“In July 2015, journalist Johann Hari gave a TED Talk that over 20 million people have since viewed. Hari offered convincing evidence that vulnerability to opioid addiction is a consequence of the conditions under which people live — the social determinants of health — rather than simple exposure to opioid pain relievers. This theme is brilliantly elaborated by economist Anne Case and Nobel Prize winner Angus Deaton in their book, “Deaths of Despair and the Future of Capitalism.”
Unfortunately for all of us, the U.S. Centers for Disease Control, Department of Veterans Affairs, and Drug Enforcement Administration have been running away from the evidence ever since.
I offer a short review of information extracted from 15 years of research in published medical literature and mass media. It is time for the Attorney General’s staff to read and understand the science — and for Congress to require changes in U.S. public health policy to reflect science rather than the prevailing anti-opioid hysteria.
First: There is no cause-and-effect relationship between opioid prescribing to pain patients versus either hospitalization for opioid toxicity or mortality involving prescription opioid pain relievers as one contributor. This is true despite the fact that persistent false CDC claims to the contrary. And it has been true for at least the past 12 years.
Second: Some anti-opioid advocates grossly overestimate the “risks” of opioid prescription to medical patients. In reality, opioid addiction is not a predictable outcome of medical treatment and is rare even in patients with histories believed to be associated with increased risk. Opioid abuse among medical patients is so low, it gets lost in the noise of measurement confounds. For instance, among post-surgical patients treated with opioids for pain, prescribing is continued in fewer than 0.6 percent over the course of the following year. Prescribing varies significantly between types of surgery. The primary drivers of this relatively rare pattern appear to be failed surgeries and the onset of chronic pain, not opioid dependency or misuse.
Third: Again, contrary to the assertions of the CDC, for millions of patients who have severe chronic pain, there are no “preferable” alternatives to long-term treatment with prescription opioid pain relievers. In an exhaustive review by the Agency for Healthcare Quality of non-invasive, non-pharmaceutical treatments for chronic pain, only 218 out of nearly 5,000 published trials passed quality review. Among those, medical evidence was assessed as “weak” in more than 150, and no trials were found that attempted either-or comparisons with opioid therapy. At best, such complimentary therapies assist some patients marginally and temporarily, part of the time. They are not viable replacements for opioid therapy.
Fourth: At least two U.S. courts have found that prescription opioid pain relievers are not a “public nuisance” or inherently dangerous when used as directed. Drug companies cannot be held liable for abuses of their products by others. Likewise, a June 2022 U.S. Supreme Court decision (Ruan vs. the United States) has held that “the government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner” before a doctor can be convicted of prescribing opioids outside the normal course of medical practice.
It can be compellingly argued that U.S. public policy on the regulation of opioid pain relievers has been turned into a vast Department of Justice overreach that falsely and unfairly criminalizes physicians.
Doctors have had their assets seized before even being charged. Such forfeitures seem calculated to “result in plea bargains or civil settlements, given the cases can drag on for years, and the asset seizure leaves the accused with no means to live, much less pay attorney’s fees and court costs.” This is not legal or ethical prosecution. It is better characterized as malicious persecution.
We hear much discussion these days of steps being taken to ensure fair distribution of multi-billion-dollar financial “settlements” made by Purdue Pharma, other major drug manufacturing firms and intermediary distributors. There is evidence that some manufacturers and distributors contributed to the easy availability of pharmaceutical-grade opioids through “pill mills,” aided by the U.S. Congress itself.
However, considering the lack of cause-and-effect summarized above, it is also glaringly obvious that regardless of corporate negligence in over-promoting pain-relieving drugs, the pharmaceutical company’s financial “settlements” were made on expediency, not scientific merit.
Companies like Purdue Pharma correctly calculated that the unlimited power of state and federal governments to spend money on repeated prosecutions would eventually succeed in finding judges and juries sufficiently ignorant of science to gain a verdict against them. Rather than letting themselves be driven out of business, the companies “settled” on relatively favorable terms. With regard to science, the settlements were and still are bogus as a three-dollar bill.
Meanwhile, medical patients continue being denied treatment for severe chronic pain, with predictable results. Many patients, through no fault of their own, face medical collapse. At least hundreds, if not thousands, overcome by their pain, have committed suicide. Among those who continue to struggle, it is nearly impossible to find a doctor to treat them or a pharmacy to fill their prescriptions.
Almost everybody except CDC and U.S. law enforcement seems to understand that present U.S. public policy on opioids is mired in mythology.
This is lethal madness, and it is time for the Department of Justice and the DEA to stop promoting it. As publicly declared by the American Academy of Family Physicians and five other associations representing over 500,000 clinicians and medical students, it is time to end political interference in the practice of evidence-based medicine. And it is time for the U.S. Department of Justice to get out of Dodge.
We are a nation in pain and will not be silenced!
Richard A. Lawhern is a patient advocate.