Burden of Pain: How the CDC and DEA Criminalized Medicine

(Jay K. Joshi, MD, is a primary care physician in Indiana who spent nearly a year in prison after pleading guilty to prescribing opioids without a “legitimate medical need” to an undercover DEA agent who was posing as a pain patient. Joshi now regrets that guilty plea and is trying to vacate his conviction due to alleged DEA misconduct.

While in prison, Joshi began writing “Burden of Pain: A Physician’s Journey through the Opioid Epidemic.” His book is a cautionary tale about misguided public health policy and overzealous law enforcement, which often portray doctors as drug dealers and patients as addicts.

PNN editor Pat Anson recently spoke with Joshi, who is practicing medicine again and hopes to regain his license to prescribe opioids. This interview has been edited for content and clarity.)

JAY K. JOSHI, MD

Anson: Dr. Joshi, who is your book intended for and what is the main message you're trying to send?

Joshi: The book really is for the general public and those that have a vested interest in helping to rectify misguided federal policy, as it pertains to not just the opioid epidemic, but the overdose crisis as a whole.

My main message is that we have to understand that healthcare has a lot of uncertainty and complexity. And if we just use simplified rubrics, like cookie cutter medical guidelines or restrictive laws, we're going to create unintended consequences. It's time that we start to re-examine clinical decisions and health policy as a whole, so that we can make better informed decisions.

Anson: Do you think the general public has a good understanding of the opioid crisis and what caused it? Or is there misinformation going around that they've bought into?

Joshi: I would say there's a strong degree of misrepresentation among policymakers, who should have known better before and certainly should know better now. I think the narrative of opioid prescriptions running amok and creating this overdose crisis is a story that’s taken on a life of its own.

Did prescription opioids contribute to the overdose crisis that we see now? Yes. Was it the main driving factor? No. But there were trends in drug use and drug policy through the 2000’s and 2010’s that falsely conflated prescription opioids with illicit opioids. Policymakers should now understand that there are fundamental differences in how opioids are abused versus how they're used in a proper clinical setting.

Anson: Given what's transpired over the last few years, with overdoses soaring from illicit fentanyl and opioid prescriptions declining, do you think policymakers now know better?

Joshi: You know, in life as a general rule of thumb, often you learn more about what a person doesn't say, than what they do say. And this kind of hollow resonance in connecting fentanyl overdoses to previous manifestations of the overdose crisis to me is a glaring omission of responsibility from federal policymakers at the CDC level and law enforcement at the DEA and state level.

They’ve failed to acknowledge that the current fentanyl crisis is a manifestation of restrictive and overly simplified opioid policies that began nearly a decade ago. And I think the fact that people are not correlating that when the data clearly shows it indicates there is a willful understanding and a willful intent to not accept responsibility for prior failures and opioid policies.

Anson: Do you think the CDC and the DEA made the fentanyl crisis worse?

Joshi: It's difficult to say because when you use the word “worse,” then you almost have to apply some sort of causality. I like to look at the overdose crisis a little differently.

Did the CDC with their opioid policy guidelines contribute to the trends and overdoses that we're seeing now? Yes. By not recognizing that the guidelines would be codified into law and policy, and deliberately affect clinical decision making. They're not taking accountability for all the damaging effects. So, by that logic, you can say the CDC made the opioid epidemic worse.

But I would instead reframe it to say the CDC needs to better educate itself. What you see from them is a conflation of words, reflecting a lack of proper understanding. That's how I would define the revised 2022 CDC opioid prescribing guideline.

They talk a lot about nuances. They talk a lot about “uncertainty,” although not using that word as much as I believe that they should. But then eventually they revert to the same policy trend of creating overly simplified stipulations using morphine milligram equivalents (MME) as this rubric of clinical care, even though it was never intended to be used as a clinical decision-making tool.

The CDC needs to be better aware of its own conflicts of interest in the leadership making policy decisions. We can go down line by line looking at these individuals and assessing their conflicts of interest. And I certainly have seen things that would be quite alarming for anybody who values scientific objectivity.

But I feel like when you go down that pathway, you're simply entrenching people in their own lease, meaning the CDC will simply double down and say,”No, what we're doing is right” and the DEA will simply double down and say,” No, what we're doing is right.”

Anson: Do you think the CDC should even have an opioid guideline?

Joshi: It is odd that a public health organization would get involved with something that has, for all intents and purposes, a direct patient to physician relevancy. It's hard for me to understand how the CDC initially thought that when the guidelines made it a public health issue. It was almost as if it became a self-fulfilling prophecy.

The CDC felt like prescription opioids were a public health issue, and therefore created guidelines that affected the patient-physician relationship, thereby creating undue stigmatization in a clinical encounter that should otherwise be based upon a foundation of trust and respect.

And by doing so, they almost exacerbated the overdose crisis into a public health issue. It's very difficult to understand why they felt like those guidelines would help, as opposed to focusing on keeping prescription opioids within the framework of the patient-physician encounter, as it already had been.

I guess they were looking at rising overdose rates and conflated illicit opioids, heroin and fentanyl with prescription opioids. I'm not sure where that direct line of logic really came from. It's difficult to really justify that.

Anson: And what about the DEA? As you very well know, a lot of doctors have stopped prescribing opioids or have really scaled back the doses that they give to patients, because they don't want to go to prison like you did.

Joshi: Definitely, and I can understand that. What's interesting is that I've had direct engagements with DEA officers, and from my perspective they lack the necessary understanding of prescription opioids and the benefit it provides patients. They lack the healthcare context.

What the DEA does is correlate the clinical encounter with what you would see in a routine drug transaction. In their eyes, having a hammer as the only tool, everything looks like a nail. So the drug dealer in Mexico running Chinese products through a drug cartel entering the United States is cognitively equivalent to a physician treating patients with chronic pain.

They don't have the ability to discern context and the role clinical need plays in how patients are treated. And I think that really does an injustice to both the patients and the physicians, because effectively the only tool the DEA has to address prescription opioid use is fear. And when you use fear in the clinical context, you’ve harmed the most vulnerable patients. It's a shame that the DEA is not acknowledging this.

I wrote an op/ed in Medpage Today about a month ago, in which I asked the DEA to take a stance on harm reduction. Many medical societies talk about how harm reduction is a better overall policy to help patients. But medical societies are not implementing the laws, the DEA is implementing the laws.

So regardless of how high-minded the policies may be, unless implementation of the policies aligns with intent, you're not going to have patients being treated the way that they should be. And I think what the DEA really needs to do is to assess its role in the clinical encounter and make honest determinations on whether they have the capabilities to understand clinical need for opioids as it pertains to patients with chronic pain or acute pain. I think the DEA is lacking in that capacity.

Anson: Is the DEA practicing medicine? They say they don't.

Joshi: I know. And I disagree. I would say that the DEA is very much involved in the practice of medicine. If you are influencing clinical decisions through fear, you are engaging in the practice of medicine.

What is clinical medicine? If you present to me with headache and vision changes, and I checked your vitals and see that you have extremely high blood pressure, I'm going to consider you as somebody in hypertensive crisis. I'm making that decision based upon the facts presented to me and then, based upon that decision, I will implement a certain form of treatment. Clinical medicine is a series of decisions made in the face of uncertainty.

Should I trust my blood pressure monitor that the readings are correct? Should I trust you when you say that you have a headache and vision changes? How much of that uncertainty is simply assumed to be true when any clinical decision is made?

Now, the moment you incorporate fear into that clinical decision making, you're influencing how the decisions are made and the eventual course of clinical action.  So very much the DEA is practicing medicine, and I would greatly appreciate if they were honest about that.

Anson: You've obviously given this a lot of thought and, at the same time, you don't sound that bitter about what happened to you. Why is that?

Joshi: You know, when I was in federal prison, I was extremely depressed. I lost my medical practice. I lost my freedom. But I always felt like, in the end, things would turn out right and the truth would come out. Whether that was a delusional belief sitting in a federal prison, I don't know. But I held onto that belief.

It's through that belief that I improved my writing abilities and hand wrote the first version of “Burden of Pain.” It’s through that belief that I regained my medical license and was reinstated as a Medicare provider.

I don't feel bitter because I feel that I have a responsibility to patients and to physicians who might be going through similar situations. And if I can behave in a certain way that is productive, that can turn what I went through into an overall good for patients and for society as a whole, then I’ll feel like what I went through was worth it.

“Burden of Pain” and other books are featured in PNN’s Suggested Reading section.