Deflecting the Real Drug Problem -- The Loss of Human Life

"However things may seem, no evil thing is success and no good thing is failure." Henry Wadsworth Longfellow

Gil Kerlikowske

(MYRTLE BEACH, S.C.) - Is the American Medical Association a friend or foe in the prescription drug epidemic -- as White House "drug czar", R. Gil Kerlikowske comes face to face with the "grim reaper", J. David Haddox, DDS, MD, responsible for the OxyContin epidemic in the U.S. and Canada?

The American Medical Association (AMA) will be assisting physicians in preventing the misuse and abuse of prescription drugs. At an Interim Meeting last month, the AMA was directed to promote training and competence by physicians in the proper use of controlled substances and to encourage physicians to utilize tools from the National Institute on Drug Abuse to single out patients who are potential drug abusers. The AMA will also make treatment resources available and encourage physicians to participate in prescription drug monitoring programs which have been set up in 36 states.

The growing problem of prescription drug abuse was the subject of an educational session at the meeting that drew a standing-room-only crowd of delegates and other physicians. R. Gil Kerlikowske, Director of the White House Office of National Drug Control Policy, outlined the Obama administration's plan, launched in April, to cut nonmedical use of prescription drugs and opioid-related overdose deaths by 15% during the next five years. (The overdose deaths are growing considerably more than 15% each year -- a fact Mr. Kerlikowske and the Obama administration should take into account).

"We think it's a very balanced and comprehensive approach, focused much more on public health and prevention than in the past," Kerlikowske said. "We wanted to look at this much more as a public health issue, rather than pointing the finger at prosecutors, police chiefs and sheriffs and saying, 'Fix the problem."

The administration's plan calls for expanding prescription-monitoring programs to all 50 states, making environmentally safe disposal of prescription drugs easier, and raising public awareness among patients and teens about the dangers of misusing controlled substances. The plan also backs the idea of linking Drug Enforcement Administration registration to required training on controlled-substances prescribing, which the AMA opposes. (Anyone wonder why the AMA has a problem with the DEA?) Making "environmentally safe disposal of prescription drugs easier" -- Mr. Kerlikowske we are losing our kids to prescription drugs being over produced by the pharmaceutical companies and finding their way to the streets -- why are you not addressing this? "Environmentally safe disposal" is a deflection of the real problem -- the loss of human life.

The Food and Drug Administration has ordered manufacturers of extended-release and long-acting opioids to devise a risk-reduction plan to educate physicians and other prescribers on the risks and benefits of opioids, patient selection, management and monitoring, and counseling patients on the safe use of painkillers.

Why has the FDA sat back while the prescription drug epidemic has devastated every state in the country in the loss of life? The FDA having pharmaceutical companies prepare REMS is a too little -- too late strategy. A more aggressive stance in saving lives would be reclassifying dangerous drugs such as OxyContin, which has been responsible for the prescription drug epidemic since its approval by the FDA in 1995, for "severe" pain only and never for "moderate" pain.

The companies delivered their plan in August, according to J. David Haddox, DDS, MD, vice president of health policy at Purdue Pharma, who spoke at the educational session. The FDA is accepting comments on the proposal until December 7, 2011. 

Anyone interested in submitting comments can do so by referring to the following link http://www.gpo.gov/fdsys/pkg/FR-2011-11-07/pdf/2011-28669.pdf).  The FDA is scheduled to issue a final prescriber-education plan in February 2012. The training will not be mandatory, but drugmakers will be required to set goals for the number of prescribers trained and meet those goals. The plan would affect nearly 4 million patients and about 1 million prescribers, Dr. Haddox said.

Peter W. Jackson, President of Advocates for the Reform of Prescription Opioids forwarded me the link to his group's comments to the FDA on REMS.  The organization makes some very strong recommendations to the FDA which hopefully the agency, who thus far has been complacent to the wishes of the pharmaceutical industry, will seriously consider.  http://mail.aol.com/35112-111/aol-6/en-us/mail/get-attachment.aspx?uid=28900294&folder=OldMail&partId=3&saveAs=ARPO_Statement_on_Draft_Blueprint_for_Long-Acting_Opioids_Nov_2011.docx

The action comes in response to data highlighting the dangers associated with controlled substances, especially opioids. The painkillers were linked to 14,800 overdose deaths in the U.S. in 2008 -- nearly four times the 1999 death toll of 4,000 -- according to the Centers for Disease Control.

By way of introduction Mr. Kerlikowske meet Dr. Haddox. In case you are not familiar with his name or the company he is employed by - Purdue Pharma, I will give you an education into their criminal background.

Purdue Pharma was convicted in 2007, in Federal court and pleaded guilty to misleading physicians and patients as to the addictive and abusive qualities of OxyContin. Want to hear more Mr. Kerlikowske?

Between 2000 and 2010, Purdue Pharma paid the University of Wisconsin Pain Group approximately $1.6 million and played a critical role in the rapid growth of OxyContin throughout the U.S. and Canada. A consensus statement suggested that opioids were safe and effective for chronic, noncancer pain and that the risk of addiction was low. Interested in what Dr. Haddox wrote in the consensus statement he authored, Mr. Kerlikowske? It is provided below in its entirety. I have taken the liberty of giving you some highlights of Dr. Haddox's definition of "addiction" --

Addiction: Misunderstanding of addiction and mislabeling of patients as addicts result in unnecessary withholding of opioid medications. Addiction is a compulsive disorder in which an individual becomes preoccupied with obtaining and using a substance, the continued use of which results in a decreased quality of life. Studies indicate that the de novo development of addiction when opioids are used for the relief of pain is low.

Dr. Haddox also teamed up as chairman and co-author with two individuals from the University of Wisconsin Pain Group in 2002 to co-author a paper, warning state medical boards that fears of regulatory scrutiny could harm the efforts to manage pain in the U.S. The paper made no mention of the money the group was getting from Purdue Pharma and other makers of narcotic pain killers. In April 2011 I wrote about Haddox and the money trail to the University of Wisconsin  http://www.salem-news.com/articles/april222011/pain-studies-ms.php   The two individuals working with Haddox at the Wisconsin Pain Group have resigned.

Critics say there was little evidence supporting the use of opioids for chronic, noncancer pain, both at the time the statement was made and today. Physicians in the field say prescribing those drugs long-term for noncancer pain may cause serious problems, including physical dependence, increased pain sensitivity, unintentional overdoses, and death.

A few years ago, CBS - 48 Hours interviewed J. David Haddox and then Connecticut Attorney General Richard Blumenthal about the problems the country was experiencing with OxyContin. Haddox was quoted as saying "Patients who are taking OxyContin appropriately don't get addicted."

Haddox also stated that "Patients trying to get off of OxyContin may, in fact, be confusing physical dependence for addiction. But in my practice of prescribing this for over 1,000 patients, I never saw that happen in my practice. Patients got relief, and I didn't have a single case of addiction." (Haddox conveniently forgets that in a lawsuit filed in Georgia, he was charged with prescribing OxyContin for "sleep" to one of his patients - Sowell v. Purdue Pharma, L.P. et al, filed in Fulton County, Georgia).

AG Blumenthal disagreed with Haddox's theory of physical dependence vs. addiction and stated "For a substantial proportion of the people who take it, OxyContin is addictive." He also said that Purdue Pharma downplayed the addictive qualities of OxyContin.

In a video made by Purdue Pharma an unidentified man says that "less than 1 percent of patients taking opioids actually become addicted."

AG Blumenthal was asked what he thought about that statement. He replied "There's no question that this kind of video belittles, demeans, diminishes the very severe potential for abuse in this drug."

So tell me Mr. Kerlikowske -- would you buy a used car from J. David Haddox -- or do you think Haddox may be better served to the country making license plates?

LP - You are truly the guardian of my heart every day -- and even more when I heard your words today in Union and Lakeview. I cherish and love you always.

Consensus StatementAugust 16, 2007

Advocacy

The Use of Opioids for the Treatment of Chronic Pain

A consensus statement from American Academy of Pain Medicine and American Pain Society

I. The management of pain is becoming a higher priority in the United States.

In the last several years, health-policymakers, health professionals, regulators, and the public have become increasingly interested in the provision of better pain therapies. This is evidenced, in part, by the U.S. Department of Health and Human Services' dissemination of Clinical Practice Guidelines for the management of acute pain and cancer pain.

These publications, which have been endorsed by AAPM and APS, state that opioids, sometimes called "narcotic analgesics," are an essential part of a pain management plan. There is currently no nationally accepted consensus for the treatment of chronic pain not due to cancer, yet the economic and social costs of chronic pain are substantial, with estimates ranging in the tens of billions of dollars annually.

II. Current conditions dictate the need for a joint consensus statement of two major national pain organizations.

AAPM and APS believe that the United States is in a critical phase of state-level policy development with respect to the use of opioids in pain treatment. In this regard, there has been recent activity in state legislatures (i.e., intractable pain treatment acts and the establishment of pain commissions) and at the regulatory level (statements of policy from state boards of medical examiners). In response to inquiries from concerned boards, AAPM and APS wish to encourage a dialogue with regulators about the appropriate relation between law and the practice of pain medicine. The purpose of laws that govern controlled substances and professional conduct is to protect the public. Our objective is for state policies to recognize but not interfere with the medical use of opioids for pain relief, while continuing to address the issue of prescribing that may contribute to drug abuse and diversion.

It is imperative that this statement not be misconstrued as advocating the imprudent use of opioids. Rather, if a practitioner decides to treat chronic pain with opioids, this document should serve as a guide for both the practitioner and regulators with regard to the judicious use of these drugs in the course of medical practice.

III. Pain is often managed inadequately, despite the ready availability of safe and effective treatments.

Many strategies and options exist to treat chronic noncancer pain. Since chronic pain is not a single entity but may have myriad causes and perpetuating factors, these strategies and options vary from behavioral methods and rehabilitation approaches to the use of a number of different medications, including opioids.

Pain is one of the most common reasons people consult a physician, yet it frequently is inadequately treated, leading to enormous social cost in the form of lost productivity, needless suffering, and excessive healthcare expenditures.

Impediments to the use of opioids include concerns about addiction, respiratory depression and other side effects, tolerance, diversion, and fear of regulatory action.

IV. Current information and experience suggest that many commonly held assumptions need modification.

Addiction: Misunderstanding of addiction and mislabeling of patients as addicts result in unnecessary withholding of opioid medications. Addiction is a compulsive disorder in which an individual becomes preoccupied with obtaining and using a substance, the continued use of which results in a decreased quality of life. Studies indicate that the de novo development of addiction when opioids are used for the relief of pain is low. Furthermore, experience has shown that known addicts can benefit from the carefully supervised, judicious use of opioids for the treatment of pain due to cancer, surgery, or recurrent painful illnesses such as sickle cell disease.

Respiratory depression and other side effects: Fear of inducing respiratory depression is often cited as a factor that limits the use of opioids in pain management. It is now accepted by practitioners of the specialty of pain medicine that respiratory depression induced by opioids tends to be a short-lived phenomenon, generally occurs only in the opioid-naive patient, and is antagonized by pain. Therefore, withholding the appropriate use of opioids from a patient who is experiencing pain on the basis of respiratory concerns is unwarranted. Other side effects, such as constipation, can usually be managed by attention to diet, along with the regular use of stool softeners and laxatives. Sedation and nausea, possible early side effects, usually dissipate with continued use.

Tolerance: It was previously thought that the development of analgesic tolerance limited the ability to use opioids efficaciously on a long-term basis for pain management. Tolerance, or decreasing pain relief with the same dosage over time, has not proven to be a prevalent limitation to long-term opioid use. Experience with treating cancer pain has shown that what initially appears to be tolerance is usually progression of the disease. Furthermore, for most opioids, there does not appear to be an arbitrary upper dosage limit, as was previously thought.

Diversion: Diversion of controlled substances should be a concern of every health professional, but efforts to stop diversion should not interfere with prescribing opioids for pain management. Attention to patterns of prescription requests and the prescribing of opioids as part of an ongoing relationship between a patient and a healthcare provider can decrease the risk of diversion.

V. Policy is evolving.

State law and policy about opioid use are currently undergoing revision. The trend is to adopt laws or guidelines that specifically recognize the use of opioids to treat intractable pain. These statements serve as indicators of increased public awareness of the sequelae of undertreated pain and help clarify that the use of opioids for the relief of chronic pain is a legitimate medical practice.

VI. Accepted principles of practice for the use of opioids should be promulgated.

Due to concerns about regulatory scrutiny, physicians need guidance as to what principles should generally be followed when prescribing opioids for chronic or recurrent pain states. Regulators have also expressed a need for guidelines to help them to distinguish legitimate medical practice from questionable practice and to allow them to appropriately concentrate investigative, educational, and disciplinary efforts, while not interfering with legitimate medical care.

VII. Principles of good medical practice should guide the prescribing of opioids.

AAPM and APS believe that guidelines for prescribing opioids should be an extension of the basic principles of good professional practice.

Evaluation of the patient: Evaluation should initially include a pain history and assessment of the impact of pain on the patient, a directed physical examination, a review of previous diagnostic studies, a review of previous interventions, a drug history, and an assessment of coexisting diseases or conditions.

Treatment plan: Treatment planning should be tailored to both the individual and the presenting problem. Consideration should be given to different treatment modalities, such as a formal pain rehabilitation program, the use of behavioral strategies, the use of noninvasive techniques, or the use of medications, depending upon the physical and psychosocial impairment related to the pain. If a trial of opioids is selected, the physician should ensure that the patient or the patient's guardian is informed of the risks and benefits of opioid use and the conditions under which opioids will be prescribed. Some practitioners find a written agreement specifying these conditions to be useful.

An opioid trial should not be done in the absence of a complete assessment of the pain complaint.

Consultation as needed: Consultation with a specialist in pain medicine or with a psychologist may be warranted, depending on the expertise of the practitioner and the complexity of the presenting problem. The management of pain in patients with a history of addiction or a comorbid psychiatric disorder requires special consideration, but does not necessarily contraindicate the use of opioids.

Periodic review of treatment efficacy: Review of treatment efficacy should occur periodically to assess the functional status of the patient, continued analgesia, opioid side effects, quality of life, and indications of medication misuse. Periodic reexamination is warranted to assess the nature of the pain complaint and to ensure that opioid therapy is still indicated. Attention should be given to the possibility of a decrease in global function or quality of life as a result of opioid use.

Documentation: Documentation is essential for supporting the evaluation, the reason for opioid prescribing, the overall pain management treatment plan, any consultations received, and periodic review of the status of the patient.

VIII. The Mission Statements of AAPM and APS are consistent with this collaborative effort.

The American Academy of Pain Medicine is the AMA-recognized specialty society of physicians who practice pain medicine. The American Pain Society is the national chapter of the International Association for the Study of Pain and is composed of physicians, nurses, psychologists, scientists, and members of other disciplines who have an interest in the study and treatment of pain.

The mission of the American Academy of Pain Medicine is to enhance pain medicine practice in this country by promoting a socioeconomic and political climate conducive to the effective and efficient practice of pain medicine and by ensuring quality medical care by physicians specializing in pain medicine, for patients in need of such services.

The mission of the American Pain Society is to serve people in pain by advancing research, education, treatment, and professional practice. The undertreatment of pain in today's society is not justified. This joint consensus statement has been produced pursuant to the missions of both organizations, to help foster a practice environment in which opioids may be used appropriately to reduce needless suffering from pain.

Approved by the AAPM Board of Directors on June 29, 1996:
American Academy of Pain Medicine
4700 W. Lake Avenue
Glenview, IL 60025-1485
847/375-4731

Fax 847/375-4777
E-mail info@painmed.org
www.painmed.org/

>Approved by the APS Executive Committee on August 20, 1996:
American Pain Society
4700 W. Lake Avenue
Glenview IL 60025-1485

847/375-4715
Fax: 847/375-4777
E-mail info@ampainsoc.org
http://www.ampainsoc.org/

Copyright © 1996-2007 American Pain Society. All Rights Reserved.

Salem-News.com Reporter Marianne Skolek, is an Activist for Victims of OxyContin and Purdue Pharma throughout the United States and Canada. In July 2007, she testified against Purdue Pharma in Federal Court in Virginia at the sentencing of their three CEO's - Michael Friedman, Howard Udell and Paul Goldenheim - who pleaded guilty to charges of marketing OxyContin as less likely to be addictive or abused to physicians and patients. She also testified against Purdue Pharma at a Judiciary Hearing of the U.S. Senate in July 2007. Marianne works with government agencies and private attorneys in having a voice for her daughter Jill, who died in 2002 after being prescribed OxyContin, as well as the voice for scores of victims of OxyContin. She has been involved in her work for the past 8-1/2 years and is currently working on a book that exposes Purdue Pharma for their continued criminal marketing of OxyContin.

Marianne is a nurse having graduated in 1991 as president of her graduating class. She also has a Paralegal certification. Marianne served on a Community Service Board for the Courier News, a Gannet newspaper in NJ writing articles predominantly regarding AIDS patients and their emotional issues. She was awarded a Community Service Award in 1993 by the Hunterdon County, NJ HIV/AIDS Task Force in recognition of and appreciation for the donated time, energy and love in facilitating a Support Group for persons with HIV/AIDS.

Marianne Skolek
National Activist for Victims of OxyContin and
Purdue Pharma - a criminally convicted pharmaceutical company
Staff Writer, Salem-News.com

http://www.purduepharma.com/pressroom/app/news_announc/USGovt_reponse_Main.pdf

judiciary.senate.gov/hearings/testimony.cfm?id=2905&wit_id=6612

http://i.bnet.com/blogs/sebelius-response.pdf

www.vawd.uscourts.gov/PurdueFrederickCo/default.asp