The United States federal government is a single entity, despite its three equal branches having more heads than a hydra and more arms than Mahakali. One part of that federal government is not supposed to create and propagate standards that another part arrests you for following, as confirmed by the U.S. Supreme Court in Gonzales v. Oregon. When it comes to the criminalization of medicine by the DEA and other federal law enforcement agencies, that rule has clearly been broken. The FDA has the statutory power to approve medications for use in the United States in accordance with the Food, Drug, and Cosmetic Act of 1938.
The FDA has approved controlled medications like opiates, stimulants, and sedatives for use. Opiates are approved for pain management, cough suppression, and anesthesia. Stimulants are approved for treating attention deficit hyperactivity disorder (ADHD), narcolepsy, and, in some cases, obesity. Sedatives are approved for anxiety, sleep disorders, seizure control, muscle spasms, and as an anesthesia adjunct. Any licensed and certified doctor can absolutely prescribe those medications for those purposes and be within the law as long as they do so for a legitimate medical purpose and in the usual practice of medicine.
What is a “legitimate medical purpose” and the “usual practice of medicine?” The U.S. Supreme Court admitted that it did not know, which is not surprising, as they aren’t doctors. Still, any sane physician would include prescribing to patients with the above disorders (legitimate purpose) after a patient has been seen and evaluated by a physician or other prescribing health care provider (usual practice). The Supreme Court also ruled that once the FDA approves a medication for one use, physicians have the authority to prescribe it for other purposes based on medical judgment. The term “medical judgment” is critical here, as this is what the DEA is usurping—the right to make a medical judgment call.
The DEA was allowed by the Supreme Court to prosecute Dr. Thomas Moore when he, 1) charged for medications by the milligram and count, and 2) did not see or evaluate his patients, not even trying to practice medicine but effectively just selling pills. The DEA is now targeting and sending to prison physicians who 1) reviewed patient records, 2) charged a fee based on time seen, 3) saw and evaluated the patient, and 4) prescribed medications approved for the condition diagnosed by the doctor. They are getting away with this because there is no effective oversight of their actions. One might think that the courts can do this, but here we run into a problem.
Judges are not medical experts, and they are not trained to discern the complicated medical issues argued by medical experts. Judges have said that it is illegal to prescribe opiate medications to addicts when this is not the law. The Controlled Substances Act of 1970, which effectively created the DEA and allowed them to certify doctors to prescribe controlled medications and police noncertified persons who distribute controlled medications, clearly states that it is illegal for doctors to prescribe controlled substances “for the purpose of maintaining the addiction.” Prescribing a controlled medication to an addict for the purpose of treating their pain or ADHD is perfectly legal.
The DEA, as can be readily seen in their press releases and indictments, routinely charges doctors for “ignoring the risks of overdose and addiction” when the doctors actually considered these issues and just made a judgment call, just in a manner that the DEA disapproved of. Going so far as to bring in paid federal witnesses to retroactively diagnose patients with “substance use disorder” and claim that this post-facto and illegitimate action—the “expert” never saw the patients and therefore cannot legally make any diagnosis (usual practice, etc.)—justifies sending doctors to prison for decades or even life. Nothing could be further from the truth.
Pried from the DEA’s hands by the tenacious Dr. Neil Anand, wielding the Freedom of Information Act, the DEA’s own words prove its actions are illegal. These documents prove that to justify an inexcusable intrusion into the practice of medicine, the DEA sought any excuse to brand physicians as “dirty doctors”—their words, not mine. Individual DEA agents, without the input of any legitimate medical authority, were allowed to decide which physicians would be targeted and prosecuted, applying false metrics such as that a physician used “dangerous medications in dangerous combinations,” a doctor’s very raison d’être, which I’ve touched on before, and for exceeding the CDC’s “voluntary, non-binding guidelines.”
The common definition of “voluntary” denotes an informed decision made without coercion or fraud. The DEA-created reality is the exact opposite of the CDC’s “voluntary, non-binding guidelines,” first propagated in 2016 and revised in 2022, after six years of, according to the CDC itself, misapplications resulting in laws and policies that “are inconsistent with a central tenet of the guideline: that the recommendations are voluntary and intended to be flexible to support, not supplant, individualized, patient-centered care.” Now, because of these previously withheld documents, we can have no doubt that the CDC’s guidelines, by themselves, are being used to target and prosecute doctors.
This travesty of federal overreach has resulted in physicians like me (and a few thousand others) who read the CDC guidelines and were trusting enough to believe the government would follow them being targeted by DEA agents who enforced these “voluntary, non-binding guidelines” as if they had come down from Mount Sinai. They did this with a zeal that would make Tomás de Torquemada himself proud, disregarding any evidence of honorable intent and lawful practice. This is despite their own admission in confidential DEA records that they do not have the authority to take these actions. Here are their exact words and a link to where they can be found:
“While the CSA is one component of the overall regulation of the practice of medicine in the United States,\10\ it bears emphasis that the CSA does not regulate the practice of medicine as a whole. Therefore, although DEA is the agency responsible for administering the CSA, DEA does not act as the federal equivalent of a state medical board overseeing the general practice of medicine. State laws and state licensing bodies (such as medical licensing boards) collectively regulate the practice of medicine.
“One of the chief purposes of this document is to make clear that the longstanding requirement under the law that physicians may prescribe controlled substances only for legitimate medical purposes in the usual course of professional practice should in no way interfere with the legitimate practice of medicine or cause any physician to be reluctant to provide legitimate pain treatment. DEA also wishes to dispel the mistaken notion among a small number of medical professionals that the agency has embarked on a campaign to ‘target’ physicians who prescribe controlled substances for the treatment of pain (or that physicians must curb their legitimate prescribing of pain medications to avoid legal liability). To achieve these aims, this document begins with a general summary of the relevant legal principles and an explanation of the role of DEA with respect to regulation of controlled substances. The document then addresses specific issues and questions that have been raised on a recurring basis by physicians who seek guidance on the subject of dispensing controlled substances for the treatment of pain. It should be understood that the legal standard under the Controlled Substances Act (CSA) for prescribing controlled substances to treat pain is the same as that for prescribing controlled substances generally: the prescription must be issued for a legitimate medical purpose by a registered physician acting within the usual course of professional practice. The reason this document focuses on the prescribing of controlled substances for the treatment of pain is that there has been considerable interest among members of the public in having DEA address this specific issue.”
Next, we have the provider alerts proving this illegal activity occurred. They were found in a document forced from their hands by the heroic efforts of Dr. Neil Anand.
Provider alerts posted through the health care fraud prevention partnership:
Seven providers appeared to be prescribing high amounts of controlled substances. Further analysis identified patients with prescriptions equal to or exceeding a daily average of 90 morphine milligram equivalents (MME). The prescribing providers were identified as outliers for prescribing opioids compared to their peers. Clinical documentation is unavailable. The investigations are currently ongoing.
An investigation identified provider prescription fraud related to inappropriate prescribing of medication. The provider appeared to be prescribing high amounts of controlled substances (82 percent controlled and 18 percent non-controlled substances), and was identified as an outlier. Further analysis revealed patients with prescriptions exceeding a daily average of 90 morphine milligram equivalents (MME). The investigation is ongoing.
An investigation identified potential fraud related to inappropriate prescribing of medication. A physician appeared to be prescribing large quantities of multiple opioids that exceeded current dosage guidelines, placing patients at risk. The investigation is ongoing.
An investigation identified inappropriate prescribing of opioids and benzodiazepines, placing patients at an increased risk of overdose. Further analysis revealed that the provider is an outlier for high opioid prescribing.
This shows that doctors still treating pain or other medical conditions with controlled substances are assumed to be “outliers” outside the “usual practice of medicine,” and anything over 90 MME is assumed to be “placing patients at risk.” Despite the fact that “clinical documentation is unavailable.” This is exactly what was promised would not happen when states started creating PDMP databases and why the DEA should stay out of medicine. They were not supposed to troll through everyone’s otherwise private medical information in a search to find people to prosecute, and administrative data is not supposed to be used for criminal prosecutions without a search warrant in accordance with the 4th Amendment.
It also shows that despite both the CDC and the DHHS making clear that prescribing opiates and benzodiazepines together is sometimes warranted, the DEA feels qualified to state that the doctor is “placing patients at an increased risk of overdose.” The punitive actions of the DEA, coupled with direct threats to physician board members, have resulted in pain review committees and state medical boards all over the U.S. ordering physicians to rapidly taper patients off benzodiazepines when on opiates, placing patients at a 60 percent increased risk of death over the next three years. If a patient comes to a doctor already on both medications, it is safer to continue them rather than discontinue the benzodiazepines (or opiates).
Despite these evidence-based facts, juries all over America are being told by paid witnesses to send doctors to prison because the DEA, despite the evidence, thinks otherwise. This clearly encroaches on physicians’ medical judgment, something the DEA is forbidden from doing by federal law (42 U.S.C. 1395) and Supreme Court rulings (Gonzales). Only state medical boards have the authority to police those judgments. Every physician targeted leaves more than a thousand patients without care. The doctors willing to treat the most complicated patients, those who have failed other treatments and are at the end of their rope, will always be exceptional.
It is usual for some physicians to take on this challenge. What is not usual is for the DEA to usurp these decisions from the physicians and lawful state authorities. Worse than that. The entire dependence on MME is not only flawed but outright fraudulent. Any test or calculation used as evidence in federal court is supposed to undergo a rigid assessment for accuracy and reliability. By the CDC’s own admission, the concept of MME does not meet this standard. MME was the brainchild of a few physicians who basically guessed at the relative strength of different opiate medications based on their own personal experiences so they could have some conversion metric.
If this were left to opinion and choice, that would be fine. However, once propagated in federal courtrooms as some kind of mandatory metric, it violates the rules of evidence and FDA regulations, as it is being used to influence diagnosis (“addiction risk”) and treatment. The FDA requires that any “device,” including any software used to influence diagnosis but does not make final decisions (Class II) or those influencing critical treatment (Class III), require special controls and rigorous testing, including usability testing, bench testing, as well as verification and clinical validation. The latter would mean verifying safety and effectiveness through clinical trials. There is absolutely no evidence that this was ever done.
Not only have the proper studies not been accomplished to prove these conversion rates, but patients are so variant in opiate processing that they can never be applied to an individual. The main two hepatic cytochrome P450 enzymes that process opiates are CYP2D6 and CYP3A4. Processing speeds of 2D6 can vary 100-fold, and 3A4 by 20-fold. Also, responsiveness to opiates by mu opiate receptors can vary by as much as 20-fold. A good paper on these factors is here. All of this combined means that “average” patients will have vastly different effects from the same opioid dose, making individualized treatment paramount to treating severe chronic pain effectively. Paramount, but, according to Dr. DEA, illegal.
The results are clear. As the regulations regarding pain and other controlled medication therapy became more byzantine and medical boards, pressured by the DEA, began insisting on unproven metrics, doctors became reluctant to treat pain. This placed a higher burden on those still willing to treat, which made them, according to the DEA’s AI-enforced algorithms, “outliers,” and an inquisition was started to find an excuse to prosecute. Once the prosecutions started and the doctors willing to treat complicated patients were locked away, most physicians quit prescribing at all, and patients suffering from severe chronic pain had nowhere to go but the streets. Funneled into the arms of the cartels, the death rates skyrocketed.
There can be no doubt. The DEA, through its unlawful influence on the practice of medicine and targeting of exceptional physicians with false metrics, is responsible for the deaths of over a million Americans.
L. Joseph Parker is a research physician.
