Pharmacists and Rx Wholesalers Charged with Drug Trafficking

By Pat Anson, PNN Editor

Major pharmaceutical companies like Purdue Pharma, Mallinckrodt and Johnson & Johnson are often singled out for their role in the nation’s opioid crisis. But wholesalers, pharmacies and other parts of the drug distribution system are also coming under scrutiny.

This week the former president and former compliance officer for an Ohio drug distributor and two West Virginia pharmacists were arrested after being indicted with conspiring to distribute controlled substances.

Miami-Luken supplied pharmaceutical drugs to over 200 pharmacies in Ohio, West Virginia, Indiana and Tennessee. According to the DEA, the company generated over $173 million in sales annually.

Prosecutors say Miami-Luken distributed opioid pain medication “outside the scope of professional practice and not for a legitimate medical purpose.”

Between 2011 and 2015, the company allegedly ignored “obvious signs of abuse” by distributing more than 2.3 million oxycodone pills and 2.6 million hydrocodone pills to a pharmacy in Oceana, West Virginia, a town of less than 1,400 people.

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From 2008 to 2011, over 3.7 million hydrocodone pills were sent by Miami-Luken to a pharmacy in Kermit, West Virginia, which has about 400 people.

Criminal Charges Rare

According to CNN, it’s only second time a drug distributor has been criminally charged with illegally distributing opioid painkillers. In April, two former executives of the Rochester Drug Co-Operative in upstate New York were charged with drug trafficking for failing the stop suspicious orders for opioids.

In previous cases, wholesalers, pharmacies and even hospitals paid heavy fines for not being alert to suspicious activity. For example, Effingham Health System of Georgia agreed to pay a $4.1 million settlement after the DEA uncovered the diversion of tens of thousands of oxycodone tablets from its hospital.

Last year, CVS Health agreed to pay a $5 million fine to settle allegations that several CVS pharmacies in California failed to detect thefts of hydrocodone. In 2015, CVS paid a $22 million fine because two of its Florida pharmacies filled bogus prescriptions for opioids.  

Cardinal Health, one of the nation’s largest drug wholesalers, was fined $34 million by the DEA in 2012 after it failed to report suspicious orders for hydrocodone at a Florida distribution facility.

The list goes on and on. The point is that no one went to prison or was criminally charged in any of these cases. Which may be about to change. The four defendants in the Miami-Luken case face up to 20 years in prison. 

“Today’s arrests should be a wakeup call to distributors and pharmacists who are allowing opioid prescription pills to be illegally sold and dispensed from their facilities,” said DEA Assistant Administrator John Martin. “These actions will not be tolerated by the DEA, and they will be brought to justice.”

Patients Caught in the Middle

Big fines and prison terms may be appropriate, but not if they result in legitimate patients with legitimate prescriptions being denied access to opioids.  That’s what happened in April to a California woman with Stage 4 terminal breast cancer who couldn’t get a prescription filled for Norco at her local Rite Aid pharmacy.  

April Doyle’s tearful, 6-minute video about her experience went viral online, and she wound up getting apologies from a Rite Aid vice-president, the store manager and even the pharmacist who sent her away without pain medication.

Rite-Aid’s caution in filling opioid prescriptions may have stemmed from being added a few months earlier as a defendant in New York City’s opioid lawsuit (along with CVS, Walgreens and Walmart) by the law firm of Simmons Hanly Conroy.  

“Many plaintiffs in opioid lawsuits are amending their complaints to include these retailers because they failed to monitor the drugs sold out of their pharmacy windows,” Simmons Hanly said in a statement.

The Washington Post released a report this week on how drug companies, wholesalers and pharmacies “saturated the country” with 76 billion oxycodone and hydrocodone pills from 2006 through 2012. Those pills, according to the Post, “fueled the prescription opioid epidemic” and resulted in nearly 100,000 deaths.

But as Jeffrey Singer points out in Cato at Liberty, the Post is fueling a false narrative about the opioid crisis by pinning the blame on prescription opioids, while largely ignoring the fact that most people who abuse drugs do it to escape emotional pain, not physical.

“The overdose problem has never been a product of doctors treating patients for pain. It has always been a product of (a growing population of) nonmedical users accessing drugs in a dangerous black market fueled by drug prohibition,” Singer wrote.  “The continued obsession about the number of pain pills being prescribed causes patients to go undertreated for their pain and will not make one IV drug user pull the needle out of their arm.”

Study Debunks Myths About Origins of Opioid Abuse

By Pat Anson, PNN Editor

It’s become a popular myth – and for some, a propaganda tool – to claim that opioid pain medication is a gateway drug to heroin and other street drugs.

An opioid education campaign called The Truth About Opioids – funded with taxpayer dollars from the White House Office of National Drug Control Policy — declares in big bold letters on its website that “80% of heroin users started with a prescription painkiller.”

The 80% figure stems from a 2013 study that found four out of five new heroin users had previously abused prescription opioids by using them non-medically.

Importantly, the heroin users were not asked if they had a valid prescription for opioids or even where they got them – but that doesn’t stop federal agencies from citing the study as proof that illegal drug use often starts with a legal opioid prescription.

The Drug Enforcement Administration last year used the 80% figure to justify steep cuts in the supply of prescription opioids, claiming in the Federal Register that addicts often get hooked “after first obtaining these drugs from their health care providers.”

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“The 80% statistic is misleading and encourages faulty assumptions about the overdose crisis and medical care,” Roger Chriss explained in a PNN column last year.

A new study by researchers at Penn State University debunks the myth that the opioid crisis was driven primarily by doctors’ prescriptions. The researchers conducted a series of surveys and in-depth interviews with opioid abusers in southwestern Pennsylvania -- a region hard hit by opioid addiction -- asking detailed questions about their drug use.

The study was small – 125 people were surveyed and 30 of them were interviewed – but the findings provide a an important new insight into the origins of opioid abuse and the role played by painkillers.

"What emerged from our study -- and really emerged because we decided to do these qualitative interviews in addition to a survey component -- was a pretty different narrative than the national one,” said lead author Ashton Verdery, PhD, an assistant professor of sociology, demography and social data analytics at Penn State. "There's a lot about that narrative that I think is an overly simplistic way of thinking about this."

‘Opioids Were Never the First Drug’

Verdery and his colleagues found that over two-thirds of those interviewed (66.7%) first abused a prescription opioid that was given, bought or stolen from a friend or family member. Another 7% purchased the drugs from a stranger or dealer. Only one in four (26%) started by abusing opioid medication that was prescribed to them by a doctor.

“We found that most people initiated through a pattern of recreational use because of people around them. They got them from either siblings, friends or romantic partners," said Verdery. “Participants repeatedly reported having a peer or caregiver in their childhood who had a substance use problem. Stories from childhood of witnessing one of these people selling, preparing, or using drugs were very common. Being exposed to others’ substance use at an early age was often cited as a turning point for OMI (opioid misuse) and of drug use in general.”

And prescription opioids were not the gateway drugs they are often portrayed to be. Polysubstance abuse was common and usually began with drugs such as alcohol, marijuana, cocaine, methamphetamine, prescription sedatives and prescription stimulants.

“It is important to note that interviewees universally reported initiating OMI only after previously starting their substance use career with another drug (e.g., alcohol, marijuana, cocaine). Opioids were never the first drug used, suggesting that OMI is likely associated with being further along in one’s drug using career,” Verdery reported in the Journal of Addictive Studies.

Verdery says additional studies are needed on the origins of drug abuse and that researchers should focus on the role that other substances play in opioid addiction. Only then can proper steps be taken to prevent abuse and addiction before they start.

"We think that understanding this mechanism as a potential pathway is worth further consideration," said Verdery. "It's not just that people were prescribed painkillers from a doctor for a legitimate reason and, if we just crack down on the doctors who are prescribing in these borderline cases we can reduce the epidemic.”

Doctors Prosecuted for Opioid Prescribing Should Fight Back

(Editor’s note: In 2016, Dr. Mark Ibsen’s medical license was suspended by the Montana Board of Medical Examiners for his opioid prescribing practices. Two years later, the suspension was overturned by a judge who ruled that the board made numerous errors and deprived Ibsen of his legal right to due process.)

By Mark Ibsen, MD, Guest Columnist

The headlines are pretty typical: “60 Doctors Charged in Federal Opioid Sting.” The story that follows will include multiple damning allegations and innuendos, including a claim by prosecutors that they are “targeting the worst of the worst doctors.”

Sometimes there is a trial, but often the doctors plead guilty to lesser charges and give up their license rather than mount a lengthy and costly legal defense.

Why are doctors losing every case to their medical boards and DEA? Are there that many criminal doctors? If so, what happened to our profession?

I see a pattern emerging: A doctor sees patients and treats pain in the course of their practice. As other doctors give up prescribing opiates for fear of going to prison or losing their license, the ones left end up seeing more and more patients.

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They soon become the leading prescribers of opioids in their state and become suspect just based on the volume of opioids they prescribe.

Given that law enforcement and medical board investigators usually don’t have training in statistics (or medicine), they are unable to see that the number of pain patients remains the same, but there are fewer practitioners willing to treat them.

“The Criminalization of Medicine: America’s War on Doctors” was published in 2007, but is even more relevant today.   

“Physicians have been tried and given longer prison sentences than convicted murderers; many have lost their practices, their licenses to practice medicine, their homes, their savings and everything they own,” wrote author Ronald Libby. “Some have even committed suicide rather than face the public humiliation of being treated as criminals.”

Libby wrote over a decade ago about doctors’ homes and offices being raided, DEA agents posing as pain patients to entrap them, and law enforcement task forces being created to target doctors for fraud, kickbacks and drug diversion.

Sound familiar?

I was reviewing a case about a nurse practitioner in Michigan who recently had her license suspended because she prescribed opioids “contrary to CDC guidelines” and “ranked among Michigan’s highest-volume prescribers of commonly abused and diverted controlled substances.”

This unsubstantiated crap put out by the Michigan Board of Nursing and its investigator is unethical and immoral. It should lead to a mistrial in court or dismissal at hearings. 

Fight Fire With Fire

This is an Amber alert for physicians. While pejorative headlines contaminate the discourse, the prescriber’s reputation bleeds away. The Montana Board of Medical Examiners did this in my case, and since I knew that the board was relentlessly after my license for “overprescribing” opioids, I gave up any hope of fairness.

My proposal: Lawyers representing doctors must counter the negative headlines with their own, and doctors should use whatever goodwill is left to rally their staff and patients, counteracting the pressure to testify against the doctor. 

I used what was left of my bully pulpit to save my own license and freedom. How? My assistant assembled my patients in large crowds at my hearings. I also made myself available to the media to counter the narrative put out by Mike Fanning, the board’s attorney, who went so far as to publicly question my sanity.

Fanning’s title was special assistant Attorney General, which told me the medical board works for DOJ in my state. I knew this for sure when DEA agents came to my office and tried to intimidate me.

“Doctor Ibsen, you are risking your license and your freedom by treating patients like these.”

Patients like what?

“Patients who might divert their medicine.”

Might? Isn’t that everyone? What would you have me do?

“We can’t tell you, we’re not doctors.”

My plea to doctors: Let’s reinvent our defense. The DEA and medical boards have a formula. It’s winning. 

We need a new response: Fight back and hold on. Just like with any bully, reveal their game and fight fire with fire.

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Dr. Mark Ibsen continues to practice medicine in Montana, but focuses on medical marijuana as a treatment. He no longer prescribes opioids. Six of his former patients have died after losing access to Dr. Ibsen’s care, three by suicide.

Do you have a story you want to share on PNN? Send it 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.

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.

CDC: Opioid Guideline Should Not Be Used to Taper Patients

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has taken its first concrete step to address the widespread misuse and misapplication of its opioid prescribing guideline.

In a commentary published in The New England Journal of Medicine, the guideline’s authors say the agency does not support abrupt tapering or discontinuation of opioid medication, and that the guideline’s recommendation that daily doses be limited to no more than 90 MME (morphine milligram equivalent) should only be applied to patients who are starting opioid therapy.

“Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations,” wrote Deborah Dowell, MD, Tamara Haegerich, PhD, and Roger Chou, MD. “A consensus panel has highlighted these inconsistencies, which include inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages, resulting in sudden opioid discontinuation or dismissal of patients from a physician’s practice.”

The co-authors also noted that the guideline “does not address or suggest discontinuation of opioids already prescribed at higher dosages,” nor does it seek to deny opioids to patients with cancer, sickle cell disease or recovering from surgical procedures.

The CDC’s clarification was cheered by patient advocates, who have been calling on the agency to address the suicides, patient abandonment and other unintended consequences of the guideline for over three years.

“The statement from the CDC is a long-awaited, robust clarification that has come at a critical time. They clearly defined that its Guideline cannot and should not be invoked to justify the forced reduction or denial of opioid pain medication to patients who use opioids to manage their long-term pain,” said Andrea Anderson, a patient advocate with the Alliance for the Treatment of Intractable Pain (ATIP).

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The CDC’s controversial guideline was released in March 2016 as a voluntary set of recommendations meant to discourage primary care physicians from prescribing opioids for chronic non-cancer pain. But the guideline was quickly adopted by states, insurers, pharmacies, practitioners and even law enforcement agencies, who saw it as a mandatory policy that all physicians should follow to reduce rates of opioid addiction and overdose.

Reports soon began surfacing of patients being forcibly tapered off opioids or being abandoned by doctors who no longer wanted to treat them. Within months of the guideline’s release, CDC was warned by its own public relations consultants that “doctors are following these guidelines as strict law” and that some patients “are now left with little to no pain management.”

In PNN’s recent survey of nearly 6,000 patients, over 85 percent said the guideline has made their pain and quality of life worse. Nearly half say they have considered suicide because their pain is poorly treated. Many are hoarding opioids because they fear losing access to the drugs and some are turning to other substances – both legal and illegal – for pain relief.

‘Unintended Harms’

Not until this month did CDC acknowledge that its guideline was causing patient harm.

“CDC is working diligently to evaluate the impact of the Guideline and clarify its recommendations to help reduce unintended harms,” CDC Director Dr. Robert Redfield wrote in an April 10 letter to a group of healthcare professionals. who had asked the agency to make a “bold clarification” of the guideline.

Redfield’s letter was sent the day after the Food and Drug Administration warned doctors not to abruptly taper or discontinue opioids. The FDA said it had received reports of “serious harm” to patients, including withdrawal, uncontrolled pain, psychological distress and suicide.    

“The clarification is an essential beginning because it is the CDC guideline that has been used by law enforcement agencies to surveil doctors and by major insurers and pharmacies in ways that deny pain patients access to opioid analgesia,” said Kate Nicholoson, a civil rights attorney and pain patient.  

It is the CDC guideline that has been used by law enforcement agencies to surveil doctors and by major insurers and pharmacies in ways that deny pain patients access to opioid analgesia.
— Kate Nicholson, Civil Rights Attorney

“Given the harms suffered by pain patients, a muscular, public-facing clarification from the CDC was needed. We hope that this action and the warning the FDA issued last week against abrupt tapering of pain patients will mark a beginning in protecting the rights of patients who use opioid medication appropriately to manage pain.” 

But other patient advocates wonder why it took so long for the CDC to act.

“It's gratifying to see CDC admit that its guideline is being misinterpreted and misapplied, as many of us have been warning for some time,” said Bob Twillman, PhD, former Executive Director of the Association of Integrative Pain Management. “It's a bit puzzling to me why it has taken them three years to do so, when many of us, myself included, told them within days of the guideline's issuance that these things were going to happen.

“Unfortunately, we've spent the past three years watching three dozen states violate CDC's stated intent that the guideline not be legislated, not to mention the untold numbers of insurance companies, health care systems, private practices, and pharmacy chains that have created a whole population of opioid refugees by misusing the guideline. Serious harms, including patient deaths, have resulted, and there is virtually no evidence that the intended effect of reducing prescription opioid overdose deaths has occurred, while overall opioid overdose deaths continue to climb rapidly.”

The New England Journal of Medicine is a respected publication with a wide reach among healthcare professionals, but it is not clear what CDC will do to caution states, insurers, pharmacies and law enforcement agencies about their misuse of the guideline.

“Unless Congress and the Executive Branch tell the DEA (and by association, state drug enforcement authorities and prosecutors) to stand down from persecuting doctors, I don't see any useful impact for this statement at all,” Richard “Red” Lawhern, PhD, of ATIP wrote in an email. “Doctors will continue to leave pain management and to desert their patients until they can be assured they will not be sanctioned, so long as they act in good faith to treat pain and manage their patients.” 

In recent months, federal prosecutors in Wisconsin and several other states sent letters to hundreds of physicians warning them that their opioid prescribing practices exceed those recommended by the CDC. The doctors were identified through data-mining of prescription drug monitoring programs (PDMPs), which have been weaponized to target physicians. 

“Practitioners were identified where they prescribed on average 90 MMEs (or more) per patient per day. That’s the threshold where the CDC and the Wisconsin Medical Examining Board say there is no real evidence to suggest that above that amount has any better effect on chronic pain,” a DOJ spokesperson told PNN.  

Just last week, a DEA task force charged dozens of doctors and other healthcare providers with illegal opioid prescribing. Prosecutors say more criminal cases are in the pipeline. 

"We have hyper-accurate data at the DEA and other agencies in the federal government where we are able to (use) that data and we can sort of pinpoint where these pills are being over-prescribed just by the population center in which they're being prescribed," said Jay Town, a federal prosecutor in Alabama.  "There are more doctors out there, there are more people working in clinics, and physicians’ offices, or pharmacies, or in compounding pharmacies, that we still have ongoing investigations or beginning investigations.” 

‘Achieve Widespread Adoption’ 

The CDC may have finally acknowledged the “unintended harms” caused by the guideline, but the data-mining and wholesale adoption of its recommendations are exactly what the agency outlined in a 2015 CDC memo obtained by PNN:   

“Efforts are required to disseminate the guideline and achieve widespread adoption and implementation of the recommendations in clinical settings. CDC is dedicated to translating this guideline into user-friendly materials for distribution and use by health systems, medical professional societies, insurers, public health departments, health information technology developers, and providers, and engaging in dissemination efforts.  

Activities such as development of clinical decision support in electronic health records to assist providers’ treatment decisions at the point of care, identification of mechanisms that insurers and pharmacy benefit plan managers can use to promote safer prescribing within plans, and development of clinical quality improvement measures and initiatives to improve prescribing and patient care.”

Can the CDC undo all the harm its “user-friendly materials” have caused over the last three years? Will states be advised to rollback their laws and regulations? Will insurers and pharmacies be told to stop limiting the dose of opioid prescriptions? And what about the patients who committed suicide? The CDC did not respond to a request for comment.

“That no one at CDC anticipated that the guideline would be misinterpreted and misapplied in this way is hard to swallow,” said Twillman. “I would have hoped that they would be vigilant for such occurrences, and taken action swiftly and effectively when they became apparent.”

60 Arrested in Latest Crackdown on Rx Opioids

By Pat Anson, PNN Editor

Sixty people in five states face charges of illegal opioid prescribing and healthcare fraud in the latest federal crackdown on opioids. The arrests are the first since the Justice Department established an opioid strike force last year to concentrate on drug crimes in the Appalachian region.

The defendents include 31 doctors, 7 pharmacists, 8 nurse practitioners and 7 other licensed medical professionals.

“The opioid epidemic is the deadliest drug crisis in American history, and Appalachia has suffered the consequences more than perhaps any other region,” Attorney General William Barr said in a statement. 

“But the Department of Justice is doing its part to help end this crisis. One of the Department's most promising new initiatives is the Criminal Division's Appalachian Regional Prescription Opioid Strike Force, which began its work in December.  Just four months later, this team of federal agents and 14 prosecutors has charged 60 defendants for alleged crimes related to millions of prescription opioids.” 

The charges involve over 350,000 opioid prescriptions and over 32 million pills. A federal prosecutor claimed that was the equivalent of a dose of opioids for every man, woman and child in Ohio, Kentucky, Tennessee, West Virginia and Alabama.

In one case, a doctor and several pharmacists are accused of operating a pill mill in Dayton, Ohio. Over a two-year period, the pharmacy dispensed over 1.75 million pills. 

In Kentucky, a doctor operating a pain management clinic allegedly provided pre-signed, blank prescriptions to office staff who then used them to prescribe controlled substances when he was out of the office. 

And in Tennessee, a doctor who called himself the “Rock Doc” allegedly prescribed dangerous combinations of opioids and benzodiazepines, sometimes in exchange for sexual favors.

“Reducing the illicit supply of opioids is a crucial element of President Trump’s plan to end this public health crisis,” Health and Human Services Secretary Alex Azar said in a statement.  “It is also vital that Americans struggling with addiction have access to treatment and that patients who need pain treatment do not see their care disrupted, which is why federal and local public health authorities have coordinated to ensure these needs are met in the wake of this enforcement operation.”

A DOJ press release provided a list of hotlines, websites and other resources where effected patients can get addiction treatment. None of them, however, appear to offer pain management.

Pain patients are often the forgotten victims in law enforcement crackdowns on healthcare providers. Dawn Anderson, for example, a double amputee and diabetic, died last month in “sheer agony” because she was no longer able to get opioid medication from a pain management doctor who stopped practicing medicine after he was accused and convicted of healthcare fraud.    

Most Overdoses Don’t Involve Rx Opioids

The Appalachian region – and West Virginia in particular – has been ground zero in the opioid crisis. But a new study by researchers at West Virginia University shows just how much the crisis has shifted away from prescription opioids.

Researchers analyzed over 8,800 drug-related deaths in West Virginia from 2005 to 2017 and found that deaths involving fentanyl soared by 1,325% over that period.

From 2005 to 2014, prescription opioids were involved in almost 60% of drug related deaths in West Virginia, but from 2015 to 2017 they were only involved in about 30% of drug deaths.

West Virginians are now twice as likely to die from fentanyl than they are from oxycodone. Deaths linked to fentanyl, heroin, alcohol, alprazolam (Xanax) and cocaine outnumber those from oxycodone or any other opioid pain reliever.

Fentanyl and its analogs are synthetic opioids 50-100 stronger than morphine. They’ve become a scourge on the black market, where they are frequently mixed with heroin and cocaine to boost their potency or used in the manufacture of counterfeit medication.

Reducing the supply of prescription opioids and locking up doctors isn’t going to solve the fentanyl problem.

"One of the proven ways to reduce overdoses is to decrease the number of people who are addicted and using. But with fentanyl, you could halve the number of addicts in West Virginia, and the overdose rate could still go up because the strength of the drug coming in is so much stronger and can vary widely from one day to the next," said Gordon Smith, MD, an epidemiologist in the West Virginia School of Public Health. "This is an absolute quandary."

West Virginia's increase in fentanyl-related deaths is part of a national trend. As the CDC reported, deaths from fentanyl overdoses spiked across the United States in 2015 and are still climbing. West Virginia leads the nation in fentanyl-related deaths and has the highest per capita rate of overdose deaths overall.

CVS Fined $535,000 for Filling Forged Opioid Prescriptions

By Pat Anson, PNN Editor

CVS Pharmacy has agreed to pay a $535,000 fine to resolve allegations that several of its Rhode Island stores filled dozens of forged prescriptions for Percocet, a potent opioid painkiller. It’s the latest in a series of fines the nation’s largest pharmacy chain has paid for violations of the Controlled Substances Act.

According to DEA investigators, CVS pharmacists filled 39 forged prescriptions for Percocet between 2015 and 2017 even though they “knew or had reason to know that the prescription in question was invalid or unauthorized.”

In a settlement agreement with the Department of Justice, CVS agreed to pay the fine while making no admission of any liability or wrongdoing. The company said it wanted to avoid the expense and uncertainty of going to trial. In return, the DOJ agreed to drop all civil or criminal prosecution of the case.

“DEA registrants like CVS have a corresponding responsibility to dispense controlled substances in accordance with the Controlled Substance Act,” said DEA Special Agent in Charge Brian Boyle. 

“Pharmacies put patients at risk when they dispense Schedule II narcotics, which have the highest potential for abuse, without a valid and legal prescription.  Today’s settlement demonstrates DEA’s commitment to work with our law enforcement and regulatory partners to ensure that these rules and regulations are followed.”

It’s not the first time CVS has been accused of lax or fraudulent behavior involving opioid medication.

In 2017, CVS agreed to pay a $5 million fine to settle allegations that several of its pharmacies in California failed to detect thefts of the opioid painkiller hydrocodone.

In 2016, CVS agreed to pay a $3.5 million fine to resolve allegations that 50 of its pharmacies in Massachusetts and New Hampshire filled forged prescriptions for opioids. One forger signed a dentist’s name on 131 prescriptions for hydrocodone and had them filled at eight different CVS stores.

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And in 2015, CVS paid a $22 million fine after two of its pharmacies in Florida were found to be routinely filling bogus prescriptions for painkillers, including some for customers as far away as Kentucky.

All of these cases were settled out of court.

In 2018, CVS angered pain patients when it began to limit the initial dose of opioids to 7 days’ supply for customers enrolled in CVS Caremark health plans. For both acute and chronic pain patients, CVS said daily doses of opioids should not exceed 90 MME (morphine milligram equivalent) and patients would be required to use immediate release formulations. CVS said it was making the CDC opioid guideline the “default approach” to prescribing opioids.

Last week, CDC Director Dr. Robert Redfield acknowledged for the first time the agency’s voluntary guideline was causing “unintended harms” and that patients should only be tapered to lower doses “if a patient would like to taper.”  

“The Guideline does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm,” Redfield said. “The Guideline includes recommendations for clinicians to work with patients to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy.”

Nothing in the guideline empowers pharmacists to set dose limitations. CVS operates 9,700 pharmacies and 1,100 walk-in medical clinics nationwide

‘Mexican Oxy’ Flooding U.S. Black Market

By Pat Anson, PNN Editor

New York City police and DEA agents have announced the seizure of 20,000 counterfeit oxycodone pills made with illicit fentanyl. The pills, which have an estimated street value of $600,000, are blue in color and stamped “M” on one side and “30” on the other, making them virtually indistinguishable from prescription oxycodone.

The fentanyl pills are believed to have originated in Mexico. Known on the street as “Mexican Oxy,” the highly potent counterfeit pills are often cheaper and easier to obtain than pharmaceutical-grade oxycodone. Black market 30 mg oxycodone pills sell on the street for $9 to $30 each and are surfacing around the country.

“If you take prescription pills that did not come directly from a pharmacy, you are risking your life,” said New York City Special Narcotics Prosecutor Bridget Brennan. “Throughout New York City, we have seen a spate of cases involving tens of thousands of potentially lethal fentanyl pills masquerading as oxycodone.

“Just because black market pills have the same color and design as legitimate pills, it does not mean they are safe. The ingredients and potency are all unknown, and minuscule amounts of fentanyl can cause overdose or death. Consuming a counterfeit pill is akin to playing Russian Roulette.”

Overdose deaths in New York City are at record-high levels and fentanyl is involved in over half of them. Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine. A customer accustomed to taking oxycodone would not necessarily have the tolerance to ingest illicit fentanyl without suffering an overdose.

DEA PHOTO

DEA PHOTO

Fentanyl powder is typically produced by illicit labs in China and then smuggled into the U.S. through Mexico. The powder is transformed into tablets by pill presses purchased online and then sold by drug traffickers. Four arrests in New York were made in connection with the latest seizure.

“These arrests highlight a growing trend in illicit street drugs which increases the risk of drug overdose,” said DEA Special Agent in Charge Ray Donovan. “Traffickers are mass producing pseudo-pharmaceutical pills made of heroin, fentanyl and other illicit drugs in makeshift laboratories throughout New York City. These pills attract users because they are more convenient and less conspicuous; but users should beware because they are unregulated and lethal.”

Fentanyl Seizures at Mexican Border

Mexican Oxy is also blamed for a rash of overdoses in Arizona, where fentanyl deaths have tripled in recent years.

“It’s the worst I’ve seen in 30 years, this toll that it’s taken on families,” Doug Coleman, DEA Special Agent in Charge of Arizona told the Associated Press. “The crack (cocaine) crisis was not as bad.”  

Last month, the U.S. Border Patrol announced its biggest fentanyl seizure ever — over 250 pounds were found in a truckload of cucumbers at a border crossing in Nogales, Arizona.

Most of the fentanyl was in powder form and over two pounds were made up of pills. Together, they had the potential to kill millions of people.  

Just because black market pills have the same color and design as legitimate pills, it does not mean they are safe.
— Bridget Brennan, NYC Narcotics Prosecutor

Most of the fentanyl seized by law enforcement is found hidden inside vehicles at official border crossings around Nogales and San Diego, according to the AP. Smaller shipments of fentanyl are sent directly to the U.S. from China through the mail. The Postal Service’s Inspector General recently reported that over 90 percent of illegal online pharmacies use the mail to ship illicit drugs.

The Postal Service is prohibited from opening packages without a search warrant and is obligated to accept inbound international mail. This makes it more difficult for postal inspectors to identify and track packages suspected of containing illicit drugs. By comparison, private carriers are able to open and inspect packages and can track shipments from beginning to end.

The Inspector General recommended that Congress pass legislation that would give postal inspectors authorization to open and inspect domestic packages suspected of carrying illicit drugs.

The 7 Golden Rules of Opioid Prescribing for Patients

By Jeffrey Grolig, MD, JD, Guest Columnist  

“Don’t do it!” is the advice often given to brand new physicians about whether to specialize in pain medicine. Increasing numbers of doctors are being fined, disciplined or arrested due to scrutiny caused by the nation’s opioid crisis. Every single opioid prescription, even the mildest painkiller, is being tracked, and prescription drug database searches tell the DEA and state board investigators who to watch.  

The unfortunate innocent victims of this crisis have been those legitimate patients who suffer in chronic pain, with up to 100 million in the United States alone. Each time a physician or pharmacy is attacked, thousands of pain patients must pay the price.

A pharmacy in my northern California town recently closed after the owner was charged with 200 counts of failing to properly keep records. Each count carries a $20,000 fine.

A local physician’s license was restricted for failure to warn in writing about the risks of combining sleeping pills with opioids. This family physician had already spent $56,000 in legal fees for previous documentation lapses.

A pulmonary specialist with English as his second language was arrested for prescribing codeine-containing cough syrup to four undercover DEA agents posing as patients. He is facing 20 years in prison and $2 million in fines.   

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I still accept pain patients, but my background as an attorney compels me to use “universal precautions,” something I advise every physician who prescribes opioids to do. This boils down to following what I call “The 7 Golden Rules of Opioid Prescribing.” If you, as the patient, understand that your doctor must follow these 7 golden rules, it will make it much easier for you to obtain excellent pain management, including opioids.  

I developed the 7 golden rules by analyzing the most common documentation lapses of doctors who were disciplined or prosecuted. I included them when I wrote the “Physician Primer: Prescribe Like a Lawyer” to empower doctors to think and practice like a lawyer and not lose their careers over simple documentation errors.

If you write a cover letter like the one below to your current or prospective physician, touching on each and every one of these 7 golden rules, your pain control will vastly improve, I promise. 

Dear Doctor,

#1 I have a legitimate medical reason for needing opioids. My medical diagnosis is… (be specific: examples include diabetic neuropathy, failed spine surgery, spinal stenosis, CRPS, etc.). Attached is my MRI report (or EMG, CT, X-ray, Bone Scan, lab test, etc.) proving this.  

#2 I am not now, nor have I ever been addicted to prescription medication, illegal drugs or alcohol.   

#3 I have no depression, psychosis or bipolar disorder.  

#4 I understand all the risks of opioids and related medications, as well as my options for all non-opioid alternative treatments.  

#5 I am not taking benzodiazepines and drinking alcohol.  

#6 I have attached my last 12 months of medical records (not applicable if you have been with the same physician for one year).  

#7 These records reflect that I am an honest, compliant and responsible patient.  

Respectfully,  

Pain Patient

If you do not meet these criteria, it means you are in a higher risk category and would be better managed at a university medical center or a teaching hospital. To my knowledge, the DEA or state medical board has never raided a teaching hospital or university medical center. 

The best way a patient can signal to me they are responsible and low risk is to write a letter covering each of the 7 golden rules, attached to one year’s worth of medical records. This essentially does my work for me, and it makes it easy for me to decide whether or not to accept the patient.

If your doctor still won’t budge, hand him my free “Primer Flyer,” a pamphlet that explains risk management, that’s available on my website: ThePhysicianPrimer.com.

If all else fails, have him watch my YouTube video on The 7 Golden Rules of Opioid Prescribing for Doctors. 

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Jeffrey W. Grolig, MD, JD, is a board-certified specialist in Physical Medicine & Rehabilitation. He has taught at UC Davis Medical Center in both the departments of Family Practice and Physical Medicine & Rehabilitation. Dr. Grolig has formerly worked as a licensed attorney and has authored 6 books.

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.

Is Kratom Being Spiked With Other Drugs?

By Pat Anson, PNN Editor

It’s no secret that illicit fentanyl has become a scourge on the black market. The potent synthetic opioid – about 100 times stronger than morphine --  is now involved in over half of U.S. overdoses. Fentanyl is being found in a wide variety of street drugs, including heroin, meth, cocaine and marijuana, and it is increasingly used in the manufacture of counterfeit painkillers and other fake medications.  

“As traffickers have expanded into the sale of fentanyl-containing counterfeit pills, the scope of users who were exposed to fentanyl increased significantly; the prescription pain reliever misuser population is almost ten times that of the heroin user population,” a recent DEA report warns. “The presence of fentanyl-containing counterfeit pills in an area is increasingly associated with spikes in overdose deaths.”

Although there is no hard evidence that drug dealers are mixing fentanyl with kratom to boost its potency, some in the kratom community think it is inevitable that someone will try. There have already been cases of kratom products being adulterated with hydrocodone and other opioids.

“I don’t know that there’s been a case of fentanyl in kratom, but since that’s what they are finding in everything else and that is the most dangerous drug out there now, it stands to reason that someone who would spike kratom with hydrocodone would now spike it with fentanyl either wittingly or unwittingly,” said Jane Babin, PhD, a molecular biologist and consultant to the American Kratom Association (AKA), an advocacy group for kratom vendors and consumers.

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Like other dietary supplements, kratom products are essentially unregulated and there are little or no quality controls.

In an effort to change that, this week the AKA officially launched a good manufacturing practice (GMP) program, which will require producers of kratom products to meet strict manufacturing standards verified by a third-party auditor if they want to be certified by the AKA.  

"The AKA GMP Standards Program will help reassure the public and demonstrate to the FDA, DEA, lawmakers, and others that the kratom industry is acting responsibly," AKA president Dave Herman said in a statement. 

"The AKA GMP Standards Program will also protect kratom consumers from unscrupulous vendors who produce kratom products using sloppy manufacturing procedures that allow for contamination, and equally important the standards program will exclude vendors who deliberately adulterate kratom products to boost their effect by adding dangerous and sometimes deadly substances like fentanyl or morphine." 

In recent years, millions of Americans have discovered kratom, which has been used in southeast Asia for centuries as a natural stimulant and pain reliever. Kratom is widely available online and in smoke shops, but the quality of what’s being sold and where it comes from is often unknown – even by the people selling it.

“The stuff that’s sold as kratom in the United States cannot be reliably proven to be kratom,” Edward Boyer, MD, a Professor of Emergency Medicine at Harvard Medical School, recently told PNN.  “There is evidence to suggest that some of the kratom sold in the United States is adulterated to make it more potent, to make it more powerful.”

Boyer says some kratom products have been found to contain artificially high levels of 7-hydroxymitragynine, one of the naturally occurring alkaloids that make kratom act on opioid receptors in the brain. Manufacturers may also be lacing kratom with opioids and other drugs.

“One theory is that some unscrupulous vendors may be spiking kratom with something more potent to drive business. It may be even more prevalent than we know, which could account for some of the reports on Reddit and Blue Light (online message boards) that say kratom is addictive and it does lead to euphoria,” Babin said in an email.

A handful of states have already banned kratom and there is speculation that the DEA will soon try again to schedule it as a controlled substance, something the agency backed away from in 2016 after a public outcry. The FDA has recently mounted a public relations campaign against kratom, what the AKA calls a “shadow ban” that has led to kratom shortages.

Could the AKA’s effort to improve the quality of kratom products backfire by giving ammunition to federal regulators who want a nationwide ban?

“That kratom may be adulterated is not a reason to ban it.  There are reports all the time of dietary supplements, even ones sold by reputable companies like GNC and Vitamin Shoppe, are adulterated with prescription drugs, banned substances and who knows what else,” says Babin.

“The other thing to consider is that if kratom is banned, demand may lead to a black market.  It will likely be smuggled in and/or products not containing kratom will be sold as kratom and those may be spiked with other substances, including fentanyl.”