The topic of 'prescription drug abuse' should never be discussed in Congress or in the press without considering what drug policy does to pain patients. Ever.
Also, I'm tired of the "prescription drug crisis" being accepted by everyone as if it is a scientifically proven fact. It. Is. NOT.
Along these lines, you all might enjoy these "Questions for Nora Volkow" (head of NIDA, who was present at the "Gen-Rx" Senate hearings earlier this month) that were submitted, to Chairperson Biden's staffers, but probably not asked. In fairness to all concerned, especially me, this was an EXTREMELY rushed job, and what follows is several drafts away from what might be a useful resource for this sort of purpose.
This is a very rough draft. And I hardly ever publish rough drafts... Consider this a treat?
Questions about definitions, statistics, and the meaning of Govt. statements Re: prescription drug abuse. Prepared for Senator Biden for his Committee’s March 2008 Hearings on Prescription Drug Abuse.
Alexander DeLuca, M.D., MPH
Senior Consultant, Pain Relief Network
New York City, 2008-03-11
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Dr. Volkow, as you know this committee has oversight over ONDCP, characterized accurately by Director Walters in 2004 as the agency responsible for taking the lead in setting U.S. drug policy and priorities.(1) ONDCP regularly issues important reports, most prominently the yearly President's National Drug Control Strategy, but agencies under ONDCP purview, for example the DEA, also issue reports and press releases regarding substance abuse trends and statistics, and frankly, Doctor, the terminology and numbers can get pretty confusing.
As we discuss the illegal use of controlled substances in these hearings, and as we consider legislative efforts to combat this problem, we must also be cognizant that these substances are FDA approved medications for the treatment of chronic and severe pain, which is widely understood to be a problem of crisis proportions in its own right.(8) And so we have to analyze the effects of out drug control efforts on the millions of Americans in chronic pain who experience difficulty finding physicians willing to treat them, or treat them adequately, due in part to the unintended consequences of drug control policy and enforcement.(2)
We have been told that the increased medical use of opioid analgesic medications for the treatment of acute and chronic pain over the past decade has led to diversion of these medications to the illicit market, resulting in what is often termed, a prescription drug abuse crisis or epidemic. And as you know, Dr. Volkow, there are various efforts both implemented and proposals under active discussion at both the state and federal levels, and these include prescription monitoring programs to catch "doctor shoppers," heightened scrutiny of physicians' practices, restrictions on certain medications or on permitted dosage, increased prosecution of physicians, and encouragement of more rigorous patient screening. Such measures it has been claimed, will reduce the diversion of prescription drugs.
Dr. Volkow, please help us understand the nature of this prescription drug abuse crisis, the scientific and correct definitions of various terms that I will ask you about in this line of questioning, and help us please to understand what these statistics really mean.
Question:
What is "non-medical use" of prescription drugs? Is non-medical use a medical condition in the sense that substance abuse and dependence are medical conditions? Is "non-medical use" the same thing as "abuse" of prescription drugs? And please briefly explain what the criteria are, based on medical history and physical examination, for a diagnosis of "substance abuse", and what additional criteria are needed for a diagnosis of "substance dependence", and finally shall we agree for today that "addiction" is synonymous with DSM IV "substance dependence"?(3)
Thank you for that explanation. Now, as you know, Dr. Volkow, ONDCP sets U.S. drug policy and priorities, and allocates a drug war budget of over 15 billion dollars a year. In accomplishing it's mission, ONDCP depends most heavily on the Monitoring the Future survey, and to a lesser extent, the National Household Survey of Drug Abuse. Dr. Volkow, you have explained the relationship between abuse and dependence, but it seems crucial that we understand what happens to people of various ages in the "non-medical use" category? That is, to what extent does exposure to opioid analgesic medications for non-medical purposes lead to opioid abuse and/or dependence, and what proportion, on the other hand, of misusers subsequently quit without becoming continuous, problematic abusers or addicts?
Follow-up Question:
Are you aware of any recent literature, say published over the past five years, analyzing government data in an attempt to answer these questions? To your knowledge, does non-medical use usually progress to prescription drug abuse or addiction, or is this a relatively uncommon outcome?
Statistical Analysis:
Contrary to commonly held beliefs, non-medical use of pain relievers does not lead to abuse or dependence in the majority of those exposed.[/b] "In each age category, discontinuation of use after some period of exposure is a common outcome, and the proportion of those discontinuing use increases with age, from a low of 32.1% in the 12-17 age group to 72.1% among those 26 and older. Even among those who have used in the past year, the rate of abuse/dependence is 15.3% or less."(4) (emphasis added) See Tables 6 and 7, which are based on Table 5, which represents National Household Survey data from 2002, extracted and compiled as noted.
Ending This Line of Questioning to Dr. Volkow...
Dr Volkow, in light of our discussion of, would you agree that the following statement, from a Department of Justice website, entitled: "Fact Sheet: Prescription Drug Abuse - a DEA Focus" misleading?
"Nearly 1 in 10 high school seniors admits to abusing powerful prescription painkillers."
Shouldn't that, in fact, be:
Nearly 1 in 10 high school seniors admits to non-medical use of powerful prescription painkillers.
And, Dr. Volkow, when ONDCP reported on 2006 survey data in the recently released 2008 National Drug Control Policy(5),
"Abuse of prescription drugs among 12 and 13 year-olds now exceeds marijuana use, and among 18 to 25 year-olds, it has increased 17 percent over the past 3 years."
was that use of the term "abuse" accurate? Wouldn't it be more accurate to say, based on the thorough 2005 analysis of government data we have been discussing(4):
Non-medical use of prescription drugs among 12 and 13 year-olds now exceeds marijuana use, and among 18-25 year-olds, it has increased 17% over the past three years.
Of these non-medical users roughly 5% will progress to clinically significant substance abuse or dependence, while over 90% can be expected to discontinue use without progressing to abuse or addiction.
Of the 18-25 year-old subset, approximately one third will have used 3 times or less in the prior year, and approximately one-half will have used 10 times or less in the past year, and only approximately 6% of this group can be expected to manifest ongoing, compulsive, problematic prescription drug abuse.
Conclusion:
The point is not that non-medical use isn't dangerous, or that we should not make reasonable efforts to curtail it.
However, when a prescription drug "crisis" is held out as the raison d'etat for more of the same physician-patient focused drug control policies that are a significant cause, in all studies on the matter over decades, of the undertreatment of chronic pain by physicians(6, 7, 8), then clearly hyperbole and exaggeration and gross misuse of accepted medical terminology by agencies reporting to this Congressional committee, and to the American people, is harmful, unacceptable, and impedes our work.
Footnotes:
1. Walters, J. Comments of the Director of the Office of National Drug Control Policy (ONDCP) to the attendees of the annual meeting of the Academy of Criminal Justice Sciences (ACJS), Las Vegas, Nevada, 2004-03-11.
2. Many studies have shown the practice and custom of physicians in managing pain, even in terminal cancer cases, is extremely conservative and below the (textbook) standard of care. In the literature analyzing this discrepancy a number of barriers to effective pain relief have been identified and include fear of regulatory scrutiny of opioid prescribing practices, and the persistence of irrational beliefs and unsubstantiated fears about addiction, tolerance, dependence, and opioid side effects. See literature review by Rich, B.A. An Ethical Analysis of the Barriers to Effective Pain Management. Cambridge Quarterly Journal of Healthcare Ethics; Vol 9; 2005. (Available: http://www.doctordeluca.com/Library/Pai … inTx2K.pdf)
3. Using DSM-IV terminology, "substance abuse" and "substance dependence" are the two varieties of "substance use disorders." Diagnostic criteria require continued and compulsive use despite adverse consequences, plus evidence of tolerance or withdrawal for a "dependence" diagnosis. "Non-medical use" is not a DSM recognized disorder, but when used to identify a state of being distinct from "abuse" or "dependence", "non-medical use" logically connotes non-compulsive use without adverse consequences that rise to the level of "substance abuse."
4. Hurwitz, W. The Challenge of Prescription Drug Misuse: A Review and Commentary. Pain Medicine, 6(2): 151-161; 2005. (Available: http://www.doctordeluca.com/Library/WOD … witz05.htm)Tables 6, 7, and 5 are reproduced here from this peer-reviewed article.
5. ONDCP. The President's National Drug Control Strategy. February 2008. (Available: http://www.whitehousedrugpolicy.gov/pub … index.html) Excerpt is from page 17 under the heading, "Fighting Pharmaceutical Diversion and Preventing Addiction."
6. SUPPORT Principle Investigators. A Controlled Trial to Improve Care for Seriously Ill Patients.; JAMA; 274: 1591-1598; 1995. Among many significant findings, 50% of ICU patients suffer moderate to severe pain in their last days of life. Literature review documenting widespread undertreatment of pain beginning with a 1973 study of inpatients.
7. Marks,R.M., Sachar,E.J. Undertreatment of medical inpatients with narcotic analgesics; Archives of Internal Medicine; 78:173-181; 1997.
8. Chronic Pain in America: Roadblocks to Relief. Report to the American Pain Society, Glenville, IL, 1999. (Available: http://www.ampainsoc.org/links/roadblocks/index.htm#toc). "More than four out of every 10 people with moderate to severe chronic pain have yet to find adequate relief, saying their pain is out of control... 'This survey suggests that there are millions of people living with severe uncontrolled pain,' [said Dr. Portenoy, President of the APS]."
[END]
