June 9, 2009
The statisticians at the Adverse Events Reporting System clearly state that the system does not report incidence but occurrence, and is unreliable. Is there any data other than from AERS that substantiates an imminent risk from prescribed opioids?
“Reports contain only those reactions voluntarily submitted either directly to the FDA or to the drug manufacturer by consumers and /or members of the health profession and which have been entered into the AERS computerized filing system since November 1, 2007.
The information contained in the reports has not been scientifically or otherwise verified. For any given report there is no certainty that the suspected drug caused the reaction. This is because physicians are encouraged to report suspected reactions. The event may have been related to the underlying disease for which the drug was given to concurrent drugs being taken or may have occurred by chance at the same time the suspected drug was taken.
Accumulated case reports cannot be used to calculate incidence or estimates of drug risk Numbers from these data must be carefully interpreted as reporting rates and not occurrence rates. True incidence rates cannot be determined from this database. Comparisons of drugs cannot be made from these data.”
The “National Prescriptive Drug Threatö is based upon “synthesized dataö. The data quoted by the DEA (National Drug Threat Assessment 2009), available at:
* HYPERLINK "http://www.usdoj.gov/ndic/pubs31/31379/index.htm" *http://www.usdoj.gov/ndic/pubs31/31379/index.htm#Contents*
* HYPERLINK "http://www.usdoj.gov/ndic/pubs31/31379/appendb.htm" *http://www.usdoj.gov/ndic/pubs31/31379/appendb.htm#Top*
simply does not support the claim of an “epidemic of diversion and abuse”. What data substantiates an “epidemic”?
In the data cited above, from 2001 to 2005, opioid deaths are said to have increased 113.8% (from 3994 to 8451). However, the survey “drug use in the past month” reports that the use of opioids has increased only 5% from 2003 to 2007 û from 2% of the population to 2.1%. During the same period the population grew 6%. How can this be called an “epidemic”?
In the DEA cited data from the survey “the use of psychotherapeutic drugs in the previous month”, the use of pain medications decreased 12.5% from 2003 to 2007. How was this data considered in arriving at a conclusion that an epidemic is occurring?
From 2003 to 2007, the DEA reports that the annual opioid production rose 51% - from 25,607 kg to 38,680 kg. Despite this increase, the “use of pain medication in the previous month” decreased 12.5% . Based on this data, how can DEA or FDA claim an “epidemic”?
Again, using the DEAÆs own data, the incidence of deaths per grams produced, per 100,000 population, decreased 11.6% from 2003 to 2007, while the amount manufactured increased 51.5%. DoesnÆt this data disprove any form of “epidemic” of drug use?
Based upon the federal government’s survey data, drug use of every drug, by all age groups, declined slightly from 2003 to 2008, and occurred amongst no more than 6.9% of adults for the use of cocaine, 1% for the use of crack, 0.5% for the use of Heroin, 1.9% for the use of metamphetamine, 12.4% of adults between the ages of 18 and 25, and 3.6% of adults 26 and over, for the use of prescription drugs. The use of “Prescription Narcotics” (presumably referring to opioids, benzodiazepines, barbiturates and other central nervous system affecting pharmaceuticals) has occurred in no more than 5.1% of all people over the age of 12, and has actually increased no more than 0.1% over the last five years. Doesn’t this data argue against an “epidemic” of prescription drug abuse?
Based upon the DEA’s data from “Monitoring the Future”, the use of “prescription narcotics” reached a maximum of 9.5% of 12th graders in 2004 and decreased to 9.2% in 2007. The use of sedative/barbiturates reached a high of 7.2% of 12th graders in 2005 and decreased to 6.2% in 2007. The use of tranquilizers dropped from 6.7% in 2003 to 6.2 % in 2007. Where is the “epidemic” in this data?
The incidence of hospitalizations primarily for substance abuse from 2002 to 2006 declined dramatically for heroin, barbiturates and tranquilizers. Hospitalizations for barbiturates declined 36.1% from 2002. However, hospitalizations for opiates and synthetics increased 62.0% for the period, from 46,138 to 74,750.
Given that there were 150,000,000 opioid doses legitimately prescribed in that year, will FDA and the DEA acknowledge that the incidence of hospitalization could have been no more than 74,750/150,000,000 (0.41%)?
Will FDA and the DEA acknowledge that the incidence of fatal overdoses from opioids diverted or illegally obtained could have been no more than 8,450/150,000,000? (0.0053%)?
Given that use of opioids has not increased dramatically in the last five years, will the FDA and the DEA acknowledge that the most logical conclusion is not that there is an “epidemic” of opioid usage, but that usage has become more frequent and reckless among a numerically tiny group of abusers and diverters?
Lastly, can the FDA and the DEA acknowledge that reducing the availability of life-saving pain medication for 50,000,000 legitimate and innocent chronic pain patients is an indefensible and inappropriate approach to reducing the abuse and diversion of opioids by, comparatively speaking, an extremely small number of reckless non-pain patients?
How will the FDA guarantee that any opioid-related REMS will not increase the current unavailability and unwillingness of physicians to prescribe effective pain control for legitimate, innocent and deserving chronic pain patients?
The National Foundation for the Treatment of Pain
J.S. Hochman, M.D.
Executive Director
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Anyone wishing to obtain a copy of the PowerPoint presentation specifically reviewing the data, please email jfshmd@gmail.com
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