(Note: The endnotes which provide the references for this critique have been collected into the final part of this document.)
Rather than blaming prescribers, as the CDC and most of the contributors to its draft guidelines do, the International Narcotics Control Board declares that “diversions of narcotic drugs and psychotropic substances mostly occur when consignments pass from the wholesale level to the retail level.” Criticizing preoccupations with physician prescriptions, others point to robberies, break ins, and pilferage of as much of 22.4% of total U.S. pharmaceutical production, based upon data from the Drug Enforcement Administration (DEA). “The unchecked flow of pain medications diverted from nonmedical sources will not be addressed if diversion control focuses only on prescribers and patients.” Moreover, such figures are likely to seriously underestimate the diversion problem, because “criminals have penetrated the legitimate supply chain to divert legitimate product to illegitimate uses and have introduced illegitimate product into the legitimate supply chain” with near impunity, avoiding detection by simply replacing the diverted pharmaceuticals with counterfeits.[152, 153] The controlled substances of all sorts that are readily available on the Internet require a credit card, not a prescription, but these “credit card painkillers” inflate statistics on “prescription painkillers.”
“More often than not, laboratory tests reveal the presence of one or more substances in addition to the opioid, suggesting that the depressant effects of alcohol or other drugs on the central nervous system were additive with those of the pain reliever in causing death.”
Furthermore, the assumption that the finding of a “prescription painkiller” is due to a pharmaceutical product is often false.
Under the best of circumstances, drug testing after death is fraught with pitfalls. “Identifying risk factors among opioid overdose decedents has been difficult due, in part, to the widely varying methods employed by state death investigators to collect mortality data and to report on drug involvement in overdose.” Even in life, drug testing is complicated, for example, by the fact that heroin (and codeine) are rapidly converted to morphine in the body. This is important, if for no other reason than that morphine, but not heroin, might be a “prescription painkiller.” Even though heroin is more commonly abused than morphine, the default assumption is to blame a prescription opioid: “The finding of a morphine blood concentration in a decedent is classified as a morphine-caused death if the differentiation between heroin- and morphine-caused death is not definitive.” Even when the drug is correctly identified, the practice of automatically attributing death to a drug found in the blood is invalid, because “no concentration of a drug of abuse can be interpreted in isolation without a thorough examination of the relevant circumstances and after the conduct of a post-mortem to eliminate or corroborate relevant factors that could impact on the drug concentration and the possible effect of a substance on the body.”
“…the exact number of deaths remains unknown for several reasons: 1) lack of standardized national definitions among death investigators to interpret postmortem toxicology findings, 2) state-level variations in determining the manner of death (e.g., suicide vs accident vs undetermined), and 3) poorly defined toxicology categories used to classify deaths in the ICD-10.”
Failure to distinguish between counterfeit and pharmaceutical versions of a drug also inflates the apparent rates of “prescription” drug abuse and overdoses. For example, fentanyl is a “prescription painkiller,” but not necessarily a pharmaceutical. It is easily manufactured. One kitchen chemist provides detailed instructions for what he claims to be a greater than 80% overall yield of more than 99.5% pure fentanyl, which he cuts 1:100 with milk sugar and sells as “white heroin.” Counterfeit “Percocet” (oxycodone), that is actually nonpharmaceutical fentanyl, is widely available, and heroin laced with fentanyl is commonplace.[161, 162] Since illicit fentanyl tests the same as legitimate fentanyl, and since heroin rapidly converts into morphine, without additional information, heroin and illicit fentanyl inflate statistics on “prescription painkillers.”
Even if the product is a pharmaceutical, until the recent rescheduling of hydrocodone combination products, people could “get a doctor’s DEA number, call up a pharmacy, pretend to be the doctor, and get themselves a hydrocodone prescription with five refills on it.” Likewise, a pharmaceutical opioid may never have been intended to fill a prescription in the United States. Considering the status of our border, smuggling of pharmaceutical controlled substances from Canada, for example, is big, highly profitable, and easy. These factors also inflate statistics on “prescription painkillers.”
Adding to the complication, one study found that one-in-six nondependent “nonmedical” users of pharmaceutical opioids reported exclusively using them to self-medicate pain. Another study of 2262 opioid dependent substance abusers whose primary drug was a prescription opioid analgesic found, “Although getting high was the desire of nearly all users of both oxycodone and hydrocodone, 50–60% also indicated that the management of pain was an important factor.”
The CDC‘s obsession with prescriptions also puts it at odds with the International Narcotics Control Board, which declares that “focus on supply…does not and cannot have a long-term effect.”
Even before he began his tenure as Director of the CDC, Tom Frieden was criticized by those who knew him as “a vindictive man” with a “an authoritarian my-way-or-the-highway approach and an unabashed secretiveness undignified of a public servant.” The secretiveness[17, 18] and the forced outcomes in the opioid analgesic guidelines developed under him are extensions of this pattern.
Unfortunately, Frieden’s incompetent Ebola leadership[169, 170, 171, 172] is not the only reason for him to go. His blatant biases, his presumptuous disregard for the opinions of those who are internationally-recognized experts in addiction and abuse, his indifference toward facts, and his heavy-handed violations of the public trust have made it impossible to have confidence in guidelines produced by the CDC, so long as it remains under his politicized control.
There is a better approach, such as the open and comprehensive National Pain Strategy. Instead of applying generic restrictions prescriptions of opioid analgesics for chronic pain, we ought to be prescribing them to those patients who clearly demonstrate significant functional improvements because of them, while we maximize alternative therapies. Whether the number of such patients will be many or few, patients and their physicians deserve guidelines that they can trust.
Until January 13, 2016, you may comment upon these guidelines by Internet (http://www.regulations.gov) or by mail (National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE., Mailstop F-63, Atlanta, GA 30341, Attn: Docket CDC-2015-0112).