How Long Does OxyContin Last?

By Pat Anson, Editor

The pain relieving effects of OxyContin, Purdue Pharma’s best-selling opioid painkiller, often wear off early and the company has been aware of the problem for many years, according to a lengthy investigation by the Los Angeles Times.

The Times investigation of OxyContin, which was based on court records and thousands of “confidential” Purdue documents, found that a single dose of the extended release painkiller often doesn’t last for the intended 12 hours and that it performs more like “an 8-hour drug.” That makes some patients take extra doses or stronger ones, raising the risk of abuse and addiction.

“Such results shouldn’t come as a surprise. After all, the FDA doesn’t require drugs to work as promised for all patients. What was eye-popping about The Times’ findings was how Purdue responded when doctors told them their patients weren’t getting the full 12 hours of relief promised,” The Times said in an editorial.

“Instead of recommending that such patients take OxyContin more than twice per day — which might make it less appealing than cheaper generic opioids with short durations — Purdue’s representatives told doctors to stick to the 12-hour regimen and prescribe higher-strength pills.”

Purdue quickly issued a statement rejecting The Times’ story, saying it was “short on facts.”

“In an attempt to resurrect a long-discredited theory, the paper ignores the clinical and regulatory data that directly contradicts their story,” Purdue said. “Over the course of two years, Purdue Pharma provided the LAT (Los Angeles Times) with more than a dozen hours of briefings and discussions regarding the clinical evidence supporting OxyContin’s 12-hour dosing and the regulatory requirement that we promote the product as such. Unfortunately, the paper disregarded this information, instead publishing a story that’s long on anecdote and short on facts.”

Purdue said the FDA rejected claims over a decade ago that OxyContin was misbranded as a “twice-a-day” drug and was being prescribed inappropriately.

The Times published its own rebuttal to Purdue’s statement online, which you can see by clicking here.

Pain News Network asked readers what they thought about OxyContin’s pain relieving qualities and got a mixed response.

“Worked like a dream for me, but too expensive,” wrote one patient on our Facebook page, who said she switched to generic oxycodone.

“Doesn't start working for 3 hrs. Seems like it ends at the 9th hour. Not really happy about that, but what can you do?” wrote another patient, who said she had too many side-effects from other pain medications.

“It only lasted 5-6 hours for me. Stopped taking it years ago because it was ineffective,” said another pain patient.

Since its introduction in 1996, OxyContin has reportedly generated over $31 billion in revenue for Purdue, but it also created a tainted legacy that the company is still trying to shed two decades later. Many believe OxyContin helped spark the so-called opioid “epidemic” because its sales reps initially told doctors the drug had a low risk of abuse and addiction.

In 2007, a class action lawsuit against Purdue for deceptive marketing ended with several company executives pleading guilty to a felony count of misbranding OxyContin. The company and its executives were fined $634 million.

In 2010, Purdue introduced an abuse-deterrent formula of OxyContin that makes it harder for drug abusers to crush or liquefy the tablet for snorting or injecting. Some patients have complained the new formulation isn't as effective or causes gastrointestinal problems.

Prince Sought Addiction Treatment Before Death

By Pat Anson, Editor

The late pop icon Prince was planning to meet with an addiction treatment doctor in the hours before he died in a last ditch effort to kick an addiction to opioid painkillers, according to the Minneapolis Star Tribune.

Howard Kornfeld, MD, an opioid addiction specialist in California, was called by Prince representatives the night of April 20 because Prince “was dealing with a grave medical emergency,” according to William Mauzy, a prominent Minneapolis attorney working with the Kornfeld family.

Prince’s body was found the next morning in an elevator at his Minneapolis home. An autopsy has been performed and the body cremated, but the official cause of death has not yet been released. Foul play or suicide are not suspected.

Kornfeld, who runs Recovery Without Walls, an upscale addiction treatment center in Mill Valley, California, is considered a pioneer in the use of buprenorphine to treat both addiction and chronic pain. The medication has long been sold under the brand name Suboxone, but is usually prescribed just to treat addiction.

Kornfeld was unable to meet with Prince immediately, but planned to fly to Minneapolis for “a lifesaving mission” on April 22. 

“The plan was to quickly evaluate his health and devise a treatment plan,” Mauzy told the Star Tribune, which said several other sources corroborated Mauzy’s account.

Kornfeld’s son Andrew took a red-eye flight to Minneapolis on the morning of April 21 to lay the groundwork for Prince’s treatment program with his father. He was one of three people at Prince’s Paisley Park compound when the entertainer's body was found.

Mauzy said Andrew Kornfeld was the one who called 911 because the others “were in too much shock.” Kornfeld did not know the address and could only tell the dispatcher, “We’re at Prince’s house.”

Paramedics arrived within five minutes but were unable to revive the 57-year old Prince.

Sources told the Star Tribune that painkillers were found at the scene and have become the focus of the investigation.  Investigators are trying to determine where Prince got the pills and who prescribed them.

Andrew Kornfeld reportedly had a small amount of buprenorphine to give to Prince, but it was never administered, according to Mauzy.

The Star Tribune story appears to add credence to reports in TMZ and other tabloids that Prince suffered from chronic hip pain and was addicted to opioid pain medication. Just days before his death, TMZ said Prince’s plane made an emergency landing in Moline, Illinois, where he was briefly hospitalized for an overdose of Percocet. He left against medical advice and flew back to Minneapolis a few hours later.

Survey: Painkillers Bigger Problem than Alcohol

By Pat Anson, Editor

A new poll is adding further fuel to the fire over opioid abuse and the disproportionate amount of attention it gets compared to other health problems.

The survey by the Kaiser Family Foundation found that two-thirds of Americans consider the abuse of opioid pain medication an extremely or very serious problem. And four out of ten said they knew someone who was addicted to prescription painkillers, often a close friend or family member.

The problem is so serious that more Americans now consider painkillers a bigger problem than alcohol (66% vs. 57%), even though four times as many Americans die from alcohol related causes than from opioids.

Nearly 19,000 Americans died from prescription opioids in 2014, according to the Centers for Disease Control and Prevention. The National Institutes of Health estimates 88,000 people die annually from alcohol related causes.

Alcohol misuse is also estimated by NIH to cost the U.S. economy nearly $250 billion annually, while the “economic burden” of opioid abuse was estimated by the DEA at $53 billion in 2011.   

The Kaiser Foundation poll comes in the middle of an election season, as the White House and Congress consider various funding measures to address the so-called epidemic of opioid abuse and addiction.

The survey found that a large majority of Americans believe federal and state governments, doctors, and individuals who use prescription opioids are not doing enough to fight opioid addiction. Only about a third said police officers weren’t doing enough to enforce drug laws, a sign that many Americans don’t consider opioid abuse just a law enforcement issue.

Asked which policy efforts would be very or somewhat effective in reducing opioid abuse, over eight in ten said doctors and medical students should have better training in pain management and that there should be increased access to addiction treatment programs.  Less than half said putting warning labels on prescription opioids explaining the risk of addiction would be effective. Respondents were not asked if access to opioid pain medication should be reduced.

Policies Rated Very or Somewhat Effective in Fighting Opioid Abuse

• 88% Increase pain management training
• 86% Increase access to addiction treatment
• 84% Public education and awareness programs
• 83% Increase research about pain and pain management
• 82% Monitor doctors’ prescribing habits
• 63% Encourage disposal of extra pain meds
• 60% Reduce stigma of opioid addiction
• 48% Put addiction warning labels on opioid bottles

Putting the issue in perspective, while most Americans consider painkiller abuse a serious problem, the issue ranks well behind several other health problems such as cancer, diabetes, obesity and heart disease.

Health Problems Considered Extremely or Very Serious

• 86% Cancer
• 78% Diabetes
• 74% Lack of access to mental healthcare
• 73% Obesity
• 72% Heart disease
• 71% Contaminated drinking water
• 70% Heroin abuse
• 66% Painkiller abuse
• 61% Lack of access to healthcare
• 57% Environmental contamination
• 57% Alcohol abuse
• 54% Lack of access to affordable food

The Kaiser Foundation survey was conducted in mid-April in a random telephone sample of 1,201 American adults. The poll is estimated to have a sampling error of 3 percent.

To see the complete results of the Kaiser poll, click here.

Tennessee Pain Clinics to Stop Using Opioids

By Pat Anson, Editor

One of the largest healthcare systems in Tennessee will no longer prescribe long term opioid pain medication to patients at two of its pain management clinics.

The move is the latest fallout from the prescribing guidelines released last month by the Centers for Disease for Prevention (CDC), which discourage the use of opioids for treating chronic pain. Although the CDC guidelines are voluntary and meant only for primary care physicians, many doctors around the country are adopting them and either weaning their patients off opioids or cutting them off entirely.

"This change was considered for several months in response to changing regulations and increasing national opiate addiction rates, and we began notifying physicians and patients of this decision in early April," Jerry Askew, Tennova Healthcare’s vice president of external relations said in a statement.

Tennova Healthcare is managed by the Sisters of Mercy, an organization of Roman Catholic nuns. Tennova operates a chain of 17 hospitals in Tennessee, but its new opioid policy only applies to patients at two pain clinics affiliated with Tennova hospitals in Knoxville and Turkey Creek.  

“After 30 days of your receipt of this letter, we no longer plan to provide long-term opiate pain medication to our patients,” Tennova said in a letter to patients.

“While pain medication therapy is widely used, non-opiate alternatives can be equally effective and can be generally safer for the patients who use them. The Center in Knoxville will continue to provide effective and compassionate treatment with non-opiate options including non-opioid pain medications, interventional procedures such as injections and radiofrequency ablations; referral to neurology and spine specialists; physical and aquatic therapy; weight loss strategies; acupuncture; massage therapy; and lifestyle counseling programs.”

But many of those alternative treatments do not work and are not covered by insurance, according to a recent survey of over 2,000 patients by Pain News Network and the International Pain Foundation. Three out of four patients said over-the-counter pain relievers did not help them at all and over half said non-opioid prescription drugs like Lyrica and Cymbalta are also ineffective.   

Tennessee has one of the highest rates of opioid abuse in the country. The state took a series of steps last year to limit opioid prescribing, such as requiring pharmacies to limit opioids to a 30 day supply and requiring doctors at pain clinics to regularly give patients urine drug tests.

"The bottom line is that fewer opioid prescriptions are being written and fewer Tennesseans are experiencing the downside and disastrous consequences of a painkiller addiction," said Douglas Varney, commissioner of the Department of Mental Health and Substance Abuse Services. "We are succeeding in reducing the number of prescriptions being written. We have helped more people into treatment and recovery and rallied a new generation of Tennesseans to live a life free of addiction."

But patient advocates say the crackdown on painkillers is unfairly focused on pain sufferers, not on the addicts who abuse opioid medication.

“I am seeing literally hundreds of reports from people who are being denied renewal of opioid meds which work well for them and are frequently the only medical treatments that give them any quality of life. Doctors are giving up their pain management practices for fear of prosecution by the DEA,” said Richard Lawhern, PhD, who became an advocate after his wife developed trigeminal neuralgia, a chronic facial pain disorder.

“I am convinced that the CDC guidelines are creating what we will later recognize to be a wave of patient suicides due to resurgent pain and hopelessness, as well as a surge in patients seeking out street drugs because they cannot function without pain relief and are being forced by their doctors to do so.”

In recent weeks, at least 14 people died and dozens were hospitalized in California after ingesting counterfeit pain medication made with illicit fentanyl, a powerful and deadly analgesic. Some of the victims were pain patients. Fake pain pills are being sold by dealers in the Sacramento and San Francisco Bay areas, and have also been intercepted at the California-Mexico border.

Counterfeit Pain Pills Spread in California

By Pat Anson, Editor

At least seven people in the San Francisco Bay Area sought medical help after ingesting counterfeit pain medication laced with fentanyl, according to a new report from the Centers for Disease Control and Prevention (CDC).  The cases were reported in Contra Costa, Alameda, San Francisco and Santa Clara counties.

The fake pills were disguised to look like Norco, a widely prescribed opioid pain medication that combines hydrocodone with acetaminophen.

The pills are similar to counterfeit medication blamed in recent weeks for 14 fatal overdoses in the Sacramento area, except that they contain promethazine, an antihistamine that acts as a sedative and is sometimes used to boost the “high” from illicit opioids.

At least one of the fake tablets was also found to contain cocaine.

california poison control system

The CDC said all of the Bay Area patients had symptoms of opioid intoxication, but recovered within 24 hours. The pills were obtained from friends or bought off the street.  The outbreak lasted about two weeks, from March 25 to April 5, but was not publicly reported until today. There was no explanation for the three week delay in reporting what the CDC considers a "serious public health threat."

“The distribution of counterfeit medications, especially those containing fentanyl, is an emerging and serious public health threat,” the CDC said. “Efforts to identify the source of the current counterfeiting are ongoing. Patients with signs and symptoms of acute opioid overdose including central nervous system and respiratory depression, and in whom larger doses of naloxone are required to reverse symptoms, should raise suspicion for intoxication with a counterfeit product containing fentanyl.”

The CDC calls opioid abuse “the fastest-growing drug problem in the United States” and has often blamed that trend on prescription pain medication. However, as Pain News Network has reported, prescriptions for most opioids have actually been in decline for several years, especially for hydrocodone, at a time when opioid overdose deaths are rising.

Illicit fentanyl is a dangerous and sometime deadly opioid that is 50 times more potent than morphine. It has been blamed for thousands of overdose deaths in the U.S. and Canada. Last year, the DEA issued a nationwide public health alert for acetyl fentanyl, a synthetic opioid produced by illegal drug labs in China and Mexico. Acetyl fentanyl is virtually identical to prescription fentanyl, a Schedule II controlled substance that is often used in patches to treat more severe forms of chronic pain.

Acetyl fentanyl typically is mixed with heroin and cocaine to make the drugs more potent, but is increasingly showing up in pill form – usually disguised as pain medication.

In February, a smuggler was caught with nearly 1,200 fake oxycodone pills at the California-Mexico border, the first time counterfeit pain medication made with fentanyl was seized at a border crossing in California.

In March, the DEA arrested four men in southern California who were operating four large pill presses to make counterfeit hydrocodone and Xanax, an anti-anxiety medication. At least two people died in Orange county late last year after ingesting fake Xanax made with fentanyl. Counterfeit medication has also recently been reported in Florida and Ohio.

Last month the CDC adopted guidelines that discourage primary care physicians from prescribing opioids for chronic pain. Several pain patients have told PNN recently that their doctors are now reducing their opioid doses or cutting them off entirely.

“Since the guidelines changed, my quality of life has been destroyed & relentless suffering has become my identity,” wrote a pain patient who said she lost access to the opioid medication she’s been using for pain relief for a dozen years.

“I never considered using drugs for anything other than what & how they were prescribed. I can't say the thought of seeking relief from constant suffering hasn't flirted with the possibility of something a little less legal, or regulated. The fact that I've considered something so obscene makes me sick, but the fact that my healthcare providers were forced to allow me to suffer & reach such a point of desperation is disgusting.”

In a survey of over 2,000 pain patients last fall by Pain News Network and the International Pain Foundation, 60 percent predicted patients would get opioids off the street or through other sources if the CDC guidelines were adopted. Another 70% said use of heroin and illegal drugs would increase.

Will CDC Opioid Guidelines Help Reduce Overdoses?

By Lynn Webster, MD, Guest Columnist

Politicians and some government officials tell us that the new CDC opioid guidelines will reduce deaths due to overdoses. But, based on the evidence we’ve seen so far, that is unlikely.

The latest CDC report shows a continual increase in opioid-related overdose deaths despite about a 25% decrease in the number of opioids prescribed.  This data demonstrates that an absolute reduction in opioid prescribing hasn’t resulted in the intended outcome – so far, at least. It may be counter-intuitive, but I think you’ll understand why in a moment.

The problem is more complex than the lawmakers, CDC, and regulators would have us believe. Simply reducing the amount of opioids prescribed will not necessarily affect overdose death rates as you might expect. In fact, it might do just the opposite.

What happens is that, when we reduce the amount of opioids that are prescribed, we force many of those with opioid addictions to switch to illegal opioids such as heroin and synthetic fentanyl, which are far more dangerous than prescription opioids.

If the amount of opioid prescribing were reduced dramatically, it would likely reduce the number of deaths from prescription opioids. But there would almost certainly be a significant increase in abuse of other drugs. That could result in more overdoses than we’re seeing now. We’ve already seen more deaths due to the increased use of heroin, but heroin is only one of many illegal drugs that can be abused.

Reducing the supply side of the addiction problem does not address the demand for opioids, nor does it help address the needs of people with the disease of addiction.

Of course, additional “collateral harm” can occur with people in pain who benefit from opioids, and it is unacceptable to any person with compassion. Denying prescriptions to people who have been benefiting from opioids is a misguided attempt to save the lives of people with opioid addictions at the expense of people with pain.

People with pain will suffer, and that suffering won’t save the lives of people with addictions who turn to illegal substances. Additionally, in all likelihood, we will see an increase in suicides from people who just cannot live with their level of pain.

There are about 104 suicides per day (compared to 44 opioid-related overdoses per day). In my opinion, intractable pain is a contributing factor in many of these suicides. I suspect that, as we see more and more people denied opioids for their pain, we will see an increase in the number of suicides. I base this on my experience of seeing many patients commit suicide in my practice despite having access to all of the available treatments.

Severe pain is not always compatible with choosing to live.

Reducing deaths related to over-prescribing opioids would be a good thing and must be a priority. But, if we want to reduce the amount of opioids prescribed for people in pain, then we must provide them another, safer way to handle their pain.

Trading opioid-related deaths for either death related to illegal drugs or to suicides because of pain, is not an acceptable solution. We need something better to offer people in pain, and we need it soon.

Lynn R. Webster, MD, is past President of the American Academy of Pain Medicine, Vice President of scientific affairs at PRA Health Sciences, and the author of “The Painful Truth.”

This column is republished with permission from Dr. Webster’s blog.

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

FDA Nearing Decision on Drug Implant

By Pat Anson, Editor 

The U.S. Food and Drug Administration is expected to finally make a decision next month on a new drug delivery system to treat opioid addiction – an implant that could also be used someday to treat pain and other chronic illnesses that require steady doses of medication.

The latest results from a Phase 3 double blind study of a buprenorphine implant called Probuphine would appear to boost its chances of winning FDA approval. Titan Pharmaceuticals (NASDAQ: TTNP) said over 85% of the patients who had the implant for six months abstained from using illicit opioids, compared to about 72% of patients who used oral buprenorphine film strips that were taken daily.

The study findings were recently presented at the annual meeting of the American Society of Addiction Medicine in San Francisco.

"This was the first head-to-head comparison study of Probuphine and sublingual buprenorphine, demonstrating the efficacy of a long-acting six month buprenorphine implant," said lead investigator Richard Rosenthal, MD, Professor of Psychiatry and Medical Director of Addiction Psychiatry at the Icahn School of Medicine at Mount Sinai. “If approved, Probuphine could help expand access to medication to treat opioid use disorders, providing people with a new option."

titan pharmaceuticals image

Probuphine is about the size of a matchstick and is implanted under the skin. For six months it delivers a steady dose of buprenorphine, a weaker acting opioid that’s long been used as an addiction treatment drug sold under the brand name Suboxone.

There are many advantages to an implant. The dosage is controlled and there’s little risk of abuse, diversion or overdose. Users also never have to remember to take a pill.

Probuphine’s path to the marketplace has been rocky at times. Titan and its partner, Braeburn Pharmaceuticals, were stunned in 2013 when the FDA denied approval of the implant and asked for a new clinical study proving Probuphine’s effectiveness.  

Positive results from a Phase 3 trial were submitted in 2015 and in January of this year an FDA advisory committee voted 12 to 5 in favor of approving the implant. But then the agency added another delay by extending its decision date to May 27.  

The time may be ripe for approval this time around, as the FDA is under intense political pressure to do more to address the nation's opioid abuse epidemic. The Obama administration has proposed a rule change that would double the number of patients that a doctor can treat with buprenophine from 100 to 200. And Congress is considering funding proposals that would allocate another $1 billion to the war on drugs, with most of the money spent on addiction treatment.

Probuphine was developed using a patented implant technology called ProNeura, which is designed to provide continuous levels of medication in the blood. Titan is also developing implants to treat Parkinson’s disease and hypothyroidism, and its CEO told Pain News Network in a recent interview that ProNeura could also potentially be used to deliver pain medication.

“Clinical studies will need to be done to establish the ability, but the drug levels can certainly be delivered that are going to be beneficial for treating chronic pain,” said Titan CEO and President Sunil Bhonsle. “There are many applications for this technology and I think the medical community is now more in tune with looking at long-term delivery technology in the chronic disease setting.”

Pain and Addiction Should Be Treated Separately

By Emily Ullrich, Columnist

Once again, the lack of humanity, honesty, and desire to provide quality pain care to patients on the part of doctors, hospitals, and medical and government organizations has astounded me.

Andrew Kolodny, MD, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), whose name seems to be six degrees of separation from all movements to thwart proper pain care, has submitted a petition asking Medicare to stop requiring hospitals to survey patients about the quality of their pain management.

A group of U.S. senators has gone even further, introducing the PROP Act in Congress, which would prevent Medicare by law from making "any assessments" of pain in hospitalized patients.

As I and others have written, pain is not merely discomfort. It is unhealthy and can even be life-threatening. If a patient is left in severe, unattended pain during a hospital stay, their acute pain can become chronic, triggering a host of other medical problems, such as high blood pressure, impaired immune function, ulcers, rashes, anxiety and depression. So, reporting one’s pain care while hospitalized is essential to the outcome of healing.

But, according to Kolodny and others who signed his petition, asking patients about their pain care leads to “dangerous pain control practices” and “aggressive opioid use.”

My question is, since patient surveys have contained pain evaluating questions for years, where is the evidence that doctors have over-medicated patients so their hospitals will have satisfactory survey ratings?

My guess is there is none. I have been hospitalized and suffered untreated or undertreated pain many times. I not only filled out surveys, but called hospital administrators, wrote the Joint Commission for hospital accreditation, and more, and STILL received sub-par pain care from doctors.

I am not alone. A recent survey of over 1,200 patients by Pain News Network and the International Pain Foundation found that over half rated the quality of their pain care in hospitals as either poor or very poor.

My next question is why doesn’t Kolodny want people to know about our pain? I suspect I know the answer.

As mentioned earlier, Kolodny can be traced back to nearly every movement to intervene in the proper medication of pain patients. In addition to running PROP, he is chief medical officer for the addiction treatment chain Phoenix House, and seemingly has an elaborate plan to have every patient on opioids be treated as an “addict.”  

This brings me to one final question. Why doesn’t any major American media outlet look into the conspicuous ulterior motives of Kolodny, PROP and Phoenix House? I am not much on conspiracy theories, but at this point I am compelled to say there might be something there, but our government and society are already so brainwashed to associate pain with addiction that no media outlet will touch it. Not to mention the political funding and special interest groups that also have a stake in this.

It all boils down to money. Healthcare in this country is treating pain on a financial hierarchy. The Obama administration has bought into the CDC guidelines on opioid prescribing, and the passing of the PROP Act will only further the notion that pain and addiction are one in the same.

Despite what we are being told, pain and addiction are two different issues, which need to be addressed separately. If this havoc wreaking discrimination continues, there will be no such thing as pain care left in this country.

Emily Ullrich suffers from Complex Regional Pain Syndrome (CRPS), Sphincter of Oddi Dysfunction, Carpal Tunnel Syndrome, Endometriosis,  Interstitial Cystitis, migraines, fibromyalgia, osteoarthritis, anxiety, insomnia, bursitis, depression, multiple chemical sensitivity, and chronic pancreatitis

Emily is a writer, artist, filmmaker, and has even been an occasional stand-up comedian. She now focuses on patient advocacy for the International Pain Foundation, as she is able.

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.

U.N. Report: War on Drugs a Failure

By Pat Anson, Editor

The international war on drugs has been a costly failure that has created a “public health and human rights crisis,” according to a new report commissioned by the United Nations, which is meeting in special session this week to discuss global drug policy.

The 54-page report by the Johns Hopkins–Lancet Commission on Drug Policy and Health found that many drug policies are based on ideas about drug use and dependence that “are not scientifically grounded” and have been particularly harmful to pain patients.

The commission estimates that about 5.5 billion people worldwide do not have adequate access to controlled drugs for the management of pain. 

“Inequity of access to controlled drugs for pain management and other clinical uses is now a public health and human rights crisis,” the report found. “Yet the obligation to prevent abuse of controlled substances has received far more attention than the obligation to ensure their adequate availability for medical and scientific purposes, and this has resulted in countries adopting laws and regulations that consistently and severely impede accessibility of controlled medicines.”

The commission said there were many “myths and exaggerations” about opioid use that have stigmatized people who use the drugs. And rather than lowering the risk of abuse and addiction, drug prohibition was making the problem worse by forcing some people to turn to the streets for opioids.

“Prohibition creates unregulated illegal markets in which it is impossible to control the presence of adulterants in street drugs, which add to overdose risk,” the commission said. “The idea that all drug use is dangerous and evil has led to enforcement-heavy policies and has made it difficult to see potentially dangerous drugs in the same light as potentially dangerous foods, tobacco, and alcohol.”

Four mothers who lost their children to drugs have been invited by the Canadian government to attend the U.N. assembly on drug policy. One of them is Jennifer Woodside of Vancouver, whose 21-year son Dylan died of an overdose two years ago after he took a pill he thought was oxycodone, but was actually laced with illicit fentanyl.

 “This is a big epidemic,” Woodside told The Globe and Mail. “I think we’ve got our head in the sand if you think it can’t affect you.”

“The war on drugs has been a war on our families,” said Lorna Thomas, who also lost a son to an overdose of oxycodone and will attend the U.N. conference. “The starting point for it, that we were going to punish people out of using drugs has failed. People will continue to use drugs and we need to acknowledge that reality and keep people safe.”

As Pain News Network has reported, counterfeit pain medications laced with fentanyl began appearing in the U.S. this year and are blamed for a dozen overdose deaths in California and Florida. Coincidentally, the fake pain pills appeared just as the Centers for Disease Control and Prevention (CDC) finalized new guidelines that discourage primary care physicians from prescribing opioids for chronic pain.  Many patients fear losing access to opioids because of the guidelines.

“These CDC guidelines are brand spanking new. I think it’s hard to draw any sort of conclusions from that,” said Rusty Payne, a spokesman for the Drug Enforcement Administration. “I don’t think the Mexican cartels are paying one lick of attention to what the CDC guidelines are. What they see are thousands and thousands of addicts that they can push a product on, whether it be heroin or now fentanyl. And introducing it in pill form is just another way to make a lot of money."

The U.N. report on drug policy recommends decriminalizing nonviolent drug offenses and phasing out the use of military forces to enforce drug laws.

“Policies meant to prohibit or greatly suppress drugs present a paradox. They are portrayed and defended vigorously by many policy makers as necessary to preserve public health and safety, and yet the evidence suggests that they have contributed directly and indirectly to lethal violence, communicable disease transmission, discrimination, forced displacement, unnecessary physical pain, and the undermining of people’s right to health,” the report concludes.

The president of Columbia, which has long been on the front lines of the war on drugs, will urge the U.N. to radically change drug policies.

"Vested with the moral authority of leading the nation that has carried the heaviest burden in the global war on drugs, I can tell you without hesitation that the time has come for the world to transit into a different approach in its drug policy," President Juan Manuel Santos wrote in a column published in The Guardian.       

"No other nation has had to endure the terrible effects of the world drug problem in such magnitude and over such extended period of time as Colombia. The international community can rest assured that, when we call for a new approach, we are not giving up on confronting the problem; we are moved by the aim of finding a more effective, lasting and human solution."

Fake Oxycodone Seized at US-Mexican Border

By Pat Anson, Editor

Federal prosecutors this week filed charges against an alleged smuggler caught at the California-Mexico border with nearly 1,200 fake oxycodone pills, the latest sign that Mexican drug cartels are targeting pain patients in the U.S.

The pills were made with illicit fentanyl, a synthetic opioid that is 50 to 100 times more potent than morphine and can be lethal in very small doses. Counterfeit fentanyl pills are blamed for 11 deaths and dozens of overdoses in recent weeks in the Sacramento area, where they were disguised to look like Norco pain medication. Some of the victims were patients who sought painkillers on the street because they couldn’t obtain them legally.

Fake oxycodone, Percocet and Xanax pills have also been appearing in Florida, where they are blamed for at least one death.

19-year old Sergio Linyuntang Mendoza Bohon of Tijuana, Mexico was arrested at the Otay Mesa port of entry on February 10. Border patrol agents became suspicious when they saw “an unnatural looking bulge” in his underwear.

A search turned up 1,183 tablets labeled as oxycodone and 5.4 grams of powdered fentanyl. Laboratory tests later determined the pills were made with fentanyl, not oxycodone.

“This investigation involves the first interdiction of counterfeit oxycodone pills containing fentanyl that were smuggled from Mexico into the U.S. at the local ports of entry,” said Dave Shaw, special agent in charge for Homeland Security in San Diego.

FILE PHOTO of otay mesa border crossing

“While this time we’ve successfully prevented a potentially deadly drug from reaching the streets, we face an uphill battle stemming from the rapidly growing demand for pharmaceutical painkillers on the black market.”

Last year, the DEA issued a nationwide public health alert for acetyl fentanyl, a synthetic opioid produced by illegal drug labs in China and Mexico. Acetyl fentanyl is virtually identical to fentanyl, a Schedule II controlled substance that is often used in patches to treat more severe forms of chronic pain.

Acetyl fentanyl has been blamed for thousands of overdose deaths in the U.S. and Canada. It typically is mixed with heroin and cocaine to make the drugs more potent, but is now showing up in pill form – sometimes disguised as pain medication.

“These criminals are putting fentanyl into fake pills and passing them off as legitimate prescription medications.  Fentanyl is extremely powerful and can very easily lead to overdose deaths,” said William Sherman, DEA Special Agent in Charge.

“Unsuspecting individuals who illegally purchase oxycodone could potentially die from the ingestion of what turns out to be fentanyl tablets,” said U.S. Attorney Laura Duffy. “We are very concerned that these counterfeit pills could cause serious harm to users. Even miniscule amounts of fentanyl can have devastating consequences for those who abuse it or literally even touch it.”

Bohon faces up to 20 years in prison if convicted of unlawfully importing a controlled substance. His next court appearance is scheduled for May 2.

Public Health Emergency in Canada

British Columbia this week became the first province in Canada to declare a public health emergency due to a spike in fentanyl overdoses. Health officials say 201 overdose deaths were recorded in the first three months of 2016. 

Counterfeit fentanyl pills disguised as oxycodone started appearing in Canada about two years ago, where they are often called “greenies” when sold on the street.

ROYAL CANADIAN MOUNTED POLICE photo

“When it's mixed into these tablets it's highly variable from one to the next. So an individual who uses a pill they bought off the street that contains fentanyl may crush up a tablet, inject it and be fine but with the next one they do they may overdose.” Dr. Matthew Young, a substance abuse epidemiologist in Ottowa, told Vancouver Metro.

Like the United States, Canada has a serious problem with opioid abuse and addiction. Young says efforts to reduce opioid prescribing may have contributed to the current wave of fentanyl overdoses.

“That also created a market where organized crime stepped in and started selling these counterfeit tablets containing fentanyl,” he said.

PROP Leads New Effort to Silence Pain Patients

By Pat Anson, Editor

Physicians for Responsible Opioid Prescribing (PROP) has joined in the lobbying effort to stop asking hospital patients about the quality of their pain care.

In a petition to the Centers for Medicare and Medicaid Services (CMS), PROP founder and Executive Director Andrew Kolodny calls on the agency to stop requiring hospitals to survey patients about their pain care because it encourages “aggressive opioid use.” PROP is funded and operated by Phoenix House, which runs a chain of addiction treatment centers, and Kolodny is its chief medical officer.

“Medication is not the only way to manage pain and should not be over-emphasized. Setting unrealistic expectations for pain relief can lead to dissatisfaction with care even when best efforts have been made to resolve pain. Aggressive management of pain should not be equated with quality healthcare,” Kolodny wrote in the petition on PROP stationary, which is co-signed by dozens of addiction treatment specialists, healthcare officials, consumer advocates and PROP board members.

The same group signed a letter, also on PROP stationary, to The Joint Commission (TJC) that accredits hospitals and healthcare organizations, asking it to change its pain management standards.

“The Pain Management Standards foster dangerous pain control practices, the endpoint of which is often the inappropriate provision of opioids with disastrous adverse consequences for individuals, families and communities. To help stem the opioid addiction epidemic, we request that TJC reexamine these Standards immediately,” the letter states.

Medicare has a funding formula that requires hospitals to prove they provide good care through a patient satisfaction survey known as the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS).  The formula rewards hospitals that are rated highly by patients, while penalizing those that are not. 

The petition asks that these three questions be removed from the survey:

During this hospital stay, did you need medicine for pain?

During this hospital stay, how often was your pain well controlled?

During this hospital stay, how often did the hospital staff do everything they could to help you with your pain?

As Pain News Network has reported, 26 U.S. senators and the Americans College of Emergency Physicians have sent similar letters to Medicare asking that the pain questions by dropped from the survey. A recently introduced bill in the U.S. Senate called the PROP Act of 2016 would also amend the Social Security Act to remove "any assessments" of pain in hospitalized patients.

The PROP-led petition cites a 2013 study that found opioid pain medication was prescribed to over half of the non-surgical patients admitted to nearly 300 U.S. hospitals.

“Pain management is obviously an important part of patient care and we’ve always acknowledged that. But the problem here is that one should not have financial incentives and that’s essentially what happens through the CMS survey,” said Dr. Michael Carome of the consumer advocacy group Public Citizen, who co-signed the petition.

“The way the CMS survey and Joint Commission standards have driven the focus on pain has overemphasized its importance. We’re not saying don’t assess it at all, we’re saying the survey and standards have done more harm than good,” Carome told Pain News Network.

A top Medicare official recently wrote an article in JAMA defending the CMS survey.

"It has been alleged that, in pursuit of better patient responses and higher reimbursement, HCAHPS compels clinicians to prescribe prescription opioids. However, there is no empirical evidence that failing to prescribe opioids lowers a hospital’s HCAHPS scores," wrote Lemeneh Tefera, MD, Centers for Medicare & Medicaid Services. “Nothing in the survey suggests that opioids are a preferred way to control pain.”

Before joining Phoenix House in 2013, Kolodny was Chairman of Psychiatry at Maimonides Medical Center in New York City, a hospital that was given a one-star rating by patients in the CMS survey.   Only 61 percent of the patients said their pain was "always" well controlled at Maimonides and 11 percent said their pain was "sometimes" or "never" controlled. Only 59% of the patients said they would recommend Maimonides, compared to a national average for hospitals of 71 percent.

PROP has long been active in lobbying federal agencies to rein in the prescribing of opioids. It recently had some major successes in achieving its goals.

Five PROP board members helped draft the opioid prescribing guidelines released by the Centers for Disease Control and Prevention, which discourage primary care physicians from prescribing opioids for chronic pain. 

The Obama administration also recently asked Congress for over a billion dollars in additional funding to fight opioid abuse, with most of the money earmarked for addiction treatment programs such as those offered by Phoenix House, which operates a chain of addiction treatment clinics. A proposed rule would also double the number of patients that physicians can treat with buprenorphine, an addiction treatment drug. 

According to OpenSecrets, Phoenix House spent over a million dollars on lobbying from 2006-2012.  PROP calls itself “a program of the Phoenix House Foundation” on its website.     

PNN and the International Pain Foundation recently conducted a survey of over 1,250 pain patients and found that over half rated the quality of their pain treatment in hospitals as poor or very poor. Over 80 percent said hospital staffs are not adequately trained in pain management. Nine out of ten patients also said they should be asked about their pain care in hospital satisfaction surveys.

Canada: Abuse Deterrent Opioids Too Expensive

By Pat Anson, Editor

At a time when the U.S. Food and Drug Administration is actively promoting the development of more opioid pain medication with abuse deterrent formulas (ADFs), Canada is saying the drugs are too expensive and will have “little to no effect” in the fight against opioid abuse and addiction.

Health Canada last week rejected a proposed regulation that would require all medications containing the painkiller oxycodone to have tamper resistant properties.  ADFs generally make it harder for drug abusers to crush or liquefy opioids so they can be snorted or injected.

“(After) a review of the latest scientific evidence, the department has concluded that this specific regulatory approach, requiring tamper-resistance, would not have had the intended health and safety impact,” Health Canada said in a statement.

“Specifically, requiring tamper-resistant properties on all legitimate preparations of controlled-release oxycodone would have served to eliminate certain lower cost drugs from the market, increasing costs for patients and the health system, while having little to no effect in the fight against problematic opioid use.”

Like the United States, Canada has a severe and growing drug problem. According to the World Health Organization, Canada consumes more opioid painkillers per capita than any other country.

But Health Canada recently told drug makers to conduct more research demonstrating that ADFs do not change the safety and effectiveness of drugs. Until those studies are completed, the agency said it would rely on programs educating patients and prescribers about the safe use of opioids.

Purdue Pharma Canada released a statement saying it was disappointed in Health Canada’s decision and asked Health Minister Jane Philpott to reconsider.

“We continue to believe products with features designed to deter misuse, abuse and diversion, can and do have a positive impact on public health, based on the abundance of published evidence,” Purdue said in a statement. The company also urged Canada to “align with the FDA” by moving to require ADFs “across the entire class of opioids.”

In 2010, Purdue's OxyContin became the first opioid to be reformulated to make it harder for addicts to crush or liquefy. Since then, four other ADF opioids have been approved by the FDA and drug makers have spent hundreds of millions of dollars developing new formulas to make opioids even harder to abuse. Last month the FDA issued draft guidance encouraging drug makers to develop generic versions of opioids with ADF.

A major issue that has slowed the use of opioids with ADF is their cost. According to the Healthcare Bluebook, a website that estimates the market price of medications, the fair price for a 60-day supply of OxyContin 20mg in southern California is $352. A 60-day generic version of oxycodone -- without abuse deterrence -- retails for as little as $138.

Many health insurers have been reluctant to pay the extra cost of ADF.  A recent study found that only a third of Medicare Part D plans cover OxyContin and in many cases prior authorization is needed. Oxycodone, however, is covered by all Medicare Part D plans and prior authorization is rarely required.

Another recent study found that over a quarter of patients admitted to drug treatment facilities in the U.S. were still abusing OxyContin, five years after it was reformulated.

Fentanyl ‘Death Pills’ Spreading Coast-to-Coast

By Pat Anson, Editor

Law enforcement officials are warning that counterfeit pain and anxiety medications laced with illicit fentanyl have started appearing in Florida, where they are blamed for at least one overdose death.

The pills in Florida are disguised to look like oxycodone, Percocet or Xanax, but are actually made with fentanyl, a powerful and dangerous drug 50 times more potent than morphine. Similar counterfeit pills, made to look like Norco hydrocodone medication, are blamed for at least ten deaths and dozens of overdoses in the Sacramento, California area in recent weeks.

“I've had one of these so called super Norco’s,” said David, a 25-year old father of two, who started using street drugs for back pain.  “I only took a half just in case because of the news from the day and luckily I did. It was unlike any high I've had. It made me dizzy.  I couldn't see straight or sleep.”

As Pain News Network has reported, some of the victims in California are pain patients like David who sought opioid medication on the street because they can no longer get it prescribed legally.

"The people who have overdosed are not typically drug addicts," Olivia Kasirye of the Sacramento County health department told Agency France-Presse. “Many of the individuals said at one time or another they had a prescription and either they didn't get it refilled or the doctor said they didn't need it anymore."

Florida "Death Pills"

fake fentanyl pills disguised as norco

"It is here, it is deadly and it will continue to grow in our community,” said Danny Banks of the Florida Department of Law Enforcement in the Orlando Sentinel.

“If you are dependent upon or if you are experimenting with prescription painkillers, please make sure you are getting those painkillers from a licensed pharmacy. I cannot assure you right now, if you are buying prescription painkillers from either the black market or on the street, I cannot assure that they will not be laced with a deadly concoction that contains fentanyl. And it will kill you.”

In many cases, Banks said, neither buyers or sellers know the so-called “death pills” contain fentanyl.  He said fentanyl-laced pain pills have been seized in Osceola and Brevard counties, and have been linked to at least one fatality.

Florida’s Pinellas County Sheriff's Office has attributed nine recent fentanyl deaths to a batch of fake Xanax, an anxiety medication.

DEA Sees No Link to CDC Guidelines

In recent years, Illicit fentanyl has been blamed for thousands of overdose deaths. It is usually produced in China and then imported by Mexican drug cartels, which often mix fentanyl with heroin or cocaine before smuggling it into the U.S. The recent appearance of fentanyl in counterfeit pills is an ominous sign that drug dealers could now be targeting patients as customers, not just addicts.

But a DEA spokesman in Washington, DC disputes that notion.

“I don’t think you’re seeing that at all,” says the DEA’s Rusty Payne. “They’re going after anybody who will buy the product. By and large they are reaching hard-core addicts.”

Payne also sees no connection between the fake fentanyl pills and the recent adoption of the CDC’s opioid guidelines, which discourage primary care physicians from prescribing opioids for chronic pain. Many patients fear losing access to opioids because of the guidelines.

“These CDC guidelines are brand spanking new. I think it’s hard to draw any sort of conclusions from that,” Payne told PNN. “I don’t think the Mexican cartels are paying one lick of attention to what the CDC guidelines are. What they see are thousands and thousands of addicts that they can push a product on, whether it be heroin or now fentanyl. And introducing it in pill form is just another way to make a lot of money."

In a survey of over 2,000 pain patients last fall by Pain News Network and the International Pain Foundation, 60 percent predicted patients would get opioids off the street or through other sources if the CDC guidelines were adopted. Another 70% said use of heroin and illegal drugs would increase.

According to a story in STAT, drug cartels are now shipping machinery into the U.S. that can manufacture pills, allowing dealers to mass produce fentanyl in pill form. In March, the DEA arrested four men in southern California who were operating four large presses to make counterfeit hydrocodone and Xanax pills.

Recently the Royal Canadian Mounted Police arrested 14 people in British Columbia, seizing firearms, diamonds, cash and about a thousand fentanyl pills.

A Brush with Death and Fake Pain Pills

By Pat Anson, Editor

At least ten deaths and 42 overdoses have now been blamed on counterfeit pain pills in the Sacramento, California area.

The pills are disguised as Norco – the brand name of a common hydrocodone medication – but they are actually made with illicit fentanyl, a dangerous and sometimes deadly drug that is 50 times more potent than morphine.      

One of those fatal overdoses could have easily been a 25-year year old father of two, who we’ll call “David” to protect his identity.

“I've had one of these so called super Norcos,” says David.  “It had the markings of a regular prescription, M367. I only took a half just in case because of the news from the day and luckily I did. It was unlike any high I've had. It made me dizzy.  I couldn't see straight or sleep.”

It’s not just street addicts who are being victimized by the fentanyl scam. Many are pain patients like David who turned to the black market for relief when they could no longer get opioid prescriptions legally.

David suffered a herniated disc several years ago. He was prescribed morphine for his pain and took it three times a day for six months before being abruptly cut off by his doctor. 

counterfeit norco pills

“I tried everything to get more and more prescription drugs prescribed. After that I had no choice but to turn to the street. It's a huge problem here in Sacramento,” David told Pain News Network.

“Ever since middle school and high school I recall the widespread use of opiates and heroin. But now there is such a high demand for the pills because of the increased regulations on them and not being able to scam an early refill. It has caused the price to spike on the streets and as soon as the word gets out someone has them they are immediately sold for ridiculous prices. It’s not all addicts and not all pain patients. The doctors around here are cutting people down on the amount they are prescribed, causing them to have nowhere else to turn but the neighborhood dealer.”

After three years of buying street drugs, David knew he had a problem and entered a treatment program, where he was prescribed Suboxone, an opioid medication that’s widely used to treat addiction. The treatment worked well for several months, but then his health insurance with Covered California lapsed and he missed a re-enrollment period. David could no longer get treatment.

“The withdrawal from that (Suboxone) was about 3 weeks and felt like it was getting worse, so I really felt as if I had no choice but to ease the pain by once again turning to the streets to feel better. I told myself I'd only do it for a month then that turned into two months, now it's going on seven and I can't stop,” said David. “I got the Norco from a friend who is usually prescribed oxycodone but had run out and he too was forced to go out and find something to get him through till his refill was due.”

David bought 16 Norco pills for $5 each, not knowing he was actually getting fentanyl.

“Adding fentanyl of course to the Norco makes it much more powerful and deadly at the same time,” says John Burke, a former drug investigator for the Cincinnati Police Department who is now president of the International Health Facility Diversion Association. “Dealers brag about the potency of their products, and even brag when someone overdoses or even dies as proof of superior product. Screwed up thought process, but nevertheless that’s the world of illicit drug dealing.”

Burke says the counterfeit Norco most likely came from Mexico, where drug cartels manufacture fentanyl before smuggling it into the United States. Usually the fentanyl is mixed with heroin or cocaine to boost their potency. By disguising fentanyl as a legitimate pain medication, the dealers are tapping into a large and growing black market for opioids sought by addicts and pain patients.

“Putting fentanyl in pill form makes it less of a problem in hiding and transporting the drugs,” says Burke. “These pills probably bring more money, especially when the testimonials roll in as to how potent they are. Their drive is their bottom line.”

The bottom line for David is that he nearly overdosed and could have died. For the sake of his children, he’s gotten rid of the remaining Norco pills and is hoping to wean himself off opioids.

“I'm starting to taper myself down. I have to, this pill scare is enough to scare someone that has a lot to lose like myself,” he said.

DEA Warns of Fake Fentanyl Pain Pills

By Pat Anson, Editor

In the wake of nine deaths and dozens of overdoses in the Sacramento, California area in recent weeks, the U.S. Drug Enforcement Administration has issued a public safety alert about illicit fentanyl being disguised as opioid pain medication and sold on the black market.

Fentanyl is a synthetic opioid that is 50 to 100 times more potent than morphine and can be lethal in very small doses. Fentanyl is available by prescription to treat more severe types of chronic pain, but illicitly manufactured fentanyl is fast becoming a scourge across the U.S. and is blamed for thousands of fatal overdoses.

White fentanyl powder is usually mixed with heroin or cocaine to give those drugs an extra kick, but in Sacramento the drug was disguised as counterfeit Norco pills, a legal opioid pain medication that combines hydrocodone with acetaminophen.

“Public Health and Law Enforcement officials believe that the pills containing Fentanyl were likely sold on the street under the guise of being legitimate hydrocodone.  Additionally, the pills are marked to mimic the authentic hydrocodone product. However, the Sacramento County Department of Health and Human Services reports that test results show that some of the tested pills did not contain hydrocodone, but rather fentanyl,” the DEA said in a statement. 

IMAGE OF COUNTERFEIT NORCO

“The DEA urges the public not to take a prescription drug unless prescribed by your own physician and obtained from a reputable pharmacy."

One of the overdose victims in California was David Alfaro, a 53-year old man who suffered chronic pain from a leg injury, according to a report by KCRA-TV.

"He bought what he thought was Norco, and it ended up being fentanyl -- and it killed him," said Marinda Conway, Alfaro’s common law wife. "He wasn't a heroin addict that was looking to substitute his addiction by buying street pills. He wasn't an opioid addict by any means.”

Conway said a single fake Norco pill was enough to kill Alfaro, although autopsy results are pending.

"This has been my fear with the new CDC guidelines that more people with pain will have less access to prescription medications; therefore taking matters into their own hands, self-medicating with medications bought on the street," said Paul Gileno, president of U.S. Pain Foundation, referring to recently adopted government guidelines that discourage primary care physicians from prescribing opioids for chronic pain.

"The CDC never thought about the unintended consequences from limiting access to legitimate patients needing care whose clinicians now feel unable to prescribe or treat appropriately. My worst nightmare is the possible repercussions looming in the future due to these hindering guidelines," Gileno said.

In a survey last fall of over 2,000 pain patients by Pain News Network,  70 percent predicted that use of heroin and other illegal drugs would increase if the CDC guidelines were adopted.

The DEA says illicit fentanyl is primarily manufactured in Mexico and China before being smuggled into the U.S. Because of the nature of the drug, it’s impossible to tell if fentanyl was prescribed legally and used for medical reasons or manufactured illegally and used recreationally. The CDC admits many fentanyl overdoses may have been misclassified as deaths caused by prescription painkillers.