overdoses

FDA Commissioner Gottlieb’s Sunday “Tweetorial” Is Both Encouraging and Frustrating

A fair reading of Food and Drug Administration Commissioner Scott Gottlieb’s “Sunday Tweetorial” on the opioid overdose crisis leaves one simultaneously encouraged and frustrated. 

First the encouraging news. The Commissioner admits that the so-called epidemic of opioid overdoses has “evolved” from one “mostly involving [diverted] prescription drugs to one that’s increasingly fueled by illicit substances being purchased online or off the street.” Most encouraging was this passage:

Even as lawful prescribing of opioids is declining, we’re seeing large increases in deaths from accidental drug overdoses as people turn to dangerous street drugs like heroin and synthetic opioids like fentanyl. Illegal online pharmacies, drug dealers and other bad actors are increasingly using the Internet to further their illicit distribution of opioids, where their risk of detection and the likelihood of repercussions are seen by criminals as significantly reduced.

As I have written here and here, the overdose crisis has always been primarily caused by non-medical users accessing drugs in a dangerous black market fueled by drug prohibition. As government interventions have made it more expensive and difficult to obtain diverted prescription opioids for non-medical use, the black market responds efficiently by filling the void with heroin, illicit fentanyl (there is a difference) and fentanyl analogs. So policies aimed at curtailing doctors’ prescriptions of opioids to patients only serve to drive up deaths from these more dangerous substitutes, while causing patients to suffer needlessly, sometimes desperately, in pain. Gottlieb validates my argument in his “tweetorial,” providing data from the Centers for Disease Control and Prevention and the Drug Enforcement Administration.

Now for the frustrating news. Gottlieb next reminds us, “No controlled substances, including opioids, can be lawfully sold or offered to be sold online. There is no gray area here.” He provides evidence of rampant illegal internet marketing of prescription opioids, with 95 percent of internet pharmacy websites selling opioids without a prescription, often conducting transactions with cryptocurrencies, and shipping these orders “virtually anywhere in the US.” This is also the way illicit fentanyl is flooding the market.

Politicians Cannot Stop Punishing Patients for the Unintended Consequences of Drug Prohibition

It seems no amount of evidence can make political leaders disabuse themselves of the misguided notion that the nation’s opioid overdose crisis is caused by doctors getting patients hooked on prescription opioids. A group of eight senators unveiled the CARA(Comprehensive Addiction and Recovery Act) 2.0 Act on February 27, targeting the opioid crisis. It would impose a 3-day limit on all opioid prescribing for patients in acute and outpatient postoperative pain.

But the movement to restrict prescriptions is not evidence-based, as prominent experts have pointed out. The politicians base their proposal on the 2016 opioid guidelines put out by the Centers for Disease Control and Prevention. The guidelines stated:

When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.

The guidelines pointed out that the above recommendations were based on “Type 4” evidence:

Type 4 evidence indicates that one has very little confidence in the effect estimate, and the true effect is likely to be substantially different from the estimate of the effect.

It further described Type 4 evidence as being based upon “clinical experience and observations, observational studies with important limitations, or randomized clinical trials with several major limitations.”

Arizona Governor, Legislature, Rush Through Flawed “Emergency” Opioid Legislation

Late on the night of January 25, the Arizona legislature unanimously approved “The Arizona Opioid Epidemic Act,” introduced at the urging of Governor Doug Ducey (R) just 3 days earlier. The Governor and legislature were in such a hurry that they took no time to request testimony from representatives of the medical profession or from any other experts that might have differing views about the best ways to approach the overdose crisis. The overdose crisis is such an “emergency” that there was no time for that. Yet, most of the Act’s provisions are not scheduled to take effect until 2019.

Among the harmful features of the Act are strict restrictions on the amount and dose of opioids doctors can prescribe to new and postoperative patients. Prescriptions may be for only 5 days, and the dosages are capped. Doctors wishing to exceed these limits must first consult a board-certified pain management specialist which, of course, might take several days. This policy is not evidence-based. It will cause injured patients and those recovering from surgery to suffer needless and agonizing pain. In December, the Arizona Medical Association and the Arizona Osteopathic Medical Association wrote the state Department of Health Services warning of harmful “unintended consequences” that may ensue from one-size-fits-all 5-day limits on prescriptions and dosages for patients in acute pain.

This policy is not just inhumane, it’s dangerous. Desperate patients might seek to get better relief for their undertreated pain by supplementing their prescriptions with alcohol and/or other drugs, or by obtaining drugs through the illegal market, increasing the risk of overdose or death.

Another provision requires all providers to use a state-approved E-prescription system to prescribe opioids, placing a burden on health care providers in remote and rural areas of the state, where broadband internet access is inadequate and where some practitioners lack technological sophistication in their practices.

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