharmacologic and non-pharmacologic modalities. Pain should be assessed and treated promptly and the quantity and frequency of doses should be adjusted according to the intensity and duration of the pain. Physicians should recognize that tolerance and physical dependence are normal consequences of sustained use of opioid analgesics and are not synonymous with addiction.

The (state medical board) is obligated under the laws of the State of (name of state) to protect the public health and safety. The Board recognizes that inappropriate prescribing of controlled substances, including opioid analgesics, may lead to drug diversion and abuse by individuals who seek them for other than legitimate medical use. Physicians should be diligent in preventing the diversion of drugs for illegitimate purposes.

Physicians should not fear disciplinary action from the Board or other state regulatory or enforcement agency for prescribing, dispensing, or administering controlled substances, including opioid analgesics, for a legitimate medical purpose and in the usual course of professional practice. The Board will consider prescribing, ordering, administering, or dispensing controlled substances for pain to be for a legitimate medical purpose if based on accepted scientific knowledge of the treatment of pain or if based on sound clinical grounds. All such prescribing must be based on clear documentation of unrelieved pain and in compliance with applicable state or federal law.

Each case of prescribing for pain will be evaluated on an individual basis. The board will not take disciplinary action against a physician for failing to adhere strictly to the provisions of these guidelines, if good cause is shown for such deviation. The physician's conduct will be evaluated to a great extent by the treatment outcome, taking into account whether the drug used is medically and/or pharmacologically recognized to be appropriate for the diagnosis, the patient's individual needs including any improvement in functioning, and recognizing that some types of pain cannot be completely relieved.

The Board will judge the validity of prescribing based on the physician's treatment of the patient and on available documentation, rather than on the quantity and chronicity of prescribing. The goal is to control the patient's pain for its duration while effectively addressing other aspects of the patient's functioning, including physical, psychological, social and work-related factors. The following guidelines are not intended to define complete or best practice, but rather to communicate what the Board considers to be within the boundaries of professional practice.

Section II: Guidelines

The Board has adopted the following guidelines when evaluating the use of controlled substances for pain control:

Evaluation of the Patient
A complete medical history and physical examination must be conducted and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record should also document the presence of one or more recognized medical indications for the use of a controlled substance.
Treatment Plan
The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.
Informed Consent and Agreement for Treatment
The physician should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient, or with the patient's surrogate or guardian if the patient is incompetent. The patient should receive prescriptions from one physician and one pharmacy where possible. If the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the physician may employ the use of a written agreement between physician and patient outlining patient responsibilities including (1) urine/serum medication levels screening when requested (2) number and frequency of all prescription refills and (3) reasons for which drug therapy may be discontinued (i.e. violation of agreement).
Periodic Review
At reasonable intervals based upon the individual circumstance of the patient, the physician should review the course of treatment and any new information about the etiology of the pain. Continuation or modification of therapy should depend on the physician's evaluation of progress toward stated treatment objectives such as improvement in patient's pain intensity and improved physical and/or psychosocial function, such as ability to work, need of health care resources, activities of daily living, and quality of social life. If treatment goals are not being achieved, despite medication adjustments, the physician should re-evaluate the appropriateness of continued treatment. The physician should monitor patient compliance in medication usage and related treatment plans.
Consultation
The physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those pain patients who are at risk for misusing their medications and those whose living arrangement pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care, monitoring, documentation, and consultation with or referral to an expert in the management of such patients.
Medical Records
The physician should keep accurate and complete records to include (1) the medical history and physical examination (2) diagnostic, therapeutic and laboratory results (3) evaluations and consultations (4) treatment objectives (5) discussion of risks and benefits (6) treatments (7) medications [including date, type, dosage, and quantity prescribed] (8) instructions and agreements and (9) periodic reviews. Records should remain current and be maintained in an accessible manner and readily available for review.
Compliance with Controlled Substances Laws and Regulations
To prescribe, dispense, or administer controlled substances, the physician must be licensed in the state, and comply with applicable federal and state regulations. Physicians are referred to the Physicians Manual of the U.S. Drug Enforcement Administration and (any relevant documents issued by the state medical board) for specific rules governing controlled substances as well as applicable state regulations.

Section III: Definitions For the purposes of these guidelines, the following terms are defined as follows:

Acute pain:

Acute pain is the normal, predicted physiological response to an adverse chemical, thermal, or mechanical stimulus and is associated with surgery, trauma and acute illness. It is generally time limited and is responsive to opioid therapy, among other therapies.

Addiction:

Addiction is a neurobehavioral syndrome with genetic and environmental influences that results in psychological dependence on the use of substances for their psychic effects and is characterized by compulsive use despite harm. Addiction may also be referred to by terms such as "drug dependence" and "psychological dependence." Physical dependence and tolerance are normal physiological consequences of extended opioid therapy for pain and should not be considered addiction.

Analgesic Tolerance:

Analgesic tolerance is the need to increase the dose of opioid to achieve the same level of analgesia. Analgesic tolerance may or may not be evident during opioid treatment and does not equate with addiction.

Chronic Pain:

A pain state which is persistent and in which the cause of the pain cannot be removed or otherwise treated. Chronic pain may be associated with a long-term incurable or intractable medical condition or disease. Pain: an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.

Physical Dependence:

Physical dependence on a controlled substance is a physiologic state of neuroadaptation which is characterized by the emergence of a withdrawal syndrome if drug use is stopped or decreased abruptly, or if an antagonist is administered. Physical dependence is an expected result of opioid use. Physical dependence, by itself, does not equate with addiction.

Pseudoaddiction:

Pattern of drug-seeking behavior of pain patients who are receiving inadequate pain management that can be mistaken for addiction.

Substance Abuse:

Substance abuse is the use of any substance(s) for non-therapeutic purposes; or use of medication for purposes other than those for which it is prescribed.

Tolerance:

Tolerance is a physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce the same effect or a reduced effect is observed with a constant dose.

National Association of State Controlled Substance Authorities Resolution Endorsing the Federation's Model Guidelines
http://www.medsch.wisc.edu/painpolicy/domestic/NASCSA.htm

American Academy of Pain Medicine Position and Consensus on The Use of Opioids for the Treatment of Chronic Pain:
http://www.painmed.org/productpub/statements/opioidstmt.html

Tim Guith's Page 5. Sections on Opiods WAR ON PAIN: THE FLEECING OF AMERICA'S PAIN PATIENTS UNDER OPIOID THERAPY Trigeminal Neuralgia, aka Tic douloreaux or TN
& Temporomandibular Joint aka TMJ Click Here to see my other record file at IAmFightingCancer.com Bookmark this page now!
Scan down to read my very lengthy and detailed web journal. Call me if I can help you. 713-467-3025 Brian

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111 http://www.painandthelaw.org/mayday/ziegler_lovrich_010702.php

OxyContin and the Need for Perspective

OxyContin and the Need for Perspective
Stephen J. Ziegler, JD and Nicholas P. Lovrich, Jr., PhD
Washington State University
January 2002

If citizens were to take at face value what is most often heard from contemporary politicians and the broadcast media, they would probably think that OxyContin constitutes one of the most significant current health threats to our nation, and believe further that the drug should either be much more strictly controlled or taken out of circulation entirely. However, as a matter of actual fact the danger posed by the availability of this drug is not nearly so great as it is made out to be. If we look beyond the media sensationalism and the demagogic politics associated with the drug, we would find that OxyContin is likely the newest target in an on-going, multi-faceted war on drugs; this war is rather unusual in that it represents a national campaign that is being waged primarily against its own citizens. Although we fully recognize that the abuse of OxyContin has led to indisputable harm, it is also the case that other, far less strictly regulated substances pose a substantially greater risk without attracting anywhere near the same attention. In the following essay we examine some of the state and national politics involved in the war against OxyContin, and we argue that not only should the drug be put in proper perspective, Congress should follow its very own advice.

First, there should be little doubt that OxyContin serves as a very convenient target in the war on drugs. The past four decades have witnessed numerous drug wars, most of which have been waged on our own domestic soil. Drug wars have been initiated against heroin, LSD, cocaine, marijuana, methamphetamine, and most recently OxyContin. But is this declaration of intense and sustained public effort really aimed at drugs per se, or are there other policy objectives that are well served by maintaining a "war on drugs" of some kind? According to Joseph Miranda this war is not being waged against drugs, but is rather being directed against some groups of people and "society in general" (1). In fact, Miranda goes so far as to argue that the actual goal in this war "is not to suppress drugs, but to carry out some unstated political agenda" (1, 2). There is likely some support for this contention inasmuch as drugs and politics would seem to be tailor-made for each other; few public figures can argue against public efforts to prevent drug addiction or to prosecute drug violators, so fighting the war on drugs is often a very attractive political issue at both the state and federal level (3, 4).

For example, as sensationalized media reports fueled the OxyContin controversy, Connecticut Attorney General Richard Blumenthal felt compelled to enter the fray by offering his own suggestions concerning the dispensing and marketing of the drug. In a letter addressed to the president of Purdue Pharma, the manufacturer of OxyContin, Attorney General Blumenthal called for the centralization of distribution and the reduction in the number of pharmacies which could dispense the drug (5). Moreover, Attorney General Blumenthal also suggested that Purdue Pharma "voluntarily limit the distribution of OxyContin only to physicians who have extensive experience or training in pain management" (5). These recommendations raise serious questions and concerns. What is to be done about patients who cannot travel to a centralized pharmacy or who are not under the care of a physician who is specifically trained to use this drug? Reducing the number of pharmacies that can dispense the drug or limiting the number of physicians that can prescribe may help fight the war on drugs to a very limited degree, but it does so at the expense of patients who need the drug to manage pain. Although we think these recommendations would amount to bad policy if adopted, Attorney General Blumenthal is not alone in making recommendations concerning OxyContin; Congress has also jumped on the OxyContin band-wagon.

On December 11, 2001, a congressional subcommittee hearing was held on the use and abuse of OxyContin (6). Over the course of six hours, testimony was heard from five panels of witnesses, most of whom represented the law enforcement or addiction treatment community and took up a substantial portion of the hearing. Although the chair of the subcommittee, Representative Frank Wolf (R-VA.), appeared to be legitimately concerned about the need to balance patient care against regulation and prevention of abuse, several comments by other subcommittee members represented demagogic politics as usual (e.g., one stated that OxyContin abuse represented the worst scourge in the drug wars, that it wreaked havoc on adolescents and was linked to a rise in prostitution). In addition to the issuing of politically charged statements, more than one member of Congress raised the possibility that a ban could be placed on the drug. In fact, near the close of Dr. Goldenheim's testimony (Purdue Pharma), Representative Jose Serrano (D-NY) offered the drug company the following unsolicited advice: "It really won't matter how many people are being helped [by your drug], the focus will be on how many lives are being lost" (6). Not only is this statement an interesting recognition of the value of the drug as a medical tool in pain management, but it serves to set the OxyContin controversy in its proper politicized perspective.

For instance, much has been made of the allegation that the availability of OxyContin has lead to several hundred deaths and/or cases of addiction. Although the improper use of OxyContin has undoubtedly led to some deaths, the risk of death or harm is certainly not limited to OxyContin. For example, 16,500-20,000 deaths per year have been attributed to the use of non-steroidal anti-inflammatory drugs (NSAIDs) (7-9). Moreover, some patients who are already on prescription NSAIDs supplement their drug regimen with over-the-counter (OTC) NSAIDs that may increase "the risk of experiencing an NSAID-related gastrointestinal hemorrhage" (7). Granted, NSAIDs are not scheduled drugs, nor are they addictive, but if the focus is not how many people are helped but on the number of lives being lost, where are the press coverage and the congressional hearings on NSAIDs? If we are indeed focusing our societal attention on the number of deaths associated with the misuse of controlled substances, what should be done about the risk posed by the habitual use of tobacco? Albeit tobacco is subject to some level of regulation, unlike OxyContin it can be purchased legally without a prescription by anyone of legal age in any state. Moreover, unlike the hundreds of deaths attributed to OxyContin, the Center for Disease Control (CDC) reports that a staggering 430,000 deaths per year are attributable to the abuse of tobacco (smoking) (10). Consequently, do the number of lives lost really determine whether Congress will ban a substance or procedure? Whereas OxyContin has no doubt helped a great number of patients, how many people are "being helped" by tobacco?

In conclusion, as the testimony of Dr. Simmons and other witnesses on the medical panel indicated, preventing pharmaceutical diversion while ensuring opioid availability is an extremely complex problem deserving of careful study and tempered judgment (6, 11-12). The underlying problem is drug abuse; the problems associated with OxyContin are merely symptoms of a greater disease. This is a matter of societal pathology that will not be cured by passing tougher drug laws, arresting more people, or using OxyContin as a popular political issue to spice up the news or to promote reelection prospects. What is needed is an informed and civil policy debate; such a debate would likely require the making of some tough choices, choices that may even require a partial departure from the war on drugs. We are inclined to believe that Congressman Serrano's advice is basically sound - that is, the focus of our attention in public policy should be on the number of lives lost. However, if Congress followed its own advice, we doubt that the focus of its attention would remain on OxyContin.

112

Current Age	Life Expectancy
50	30 years
55	28 years
60	24 years
65	20 years
70	16 years
75	12 years
80	9 years
85	6 years
90	5 years

(data from IRS Publication 590, Appendix E, Table 1, December 12, 1999)

I just thought you would like to see this little chart. Only Las Vegas can give better odds.

113 http://www.pslgroup.com/dg/CAD6.htm

OxyContin Tablets Hailed by World Pain-Care Community

VANCOUVER, B.C., Sept. 27, 1996 -- OxyContin(TM) generated a groundswell of international support at this year's meeting of the International Association of the Study of Pain (IASP). The enthusiasm of IASP members parallels the powerful U.S. response to the launch of OxyContin -- enabling the drug to achieve its entire expected first-year sales in only eight months.
OxyContin, a unique, controlled-release form of oxycodone, fits the profile of opioids hailed by experts at IASP. As Stephen Long, MD, Pain Specialist at the Virginia Commonwealth University/Medical College of Virginia, declared: "Now, thanks to controlled-release opioids, we can give our patients around-the-clock, opioid pain control for both cancer and non- cancer pain."
Dr. Long's opinion echoed through the 3-day meeting. Many IASP members shared the opinion that OxyContin is an excellent opioid for moderate to severe pain requiring opioid therapy for more than a few days. For instance, OxyContin may be appropriate for pain of back injury, arthritis, and other types of noncancer pain, as well as for cancer pain. In the past, other opioid drugs, such as morphine, were generally reserved for only cancer pain.
OxyContin reached total U.S. sales of $26 million, four months earlier than projected by Purdue Pharma L.P. -- the company that developed and patented OxyContin. Abbott Laboratories now copromotes OxyContin with Purdue Pharma. By year's end, sales will range from $130,000 to $150,000 for each Purdue or Abbott sales representative, bringing total sales to more than $40 million.
OxyContin is the only oral oxycodone that acts for a full 12 hours to relieve pain -- making it the longest-lasting oxycodone ever. Unlike Percodan(R)*, Percocet(R)* and other combination products, it contains no aspirin or acetaminophen that may be potentially toxic in maximal daily doses.
With OxyContin, analgesic onset occurs within 1 hour in most patients. There is no ceiling effect to analgesia, allowing physicians to titrate the dosage upward when needed for pain control. Common opioid side effects, except for constipation, often diminish over time for many patients taking OxyContin.
Please read the accompanying prescribing information for OxyContin Tablets.
OxyContin Tablets are to be taken whole. Taking broken, chewed, or crushed tablets could lead to the rapid release and absorption of a potentially toxic dose of oxycodone.
The most serious risk associated with opioids, including OxyContin, is respiratory depression. Common opioid side effects are constipation, nausea, sedation, dizziness, vomiting, pruritus, headache, dry mouth, sweating, and weakness.
* Registered trademark, DuPont Merck Pharmaceutical Co.
q12h
OxyContin(TM) CII
(Oxycodone HCl Controlled-Release) Tablets
Warning -- May be habit forming
10 mg * 20 mg * 40 mg
Brief Summary on OxyContin(TM) (oxycodone hydrochloride controlled-release) Tablets.
Before prescribing, see complete prescribing information, including DOSAGE AND ADMINISTRATION.
INDICATIONS AND USAGE:
For the management of moderate to severe pain where use of an opioid analgesic is appropriate for more than a few days.

CONTRAINDICATIONS:
OxyContin is contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated. This includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment), and patients with acute or severe bronchial asthma or hypercarbia. OxyContin is contraindicated in any patient who has or is suspected of having paralytic ileus.
WARNINGS:
OxyContin TABLETS ARE TO BE SWALLOWED WHOLE, AND ARE NOT TO BE BROKEN, CHEWED OR CRUSHED. TAKING BROKEN, CHEWED OR CRUSHED OxyContin TABLETS COULD LEAD TO THE RAPID RELEASE AND ABSORPTION OF A POTENTIALLY TOXIC DOSE OF OXYCODONE.
Respiratory Depression
Respiratory depression, the chief hazard from all opioid agonist preparations, occurs most frequently in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration.
Oxycodone should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression. In such patients, even usual therapeutic doses of oxycodone may decrease respiratory drive to the point of apnea. In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.
Head Injury
The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in the presence of head injury, intracranial lesions, or other sources of preexisting increased intracranial pressure. Oxycodone produces effects which may obscure neurologic signs of further increases in intracranial pressure in patients with head injuries.
Hypotensive Effect
OxyContin, like all opioid analgesics, may cause severe hypotension in an individual whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone. OxyContin may produce orthostatic hypotension in ambulatory patients. OxyContin, like all opioid analgesics, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.
PRECAUTIONS:
General -- OxyContin tablets are intended for use in patients who require oral pain therapy with an opioid agonist of more than a few days duration. As with any opioid analgesic, it is critical to adjust the dosing regimen individually for each patient.
Selection of patients for treatment with OxyContin should be governed by the same principles that apply to the use of similar controlled-release opioid analgesics. Opioid analgesics given on a fixed-dosage schedule have a narrow therapeutic index in certain patient populations, especially when combined with other drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension. Physicians should individualize treatment in every case, using non-opioid analgesics, prn opioids and/or combination products, and chronic opioid therapy with drugs such as OxyContin in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Health Care Policy and Research, and the American Pain Society.
Use of OxyContin is associated with increased potential risks and should be used only with caution in the following conditions: acute alcoholism; adrenocortical insufficiency (e.g., Addison's disease); CNS depression or coma; delirium tremens; debilitated patients; kyphoscoliosis associated with respiratory depression; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; severe impairment of hepatic, pulmonary or renal function; and toxic psychosis.
The administration of oxycodone, like all opioid analgesics, may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Oxycodone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.
Interactions with other CNS Depressants
OxyContin, like all opioid analgesics, should be used with caution and started in a reduced dosage (1/3 to 1/2 of the usual dosage) in patients who are concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, other tranquilizers and alcohol. Interactive effects resulting in respiratory depression, hypotension, profound sedation or coma may result if these drugs are taken in combination with the usual doses of OxyContin.
Interactions with Mixed Agonist/Antagonist Opioid Analgesics
Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol and buprenorphine) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as oxycodone. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of oxycodone and/or may precipitate withdrawal symptoms in these patients.
Ambulatory Surgery
OxyContin is not recommended pre-operatively (preemptive analgesia) or for the management of pain in the immediate post-operative period (the first 12 to 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established.
Patients who are already receiving OxyContin tablets as part of ongoing analgesic therapy may be safely continued on the drug if appropriate dosage adjustments are made considering the procedure, other drugs given and the temporary changes in physiology caused by the surgical intervention (see PRECAUTIONS: Drug-Drug Interactions).
Use in Pancreatic / Biliary Tract Disease
Oxycodone may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids like oxycodone may cause increases in the serum amylase level.
Tolerance and Physical Dependence
Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is the occurrence of withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.
Significant tolerance should not occur in most of the patients treated with the lowest doses of oxycodone. It should be expected, however, that a fraction of cancer patients will develop some degree of tolerance and require progressively higher dosages of OxyContin to maintain pain control during chronic treatment. Regardless of whether this occurs as a result of increased pain secondary to disease progression or pharmacological tolerance, dosages can usually be increased safely by adjusting the patient's dose to maintain an acceptable balance between pain relief and side effects. The dosage should be selected according to the patient's individual analgesic response and ability to tolerate side effects. Tolerance to the analgesic effect of opioids is usually paralleled by tolerance to side effects, except for constipation. Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug or may be precipitated through the administration of drugs with opioid antagonist activity (see OVERDOSAGE). If OxyContin is abruptly discontinued in a physically dependent patient, an abstinence syndrome may occur. This is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia and mydriasis. Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate or heart rate.

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THE FEDERATION OF STATE MEDICAL BOARDS OF THE UNITED STATES, INC. MODEL GUIDELINES FOR THE USE OF CONTROLLED SUBSTANCES FOR THE TREATMENT OF PAIN(Adopted May 2, 1998)

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MODEL GUIDELINES FOR THE USE OF CONTROLLED SUBSTANCES FOR THE TREATMENT OF PAIN(Adopted May 2, 1998)