Is the DEA Overreaching Its Authority?

By Lynn Webster, MD, PNN Columnist 

The U.S. Department of Justice (DOJ) does not have the legal authority to determine which health care activities constitute a “legitimate medical purpose.” However, an increasing number of prescribers have been subjected to DOJ criminal investigations that operate under an expanded interpretation of federal law.

In 1970, Congress passed and President Nixon signed into law the Controlled Substances Act (CSA). In its broadest sense, the CSA regulates every aspect of controlled substances, from production to delivery, distribution, prescribing, possession and use. The CSA’s impact is far-reaching, touching many different sectors of our society, including healthcare, pharmaceuticals, law enforcement, politics, and state and federal judiciaries.

According to the CSA, a prescription for a controlled substance “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” This statutory language is at the root of the issue. But who decides what is a legitimate medical purpose?

The Drug Enforcement Administration (DEA) is the branch of the DOJ that is tasked with enforcing the controlled substances laws and regulations of the United States.

In the context of trying to address the opioid crisis, the DEA has taken a proactive approach in determining which medical practices have a legitimate medical purpose and which do not. This hands-on approach is in direct contravention with the CSA. 

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The DEA is effectively preempting state law as it relates to the regulation of controlled substances. In Gonzales v. Oregon, the U.S. Supreme Court ruled in 2006 that the authority to determine a legitimate medical purpose rests with state governments.

This means it is state lawmakers, not federal officials, who should regulate the practice of medicine. Medical boards are established by the authority of each state to protect the health, safety and welfare of patients through proper licensing and regulation of physicians and other practitioners.

If a doctor engages in an obviously nefarious activity, such as selling or trading prescriptions for sex or money, then that doctor is not in any way prescribing for a legitimate or legal medical purpose under the CSA. Remedies for this conduct would be within the authority of the DOJ, as well as state regulators.

The key phrases -- "legitimate medical purpose" and "in the usual course of a professional practice" -- are not defined in the CSA. This omission, unfortunately, has invited conjecture about the meaning of the phrases in recent years. The only way the phrase "legitimate medical purpose" would have any legal meaning would be if the concept of an "illegitimate medical purpose" were defined by the CSA -- and it is not.

Moreover, the words "legitimate" and "medical" are redundant. The practice of medicine is inherently legitimate, according to the CSA. The phrase "legitimate medical purpose" can be reduced to "medical purpose" without changing its meaning.

Any practice that is medical is legitimate and should be deemed consistent with the CSA regulation. The CSA, in other words, precludes the possibility that doctors who prescribe high doses of opioids have behaved criminally based only on the level of doses they prescribe.

Standard of Care

The DOJ is now using deviation from the “standard of care” to determine whether or not practitioners have a legitimate medical purpose to prescribe opioids. A standard of care is generally considered the customary or usual practice of the average physician.

In an attempt to address the opioid problem, the DOJ has hired medical experts who claim that any deviation from standard of care amounts to practicing without a legitimate medical purpose. In some instances, the government's experts have even used the CDC opioid guideline’s dose recommendation as a test of whether or not the prescribing of opioids has a legitimate medical purpose.

Using deviations from "standard of care" as criteria for compliance with the CSA is in direct conflict with the Supreme Court ruling in Gonzalez v Oregon, which found that the Attorney Generalis not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law.”

Even substandard treatment by providers is not necessarily criminal behavior and should rarely involve prosecution by the DOJ. This is supported by a 1983 statement in a DEA newsletter that declares acts of prescribing or dispensing controlled substances lawful when they are done within the course of a provider’s professional practice. Even if a physician's behavior reflects the grossest form of medical misconduct or negligence, it is nevertheless legal.

The information provided in the newsletter isn't an opinion. It's the law.

Unquestionably, prescribers should be held to a high standard of care at all times. However, it is the responsibility of state medical boards to hold them to that standard. It is not the DOJ's role to determine the quality or boundaries of the practice of medicine.

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 Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and the author of “The Painful Truth.”

You can find Lynn on Twitter: @LynnRWebsterMD. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

I’m Ashamed of the U.S. Justice Department

By Drew Pavilonis, Guest Columnist

I was a federal law enforcement officer with the U.S. Department of Justice (DOJ) for 14 years. Hard work, a willingness to transfer, and a graduate degree brought fast promotions and a coveted position in management at a DOJ training academy just outside of Denver.

However, a rare type of brain tumor deep in the thalamus brought everything to a sudden halt after ten years in Denver. My doctors initially said the brain tumor was inoperable due to its sensitive location, but the tumor continued to grow, and I eventually flew to Phoenix to have a talented neurosurgeon perform the difficult surgery to remove it.

The thalamus and brainstem proved to be a very challenging surgery and I suffered permanent disability because of it. I spent several months as an inpatient at a neuro-rehabilitation hospital, relearning how to walk and speak, dress and bath myself.

The DOJ medically retired me because cripples can't be law enforcement officers. Fortunately, I had 19 years of federal service and was able to retire with a pension, which was a good thing since I was not able to work due to my significant disability. 

However, the suffering didn’t end there. I developed chronic, debilitating pain 3 years after the surgery.

DREW PAVILONIS

DREW PAVILONIS

Fortunately, at the urging of my sister, I had moved close to Duke University Hospital in North Carolina for follow up medical care. The doctors at Duke hypothesized that my pain was due to scar tissue that formed in my thalamus after the brain surgery. The thalamus is the brain's pain center and my pain “switch” had been permanently turned on.

I was bedridden and prayed for death daily. The pain was so bad that I could not walk. I was taken by ambulance to Duke Hospital for a one week stay as an inpatient and was medically tested to the extreme. Eventually, the doctors determined that I had real pain and referred me to pain management. 

I was prescribed methadone, four times a day. Additionally, to fight the debilitating nerve pain that I also have, I was put on the maximum dose of gabapentin. The medications just allow me to live, much like diabetics need insulin to survive. I am always in pain, but the medications control it to a tolerable level.

I am able to travel internationally (I write this from my hotel room in Berlin, Germany), do volunteer work, and ride an outdoor wheelchair. However, I worry that that I will someday become collateral damage in this “war on opioids.”

I cringe every time I see a journalist cite the CDC report about opioid related deaths in America. That report was full of errors and incorrect by the CDC's own admission. Also concerning are the jack-booted tactics of the DEA, which attacks legitimate pain treatment as if doctors were responsible for all the heroin in the country.

Those rogue tactics have had a chilling effect on the practice of pain management and contributed to a growing number of patient suicides. Many chronic pain patients have taken their own lives because they could not get the appropriate medication that they so desperately need to live.

I never thought I would see human rights violations conducted by my own government against fellow Americans. It is unbelievable.  I no longer tell people that I am retired from the DOJ because I am ashamed of it. I just say that I’m retired from the federal government. That's sad.

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Drew Pavilonis lives in North Carolina.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Sessions Creates New Task Force to Target Rx Opioids

By Pat Anson, Editor

U.S. Attorney General Jeff Sessions has announced the creation of a new task force targeting manufacturers and distributors of opioid pain medication, as well as physicians and pharmacies engaged in the “unlawful” prescribing of opioids.

“We are attacking this crisis at its root: the diversion and overprescription of opioid painkillers,” Sessions said at a news conference. “We will use criminal penalties.  We will use civil penalties.  We will use whatever tools we have to hold people accountable for breaking our laws.”

Sessions also said the Justice Department would file a “statement of interest” in hundreds of lawsuits filed by states, counties and cities seeking to recover billions of dollars in damages from opioid manufacturers who used deceptive marketing practices. Such a statement could result in the federal government joining as a party in the lawsuits and recovering damages.

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Sessions said the government had borne “substantial costs” as a result of the opioid crisis, including $4 billion paid by Medicare for opioid pain medication in 2016.

“The hard-working taxpayers of this country deserve to be compensated by those whose illegal activity contributed to those costs.  And we will go to court to ensure that the American people receive the compensation they deserve,” Sessions said.

“These are not our last steps.  We will continue to attack the opioid crisis from every angle.  And we will continue to work tirelessly to bring down the number of opioid prescriptions, reduce the number of fatal overdoses, and to protect the American people.”

Sessions’ announcement avoided any mention of the growing scourge of black market opioids, such as heroin, illicit fentanyl and counterfeit medication, which are now responsible for most overdose deaths. He also did not acknowledge that opioid prescribing has been declining for several years and that less than one percent of legally prescribed opioids are diverted.

The new task force – called the Prescription Interdiction & Litigation (PIL) Task Force -- will include senior officials from the Attorney General’s Office and the Drug Enforcement Administration. It appears to be focused solely on prescription opioids.

“The PIL Task Force will use the criminal and civil tools available under the Controlled Substances Act against doctors, pharmacies, and others that break the law,” the DOJ said in a statement.

Sessions directed the task force to improve coordination with the Department of Health and Human Services – which includes the FDA, CDC and the Centers for Medicare and Medicaid Services (CMS) – in sharing healthcare data to identify “patterns of fraud related to the opioid epidemic.”

The Attorney General's single-minded focus on pain medication as the cause of the opioid crisis has angered many pain patients and advocates.

"I am operating on the assumption that this country prescribes too many opioids," Sessions said during a speech earlier this month. "People need to take some aspirin sometimes and tough it out.”

“I hope Sessions falls down, hits his head and breaks a hip and has to take two aspirin and get over it,” wrote one PNN reader.

“Jeff Sessions is an instrument of hate. He has succeeded in driving a wedge through the most sacred trusts -- the relationships between doctors and patients. Doctors now fear and loathe their patients for putting their licenses at risk, and patients fear and loathe their doctors for abandoning their compassionate care plans,” wrote another reader.

"This is exactly why we don't need, a group of people that know nothing about what they are making laws for. Jeff Sessions, if you or one of your family had Reflex Sympathetic Dystrophy, you would never have made a fool out of yourself with your aspirin remarks," said another.

Sessions Resumes Enforcement of Marijuana Laws

By Pat Anson, Editor

Attorney General Jeff Sessions has followed through on his threat to resume enforcing federal laws that outlaw the cultivation, distribution and possession of marijuana.

Session has rescinded the Cole memo, a lenient policy adopted by the Justice Department in 2013 that instructed U.S. Attorneys not to investigate or prosecute marijuana cases in states that have legalized cannabis. Although 29 states and the District of Columbia have legalized marijuana in some form, federal law still prohibits its sale or possession under the Controlled Substances Act.

ATTORNEY GENERAL JEFF SESSIONS

ATTORNEY GENERAL JEFF SESSIONS

In a one-page memorandum sent to U.S. Attorneys around the country, Sessions called the Cole memo “unnecessary” and authorized prosecutors to use their own discretion in investigating and prosecuting marijuana cases.

"It is the mission of the Department of Justice to enforce the laws of the United States, and the previous issuance of guidance undermines the rule of law and the ability of our local, state, tribal, and federal law enforcement partners to carry out this mission," Sessions said in a statement.

"Therefore, today's memo on federal marijuana enforcement simply directs all U.S. Attorneys to use previously established prosecutorial principles that provide them all the necessary tools to disrupt criminal organizations, tackle the growing drug crisis, and thwart violent crime across our country."

“This change will allow any US Attorney who is looking to make a name for themselves to take unilateral action, thus depriving any semblance of certainty for state-lawful consumers or businesses moving forward," said Justin Strekal, NORML Political Director.

Sessions released his memo just three days after California legalized the recreational use of marijuana by adults – the eighth and largest state to do so. California was the first state to legalize medical marijuana in 1996.

It is not yet clear how rigidly Sessions plans to enforce federal marijuana laws. Since 2013, Congress has attached a rider to the Justice Department budget that prevents it from using federal funds to enforce federal law in states where medical marijuana is legal. The Rohrabacher-Blumenauer amendment is still in force, but is set to expire on January 19 unless it is extended by Congress.

Sessions’ memo drew a swift and angry response from some members of Congress.

“This reported action directly contradicts what Attorney General Sessions told me prior to his confirmation. With no prior notice to Congress, the Justice Department has trampled on the will of the voters in CO and other states,” Sen. Cory Gardner (R-CO) said in a tweet. “I am prepared to take all steps necessary, including holding DOJ nominees, until the Attorney General lives up to the commitment he made to me prior to his confirmation.”

“This is outrageous. Going against the majority of Americans -- including a majority of Republican voters -- who want the federal government to stay out of the way is perhaps one of the stupidest decisions the Attorney General has made,” said Rep. Earl Blumenauer (D-OR), one of the co-authors of the Rohrabacher-Blumenauer amendment.

“One wonders if Trump was consulted -- it is Jeff Sessions after all -- because this would violate his campaign promise not to interfere with state marijuana laws.”

In an interview during the 2016 campaign, President Trump said he would not change the federal enforcement policy on marijuana. “I wouldn’t do that, no,” Trump said. “I think it’s up to the states. I’m a states’ person. I think it’s up to the states, absolutely.”

According to a recent Gallup Poll, 64% of Americans say marijuana should be legalized. The issue has broad bipartisan support, with 51% of Republicans and 72% of Democrats supporting legalization.

“The rollback of this policy towards state legalized marijuana will only create chaos and confusion for an industry that is currently responsible for creating over 150,000 American jobs and generating countless millions in state tax revenue. This instability will only push consumer dollars away from these state sanctioned businesses and back into the hands of criminal elements," said Erik Altieri, NORML Executive Director.

"This is not just bad policy, but awful politics and the Trump Administration should brace itself for the public backlash it will no doubt generate."