Counterfeit Pill Lab Exposed in BBC Report  

By Pat Anson, PNN Editor

Counterfeit prescription drugs have emerged as a worldwide problem – from fake “Mexican Oxy” sold in United States to bogus cancer drugs recently found in Turkey, Argentina and Switzerland.

This week a chilling BBC documentary took viewers inside a dingy underground lab in the UK where counterfeit Xanax pills are made – often laced with illicit fentanyl and other dangerous chemicals.

One dealer bragged to BBC reporter Livvy Haydock that he could make 42,000 Xanax pills in three hours.

"I import the raw ingredients and chemicals needed and then I press the tablets with a tablet press machine,” he said.

"I've been doing this for many years and I've never been at the point where I can produce and supply enough to meet the demand for my product. I'm always turning away customers.”

BBC ‘INSIDE BRITAIN’S BLACK MARKET”

BBC ‘INSIDE BRITAIN’S BLACK MARKET”

The fake anti-anxiety pills are manufactured in a converted cement mixer and tested on volunteer “guinea pigs” before being sold on the street, often to teenagers.

"They're taking that risk, they're paying the money. I'll make it and I'll do it as best as I can and I'll give a good service and provide a good product and the rest is on them," the dealer said.

He boasted that overworked customs officials send him warning letters when his shipments are seized, but they rarely tell police.

"I've had plenty of packages stopped from customs to addresses. A lot of the time you just receive a letter saying it's been seized,” he explained. “"They don't really follow it up. Sometimes they do, but the majority of the time they don't.”

A similar problem exists in the United States, where the Postal Service processes and delivers nearly half of the world’s mail. Postal inspectors can’t even open suspicious packages without a search warrant.

“Drug traffickers have familiarized themselves with and exploited vulnerabilities in the Postal Service network,” a recent Inspector General report warned. “Individuals can now order nearly any type of illicit drug online and have it delivered to a location of their choosing, all from the comfort of their own home.

“These illicit purchases often rely on mail shipment companies, including the Postal Service, to deliver products to customers as they provide greater opportunities for anonymity than other delivery options, such as human couriers.”

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

According to the World Health Organization, the counterfeit drug market is worth $200 billion worldwide, with almost half of the fake and low-quality medicines sold in Africa. Up to 300,000 people may die from pneumonia and malaria every year due to substandard medications primarily made in China, India, Pakistan and the United Kingdom.

‘Benzo Crisis’ Keeps Not Happening

By Roger Chriss, PNN Columnist

A new study published in The Journal of Clinical Psychiatry has found that the misuse and abuse of benzodiazepine is relatively rare, even though the drug is sometimes hyped as the next overdose crisis in healthcare.

Benzodiazepines – often called “benzos” -- are a class of sedative that includes Valium and Xanax. The medications are usually prescribed to treat anxiety and insomnia.

Data on over 100,000 adults in the 2015-16 National Surveys on Drug Use and Health was analyzed by researchers, who found that benzodiazepines were used by 12.5% of American adults. Of those, about 17% “misused” the drug at least once, but only 2% had what was diagnosed as a benzodiazepine use disorder.

The study found several risk factors for benzo misuse, including younger age, male gender, lower levels of education, lack of health insurance or employment, and lower income levels — factors often associated with other substance use disorders.

Benzos-1024x576.jpg

The National Institute on Drug Abuse (NIDA) recently reported that most misusers obtained benzodiazepines from friends or relatives, with only about 20% receiving them from their doctor.

These findings, both the statistics and the specific risks factors and usage patterns, run counter to inflammatory media headlines such as “Xanax, Valium looking like America's next drug crisis” or “Benzodiazepines: our other prescription drug epidemic.”  

Instead, benzodiazepines are better viewed as part of an ongoing problem of drug abuse and addiction that primarily occurs outside of medical care. They are a factor in many drug overdoses, partly because of increasing rates of counterfeit Xanax and Valium being contaminated with illicit fentanyl, and because overdose rates increase when benzodiazepines are combined with opioids or alcohol.

Until recently, benzodiazepines were commonly co-prescribed with opioids to chronic pain patients, a practice that is now strongly discouraged by regulators and insurers.

There are indeed risks with benzodiazepines, including not only sedation and somnolence, but also cognitive effects and worsening of psychiatric symptoms. Moreover, chronic benzodiazepine use can lead to physiologic dependence independent of any abuse or addiction, and this dependence can make tapering off benzodiazepines difficult. Benzodiazepine withdrawal syndrome is sufficiently important to merit extensive treatment in the online guide known as the Ashton Manual.

But there are also benefits in using these drugs, even for long-term therapy. For instance, REM sleep behavior disorder is a sleep disorder in which people act out vivid, unpleasant dreams with violent arm and leg movements, often harming themselves or bed partners in the process. The benzodiazepine clonazepam (Klonopin) is the traditional choice for treatment for that. 

Stiff person syndrome is a rare neurological disorder involving intense muscle spasms in the limbs and trunk. The benzodiazepine diazepam (Valium) helps reduce those muscle spasms and stiffness.

There are also intriguing novel uses for benzodiazepines as well. Some researchers are investigating low-dose benzodiazepine therapy for people with treatment-resistant obsessive-compulsive disorder (OCD). This is not the cuddly version of OCD seen in TV shows like “Monk” but crippling dysfunction that renders a person incapable of leaving their bed for days at a stretch.

Benzodiazepines need careful consideration, but not a hyped crisis. In a reference to the opioid crisis, NIDA director Nora Volkow, MD, told Opioid Watch: “As always, science should be the driver of smart policies designed to reverse the course of this crisis.”

The same wisdom should be applied to all medications.

Roger Chriss.jpg

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.

Chronic Pain and Depression Common in Overdoses

By Pat Anson, Editor

People who die from opioid overdoses are significantly more likely to suffer from chronic pain and depression, according to a new study that highlights the risk of combining opioid pain relievers with benzodiazepines, a class of anti-anxiety medication.

Researchers at Columbia University Medical Center analyzed over 13,000 overdose deaths among Medicaid patients and found that over 61 percent had been diagnosed with back pain, headaches or some other chronic pain condition. Many also suffered from depression, anxiety, bipolar disorder, schizophrenia and other mental health problems.

Significantly, nearly half of those with chronic pain (49%) filled a prescription for opioid pain medication during the last 30 days of their lives, and just over half (52%) filled a prescription for benzodiazepines. Prescriptions for anti-depressants, anti-psychotics and mood stabilizers were also common.

“This medication combination is known to increase the risk of respiratory depression, which is the unusually slow and shallow breathing that is the primary cause of death in most fatal opioid overdoses," said Mark Olfson, MD, a professor of psychiatry at Columbia and lead investigator of the study.

bigstock-Young-Blond-Woman-With-Medicin-12068330.jpg

“Most persons with opioid-related fatalities were diagnosed with one or more chronic pain condition in the last year of life. As compared to people with opioid-related deaths without diagnosed chronic pain conditions, the decedents with chronic pain diagnoses were more likely to have also received substance use and other mental health disorder diagnoses. They were also more likely to have filled prescriptions for opioids, benzodiazepines, and other psychotropic medications and to have had a nonfatal drug overdose.”

The Columbia study included opioid overdoses linked to both pain medication and illegal opioids such as heroin, but was limited to Medicaid patients who died between 2001 and 2007. Since that time, opioid prescribing has declined, while illegal opioids and counterfeit medication have become increasingly available on the black market.

Public health officials have only recently started warning about the risks of combining opioids with benzodiazepines, and some insurers now refuse to pay for the medications when they are prescribed jointly.

A recent study of overdose deaths in Florida found that benzodiazepines such as Xanax and Valium killed nearly twice as many Floridians in 2016 as oxycodone. Another study in Pennsylvania also found that overdose deaths involving benzodiazepines exceeded those from opioid painkillers.

The Columbia study was published online in the American Journal of Psychiatry. The study was funded by the Agency for Healthcare Research and Quality, the National Institute on Drug Abuse, and the New York Psychiatric Institute.

Florida’s Deadliest Rx Drug is Not a Painkiller

By Pat Anson, Editor

A new report from Florida’s Medical Examiners Commission is debunking a popular myth about the overdose crisis.

The most deadly prescription drugs in the state are not opioid painkillers, but benzodiazepines – a class of anti-anxiety medication that includes Xanax (alprazolam) and Valium (diazepam).  Xanax alone killed more Floridians last year (813) than oxycodone (723).

The medical examiners analyzed toxicology and autopsy results for 11,910 people who died in Florida in 2016, noting not only what drugs were present at the time of death, but which drug actually caused the deaths.

The distinction is important and more accurate than the death certificate (ICD) codes often used by the CDC, which merely list the drugs that were present. Critics have long contended that CDC researchers cherry pick ICD data to inflate the number of deaths "involving" or "linked" to opioid medication, in some cases counting the same death twice.   

000090094.jpg

Florida made an effort to get the numbers right.

“Florida’s medical examiners were asked to distinguish between the drugs determined to be the cause of death and those drugs that were present in the body at the time of death. A drug is indicated as the cause of death only when, after examining all evidence, the autopsy, and toxicology results, the medical examiner determines the drug played a causal role in the death,” the report explains.  “A decedent often is found to have multiple drugs listed as present; these are drug occurrences and are not equivalent to deaths.”

The five drugs found most frequently in Florida overdoses were alcohol, benzodiazepines, cocaine, cannabinoids and morphine. The medical examiners noted that heroin rapidly metabolizes into morphine, which probably led to a substantial over-reporting of morphine-related deaths, as well as a significant under-reporting of heroin-related deaths.

Benzodiazepines also played a prominent role as the cause of death, finishing second behind cocaine as the drug most likely to kill someone.  Benzodiazepines were responsible for almost twice as many deaths in Florida in 2016 than oxycodone. Like opioids, benzodiazepines can slow respiration and cause someone to stop breathing if they take too many pills.

DRUG CAUSED DEATHS IN FLORIDA (2016)

Source: Florida Medical Examiners Commission

As in other states, deaths caused by cocaine, heroin and illicit fentanyl have soared in Florida in recent years. In just one year, the number of overdose deaths there jumped 22 percent from 2015 to 2016.

"We don't talk about it much now there's the opioid crisis, but cocaine and alcohol are still a huge issue, there are still a lot of deaths due to those things," Florida addiction treatment director Dustin Perry told the Pensacola News Journal.

Florida is not an outlier. Several other states are also using toxicology reports to improve their analysis of drugs involved in overdose deaths and getting similar findings.  In Massachusetts, deaths linked to illicit fentanyl, benzodiazepines, heroin and cocaine vastly outnumber deaths involving opioid medication.  Prescription opioids were present in only 16 percent of the overdose deaths in Massachusetts during the second quarter of 2017.

SOURCE: MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

SOURCE: MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

Although it is becoming clear that many different types of drugs -- opioids and non-opioids -- are fueling the nation’s overdose crisis, politicians, the media and public health officials still insist on calling it an “opioid epidemic” or an “opioid crisis” -- diverting attention and resources away from other drugs that are just as dangerous when abused.  We never hear about a Xanax epidemic or a Valium crisis.

President Trump's opioid commission recognized the need to improve drug overdose data when it released its final report this month.

"The Commission recommends the Federal Government work with the states to develop and implement standardized rigorous drug testing procedures, forensic methods, and use of appropriate toxicology instrumentation in the investigation of drug-related deaths. We do not have sufficiently accurate and systematic data from medical examiners around the country to determine overdose deaths, both in their cause and the actual number of deaths,” the commission found.

How Chronic Pain Killed My Husband

By Meredith Lawrence, Guest Columnist

So much has been written about the opioid epidemic, but so little seems to be out there about what living with true chronic pain is like. My husband, Jay, lived and died in incredible pain at the age of 58.  As his wife, I lived that journey with him. 

Jay is no longer here to tell his story, but I want the world to see what I saw.  I want you to know how he went from working 60 hours a week doing hard physical labor, until his pain grew worse and he could not even get out of a chair on his own. 

I want you to know the deterioration Jay went through over the last ten years. I want you to know what a good day and a bad day is like when you live with chronic pain.  I want you to know exactly what happened when the doctor decreased his pain medication. And I want you to know how my husband finally made the decision to commit suicide. 

I want people to understand that when chronic pain runs your life, eventually you just want the pain to stop. 

First a bit of history.  I met Jay in 2005, when we both stopped drinking.  Two years later, Jay began to lose feeling in his legs and started having falls, as a result of compressed nerves in his spine. The pain was so bad Jay had to stop working and go on disability, which started his depressive episodes.

JAY LAWRENCE

JAY LAWRENCE

Jay had a series of lower back and neck fusion surgeries.  This was when he was first prescribed painkillers, antidepressants and anti-anxiety medications.  From 2008 to 2011, Jay tried various treatments to control the pain that lingered even after a third back surgery.  These included steroid shots, nerve blocks and a spinal cord stimulator.  Ultimately he had a drug pump implanted that delivered morphine, in addition to the pain pills he was being prescribed.

In 2012, Jay was diagnosed with trauma induced dementia.  I believe that diagnosis was right, based on his symptoms, but not all of the doctors agreed.  Some believed the confusion was due to high doses of morphine and/or his sleep apnea.  

By 2016, Jay’s confusion and memory issues were increasing. He was on a steady dose of 120mg morphine daily, in addition to the medication he was receiving from his pain pump. 

Jay’s depression seemed to come and go, depending on the day and his pain levels.  He was weaned down on his Xanax to 2mg a day to help him sleep. He was aware of the risks of combining Xanax and morphine. 

JAY AND MEREDITH LAWRENCE

JAY AND MEREDITH LAWRENCE

Let me tell you what a good day was like before they changed his medications. I worked a full time job from 2 pm to 10 pm five days a week. I would get home, and Jay would have my coffee ready for me at night.  We would stay up and watch TV until 2 or so.  When it was time for sleep, I went to bed and he slept in his recliner.

We started sleeping apart after his first surgery in 2007. He was more comfortable sitting up in the chair, but could never sleep more than three hours at a time.  He knew sleeping in bed would just keep me awake. 

A good day always meant it was not cold or raining.  On a good morning, he would be up first and get coffee started.  He would take our two miniature pinchers outside in the yard on their leash for potty time. 

We usually had at least one appointment a week, but if not we could have a nice quiet morning.  That meant coffee in front of the TV.  After a couple of hours of that, he might switch over to playing his computer games, but he was never far from his chair. 

A typical adventure for us would involve going to Walmart.  Jay was not able to walk through the store, but he hated using the handicapped carts. I could always see a look on his face when he had to do it.  After going to the store, we might have lunch or an early dinner at Steak n Shake or Cracker Barrel.  It always needed to be some place familiar and comfortable for him.  More than once we sat, ordered and then took our food home because he was in too much pain. 

In the summer we might walk the dogs after dinner.  Just a quick two block walk, but a lot of times he would have to stop halfway and go back home.  A couple of times I had to go get the car and pick him up because his legs just would not support him anymore. 

A bad day was awful for me to watch, and absolutely horrible for Jay to live. It meant no real sleep, just catnaps in the chair whenever he could.  He always made coffee for us, but on a bad day he would forget to add coffee to the coffee maker and we would just have hot water.  The pain was so much he was just distracted. 

On many bad days, I would look over and see tears just running down his face because he was in so much pain.  It also made Jay’s depression worse.  We spent many cold winter nights talking about how much pain would be too much and would make life not worth living.  It is the most horrible feeling in this whole world to hear the person you love most talk about ending their life. 

In January, 2017 Jay’s pain clinic decided they could no longer prescribe the high doses of morphine he was on.  In addition, they were not going to continue seeing him if he decided to stay on Xanax.  The Xanax was prescribed by another doctor, but they did not care.

I begged the pain doctor -- yes, literally begged -- for some other option. The doctor said that if Jay continued the Xanax he would no longer see him.  He would not give another option for medications, and at one point even said that most of his patients with pain were “making it up.”

The last thing the doctor said to us will stick with me forever.  He said, “My patient’s quality of life is not worth losing my practice over.”

When we left that day, we were barely in the car and I knew what Jay was going to say to me.  I will never forget how sad his voice was when he told me this was it for him. He was not going to continue to live like this.

IMG_1909.jpg

Through the month of February, as Jay’s medication was decreased, we spent time doing things we did not normally do.  We went out on Valentine’s Day, he bought me the first jewelry he had bought since my engagement ring, and we went out to a fancy restaurant for dinner.  Jay tried to cram in as many good memories as he could into that last month, but I knew it was costing him.

Jay’s next doctor’s appointment was scheduled for March 2, and we knew they were going to decrease his medications again.  The night before, he woke me up to tell me it was time.  I knew what that meant, but I tried to be strong for his sake.  We talked all night long about what it meant, and how it should be.  It was the saddest, strangest, longest night of my life. 

Jay knew he did not have enough pills to kill himself.  He also knew that if he were to try and purchase a gun, they would not sell it to him.  It would have been almost obvious what he was going to use it for. 

In the end, I bought the gun that Jay used -- and yes, we talked about the ramifications of that action.  We went to the park where we had renewed our vows in 2015.  We talked in the car for a while, and then we sat in the same place we had cut our wedding cake.  I was holding his hand when he pulled the trigger. .

Through the shock and horror, my immediate feeling was one of relief for Jay. To know that he was finally out of pain was a weight lifted off both of us.

Because I purchased the gun that Jay used to end his life, I was charged under our state's assisted suicide law.  This charge was later reduced to reckless endangerment, and I am currently on probation. People close to me want me to be quiet about my role in Jay’s death, and I was at first. But I cannot continue that way. 

I know Jay wanted me to put his story out there.  I know he wanted people to know what it was like to live with the pain he lived with daily. When the doctor took away Jay’s medications, they took away his quality of life. That was what led to his decision. Jay fought hard to live with his pain for a long time, but in the end fighting just was not enough. 

Something has to be done to wake up the doctors, insurers and regulators to make them see pain patients as real people. People with husbands, wives and children that love them.  People that are suffering and just barely holding on. 

suicide hotline.png

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

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

Utah Raid Uncovered Large Fentanyl Pill Ring

By Pat Anson, Editor

A drug bust in a Utah home last November has uncovered one of the largest counterfeit pill operations in U.S. history.

This week a federal grand jury in Salt Lake City indicted six individuals for manufacturing nearly 500,000 pills laced with illicit fentanyl that were disguised to look like the painkiller oxycodone and the anti-anxiety drug alprazolam (Xanax). The counterfeit pills were distributed throughout Utah and the United States to customers who ordered them online.

Fentanyl is a powerful synthetic opioid that it is 100 times more potent than morphine and 50 times more potent than heroin. In recent years, illicit fentanyl has been blamed for thousands of overdose deaths in the U.S. and Canada.

“What we feared and hoped somehow would stay away has arrived in spades,” said Brian Besser, the DEA’s agent in charge in Utah. “Fentanyl is as dangerous as it gets.”

According to documents filed in federal court, the pill ring was created by Aaron Shamo and Drew Crandall, both Utah residents who worked together at eBay, but quickly grew to include the other conspirators. Prosecutors say the defendants purchased pill presses, dies and stamps so the counterfeit pill markings would match those of legitimate pharmaceutical drugs. Some items were purchased legally and others, such as fentanyl and alprazolam, were illegally imported from China

The fake pills were sold on a “dark net online store” at a significant profit. Once sold, Shamo and Crandall used their co-conspirators to package the pills and ship them to customers. In less than a year, the operation mailed 5,606 drug orders totaling $2.8 million, according to court documents.

“Shamo’s customer base was extremely comprehensive and widespread, touching every corner of the United States,” Besser said. “It touched large cities and rural communities.”

The round blue tablets manufactured by the pill ring were offered for sale online as oxycodone 30mg tablets. The tablets were debossed with “A 215” on the bisected side, with an “M” on one side and a “30” above the bisect on the other side. The indictment alleges the defendants did not use oxycodone at all in the manufacturing process, but instead used illicit fentanyl.

Federal agents arrested Shamo last November. During a raid on Shamo’s suburban Salt Lake City home, agents discovered a pill press capable of manufacturing several thousand pills an hour. Agents also seized 70,000 pills and $1.2 million in cash stuffed in garbage bags.

Crandall fled to Australia with his girlfriend and was in Laos when agents raided Shamo’s house. He was arrested last month in Hawaii. A summons will be issued for the other four conspirators for their initial appearances in federal court.

Anti-Anxiety Meds Raise Risk of Opioid Overdose

By Pat Anson, Editor

Taking opioid painkillers with benzodiazepines – a class of anti-anxiety medication that includes Xanax and Valium – significantly raises the risk of an emergency room visit or hospital admission for an overdose, according to a large new study.

Opioids and benzodiazepines are both central nervous system depressants that can cause sleepiness, respiratory depression, coma and death. Nearly 30% of fatal overdoses in the U.S. linked to opioids also involve benzodiazepines.

Researchers at Stanford University School of Medicine analyzed private insurance claims for over 315,000 people prescribed opioids from 2001 to 2013.

In 2001, they found that 9 percent of opioid users also received a prescription for a benzodiazepine. By 2013, the co-prescribing rate nearly doubled to 17 percent.

Their study, published in The BMJ, found that use of both drugs was associated with a substantially higher risk of an emergency room visit or inpatient admission for opioid overdose.

“We found that opioid users who concurrently used benzodiazepines were at an increased risk of opioid overdose and that eliminating concurrent benzodiazepine/opioid use could reduce the risk of opioid overdose by 15%,” wrote lead author Eric Sun, MD, an assistant professor at Stanford University School of Medicine.

“Providers should exercise caution in prescribing opioids for patients who are already using benzodiazepines (or vice versa), even in a non-chronic setting. Indeed, we note that the association between concurrent benzodiazepine/opioid use and the risk of opioid overdose was broadly similar for both intermittent and chronic opioid users.”

The Food and Drug Administration recently expanded the warning labels on opioids and sedatives because of the risk of overdose. Insurance companies are also actively discouraging doctors from prescribing the two together..

A recent study by the Centers for Disease Control and Prevention ranked Xanax (alprazolam) as the fourth deadliest drug in the United States, while Valium (diazepam) was ranked tenth. Xanax was involved in about a quarter of the overdoses involving opioid pain medication.