Illicit Fentanyl Deaths Rising at ‘Exponential Rate’

By Martha Bebinger, Kaiser Health News

Men are dying after opioid overdoses at nearly three times the rate of women in the United States. Overdose deaths are increasing faster among black and Latino Americans than among whites. And there’s an especially steep rise in the number of young adults ages 25 to 34 whose death certificates include some version of the drug fentanyl.

These findings, published in a new report by the Centers for Disease Control and Prevention, highlight the start of the third wave of the nation’s opioid epidemic. The first was prescription pain medications, such as OxyContin; then heroin, which replaced pills when they became too expensive; and now illicit fentanyl, which is often mixed with heroin or used in the production of counterfeit pills

Fentanyl is a powerful synthetic opioid that can shut down breathing in less than a minute, and its popularity in the U.S. began to surge at the end of 2013. For each of the next three years, fatal overdoses involving fentanyl doubled, “rising at an exponential rate,” said Merianne Rose Spencer, a statistician at the CDC and one of the study’s authors.

Spencer’s research shows a 113 percent average annual increase from 2013 to 2016 (when adjusted for age). That total was first reported in late 2018, but Spencer looked deeper with this report into the demographic characteristics of those people dying from fentanyl overdoses.

FENTANYL DEATHS BY QUARTER (2011 TO 2016)

FENTANYL DEATHS BY QUARTER (2011 TO 2016)

Increased trafficking of the drug and increased use are both fueling the spike in fentanyl deaths. For drug dealers, fentanyl is easier to produce than some other opioids. Unlike the poppies needed for heroin, which can be spoiled by weather or a bad harvest, fentanyl’s ingredients are easily supplied; it’s a synthetic combination of chemicals, often produced in China and packaged in Mexico, according to the U.S. Drug Enforcement Administration. And because fentanyl can be 50 times more powerful than heroin, smaller amounts translate to bigger profits.

Jon DeLena, assistant special agent in charge of the DEA’s New England Field Division, said 1 kilogram of fentanyl, driven across the southern U.S. border, can be mixed with fillers or other drugs to create 6 or 8 kilograms for sale.

“I mean, imagine that business model,” DeLena said. “If you went to any small-business owner and said, ‘Hey, I have a way to make your product eight times the product that you have now,’ there’s a tremendous windfall in there.”

For drug users, fentanyl is more likely to cause an overdose than heroin because it is so potent and because the high fades more quickly than with heroin. Drug users say they inject more frequently with fentanyl because the high doesn’t last as long — and more frequent injecting adds to the risk of overdose.

There are several ways fentanyl can wind up in a dose of some other drug. The mixing may be intentional, as a person seeks a more intense or different kind of high. It may happen as an accidental contamination, as dealers package their fentanyl and other drugs in the same place.

Or dealers may be adding fentanyl to cocaine, meth and counterfeit medication on purpose, in an effort to expand their clientele of users hooked on fentanyl.

“That’s something we have to consider,” said David Kelley, referring to the intentional addition of fentanyl to cocaine, heroin or other drugs by dealers. Kelley is deputy director of the New England High Intensity Drug Trafficking Area. “The fact that we’ve had instances where it’s been present with different drugs leads one to believe that could be a possibility.”

The picture gets more complicated, said Kelley, as dealers develop new forms of fentanyl that are even more deadly. The new CDC report shows dozens of varieties of the drug now on the streets.

The highest rates of fentanyl-involved overdose deaths were found in New England, according to the study, followed by states in the Mid-Atlantic and Upper Midwest. But fentanyl deaths had barely increased in the West — including in Hawaii and Alaska — as of the end of 2016.

Researchers have no firm explanations for these geographic differences, but some experts watching the trends have theories. One is that it’s easier to mix a few white fentanyl crystals into the powdered form of heroin that is more common in Eastern states than into the black-tar heroin that is sold more routinely in the West. Another hypothesis holds that drug cartels used New England as a test market for fentanyl because the region has a strong, long-standing market for opioids.

Spencer, the study’s main author, hopes that some of the other characteristics of the wave of fentanyl highlighted in this report will help shape the public response. Why, for example, did the influx of fentanyl increase the overdose death rate among men to nearly three times the rate of overdose deaths among women?

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Some research points to one factor: Men are more likely to use drugs alone. In the era of fentanyl, that increases a man’s chances of an overdose and death, said Ricky Bluthenthal, a professor of preventive medicine at the University of Southern California’s Keck School of Medicine.

“You have stigma around your drug use, so you hide it,” Bluthenthal said. “You use by yourself in an unsupervised setting. [If] there’s fentanyl in it, then you die.”

Traci Green, deputy director of Boston Medical Center’s Injury Prevention Center, offers some other reasons. Women are more likely to buy and use drugs with a partner, Green said. And women are more likely to call for help — including 911 — and to seek help, including treatment.

“Women go to the doctor more,” she said. “We have health issues that take us to the doctor more. So we have more opportunities to help.”

Green noted that every interaction with a health care provider is a chance to bring someone into treatment. So this finding should encourage more outreach, she said, and encourage health care providers to find more ways to connect with active drug users.

As to why fentanyl seems to be hitting blacks and Latinos disproportionately as compared with whites, Green points to the higher incarceration rates for blacks and Latinos. Those who formerly used opioids heavily face a particularly high risk of overdose when they leave jail or prison and inject fentanyl, she noted; they’ve lost their tolerance to high levels of the drugs.

There are also reports that African-Americans and Latinos are less likely to call 911 because they don’t trust first responders, and medication-based treatment may not be as available to racial minorities. Many Latinos said bilingual treatment programs are hard to find.

CDC researcher Spencer said the deaths attributed to fentanyl in her study should be seen as a minimum number — there are likely more that weren’t counted. Coroners in some states don’t test for the drug or don’t have equipment that can detect one of the dozens of new variations of fentanyl that would appear if sophisticated tests were more widely available.

There are signs the fentanyl surge continues. Kelley, with the New England High Intensity Drug Trafficking Area, notes that fentanyl seizures are rising. And in Massachusetts, one of the hardest-hit areas, state data show fentanyl present in more than 89 percent of fatal overdoses through October 2018.

Still, in one glimmer of hope, even as the number of overdoses in Massachusetts continues to rise, associated deaths dropped 4 percent last year. Many public health specialists attribute the decrease in deaths to the spreading availability of naloxone, a drug that can reverse an opioid overdose.

This story is part of a partnership that includes WBUR, NPR and Kaiser Health News.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Survey: CDC Guideline Having ‘Horrendous’ Impact on Pain Patients

By Pat Anson, PNN Editor

The CDC opioid prescribing guideline has harmed pain patients, significantly reduced their access to pain care, and forced many patients to turn to alcohol and other drugs for pain relief, according to a large new survey of over 6,000 patients and healthcare providers by Pain News Network. 

Today marks the third anniversary of the CDC guideline, which discourages the prescribing of opioid medication for chronic pain. Although voluntary and only intended for primary care physicians, the guideline has been implemented as mandatory policy by many states, insurers, pharmacies and throughout the U.S. healthcare system. The survey found many unintended consequences for both patients and providers.

Over 85 percent of patients say the guideline has made their pain and quality of life worse. And nearly half say they have considered suicide because their pain is poorly treated.

“The guidelines are affecting legitimate patients in a horrendous way while the actual addicts are just turning to street drugs,” said one pain sufferer.  “My quality of life has been so drastically reduced I attempted to take my life last year. Fortunately, I was found before I could bleed out but every single day has been an absolute struggle.”

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Over two-thirds of healthcare providers are worried about being sanctioned or prosecuted for prescribing opioids. Rather than risk going to prison, many have stopped treating pain, closed their practice or retired.

“Many of those doctors are scared to do their job, leaving patients in unnecessary pain, both acute and chronic. Tapering patients on chronic stable doses of opioids because some people abuse opioids is not just unjustified, it’s cruel and harmful,” a doctor wrote.

The PNN survey was conducted online and through social media from February 17 to March 15.  A total of 5,856 patients and 157 doctors and other healthcare providers in the U.S. participated.

Asked if the guideline is helpful or harmful, 96 percent of respondents said it has harmed pain patients — a startling verdict for an agency with a mission statement that says “CDC saves live and protects people from health threats.”

“Cannot understand or know why the CDC will not speak out on the harm done to undertreated, denied and abandoned patients,” one patient said.

“It was a criminal act. The outcome was foreseen, the guidelines were written in secret, and the carnage that we predicted has come to pass,” said an emergency medicine physician.

“They should be revoked. People are suffering and committing suicide due to inability to tolerate suffering. This is inhumane,” another provider wrote. “It blemishes CDC’s reputation.”

HAS CDC GUIDELINE BEEN HELPFUL OR HARMFUL TO PAIN PATIENTS?

Opioid Prescriptions Declining

Opioid prescriptions in the U.S. have been declining for several years and now stand at their lowest level since 2003. The drop in prescriptions appears to have accelerated since the CDC guideline was released in 2016.

Eight out of ten patients said they are being prescribed a lower dose or that their opioid prescriptions were stopped. Many indicated they were forcibly tapered off opioids without an effective alternative.

“I had my pain under control until my doctor told me he was cutting my pain meds by half,” a patient said. “He lied to me, he cut them by 85% and now I am home ridden! The CDC guidelines are a disaster to the chronic/intractable pain patients.”

“I have lost all quality of life and many days I no longer want to live with this pain,” another patient wrote. “I've never abused my meds, yet I'm being treated like a drug addict.”

“VA doctors are afraid to prescribe any opioids or narcotics, because of mandatory education courses given to all VA doctors,” a nurse with the Veterans Administration said. “The veterans are not being treated for chronic pain. Suicides have increased!”

“Our doctors should not have to choose between treating their patients in a safe meaningful way or feeling like they could lose their licenses to practice,” another patient said.

HOW HAS CDC GUIDELINE AFFECTED YOUR OPIOID PRESCRIPTIONS?

Patient Abandonment

It’s not just opioids that patients are losing access to. Nearly 9 out 10 pain patients report problems finding a doctor that’s willing to treat them. Many say they’ve been discharged or abandoned by a doctor or had problems with a pharmacy or insurer. Only a small percentage of patients have been referred to addiction treatment.

  • 73% of patients say it is harder to find a doctor

  • 15% unable to find a doctor

  • 34% abandoned or discharged by a doctor

  • 27% insurer refused to pay for a pain treatment

  • 27% pharmacy refused to fill an opioid prescription

  • 5% given a referral for addiction treatment

“As an RN in pain management I have seen decreased quality of life, increased pain and anxiety for patients. Providers fear for their license and livelihood. My staff spends HOURS on the phone trying to authorize scripts,” a nurse wrote.

“Most doctors in our area are refusing to prescribe any opioids, even the pain management doctors. This is forcing some patients to buy street drugs,” a primary care physician said.

Desperate Measures

The widespread denial of care has many patients taking desperate measures for pain relief. One in five are hoarding opioid medication because they fear losing access to the drugs. Many others are using alcohol, marijuana or the herbal supplement kratom for pain relief. A small percentage are using illicit drugs. Few have found medical treatments that work as well as prescription opioids.

  • 22% of patients hoarding opioid medication

  • 11% obtained opioid medication from family, friends or black market

  • 26% used medical marijuana for pain relief

  • 20% used alcohol for pain relief

  • 20% used kratom for pain relief

  • 4% used illegal drugs (heroin, illicit fentanyl, etc.) for pain relief

  • 2% found other treatments that work just as well or better than Rx opioids

“I know seven people personally that have gone to the streets to get pain relief. Four of them died because it was mixed with fentanyl. Two committed suicide,” one patient said.

“Since my doctor stopped prescribing even my small amount of opioids, I deal with days where I can’t even get out of bed because I hurt so much and I’m stuck turning to alcohol, excessive amounts of acetaminophen and NSAIDs,” another patient wrote. “Kratom has been the omly thing that has helped my pain.”

“I have been without a prescription for two years and have been getting medication on the street. I cannot afford this and I have no criminal history whatsoever. I have tried heroin for the first time in my life, out of desperation and thank God, did not like it. It was stronger than anything I need to help with pain,” wrote another patient.

Addiction and Overdoses Still Rising

While the guideline appears to have significantly reduced the dose and quantity of opioid prescriptions, patients and providers overwhelmingly believe it has failed to reduce opioid addiction and overdoses. Nearly 49,000 Americans died from opioid overdoses in 2017, but over half of the deaths involved illicit fentanyl or heroin, not prescription opioids.

“They are attacking the wrong problem. Pain patients are under strict scrutiny by their doctors and therefore have an addiction rate lower than the general population. The large numbers of deaths are among those who are using heroin and other illegal drugs,” one patient wrote.

“As a retired substance abuse counselor, these new guidelines do nothing to stop the real addict. It only hurts those of us in chronic pain,” said another patient.

“What happened to care for the elderly, disabled and sick?” asked one patient. “We are not the problem. The amount of prescription pain medicine has significantly gone down but the overdoses are continuing to rise. This is targeting the wrong people!”

HAS CDC GUIDELINE REDUCED OPIOID ADDICTION AND OVERDOSES?

Guideline Revisions Needed

An overwhelming majority (97%) of patients and healthcare providers believe the CDC guideline should be revised. When it released its recommendations in 2016, the agency said it was “committed to evaluating the guideline” and would make future updates “when warranted.” A CDC spokesperson recently told PNN there are several studies underway evaluating the impact of the guideline, but gave no indication that any changes are imminent.

Patients and providers say the the guideline is misunderstood, based on faulty evidence and needs revision.

“It is a falsified document created only to satisfy political pressure which demanded such a report. There is no medical/scientific evidence to support the conclusions made in the document,” a patient wrote.

“The CDC needs to correct their glaring error. They need to make sure that every doctor in America is re-educated and reassured that they can treat people with serious pain disorders without being jailed,” said another patient. “The CDC needs to stand up and admit their mistake, they need to correct the damage.”

“While the guidelines are useful, they should not have been made into mandatory rules followed by states and insurers. The patients with chronic pain issues are suffering. Can we revisit them?” asked a palliative care doctor.

SHOULD CDC GUIDELINE BE REVISED?

For more survey results and comments on the guideline, see “What Pain Patients Say About CDC Opioid Guideline” and “What Doctors Say About the CDC Opioid Guideline.”

Over 6,200 people responded to PNN’s survey. In tabulating the results, we did not include the responses of caretakers, spouses and friends of patients or those who live outside the U.S. We greatly appreciate everyone who participated and will be releasing more survey results in coming days.

The Complexity of Rx Opioid Misuse

By Roger Chriss, PNN Columnist

The misuse of prescription opioids is a complex phenomenon. Recent research has found that non-medical opioid use almost always involves a variety of other substances -- not just exposure in the course of routine medical care.

The risks of non-medical prescription opioid use developing into addiction need to be better understood to develop more effective measures to prevent misuse and to ensure that patients who use opioids responsibly are not wrongly targeted.

A new study in The American Journal on Addictions looked closely at the 2016 National Survey on Drug Use and Health, which found that that about 2.5% of respondents had misused prescription opioids in the previous 30 days. Almost half (43.9%) obtained opioid analgesics from a friend or relative for free and most were using other substances, such as cigarettes, alcohol, marijuana or street drugs.

“So much of the public discussion focuses on the opioid epidemic as though it is happening in a vacuum when, in fact, so many people misusing prescription opioids are also engaging in other substance use,” says lead author Timothy Grigsby, PhD, an assistant professor at The University of Texas at San Antonio.

“If we want to end the opioid epidemic, and stop another similar one from taking its place, then we need to consider the entire clinical picture of the patient including their use of other substances.”

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Grigsby and his colleagues found that prescription opioid and polydrug users were also more likely to engage in stealing, selling drugs, have suicidal thoughts, suffer from major depression and need substance use treatment.

A similar study recently published in the journal Pediatrics examined non-medical prescription opioid use by parents and teenagers. The study found that parental misuse of opioid analgesics was associated with teenagers doing the same, with mothers’ use having a stronger association than fathers’ use.

Parental smoking, low parental monitoring and parent-adolescent conflict were also associated with teenage prescription opioid misuse, as were adolescent smoking, marijuana use, depression, delinquency and schoolmates’ drug use.

Despite what you may have heard, non-medical prescription opioid use does not usually lead to heroin. The National Institute on Drug Abuse reports that only 4 to 6 percent of people who misuse prescription opioids transition to heroin.

But trends in this transition have been shifting. A new study in PLOS One found that people who injected illicit drugs who were born after 1980 were more likely to initiate drug use with prescription opioids and non-opioids, and had higher levels of polydrug use. This study was limited to Baltimore, but similar findings have been reported for other parts of the U.S.

Importantly, most non-medical prescription opioid use occurs in the context of more general substance use. U.S. News recently reported that most patients treated in emergency rooms for misuse of prescription medications get into trouble because they mixed different substances.

"Most of the time there may have been only one pharmaceutical involved, but there were other non-pharmaceutical substances or psychoactive drugs or alcohol involved as well. When people get into trouble with misusing medicines, they're usually taking more than one substance," Dr. Andrew Geller of the CDC told U.S. News.

This is a long-standing trend in the opioid crisis. The 2014 Overdose Fatality Report in Kentucky found that the top five drugs in drug-related deaths were morphine, cannabis, heroin, alcohol and alprazolam (Xanax), with more than one drug present in many overdoses.

Moreover, a new study in the Journal of Substance Abuse Treatment compared 2013 and 2017 data on patients seeking opioid addiction treatment. Researchers found that many patients had employment, psychiatric, alcohol and drug problems, and were more likely to have depression, anxiety, hallucinations and suicidal thoughts. In other words, the overdose crisis is far more complex and dangerous than just opioids alone.

Fortunately, these long-standing trends are now starting to be appreciated. Public and private health officials in Ohio have started looking at data from multiple sources to better address mental health and substance abuse. 

The overdose crisis is a fast-moving target that is rapidly evolving. Overdoses now more than ever involve multiple drugs, and may not even occur among people who use opioids non-medically or people who have a substance use disorder. Understanding these features of the crisis is essential for developing better responses.

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Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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.

‘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.

Are Most Retired NFL Players Really Addicts?

By Lynn Webster, MD, PNN Columnist

Many of us watched the Super Bowl on Sunday. It was a great defensive game, which means there was a lot of hard-hitting contact. Physical trauma can bring about long-term consequences and that is the subject of a recent New York Times column, "For NFL Retirees, Opioids Bring More Pain" by Ken Belson.

Belson suggests that many retired NFL players become addicted to opioid medication. I don’t know how many former players become addicted, but the summation of players he describes as addicted doesn’t quite add up.

The column cites a recent study published in the Clinical Journal of Sport Medicine that found about 26 percent of retired football players used opioid medication during the past 30 days. Belson suggests that percentage is excessive.

Of course, the players were not addicted just because they used an opioid. Moreover, 26 percent does not seem to be an unreasonable number, given that this is a population with a history of tremendous physical trauma. In fact, it seems like a surprisingly low number given that most former football players experienced enormous physical trauma for years.

Whatever the actual data may be, we can probably attribute the use or misuse of opioids to the fact that these retired players were trying to mitigate severe pain.  

What is Misuse?

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The accepted definition of opioid "misuse" is taking an opioid contrary to how it was prescribed, even if it is taken to treat pain. For example, let's say a person is told they can use one hydrocodone three times a day. If that person uses one pill six times a day so they can function (and not to get high), that is considered misusing. However, that is not a sign of addiction. It only reflects the person's desire to escape pain and the therapeutic inadequacy of the prescribed medication. 

Misuse of opioids in the general population is relatively rare, according to a large new study published in the journal Pharmacoepidemiology & Drug Safety. Over 31,000 adults were surveyed about their opioid use, and only 4.4% admitted taking a larger dose or a dose more frequently than prescribed.  

The figure below helps explain the relationships of misuse, abuse and addiction. Some retired football players may misuse their medication, but few will abuse them and even fewer will become addicted. All people with addiction abuse their medication. But people who misuse their medication may not be abusing or addicted to it.  

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In his column, Belson cites a 2011 survey by researchers at the Washington University School of Medicine that found over half of former NFL players used opioids during their playing careers and 71 percent misused them.

The same study found that many of these retired players who misused opioids were heavy drinkers. But in his column, Belson reported that "players who abused opioids” were likely to be heavy drinkers.  

Belson uses the words “misuse” and “abuse” interchangeably, as if they have the same meaning. They do not. If Belson means that retired players took opioids in excess of what their doctors prescribed due to uncontrolled pain, that would not be abuse. It would be misuse. If the players were using opioids to get high, that would be abuse. 

Belson mentions one retired player using the same amount of pain medicine as a stage 4 cancer patient and suggests that is an excessive amount. However, the player's need for that amount of opioids should not surprise us. Cancer pain is not more painful than non-cancer pain. People with painful diseases and physical injuries may have pain just as debilitating as a patient dying from cancer.

It is unfortunate, but not shocking, that a retired football player would have as much pain as someone dying of cancer. When someone who does not have cancer uses excessive medication to relieve pain, we are more likely to label that as "abuse." We show more compassion to patients with cancer pain than we do toward anyone else who requires treatment for chronic pain.  

Why We Need Clarity About Our Terms 

Belson writes, "Now, a growing number (of players) are saying the easy access to pills turned them into addicts." That is another statement that gravely concerns me. It is misleading and consistent with the common misunderstanding of what causes addiction or even what addiction is.  

Becoming dependent on opioids, becoming tolerant to opioids, requiring more opioids over time to achieve the same level of pain relief, and experiencing withdrawal if the opioids are suddenly stopped are not necessarily signs of addiction, any more than they would be if the same consequences resulted from taking a blood pressure medication or a sleep aid.  

People frequently write and talk about misuse, abuse and addiction, but many of them don't know what the terms mean.  This has troubling implications for the pain and addiction communities. Mislabeling and misdiagnosing people with addiction leads to harmful policies that adversely affect treatment. It even has legal implications that prevent people in pain or with addiction from accessing appropriate clinical care.  

Severe chronic pain and addiction can devastate lives. But we need to know the differences between misuse of, abuse of, and addiction to medications for the appropriate policies to be implemented. 

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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: What Chronic Pain Is Really Like and Why It Matters to Each of Us.”

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.

Heart Transplants Surge as Overdoses Increase

By Pat Anson, PNN Editor

One of the more ghoulish and yet beneficial aspects of the overdose crisis is that it has led to a surge in organ transplants. In 2000, only about 1 percent of organ donors were overdose victims. By 2017, when over 70,000 Americans died from drug overdoses, over 13 percent of organ donors were overdose victims.

A new study by researchers at Brigham and Women’s Hospital has documented how the number of hearts available for transplant has increased dramatically, particularly in states like Pennsylvania that have been hard hit by the overdose crisis.  

"In the U.S., the drug crisis is clearly not uniform, and neither is the rate of recovered hearts from drug-intoxication-related deaths," said lead author Mandeep Mehra, MD, the medical director of Brigham's Heart and Vascular Center.

Mehra and his colleagues analyzed CDC data on overdose deaths and from the Organ Procurement and Transplantation Network, and reported their findings in The New England Journal of Medicine.

They found major increases in drug-related deaths and organ harvesting in Pennsylvania, New York, Ohio and other Northeast states, and in Florida and Texas. Overall, the team estimated that 6.24 hearts were recovered for every 1,000 lives lost due to drug intoxication.

NEW ENGLAND JOURNAL OF MEDICINE

NEW ENGLAND JOURNAL OF MEDICINE

Among the 37,232 donors whose hearts were transplanted from 1999 through 2017, the percentage of those who died from overdoses rose from 1.5% to 17.6 percent. And as the number of hearts available for transplant grew, the waiting list for donated hearts began shrinking in 2016. According to the United Network for Organ Sharing, there are currently 45 people in the U.S. waiting for a heart transplant.

"This is a very important outcome indicating that people are now adopting organs from drug-intoxication-related deaths as a viable source for lifesaving donor organs," said Mehra. "Although we support organ donation recovery from this source, those of us in the transplant community also strongly support effective efforts to combat the drug overdose crisis. We must pursue ways to target the crisis while simultaneously looking for new ways to increase the availability of viable donor organs."

There has long been a stigma against using donated organs from overdose victims because the organs may be damaged due to reduced oxygen supply and because drug addicts are more likely to be infected with HIV, hepatitis and other communicable diseases. But those risks have been minimized with modern testing.

The United Network for Organ Sharing requires organ recipients to be made aware of the circumstances of higher risk donations, so they can decide whether or not to accept it. There are over 113,000 Americans currently waiting for an organ donation, including many who have been on the waiting list for years.

FDA: Pain Patients Dependent On Opioids Are Not Addicted

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has released new guidance to drug makers to streamline the development of buprenorphine products to treat opioid addiction. Commonly known by the brand name Suboxone, buprenorphine has long dominated the market for addiction treatment.

Of importance to pain patients is a statement about the guideline by FDA commissioner Scott Gottlieb, MD, that seeks to clarify the difference between opioid addiction and patients who need opioids for pain relief.

Gootlieb said there is still stigma and misunderstanding – even in the medical and addiction fields – about the difference between opioid addiction and dependence.

“Because of the biology of the human body, everyone who uses a meaningful dose of opioids for a modest length of time develops a physical dependence. This means that there are withdrawal symptoms after the use stops,” Gottlieb said. “A physical dependence to an opioid drug is very different than being addicted to such a medication.

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“Addiction requires the continued use of opioids despite harmful consequences on someone’s life. Addiction involves a psychological preoccupation to obtain and use opioids above and beyond a physical dependence. But someone who is physically dependent on opioids as a result of the treatment of pain but who is not craving the drugs is not addicted.”

Someone who is physically dependent on opioids as a result of the treatment of pain but who is not craving the drugs is not addicted.
— Dr. Scott Gottlieb, FDA Commissioner

In recent years new and generic formulations of buprenorphine have been released in tablets, sublingual films, injections and implants, and the FDA is trying to promote the development of more of them.

The guidance released by the agency basically tells drug makers they may be able to submit new drug applications for buprenorphine products without conducting the safety and efficacy trials that are usually required for other medications.

“The guidance we’re finalizing today is one of the many steps we’re taking to help advance the development of new treatments for opioid use disorder, and promote novel formulations or delivery mechanisms of existing drugs to better tailor available medicines to individuals’ needs,” Gottlieb said. “Our goal is to advance the development of new and better ways of treating opioid use disorder to help more Americans access successful treatments.”

There are currently only three drugs approved by the FDA for medication-assisted treatment (MAT) – buprenorphine, methadone and naltrexone. Physicians wishing to prescribe buprenorphine to patients must have a special certification from the DEA and are limited in the number of patients they can treat.

Buprenorphine is an opioid that is also used to treat pain. When combined with naloxone, buprenorphine reduces cravings for opioids and lowers the risk of abuse.

Some addicts have discovered that buprenorphine can also be used to get high or to ease their withdrawal pain from heroin and other opioids. Buprenorphine is such a popular street drug that the National Forensic Laboratory Information System ranked buprenorphine as the third most diverted opioid medication in the U.S. in 2014. 

Diarrhea Drug Involved in Growing Number of Overdoses

By Pat Anson, PNN Editor

A little over a year ago, the Food and Drug Administration asked Johnson & Johnson and other drug makers to limit the number of anti-diarrhea pills they sell. FDA commissioner Scott Gottlieb, MD, said the “unprecedented and novel action” was needed because Imodium and other over-the-counter formulations of loperamide were being abused by opioid addicts.  

A few of us guffawed at the news as another example of government regulation gone amuck.

But it turns out there is cause for concern.

Researchers at Rutgers University have documented that overdoses of loperamide have been steadily increasing in number and severity, and have even resulted in some deaths.

Their study, published in the journal Clinical Toxicology, found a growing number of people addicted to opioids who are using loperamide to prevent or self-treat withdrawal symptoms. Some are even taking massive doses to get a high similar to heroin, fentanyl or oxycodone.

The New Jersey Poison Control Center has reported several fatalities or near-fatalities from loperamide in the past 12 months.

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“When used appropriately, loperamide is a safe and effective treatment for diarrhea – but when misused in large doses, it is more toxic to the heart than other opioids which are classified under federal policy as controlled dangerous substances,” said senior author Diane Calello, MD, executive director of New Jersey Poison Control at Rutgers New Jersey Medical School.

“Overdose deaths occur not because patients stop breathing, as with other opioids, but due to irregular heartbeat and cardiac arrest.”

The researchers reviewed toxicology cases in a national poison control center database from 2011 to 2016, and found a 91 percent increase in loperamide overdoses during that time period.  In 2015 alone, there were 916 cases and two deaths.

Patients who misused loperamide were predominantly young Caucasian men and women. The majority used extremely high doses of loperamide, the equivalent of 50 to 100 two-milligram pills per day.

“Possible ways of restricting loperamide misuse include limiting the daily or monthly amount an individual could purchase, requiring retailers to keep personal information about customers, requiring photo identification for purchase and placing medication behind the counter,” Calello said. "Most importantly, consumers need to understand the very real danger of taking this medication in excessive doses."

Misuse of loperamide is concerning because it is readily available over-the-counter, undetectable in routine drug tests, and can be bought in large quantities online or in retail stores.

In 2017, the FDA added a warning label to loperamide products cautioning consumers not to ingest high doses. Some drug makers are now selling the anti-diarrhea pills in smaller packages and in blister packs that are harder to open.

How Sackler Family Built an OxyContin Fortune

By Christine Willmsen and Martha Bebinger, WBUR

The first nine months of 2013 started off as a banner year for the Sackler family, owners of the pharmaceutical company that produces OxyContin, the addictive opioid pain medication. Purdue Pharma paid the family $400 million from its profits during that time, claims a lawsuit filed by the Massachusetts attorney general.

However, when profits dropped in the fourth quarter, the family allegedly supported the company’s intense push to increase sales representatives’ visits to doctors and other prescribers.

Purdue had hired a consulting firm to help reps target “high-prescribing” doctors, including several in Massachusetts. One physician in a town south of Boston wrote an additional 167 prescriptions for OxyContin after sales representatives increased their visits, according to the latest version of the lawsuit filed in Suffolk County Superior Court in Boston.

The lawsuit claims Purdue paid members of the Sackler family more than $4 billion between 2008 and 2016. Eight members of the family who served on the board or as executives as well as several directors and officers with Purdue are named in the lawsuit.

This is the first lawsuit among hundreds of others that were previously filed across the country to charge the Sacklers with personally profiting from the harm and death of people taking the company’s opioids.

WBUR along with several other media sued Purdue Pharma to force the release of previously redacted information that was filed in the Massachusetts Superior Court case. When a judge ordered the records to be released with few, if any, redactions, Purdue filed two appeals and lost.

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The complaint filed by Massachusetts Attorney General Maura Healey says that former Purdue Pharma CEO Richard Sackler allegedly suggested the family sell the company or, if they weren’t able to find a buyer, to milk the drugmaker’s profits and “distribute more free cash flow” to themselves.

That was in 2008, one year after Purdue pleaded guilty to a felony and agreed to stop misrepresenting the addictive potential of its highly profitable painkiller, OxyContin.

At a board meeting in June 2008, the complaint says, the Sacklers voted to pay themselves $250 million. Another payment in September totaled $199 million.

The company continued to receive complaints about OxyContin similar to those that led to the 2007 guilty plea, according to unredacted documents filed in the case.

While the company settled lawsuits in 2009 totaling $2.7 million brought by family members of those who had been harmed by OxyContin throughout the country, the company amped up its marketing of the drug to physicians by spending $121.6 million on sales reps for the coming year. The Sacklers paid themselves $335 million that year.

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The lawsuit claims Sackler family members directed efforts to boost sales. An attorney for the family and other board directors is challenging the authority to make that claim in Massachusetts. A motion on jurisdiction in the case hasn’t been heard. That attorney hasn’t responded to a request for comment on the most recent allegations.

Purdue Pharma, in a statement, said the complaint filed by Healey is “part of a continuing effort to single out Purdue, blame it for the entire opioid crisis, and try the case in the court of public opinion rather than the justice system.”

Purdue went on to charge Healey with attempting to “vilify” Purdue in a complaint “riddled with demonstrably inaccurate allegations.” Purdue said it has more than 65 initiatives aimed at reducing the misuse of prescription opioids. The company says Healey fails to acknowledge that most opioid overdose deaths are currently the result of fentanyl.

Purdue fought the release of many sections of the 274-page complaint. Attorneys for the company said at a hearing on Jan. 25 that they had agreed to release much more information in Massachusetts than has been cleared by a judge overseeing hundreds of cases consolidated in Ohio. Purdue filed both state and federal appeals this week to block release of the compensation figures and other information about Purdue’s plan to expand into drugs to treat opioid addiction.

The attorney general’s complaint says that in a ploy to distance themselves from the emerging statistics and studies that showed OxyContin’s addictive characteristics, the Sacklers approved public marketing plans that labeled people hurt by opioids as “junkies” and “criminals.”

Richard Sackler allegedly wrote that Purdue should “hammer” them in every way possible.

Addiction Treatment ‘Attractive Market’

While Purdue Pharma publicly denied its opioids were addictive, internally company officials were acknowledging it and devising a plan to profit off them even more, the complaint states.

Kathe Sackler, a board member, pitched “Project Tango,” a secret plan to grow Purdue beyond providing painkillers by also providing a drug, Suboxone, to treat those addicted.

“Addictive opioids and opioid addiction are ‘naturally linked,'” she allegedly wrote in September 2014.

According to the lawsuit, Purdue staff wrote: “It is an attractive market. Large unmet need for vulnerable, underserved and stigmatized patient population suffering from substance abuse, dependence and addiction.”

They predicted that 40-60 percent of the patients buying Suboxone for the first time would relapse and have to take it again, which meant more revenue.

Purdue never went through with it, but Attorney General Healey contends this and other internal documents show the family’s greed and disregard for the welfare of patients.

This story is part of a reporting partnership between WBUR, NPR and Kaiser Health News

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Overdose Crisis Will Worsen, But Not Due to Rx Opioids

By Pat Anson, PNN Editor

The opioid crisis will “substantially worsen” in coming years and could result in the overdose deaths of over a million Americans by 2025, according to an eye-opening new study. Because most of the deaths will involve illicit opioids, researchers say limiting the supply of prescription opioids will have only a “modest” effect in reversing the trend.      

The study, published in JAMA Network Open, is based on mathematical models developed by a team of researchers at Harvard Medical School, Boston University School of Medicine, Pennsylvania State University and other academic institutions.

“Our study also highlights the changing nature of the epidemic. The opioid crisis is expected to worsen in the next decade owing to multiple factors,” said lead author Jagpreet Chhatwal, PhD, a researcher at Massachusetts General Hospital.

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“First, the number of individuals using illicit opioids is expected to increase substantially. Second, unlike historical trends where prescription opioid use has served as a path to heroin use, more people are directly initiating opioid use with illicit opioids. Third, there has been a rapid increase in illicit opioid lethality, likely mainly driven by the infiltration of the heroin supply with the highly potent synthetic opioid fentanyl.”

Under a “base-case” scenario, with the opioid crisis stabilizing by 2020, researchers project that over 700,000 Americans will die from opioid overdoses from 2016 to 2025. Nearly 80 percent of the deaths will involve fentanyl, heroin and other illicit opioids. Overdoses involving prescription opioids would decrease by about 10% during that period.

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A “pessimistic” scenario developed by researchers is even more jaw dropping. If the opioid crisis does not stabilize until 2025, they project over 1.2 million Americans will die from overdoses. Over 88% of the deaths will involve illicit opioids.

In either scenario, efforts to reduce the misuse of opioid medication, such as limiting the dose and supply of prescription opioids, will only reduce the number of overdose deaths by 3 to 5 percent.

“State and local governments have instituted several interventions aimed at preventing individuals from exposure to prescription opioids, including a recently proposed goal to lower opioid prescriptions by one-third in the coming 3 years,” said Chhatwal.

“Our study does not devalue these efforts and it is possible that their effect could improve over time, which may ultimately yield a substantial benefit in the long term. However, given the large number of individuals who have already engaged in prescription opioid misuse or illicit opioid use, our study indicates that prevention efforts, in isolation, are unlikely to have the desired level of effect on opioid overdose deaths the near term.”

The researchers say a strong, multi-pronged approach is needed to reduce overdoses, including greater scrutiny of patients for signs of opioid use disorder (OUD).

"It could include implementation of screening for OUD in all relevant health care settings, improving access to medications for OUD such as methadone and buprenorphine, increasing OUD training programs at medical and nursing schools, improving access to harm-reduction services, and controlling the supply of illicit opioids,” they concluded.

Another recent study also predicts that reducing the supply of prescription opioids will have little effect on the overdose rate and could lead to increased use of heroin.