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A Message from Advocates for Prescription Opioid Drug Reform
It has been my privilege to be part of a group of determined citizens from all walks of life who are dedicated to educating the medical community, the FDA and the public on the ravages being caused by prescription opioid addiction. Our group is convinced that when people understand this problem it will not be allowed to continue.
Our group has come together through our association with Larry Golbom and his Prescription Addiction Radio Show. The article below was written by Dr. Kirk Van Rooyan. Dr. Van Rooyan is a plastic surgeon and consultant to the Medical Board of California. He lost a stepson to a single dose of OxyContin and is committed to sparing other parents and families a loss like this.
This letter is being sent to Dr. Joshua Sharfstein. Dr. Sharfstein is currently the Baltimore Health Commissioner but is widely believed to be appointed to head the FDA in January.
All of us at Novus Medical Detox Center wish you a Merry Christmas and Happy Holidays!
A MESSAGE FROM ADVOCATES
FOR PRESCRIPTION OPIOID DRUG REFORM
For more than a decade prescription opioids have been aggressively marketed to America’s physicians for treatment of chronic, non-cancer pain of moderate severity. As a result, hydrocodone prescribing increased by 198%, fentanyl by 423%, oxycodone by 588%, and methadone by 933% during this period, and 80% of the world’s prescription opioid supply is now consumed in the U.S. An unfortunate, but not surprising, parallel to this phenomenon has been a dramatic rise in the abuse of prescription opioids; these drugs are now second only to marijuana, and ahead of cocaine and heroin. Worse, recent data revealed that oxycodone was the most frequent cause of drug-related deaths reported to the FDA, that more than twice as many died from prescription opioids than from combat in Iraq in 2006, and that deaths from these drugs increased 160% from 1999-2004. Leading experts concur that a national epidemic of prescription opioid abuse and death exists, and that it is worsening.
The rationale for the explosion in prescription opioid use has been the allegation that chronic pain is substantially under-treated in this country. Its impetus has come from pain treatment medical professionals, pain advocacy groups, the pharmaceutical industry, and the media, reinforced by the perception that these are legitimate drugs with established efficacy, safety, and controls. These same entities have largely attributed the observed concomitant escalation in prescription opioid abuse and death to improper internet availability, illicit diversion, and the prevalence of drug addiction tendencies in our society. Very few of these premises can be supported by current statistics, scientific facts, and medical studies.
While it may be true that there has been historical under-treatment of chronic pain in the U.S., the degree of this has been overstated, and the issue has been distorted by failure to factor in types, causes, severity, and the expertise of prescribing physicians. Pain is a symptom, not a disease, and its proper management must involve accepted diagnostic determination of its nature and source. In contrast to chronic pain due to specific diseases such as cancer, nerve damage, or end-stage arthritis, central (brain) mediated pain, while just as real, has no demonstrable tissue pathology and has been proven to be affected by emotional and psychological factors. This is a critical distinction which mandates selectivity in pain treatment, especially since patients with central pain have been shown to receive less benefit from opioids and to have increased susceptibility to abuse, diversion, and addiction. Considering that they comprise the majority of chronic pain patients, that they are the largest segment taking prescription opioids, and that 90% of patients in pain management centers are on opioids, it is apparent that central pain patients are not being treated selectively. Also, based on data from the DEA and other studies, physicians not adequately trained in chronic pain management and/or unable to spend sufficient time with patients have been a sizable contributing factor to the inappropriate, indiscriminate, and counterproductive over-prescribing of opioid drugs.
There are similar inaccuracies regarding the realities of prescription opioid pharmacology and control. Purdue Pharma (PP), the largest manufacturer of sustained-release opioids, failed to properly establish and correctly represent the effectiveness and addiction potential of its drug OxyContin, an omission whose effect was aggravated by unscrupulous and irresponsible marketing practices. Further, these deficiencies were not
detected by the primary regulatory agency, the FDA, and were only addressed by the federal court system in the form of an indictment and sanctions in 2007. In truth, numerous independent studies have refuted the previously claimed low addiction potential and incidence of side effects of sustained-release opioid drugs, documented their actual high risk of tolerance, hyperalgesia and respiratory depression when combined with certain other medications and alcohol, and demonstrated lack of efficacy in the treatment of chronic non-cancer pain, especially that of central origin, for more than eight months or in comparison to conventional opioid preparations.
The final mischaracterization of the existing prescription opioid drug problem surrounds the role of legitimate versus illicit use and causation. The position that this acknowledged epidemic is ascribable primarily to illicit sources, non-medical use, and poor judgment can no longer be supported. Not only is there reliable evidence that abuse, addiction, and death from prescription drugs–with opioids topping the list—now exceed that of non-prescription drugs, but also that it is legitimate, albeit excessive and improper, medical prescribing, not the internet or drug dealers, which leads to chemical dependence or diversion through family and friends. Further, a correct understanding of the mechanisms of addiction and the profound chemical effects of opioids on the brain precludes the assertion that most individuals freely “choose” this pathway/outcome.
When viewed in the light of objectivity, then, the origin and progression of what now constitutes one of the worst public health crises in U.S. history represents a chronology of abrogation of numerous medical, ethical, social, and governmental principles and priorities. These include purposeful misrepresentation of the chemical characteristics, safety, and clinical indications of sustained-release opioid drugs; egregiously self-serving and unconscionable marketing and financial agendas which unjustifiably elevated chronic pain to a disease entity and intentionally targeted physicians marginally trained in pain management ( both by Purdue Pharma–OxyContin); inadequate cognizance of and adherence to accepted criteria for medical diagnosis and treatment which generated hugely excessive quantities and availability of one of the intrinsically most high risk, dangerous classes of drugs (by complicit physicians); and despite inherent potential danger to the public welfare, insufficient monitoring and assessment of submitted data for new opioid drugs, and a lack of regulatory response to both legal sanctions and valid scientific recommendations for more restricted use of these medications (by the FDA).
Although this is really a summary paper, it should make clear that the existing approach to the problem of chronic pain has not only been ineffective but has inflicted serious societal harm and personal suffering upon our nation, that ongoing attempts to redirect this effort have essentially been ignored or rebuffed by the FDA, and that SIGNIFICANT CHANGE is urgently needed. It is important to emphasize that we do not oppose use of prescription opioid drugs for patients truly in need of or likely to benefit from them; that is, a program based on sound research and clinical data and outcomes, combined with other appropriate medical and non-medical treatment modalities, and administered selectively by properly trained and motivated medical professionals.
For those interested, more detailed and specific discussion and references by those who have contributed to this document, as well as some recommendations for a new direction, are contained in the Attachments. As a group sharing the bond of the loss–to addiction or death from opioids–of a family member or loved one, it is our sincere hope that the Obama Administration, particularly those agencies most involved in drug and public health issues and safety, will respond to the challenge posed by the prescription opioid crisis, bringing to bear its already demonstrated passion, innovation, and competence.
Kirk W. Van Rooyan, M.D.
Barbara A. Van Rooyan, MS
Peter W. Jackson
Stephen G. Gelfand, M.D.
Larry Golbom, R.Ph., MBA (Learn to Cope) (Prescription Addiction Radio)
Art Van Zee, M.D.
Edward M. Vanicky, Jr. (email@example.com)
Melissa Zuppardi (HARMD)
Sandra S. Kresser
1) Manchikanti, Laxmaiah, MD; Pain Physician 2008: 11:S63-S88
2) Gelfand, S., MD ; “Perils of Pain Meds”; Rheumatologist: 2008
Commentary to the FDA; May, 2008
3) Van Zee, Art, MD; “Roadmap to a Reduction in Opioid Abuse”
4) “Why Are People Still Dying From OxyContin?”
5) Jackson, Peter W.; Commentary to the FDA; May, 2008
6) Van Rooyan, K/B; FDA Citizen Petition 2005 P-0076
“NEVER DOUBT THAT A SMALL GROUP OF THOUGHTFUL, COMMITTED CITIZENS CAN CHANGE THE WORLD; INDEED IT’S THE ONLY THING THAT EVER HAS” …… Margaret Mead
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