Ten years ago, federal and state governments began their crackdown on the prescribing of opioids to relieve pain. They enacted manufacturing quotas, Prescription Drug Monitoring Programs (PDMPs), imposed one‐size‐fits‐all practice guidelines on doctors, arrested doctors for “overprescribing,” and sued pharmaceutical companies. Yet, as the American Medical Association stated in the 2020 report from its Opioid Task Force, this approach has been an abject failure:
Despite these efforts, illicitly manufactured fentanyl, fentanyl analogues and stimulants (e.g. methamphetamine, cocaine) are now killing more Americans than ever. The use of these illicit drugs has surged and their overdose rate increased by 10.1% and 10.8%, respectively.
The Opioid Task Force reported a 37.1 percent decrease in opioid prescriptions from 2014 to 2019, and a 64.4 percent increase in the use of PDMPs in 2019 (739 queries that year).
On July 5 the Centers for Disease Control and Prevention released a preliminary report showing opioid‐related overdose deaths increased 6.2 percent from December 2018 to December 2019. Deaths due to fentanyl and its analogs increased 15.8 percent during that same period. Seemingly in a state of denial, Representative Matt Cartwright (D-PA), on July 21, introduced H.R. 7701, to double down on the same failed policies.
Still wedded to the false narrative that the overdose crisis was caused by doctors prescribing opioids to patients in pain, H.R. 7701 would require sales representatives of opioid manufacturers obtain a federal license.
H.R. 7701 would outlaw any prescription opioid with a strength greater than the maximum daily dose suggested by the CDC pain management guidelines in 2016 (or any updates thereafter). H.R. 7701 doesn’t stop there. It requires that any practitioner seeking a federal license to prescribe controlled substances be trained to follow the 2016 CDC guidelines and to prescribe no more than a 72‐hour supply of pain medicine during the 1‐year period prior to obtaining or renewing that license. The licensee must also register with the state’s PDMP.
Keep in mind that the CDC guidelines have been criticized by many experts for lacking a basis in the evidence as well as any nuance. In fact, on June 16, James L. Madara, MD sent a letter to the CDC on behalf of the AMA, stating:
As a starting point, the AMA points to the well‐received recommendation from the U.S. Health and Human Services Pain Management Best Practices Interagency Task Force that patients experiencing pain need to be treated as individuals, not according to one‐size‐fits‐all algorithms and policies that do not take individual patient’s needs into account. A similar statement was made by the CDC in 2016 when it published the CDC Guideline, where the authors plainly stated that:
“The recommendations in the guideline are voluntary, rather than prescriptive standards. They are based on emerging evidence, including observational studies or randomized clinical trials with notable limitations. Clinicians should consider the circumstances and unique needs of each patient when providing care.” (emphasis added)
Yet, the CDC Guideline also included multiple arbitrary dosage and quantity recommendations that have been consistently misapplied by state legislatures, national pharmacy chains, pharmacy benefit management companies, health insurance companies, and federal agencies. Early on, the AMA feared that the arbitrary opioid analgesic dosage and quantity thresholds appearing in the CDC Guideline would cause unintended consequences when used to severely limit individual treatment decisions made by physicians…
…It is clear that the CDC Guideline has harmed many patients—so much so that in 2019, the CDC authors and HHS issued long‐overdue, but greatly appreciated, clarifications that states should not use the CDC Guideline to implement an arbitrary threshold…
In November 2018 dozens of pain and addiction specialists published a letter condemning the misuse of the already‐suspect CDC guidelines, calling it a “large‐scale humanitarian issue.”
The bill also requires all states to create PDMPs that fit certain prescribed standards. These PDMPs will be required to report annually to the Secretary of Health and Human Services the name of every practitioner who prescribed controlled substances and the amount prescribed during the previous year, with the Secretary required to maintain surveillance.
PDMPs have cast a chilling effect on health care practitioners treating patients in pain. Numerous studies have shown that, while PDMPs intimidate prescribers into reducing—or even abandoning—their prescribing of pain medication, they have not reduced overdoses. Rather, they may be contributing to them by driving patients and nonmedical users alike to the dangerous black market. The Cato Institute held a policy forum that examined the impact of PDMPs last October.
Policymakers’ misguided focus on prescribers of pain medication has already caused countless patients to suffer needlessly. Many have turned to street drugs to get relief. Others have turned to suicide. H.R. 7701, if passed, will only exacerbate this “humanitarian issue.”
Dr. Madara was correct when he stated in his June 16 letter to the CDC:
The nation no longer has a prescription opioid‐driven epidemic. However, we are now facing an unprecedented, multi‐factorial and much more dangerous overdose and drug epidemic driven by heroin and illicitly manufactured fentanyl, fentanyl analogs, and stimulants. We can no longer afford to view increasing drug‐related mortality through a prescription opioid‐myopic lens. This is why the AMA continues its aggressive advocacy efforts in support of patients with pain and those with a substance use disorder as well as broad support for harm reduction policies and practices that address the wide range of factors affecting patients. The nation’s opioid epidemic has never been just about prescription opioids, and we encourage CDC to take a broader view of how to help ensure patients have access to evidence‐ based comprehensive care that includes multidisciplinary, multimodal pain care options as well as efforts to remove the stigma that patients with pain experience on a regular basis.
As researchers at the University of Pittsburgh reported in 2018, overdoses from the nonmedical use of licit and illicit drugs have been increasing steadily and exponentially since at least the late 1970s (well before the invention of OxyContin in 1996), with different drugs dominating the fatality statistics during different periods.
In the end, the fact remains that drug prohibition caused the overdose crisis. A growing population of nonmedical users of licit and illicit drugs are accessing increasingly dangerous drugs provided by the black market fueled by prohibition. The emphasis on prescription opioids only makes patients needlessly suffer and drives nonmedical users away from “diverted” prescription opioids and towards heroin and fentanyl.
Until Representative Cartwright and his colleagues in Congress accept this reality, the pain, the suffering, and the overdoses will continue to mount.